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THE FEDERAL REGISTER

THE DAILY JOURNAL OF THE UNITED STATES GOVERNMENT

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LEGAL STATUS

RULE

DISPOSAL OF CONTROLLED SUBSTANCES

A Rule by the Drug Enforcement Administration on 09/09/2014

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DOCUMENT DETAILS

Information about this document as published in the Federal Register.

Printed version: PDF Publication Date: 09/09/2014 Agencies: Drug Enforcement
Administration Document Type: Rule Document Citation: 79 FR 53519 Page:
53519-53570 (52 pages) CFR: 21 CFR 1300 21 CFR 1301 21 CFR 1304 21 CFR 1305 21
CFR 1307 21 CFR 1317 Agency/Docket Number: Docket No. DEA-316 RIN: 1117-AB18
Document Number: 2014-20926

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* AGENCY:
* ACTION:
* SUMMARY:
* DATES:
* FOR FURTHER INFORMATION CONTACT:
* SUPPLEMENTARY INFORMATION:
* Outline
* I. Executive Summary
* A. Purpose of the Regulatory Action
* B. Summary of the Major Provisions of the Regulatory Action
* Ultimate User Disposal
* DEA Registrant Disposal
* Reverse Distributors
* Return and Recall
* Methods of Destruction
* C. Summary of the Changes in the Final Rule
* Authorized Collectors
* Long-Term Care Facilities (LTCFs)
* Destruction
* Practitioner Physical Security
* Other Changes to the Final Rule
* II. Background and Legal Authority
* III. Discussion of Comments
* A. Support for the Proposed Rule (1 Issue)
* B. Definitions and Terms 6 (12 Issues)
* C. Types of Entities That May Operate a Collection Program (9 Issues)
* D. Locations Where Authorized Collectors May Maintain Collection
Receptacles or Host Take-Back Events (1 Issue)
* E. Registration Requirements for Authorized Collectors (5 Issues)
* F. Law Enforcement (7 Issues)
* G. Collection Receptacle Design, Inner Liners, Placement, and Security (24
Issues)
* Clarification of Terms
* Collection Receptacle Design
* Collection Receptacle Inner Liners
* Collection Receptacle Placement and Safety
* H. Mail-Back Programs (11 Issues)
* I. Take-Back Events (6 Issues)
* J. Prohibition on Handling, Sorting, and Inventorying Inner Liner Contents
and Mail-Back Package Contents (8 Issues)
* K. Long-Term Care Facilities (LTCFs) (21 Issues)
* Definitions and Terms Specific to LTCFs
* Registration of Collection Receptacles at LTCFs
* Disposal Methods and Procedures at LTCFs
* Collection Receptacle Maintenance at LTCFs
* Security at LTCFs
* Other Concerns Regarding LTCF Drug Disposal
* L. Disposing on Behalf of Ultimate Users (Other Than Residents of LTCFs)
(3 Issues)
* M. Registrant Return, Recall, and Transfer (3 Issues)
* N. Destruction (19 Issues)
* Non-Retrievable Destruction Standard
* Incineration and Chemical Digestion Destruction Methods
* On-Site Destruction Methods
* Other Destruction-Related Concerns
* O. Economic Concerns (18 Issues)
* Continuation of Existing Programs
* Two Employee Requirement
* Implementation Costs
* Funding and Incentives
* Other Economic Concerns
* P. Recordkeeping and Reporting (8 Issues)
* Q. Hazardous Materials Transportation and Hazardous Waste Destruction (3
Issues)
* R. Transporting Collected Substances (3 Issues)
* S. Miscellaneous Comments (2 Issues)
* IV. Regulatory Analyses
* Regulatory Flexibility Act
* Executive Orders 12866 and 13563
* Paperwork Reduction Act
* Title: Implementation of Registrant Recordkeeping Requirements Pursuant to
the CSA, 21 U.S.C. 827
* Title: Registrant Record of Controlled Substances Destroyed—DEA Form 41
* Executive Order 12988
* Executive Order 13132
* National Environmental Policy Act (NEPA)
* Unfunded Mandates Reform Act
* Executive Order 13175
* Congressional Review Act
* Rule Text
* List of Subjects
* 21 CFR Part 1300
* 21 CFR Part 1301
* 21 CFR Part 1304
* 21 CFR Part 1305
* 21 CFR Part 1307
* 21 CFR Part 1317
* PART 1300—DEFINITIONS
* PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF
CONTROLLED SUBSTANCES
* PART 1304—RECORDS AND REPORTS OF REGISTRANTS
* PART 1305—ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
* PART 1307—MISCELLANEOUS
* PART 1317—DISPOSAL
* Subpart A—Disposal of Controlled Substances by Registrants
* Subpart B—Disposal of Controlled Substances Collected From Ultimate Users
and Other Non-Registrants
* Subpart C—Destruction of Controlled Substances
* Subpart A—Disposal of Controlled Substances by Registrants
* Subpart B—Disposal of Controlled Substances Collected From Ultimate Users
and Other Non-Registrants
* Subpart C—Destruction of Controlled Substances
* Footnotes

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Start Preamble Start Printed Page 53520

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Final rule.

SUMMARY:

This rule governs the secure disposal of controlled substances by registrants
and ultimate users. These regulations will implement the Secure and Responsible
Drug Disposal Act of 2010 by expanding the options available to collect
controlled substances from ultimate users for the purpose of disposal,
including: Take-back events, mail-back programs, and collection receptacle
locations. These regulations contain specific language allowing law enforcement
to voluntarily continue to conduct take-back events, administer mail-back
programs, and maintain collection receptacles. These regulations will allow
authorized manufacturers, distributors, reverse distributors, narcotic treatment
programs (NTPs), hospitals/clinics with an on-site pharmacy, and retail
pharmacies to voluntarily administer mail-back programs and maintain collection
receptacles. In addition, this rule expands the authority of authorized
hospitals/clinics and retail pharmacies to voluntarily maintain collection
receptacles at long-term care facilities. This rule also reorganizes and
consolidates previously existing regulations on disposal, including the role of
reverse distributors.

DATES:

Effective Date: This rule is effective October 9, 2014.

Compliance Date: All Memoranda of Agreement (MOAs) and Memoranda of
Understanding (MOUs) issued pursuant to current 21 CFR 1307.21 will not be
effective after October 9, 2014. Registrants may consult § 1317.05(a)(5) for
information on requesting new MOAs and MOUs for disposal of controlled
substances.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Imelda L. Paredes, Office of Diversion Control, Drug Enforcement Administration;
Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone:
(202) 598-6812.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

OUTLINE

I. Executive Summary

A. Purpose of the Regulatory Action

B. Summary of the Major Provisions of the Regulatory Action

C. Summary of Changes in the Final Rule

II. Background and Legal Authority

III. Discussion of Comments

A. Support for the Proposed Rule (1 Issue)

B. Definitions and Terms (12 Issues)

C. Types of Entities That May Operate a Collection Program (9 Issues)

D. Locations Where Authorized Collectors May Maintain Collection Receptacles or
Host Take-Back Events (1 Issue)

E. Registration Requirements for Authorized Collectors (5 Issues)

F. Law Enforcement (7 Issues)

G. Collection Receptacle Design, Inner Liners, Placement, and Security (24
Issues)

H. Mail-Back Programs (11 Issues)

I. Take-Back Events (6 Issues)

J. Prohibition on Handling, Sorting, and Inventorying Inner Liner Contents and
Mail-Back Package Contents (8 Issues)

K. Long-Term Care Facilities (LTCFs) (21 Issues)

L. Disposing on Behalf of Ultimate Users (Other than Residents of LTCFs) (3
Issues)

M. Registrant Return, Recall, and Transfer (3 Issues)

N. Destruction (19 Issues)

O. Economic Concerns (18 Issues)

P. Recordkeeping and Reporting (8 Issues)

Q. Hazardous Materials Transportation and Hazardous Waste Destruction (3 Issues)

R. Transporting Collected Substances (3 Issues)

S. Miscellaneous Comments (2 Issues)

IV. Regulatory Analyses

I. EXECUTIVE SUMMARY

A. PURPOSE OF THE REGULATORY ACTION

On October 12, 2010, the Secure and Responsible Drug Disposal Act of 2010
(Disposal Act) was enacted (Pub. L. 111-273, 124 Stat. 2858). Before the
Disposal Act, ultimate users who wanted to dispose of unused, unwanted, or
expired pharmaceutical controlled substances had limited disposal options. The
Controlled Substances Act (CSA) only permitted ultimate users to destroy those
substances themselves (e.g., by flushing or discarding), surrender them to law
enforcement, or seek assistance from the United States Drug Enforcement
Administration (DEA). These restrictions resulted in the accumulation of
pharmaceutical controlled substances in household medicine cabinets that were
available for abuse, misuse, diversion, and accidental ingestion.

The Disposal Act amended the CSA to authorize ultimate users to deliver their
pharmaceutical controlled substances to another person for the purpose of
disposal in accordance with regulations promulgated by the Attorney General. 21
U.S.C. 822(g), 828(b)(3). This final rule implements regulations that expand the
entities to which ultimate users may transfer unused, unwanted, or expired
pharmaceutical controlled substances for the purpose of disposal, as well as the
methods by which such pharmaceutical controlled substances may be collected.
Specified entities may voluntarily administer any of the authorized collection
methods in accordance with these regulations.

B. SUMMARY OF THE MAJOR PROVISIONS OF THE REGULATORY ACTION

The DEA is implementing new regulations for the disposal of pharmaceutical
controlled substances by ultimate users in accordance with the Disposal Act. In
drafting the implementing regulations, the DEA considered the public health and
safety, ease and cost of program implementation, and participation by various
communities. To this end, the DEA found that in order to properly address the
disposal of controlled substances by ultimate users, it was necessary to conduct
a comprehensive review of DEA policies and regulations related to each element
of the disposal process, including the transfer, delivery, collection,
destruction, return, and recall of controlled substances, by both registrants
and non-registrants (i.e., ultimate users). The reverse distributor registration
category, which is pertinent to the process of registrant disposal, was included
in this comprehensive review. These regulations are incorporated into a new part
1317 on disposal. Definitions relating to the disposal of controlled substances
are added to § 1300.05(b), including definitions for “employee,” “law
enforcement officer,” “non-retrievable,” and “on-site” and definitions relating
to controlled substances generally are revised or added to § 1300.01.

The goal of this new part on disposal, consistent with Congress's goal in the
Disposal Act, is to set parameters for controlled substance diversion prevention
that will encourage public and private entities to develop a variety of methods
for collecting and destroying pharmaceutical controlled substances in a secure,
convenient, and responsible manner. Also, consistent with the Disposal Act's
goal to decrease the amount of pharmaceutical controlled substances introduced
into the environment, particularly into the water, these regulations provide
individuals with various additional options to dispose of their unwanted or
unused pharmaceutical controlled substances beyond discarding or Start Printed
Page 53521flushing the substances. As a result of these regulations, the DEA
hopes that the supply of unused pharmaceutical controlled substances in the home
will decrease, thereby reducing the risk of diversion or harm.

ULTIMATE USER DISPOSAL

An ultimate user is defined by the CSA as a “person who has lawfully obtained,
and who possesses, a controlled substance for his own use or for the use of a
member of his household or for an animal owned by him or by a member of his
household.” 21 U.S.C. 802(27). This rule provides three voluntary options for
ultimate user disposal: (1) Take-back events, (2) mail-back programs, and (3)
collection receptacles. Individuals lawfully entitled to dispose of an ultimate
user decedent's property are authorized to dispose of the ultimate user's
pharmaceutical controlled substances by utilizing any of the three disposal
options. All of the collection methods are voluntary and no person is required
to establish or operate a disposal program. The rule also does not require
ultimate users to utilize any of these three methods for disposal of controlled
substances. Although the three methods of disposal allowed by this rule seek to
help protect the environment and prevent controlled substances from being
diverted to illicit uses, this rule does not prohibit ultimate users from using
existing lawful methods.

The DEA regulations provide specific language that will continue to allow
Federal, State, tribal, and local law enforcement to maintain collection
receptacles at the law enforcement's physical location; and either independently
or in partnership with private entities or community groups, to voluntarily hold
take-back events and administer mail-back programs. 21 CFR 1317.35. Thus,
ultimate users will continue to be able to surrender their unwanted
pharmaceutical controlled substances to law enforcement.

The DEA is also authorizing certain registrants (manufacturers, distributors,
reverse distributors, narcotic treatment programs (NTPs), hospitals/clinics with
an on-site pharmacy, and retail pharmacies) to be “collectors,” with
authorization to conduct mail-back programs. 21 CFR 1317.40 and 1317.70. All
registrants that choose to establish mail-back programs must provide specific
mail-back packages to the public, either at no cost or for a fee, 21 CFR
1317.70. Collectors that conduct mail-back programs must have and utilize an
on-site method of destruction to destroy returned packages, 21 CFR 1317.05.

These DEA regulations authorize collectors to maintain collection receptacles at
their registered location. 21 CFR 1317.40. Thus, ultimate users will be able to
carry their unwanted pharmaceutical controlled substances to an authorized
retail pharmacy or other authorized collector location and deposit those
controlled substances in a secure container for disposal. Hospitals/clinics and
retail pharmacies that are authorized to be collectors may also maintain
collection receptacles at long-term care facilities (LTCFs). 21 CFR 1317.40.
LTCFs may dispose of pharmaceutical controlled substances on behalf of an
ultimate user who resides, or has resided, at that LTCF, 21 CFR 1317.80, through
a collection receptacle that is maintained by an authorized hospital/clinic or
retail pharmacy at that LTCF. 21 CFR 1317.40 and 1317.80.

With this rule, the DEA allows all pharmaceutical controlled substances
collected through take-back events, mail-back programs, and collection
receptacles to be comingled with non-controlled substances, although such
comingling is not required. 21CFR 1317.65, 1317.70, and 1317.75. Pharmaceutical
controlled substances collected by collectors may not be individually counted or
inventoried. 21 CFR 1317.75. This rule also imposes various registration,
security, and recordkeeping requirements.

The DEA appreciates there is a cost to entities that choose voluntarily to
provide these methods of collection and destruction. The DEA acknowledges that
some State and local pharmaceutical disposal programs receive funding and other
support from numerous sources, including conservation groups, local governments,
State grants, and public and private donations. These expanded methods of
disposal are expected to benefit the public by decreasing the supply of
pharmaceutical controlled substances available for misuse, abuse, diversion, and
accidental ingestion, and protect the environment from potentially harmful
contaminants by providing alternate means of disposal for ultimate users.
However, other advantages may accrue directly to those entities that opt to
maintain a disposal program. For example, those authorized registrants that
choose to maintain collection receptacles may be enhanced by the increased
consumer presence at their registered locations and the goodwill that develops
from providing a valuable community service. In addition, mail-back program
collectors may partner with third parties to make mail-back packages available
to the public. Those authorized registrants that choose to administer mail-back
programs may gain from the opportunity to distribute to consumers promotional,
educational, or other informational materials with the mail-back packages.

DEA REGISTRANT DISPOSAL

The DEA has deleted the existing rule related to registrant disposal, 21 CFR
1307.21, and incorporated similar requirements on proper disposal procedure and
security in a new part 1317 on disposal. These changes provide consistent
disposal procedures for each registrant category, regardless of geographic
location. In addition, the DEA has modified DEA Form 41 and is explicitly
requiring that form to be used to record the destruction of controlled
substances that remain in the closed system of distribution and also to account
for registrant destruction of pharmaceutical controlled substances collected
from ultimate users and other non-registrants pursuant to the Disposal Act. As
stated in the NPRM, a controlled substance dispensed for immediate
administration pursuant to an order for medication in an institutional setting
remains under the custody and control of that registered institution even if the
substance is not fully exhausted (e.g., some of the substance remains in a vial,
tube, transdermal patch, or syringe after administration but cannot or may not
be further utilized, commonly referred to as “drug wastage” and “pharmaceutical
wastage”). Such remaining substance must be properly recorded, stored, and
destroyed in accordance with DEA regulations (e.g., § 1304.22(c)), and all
applicable Federal, State, tribal, and local laws and regulations, although the
destruction need not be recorded on a DEA Form 41.

REVERSE DISTRIBUTORS

The DEA is providing regulations for entities that reverse distribute that are
clear and consistent. Entities that reverse distribute are often the last
registrant to possess controlled substances prior to destruction; however, the
recordkeeping safeguards that exist when controlled substances are distributed
between registrants are not present when these registrants destroy controlled
substances. Because reverse distributors routinely acquire controlled substances
for destruction from other registrants and may also be authorized as collectors,
reverse distributors accumulate greater amounts of controlled substances that
are destined for destruction in comparison to other registrants. The DEA is
defining “reverse distribute;” revising the definition of “reverse distributor;”
(21 Start Printed Page 53522CFR part 1300) outlining security (21 CFR part
1301), inventory, recordkeeping requirements, and other procedures that reverse
distributors must follow to acquire controlled substances from registrants and
to destroy such acquired substances. 21 CFR part 1304. The DEA also is
clarifying that these security, inventory, and recordkeeping requirements apply
to certain specified entities that reverse distribute but are not registered as
reverse distributors. See, e.g., 21 CFR 1304.11(e)(3) (“each person registered
or authorized to reverse distribute”). The DEA believes that these regulations
will help all registrants that reverse distribute comply with the CSA in a
manner that decreases the risk of the diversion of controlled substances during
the disposal process.

RETURN AND RECALL

This rule removes the existing regulation on return and recall, 21 CFR 1307.12,
and incorporates separate return and recall requirements for registrants and
non-registrants into new §§ 1317.10 and 1317.85. This rule also imposes various
recordkeeping requirements pertaining to controlled substances acquired for the
purpose of return or recall in §§ 1304.22 and 1305.03. The DEA has simplified
the requirements of § 1317.10(a) to more clearly describe the records that
registrants must keep.

METHODS OF DESTRUCTION

Existing DEA regulations do not specify a standard to which controlled
substances must be destroyed. With this final rule, the DEA is implementing a
standard of destruction—non-retrievable—for registrants that destroy controlled
substances, and procedures for the destruction of controlled substances. 21 CFR
1300.05 (“non-retrievable”), 1317.90, and 1317.95. The DEA is not requiring a
particular method of destruction, so long as the desired result is achieved.
This standard is intended to allow public and private entities to develop a
variety of destruction methods that are secure, convenient, and responsible,
consistent with preventing the diversion of such substances. Destruction of
controlled substances must also meet all other applicable Federal, State,
tribal, and local laws and regulations. Once a controlled substance is rendered
“non-retrievable,” it is no longer subject to the requirements of the DEA
regulations.

As explained above under “Compliance Date,” this final rule supersedes all
existing MOAs and MOUs that registrants may have pursuant to § 1307.21,
including MOAs and MOUs pertinent to storage of controlled substances. The DEA
retains in the new part 1317 the ability for practitioners to request assistance
from the local Special Agent in Charge (SAC) regarding the disposal of
controlled substances. 21 CFR 1317.05. Practitioners may request a new MOA or
MOU pursuant to the new § 1317.05(a)(5).

C. SUMMARY OF THE CHANGES IN THE FINAL RULE

The DEA carefully considered the 192 individually-submitted comments received in
response to the Notice of Proposed Rulemaking (NPRM) on the Disposal of
Controlled Substances.[1] 77 FR 75784, Dec. 21, 2012. The comment period closed
on February 19, 2013. The DEA is making a number of significant changes after
thorough consideration of the issues raised by the comments and the potential
diversion risks associated with these changes.

In response to concerns regarding ultimate users' ability to have convenient
disposal options, the DEA is vastly expanding those entities that may be
authorized as collectors, expanding the authority of those collectors to
maintain collection receptacles at LCTFs, and relaxing some of the proposed
security requirements related to storage and destruction of controlled
substances.

AUTHORIZED COLLECTORS

In addition to manufacturers, distributors, reverse distributors, and retail
pharmacies, the final rule also authorizes registered NTPs, as well as
hospitals/clinics with an on-site pharmacy, to operate disposal programs. 21 CFR
1317.40. By permitting these additional registrant categories to be collectors,
the DEA anticipates that ultimate users will now have even more locations where
they can securely, safely, responsibly, and conveniently dispose of their
unwanted pharmaceutical controlled substances.

In this final rule, the DEA is permitting those entities registered as NTPs to
become authorized collectors to manage collection receptacles at their
registered locations. As stated in the Disposal Act, “the nonmedical use of
prescription drugs is a growing problem in the United States.” Multiple
commenters, including a national organization that represents NTPs, recommended
that the DEA include NTPs as authorized collectors. The DEA recognizes the
valuable role that NTPs have in helping those seeking substance abuse treatment.
After considering the importance of providing secure, convenient, and
responsible disposal options for those ultimate users currently receiving
treatment for narcotic substance abuse or entering a narcotic treatment program,
and the benefits of allowing NTPs to provide the opportunity to patients to
dispose of unused controlled substances, the DEA is permitting NTPs to be
collectors with certain enhanced security controls. 21 CFR 1317.75.

Due to the nature of the healthcare provided, NTPs face unique security
challenges and heightened diversion risks and, as such, the final rule requires
NTPs to securely place and maintain collection receptacles in a room that does
not contain any other controlled substances and is securely locked with
controlled access. 21 CFR 1317.75. The DEA understands that this security
measure will require employees of the NTP to accompany the patient to the
collection receptacle to facilitate the patient's disposal. See 21 CFR 1317.75.
Additionally, as the Disposal Act and these regulations are intended to address
the prescription drug abuse problem, NTPs and other collectors are not
authorized to collect schedule I controlled substances. E.g., 21 CFR 1317.75.
Collectors must be vigilant in ensuring that such illicit substances are not
collected intentionally or inadvertently. E.g., 21 CFR 1317.70 and 1317.75.

After extensive review and careful deliberation, in this final rule, the DEA is
also permitting registered hospitals/clinics with an on-site pharmacy to become
authorized collectors to maintain collection receptacles inside their registered
locations or at LTCFs, and to conduct mail-back programs. 21 CFR 1317.30,
1317.40, 1317.70, and 1317.80. In response to the NPRM, many commenters stated
that collection receptacles located inside of hospitals would provide ultimate
users with an opportunity to dispose of medication that may no longer be needed
or may be expired. In determining whether to allow hospitals/clinics to become
authorized collectors, the DEA carefully weighed the diversion risks with the
convenience of authorizing such entities to be collectors. The DEA determined
that the diversion risks require the DEA to limit those registered
hospitals/clinics that may become collectors to those with on-site pharmacies,
and also impose separate security conditions on the monitoring and location of
collection receptacles inside hospitals/Start Printed Page 53523clinics that
become authorized collectors. 21 CFR 1317.75.

The DEA is requiring these additional security measures in order to help protect
against the diversion of collected controlled substances because
hospitals/clinics are generally much larger and are open to a much larger
general population than the other registrants authorized to be collectors; and,
as discussed in the NPRM, hospitals/clinics do not operate under the same
business model or with similar theft and loss prevention procedures as the other
registrants authorized to become collectors. For example, the general public
typically enters retail pharmacies for short durations in order to conduct
retail business and retail pharmacies generally have open, clearly observable
common areas with little opportunity to conceal an unlawful purpose. It would be
unusual and suspicious for a person to spend an extended amount of time in a
retail pharmacy without a known, specific purpose, triggering routine theft and
loss prevention measures.

In contrast, hospitals are generally open 24-hours per day and allow for
unsupervised public access for extended periods of time; they are much larger
than retail pharmacies and many interactions occur behind closed doors without
routine theft and loss prevention measures; and foot traffic generally is not
routinely monitored for unlawful purposes. The DEA believes that limiting
authorized collection activities to hospitals/clinics with an on-site pharmacy
is necessary to help protect against diversion because these hospitals/clinics
routinely handle a large volume of controlled substances that are dispensed to
in-patients as well as to the public, and these entities are more experienced
with security, theft and loss prevention procedures, and inventory,
recordkeeping and reporting requirements than those hospitals/clinics without an
on-site pharmacy.

For reasons discussed in the NPRM, this final rule generally requires that, when
authorized collectors choose to install collection receptacles, those collection
receptacles must be placed inside their registered locations in the immediate
proximity of a designated area where controlled substances are stored and at
which an employee is present. 21 CFR 1317.75; see also 1317.05. The DEA
recognizes that hospitals/clinics with an on-site pharmacy can be unique in
their design and it may be more effective to install collection receptacles at
various locations within the hospital/clinic, depending on factors such as
security, convenience, and accessibility. As such, it would be challenging for
authorized hospitals/clinics to adhere to the general rule to place collection
receptacles in the immediate proximity of where controlled substances are stored
and at which an employee is present. Accordingly, the DEA is requiring
hospitals/clinics that are collectors to place collection receptacles in
locations that are regularly monitored by employees. 21 CFR 1317.75. In
addition, the DEA is prohibiting such collectors from placing collection
receptacles in the proximity of any area where emergency or urgent care is
provided. In the DEA's experience, the risk of diversion is particularly high in
areas where emergency or urgent care is provided because of the often chaotic
environment and the extended amounts of time persons spend in such areas.

This rule also makes clear that DEA registrants cannot use the collection
receptacles to dispose of unused controlled substances in their inventory or
stock. 21 CFR 1317.05 and 1317.75. Pharmaceutical controlled substances remain
under the custody and control of the DEA registrant if they are dispensed by a
practitioner for immediate administration at the practitioner's registered
location (such as a hospital) pursuant to an order for medication. If that
substance is not fully exhausted (e.g., some of the substance remains in a vial,
tube, or syringe after administration but cannot or may not be further
utilized), then the DEA registrant is obligated to destroy the remaining,
unusable controlled substances, and record the destruction in accordance with
§ 1304.22(c). The DEA registrant shall not place such remaining, unusable
controlled substance in a collection receptacle as a means of disposal.
Hospital/clinic staff must also not dispose of any controlled substances in
inventory or stock in a collection receptacle.

The security requirements described above are the minimum required in order to
detect and prevent diversion in the unique circumstances of NTPs and
hospitals/clinics. These registrants should be vigilant in the execution of
their responsibilities as registrants to ensure that collected controlled
substances are not diverted to illicit use, and that they do not collect illicit
substances. Finally, all registrants are reminded of the responsibility to
report theft and significant loss of controlled substances within one business
day of discovery.

LONG-TERM CARE FACILITIES (LTCFS)

Significant changes are made in this final rule to help ensure that LTCFs have
adequate disposal options. In addition to allowing retail pharmacies to manage
and maintain collection receptacles at LTCFs, the DEA is also allowing
hospitals/clinics with an on-site pharmacy to manage and maintain collection
receptacles at LTCFs. The DEA hopes that expanding those authorized to collect
at LTCFs will maximize disposal opportunities for LTCF residents.

In addition, the DEA is alleviating two security requirements proposed to apply
to collection receptacles located at LTCFs. First, the DEA is permitting
authorized hospitals/clinics and retail pharmacies to store inner liners that
have been sealed upon removal from a collection receptacle at LTCFs in a
securely locked, substantially constructed cabinet or a securely locked room
with controlled access for up to three business days until the liners can be
transferred for destruction. The DEA encourages collectors to schedule inner
liner removals and installations to coincide with existing LTCF visits when
possible, for example, arranging a routine system in which medication deliveries
coincide with the removal and transfer of sealed inner liners for appropriate
destruction, thereby making storage of sealed inner liners unnecessary.
Collectors may not transfer sealed inner liners from LTCFs to their primary
registered location (i.e., the hospital/clinic or retail pharmacy location). As
echoed in the comments, the DEA remains concerned about the security risks of
hospital/clinic and retail pharmacy employees transporting large quantities of
collected substances, making them potential targets for drug seekers. Instead,
collectors should deliver sealed inner liners to a reverse distributor or
distributor's registered location by common or contract carrier pick-up or by
reverse distributor or distributor pick-up at the LTCF, pursuant to
§ 1317.05(c)(2)(iv).

Second, the DEA relaxed the two-employee integrity requirement for inner liner
installation, removal, storage, and transfer at LTCFs. Collectors will retain
the option to authorize two of their own employees to install, remove, store,
and transfer inner liners; however, the DEA is permitting collectors the option
to designate a supervisor-level employee of the LTCF (e.g., a charge nurse,
supervisor, or similar employee) to install, remove, store, or transfer inner
liners with only one employee of the collector.

The DEA modified the above security requirements (storage and two-person
integrity) to provide flexibility sufficient to encourage authorized
hospitals/clinics and retail pharmacies to collect at LTCFs, while ensuring the
minimum protections required to prevent Start Printed Page 53524diversion at
LTCFs. The DEA hopes that the inclusion of certain hospitals/clinics as
authorized to maintain collection receptacles at LTCFs, and the modifications
described above will result in expanded safe and secure disposal options for
LTCF residents. The DEA emphasizes that if LTCFs dispose of LTCF residents'
controlled substances in collection receptacles, such activity must be in
accordance with this regulation and all other applicable Federal, State, tribal
and local laws and regulations, including environmental laws and regulations.

The DEA acknowledges that there may be some LTCFs that will not have a
collection receptacle, and there will be instances where LTCF residents are
incapable of disposing of their own unused or unwanted medication. As ultimate
users, LTCF residents may use any of the disposal options afforded other
ultimate users in this final rule (e.g., mail-back programs), in addition to the
disposal options currently available to ultimate users (e.g., flushing or
otherwise discarding) that will remain options even after this final rule is
implemented. For example, an LTCF resident may request that LTCF personnel place
the resident's unwanted medication in a mail-back package, seal the mail-back
package, and deposit that package into the facility's outgoing mail system. 21
CFR 1317.70. LTCFs should be mindful however that the touchstone for this
disposal method is the individual nature of the disposal activity; institutional
facilities such as LTCFs should ensure that the individual patient is the
disposer, and should be wary of establishing any protocols whereby the facility
itself is engaging in collection activities. Simply providing the method of
disposal (e.g., mail-back packages) does not implicate that concern.

DESTRUCTION

After careful and thorough consideration of comments received regarding the
burdens associated with the proposed 14-day destruction requirement, the DEA is
extending the time those registrants that reverse distribute have to destroy
controlled substances to 30 days. 21 CFR 1317.15(d). The DEA anticipates that
this extension will allow reverse distributors and distributors adequate time to
collect and destroy controlled substances in a safe, convenient, and secure
manner, while also preventing diversion and diversion opportunities.

PRACTITIONER PHYSICAL SECURITY

In this final rule, the DEA is not amending § 1301.75(b) pertaining to
practitioner physical security and is instead adding a new paragraph (c) to
clarify that practitioners shall only store sealed mail-back packages and inner
liners containing collected substances at their registered location in a
securely locked, substantially constructed cabinet or a securely locked room
with controlled access. The DEA has made corresponding changes to
§§ 1317.05(c)(1)(ii) and (c)(2)(ii). Part of this requirement was included in
the proposed rule; however, after careful consideration of a number of comments,
the DEA believes that the proposed requirement did not provide sufficient
controls to protect against diversion and was impracticable. Pharmacies and
institutional practitioners cannot store sealed inner liners or returned
mail-back packages by dispersing them throughout the stock of noncontrolled
substances. 21 CFR 1301.75(b) and (c).

OTHER CHANGES TO THE FINAL RULE

In addition to the changes described above, the DEA determined that the rule, as
proposed, required other modifications, as generally described below. The DEA is
also implementing additional technical modifications that will not have a
substantive effect on this rule (e.g., relocating some sections in proposed part
1317 to other sections within title 21 of the CFR, re-phrasing some sections
from the proposed rule to be simpler, clearer and easier to understand, and
eliminating redundancy).

In the general definitions section of the DEA regulations, the DEA is amending
§ 1300.01(b) to be clear that the definitions that generally apply to most other
parts of chapter II of title 21 of the CFR also apply to part 1317. In response
to a number of comments, in § 1300.01(b) the DEA is amending the definition of
“reverse distributor” to clarify that a reverse distributor is a person
registered with the DEA as a reverse distributor.

Definitions were moved from § 1317.02 to § 1300.05 to provide consistency within
the CFR pertaining to definitions. The DEA adds § 1300.05 “Definitions relating
to the disposal of controlled substances,” moves the terms “authorized
employee,” “law enforcement officer,” and “non-retrievable” from part 1317 to
§ 1300.05(b), adds a definition of “on-site” to § 1300.05(b), and deletes the
definitions of “for cause” and “inner liner” that were in proposed part 1317.
The DEA also moves the definition of “collection” to § 1300.01(b). These changes
are in response to comments or related to the movement of several other
requirements from part 1317 to other parts, as discussed below.

In addition to moving them to § 1300.05(b), the DEA amends the definitions of
“authorized employee” and “law enforcement officer.” The DEA is omitting the
word “authorized” from the definition of “authorized employee,” and codifying
the definition of “employee” in harmony with the general common law of agency.
The DEA is modifying the definition of “law enforcement officer” in part 1317 to
specifically include officers from law enforcement components of Federal
agencies, and authorized police officers of the Veterans Health Administration
and the Department of Defense. In addition, this rule clarifies who may qualify
as a “law enforcement officer” for the purpose of disposal. The DEA is changing
references to “law enforcement agencies” to “law enforcement” in order to
include law enforcement components of Federal agencies.

Although the DEA defined “inner liner” in the NPRM, the final rule does not
amend the CFR to add a definition for inner liner. As described below, inner
liners used in the collection of controlled substances must meet the
specifications outlined in § 1317.60. The DEA also is not amending the CFR to
add a definition of “for cause,” and instead is providing an explanation of “for
cause” as it relates to the sections to which it applies.

The DEA added a definition of “on-site” to § 1300.05(b) to clarify that
“on-site” means “located on or at the physical premises of the registrant's
registered location” for purposes of destruction and registration as a
collector. Specifically, a controlled substance is destroyed “on-site” when
destruction occurs on the physical premises of the destroying registrant's
registered location, and a hospital/clinic has an “on-site” pharmacy when it has
a pharmacy located on the physical premises of the registrant's registered
location.

Text was added to the registration table in § 1301.13 to reflect that
distributors, as a coincident activity to distribution, may acquire controlled
substances from collectors for the purpose of destruction. The registration
table was updated so that it would be consistent with the regulations in the
final rule, which authorize distributors to destroy controlled substances
acquired from collectors.

The DEA received a number of comments indicating confusion regarding the
procedures a registrant must follow to modify their DEA registration to become a
collector. In Start Printed Page 53525order to clarify such requirements, the
DEA is further revising § 1301.51. The additional revisions clarify the
requirements by listing them independently of other types of registration
modifications (e.g., change of name or address) and clearly indicating that any
modifications may be made in writing by mail or online. 21 CFR part 1301. Also,
the submission method has been modified from “letter” to “written request” to
accurately encompass the various ways the modification request may be submitted
(e.g., online), and the phrase “to be paid” was deleted from § 1301.51(c) for
stylistic reasons. Similarly, the DEA is further revising § 1301.52 to clarify
that any registrant who has been authorized as a collector and who desires to
discontinue their collection of pharmaceutical controlled substances from
ultimate users must notify the DEA.

The DEA is also streamlining certain registration and security procedures by
moving certain requirements from part 1317, as proposed in the NPRM, to part
1301. Reverse distributor employee security requirements in proposed § 1317.20
were moved to § 1301.74(m) for ease of reference and consistency. Collector
security requirements in proposed § 1317.45 were moved to § 1301.71(f) for
clarity and consistency.

The DEA determined that inclusion of recordkeeping and reporting requirements in
part 1317 may lead to confusion among registrants. As such, the DEA is moving
all recordkeeping and reporting requirements from part 1317, as proposed in the
NPRM, to part 1304—Records and Reports of DEA Registrants—in order to maintain
consistency and consolidate all recordkeeping and reporting requirements into
one part. In § 1304.03, “each” was changed to “every,” and “who” was changed to
“that” for stylistic reasons. In § 1304.11(e)(2), the first sentence, pertaining
to an exception for reverse distributors, was removed and incorporated into
§ 1304.11(e)(3) of the final rule to accurately reflect the type of registrants
to which the section applies.

The DEA is expanding the locations where a collector may maintain records in
§ 1304.04(a)(3). The text in § 1304.21(a) was updated to specifically include
inner liners and mail-back packages, which were inadvertently overlooked in the
NPRM. 21 CFR § 1304.21(c) was updated to include the general recordkeeping
requirements for collection activities as outlined in the final rule. The
recordkeeping requirements for disposal of controlled substances in 21 CFR
§ 1307.21 were moved to § 1304.21(e) and amended to include recordkeeping
procedures for destruction. The title and introductory text in § 1304.22 were
updated to accurately reflect their contents. Additionally, § 1304.22 was
modified to include recordkeeping requirements for collected controlled
substances. The second sentence in both § 1304.25(a)(9) and § 1304.25(b)(9),
which required compliance with part 1317 when destroying narcotic controlled
substances, were removed as superfluous. All disposal and destruction activities
are clearly delineated in part 1317. Also, various Automation of Reports and
Consolidated Ordering System (ARCOS) requirements are removed from part 1317, as
proposed in the NPRM, and are consolidated and moved to § 1304.33. In addition,
the title of § 1304.33 has been changed to add clarity, and the acronym “ARCOS”
is clearly spelled out. The formatting for § 1304.33(f) was modified for ease of
understanding, and “who” was changed to “that” in two locations for consistency.

The DEA is also amending § 1305.03 to add a new paragraph (f) to clarify that
collectors are exempt from order form requirements for pharmaceutical controlled
substances collected through mail-back programs and collection receptacles for
the purpose of disposal. The title of § 1307.11 no longer references reverse
distributors and has been changed to “Distribution by dispenser to another
practitioner” because reverse distributor activities were moved to part 1317.

As discussed in the preamble to the NPRM and as mentioned in proposed
§ 1317.100, the DEA clarifies in § 1304.21 of this final rule that, in addition
to any other recordkeeping requirements, all registrants that destroy or cause
the destruction of a controlled substance must maintain a record of that
destruction on a DEA Form 41. This requirement had been discussed in the
preamble to the proposed rule, and in proposed § 1317.100 the DEA stated “any
registered person that destroys or causes the destruction of a controlled
substance shall maintain a record of destruction on a form issued by DEA . . ..”
The DEA has determined that this requirement to keep such records on DEA Form 41
should be explicitly stated in the regulatory text, and not just the preamble,
for registrants to clearly understand the requirements to which they are bound.
As stated above, this requirement to record destruction activities on the DEA
Form 41 does not apply to drug wastage or pharmaceutical wastage which must be
properly recorded, stored, and destroyed in accordance with DEA regulations, and
all applicable Federal, State, tribal, and local laws and regulations. 21 CFR
part 1304.

The DEA is modifying proposed § 1317.70 to address the procedures that a
collector must follow when ceasing operation of a mail-back program. This
modification requires such collector to make reasonable efforts to notify the
public of their intent to cease mail-back collection activities. 21 CFR 1317.70.
Such collector must also establish an agreement with another collector
authorized to conduct a mail-back program to receive all remaining packages and
arrange for the forwarding of such packages to the second collector's registered
location. These procedures will ensure that another authorized entity will be
responsible for receiving and destroying any mail-back packages that were
disseminated but not received back by the collector prior to the time that they
ceased operation of their mail-back program.

Finally, the DEA is modifying proposed § 1317.75 for two purposes. The first
modification clarifies that collected controlled and non-controlled substances
can be comingled, but are not required to be comingled. 21 CFR 1317.75. As
previously discussed, the second modification to this section allows certain
LTCF employees, as designated by the collector authorized to maintain a
collection receptacle at that LTCF, to install, seal, remove, store, and
transfer for destruction the inner liners of the collection receptacle along
with an employee of the collector. 21 CFR 1317.80. This modification allows
greater flexibility for collectors authorized to maintain collection receptacles
at LTCFs.

II. BACKGROUND AND LEGAL AUTHORITY

The DEA implements and enforces titles II and III of the Comprehensive Drug
Abuse Prevention and Control Act of 1970, as amended. Titles II and III are
referred to as the “Controlled Substances Act” and the “Controlled Substances
Import and Export Act,” respectively, but are collectively referred to as the
“Controlled Substances Act” or the “CSA” for the purpose of this action. 21
U.S.C. 801-971. The DEA publishes the implementing regulations for these
statutes in title 21 of the Code of Federal Regulations (CFR), parts 1300 to
1321. The CSA and its implementing regulations are designed to prevent, detect,
and eliminate the diversion of controlled substances and listed chemicals into
the illicit market while providing for a sufficient supply of controlled
substances and listed Start Printed Page 53526chemicals for legitimate medical,
scientific, research, and industrial needs of the United States. Controlled
substances have the potential for abuse and dependence and are controlled to
protect the public health and safety. To this end, controlled substances are
classified into one of five schedules based upon: The potential for abuse,
currently accepted medical use, and the degree of dependence if abused. 21
U.S.C. 812. Listed chemicals are separately classified as list I or list II
chemicals based on their use and importance to the manufacture of controlled
substances. 21 U.S.C. 802(33)-(35).

The CSA establishes a closed system of distribution that requires the DEA to
monitor and control the manufacture, distribution, dispensing, import, and
export of controlled substances and listed chemicals until they reach their
final lawful destination. The secure destruction of unused, recalled, tainted,
expired, or otherwise unwanted pharmaceutical controlled substances is essential
to preventing the diversion of these substances into the illicit market.

In order to maintain this closed system of distribution, persons who handle
(manufacture, distribute, dispense, import, export, engage in research, or
conduct instructional activities), or propose to handle, controlled substances
and listed chemicals are required to register with the DEA at each principal
place of business or professional practice. Persons registered with the DEA are
permitted to possess controlled substances and listed chemicals as authorized by
their registration and must comply with the applicable requirements associated
with their registration. 21 U.S.C. 822.

Not all persons who possess controlled substances are required to register with
the DEA. For example, a patient who receives a pharmaceutical controlled
substance pursuant to a lawful prescription, i.e., an ultimate user, is not
required to register with the DEA in order to receive and possess that
substance. 21 U.S.C. 822(c)(3); see also 21 U.S.C. 957(b)(1)(C).[2] The CSA
defines an “ultimate user” as “a person who has lawfully obtained, and who
possesses, a controlled substance for his own use or for the use of a member of
his household or for an animal owned by him or by a member of his household.” 21
U.S.C. 802(27).

While Congress envisioned a closed system of distribution that would control a
substance from its manufacture or import through the traditional chain of
distribution moving from registrant to registrant until it reached its final
lawful use (e.g., dispensed to the ultimate user, etc.), it did not account for
circumstances in which pharmaceutical controlled substances were lawfully
dispensed to, and possessed by, an ultimate user but not fully used. Although
ultimate users are exempt from CSA registration requirements for the possession
of pharmaceutical controlled substances, if they distribute (e.g., deliver or
transfer) such substances without the appropriate registration, they are in
violation of the CSA.[3] Such unlawful distribution includes the transfer of
pharmaceutical controlled substances for the purpose of disposal.[4]

The Disposal Act, enacted on October 12, 2010, amended the CSA to allow an
ultimate user to “deliver” a pharmaceutical controlled substance “to another
person for the purpose of disposal” if the person receiving the substance is
authorized to receive it and the disposal takes place in accordance with
regulations issued by the Attorney General to prevent the diversion of
controlled substances. 21 U.S.C. 822(g)(1). The Attorney General delegated
responsibility for promulgating the Disposal Act implementing regulations to the
DEA.[5]

In addition to authorizing ultimate users to deliver their pharmaceutical
controlled substances to another person for the purpose of disposal, the
Disposal Act also authorizes any person lawfully entitled to dispose of an
ultimate user decedent's property to deliver the ultimate user's pharmaceutical
controlled substances to another person for the purpose of disposal if the
ultimate user dies while in lawful possession of the substances. The Disposal
Act also gives the DEA the ability, by regulation, to authorize LTCFs to dispose
of pharmaceutical controlled substances on behalf of ultimate users who reside,
or have resided, at the LTCF. Congress directed the DEA, in promulgating the
Disposal Act implementing regulations, to consider the public health and safety,
ease and cost of program implementation, and participation by various
communities. The implementing regulations may not require any person to
establish or operate a delivery or disposal program.

III. DISCUSSION OF COMMENTS

The DEA had received 192 comments on the NPRM when the comment period closed on
February 19, 2013. These comments are summarized below, along with the DEA's
responses.

A. SUPPORT FOR THE PROPOSED RULE (1 ISSUE)

[1] Issue: The DEA received 192 comments for this rulemaking during the 60-day
comment period. The vast majority of the comments were overwhelmingly positive
with the commenters agreeing that there should be more options for secure,
convenient, and responsible disposal of controlled substances. Nineteen
commenters supported the rule as written in the NPRM. Almost every other
commenter supported the rule to some degree, although many commenters had
concerns with the implementation of the specific disposal procedures described
in the NPRM.

Response: The DEA appreciates the support for this rulemaking and is privileged
to implement regulations to allow for the collection and disposal of controlled
substances in a secure, convenient, and responsible manner. The DEA considered
all of the comments and ramifications of implementing proposed changes to the
rule. In finalizing this rule, the DEA Start Printed Page 53527considered public
health and safety, ease and cost of program implementation, and participation by
various communities.

B. DEFINITIONS AND TERMS [6] (12 ISSUES)

[1] Issue: Five commenters asked the DEA to define “ultimate user.”

Response: An ultimate user is defined by the CSA as “a person who has lawfully
obtained, and who possesses, a controlled substance for his own use or for the
use of a member of his household or for an animal owned by him or by a member of
his household.” This definition, codified at 21 U.S.C. 802(27), was not amended
or otherwise modified by the Disposal Act.

[2] Issue: Ten commenters asked the DEA to clarify the term “retail pharmacy”
and to specify whether “closed-door pharmacies,” such as those that service
LTCFs, “Federal pharmacies,” and other pharmacies that only provide services to
a distinct population are considered retail pharmacies.

Response: The intended meaning of “retail pharmacy” with regard to collectors
was discussed in the NPRM but was not defined in the proposed rule itself. The
DEA intends “retail pharmacy” to include any entity registered with the DEA as a
retail pharmacy as opposed to those entities registered as a hospital/clinic.
Depending on a variety of factors, including State authority and authorized
business practices, some entities that dispense controlled substances may be
registered with the DEA as either a retail pharmacy or a hospital/clinic. 21 CFR
part 1301. In other words, pharmacies are not registered with the DEA as
“Federal pharmacies,” “LTCF pharmacies,” or even “closed-door pharmacies.” All
of these pharmacies may be registered as retail pharmacies provided they meet
the requirements of 21 U.S.C. 822 and 823, and they may be authorized as
collectors upon proper application. As previously discussed, the DEA is also
allowing entities registered as hospitals/clinics with an on-site pharmacy to be
collectors. 21 CFR 1317.40. Therefore, patients of pharmacies that dispense
controlled substances pursuant to a hospital/clinic registration may benefit if
the hospital/clinic opts to modify its registration to become a collector.

[3] Issue: Approximately 10 commenters asked the DEA to expand the definition of
“authorized employee.” These commenters expressed concern that the definition of
“authorized employee” in the NPRM was too limited in scope, and would result in
a burden on smaller-staffed pharmacies, as well as pharmacies that employ
contract pharmacists and part-time employees. One commenter asked whether or not
physician-owners will be considered authorized employees.

Response: The DEA carefully considered the commenters' concerns and is modifying
the proposed definition of “authorized employee.” 21 CFR § 1300.05(b). In this
rule, the DEA is omitting the word “authorized” from the definition of
“authorized employee” because the rule already specifies what conditions qualify
employees to conduct certain disposal activities (i.e., authorized collectors
may not employ, as an agent or employee who has access to or influence over
collected substances, any person who has been convicted of a felony offense
related to controlled substances or who has, at any time, had an application for
registration with DEA denied, had a DEA registration revoked or suspended, or
surrendered a DEA registration for cause). Also, the DEA is modifying the
definition of “employee” by adopting the general common law of agency's
definition of the term and moving the definition from proposed part 1317 to part
1300. As a result of these changes, part-time personnel and physician-owners may
be considered “employees” for the purpose of disposal if they meet the relevant
criteria.

Where Congress does not define “employee,” the DEA utilizes the common law to
determine who is an “employee.” Under U.S. Supreme Court precedent, the factors
relevant to determining whether a person is an “employee” under the common law
include, but are not limited to: The hiring party's right to control the manner
and means by which the product is accomplished; the skill required; the source
of the instrumentalities and tools; the location of the work; the duration of
the relationship between the parties; whether the hiring party has the right to
assign additional projects to the hired party; the extent of the hired party's
discretion over when and how long to work; the method of payment; the hired
party's role in hiring and paying assistants; whether the work is part of the
regular business of the hiring party; whether the hiring party is in business;
the provision of employee benefits; and the tax treatment of the hired party.
See Nationwide Mut. Ins. Co. v. Darden, 503 U.S. 318, 323-24 (1992). Other
applicable factors may be considered and no one factor is dispositive. See id.
at 324.

After evaluating the relevant factors in the context of controlled substance
security and diversion prevention, in the context of disposal, the following
criteria will determine whether a person is an “employee” regardless of the
number of hours per week the person works: Persons who are directly paid by the
registrant; who are subject to direct oversight by the registrant; who are
required, as a condition of employment, to follow the registrant's procedures
and guidelines pertaining to the handling of controlled substances; who receive
a performance rating or performance evaluation on a regular/routine basis from
the registrant; who are subject to disciplinary action by the registrant; and
who render services at the registrant's registered location. This definition is
incorporated in the new § 1300.05, titled “Definitions Relating to the Disposal
of Controlled Substances.” These criteria focus on the degree of management and
control that a registrant has over the person, and thus, adherence to these
criteria will directly impact the security of controlled substances within the
registrant's custody and control. The DEA believes that these criteria are the
minimum required to ensure controlled substances are accounted for and not
diverted to illicit purposes. Under the definition, contract personnel who do
not meet these criteria are not “employees” for the purposes of disposal.

[4] Issue: One commenter stated that the proposed definition of “authorized
employee” was too expansive, and that controlled substances should be handled
only by individuals who hold a professional license.

Response: The DEA carefully considered the diversion risks associated with
allowing various types of persons to handle collected substances. The definition
of “employee,” as stated in this final rule, will help reduce diversion risks
while ensuring that authorized collectors have sufficient ability to safely and
securely manage the collection of controlled substances. 21 CFR part 1300.
Individuals who do not hold a professional license are considered “employees” if
they meet the criteria as explained above.

[5] Issue: Five commenters asked the DEA to define the term “common or contract
carrier.”

Response: The DEA declines to define this term for the purpose of this rule. The
DEA's primary concern regarding common or contract carriers is not about how
these terms are defined, but whether there is adequate security to Start Printed
Page 53528prevent diversion when controlled substances are being transported. As
explained in § 1301.74(e), when shipping controlled substances, non-practitioner
registrants are responsible for selecting common or contract carriers that
provide adequate security to guard against in-transit losses. In addition,
non-practitioner registrants are responsible for employing precautions (e.g.,
assuring that shipping containers do not indicate that contents are controlled
substances) to guard against in-transit losses. Although these specific
requirements apply to non-practitioners, all registrants (practitioners and
non-practitioners) shall provide effective controls and procedures to guard
against theft and diversion of controlled substances. 21 CFR part 1301.

[6] Issue: One commenter suggested that the DEA modify the definition of
“non-retrievable” to read: “means to permanently alter any controlled
substance's physical and/or chemical state through essentially irreversible
means in order to render that controlled substance unavailable and unusable for
all practical purposes. This definition is not intended to require destruction
beyond the state at which a controlled substance becomes unavailable, unusable,
and, subsequently, no longer available for diversion.”

Response: The DEA declines to modify the definition as suggested. Such a change
would significantly weaken the non-retrievable standard to a state where
controlled substances could easily be diverted. The permanent and irreversible
alteration of controlled substances is the cornerstone of the non-retrievable
standard.

[7] Issue: Some commenters asked the DEA to clarify the meaning of the terms
“regularly” and “practitioner” used in the proposed § 1317.05(a)(4).

Response: “Practitioner” is defined in the CSA at 21 U.S.C. 802(21) as “a
physician, dentist, veterinarian, scientific investigator, pharmacy, hospital,
or other person licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices or does research, to
distribute, dispense, conduct research with respect to, administer, or use in
teaching or chemical analysis, a controlled substance in the course of
professional practice or research.” The term “regularly” has its ordinary
meaning, with no specific or technical implications. The DEA understands the
ordinary meaning of “regularly” to generally be considered as being on a routine
basis or at routine intervals.

[8] Issue: One commenter suggested that the DEA distinguish reverse distributors
who only collect controlled substances for the purpose of disposal from reverse
distributors who also handle non-controlled substances and other waste products.
This commenter suggested that the DEA lessen the requirements for those reverse
distributors that only collect controlled substances for disposal.

Response: The DEA does not distinguish between different “types” of reverse
distributors. All reverse distributors receive controlled substances for the
purpose of disposal—either through return to the manufacturer who accepts
returns, or through destruction. 21 CFR part 1300. The regulations impose the
minimum requirements for reverse distributors when handling controlled
substances regardless of whether they also handle other substances. Therefore,
there is no basis to relax the requirements for reverse distributors whose
activities are limited solely to the collection of pharmaceutical controlled
substances for the purpose of disposal.

[9] Issue: One commenter asked the DEA to clarify the difference between
“transfer” and “transport” as used in proposed § 1317.95.

Response: These terms have their ordinary meaning. Generally, the DEA uses the
term “transport” to refer to the physical movement of an item from one location
to another while “transfer” is used to refer to conveying possession or control
(actual or constructive) from one entity to another.

[10] Issue: One commenter asked the DEA to clarify the phrase “causes the
destruction” as it could be interpreted to mean any person involved in the
process.

Response: As previously discussed, proposed § 1317.100 is relocated in this
final rule to § 1304.21(e). The DEA included the term “causes the destruction”
to encompass such circumstances where a registrant does not itself destroy the
controlled substance but is still responsible for the destruction; for example,
when a registrant or a registrant's employee initiates the destruction process
by engaging a third-party destruction facility that will perform the actual
destruction pursuant to § 1317.95(c). This final rule clarifies this distinction
in §§ 1317.95(c) and 1304.21(e).

[11] Issue: One commenter stated that the rule should be clarified in use of the
word “may” with regard to individual counting and inventorying of collected
substances. The commenter indicated that the word seems open for interpretation.

Response: The commenter is specifically referring to the NPRM statement
“[c]ontrolled substances collected by collectors may not be individually counted
or inventoried.” The DEA understands that this phrase may be misinterpreted to
mean that authorized collectors are not required to count or inventory collected
substances. To clarify, the DEA is modifying §§ 1317.60 and 1317.70 to clearly
indicate that sealed inner liners and returned mail-back packages “shall not be
opened, x-rayed, analyzed, or otherwise penetrated.” The DEA also modifies
§ 1317.75(c) to specify that this prohibition includes counting or inventorying
collected substances prior to sealing and removing an inner liner that contains
collected substances, as well as after the inner liner is sealed. The DEA
discusses below the different requirements applying to law enforcement.

[12] Issue: One commenter noted that the DEA used inconsistent time requirements
throughout the proposed rule, such as “timely,” “prompt,” and “as soon as
practicable, but no later than 14 days.” Additionally, several commenters
requested clarification regarding the definition of the word “prompt” in the
proposed rule, and commenters asked for clarification regarding how the DEA
would determine whether an action is “prompt.” Commenters asked for guidance as
to what time range the DEA would find reasonably acceptable.

Response: The DEA's use of different time standards throughout the proposed rule
was intentional as the different circumstances of each requirement warrant
different standards. The various timing requirements are intended to be flexible
enough to account for individual circumstances while also ensuring sufficient
and adequate controls to prevent diversion and opportunities for diversion. The
DEA considered imposing specific timelines (e.g., three days, five days);
however, the wide variety of business models and activities made it impossible
in most circumstances to set a specific deadline that would prevent diversion
and diversion opportunities. Additionally, violations of specific timelines
would be per se violations of the regulations, whereas violations of the
flexible “prompt” and “as soon as practicable” standards would be considered
under each registrant's individual circumstances. The DEA's determination will
be guided by whether the registrant has fulfilled its responsibility to provide
effective controls and procedures to guard against theft and diversion. All
controlled substances destined for destruction must be rendered non-retrievable
in order to be destroyed in a manner Start Printed Page 53529consistent with
this rule. As such, a controlled substance will have been promptly destroyed if
it is promptly rendered non-retrievable. 21 CFR 1317.95. “Timely” refers to
actions that have a specific time period for compliance, e.g., 30 days.
Therefore, in each instance in which the rule uses the word “timely” to refer to
destruction requirements for reverse distributors, it refers to the specific
time period (14 days in the proposed rule, 30 days in the final rule) in which
reverse distributors are required to destroy controlled substances. 21 CFR
1317.15.

C. TYPES OF ENTITIES THAT MAY OPERATE A COLLECTION PROGRAM (9 ISSUES)

[1] Issue: Several commenters asked the DEA to retain the provision in the
proposed rule to permit retail pharmacies to maintain collection receptacles.
These commenters stated that retail pharmacies will provide a convenient option
for ultimate users who desire to safely and securely dispose of their unused or
unneeded controlled substances. Commenters also asked the DEA to retain the
provision to permit retail pharmacies to manage collection receptacles at LTCFs.

Response: The DEA appreciates the support for the provisions in the rule that
permit retail pharmacies to manage collection receptacles at not only the
primary registered location of the retail pharmacy, but also LTCFs. 21 CFR
1317.40 and 1317.80. The DEA believes that these two provisions will provide
ultimate users and others with convenient options to safely and securely dispose
of unused controlled substances. The DEA retained these provisions in the final
rule.

[2] Issue: Eighteen commenters asked the DEA to permit hospitals to become
authorized collectors so that they may maintain collection receptacles. An
additional two commenters asked the DEA to allow specialized hospitals and
clinics to maintain collection receptacles. These commenters stated that
collection receptacles located inside of hospitals would provide ultimate users
with an opportunity to dispose of medication that may no longer be needed or may
be expired.

Response: The DEA selected methods for disposal that provide opportunities for
ultimate users to securely, conveniently, and responsibly dispose of their
unused, unwanted, and expired pharmaceutical controlled substances while also
preventing diversion. As previously discussed, after extensive review and
careful deliberation, the DEA is permitting certain registered hospitals/clinics
to become authorized collectors. 21 CFR 1317.40. In order to counterbalance the
diversion risks of allowing collection receptacles to be located inside
hospitals/clinics, the DEA is only allowing those hospitals/clinics with on-site
pharmacies to become collectors. The DEA is requiring these collectors to place
collection receptacles in locations that are regularly monitored by employees,
and is prohibiting these collectors from placing collection receptacles in the
proximity of any area where emergency or urgent care is provided. 21 CFR
1317.75.

[3] Issue: One commenter suggested that hospitals of a certain size be required
to become authorized collectors.

Response: The DEA is not requiring, nor is the DEA authorized to require, any
entity to implement a collection program or maintain a collection receptacle.
The Disposal Act explicitly states that the “regulations may not require any
entity to establish or operate a delivery or disposal program.” 21 U.S.C.
822(g)(2).

[4] Issue: It was requested that the DEA allow military treatment facility
pharmacies (registered with the DEA as a hospital/clinic), and the Indian Health
Service (IHS), including IHS pharmacies (IHS, Tribal, and Urban programs) to
become authorized collectors. One commenter also suggested that the DEA permit
collection receptacles in select areas of military installations, such as
ambulatory care clinics and service member barracks.

Response: As previously discussed, any registered hospital/clinic with an
on-site pharmacy and any retail pharmacy may be authorized to be a collector. 21
CFR 1317.40. Ambulatory care clinics and service member barracks are generally
not registrants. As discussed in the NPRM, the Disposal Act did not give the DEA
authority to create new classes of registration solely for the purpose of
conducting ultimate user disposal activities. The DEA is allowing
hospitals/clinics with an on-site pharmacy and retail pharmacies to be
responsible for and manage collection receptacles in non-registrant LTCFs
because the Disposal Act acknowledged that LTCFs “face a distinct set of
obstacles to the safe disposal of controlled substances due to the increased
volume of controlled substances they handle.” 21 CFR 1317.80. LTCF residents
generally have limited mobility; accordingly, this final rule authorizes LTCFs
to dispose of controlled substances on behalf of ultimate users who reside or
have resided at the LTCF. 21 CFR 1317.30. Furthermore, un-registered ambulatory
care clinics and service member barracks generally lack adequate safeguards to
ensure the security of collected pharmaceutical controlled substances; thus,
allowing collection receptacles at such locations poses an unacceptable risk of
diversion and threatens the public health and safety.

[5] Issue: Eight commenters asked the DEA to permit non-registrants to collect
non-controlled substances for the purpose of disposal.

Response: The DEA's authority regarding drug disposal is specific to
pharmaceutical controlled substances. Non-registrants may collect non-controlled
substances pursuant to all applicable Federal, State, tribal, and local laws and
regulations; however, all regulations and laws relevant to controlled substances
will apply if controlled substances are collected, even inadvertently.

[6] Issue: One commenter asked the DEA to permit LTCFs to become authorized
collectors.

Response: The DEA is without authority to permit LTCFs to become authorized
collectors. As discussed in the NPRM, authorized collectors must first be
registrants in order for the DEA to impose and enforce these regulations upon
them. A majority of LTCFs do not have State authority with respect to controlled
substances—a fundamental prerequisite to obtaining a DEA registration. The
Disposal Act authorized the development of regulations to permit LTCFs to
dispose of controlled substances on behalf of ultimate users who reside or have
resided in their facilities. The DEA is permitting hospitals/clinics with an
on-site pharmacy and retail pharmacies to become authorized collectors with
authority to install and maintain collection receptacles at LTCFs, and declines
to extend this authority to the LTCFs themselves. 21 CFR 1317.40.

[7] Issue: Several commenters urged the DEA to create a new status that permits
non-registrant organizations to become authorized collectors for the sole
purpose of collecting controlled substances from ultimate users and others
authorized to dispose of controlled substances on behalf of ultimate users. One
commenter asked that the DEA allow non-profit, non-registrant organizations to
register as authorized collectors with a reduced fee.

Response: The DEA is not developing a new category of registrant specifically
for collecting pharmaceutical controlled substances from ultimate users. Any
entity that wishes to collect controlled substances from ultimate users must do
so in accordance with this rule, which includes provisions for specified Start
Printed Page 53530existing registrant categories to modify their registration to
become authorized as collectors. Any person not already registered with the DEA,
wishing to become authorized as a collector must first satisfy all of the
requirements for registration identified in the CSA and its implementing
regulations. Non-registrant organizations may partner with law enforcement and
with registrants that are collectors. 21 CFR 1317.65.

[8] Issue: One commenter asked the DEA to clarify how a local government may
register with the DEA to become an authorized collector.

Response: As discussed above, the DEA is not creating a new registration
category for the exclusive purpose of collecting controlled substances from
ultimate users. Persons registered with the DEA as manufacturers, distributors,
reverse distributors, NTPs, hospitals/clinics with an on-site pharmacy, or
retail pharmacies may apply to modify their registration to become an authorized
collector in the manner proscribed by this final rule. 21 CFR part 1301. Any
person not already registered with the DEA, wishing to become authorized as a
collector must first satisfy all of the requirements for registration identified
in the CSA and its implementing regulations. These requirements include being
authorized to handle controlled substances by the State in which the applicant
is located unless exempt by statute or regulation. The DEA encourages entities
that are not registrants to partner with authorized collectors or law
enforcement. 21 CFR 1317.65. For example, local governments may partner with
authorized mail-back collectors to provide mail-back packages to the public.

[9] Issue: One commenter asked the DEA to clarify that no Federal or State
government entity may require registrants to amend their DEA registration to
become authorized collectors.

Response: The Disposal Act specifically prohibits the DEA from requiring any
entity to establish or operate a delivery or disposal program. 21 U.S.C.
822(g)(2). The prohibition does not extend to every Federal and State agency and
the DEA does not have the authority to institute such a prohibition.

D. LOCATIONS WHERE AUTHORIZED COLLECTORS MAY MAINTAIN COLLECTION RECEPTACLES OR
HOST TAKE-BACK EVENTS (1 ISSUE)

[1] Issue: Six commenters asked the DEA to permit retail pharmacies to manage
collection receptacles at establishments other than the retail pharmacy's
registered location, such as community centers. Commenters stated other
locations may be more convenient for ultimate users and would thus maximize
participation. Two commenters asked the DEA to allow collection receptacles at
unregistered locations such as permanent household hazardous waste collection
sites.

Response: The DEA acknowledges that in some locations, and under certain
circumstances, alternative settings may be more convenient for ultimate users,
but that is not the only consideration. The DEA believes that in order to
adequately ensure the safety and welfare of the public, collection receptacles
must be located inside the DEA-registered location of authorized collectors. 21
CFR part 1317.75. Authorized collectors, as registrants, are readily familiar
with the security procedures and other requirements to handle controlled
substances. Most publicly-accessible locations where controlled substances are
not typically handled, such as community centers and hazardous waste collection
sites, are not targets for theft in the same manner as those locations where
pharmaceutical controlled substances are regularly handled. Thus, those
locations are unlikely to be familiar with, or to have in place, the security
controls necessary to ensure the security of collected substances and prevent
diversion of controlled substances. However, law enforcement may continue to
conduct take-back events, and other persons may partner with law enforcement to
conduct such take-back events at various locations. 21 CFR 1317.65.

E. REGISTRATION REQUIREMENTS FOR AUTHORIZED COLLECTORS (5 ISSUES)

[1] Issue: Several commenters asked the DEA to clarify whether or not
registration modifications for authorized collectors may be conducted online.

Response: Registration modifications may be conducted online. For the final
rule, the DEA is modifying the text of § 1301.51 to clarify that online
modifications are indeed permitted. Registrants may go to
www.DEAdiversion.usdoj.gov to modify their registration when they start or stop
collection activities.

[2] Issue: Three commenters stated that it is overly burdensome to require
authorized collectors to modify their registration each time they start or stop
collection activities. These commenters asked that the DEA provide additional
details regarding the registration modification process.

Response: The DEA carefully reviewed the registration requirements and did not
find indications to suggest that registration modifications will be overly
burdensome. The rule requires that a registrant must apply to modify their DEA
registration prior to initiating any collection activities. 21 CFR part 1301.
Authorization as a collector is subject to renewal in the same manner as
registration. The DEA will consider an authorized collector to be conducting
collection activities until the registration is modified, revoked, surrendered,
suspended, or otherwise terminated. If an authorized collector stops collection
activities, he/she must modify his/her registration to indicate such. The
requirement to modify a registration requires a simple written notification to
the DEA. This written notification can be easily and quickly conducted online in
a few minutes. 21 CFR part 1301. The registrant may go online and select the
option to indicate that the registrant has ceased collecting. Registrants
without ready access to the online notification method can easily and quickly
communicate such information to the DEA in writing via the mail, which the DEA
will process promptly upon receipt.

[3] Issue: One commenter suggested that the DEA relax requirements for
registration modifications regarding LTCF collection receptacles. This commenter
was concerned that registration modifications may outpace the DEA's resources.

Response: The DEA evaluated this request and determined that the registration
requirements regarding LTCF collection receptacle management are necessary to
ensure accountability and prevent diversion; the related procedures are the
minimum necessary to ensure that authorized collectors maintain the receptacles
in a manner that is consistent with the applicable regulations. 21 CFR part
1301.

[4] Issue: One commenter asked the DEA to clarify whether or not an entity may
apply for registration as a reverse distributor with the sole intent of
providing destruction services for collected substances.

Response: Any entity may apply for registration as a reverse distributor
pursuant to and in accordance with 21 U.S.C. 822-823, and 21 CFR part 1301.
Reverse distributors are not required to conduct all activities that they are
authorized to perform.

[5] Issue: Two commenters asked the DEA to clarify whether a destruction
facility must be registered with the DEA.

Response: Pursuant to this rule, a destruction facility is not required to
register with the DEA simply because a Start Printed Page 53531registrant
utilizes that facility to destroy controlled substances in a manner consistent
with this rule and all other applicable Federal, State, tribal, and local laws
and regulations. At this time, the DEA does not believe it is appropriate to
require these entities to be registered because the destroying registrant
maintains possession and control of the substances (and therefore retains
responsibility and accountability) until the substances are rendered
non-retrievable. 21 CFR part 1301. All handling, monitoring, reporting,
recordkeeping, and witnessing with regard to the destruction of pharmaceutical
controlled substances must be performed by registrants or their employees. The
DEA has omitted the language that was proposed for § 1317.15(c)(4) in order to
prevent confusion.

F. LAW ENFORCEMENT (7 ISSUES)

[1] Issue: Several commenters asked the DEA to expand the definition of “law
enforcement officer” to include law enforcement components of Federal agencies
and civilian law enforcement officers.

Response: The final rule definition is expanded from the proposed rule to
specifically include officers of the law enforcement components of Federal
agencies, and police officers of the Veterans Health Administration and the
Department of Defense. The NPRM proposed a definition of “law enforcement
officer” to include persons who are employees of a “law enforcement agency.” The
DEA is modifying this definition in the final rule to specifically include
employees of law enforcement components of Federal agencies. Any person who
meets the criteria for “employee” and “law enforcement officer” outlined in the
final rule will be a qualified officer for the purposes of disposal of
pharmaceutical controlled substances, regardless of whether the person is
considered a “civilian” law enforcement officer. 21 CFR part 1300.

[2] Issue: Four commenters stated it would be overly burdensome to require law
enforcement to have a collection receptacle that fits the specifications in the
NPRM. These commenters stated that the collection receptacle would pose
logistical issues, and that the volume of drugs collected would likely exceed
the volume that the receptacle could contain. Commenters also noted that it is
unnecessary to mandate that law enforcement utilize collection receptacles at
take-back events.

Response: Law enforcement are not required to have a collection receptacle that
meets all of the specifications in the rule, and the text of the rule is amended
to clarify that the specifications apply to authorized collectors and not law
enforcement. The only suggested requirements for the physical construction of
collection receptacles maintained by law enforcement are that they be securely
placed and maintained at the law enforcement's physical location. 21 CFR
1317.35. Also, law enforcement are not required to utilize collection
receptacles at take-back events. The text of the final rule states, “[e]ach
take-back event should have at least one receptacle for the collection of
permitted substances . . .” 21 CFR 1317.65. Thus, law enforcement should have
some sort receptacle at take-back events.

[3] Issue: Commenters expressed concern that law enforcement may not have the
facilities to store the collected substances until they are shipped to a
destruction facility.

Response: The rule suggests that law enforcement store collected substances in a
manner that is consistent with its standard procedures for storing illicit
controlled substances. The language used in the text of the rule, “should,” is
suggestive. Law enforcement are encouraged to follow the guidance in 21 CFR
1317.35; however, they are not required to do so. It should be noted that the
requirements in 21 CFR 1317.65 pertaining to law enforcement presence at
take-back events are mandated; however, the DEA only suggests procedures for the
storage and transportation of pharmaceutical controlled substances collected at
take-back events.

[4] Issue: One commenter asked the DEA to permit entities other than law
enforcement to conduct take-back events.

Response: If an authorized collector or other entity wishes to conduct a
take-back event, the event must be held in partnership with law enforcement, as
provided in the rule. 21 CFR 1317.65. Take-back events are intended to be
limited-duration events that may take place at an unregistered location that is
easily accessible to the public, such as a community center or town center.
Given the likelihood of publicity and low physical security at such locations,
the DEA believes that it is imperative to ensure active law enforcement
participation for the safety of the event participants and the community, as
well as to help deter theft and diversion of pharmaceutical controlled
substances.

[5] Issue: Commenters urged the DEA to relax the “authorized employee”
requirement for civilian law enforcement officers. These commenters stated that
the DEA should treat civilian law enforcement officers as “authorized employees”
for the purposes of this rule. They stated that these officers and employees
currently assist with take-back events, and if they were no longer permitted to,
there would be a staffing shortage to assist with take-back events.
Additionally, several commenters encouraged the DEA to allow civilian law
enforcement employees to handle collected substances if they meet the same
requirements as an employee or handle the substances in a manner consistent with
law enforcement protocols.

Response: In the NPRM, “authorized employee” referred to those registrant
personnel who would be permitted to directly participate in the disposal
process. “Authorized employee” did not pertain to law enforcement officers or to
take-back events. In the final rule the definition is modified, but it still
only pertains to those persons who may be permitted to directly participate in
the disposal process. 21 CFR part 1300. With respect to law enforcement and
take-back events, as discussed above, any person who meets the criteria for
“employee” and “law enforcement officer” outlined in the final rule will be a
qualified officer for the purposes of disposal of pharmaceutical controlled
substances, regardless of whether the person is considered a “civilian” law
enforcement officer. The DEA declines to expand the law enforcement authority to
specifically include civilian law enforcement employees. Only employed law
enforcement officers, as defined by this final rule, may handle pharmaceutical
controlled substances at take-back events. As discussed in the NPRM and previous
responses to this issue, the DEA believes that this level of security is
necessary to prevent theft and diversion and to ensure the safety of the public
due to the highly publicized nature of take-back events and the fact that such
events are likely to occur at locations with minimal security. The DEA does not
believe that this requirement will hinder the success of take-back events. As
previously discussed, only one law enforcement officer must oversee the
take-back event, and at the discretion of the law enforcement agency or law
enforcement component of a Federal agency, this officer may also be the law
enforcement officer who maintains control and custody of the collected
substances. 21 CFR 1317.65. There are no prohibitions against other persons
assisting law enforcement officers conduct the take-back event.

[6] Issue: One commenter asked the DEA to address what rights Military Start
Printed Page 53532Provost Marshal Officers have with respect to collecting
controlled substances from ultimate users.

Response: Under § 1317.35 of the new regulation, Federal law enforcement may
continue to conduct take-back events and mail-back programs, and operate
collection receptacles as further detailed in the regulation. If the Office of
the Provost Marshal is considered “Federal law enforcement,” it would be
eligible to conduct such collection activities. Federal law enforcement can, and
in some cases must, appoint a law enforcement officer to oversee those
activities. The appointed officer would then have the authority granted by
his/her agency.

[7] Issue: One commenter asked the DEA to clarify how law enforcement may
transport and deliver collected substances to a destruction facility (i.e.,
whether they may ship such substances using a common carrier) and how law
enforcement can comply with Department of Transportation (DOT) requirements when
transporting substances that may contain hazardous materials.

Response: The DEA has no expertise or authority to interpret or apply the DOT
laws, regulations, or guidelines regarding transportation of pharmaceutical
controlled substances that may constitute hazardous materials. As such,
interested persons are encouraged to contact the DOT directly with their
specific circumstances, and such persons can obtain more information at
www.phmsa.dot.gov/ hazmat. However, the DEA understands that the DOT's Hazardous
Materials Regulations apply to entities that place hazardous materials in
commercial transportation, and not government vehicles operated by government
personnel solely for non-commercial purposes. If more detailed guidance is
necessary, the DEA encourages law enforcement and other entities to consult the
DOT for guidance on transporting collected substances that may contain hazardous
materials. For additional commentary on hazardous material disposal please see
comment section “Q.” entitled “Hazardous Materials Transportation and Hazardous
Waste Destruction.”

G. COLLECTION RECEPTACLE DESIGN, INNER LINERS, PLACEMENT, AND SECURITY (24
ISSUES)

CLARIFICATION OF TERMS

[1] Issue: One commenter noted that the DEA interchangeably used the terms
“container” and “shell” when referring to the outer collection receptacle.

Response: The DEA is modifying the final rule to consistently use the term
“container” when referring to the outer portion of collection receptacles. This
change is purely for stylistic consistency and makes no substantive change to
the rule.

COLLECTION RECEPTACLE DESIGN

[2] Issue: The DEA specifically requested comments regarding the value of the
use of a uniform symbol to be placed on collection receptacles. The DEA received
22 comments regarding the use of a uniform symbol. Five commenters supported the
use of a uniform symbol, and 17 commenters opposed the use of a uniform symbol.
One commenter suggested that the symbol be yellow. Four commenters noted that
the use of such a symbol is unnecessary given the requirement to clearly mark
and label the receptacles. Three commenters expressed concern that the use of
such symbols would result in the receptacles becoming targets for diversion. One
commenter was not opposed to the use of a uniform symbol but does not believe it
is essential. One commenter indicated that the use of a uniform symbol should be
contingent upon the location and security of the collection receptacle.

Response: The DEA appreciates all of the comments submitted in response to this
request. After careful consideration, the DEA declines to include a uniform
symbol requirement in this final rule. However, the DEA may consider requiring a
uniform symbol on collection receptacles after a sufficient time to observe the
effects of the existing requirement to clearly mark and label collection
receptacles.

[3] Issue: Eleven commenters stated that any signage indicating what ultimate
users may deposit into the collection receptacle should be in plain language.
These commenters noted that most ultimate users cannot distinguish between
controlled substances and non-controlled substances. Other commenters stated
that no sign should be required at all, and others suggested the use of
pictograms instead of words. Others raised concerns that signage will draw
attention to the receptacles, thus increasing risk for theft and diversion.

Response: The final rule does not require any specific language, design, or
color choice for the display on the collection receptacle as long as the sign
indicates that only schedules II-V controlled substances and non-controlled
substances are acceptable. 21 CFR 1317.75. As explained above, comingling is
permitted but not required. 21 CFR 1317.75. Plain language, pictograms, or a
combination of the two, may be used, as long as it is clear that schedule I
controlled substances, controlled substances not lawfully possessed by the
ultimate user, and illicit or dangerous substances are not permitted to be
placed in the container. The DEA believes that some notice regarding what
substances may be disposed in collection receptacles is necessary in order to
provide guidance to the public and to discourage the use of receptacles for
disposing trash or other items. While the diversion risks presented by the
requirement for signage is mitigated by physical security requirements (e.g.,
that the receptacle be securely fastened to a permanent structure), authorized
collectors should be mindful that the selected signage not transform the
receptacle into a target for theft or diversion.

[4] Issue: Four commenters suggested that the collection receptacle sign
encourage ultimate users to remove medication from its container before placing
the medication in the collection receptacle. Several of the commenters who had
participated in authorized pharmaceutical controlled substance take-back
programs noted that the packaging for medication is voluminous, and that
including such packaging will be burdensome since it will necessitate changing
inner liners more frequently.

Response: The DEA appreciates these commenters' concerns. Although collectors
may encourage ultimate users to remove substances from their containers before
depositing them into a collection receptacle or mail-back package, the DEA
declines to require it. The DEA has declined to mandate whether substances must
be disposed of, with or without packaging, because such requirements would not
necessarily affect security or increase the risks of diversion, and as such,
should be left to the individual collectors and other relevant authorities who
best know the needs and requirements of their programs and locations.

[5] Issue: Other commenters indicated that some hazardous waste disposal
regulations require the disposal of medication containers, which may not fit
into the receptacles.

Response: As discussed in the immediately preceding comment, the DEA is neither
requiring nor prohibiting medication containers to be disposed of with
pharmaceutical controlled substances. Moreover, there is no indication that the
vast majority of medications will not fit into the “small opening” that the
collection receptacles specifications require. For additional commentary on
hazardous waste Start Printed Page 53533disposal please see comment section
“Q.”, entitled “Hazardous Materials Transportation and Hazardous Waste
Destruction.”

[6] Issue: The DEA received comments that the inner liner should be a large
plastic tub or bucket within a receptacle that can be easily removed and the
collected items either dumped into smaller containers or sorted before being
secured into storage for disposal or prior to destruction.

Response: The DEA carefully considered the specifications of both the inner
liner and the outer container of the collection receptacle. To prevent diversion
and protect the public health and safety, the DEA drafted this rule with the
precisely considered objective of limiting the number of people who handle the
collected substances. The DEA's extensive experiences in regulating and
enforcing the closed system of distribution established by the CSA have
demonstrated that a key factor in reducing diversion risk is limiting the
handling of controlled substances. In the context of disposal, this means
prohibiting the sorting of collected substances once they are deposited into a
collection receptacle.

[7] Issue: One commenter stated that the collection receptacle design
specifications will require current collection programs for non-controlled
substances to install new collection receptacles if those programs wish to
additionally collect pharmaceutical controlled substances. This commenter stated
that such installations will be burdensome and will discourage participation for
these programs.

Response: The DEA deeply appreciates the concern and activism of local
communities and other groups currently conducting non-controlled substance drug
take-back programs and their wish to expand collection activities to
pharmaceutical controlled substances. Programs such as these are an important
and vital component of the communities they serve. The DEA understands that
publication of this final rule may necessitate the need for some programs to
implement new procedures and install new equipment in order to additionally
collect pharmaceutical controlled substances. The DEA has not established the
new requirements lightly or without considerable deliberation as to its impacts
on existing programs. However, the risk of diversion for non-controlled
substances is relatively low compared to the much higher risk of diversion, and
the corresponding and associated risks to public health and safety, for
pharmaceutical controlled substances. The DEA has been charged by Congress with
the enforcement of the controlled substance laws of the United States, and must
ensure that pharmaceutical controlled substances are properly secured and not
easily susceptible to theft or diversion. Accordingly, the collection receptacle
design specifications outlined in § 1317.75 will be implemented as proposed.

[8] Issue: A commenter asked the DEA to permit the use of similar receptacles
that may already exist and were designed for the deposit and storage of medical
waste.

Response: The DEA is not prohibiting the use of collection receptacles that
currently exist on the market as long as such receptacles meet all of the design
specifications outlined in § 1317.75 of this rule.

[9] Issue: Five commenters stated that the requirement for a collection
receptacle to be fastened to a permanent structure is burdensome. Several
commenters pointed out that many pharmacies do not own the property that is
their DEA-registered location, and such fixtures and installments are
prohibited. One commenter pointed out that this requirement would be
particularly burdensome for small, rural pharmacies. Another commenter asked if
the requirement applies if the collection receptacle is located in a locked
room, inaccessible to the public.

Response: The DEA appreciates the willingness of pharmacies to aid in the
societal goal of helping to combat unauthorized access to and abuse of
pharmaceutical controlled substances. The DEA understands that there may be
logistical concerns for some retail pharmacies that wish to maintain a
collection receptacle at their registered location. However, the DEA believes
that permanently-secured, fixed containers are the minimum required to prevent
diversion and theft of collected substances. The requirement that collection
receptacles be securely fastened to a permanent structure applies to all
authorized collectors' collection receptacles, no matter the location of the
registrant. 21 CFR 1317.75. Although the final rule does not expressly prohibit
collection receptacles from being placed in a locked room that is inaccessible
to the public, the final rule does mandate that collection receptacles at
authorized collectors' registered locations must be accessible to ultimate
users, and others authorized to dispose of controlled substances on behalf of
ultimate users, as they are the only people who may deposit pharmaceutical
controlled substances into a collection receptacle (e.g., ultimate users cannot
transfer pharmaceutical controlled substances to pharmacy staff). 21 CFR
1317.30. The DEA encourages retail pharmacies leasing their commercial space to
work with their landlords to allow for the installation of collection
receptacles under the conditions established by this rule.

[10] Issue: Nine commenters stated that requiring an outer container with an
inner liner is unnecessary and burdensome. These commenters proposed that the
collection receptacle be designed in such a way that it can be returned to the
reverse distributor as a complete unit.

Response: The DEA appreciates the value in utilizing temporarily secured
containers that can be sealed and shipped for destruction; however, the DEA
believes that such systems present an unreasonable risk of diversion because,
even when secured, such containers can be relatively easily removed when
compared to a securely fastened and locked outer container. Relatedly, the DEA
is requiring that collection receptacles be “substantially constructed,” which
is intended to ensure that the construction is such that unauthorized access to
the contents of the receptacle is not easily obtained. 21 CFR 1317.75.
Accordingly, the DEA is requiring that collection receptacles have a
substantially-constructed outer container and removable inner liners. 21 CFR
1317.60 and 1317.75.

[11] Issue: Three commenters stated that the collection receptacle should not be
required to have a traditional lock, but that its opening be designed so that
that the contents cannot be removed.

Response: In implementing the Disposal Act to provide secure and responsible
disposal methods for pharmaceutical controlled substances by ultimate users, the
DEA must ensure that collected substances are properly secured and not easily
susceptible to theft or diversion. The requirements pertaining to collection
receptacles were carefully considered and designed to limit the handling of the
controlled substances, from ultimate user to destruction. These considerations
dictated the size of the opening. However, the NPRM and the final rule allow for
flexibility regarding a traditional lock, and require that “the small opening in
the outer container of the collection receptacle shall be locked or made
otherwise inaccessible to the public when an employee is not present (e.g., when
the pharmacy is closed).” 21 CFR 1317.75(f).

[12] Issue: One commenter suggested that the DEA conduct a national pilot
program prior to implementation of the final rule to ensure that collection
Start Printed Page 53534receptacle requirements are feasible and effective.

Response: The DEA believes that the need to implement this rule in order to
allow secure convenient options for disposal outweighs the delay and limited
benefit that may be obtained by implementing any pilot programs or other testing
or research. Through various outreach efforts, including the public meeting the
DEA held in January 2011, comments from industry, and information obtained from
pilot programs, the DEA believes that it has effectively researched and analyzed
the various aspects of this rule. Also, the DEA believes that implementation of
this rule is important to helping reduce the amount of unwanted pharmaceutical
controlled substances available for theft, diversion, and accidental ingestion.

[13] Issue: One commenter asked the DEA to allow a Special Agent in Charge (SAC)
to approve container and inner liner designs.

Response: As discussed in the NPRM, the DEA determined that the elimination of
individual SAC approval for various aspects of disposal or destruction is
necessary in order to ensure clear and consistent requirements throughout the
United States, thus reducing the potential for confusion regarding requirements
for ultimate users and authorized collectors. Specific approval of individual
collection receptacles and inner liner designs is not required. All collection
receptacles and inner liner designs must meet the specifications outlined in
this final rule. 21 CFR 1317.60 and 1317.75.

[14] Issue: One commenter suggested that national pharmacy organizations educate
the public on proper disposal methods and various disposal options. This
commenter suggested that such organizations post information online and
disseminate leaflets at retail establishments.

Response: With regard to patient information regarding disposal, the DEA is not
requiring any entity to educate the public on proper disposal methods and their
various disposal options. However, the DEA anticipates that many entities will
voluntarily choose to do so. The DEA applauds and encourages voluntary,
educational outreach to the public on issues related to the abuse potential and
proper disposal of pharmaceutical controlled substances, whether it be through
law enforcement, community groups, or professional organizations.

COLLECTION RECEPTACLE INNER LINERS

[15] Issue: Several commenters asked for clarification regarding inner liner
tracking requirements. Specifically, commenters asked how unique identification
numbers should be assigned, how tracking systems are to be implemented, and what
entity will be responsible for placing identification numbers on inner liners.
One commenter suggested that the DEA regulate the manufacture of inner liners or
require that inner liners be sequentially numbered.

Response: The rule outlines the design requirements and the recordkeeping
requirements for inner liners. The purpose of a unique identification number is
to provide for complete and accurate records that can be inventoried to ensure
that each liner is accounted for from receipt, to installation, removal,
storage, transfer, and destruction. 21 CFR part 1304. The unique identification
numbers therefore must be unique to the individual collector. 21 CFR 1317.60.
The DEA does not intend to require any particular method for assigning such
numbers and is modifying the text of proposed § 1317.60(e) by indicating that
only inner liners must bear a permanent, unique identification number. The
company manufacturing the inner liners may assign the numbers. The DEA does not
have authority to directly regulate the manufacturers of the inner liners.

[16] Issue: One commenter suggested that the inner liner be clear so that it can
be visually inspected for non-compliant items.

Response: Due to associated increased risks for diversion, the DEA determined
that the contents of the inner liners must not be viewable once the inner liner
is sealed. 21 CFR 1317.60. The DEA appreciates the concerns regarding certain
non-compliant items being placed in collection receptacles; however, for reasons
discussed in previous comments, no one is permitted to handle the contents of
inner liners. 21 CFR 1317.75. The DEA would like to point out that the text of
the rule does not prohibit items from being observed prior to being placed in
the collection receptacle, which could be an effective way to ensure that such
non-compliant items are not placed in the collection receptacle.

[17] Issue: Several commenters indicated that the requirement to store sealed
inner liners in the same manner as schedule II controlled substances will be
overly burdensome and will reduce the amount of space available for storing
schedule II inventory at retail pharmacies. These commenters suggested that the
DEA allow the authorized collector to transfer collected substances in inner
liners to a secure warehouse facility for storage until they can be picked up or
shipped.

Response: The DEA appreciates these concerns but declines to permit authorized
collectors to transfer collected substances to warehouse facilities for storage.
Filled inner liners must be stored only at primary registered locations (and at
LTCFs in accordance with § 1317.80(c)) and may not be transported to off-site
warehouses. The basis for this requirement is that the risk of diversion
increases each time inner liners change hands or are transported. However, as
previously discussed, this final rule expands the NPRM requirement and
authorizes practitioners to store collected substances at their registered
location in either a securely locked, substantially constructed cabinet or a
securely locked room with controlled access. 21 CFR 1317.05.

[18] Issue: Four commenters stated that the DEA should permit schedule I
controlled substances to be disposed of via collection receptacles, mail-back
packages, or take-back events.

Response: The Disposal Act addresses the issue of unused prescription drugs, and
it allows the DEA to provide ultimate users with a secure and responsible method
to dispose of pharmaceutical controlled substances. This rule does not address
the disposal of illicit controlled substances, e.g., those substances controlled
in schedule I of the CSA. Schedule I controlled substances, by definition, have
no accepted medical use in treatment in the United States, and may not be
lawfully prescribed or otherwise distributed to any person. In fact, any
transfer of a schedule I controlled substance by an ultimate user is a violation
of the CSA, unless the ultimate user is participating in an investigational use
of drugs pursuant to 21 U.S.C. 355(i) and 360b(j), and the delivery is conducted
in accordance with 21 CFR 1317.85.

COLLECTION RECEPTACLE PLACEMENT AND SAFETY

[19] Issue: Ten commenters expressed concern regarding security in retail
pharmacies with collection receptacles. Several commenters asked the DEA to
provide guidance for proper security measures. One commenter asked for
clarification on an authorized collector's liability should a receptacle become
subject to diversion or if improper substances are deposited.

Response: The DEA appreciates the concerns of the commenters and has carefully
considered the risks and benefits associated with collection receptacles located
in authorized retail pharmacies. The DEA's rationale for Start Printed Page
53535allowing collection at authorized retail pharmacies was described in the
NPRM. As previously noted, the DEA is not requiring any pharmacy to provide a
collection receptacle. Each registrant is free to weigh the risks and benefits
in determining whether or not to seek status as an authorized collector. The DEA
proposed the rule with the security requirement for permanently-secured, fixed
containers based on a determination that this was the minimum required to help
reduce the risk of diversion and theft of pharmaceutical controlled substances.
21 CFR 1317.75. At retail pharmacies, the location of collection receptacles
within the immediate proximity of a designated area where controlled substances
are stored and at which an employee is present is anticipated to provide an
additional layer of security due to the increased visibility of the receptacles.
21 CFR 1317.75. While potential violations of the CSA and its implementing
regulations are investigated and assessed independently, this final rule imposes
the minimum required procedures to prevent and detect diversion. Even so, each
authorized collector's circumstances are unique. All registrants should be
mindful of their responsibility to provide effective controls and procedures to
guard against theft and diversion under 21 CFR 1301.71(a), and their duty to
report thefts and significant losses of controlled substances under 21 CFR
1301.74 and 1301.76.

[20] Issue: One commenter suggested that the inner liners be nondescript and
free of any markings that would indicate their contents. This commenter was
concerned that any markings on the inner liners would increase diversion risks
and make them potential targets for drug seekers.

Response: The DEA appreciates the commenter's concern for potential diversion
risks that inner liners might pose, and made the determination to require them
only after careful consideration of the associated risks and benefits of their
use, and alternatives to their use. The DEA is requiring the size of the inner
liner to be clearly marked on the outside of the liner, and for the inner liner
to bear a unique identification number in order to help ensure accountability,
and to identify and prevent diversion. 21 CFR 1317.60. Given the totality of
information reviewed, the DEA concluded that a requirement for the contents to
be non-viewable once the inner liner is sealed will help reduce diversion risks
and deter drug seekers.

[21] Issue: One commenter stated that requiring contents of the inner liner to
be non-viewable could lead to diversion as staff could record controlled
substances as being disposed of without actually placing them into the
receptacle.

Response: The rule prohibits authorized collectors' staff from handling
collected substances, even for the purpose of depositing them into the
collection receptacle. Ultimate users, and those who are authorized to handle
controlled substances on behalf of ultimate users for the purpose of disposal,
are the only persons who may deposit pharmaceutical controlled substances into a
collection receptacle. 21 CFR 1317.30. Therefore, the DEA does not envision a
circumstance where pharmaceutical controlled substances might be recorded as
having been disposed of, but were in actuality diverted as a result of pharmacy
staff never having placed the substances into the collection receptacle.

[22] Issue: One commenter indicated that the use of an inner liner that is
removable and sealable immediately upon removal without emptying or touching the
contents is impractical because the contents may spill or fall out and then must
be handled.

Response: The DEA carefully considered the design and security requirements for
inner liners and determined that the collection receptacle option will help to
minimize the risk of diversion while ensuring safety and convenience for
ultimate users and collectors. As discussed in the NPRM, inner liners that allow
opportunities for collectors to sort or otherwise handle the collected
substances would decrease security and increase the risk of diversion. The DEA
does not believe that overfill or spillage from the inner liners will be a
concern as the requirement that inner liners fit within the outer container of
the collection receptacle is designed to prevent such occurrences. However,
security requirements, such as the presence of two employees to remove or
supervise the removal of an inner liner, help reduce the risk of theft and
diversion if such instances do occur. 21 CFR 1304.22, 1317.60, and 1317.75. If
spillage occurs, a registrant's responsibility to provide effective controls and
procedures to guard against theft and diversion of controlled substances would
require the registrant to take corrective action to prevent spillage from
recurring.

[23] Issue: Several commenters asked the DEA to identify the maximum allowable
capacity for a receptacle and the maximum duration that controlled substances
may be stored in the receptacle.

Response: There is no maximum or minimum capacity for collection receptacles at
this time. Although there is no maximum duration that the collected substances
may remain in the collection receptacle at this time, authorized collectors are
reminded of their responsibility to provide effective controls and procedures to
guard against theft and diversion, 21 CFR 1301.71(a), and their duty to report
thefts and significant losses of controlled substances under 21 CFR 1301.74 and
1301.76.

[24] Issue: Several commenters asked the DEA to allow “disposal companies,”
distributors, and reverse distributors to manage and maintain collection
receptacles at the registered locations of authorized collector retail
pharmacies and at LTCFs on behalf of the authorized collector retail pharmacies.
These commenters also asked if such entities may establish a fee system for such
services.

Response: Distributors and reverse distributors will not be permitted to manage
or maintain collection receptacles at retail pharmacies or LTCFs. 21 CFR 1317.40
and 1317.80. The DEA determined that no entities other than retail pharmacies
and hospitals/clinics with an on-site pharmacy will be permitted to manage
collection receptacles at LTCFs. 21 CFR 1317.40 and 1317.80. As discussed in the
NPRM, this rule establishes a checked system of transfers where each registrant
who handles collected substances serves as a source of verification for the
other registrants that handle the same substances, thus ensuring that the
collected substances reach their intended destination with accountability and a
reduced risk of diversion. In order to maintain this system, all collected
substances must be handled in the manner described in this rule, including the
requirement that the handling of a collection receptacle inner liner be
restricted to employees of the authorized collector as provided, with the
limited exception for LTCFs. 21 CFR 1317.80. Such requirements ensure that
persons handling collected substances during the disposal process are
accountable to their employer, and the number of entities handling the collected
substances is reduced while also providing a secure system of checks that
increases the level of accountability.

H. MAIL-BACK PROGRAMS (11 ISSUES)

[1] Issue: Thirteen commenters stated that the on-site destruction requirement
for mail-back programs is severely Start Printed Page 53536limiting due to the
limited number of commercial incinerators. These commenters urged the DEA to
allow collectors to receive mail-back packages whether or not they have a means
of on-site destruction. Several commenters also asked the DEA to allow
collectors to use a third party to destroy mail-back packages.

Response: As discussed in the NPRM, an on-site method of destruction for
mail-back packages is the minimum necessary to prevent diversion of controlled
substances destined for destruction. 21 CFR 1317.05. Importantly, an on-site
method of destruction reduces the accumulation of controlled substances in a
single location, and minimizes the transfer of controlled substances between
various locations. This is intended to help minimize the risk of diversion. For
each of the three methods of ultimate user disposal included in this rule, the
DEA has attempted to minimize the number of entities that handle the collected
substances in order to minimize the risk of diversion, which increases each time
a controlled substance is transferred to a new person. It is emphasized that
authorized collectors may partner with reverse distributors and other authorized
registrants with on-site methods of destruction to promote mail-back programs,
e.g., empty mail-back packages may be disseminated at hospitals/clinics and
retail pharmacies and mailed back to a reverse distributor with an on-site
method of destruction.

[2] Issue: One commenter strongly supports the requirement that authorized
collectors who conduct a mail-back program use an on-site method of destruction;
however, other commenters expressed concern that the requirement would
discourage authorized collectors from conducting mail-back programs. Several
commenters noted that very few destruction facilities currently exist and there
was concern that such facilities do not have proper security to handle
controlled substances.

Response: As indicated in the previous response, mail-back programs have the
potential to provide a secure and responsible means of disposal without
geographical restriction within the United States. As such, the existence of a
small number of appropriate destruction sites should not impact ultimate users'
ability to participate or the potential for mail-back programs to develop. In
other words, a single destruction site can support many different mail-back
programs and an unlimited number of mail-back packages may be provided to
ultimate users at various locations throughout the United States to be mailed
back to a single destruction site. Also, as discussed in the NPRM, the DEA hopes
that the rule will encourage innovation and expansion of destruction methods
beyond incineration so that additional entities may provide destruction services
for mail-back programs in the future.

[3] Issue: A few commenters expressed concern that no entities will undertake
the implementation of a mail-back program because of the related expense, noting
that the requirement that mail-back packages be pre-addressed with pre-paid
postage will be very costly. A commenter also asked the DEA to clarify whether
unregistered retail pharmacies working with a registered authorized collector
would be permitted to make mail-back packages available to patients.

Response: As discussed in the NPRM, authorized collectors who conduct mail-back
programs are encouraged to collaborate to operate mail-back programs by
partnering with other entities to assist with the dissemination of mail-back
packages to ultimate users, in order to minimize costs. Additionally, pre-paid
postage will ensure that the package is not returned to sender, which will help
reduce its handling and therefore, the diversion risks. Pre-addressed envelopes
will help ensure that the package is delivered to the authorized location.

[4] Issue: One commenter asked the DEA to clarify whether there are specific
testing requirements in regard to the packaging standards (e.g., water/spill
proof, tear resistant, sealable, etc.). One commenter asked the DEA to clarify
the distinction between packages damaged as part of normal transport and
packages damaged by other means, such as tampering.

Response: The DEA is not requiring specific testing requirements to ensure
packages meet the standards provided in § 1317.70 (e.g., water/spill proof, tear
resistant, sealable, etc.). However, the packages must be consistent with these
standards. Collectors authorized to receive mail-back packages must make a
determination based on the facts and circumstances as to whether or not an
apparently damaged package became so through normal transportation or through
tampering or other intentional means.

[5] Issue: Commenters expressed concern that the requirement for mail-back
collectors to issue mail-back packages with unique identification numbers is
burdensome and does not seem to provide any useful information since ultimate
users are not required to notify collectors that they have mailed a package, and
it is likely that many packages will not be used. Five commenters asked the DEA
to explicitly state that authorized collectors who conduct mail-back programs
will not be responsible for reconciling mail-back packages that were never
returned.

Response: The DEA believes that recording the unique identification numbers of
mail-back packages in accordance with § 1317.70 is a reasonable recordkeeping
requirement designed to help identify and prevent diversion; this information
can aid investigations and is useful for that purpose alone. The DEA recognizes
that disseminated packages may go unused, and this alone should not form the
basis for unreasonable scrutiny of authorized collectors. Additionally, at this
time, authorized collectors are not responsible for tracking mail-back packages
that were disseminated but never returned.

[6] Issue: One commenter disagreed with the DEA's assessment that mail-back
programs are more susceptible to diversion and therefore require stricter
controls.

Response: The DEA carefully considered the diversion risks in mail-back
programs. Based on the DEA's experience, the DEA believes that the risks of
diversion associated with mail-back programs are great because of necessary
actions including the handling of the packages, mail sorting, and mail delivery
by non-registrants. The DEA believes that the security measures established by
this rule are the minimum required to reduce the risk of diversion inherent to
mail-back programs.

[7] Issue: One commenter expressed concern that mail-back packages would be
subject to greater risks of diversion in rural areas.

Response: The DEA appreciates the commenter's concern. The DEA has considered
the diversion risks for mail-back programs, including packages originating in
rural areas. It may be true that mail-back packages originating in some rural
areas may be subject to an increased risk of diversion due to fewer people being
able to readily witness theft from a mailbox. However, it may also be true that
risks of diversion from mail-back programs might be lower in rural areas due to
less traffic (pedestrian, vehicular, or equine), resulting in fewer
opportunities for tampering with or theft of mail-back packages. Regardless, the
DEA believes that the relative risks of diversion of mail-back packages in rural
areas are mitigated by the required security procedures and are outweighed by
the benefits of providing ultimate users a means to dispose of unused, unwanted,
Start Printed Page 53537or expired pharmaceutical controlled substances.

[8] Issue: The United States Postal Service (USPS) has raised a number of issues
relating specifically to the mail-back program, and also to the disposal
regulations in general. The USPS asked the DEA to make several changes to the
terminology used in the proposed rule, so that the DEA regulations will be
consistent with standard USPS products and services. The USPS also requested
that the DEA clarify that all registrants must comply with USPS laws and
regulations, including applicable USPS requirements for packaging and mailing
pharmaceuticals.

The USPS asked the DEA to consistently refer to “mail-back packages” as “mailing
packages” rather than “mailers” as the USPS refers to “mailers” as persons or
entities entering a mailing. The USPS also asked the DEA to remove any
references to “business reply mail” that are inconsistent with the USPS's use of
the term. The USPS asked that proposed § 1317.85 specify that ultimate users may
return recalled controlled substances to the manufacturer or other authorized
registrant by U.S. Mail. The USPS also asked the DEA to clarify that inner
liners are requirements for collection receptacles—not mail-back packages.

The USPS also requested that the DEA state that collectors operating a mail-back
program must exclusively use the United States Postal Service. The USPS also
asked the DEA to make all references to “mail system” in the preamble refer
exclusively to the United States Postal Service. The USPS asked that they not be
prohibited from transporting controlled substances to a reverse distributor on
behalf of law enforcement, especially in light of the fact that law enforcement
may operate mail-back programs.

Response: The DEA appreciates the time taken by the USPS to review the proposed
rule and submit thoughtful comments with their concerns and suggestions. In
addition, the DEA acknowledges that the USPS understands these regulations and
has experience responsibly handling controlled substances. The DEA is modifying
some of the terminology that was used in the NPRM, per the USPS's concerns and
suggestions. Rather than use the term “mailing packages,” all references to
“mailers” are changed to “mail-back packages.” The DEA believes this will better
avoid the confusion regarding “mailers” being defined as persons or entities
that enter a “mailing.” The reference to “business reply mail” is also removed.
The DEA declines to specify that “mail” or “mail system” refers exclusively to
the USPS; however, the USPS is a shipping option.

Additionally, in § 1317.85, ultimate users still have the options to return a
recalled controlled substance as is currently allowed under § 1307.12 of the
existing regulations. The text of the rule clearly states that all persons and
entities must comply with applicable Federal laws and regulations, which
includes USPS laws and regulations. Also, inner liners are requirements for
collection receptacles—not mail-back packages. The mail-back package
specifications are outlined in § 1317.70.

While the USPS asked that the text of the regulation specifically state that
mail-back packages may be sent via the U.S. Postal Service as well as by common
or contract carrier, the DEA declines to make this change. The DEA considers the
USPS to be a common or contract carrier for purposes of the CSA.

[9] Issue: One commenter asked the DEA to clarify whether the regulation that
requires mail-back programs to include only mail-back packages mailed from
within the United States will preclude USPS-serviced mail-back programs in any
of the areas in which it operates (e.g., the Caribbean District, other
territories such as Guam, and United States military installations).

Response: The term “import” means “any bringing in or introduction of” a
controlled substance into any area. Pursuant to 21 U.S.C. 952, it is unlawful to
import controlled substances into the customs territory of the United States
(the 50 States, the District of Columbia, and Puerto Rico), except under
specific circumstances not relevant to ultimate user disposal. Thus, an ultimate
user located outside of the customs territory of the United States is not
permitted to send a mail-back package into the customs territory of the United
States.

[10] Issue: One commenter asked the DEA to clarify whether authorized collectors
operating mail-back programs may use carrier services that allow packages to be
held at a carrier facility until the packages can be picked up.

Response: Although some changes to business operations may need to occur in
order for an authorized collector to effectively establish and maintain a
mail-back program, the requirements established by this rule are the minimum
required to detect and prevent diversion. As described in this rule, mail-back
packages must be pre-addressed to the authorized mail-back location with the
on-site destruction method, and thus, the packages must be delivered to the
authorized mail-back location rather than picked up by the collector. 21 CFR
1317.70. The pre-addressed delivery location must be capable of receiving such
deliveries on a regular basis without interruption. Otherwise, the opportunities
for diversion increase as the packages are delayed or stored during transit.

[11] Issue: One commenter suggested that the DEA establish a national mail-back
program.

Response: This rule authorizes certain collectors to conduct mail-back programs.
21 CFR 1317.40 and 1317.70. There is no limitation regarding the geographic
coverage of mail-back programs within the United States if the programs comply
with all applicable Federal, State, tribal, and local laws and regulations. At
this time, the DEA does not have the resources to operate a national mail-back
program.

I. TAKE-BACK EVENTS (6 ISSUES)

[1] Issue: One commenter indicated it would be difficult for ultimate users to
participate in take-back events, particularly in rural areas.

Response: The DEA has attempted to expand the variety of disposal options while
also ensuring secure and responsible drug disposal, and the DEA anticipates that
the expansion to include certain hospitals/clinics to become authorized as
collectors will provide more disposal options for ultimate users, including
those in rural areas. Additionally, the DEA encourages those persons living in
rural areas who are unable to utilize a collection receptacle or attend a
take-back event to dispose of unwanted pharmaceutical controlled substances in
the same manner in which the pharmaceutical controlled substances were received,
i.e., if the substances were delivered by a mail-order pharmacy, the DEA
encourages the pharmacy to include a mail-back package for safe disposal; or, if
the substances were dispensed at a pharmacy, the DEA encourages pharmacies to
have a collection receptacle available for safe disposal. Nonetheless, the DEA
recognizes that some ultimate users may not have convenient access to any of the
disposal options available in this rule. Until the availability of these
disposal options increases, ultimate users who wish to dispose of unwanted
pharmaceutical controlled substances may continue to dispose of them in manners
consistent with all applicable Federal, State, tribal, and local laws and
regulations. The DEA's Office of Diversion Control Web site provides information
regarding safe disposal of pharmaceutical controlled substances, including
guidance from the FDA and the EPA. Ultimate users can find this information at
www.DEAdiversion.usdoj.gov.Start Printed Page 53538

[2] Issue: Several people asked the DEA to clarify the role of law enforcement
at take-back events. One commenter asked the DEA to relax the two-employee
requirement for law enforcement officers handling collected substances. Another
commenter stated that law enforcement officer supervision, rather than direct
participation, should suffice.

Response: Law enforcement must appoint at least one law enforcement officer
employed by the agency to oversee collection at the take-back event. 21 CFR
1317.65. “Oversee” has its common, everyday meaning: To supervise, manage, watch
over, and direct in an official capacity. The direct participation this rule
mandates is that a law enforcement officer must maintain custody and control of
the collected substances from the time they are collected to the point in time
that they are securely transferred, stored, or destroyed. 21 CFR 1317.65. This
rule does not require two law enforcement officers to be present at take-back
events; however, law enforcement may determine that two or more law enforcement
officers are necessary at a particular take-back event due to safety and
security concerns. In the alternative, law enforcement may determine that the
same law enforcement officer may oversee the take back event and also maintain
custody and control of the collected substances from the time the substances are
collected from the ultimate user or person authorized to dispose of the ultimate
user decedent's property until secure transfer, storage, or destruction has
occurred, as outlined in § 1317.65(b). Although the participation of law
enforcement is required at take-back events, the DEA is not requiring law
enforcement to hold or participate in take-back events. As discussed in the
NPRM, law enforcement must determine how often available resources allow them to
hold take-back events.

[3] Issue: A few commenters requested that the DEA allow other authorized
collectors, such as retail pharmacies and reverse distributors, to become
authorized to hold take-back events. One commenter stated that law enforcement
officers' presence should be optional if there is a collection receptacle at the
event that meets the specifications in the rule.

Response: If an authorized collector or other entity wishes to conduct a
take-back event, the event must be held in partnership with law enforcement. 21
CFR 1317.65. Take-back events are intended to be limited-duration events that
may take place at an unsecure location that is easily accessible to the public,
such as a community center or town center. Given the likelihood of publicity and
limited physical security at such locations, the DEA believes that it is
important to ensure active law enforcement participation for the safety of the
event participants and the community. The DEA believes that active law
enforcement participation will help deter theft and reduce diversion risks. The
presence of a collection receptacle at a take-back event does not preclude the
need for law enforcement presence at the collection site because the publicity
for the event increases the receptacle's visibility for drug seekers, thus
increasing diversion risks.

[4] Issue: A number of entities expressed concern that the implementation of
this rule will result in the cessation of DEA-sponsored national take-back
events. These commenters felt that take-back events will be too costly for
communities and law enforcement, and commenters suggested that the DEA continue
take-back events and provide a transition plan from the national take-back
events until implementation of the rule.

Response: The DEA-sponsored national take-back events were initiated as a means
of providing safe and convenient disposal of pharmaceutical controlled
substances by ultimate users until alternative options could be implemented. The
DEA is committed to continuing national take-back events until the effective
date of this final rule. The DEA believes that implementation of disposal
methods is best tailored to local communities by local communities. The DEA
encourages public and private partnerships to optimize the expanded disposal
options in a cost-efficient manner.

[5] Issue: One commenter expressed concern that existing take-back events would
likely be unable to continue under this rule. This commenter was concerned that
the prohibition of sorting would cause a burden since non-controlled substances
and packaging could not be sorted from controlled substances. This commenter
stated that it will be overly burdensome for programs to handle all collected
substances as schedule II controlled substances.

Response: The DEA does not intend for this rule to require changes to existing
non-controlled substance take-back programs. The security measures required by
this rule are the minimum necessary to ensure a safe and secure means of
disposal of pharmaceutical controlled substances. It should be noted however,
that law enforcement are not required to follow the physical security
requirements for handling, sorting, or storing collected controlled substances.
21 CFR 1317.35. The physical security requirements applicable to law enforcement
in the final rule at §§ 1317.35 and 1317.65 state that law enforcement “should”
take certain measures; and that law enforcement “shall” appoint a law
enforcement officer to oversee a take-back event and law enforcement officers
“shall” maintain custody and control of the collected substances. Additionally,
this rule provides a number of previously unavailable means of ultimate user
disposal that are likely to decrease the frequency of and need for community
take-back events. The DEA would like to clarify that comingling of controlled
and non-controlled substances is permitted, but not required, and co-sponsors of
take-back events may specify that only controlled substances will be accepted.
Another method to alleviate the burdens would be to provide a separate
receptacle for non-controlled substances at the take-back event. Additionally,
as discussed in response to previous comments, this rule does not require that
collected substances be in their original packaging, and law enforcement may
discourage or prohibit ultimate users from disposing of original packaging into
the collection receptacle for controlled substances at take back-events.

[6] Issue: One commenter indicated that municipalities and other organizations
should be permitted to “take the lead” in organizing and conducting take-back
events in conjunction with, and in the presence of, law enforcement. Other
commenters raised concerns that such events conducted in partnership with local
government and community groups would no longer be allowed, and that the
requirements would prevent controlled substance take-back events from being held
concurrently with other take-back events, such as for the disposal of hazardous
waste and non-controlled substances.

Response: The rule permits any entity to partner with law enforcement to hold a
pharmaceutical controlled substances take-back event. 21 CFR 1317.65(a).
Municipalities or other organizations may partner with law enforcement as long
as such events are conducted in accordance with all applicable laws and
regulations pertaining to the disposal of pharmaceutical controlled substances.
The DEA emphasizes that take-back events are intended to be one-time or periodic
events held in a community center or other convenient and accessible location,
and that there is no Start Printed Page 53539prohibition against holding such
events in conjunction with events for the disposal of other substances, such as
hazardous waste or non-controlled pharmaceuticals.

J. PROHIBITION ON HANDLING, SORTING, AND INVENTORYING INNER LINER CONTENTS AND
MAIL-BACK PACKAGE CONTENTS (8 ISSUES)

[1] Issue: One commenter adamantly stated that collected substances should not
be sorted under any circumstances. This commenter expressed concerns about
diversion risks and the brokering of unused controlled substances.

Response: The DEA agrees that the diversion risks of handling, sorting, or
inventorying collected substances outweigh any perceived benefits. The DEA has
carefully considered all of the various commenters' concerns on the prohibition
of handling, sorting, and inventorying inner liner contents and mail-back
package contents, and will retain these prohibitions. As provided in
§§ 1317.60(c) and 1317.70(f), inner liners shall be sealed immediately upon
removal from the permanent outer container; sealed inner liners and returned
mail-back packages shall not be opened, x-rayed, analyzed, or otherwise
penetrated. Accordingly, their contents shall not be sorted or inventoried
subsequent to being placed into a collection receptacle or mail-back package. To
clarify this, § 1317.75(c) was modified to add the prohibition against
individually handling substances after they have been deposited into a
collection receptacle. These specific security measures are designed to help
prevent and reduce the opportunities for diversion (including the
re-introduction of tainted pharmaceutical controlled substances into the stream
of commerce).

[2] Issue: Twenty-four commenters stated that pharmacists and other volunteers
should be permitted to sort collected substances, particularly in the presence
of law enforcement officers at take-back events. One commenter stated that the
DEA should recognize the accountability, expertise, and experience of healthcare
professionals, and the DEA should utilize these experts in an effort to broaden
medication disposal efforts.

Response: The DEA appreciates the valuable expertise and experience of
healthcare professionals, including pharmacists. The DEA has carefully
considered the comments in response to the NPRM, and the remarks at the January
2011 public meeting. The DEA believes that the disposal methods outlined in this
rule will provide ultimate users and their authorized representatives with
expanded options to safely and securely dispose of unwanted, unused, and expired
pharmaceutical controlled substances. Pursuant to § 1317.65, law enforcement may
continue to conduct take-back events when a law enforcement officer maintains
control and custody of collected substances at take-back events and only the
ultimate user transfers controlled substances to law enforcement control and
custody. However, non-law enforcement personnel may assist the law enforcement
officer, and the final rule does not prohibit healthcare professionals from
voluntarily polling ultimate users about the substances they are discarding or
from assisting ultimate users to separate pharmaceutical controlled substances
from non-controlled substances during the disposal process, and inventorying the
non-controlled substances.

Furthermore, nothing in this rule prohibits law enforcement from partnering with
authorized collectors or other entities to inventory or sort substances that
have been collected by law enforcement provided that the collected substances
remain under the control and custody of law enforcement. This final rule in
§ 1317.65(b) requires that law enforcement maintain control and custody of the
collected substances from the time the substances are collected until secure
transfer, storage, and destruction has occurred. Therefore, if law enforcement
opts to inventory or sort collected substances within their possession, law
enforcement should provide adequate security to prevent diversion or theft of
controlled substances within their possession and control as a result of, or
during, inventorying or sorting.

[3] Issue: Thirty-eight commenters stated that the DEA should permit collectors
or certain non-registered persons to handle, sort, and inventory collected
substances for data collection and research purposes. Many of these commenters
urged the DEA to provide an exception to allow pharmacists and volunteers to
inventory and sort controlled substances under the supervision of law
enforcement officers. Numerous commenters stated that inventorying collected
substances is crucial to determining a root cause analysis of medication waste.
Others stated that such information could help guide prescribing practices and
be used in educational settings. Several commenters stated that inventorying
collected substances is necessary to determine outcome measures for grants for
disposal programs. Also, several commenters stated that the DEA should provide
an exception for Institutional Review Board-approved research projects.

Response: The DEA understands and appreciates these comments. As discussed in
the preceding response, law enforcement has the discretion to partner with other
entities to conduct a take-back event pursuant to § 1317.65(a). There are no
restrictions on how law enforcement handles the collected substances so long as
they maintain control and custody of the substance. Accordingly, law enforcement
may inventory and sort substances that law enforcement collects. The
diversion-related concerns present when authorized registrants collect
controlled substances from ultimate users is not present when law enforcement
collects substances from ultimate users. Taking into account the totality of the
various risks and benefits, the DEA believes that this final rule imposes the
minimum necessary controls to allow a secure and responsible means by which
ultimate users can dispose of pharmaceutical controlled substances. Relying on
its experience, and as discussed in the NPRM, the DEA finds that any potential
benefits of allowing authorized collectors or unregistered persons to
independently inventory or sort controlled substances after receipt from the
ultimate user do not outweigh the risks of diversion, except when the controlled
substances remain in the control and custody of law enforcement, as mentioned in
the previous response.

Data collection is not impossible under the rule even though collected
substances cannot be sorted or inventoried after they have been deposited into a
collection receptacle or received by a collector through a mail-back package
(unless the collection is conducted by law enforcement and the substances are
within the custody and control of law enforcement). For example, authorized
collectors may seek information voluntarily from ultimate users regarding the
substances the ultimate user is disposing. And, data such as the weight of the
inner liners, the number of ultimate users attending a take-back event, and the
number of mail-back packages received in relation to the number of packages
disseminated, can be useful measures. The rule only prohibits authorized
collectors from physically handling the substances, such as taking the
substances from the ultimate user, or sorting substances after the ultimate user
has deposited them into a receptacle or mail-back package. 21 CFR 1317.70 and
1317.75.

[4] Issue: Twenty-two commenters stated that contents should be sorted to ensure
adequate storage space. Several Start Printed Page 53540commenters stated that
packaging and pill bottles should be sorted since they are voluminous. Other
commenters stated that non-controlled substances should be sorted from
controlled substances.

Response: Pursuant to §§ 1317.70(b) and 1317.75(b), comingling of controlled and
non-controlled substances is permitted, but it is not required. In addition,
this rule does not require pharmaceutical controlled substances collected from
ultimate users to be collected and stored in the original packaging, and
collectors may institute procedures to prevent inadvertently collecting
packaging. Authorized collectors may address adequacy of space issues by
choosing not to collect comingled pharmaceutical controlled substances and
non-controlled substances, refusing to accept the original controlled substance
packaging, or by increasing destruction frequencies. In addition, the DEA has
expanded the available storage options for practitioners in this final rule by
allowing practitioners to store sealed inner liners and returned mail-back
packages in a securely locked room with controlled access. 21 CFR 1317.05.

[5] Issue: A commenter noted that authorized collectors should have direct
supervision over the substances that are placed into collection receptacles to
prevent undesirable materials from being deposited into collection receptacles.

Response: Each potential authorized collector must weigh all of the potential
risks and benefits in deciding whether to implement and manage any ultimate user
disposal program, including any necessary steps to prevent the unwanted
collection of regulated hazardous waste or otherwise undesirable materials, in a
manner consistent with this rule and all other applicable Federal, State,
tribal, and local laws and regulations. Authorized collectors may view what
ultimate users deposit into collection receptacles, and they may ask what
substances are being deposited. Although the actual disposal of a pharmaceutical
controlled substance into a collection receptacle must be performed by an
ultimate user in accordance with § 1317.30, the authorized collector maintains
ultimate control over that receptacle and should institute necessary measures to
protect against the collection of unwanted substances so long as such measures
are consistent with this rule and all other applicable Federal, State, tribal,
and local laws and regulations.

[6] Issue: Several commenters asked that the DEA permit pharmacy staff to
deposit collected substances into collection receptacles. These commenters asked
the DEA to consider situations where the pharmacy is completely blocked from the
public (such as with a bullet-proof barrier).

Response: For the reasons discussed in the NPRM and in previous comment
responses, the DEA declines to allow pharmacy staff to handle pharmaceutical
controlled substances collected from ultimate users. The registered location of
any retail pharmacy that wishes to become an authorized collector must satisfy
the specifications for collection receptacles and inner liners. 21 CFR 1317.60
and 1317.75. If a retail pharmacy desires to be an authorized collector, that
pharmacy shall only allow ultimate users (and others authorized to dispose of
controlled substances on behalf of ultimate users) to deposit the pharmaceutical
controlled substances directly into the collection receptacles in accordance
with § 1317.30. The requirements of the collection receptacles were carefully
considered and designed to limit the number of hands that handled the
pharmaceutical controlled substances in order to prevent diversion and diversion
opportunities, as well as to prevent the re-introduction of tainted
pharmaceutical controlled substances into the closed system of distribution.

[7] Issue: Twenty commenters suggested that the DEA permit some sort of
inspection for inner liner and mail-back package contents to ensure that
unacceptable contents are removed, such as x-raying and scanning. These
commenters were particularly concerned about mercury-containing thermometers,
iodine-containing medications, medical sharps, compressed cylinders, and other
hazardous waste. Other commenters expressed concern that by allowing comingling
of substances in collection receptacles, employees may be subjected to hazardous
conditions if unsafe or hazardous materials are deposited.

Response: The DEA understands and appreciates these concerns of the commenters;
however, the DEA has concluded that allowing inspection of inner liners and
mail-back packages presents an unacceptable risk of diversion. These issues were
closely reviewed prior to the NPRM and re-reviewed in association with these
comments. Whether an authorized collector comingles ultimate users'
pharmaceutical controlled substances with non-controlled substances is within
the discretion of that authorized collector. This rule does not mandate
comingling. 21 CFR 1317.75. Each potential authorized collector must weigh all
of the potential risks and benefits in deciding whether to implement and manage
any ultimate user disposal program, including any necessary steps to prevent the
unwanted collection of regulated hazardous waste or otherwise undesirable
materials, in a manner consistent with this rule and all other applicable
Federal, State, tribal, and local laws and regulations. As discussed in response
to previous comments, collectors may control the substances collected, and they
may view substances before they are deposited into collection receptacles. For
additional commentary on hazardous waste disposal, please see comment section
“Q.”, entitled “Hazardous Materials Transportation and Hazardous Waste
Destruction.”

[8] Issue: Some commenters urged the DEA to require authorized collectors to
provide clear instructions on what may and may not be placed in mail-back
packages in order to reduce instances in which hazardous materials/waste may be
inadvertently destroyed in a manner that is not consistent with environmental or
other applicable laws or regulations due to the prohibition against opening or
inspecting the contents of mail-back packages.

Response: The rule includes a requirement for the collector to provide packages
with instructions indicating what substances are permitted to be included in the
package. 21 CFR 1317.70. The rule does not require specific language for such
instructions, which must ultimately be determined by the collector in a manner
consistent with the rule.

K. LONG-TERM CARE FACILITIES (LTCFS) (21 ISSUES)

DEFINITIONS AND TERMS SPECIFIC TO LTCFS

[1] Issue: Commenters asked the DEA to clarify the meaning of “LTCF” with regard
to assisted living facilities, hospice facilities, and residential care in
private homes, as the meaning of LTCF often varies by State.

Response: LTCF is defined at § 1300.01(b) and “means a nursing home, retirement
care, mental care or other facility or institution which provides extended
health care to resident patients.”

[2] Issue: Commenters asked the DEA to clarify the meaning of “have resided”
with regard to a LTCF's ability to dispose of controlled substances on behalf of
residents.

Response: The phrase “have resided,” is utilized in the Disposal Act, but was
not defined by Congress. The DEA has Start Printed Page 53541not determined a
need to apply a technical definition for this phrase apart from its ordinary
meaning. The DEA understands the ordinary meaning of “have resided” to be
typically understood as persons who have died or otherwise recently departed a
location without manifesting intent to return. Thus, for example, as discussed
in response to issue [7] below, when a LTCF resident is transferred to another
facility, the resident “has resided” at the LTCF, and the LTCF may dispose of
the former resident's pharmaceutical controlled substances in an authorized
collection receptacle. 21 CFR 1317.30.

REGISTRATION OF COLLECTION RECEPTACLES AT LTCFS

[3] Issue: Commenters asked the DEA to clarify whether an authorized LTCF
location where an authorized collector maintains a collection receptacle would
be considered a “registered location” of the retail pharmacy.

Response: The location of the collection receptacle is both a registered
location and a controlled premise. It is a registered location of the authorized
hospital/clinic or retail pharmacy because the authorized collector may only
install and manage a collection receptacle at a LTCF pursuant to the authority
granted by the DEA, and they are limited at that location to conducting only
those activities that are specifically authorized and required under this rule
as necessary to the installation and maintenance of that authorized collection
receptacle. LTCFs with authorized collection receptacles are “controlled
premises” pursuant to 21 U.S.C. 880(a) and 21 CFR 1316.02(c); accordingly, the
DEA may enter LTCFs and conduct administrative inspections in furtherance of,
and in carrying out, the responsibilities charged to the DEA by the CSA pursuant
to 21 U.S.C. 880(b) and 21 CFR 1316.03.

DISPOSAL METHODS AND PROCEDURES AT LTCFS

[4] Issue: A commenter asked the DEA if LTCFs may use an on-site method of
destruction. Three commenters specifically asked if LTCFs may continue their
current drug disposal method of “sewering.” Other commenters asked the DEA to
clarify how existing methods of disposal utilized by LTCFs will be impacted by
this rule and to provide for an interim method of disposal for LTCFs.

Response: Although the DEA appreciates the commenters' concerns, the DEA cannot
comment on each potential method of disposal occurring at LTCFs prior to these
regulations. The implementation of authorized disposal methods for ultimate
users is strictly voluntary and, with the exception of law enforcement-sponsored
programs, generally such programs have no lawful means of existence prior to the
effective date of this rule. It is important to note that this rule provides
additional options for disposal and does not prohibit any methods currently used
by LTCFs that are consistent with Federal, State, tribal, and local laws and
regulations. For example, LTCFs are not prohibited by this final rule from
destroying patients' unwanted pharmaceutical controlled substances at the LTCF,
on behalf of the resident patients, in accordance with applicable Federal,
State, tribal, and local laws and regulations, including environmental laws and
regulations. However, as explained further below, the DEA has considered the
diversion risks and determined that the installation and maintenance of
collection receptacles by authorized hospitals/clinics and retail pharmacies is
the most secure and responsible means by which registrants may collect and
dispose of LTCF residents' pharmaceutical controlled substances.

As stated in § 1317.90(a), the requirement to render controlled substances
“non-retrievable” applies only to DEA registrants that destroy controlled
substances. The “non-retrievable” language does not apply to ultimate users. As
discussed in the NPRM, the DEA does not believe that “sewering” would render a
pharmaceutical controlled substance “non-retrievable.” However, such a
requirement would not apply to a LTCF unless the LTCF is itself a registrant and
destroying its own pharmaceutical controlled substance stock pursuant to
§ 1317.05(a).

[5] Issue: Many commenters indicated that the DEA should provide LTCFs with
additional options for disposal of controlled substances on behalf of residents.
Approximately fifteen commenters asked the DEA to expand which registrants are
permitted to manage collection receptacles at LTCFs. Seven commenters asked the
DEA to permit LTCFs to use mail-back packages. Several commenters stated that
LTCFs should be allowed to use the same disposal options that this rule affords
ultimate users.

Response: As previously discussed, this rule in § 1317.40 expands the types of
registrants that may be authorized as collectors, and permitted to manage and
maintain collection receptacles at LTCFs. In addition to retail pharmacies
(including “closed-door pharmacies” that service LTCFs), hospitals/clinics with
an on-site pharmacy may maintain collection receptacles at LTCFs. Furthermore,
the options available to all ultimate users to dispose of their pharmaceutical
controlled substances are also available to LTCF residents. As ultimate users
(defined in 21 U.S.C. 802(27) as persons who have lawfully obtained, and who
possess, a controlled substance for their own use or for the use of a member of
their household), LTCF residents may avail themselves of all disposal methods
made available by this rule to ultimate users, including participation in
authorized mail-back programs. For example, on behalf of an LTCF resident, an
LTCF employee may place the resident's unwanted pharmaceutical controlled
substances in a mail-back package, seal it, and deposit it into the facility's
outgoing mail system. Care should be taken to ensure that LTCF residents' use of
mail-back programs does not result in the accumulation of pharmaceutical
controlled substances in a single location susceptible to internal or external
diversion threats.

The DEA has carefully considered the risks and benefits of collection activities
at LTCFs. Among the DEA's specific considerations were that LTCFs typically have
large volumes of controlled substances on-site and that they are typically not
registered with the DEA. The DEA also specifically considered the risks and
benefits associated with LTCF personnel disposing of pharmaceutical controlled
substances on behalf of persons who reside or have resided at that LTCF. The DEA
determined that in order to adequately protect the public health and safety, and
to prevent diversion, the collection of such substances must be limited to
certain registrants that are well-equipped to handle the unique circumstances
surrounding the disposal of controlled substances at LTCFs. After careful
deliberation, the DEA determined such registrants should be limited to retail
pharmacies and hospitals/clinics with an on-site pharmacy. 21 CFR 1317.40. In
making its determination, the DEA took consideration of the fact that
hospitals/clinics with on-site pharmacies, and retail pharmacies, routinely
dispense large volumes of controlled substances in a public setting.
Additionally, many hospitals/clinics with on-site pharmacies and retail
pharmacies have experience working closely with LTCFs or have well-established,
on-going relationships with LTCFs. For example, many retail pharmacies and
hospitals/clinics directly deliver pharmaceutical controlled substances to LTCF
residents, some retail pharmacies have developed Start Printed Page
53542expertise in dispensing substances at LTCFs via an automated dispensing
system (ADS) (i.e., mechanical systems that perform operations or activities
relative to the dispensing of medications), and some LTCFs share common
management or ownership with hospitals/clinics.

The DEA recognizes that other types of registrants also have relationships with
LTCFs, and considered authorizing other types of registrants to install and
manage collection receptacles at LTCFs. However, after careful consideration,
the DEA determined that the presence of certain factors that increase
opportunities for diversion in the specified circumstances weigh against further
expanding the types of registrants that may collect at LTCFs.

Specifically, the DEA declines to allow reverse distributors to install and
maintain collection receptacles at LTCFs because reverse distributors are at the
end of the supply chain. It would be contrary to the public health and safety
and pose an increased risk of diversion to authorize a reverse distributor to
independently install and maintain a collection receptacle at an LTCF, remove
the inner liner, transport collected substances to the final destruction
location, and ensure they are destroyed. One of the principal factors considered
by the DEA in coming to this conclusion is the fact that in such a situation,
the reverse distributor would be the sole registrant to maintain the only
records of installation, removal, and destruction. Such an authorization would
be contrary to the closed system of distribution where each registrant who
handles controlled substances serves as a source of verification for the other
registrants that handle the same substances, thus ensuring that controlled
substances reach their intended destination with accountability and a reduced
risk of diversion. The regulations implemented by this final rule specifically
utilize this system of checks for collection activities at LTCFs. Retail
pharmacies and hospitals/clinics with an on-site pharmacy are registrants. As
established in this final rule, when retail pharmacies and hospitals/clinics
maintain collection receptacles at an LTCF, they may not transport sealed inner
liners. Rather, they are expected to transfer sealed inner liners to another
registrant for destruction pursuant to § 1317.05(c)(2)(iv). Two-registrant
integrity allows the DEA to verify and cross-check each registrants' records.
Conversely, LTCFs and destruction facilities are generally not registrants.
Therefore, if a reverse distributor were authorized to install and maintain
collection receptacles at LTCFs, and also pick-up, transport, and destroy sealed
inner liners from LTCFs, the DEA would be unable to verify the reverse
distributor's removal or destruction records with another registrant's records.
Allowing this would not meet the two-registrant integrity requirement that is
the minimum required to ensure accountability, particularly when collected
substances are destined for destruction.

As discussed in responses to other comments, because LTCFs are generally not
registrants, the DEA is unable to allow such facilities to be authorized
collectors for the purpose of disposing ultimate user-collected substances, or
handle disposed substances on behalf of another registrant. We note that
although LTCFs may not use mail-back packages or administer a mail-back program,
ultimate users who reside in LTCFs may use mail-back packages under this rule.
21 CFR 1317.30 and 1317.70.

[6] Issue: One commenter asked the DEA to allow a LTCF resident, or the
resident's legal representative, to dispose of controlled substances through all
available means, whether the resident is alive or deceased.

Response: All means of disposing of pharmaceutical controlled substances are
available to ultimate users and persons lawfully entitled to dispose of an
ultimate user decedent's property, including those ultimate users who reside, or
have resided, in a LTCF. 21 CFR 1317.30.

[7] Issue: Commenters also asked the DEA to address how LTCFs should handle
situations in which a resident is transferred to a hospital and the resident
leaves unwanted medication at the LTCF.

Response: Pursuant to the Disposal Act, Congress provided the DEA authority to
authorize LTCFs only to “dispose of controlled substances on behalf of ultimate
users who reside, or have resided,” at the LTCF. 21 CFR 1317.30. When a LTCF
resident is transferred to a hospital or other facility, the resident “has
resided” at the LTCF, and if the medication is intentionally left at the LTCF,
it is “unwanted,” and the resident has discontinued use. Accordingly, the LTCF
may dispose of the former resident's pharmaceutical controlled substances by
depositing the substances into an authorized collection receptacle immediately,
but no longer than three business days after discontinuation of use. 21 CFR
1317.80.

[8] Issue: Several commenters indicated that the three-day disposal provision
for LTCFs is overly restrictive and potentially costly for residents. These
commenters stated that three days is too short a time span and will result in
residents being forced to purchase additional medications when there is a short
break in use as a result of illness, hospitalization, or a trial dosage
reduction. One commenter stated that three days is not a long enough time period
to determine if the patient may need the medication again in the future.

Response: The DEA declines to extend the timeframe for LTCFs to dispose of
pharmaceutical controlled substances on behalf of LTCF residents. As previously
discussed, LTCFs are required to dispose of pharmaceutical controlled substances
“immediately, but no longer than three business days after the discontinuation
of use” in § 1317.80(a). With respect to “discontinuation of use,” the final
rule modifies § 1317.80(a) to include a permanent discontinuation as directed by
the prescriber, as a result of the resident's transfer from the LTCF, or as a
result of death. The DEA cannot readily foresee a circumstance where a short
break in use as a result of illness, short-term hospitalization, or a trial
dosage reduction would be considered a discontinuation of use. Also, if the
prescriber has not yet determined whether or not a medication is needed in the
future, then it is likely that there has not yet been a “discontinuation of
use.”

COLLECTION RECEPTACLE MAINTENANCE AT LTCFS

[9] Issue: Fifteen commenters indicated that the requirement to have two
employees of the authorized collector retail pharmacy remove and install inner
liners is burdensome, and it will discourage retail pharmacies from installing
and maintaining collection receptacles at LTCFs. The commenters suggested that
the DEA allow LTCF personnel to remove, store, and replace the inner liners. A
commenter suggested that LTCF personnel be permitted to sort out non-controlled
substances to reduce the amount of material collected in the receptacles.

Response: As explained above, the DEA is amending the final rule to allow
flexibility in the requirement that two employees of the authorized collector be
present for the installation and removal of inner liners at LTCF collection
receptacles. As amended, the final rule in § 1317.80(c) provides that
installation, storage, and removal may also be performed by one employee of the
authorized collector and one supervisor-level employee of the LTCF (e.g., a
charge nurse, supervisor, or similar employee) designated by the Start Printed
Page 53543hospital/clinic or retail pharmacy authorized to collect at that
location. Hospitals/clinics and retail pharmacies that choose the flexibility
allowed by using a supervisor-level employee from the LTCF are reminded that
they are still ultimately responsible for the security of the collected
substances, as well as keeping complete and accurate records and fulfilling
reporting requirements. The contents of the inner liners may not be sorted once
deposited into a receptacle, pursuant to § 1317.75(c), but, as previously
stated, § 1317.75(b) states that comingling of controlled and non-controlled
substances is permitted but not required. Therefore, the authorized collector or
the LTCF may choose to limit the collected substances to pharmaceutical
controlled substances to maximize available space in the collection receptacle.
This can be easily accomplished at LTCFs because trained medical personnel will
be depositing substances into collection receptacles and should be well-equipped
to sort controlled substances from non-controlled substances before depositing
the substances into a collection receptacle. Also, as previously discussed,
inner liners may be stored at LTCFs in accordance with § 1317.80(d). Another
available option to manage volume and the prohibition of on-site storage is for
an authorized collector to maintain more than one collection receptacle at an
LTCF.

[10] Issue: Commenters asked the DEA to clarify whether reverse distributors are
permitted to pick up collection receptacle inner liners from an authorized LTCF
location.

Response: In accordance with § 1317.05(c)(2)(iv), reverse distributors may pick
up inner liners from collection receptacles located at authorized LTCFs, and
reverse distributors may receive the inner liners that are sent to the reverse
distributor's registered location from the LTCF by common or contract carrier.
However, the inner liner must be removed from the collection receptacle under
the supervision of either two employees from the hospital/clinic or retail
pharmacy that is managing the receptacle, or one employee from the managing
hospital/clinic or retail pharmacy and one supervisor-level employee of the LTCF
(e.g., a charge nurse, supervisor, or similar employee) designated by the
authorized collector, pursuant to § 1317.80(c).

[11] Issue: Several commenters expressed concern regarding the transportation
and storage of substances collected from LTCFs, specifically with regard to the
safety of employees who transport collected substances from LTCFs and logistical
difficulties (e.g., storage space) that may result in fewer retail pharmacies
willing to install and maintain collection receptacles at LTCFs.

Response: As previously discussed, hospitals/clinics and retail pharmacies may
store sealed inner liners at the LTCF in a securely locked, substantially
constructed cabinet, or a securely locked room with controlled access for up to
three business days pursuant to § 1317.80(d). However, the DEA encourages LTCFs
and authorized collectors managing collection receptacles at LTCFs to exhaust
other, more secure, alternatives, including: Arranging regularly scheduled
pick-ups by reverse distributors or common or contract carriers to coincide with
removal of the inner liner or delivery of controlled substances to the LTCF;
operating multiple collection receptacles at a LTCF to help minimize overflow;
and pursuing ultimate user disposal options through members of the patients
household or other persons lawfully entitled to dispose of a LTCF patient's
property. The DEA believes these alternatives are better options than storage at
LTCFs. LTCFs are generally unregistered locations with large quantities of
highly pilferable controlled substances in high doses. The DEA carefully weighed
the benefits with the risks of allowing storage at LTCFs, including the
potential for creating a new avenue of diversion at a location over which the
DEA has limited regulatory oversight. However, in consideration of the
circumstances unique to LTCFs, and to ease the burden on LTCFs and authorized
collectors, the DEA is permitting in this final rule sealed inner liners to be
stored at LTCFs in accordance with § 1317.80(d).

The DEA has also relaxed the rule, in § 1317.80(c), to allow flexibility in the
two-person integrity requirement with respect to collection at LTCFs by allowing
authorized hospitals/clinics and retail pharmacies to designate a
supervisory-level employee of the LTCF as one of the authorized persons to
conduct or oversee the installation, removal, storage and transfer inner liners.
However, the authorized collector may opt to have two or more of its own
employees perform or oversee these activities. In addition, authorized
collectors that are practitioners may not themselves transport collected
substances to a destruction location. 21 CFR 1317.05. Rather, the practitioner
may destroy the collected substances by delivering the sealed inner liners to a
reverse distributor or distributor's registered location by common or contract
carrier, or a reverse distributor or distributor may pick-up sealed inner liners
at the LTCF. 21 CFR 1317.05.

[12] Issue: Commenters indicated that the installation and maintenance of
collection receptacles by retail pharmacies at LTCFs will likely result in
considerable costs, burdens, and other liabilities, and, as such, few retail
pharmacies will be willing to install and maintain collection receptacles at
LTCFs, and few LTCFs will want to bear the costs.

Response: The DEA carefully considered the costs associated with all aspects of
disposal, along with all other considerations such as convenience, safety, and
the risk of diversion, including the security and design of collection
receptacles. As discussed in the preamble to this rule, participation in any
disposal program for ultimate users is voluntary and the DEA is not authorized
to impose the burden of costs upon any specific entity. As such, each registrant
that may become authorized as a collector must individually weigh the associated
benefits and burdens in determining whether to do so. In order to accommodate
LTCF residents, the DEA has expanded the authorized collectors that may maintain
collection receptacles at LTCFs to include certain hospitals/clinics and retail
pharmacies. 21 CFR 1317.40. The DEA has also relaxed the two-person integrity
requirements with respect to LTCFs, and is allowing for storage of sealed inner
liners at the LTCF in order to reduce the burdens on hospitals/clinics and
retail pharmacies. 21 CFR 1317.80. These are the minimum requirements to ensure
that safety and security of LTCF residents, and to deter and detect diversion.

[13] Issue: Several commenters expressed concerns over liability when a
collection receptacle is installed at a LTCF because the collector pharmacy is
fully responsible for the receptacle but does not have constant, direct
supervision over it. The commenters did not specify what type of liability
(e.g., criminal, civil, administrative, etc.) was concerning, however, the
commenters suggested that the DEA provide the authorized collector retail
pharmacies a release from responsibility when installing and maintaining a
collection receptacle at a LTCF.

Response: It would be contrary to the public health and safety to authorize an
entity to collect pharmaceutical controlled substances from ultimate users, and
also absolve that entity from any responsibility for such collection. In any
event, the DEA does not have authority to provide a general release from
liability to all hospitals/clinics and retail pharmacies that apply for, and are
Start Printed Page 53544authorized to, install and maintain a collection
receptacle at a LTCF as part of their registered activities. Part of the purpose
in authorizing only certain hospitals/clinics and retail pharmacies to install
and maintain collection receptacles at LTCFs is to ensure that a responsible
registrant under the regulatory authority of the DEA is charged with ensuring
the secure and responsible collection of pharmaceutical controlled substances at
LTCFs. As such, with regard to authorized collection receptacles at LTCFs, all
responsibility for such receptacles, including compliance with the CSA and DEA
regulations, rests with the hospital/clinic or retail pharmacy authorized to
install and maintain the collection receptacle. The DEA designed the physical
security controls and other accountability measures (e.g., recordkeeping,
two-person integrity, regular monitoring by LTCF personnel) for collection
receptacles at LTCFs in an effort to minimize the risk of diversion in
circumstances where constant, direct supervision by the hospital/clinic or
retail pharmacy is not feasible. In the event an authorized collector knows or
has reason to know diversion from collection receptacles is occurring, the
authorized collector must take steps to prevent the diversion, including
reporting to the appropriate authorities pursuant to §§ 1301.74 and 1301.76.
Such action stems from the responsibility to provide effective controls and
procedures to guard against theft and diversion as required by § 1301.71(a).

SECURITY AT LTCFS

[14] Issue: One commenter asked the DEA to clarify the required security
measures for collection receptacles at LTCFs. Two commenters asked the DEA to
outline what LTCF staff must do to monitor the collection receptacle.

Response: The required security measures outlined in §§ 1317.60 and 1317.75 that
apply to all collection receptacles also apply to those located at LTCFs unless
stated otherwise in the rule. The rule provides that a collection receptacle
must be located in an area that is regularly monitored by LTCF personnel. 21 CFR
1317.75(d)(2)(iii). “Regularly monitored” has its ordinary meaning. The goal of
this requirement is to prevent diversion; accordingly, specific examples would
depend on individual circumstances. However, a sub-basement or other seldom-used
storage area would not be considered to be regularly monitored by LTCF personnel
because those areas are not routinely accessed by LTCF personnel in the course
of conducting the everyday the business of the LTCF. The requirement that the
receptacle be “regularly monitored” is designed to prevent diversion
opportunities, and to ensure that diversion would be detected as soon as
possible. Only authorized collectors may install, manage, and maintain
collection receptacles at LTCFs, therefore, only the authorized collectors may
remove, seal, transfer, and store or supervise the removal, sealing, transfer,
and storage of sealed liners. 21 CFR § 1317.80(b). The authorized collector is
responsible for ensuring the regular monitoring of LTCF personnel and ensuring
the appropriate security procedures are in place at LTCFs in the event of
suspected tampering or diversion. If tampering or diversion is suspected, LTCF
personnel should notify law enforcement authorities and the authorized
collector, as the circumstances warrant.

[15] Issue: Eight commenters expressed concern for the safety of residents of
LTCFs. These commenters are concerned that collection receptacles in LTCFs may
affect resident safety due to these locations becoming a potential target for
drug seekers. Five commenters suggested that the DEA increase penalties for
offenses related to collected substances at LTCFs. One commenter encouraged the
DEA not to authorize the installation of collection receptacles at LTCFs because
their presence may compromise the safety of staff and residents.

Response: Congress authorized the DEA to implement regulations authorizing LTCFs
to dispose of controlled substances on behalf of ultimate users who reside, or
have resided, at such LTCFs. The DEA has considered the risks associated with
authorizing the installation and maintenance of collection receptacles at LTCFs,
as discussed in the NPRM, and determined that the security measures described in
this rule, in § 1317.75, are the minimum required to ensure the safe and secure
disposal of pharmaceutical controlled substances at LTCFs. If authorized
collectors or LTCFs believe the presence of a collection receptacle endangers
the safety or security of the LTCF residents under particular circumstances,
they should take additional measures as appropriate to ensure the safety of the
residents and staff, and to ensure the security of the collected substances.
And, if those other alternatives have failed to abate the observed dangers, the
authorized collector can choose to discontinue placing a collection receptacle
at a particular LTCF.

The CSA already provides for administrative, civil, and criminal sanctions for
individuals and registrants that violate the CSA. The DEA is without authority
to mandate enhanced penalties for violations of the CSA that involve LTCFs.

[16] Issue: Two commenters expressed concern about security issues due to
potential stockpiling of unwanted controlled substances at LTCFs. These
commenters listed the following reasons as the bases for their concerns: The
three business day disposal requirement, the lack of guidance on the frequency
at which inner liners must be removed, the two employee requirement for
installing and removing inner liners, and lack of a realistic alternative for
disposal if no retail pharmacy manages a collection receptacle at the facility.
These commenters stated that stockpiling would increase diversion risks and
would be a liability for the LTCF.

Response: As discussed in the NPRM and in response to comments in this final
rule, these new regulations expand the options available to ultimate users
(including LTCF residents) to dispose of excess pharmaceutical controlled
substances. A resident, a member of the resident's household, and an individual
lawfully entitled to dispose of the decedent resident's property all may dispose
of a resident's pharmaceutical controlled substances using any of the several
methods of disposal mentioned here. 21 CFR 1317.30.

If there is a collection receptacle at the LTCF, the collected substances should
not accumulate under the procedures outlined in this rule. One of the primary
goals of the procedures outlined in these new regulations is to prevent the
accumulation of collected substances while awaiting destruction. For example,
LTCFs are required to deposit pharmaceutical controlled substances into
collection receptacles “immediately, but no longer than three business days
after the discontinuation of use,” pursuant to § 1317.80(a). Although the DEA
has not specifically proposed regulations regarding the frequency at which the
inner liners of collection receptacles must be replaced, an authorized collector
that maintains a collection receptacle at a LTCF should coordinate with that
LTCF in order to ensure that the inner liners are replaced at a frequency
suitable to ensure continuous safe and secure disposal by the LTCF. This type of
coordination is part of an authorized collector's responsibility to provide
effective controls and procedures to guard against theft and diversion as
required by § 1301.71(a). Controls against diversion are ineffective when
stockpiling of unused pharmaceutical controlled Start Printed Page
53545substances at a LTCF is the result of an authorized collector's failure to
adequately maintain a collection receptacle. It is emphasized that there is no
limit on the number of collection receptacles that an authorized collector may
install and maintain at a LTCF. Accordingly, the number of receptacles may be
increased to account for volume and/or pick-up schedules.

As previously discussed, this rule allows but does not require authorized
collectors to store sealed inner liners at a LTCF for up to three business days
in a securely locked, substantially constructed cabinet or a securely locked
room with controlled access, pursuant to § 1317.80(d). However, the DEA
encourages collectors to schedule inner liner removals and installations to
coincide with existing LTCF visits when possible, for example, arranging a
routine system in which medication deliveries coincide with the removal and
transfer of sealed inner liners for appropriate destruction, thereby making
sealed inner liner storage unnecessary.

OTHER CONCERNS REGARDING LTCF DRUG DISPOSAL

[17] Issue: One commenter expressed concern that the DEA's assumption that
controlled substances in LTCFs have been dispensed to, and are thus the property
of, a resident may result in the reluctance of LTCFs to use automated dispensing
systems to dispense to an ultimate user as needed.

Response: Congress has defined “dispense” to mean the delivery of a controlled
substance to an ultimate user by, or pursuant to the lawful order of, a
practitioner. 21 U.S.C. 802(10). The DEA is bound to this definition.
Accordingly, once a pharmaceutical controlled substance has been dispensed to a
patient, including a resident of a LTCF, the substance is the property of the
patient or ultimate user. The use of an automated dispensing system (ADS) does
not change the analysis. An ADS is conceptually similar to a vending machine. A
pharmacy stores bulk drugs in the machine in separate bins or containers and
programs and controls the ADS remotely. Only authorized staff at the LTCF would
have access to its contents, which are dispensed on a single-dose basis at the
time of administration pursuant to a prescription. The ADS electronically
records each dispensing, thus maintaining dispensing records for the pharmacy.
Because the controlled substances are not considered dispensed until the system
provides them, substances in the ADS are counted as pharmacy stock. Even though
ADSs in LTCFs are used to dispense medications for administration on an
as-needed basis (i.e., one dose at a time) in accordance with a practitioner's
prescription, the substance is the property of the LTCF resident once dispensed.
Even though a pharmaceutical controlled substance is the property of the
ultimate user once dispensed from the ADS, the LTCF may dispose of the
medication on behalf of an ultimate user who resides, or has resided at an LTCF
by depositing the medication into an authorized collection receptacle located in
the LTCF. 21 CFR § 1317.80. Controlled substances held within the ADS that have
not been dispensed to a patient are considered inventory or stock of the
registrant and therefore must be disposed of by the registrant in accordance
with 21 CFR § 1317.05.

[18] Issue: Commenters indicated that LTCFs may be serviced by multiple
pharmacies which could result in controlled substances from multiple servicing
pharmacies being disposed of in a single receptacle installed by one such
pharmacy and asked the DEA to clarify how to manage such situations (e.g., how
other pharmacies would contribute to the efforts of collection; whether drugs
dispensed by other pharmacies can be disposed of in the receptacle). Commenters
also asked the DEA to clarify the process and requirements for the collection
receptacle when the LTCF changes ownership or pharmacy service.

Response: This rule allows certain hospitals/clinics and retail pharmacies to
become collectors at LTCFs pursuant to § 1317.40, after properly modifying their
registrations, in accordance with part 1301. This rule does not require
authorized collectors to have any pre-existing or other relationships with the
LTCF. Depending on the circumstances, there may be more than one authorized
collection receptacle at a single LTCF. Other than the regulations specific to
the installation and maintenance of collection receptacles and all related laws
and regulations, the DEA is not, at this time, regulating the relationship
between the authorized collector and the LTCF, or between multiple authorized
collectors that have relationships with the LTCF, and the DEA is not prohibiting
collectors from refusing to collect any certain specified pharmaceutical
controlled substances. However, conduct that implements exclusionary or
anti-competitive actions at an LTCF that adversely affects competing registrants
will be referred to the appropriate authorities for action. It is important to
remind authorized collectors with collection receptacles at LTCFs that they are
solely responsible for the security, integrity, and maintenance of their own
collection receptacles and they must be vigilant and ensure complete
accountability for any pharmaceutical controlled substances they collect at
LTCFs. If a LTCF changes ownership and changes its name, the authorized
collector must modify its registration in accordance with § 1301.51(b)(2) to
reflect the new name of the LTCF.

[19] Issue: One commenter specifically suggested that the DEA restrict
collection receptacles at LTCFs to the collection of controlled substances and
to require signage indicating such in order to ensure compliance with State
Medicaid program directives requiring the recovering of non-controlled drugs for
potential credit or restocking.

Response: The DEA is modifying the final rule in §§ 1317.70(b) and 1317.75(b) to
clearly indicate that comingling of controlled and non-controlled substances is
permitted but not required. The DEA's authority is limited to controlled
substances. As such, the DEA cannot promulgate regulations requiring signage
pertaining to compliance with State Medicaid programs or any other programs
outside the DEA's scope of authority, but collectors are free to post signage
pertaining to non-controlled substances. Moreover, collectors may post any
information they deem appropriate for the safe and secure disposal of controlled
substances. All collections that may include pharmaceutical controlled
substances, whether comingled or not, must be consistent with this rule, and all
other applicable Federal, State, tribal, and local laws and regulations.

[20] Issue: Two commenters referenced prescription labeling requirements that
prohibit the transfer of controlled substances to a person other than to whom it
was prescribed. The commenters asked for clarification regarding such transfers
and transfers to a person lawfully entitled to dispose of an ultimate user
decedent's property. The commenters indicated that such transfers could be
considered dispensing and therefore outside of the authority of the LTCF
employee. Additional concerns included State laws that prohibit LTCFs from
giving back unused controlled substances to the resident or another person and
those that require such substances to be destroyed at the facility.

Response: Pursuant to 21 U.S.C. 825(c), FDA regulations require that when a
schedule II, III, or IV controlled substance is dispensed to or for a patient,
the label include a warning that Federal law “prohibits the transfer of Start
Printed Page 53546the drug to any person other than the patient for whom it was
prescribed.” 21 CFR 290.5. This is not a regulation within the DEA's authority;
however, the regulation does not appear to be inconsistent with the Disposal
Act. As described in detail in the NPRM, the CSA expressly provides that it is
unlawful to distribute a controlled substance except as provided. The CSA
permits an ultimate user who has lawfully obtained a pharmaceutical controlled
substance to deliver the controlled substance to another person for the purpose
of disposal only if that person is authorized to receive such substance and in
accordance with the implementing regulations. The CSA further provides that if a
person dies while lawfully in possession of a pharmaceutical controlled
substance, any person lawfully entitled to dispose of the decedent's property
may deliver the substance to another person for the purpose of disposal under
the same conditions described above. Pursuant to the Disposal Act, a LTCF may
dispose of a resident's pharmaceutical controlled substances in accordance with
these regulations. When a LTCF deposits a pharmaceutical controlled substance
into a collection receptacle in accordance with these regulations, it is not
“dispensing.” As discussed, “dispense” means the delivery of a controlled
substance to an ultimate user by, or pursuant to the lawful order of, a
practitioner. 21 U.S.C. 802(10).

With regard to State laws, the DEA cannot comment on the laws of each individual
State because these laws are outside of the DEA's purview. The DEA is tasked by
Congress with implementing Federal laws related to controlled substances.
However, nothing contained within the DEA regulations should be construed as
authorizing or permitting any person to do any act he/she is not authorized or
permitted to do under other Federal laws or under the law of the State in which
he/she desires to perform such act, nor shall compliance with the DEA's
regulations be construed as compliance with other Federal or State laws. 21 CFR
1307.02.

[21] Issue: One commenter asked the DEA to discuss whether the HHS reviewed the
rule with regard to their “anti-kickback” statute. This commenter expressed
concern over whether or not the HHS would permit a retail pharmacy that
dispenses to a particular LTCF to provide collection services to the same LTCF
free of charge.

Response: All collection and disposal of controlled substances must be conducted
in accordance with all applicable laws and regulations, including HHS
regulations. This rule neither imposes requirements or regulations for the
funding of disposal programs, nor imposes requirements or regulations regarding
fees that registrants may charge to operate disposal programs.

L. DISPOSING ON BEHALF OF ULTIMATE USERS (OTHER THAN RESIDENTS OF LTCFS) (3
ISSUES)

[1] Issue: Commenters asked the DEA to clarify how hospitals, schools, summer
camps, or other entities may dispose of controlled substances that
unintentionally end up in their possession (e.g., when persons abandon
controlled substances and return is not possible). Also, several commenters
asked the DEA to explain how controlled substances may be disposed of when the
ultimate user or other authorized person is unable to dispose of them due to
death or incapacitation.

Response: The DEA has limited authority regarding who may deliver pharmaceutical
controlled substances for the purpose of disposal. Pursuant to the Disposal Act,
Congress granted the DEA authority to authorize three groups of people to
deliver controlled substances for the purpose of disposal. First, an “ultimate
user” who has lawfully obtained a pharmaceutical controlled substance may
deliver the substance to another person who is authorized to accept it for the
purpose of disposal. The CSA defines “ultimate user” as “a person who has
lawfully obtained, and who possesses, a controlled substance for his own use or
for the use of a member of his household or for an animal owned by him or by a
member of his household.” 21 U.S.C. 802(27). Second, if a person dies while
lawfully in possession of a pharmaceutical controlled substance, any person
lawfully entitled to dispose of the decedent's property may deliver the
substance to another person for the purpose of disposal. 21 CFR 1317.30. Third,
LTCFs may dispose of pharmaceutical controlled substances on behalf of ultimate
users who reside or have resided at such facilities. 21 U.S.C. 822(g). The DEA
has no authority to expand the types of individuals and entities lawfully
permitted to deliver pharmaceutical controlled substances for the purpose of
disposal. The DEA has carefully considered its statutory authority, diversion
risks, public safety, convenience for ultimate users, and the interests of the
public. The DEA believes that this rule provides safe and convenient disposal
options for ultimate users and other authorized persons. The DEA understands
that there may be circumstances where there is no authorized person to dispose
of the controlled substances, such as when controlled substances are abandoned
at a school or summer camp, and return to the ultimate user is not feasible. In
such instances, the affected entities should contact local law enforcement or
their local DEA office for guidance on proper disposal procedures.

[2] Issue: The DEA received a number of comments regarding the lack of
provisions for hospice and other homecare programs to dispose of controlled
substances on behalf of patients. According to the commenters, many hospices
have written policies and procedures in place for the management and disposal of
controlled substances in the patient's home. Given the available options for
ultimate user disposal, commenters expressed concern that hospices may no longer
be able to assist families in disposing of a deceased patient's drugs.
Commenters suggested that the DEA allow hospice staff to dispose of a decedent's
controlled substances by sewering or landfill disposal.

Response: The DEA appreciates the difficulties facing home hospice staff with
regard to the disposal of pharmaceutical controlled substances. The Disposal Act
provides that “if a person dies while lawfully in possession of a controlled
substance for personal use, any person lawfully entitled to dispose of the
decedent's property may deliver the controlled substance to another person for
the purpose of disposal under the same conditions as provided” for ultimate
users. 21 U.S.C. 822(g)(4). Otherwise, home hospice and homecare personnel are
not authorized to receive pharmaceutical controlled substances from ultimate
users for the purpose of disposal. In addition, an ultimate user includes “a
person who has lawfully obtained, and possesses, a controlled substance for his
own use or for the use of a member of his household.” 21 U.S.C. 802(27).
Accordingly, a member of the hospice patient's household may dispose of the
patient's pharmaceutical controlled substances, but the home hospice or homecare
provider cannot do so unless otherwise authorized by law (for example, under
state law) to dispose of the decedent's personal property.

This rule provides a number of options for ultimate users and persons lawfully
entitled to dispose of a deceased ultimate user's property to safely and
securely dispose of pharmaceutical controlled substances, yet the DEA does not
require ultimate users to utilize these options. However, it is unlawful for
ultimate users to transfer pharmaceutical controlled Start Printed Page
53547substances to unauthorized persons, and it is unlawful for unauthorized
persons to receive such substances. It is also unlawful for any person to
possess a controlled substance unless authorized to do so under the CSA (i.e.,
an ultimate user, an entity registered with the DEA, or an entity exempt from
registration with the DEA). 21 U.S.C. 844(a). Home hospice and other homecare
providers are encouraged to assist their patients, and their patients' families,
in disposing of pharmaceutical controlled substances in accordance with the CSA
and its implementing regulations. While education is paramount, home healthcare
agencies are also encouraged to partner with authorized collectors to promote or
jointly conduct mail-back programs.

[3] Issue: One commenter asked the DEA to clarify the authority for a hospice
employee to utilize a LTCF's collection receptacle for the disposal of
controlled substances of a LTCF resident who is also a patient of the hospice.

Response: This rule does not specifically address hospice care or hospice
employees, who are typically not registrants. As discussed, it is unlawful to
possess a controlled substance unless authorized to do so under the CSA. 21
U.S.C. 844(a). The DEA has, however, provided options for the disposal of
pharmaceutical controlled substances by a LTCF on behalf of a person who
resides, or has resided, at the LTCF, regardless of whether or not that person
is also receiving hospice care. The Disposal Act authorized the Attorney General
to allow LTCFs to dispose of controlled substances on behalf of ultimate users
who reside, or have resided, at the LTCF, in a manner determined by the Attorney
General. 21 U.S.C. 822(g)(3). LTCF is defined as “a nursing home, retirement
care, mental care, or other facility or institution which provides extended
health care to resident patients.” 21 CFR part 1300. Congress specifically
allowed the Attorney General to consider permitting LTCFs to dispose of
pharmaceutical controlled substances on behalf of LTCF residents. This allowance
did not extend to other persons who are simply attending to a person who is
resident of the LTCF. As such, a hospice employee is not authorized to dispose
of pharmaceutical controlled substances on behalf of a person who resides or has
resided at a LTCF.

M. REGISTRANT RETURN, RECALL, AND TRANSFER (3 ISSUES)

[1] Issue: One commenter urged the DEA to retain the existing regulations in
part 1307. This commenter stated that part 1307 adequately addresses registrant
return, recall, and transfer. The commenter stated that part 1307 functions
properly; thus, there is no need to change it, and the commenter expressed
concern that the new regulations will disrupt existing business practices. The
commenter was particularly concerned that most controlled substances returned to
distributors are re-salable and “not intended for disposal.” Other commenters
indicated confusion with regard to registrants seeking assistance from a SAC
when disposing of controlled substances.

Response: The DEA first notes that the terms “disposal” and “destruction” are
not interchangeable in the context of the rule. As described in the NPRM at
footnote 4 and in this final rule at footnote 4, the terms “disposal,”
“dispose,” and “disposition” appear several times in the CSA but are not
defined. In the NPRM and this final rule, the DEA uses the terms “disposal” and
“dispose” to refer generally to the wide range of activities that result in
controlled substances being unavailable for further use or one entity ridding
themselves of such substances (e.g., returns). Within the CSA, a controlled
substance can be “disposed of” by destruction, return, recall, sale, or through
the manufacturing process. As such, the modified regulations regarding
registrant disposal codify existing practice, expand available options, and
implement consistent procedures among registrants in accordance with their
authorized business activities. This required deleting the existing regulations
at § 1307.21 which authorized the SACs to individually authorize disposal. The
new rule eliminates the authority of the SACs to individually authorize disposal
methods for non-practitioners, and retains this option for practitioners. 21 CFR
1317.05. Otherwise, the new regulations maintain existing disposal practices for
registrant inventory and authorize: Prompt on-site destruction; prompt delivery
of controlled substances to a reverse distributor; and prompt delivery (for the
purposes of return and recall) to the person from whom the controlled substance
was obtained, the manufacturer, or a registrant authorized to accept returns on
the manufacturer's behalf. Additionally, non-practitioners may promptly
transport the controlled substances to a reverse distributor, a destruction
location, or the location of any person authorized to receive the controlled
substances for the purpose of return or recall. 21 CFR 1317.05. The DEA
appreciates that by eliminating the option for a SAC to authorize specific
disposal procedures on a case-by-case basis for non-practitioners, some reverse
distributors may need to alter their disposal practices. Although this change
may impact current business practices, as discussed in the NPRM, nationwide
consistency is necessary in the disposal pharmaceutical controlled substances.

[2] Issue: One commenter asked the DEA to clarify what method of return is
permitted other than via a freight forwarding facility pursuant to § 1317.10.

Response: With regard to the use of freight forwarding facilities pursuant to 21
CFR 1317.10(c), use of the word “may” indicates that the use of freight
forwarding facilities is permitted but not required. Other authorized methods of
transferring pharmaceutical controlled substances for the purpose of return or
recall are outlined in § 1317.05(a)(3) and (4) for practitioners, and in 21 CFR
1317.05(b)(3) and (4) for non-practitioners.

[3] Issue: One commenter stated that it will be difficult for reverse
distributors to adjust current business operations to meet the 14-day
destruction requirement for recalled controlled substances, because product
returns may be received from thousands of customers across the country.
Additionally, this requirement may not be consistent with other agencies'
regulations and policies governing manufacturers' voluntary recalls and other
product recalls.

Response: As explained further below, the 14-day destruction requirement (which
this final rule extends to 30 days) does not apply to recalled pharmaceutical
controlled substances. 21 CFR 1317.15.

N. DESTRUCTION (19 ISSUES)

NON-RETRIEVABLE DESTRUCTION STANDARD

[1] Issue: Forty commenters asked the DEA to outline performance standards and
parameters for the “non-retrievable” destruction standard. Although many
commenters applauded the DEA for proposing a standard that will permit future
innovation, many commenters felt that innovation may be hindered by the
uncertain terms. Commenters asked the DEA to list currently-approved methods,
and to outline how the DEA will evaluate new technology intended to render
controlled substances “non-retrievable.”

Response: In the NPRM, the DEA indicated that incineration and chemical
digestion are some examples of current technology that may be utilized to
achieve the non-retrievable Start Printed Page 53548standard. The preamble of
the NPRM states that sewering (disposal by flushing down a toilet or sink) and
landfill disposal (mixing controlled substances with undesirable items such as
kitty litter or coffee grounds and depositing in a garbage collection) are
examples of current methods of disposal that do not meet the non-retrievable
standard. The term non-retrievable is defined in the rule and is
results-oriented because the DEA's concern is that the substance be permanently
rendered to an unusable state. The performance standard is that the method
renders the substance so that it cannot be transformed to a physical or chemical
condition or state as a controlled substance or controlled substance analogue.
21 CFR part 1300. The DEA will not be routinely engaged in evaluating new
technologies intended to render controlled substances “non-retrievable.” Much
like the DEA does not evaluate, review, or approve the specific processes or
methods utilized to produce, synthesize or propagate a controlled substance, the
DEA will not evaluate, review, or approve the processes or methods utilized to
render a controlled substance non-retrievable, as long as the desired result is
achieved.

[2] Issue: Twenty commenters asked the DEA to include the language regarding
sewering and landfill disposal in the text of the regulation. These commenters
applauded the DEA for stating that sewering and landfill disposal do not meet
the “non-retrievable” standard; however, these commenters asked the DEA to
include this same language in the text of the regulation.

Response: The DEA has determined that the most effective way of ensuring that
the non-retrievable standard of destruction remains current with continuously
changing technology is to provide a required end result rather than specify what
means achieve or fail to achieve that result. A substance is rendered
non-retrievable when its physical or chemical state is permanently and
irreversibly altered and it may be unique to a substance's chemical or physical
properties; the same means of destruction may not render every controlled
substance non-retrievable. 21 CFR part 1300. Thus, the DEA declines to amend the
text of the regulation to include such a broad prohibition. In consideration of
the Disposal Act's goal to decrease the amount of pharmaceutical controlled
substances introduced into the environment, the DEA emphasizes that sewering and
landfill alone do not meet the non-retrievable standard. Once a controlled
substance is rendered non-retrievable, it is no longer subject to the
requirements of the DEA regulations.

[3] Issue: Several commenters requested that the DEA review and approve new
destruction methods prior to allowing their use.

Response: As discussed in the immediately preceding responses, the DEA will not
be engaged in reviewing or approving new destruction methods prior to allowing
their use.

[4] Issue: One commenter suggested that the DEA provide a transition period to
allow for additional research into the means by which a non-retrievable state
may be achieved. This commenter proposed a timeframe, such as five years, to
allow appropriate technology to develop. This commenter also suggested that the
DEA permit sewering and landfill disposal in the interim.

Response: The DEA believes that technology by which pharmaceutical controlled
substances may be rendered non-retrievable currently exists, thus providing
existing opportunities for compliance with this rule and negating the need for a
transition period beyond the effective date of this rule.

[5] Issue: Several commenters suggested that the DEA collaborate with the United
States Environmental Protection Agency (EPA) to develop best practices for
achieving a non-retrievable state using environmentally responsible methods.

Response: The DEA appreciates the environmental concerns surrounding the
destruction of pharmaceutical controlled substances. The DEA has worked with,
and is continuing to work with, the EPA regarding secure and responsible drug
disposal, particularly for pharmaceutical controlled substances that may also be
considered hazardous wastes. Additionally, the DEA has clearly stated in the
rule that all methods of destruction must comply with all applicable Federal,
State, tribal, and local laws and regulations, including EPA regulations.

[6] Issue: A commenter asked the DEA to clarify whether or not the
non-retrievable standard of destruction applies to substances disposed from
households, and this commenter stated that the DEA should develop and endorse a
practical solution for in-home disposal.

Response: Ultimate users may continue to dispose of their own pharmaceutical
controlled substances in the manner recommended by other Federal and State
agencies, such as the FDA, Office of National Drug Control Policy (ONDCP), and
EPA. The non-retrievable standard is only applicable to inventoried controlled
substances (i.e., a registrant's stock) and collected controlled substances
(i.e., substances collected from ultimate users by authorized collectors) to be
disposed of by registrants, pursuant to § 1317.90. The non-retrievable standard
does not apply to non-registrants.

[7] Issue: Several commenters asked the DEA to clarify whether or not controlled
substances that were rendered “non-retrievable” will be regulated by the DEA.

Response: As provided in the definition, a controlled substance is considered
non-retrievable when it cannot be transformed to a physical or chemical
condition or state as a controlled substance or controlled substance analogue.
21 CFR part 1300. Once a substance is rendered non-retrievable, it is no longer
subject to the requirements of the DEA regulations. The DEA believes that
further regulations regarding substances that have been rendered non-retrievable
are currently unnecessary because a non-retrievable substance cannot be abused
and diversion to illicit use is futile.

INCINERATION AND CHEMICAL DIGESTION DESTRUCTION METHODS

[8] Issue: Several commenters asked the DEA to specifically recommend
incineration as the preferred method to achieve a non-retrievable state.

Response: The DEA believes that any actual or perceived endorsement or
recommendation of a specific destruction method, beyond the provision of
examples of current methods in the preamble, could suppress exploration and
implementation of new technologies as people may assume that the endorsed or
recommended methods are required at the exclusion of other methods. As such, the
DEA is specifying a required result—non-retrievable—rather than a required
method for achieving that result. 21 CFR 1317.90.

ON-SITE DESTRUCTION METHODS

[9] Issue: Several commenters asked the DEA to clarify what “on-site
destruction” means.

Response: As provided in § 1300.05(b) of the final rule, on-site destruction
means that the controlled substances are destroyed on the physical premises of
the destroying registrant's registered location. Collectors that are authorized
to conduct mail-back programs must have and utilize an on-site method of
destruction, pursuant to 21 CFR 1317.05(c)(1). The requirement for an on-site
method of destruction does not apply to non-registrants.

[10] Issue: Commenters also expressed concern that distributors are unlikely to
have an existing on-site Start Printed Page 53549method of destruction because
they are not typically licensed as waste handlers and suggested that the DEA
provide alternatives to on-site destruction for hospitals and other medical
facilities.

Response: This rule does not require any distributor or other registrant to
utilize an on-site method of destruction except under certain circumstances in
order to conduct a voluntary activity (e.g., receipt of mail-back packages as an
authorized collector in accordance with § 1317.05(c)(1)).

[11] Issue: One commenter asked the DEA to consider the use of collection
receptacles with deactivation technology.

Response: This rule does not prohibit on-site destruction of pharmaceutical
controlled substances by authorized collectors with “deactivation” capability so
long as such destruction is consistent with the standards set forth in the rule
and the destruction results in a non-retrievable state. 21 CFR 1317.90.

OTHER DESTRUCTION-RELATED CONCERNS

[12] Issue: Approximately 20 commenters stated that the 14-day destruction
requirement is impractical. These commenters suggested that the DEA allow more
time since there are a limited number of commercial incinerators in the United
States. Several commenters stated that reverse distributors must accumulate
large amounts of controlled substances in order to obtain favorable pricing.
Other commenters stated that the requirement will make it difficult for reverse
distributors to properly process and record all transactions, and it will impose
substantial financial and operational restrictions on reverse distributors as
most reverse distributors do not have on-site destruction and may need to travel
long distances to reach an appropriate destruction facility.

Response: The DEA has carefully and thoroughly considered these concerns, and
the final rule in § 1317.15(d) extends the destruction requirement timeframe
from 14 calendar days to 30 calendar days and eliminates the “as soon as
practicable” standard with respect to this destruction requirement. The DEA
remains concerned about increased diversion risks due to pharmaceutical
controlled substances remaining at a single location for extended periods of
time. As discussed in detail in the NPRM, prescription drug abuse is an American
epidemic, and it is America's fastest growing drug problem. When large volumes
of pharmaceutical controlled substances accumulate, they become an attractive
target for drug seekers and drug abusers. Accordingly, regardless of the
applicable timeframe to destroy controlled substances, reverse distributors are
reminded that they must be vigilant and adhere to the requirements in the CSA
and the implementing regulations. Finally, these registrants are reminded of
their responsibility to provide effective controls and procedures to guard
against theft and diversion, and their responsibility to notify the DEA of any
theft or significant loss of any controlled substances within one business day
of discovery. 21 CFR part 1301. The DEA continuously monitors compliance with
the CSA and applicable regulations to ensure that controlled substances are not
diverted to illicit purposes. If necessary, the DEA may consider revising the
requirements applicable to reverse distributors' destruction activities, or
imposing additional security requirements.

[13] Issue: Several commenters asked the DEA to clarify the day the clock starts
for the 14-day destruction requirement.

Response: As discussed above, the final rule extends the timeframe from 14 days
to 30 days. Day 1 is the day the substances are physically acquired through
pick-up or delivery. 21 CFR 1317.15.

[14] Issue: One commenter asked the DEA to clarify whether or not the 14-day
destruction requirement applies to law enforcement.

Response: This destruction requirement does not apply to law enforcement. Law
enforcement guidelines are outlined in § 1317.35.

[15] Issue: One commenter suggested that the DEA apply the 14-day destruction
requirement to all authorized collectors that destroy or cause the destruction
of controlled substances, not just reverse distributors.

Response: As previously discussed, the final rule extends the destruction
requirement timeframe from 14 days to 30 days. 21 CFR 1317.15. This requirement
applies to reverse distributors destroying any controlled substance, as well as
distributors when destroying sealed inner liners acquired from authorized
collectors for destruction. Pursuant to § 1317.05(c), authorized collectors that
maintain mail-back programs or collection receptacles must promptly destroy
mail-back packages and inner liners, without adhering to a certain number of
days in order to provide them some flexibility depending upon their particular
circumstances.

[16] Issue: Two commenters stated that all management and disposal of controlled
substances should be restricted to DEA-registered hazardous waste disposal
companies.

Response: The DEA believes that restricting the management and disposal of
controlled substances as suggested would severely burden registrants without
adding benefit. Pursuant to this rule, a destruction facility is not required to
register with the DEA simply because a registrant utilizes that facility to
destroy pharmaceutical controlled substances in a manner consistent with this
rule and all other applicable Federal, State, tribal, and local laws and
regulations. The DEA does not find it necessary to register these entities
because the destroying registrant maintains possession and control of the
substances (and therefore retains responsibility and accountability) until the
substances are rendered non-retrievable. This is because all handling,
monitoring, security, recordkeeping, and witnessing with regard to the
pharmaceutical controlled substances is performed or supervised by registrants.

[17] Issue: One commenter indicated that the DEA should provide for broader
Federal approval for methods of destruction rather than allowing for
regionally-based guidance through the relevant SAC.

Response: As discussed, this rule expands the options available to registrants
for proper disposal, but does not require any particular method of destruction,
so long as the substances are rendered non-retrievable. This rule does not
authorize SACs to specifically authorize any particular method of destruction,
but it does allow a practitioner to seek guidance from the relevant SAC
regarding the disposal of controlled substances. 21 CFR 1317.05.

[18] Issue: Several commenters asked for clarification regarding the means by
which an authorized collector may promptly destroy collected substances, and
whether chemical treatment of controlled substances until such time as
controlled substances can be retrieved for destruction would be considered
prompt destruction.

Response: As discussed, the DEA is not requiring any particular method or means
of destruction. All controlled substances destined for destruction must be
rendered non-retrievable in order to be destroyed in a manner consistent with
this rule. 21 CFR 1317.90. If chemical treatment renders a substance
non-retrievable, it has been properly destroyed and is no longer subject to the
DEA's regulations.

[19] Issue: One commenter suggested that the DEA require controlled substances
to be partially destroyed prior to disposal in collection Start Printed Page
53550receptacles, such as by grinding them up and mixing them with kitty litter.

Response: With regard to mixing pharmaceutical controlled substances with other
substances prior to depositing them in a collection receptacle, this rule
neither prohibits nor requires such activity. Some authorized collectors may
find it desirable to direct ultimate users to mix pharmaceutical controlled
substances with non-hazardous items, such as kitty litter, prior to depositing
in receptacles; however, the DEA declines to mandate such a requirement for all
authorized collectors. The security controls required by this rule are the
minimum required to ensure the safe and secure disposal of pharmaceutical
controlled substances.

O. ECONOMIC CONCERNS (18 ISSUES)

CONTINUATION OF EXISTING PROGRAMS

[1] Issue: Eighteen commenters with experience operating a disposal program
stated that following the new regulations will be prohibitively costly, and
their current program will be forced to stop collection activities. These
commenters stated that they sort controlled substances from non-controlled
substances and packaging. According to these commenters, controlled substances
represent a small fraction of their total volume of collected substances, and
the sorting prohibition will substantially increase costs.

Response: As explained above, comingling of controlled and non-controlled
substances is permitted by the rule in § 1317.75, but it is not required, and
this rule does not require pharmaceutical controlled substances collected from
ultimate users to be collected and stored in the original packaging. Authorized
collectors may choose to address adequacy of space issues by choosing not to
collect comingled controlled substances and non-controlled substances and by
excluding packaging materials from being deposited into the collection
receptacle. Also, law enforcement continues to have autonomy regarding their
collection activities, and this rule does not prohibit law enforcement from
handling collected substances. Prior to the effective date of this rule, it is
unlawful for ultimate users to transfer controlled substances to any entity
(excluding law enforcement), except in the limited circumstances allowed under
21 CFR 1307.21(a)(2).

[2] Issue: Several commenters stated that they would have to hire additional
help for their program to continue, and that they would no longer be able to
rely on volunteers or other personnel that did not meet the NPRM's “authorized
employee” definition.

Response: As discussed, in § 1300.05(b) the final rule modifies the proposed
definition of “authorized employee” to omit the word “authorized.” In this final
rule, the DEA is adopting the general common law of agency's definition of the
term “employee.” Any person who meets certain criteria may have access to or
influence over collected substances on behalf of an authorized collector. Also,
under this rule, volunteers may assist with disposal programs or take-back
events as long as they do not have access to or influence over the collected
controlled substances.

TWO EMPLOYEE REQUIREMENT

[3] Issue: Approximately 30 commenters felt that it would be infeasible for two
employees to oversee disposal procedures due to limited personnel. Commenters
suggested allowing an “authorized employee” of another registrant, such as a
reverse distributor, to satisfy the second “authorized employee” requirement.
One commenter stated that the DEA should clarify that under proposed
§ 1317.75(g), installation and removal of inner liners may be performed by a law
enforcement officer instead of two employees.

Response: The DEA believes that the two-employee integrity requirement is a
necessary security measure to effectively guard against diversion and to ensure
that the controlled substances are handled, transferred, and recorded in a
manner that is consistent with all applicable laws and regulations. The DEA
carefully considered the various concerns and took steps to alleviate some of
these concerns. First, as just discussed, the final rule modifies the proposed
definition of “authorized employee” to instead adopt the common law of agency's
definition of the term “employee,” thus including employees that were excluded
by the definition proposed in the NPRM (e.g., part-time employees and off-duty
law enforcement officers). 21 CFR part 1300. Second, as previously discussed,
the final rule relaxes the two employee requirement for collection receptacles
located at LTCFs in § 1317.80(c). The DEA is making this exception because of
the unique circumstances faced by LTCFs, as recognized by the Disposal Act, and
in keeping with the DEA's historically accommodating regulations with respect to
LTCFs (e.g., §§ 1306.11(f) and 1306.13(b) regarding faxing schedule II
prescriptions and dispensing partial prescriptions). The DEA believes that the
above changes will alleviate some of the concerns expressed by the commenters
while maintaining the necessary security to reduce diversion risks.

[4] Issue: Twenty-seven commenters stated that the requirement to have two
employees from the pharmacy present to remove and install a collection
receptacle's inner liner is excessive and too costly. Several commenters noted
that this requirement alone will dissuade retail pharmacies from managing
collection receptacles. Several commenters stated that small pharmacies may not
have two employees working during the same shift, or even have two people
employed full-time by the pharmacy. Two commenters suggested requiring a
dual-lock system on collection receptacles, where the collector registrant
retains one key and a reverse distributor retains the other.

Response: The DEA carefully considered the commenters' concerns, and amended the
text of the rule to address this issue. In the context of this issue, the
two-employee requirement only applies to installation and removal of the inner
liners which does not need to be accomplished by two employees on the same
shift. Also, dual-locks on collection receptacles at retail pharmacies are not a
reasonable alternative because collectors are authorized only at their own
registered location or controlled premise. If a retail pharmacy employee
retained one key in a dual-lock system, and a reverse distributor retained the
other key, then the reverse distributor would be handling collected substances
at the retail pharmacy's registered location or controlled premise, an activity
that is not permitted. Reasonable alternatives include installing and removing
an inner liner during a shift change, or other times when there is more than one
employee present. The final rule also modifies the proposed definition of
“authorized employee,” by adopting the common law of agency's definition of
“employee” and correspondingly eliminating the requirement that employees
authorized to conduct disposal activities be employed full-time by the
authorized collector. 21 CFR part 1300. The DEA believes that the two-employee
integrity requirement is a necessary security measure to effectively guard
against diversion and to ensure that the controlled substances are handled,
transferred, and recorded in a manner that is consistent with all applicable
laws and regulations.

[5] Issue: Several commenters stated that the requirement that two employees
from a retail pharmacy be present to Start Printed Page 53551install and remove
inner liners at LTCFs is prohibitively burdensome. Several commenters stated
that most retail pharmacies do not have a vehicle for this purpose, and it is a
liability to have pharmacy employees traveling to LTCFs to change inner liners.
Two commenters suggested that the requirement should be one employee from the
pharmacy and one employee from the LTCF.

Response: The DEA carefully considered alternatives that will provide convenient
options for the unique population of LTCF residents, but will also provide safe
and secure disposal. As amended, the final rule in § 1317.80(c) provides that
inner liner installations, storage, removals, and transfers at LTCFs may be
performed either by two employees of the authorized collector, or by one
employee of the authorized collector and a supervisor-level employee of the LTCF
designated by the authorized collector. The DEA believes that this modification
is important to encourage hospitals/clinics and retail pharmacies to maintain
collection receptacles for LTCF residents, by easing the burdens on authorized
collectors who maintain collection receptacles at LTCFs—the only collectors who
maintain collection receptacles at locations away from their primary registered
locations. Additionally, the DEA recognizes that some authorized collectors do
not have a vehicle specifically for the purpose of travelling to LTCFs, or
currently allow employees to travel. The DEA notes that no particular vehicle is
required to transport employees of the authorized collector to the LTCF, and, as
discussed above, the DEA encourages authorized collectors managing a collection
receptacle at a LTCF to coordinate removal of inner liners with the delivery of
controlled substances dispensed to LTCF residents.

[6] Issue: Fifteen commenters stated that it will be economically burdensome to
have two employees of the reverse distributor accompany the collected substances
to the point of destruction to witness the destruction. These commenters noted
that waste management companies often travel hundreds of miles to reach a
destruction facility. The commenters stated that it is unreasonable to have two
employees of the reverse distributor accompany the collected substances and
witness the destruction, and some commenters suggested that the DEA permit other
security mechanisms, such as GPS devices and security cameras, to serve in lieu
of the second employee.

Response: The DEA believes that the two-employee integrity requirement is a
necessary security measure to effectively guard against diversion and to ensure
that the collected substances are handled, transferred, and recorded in a manner
that is consistent with all applicable laws and regulations. 21 CFR 1317.95. The
DEA notes that the DEA registrants who expressed concern regarding this
requirement already adhere to it in their current business practices. However,
the DEA has thoroughly and carefully considered the commenters' concerns and
considered the following alternatives to the two-person integrity requirement:
(1) Requiring destruction facilities to register with the DEA; (2) requiring the
transferring registrant (e.g., retail pharmacies, hospitals/clinics, etc.) to
accompany the controlled substances to the point of destruction; (3) requiring
on-site destruction; (4) requiring additional recordkeeping and witnessing at
the point of destruction by the non-registrant destruction facility; and (5)
requiring GPS devices or security cameras to serve in lieu of the second
employee. The DEA did not elect these alternatives because the DEA is without
sufficient authority to impose them, or the alternatives were impractical,
excessive, did not provide adequate security, would result in voluminous,
difficult to maintain and verify records, and/or would reduce the disposal
options available to ultimate users.

The two-person integrity requirement is of paramount importance when
transporting controlled substances to the point of destruction because these
persons are uniquely entrusted with ensuring the substances are destroyed and
not diverted to illicit purposes. Registrants that destroy on-site also face
diversion risks and security concerns and must adhere to the two-person
integrity requirement when destroying controlled substances. These diversion
risks and security concerns increase substantially in the case of reverse
distributors because they routinely acquire from other registrants large volumes
of controlled substances destined for destruction, and they routinely transport
those substances to a remote, un-registered location for destruction, yet there
is no independent mechanism to ensure or verify that the substances within their
possession are actually destroyed and not diverted.

Furthermore, as explained previously, in every other transfer of controlled
substances in the closed system of distribution, there are two registrants on
each side of the transfer to ensure accountability and identify and prevent
diversion. When controlled substances are transferred for destruction, there may
not be a registrant verifying the destruction of the controlled substances.
Adherence to the two-employee integrity requirement will provide accountability
for the controlled substances during the destruction process, preventing
possible loss, possible theft, and diversion of the controlled substances.

Similarly, the DEA declines to allow GPS devices or security cameras to serve in
lieu of a second employee. These types of security measures can be compromised,
and do not provide the same level of deterrence or risk mitigation as the
presence of a second person because they are strictly after-the-fact methods of
diversion control as opposed to providing security throughout the transportation
and destruction process. GPS devices cannot provide information as to whether or
not controlled substances were removed from the transporting vehicle, and
cameras cannot observe transportation and destruction from all angles. For
example, a single driver being monitored by GPS and video could drive to the
destruction facility on the approved route, remove the controlled substances
from the vehicle, move with the controlled substances out of the view of the
camera, and place the controlled substances into a separate vehicle or hidden
spot off camera rather than destroying them. In such a scenario, neither the
GPS, nor the camera would indicate any sort of diversion, whereas a second
person would be present throughout transportation and destruction to serve as a
deterrent and ensure that the controlled substances were actually destroyed.

For these reasons, the DEA believes that the two-person integrity requirement is
the most reasonable, secure, and economic substitute for another registrant
serving as an independent verification method at the end of the closed system of
distribution.

IMPLEMENTATION COSTS

[7] Issue: One commenter indicated that the enhanced security procedures
proposed for the disposal process will be overly burdensome and costly. This
commenter recommended that the DEA meet with industry stakeholders to identify
options that will allow innovation while maintaining security.

Response: The security requirements in this rule are the minimum needed to
protect the public health and safety, to ensure accountability, and to reduce
the risk of diversion during the disposal process. In addition, there were
multiple opportunities for industry stakeholders (and any other interested
persons) to participate in the Start Printed Page 53552rulemaking process for
this rule through participation in the public meeting held in January 2011, and
the submission of written comments during the open comment period. The DEA
carefully considered discussion from the meeting, as well as the written
comments submitted in response to the NPRM.

[8] Issue: Eleven commenters stated that the regulations proposed in the NPRM
are too costly, and the costs will discourage potential collectors from
participating. Several commenters expressed concern about the costs associated
with retail pharmacies managing collection receptacles, particularly at LTCFs.

Response: As provided in the Disposal Act and discussed in the NPRM, the DEA
cannot require any entity to establish or maintain a disposal program. Based on
information received from the public and industry during the public meeting in
2011, as well as information received in response to the NPRM, the DEA believes
that many entities are eager to voluntarily establish disposal programs.
Entities may choose to establish disposal programs for various reasons,
including for profit, to build goodwill in the community, to attract customers,
to advertise businesses, and to preserve the environment.

[9] Issue: Several commenters provided feedback regarding costs related to
voluntary implementation and maintenance of disposal programs, although none
provided any actual data that could be applied to the cost analysis except for a
suggestion that the DEA review information from a report on waste collection,
and one commenter that provided an estimate without any supporting data.
Generally, commenters indicated that the proposed methods of collection would
have associated costs incurred through recordkeeping, purchase of inner liners,
changes in procedures, increases in destruction costs, and development of
mail-back packages and collection receptacles. Commenters encouraged the DEA to
further explore the potential costs of the proposed options as well as
additional alternatives.

Response: The DEA appreciates the commenters' concerns regarding potential costs
associated with the implementation and maintenance of disposal programs. The DEA
has updated its economic analysis to address, directly, the costs of this rule
with respect to those registrants that do choose to establish a collection
program. Such implementation, however, is strictly voluntary; thus, any entity
that does not wish to incur the related costs may choose not to participate.
Additionally, as described in the NPRM, the DEA anticipates that a variety of
interest groups, corporations, community groups, and other entities will work
together to provide secure and responsible disposal options pursuant to this
rule.

[10] Issue: One commenter suggested that the DEA provide an exception for
analytical labs from the requirements of proposed § 1317.95(c) (§ 1317.95(d) in
the final rule), which requires that two employees handle the destruction of
controlled substances, in instances where the testing renders a substance
non-retrievable.

Response: The DEA declines to provide a blanket exception for analytical
laboratories for the described situation. The DEA believes that such instances
as described by the commenter will be incidental to testing. If the testing is
specifically designed to develop new methods of destruction or destruction is
otherwise not incidental to testing, all destruction must be in accordance with
the provisions in subpart C of this rule.

[11] Issue: One commenter expressed concern that this rule will impose
obligations on authorized collectors that are inconsistent with obligations
imposed by other agencies, particularly the FDA, EPA, and DOT. The commenter
stated that the potential liability stemming from such conflicts will discourage
participation.

Response: The DEA has worked directly with other Federal agencies regarding the
implementation of this rule, including the EPA and DOT. The DEA believes that
authorized collectors may comply with this rule and other agency regulations.
Authorized collectors should contact applicable agencies for further guidance if
they believe that their specific circumstances may lead to conflicts.

FUNDING AND INCENTIVES

[12] Issue: One commenter asked the DEA to allow private/public partnerships for
collection receptacles, mail-back programs, and take-back events.

Response: This rule does not dictate what funding sources are permitted or
prohibited. Entity partnerships are not prohibited as long as the authorized
collector follows all procedures outlined in this rule.

[13] Issue: Ten commenters expressed concern that there is no mandate, funding,
or incentive for collectors to participate. Two commenters suggested that the
DEA establish incentives to encourage participation, or require all pharmacies
to install and maintain collection receptacles. Several commenters indicated
that without a clear source of funding, cost mitigation, or participation
incentive, it is unlikely that registrants will voluntarily accept the financial
burdens associated with the provision of collection opportunities.

Response: The DEA appreciates the suggestions and concerns of the commenters
regarding funding for voluntary controlled substances collection programs. The
DEA points out that the Disposal Act did not authorize the DEA to assign
responsibility of funding to any entity, and the Disposal Act specifically
required the DEA to promulgate the implementing regulations in such a way that
participation would not be mandatory. The DEA's intent in soliciting comments
regarding this rule's potential economic impact was to gain knowledge regarding
potential costs—not which entities should fund disposal programs. The DEA has
attempted to provide regulations that minimize the financial burden while
retaining a level of security to ensure public safety and reduce diversion
risks. This rule does not address the responsibility of costs associated with
any collection program. The DEA recognizes that collection programs will have
associated costs and each entity that chooses to establish and maintain such a
program must determine how to manage such costs.

OTHER ECONOMIC CONCERNS

[14] Issue: A number of commenters urged the DEA not to impose additional fees
on registrants that choose to become authorized collectors. These commenters
asked the DEA to clarify whether or not there will be any cost to modify a
registration to become an authorized collector. One commenter suggested that the
DEA offer a reduced fee for non-profit organizations to become registered as
reverse distributors.

Response: Section 1301.51(c) states that no fee will be required to modify a
registration to become authorized as a collector. Pursuant to 21 U.S.C. 886a,
fees charged by the DEA under its diversion control program must be set at a
level that ensures the recovery of the full costs of operating the various
aspects of the program. The DEA last modified the registration fees on April 16,
2012. 77 FR 15234. If the DEA determines in the future that such fees should be
modified in order to ensure the recovery of the full costs of the diversion
control program, including those contained in this rule, the DEA will propose a
modified fee schedule Start Printed Page 53553pursuant to the notice-and-comment
rulemaking process. The DEA currently provides limited exceptions and exemptions
from registration fees to very specific groups and entities as identified in
part 1301. At this time, the DEA does not anticipate expanding such exceptions
and exemptions as a result of or in conjunction with the implementation of this
rule.

[15] Issue: A few commenters noted that DEA's Economic Impact Analysis estimated
the universe of potential respondents to include distributors, reverse
distributors, manufacturers, and retail pharmacies, without considering
hospitals, surgery centers, dental clinics, veterinary practices, or physicians'
offices.

Response: The DEA's analysis included a universe of potential respondents
comprised of only those entities that may be affected by the rule—those
registrants that are eligible to become authorized collectors (i.e.,
distributors, reverse distributors, manufacturers, NTPs, and hospitals/clinics
with an on-site pharmacy, and retail pharmacies).

[16] Issue: Two commenters stated that the DEA did not appropriately calculate
the costs associated with the proposed rule. One commenter stated that the DEA
should acknowledge the costs associated with recordkeeping requirements,
purchasing inner liners, purchasing mail-back packages, procedural changes, and
increased destruction costs.

Response: As discussed previously, the economic analysis of the final rule takes
into account costs associated with voluntary performance of collection
activities even though the provisions that facilitate non-registrant disposal
are completely voluntary, not mandated. Any collector, reverse distributor,
distributor, or law enforcement that chooses to engage in the voluntary
activities described in this section, does so based on its own evaluation of
costs and benefits (tangible and intangible).

[17] Issue: One commenter stated that the economic impact analysis is inadequate
because it does not acknowledge that parts of this rule are an “indirect”
mandate for LTCFs. This commenter referred to incidents where LTCFs will have no
other options for controlled substance disposal if patients are unable to
dispose of the medication and there is no other person authorized to dispose of
the controlled substances.

Response: In response to this comment, the final rule modifies the language of
§ 1317.80(a), as proposed, which appeared to prohibit LTCFs from using any
disposal method other than a collection receptacle. Under the final rule, LTCFs
may dispose of controlled substances on behalf of an ultimate user who resides,
or has resided, at such LTCF. 21 CFR 1317.30 and 1317.80. The DEA notes that the
decision to implement and manage a collection program for ultimate user disposal
is voluntary. It should be noted that LTCF residents are ultimate users
themselves and they, members of their households, and persons lawfully entitled
to dispose of a decedent's personal property, may avail themselves of all
disposal methods made available by this rule. 21 CFR 1317.30.

[18] Issue: One commenter stated that the DEA did not consider veterinary
practices, prisons, or clinics when calculating the economic impact analysis.

Response: In the proposed rule, the DEA considered veterinary practices,
prisons, and clinics in the accompanying calculations concerning economic impact
to the extent that these entities would be registered as practitioners or
non-practitioners. For the final rule, the DEA calculated the economic impact on
these entities to the extent that they could become collectors. Not all
registrants are eligible to become authorized collectors. Of this specified list
of entities inquired about by the commenter, only a small subsection,
specifically hospitals/clinics with on-site pharmacies, may become authorized as
collectors in accordance with this final rule. 21 CFR 1317.40 and 1317.70.

P. RECORDKEEPING AND REPORTING (8 ISSUES)

[1] Issue: One commenter asked the DEA to clarify whether or not the
recordkeeping requirements in the rule apply to all registrants or only
authorized collectors.

Response: The new recordkeeping requirements contained in this rule are
applicable to all registrants, including authorized collectors. To clarify this
important distinction, the DEA moved the recordkeeping provisions in proposed
part 1317 to part 1304.

[2] Issue: Several commenters urged the DEA to remove the inventory and
recordkeeping requirements for mail-back packages and inner liners. The
commenters believe that such recordkeeping will be challenging and provide
limited benefits. One commenter suggested that the DEA instead adopt tracking
procedures currently used in some non-controlled substance collection programs.

Response: As described in the NPRM, inventory and recordkeeping requirements for
collected substances are necessary for a number of reasons, including
accountability of collected substances within the possession and control of
authorized collectors. The inventory and recordkeeping requirements included in
this rule are generally consistent with those otherwise required of registrants,
thus minimizing burden. The DEA believes that these inventory and recordkeeping
requirements are necessary to help minimize the risk of diversion and to
identify diversion of controlled substances destined for destruction.

[3] Issue: One commenter suggested that the DEA eliminate ARCOS reporting
requirements for reverse distributors regarding collected substances from
ultimate users. Another commenter asked the DEA to clarify what information is
required for ARCOS reporting.

Response: In this final rule, § 1304.33(g) (relocated from proposed § 1317.50)
exempts reverse distributors and distributors that acquire controlled substances
from collectors or law enforcement from reporting to ARCOS with respect to
pharmaceutical controlled substances collected through mail-back programs and
collection receptacles.

[4] Issue: One commenter asked the DEA to clarify what records reverse
distributors must keep when receiving collected substances from law enforcement.

Response: The recordkeeping requirements in § 1304.22(e)(4) that apply to
controlled substances acquired by registrants that reverse distribute from
collectors also apply to those acquired from law enforcement. The final rule
also adds a new paragraph in § 1304.11(e)(3)(iii) specifying the information
relating to controlled substances acquired from collectors and law enforcement
that a registrant that reverse distributes must maintain in its inventories.
Under the revised § 1304.03(a), these provisions relating to reverse
distributors apply to any entity that reverse distributes, as defined in
§ 1300.01(b), whether or not it is registered with the DEA as a reverse
distributor. Finally, the requirement in § 1304.21(e) to maintain a DEA Form 41
applies to the destruction of a sealed inner liner or mail-back package by a
registrant that reverse distributes.

[5] Issue: Commenters asked the DEA to clarify who is responsible for tracking
the mail-back packages, and how mail-back packages that were disseminated but
not returned to the authorized collector will be reconciled with the inventory.

Response: There is currently no requirement for the authorized collector to
reconcile the inventory in order to Start Printed Page 53554determine which
packages were not returned. As discussed in the NPRM, the DEA does not believe
that requiring authorized collectors to institute a tracking or notification
system for ultimate users is necessary at this time, although such systems are
not prohibited so long as the collector does not require the ultimate user to
provide personally identifiable information, as specified in § 1317.70(d).

[6] Issue: Commenters asked the DEA to eliminate the following recordkeeping
requirements for inner liners: Tracking unused inner liners on hand, recording
the acquisition date, recording the installation date, and the requirement that
two employees witness the removal and installation of inner liners.

Response: As previously discussed, the DEA believes that all of the inventory
and recordkeeping requirements in part 1304 are the minimum necessary to ensure
accountability and identify diversion.

[7] Issue: Two commenters asked the DEA if reporting to the FDA is sufficient to
satisfy the DEA's reporting requirements for cases of controlled substance
recalls.

Response: No. Regardless of any other Federal, State, tribal, or local agency
requirements, each registrant must maintain records and make reports to the DEA
in a manner consistent with the requirements of chapter II of title 21 of the
CFR.

[8] Issue: One commenter asked the DEA to clarify the recordkeeping requirements
of § 1317.50(b)(2)(iii)—specifically, the requirement to record the registration
number of the collection location when the collection occurs at a LTCF, which
typically does not have a registration number.

Response: The final rule moves the referenced requirements to new § 1304.22(f).
The record should include the approved collection location address of the LTCF
and the authorized collector's registration number.

Q. HAZARDOUS MATERIALS TRANSPORTATION AND HAZARDOUS WASTE DESTRUCTION (3 ISSUES)

[1] Issue: Approximately 20 commenters expressed concern that the requirements
outlined in this rule for the transportation of collected substances conflict
with current regulations under the DOT's Pipeline and Hazardous Materials Safety
Administration (PHMSA). One concern involved the comingling of collected
substances that the DOT considers “hazardous materials” with nonhazardous
materials or hazardous materials of a different class. Other concerns included
how inner liners from collection receptacles that contain hazardous materials
should be labeled and packaged for transport, and other notice requirements for
hazardous waste under the DOT's PHMSA.

Response: All drug disposal activities must be conducted in a manner consistent
with this rule and all other applicable Federal, State, tribal, and local laws
and regulations. Compliance with the destruction requirements outlined in
subpart C of this rule does not exempt any entity from complying with other
Federal, State, tribal, or local laws or regulations. It is not within DEA's
expertise or authority to opine what pharmaceutical controlled substances could
be hazardous materials subject to DOT regulations. However, the DEA consulted
with the DOT during various stages of this rulemaking. The DEA has been informed
that if collected substances include hazardous materials, the transportation of
those materials is subject to all applicable DOT regulations, including the
“Hazardous Materials Regulations” (HMR). The DEA encourages entities to consult
www.phmsa.dot.gov/ hazmat for information regarding the HMR. In particular, the
DEA encourages entities to contact the DOT's PHMSA regarding its “Approvals and
Permits Program.” PHMSA issues approvals and special permits to entities that
apply for authorization to use agency approved alternatives to the HMR.
Interested entities may consult www.phmsa.dot.gov/ hazmat/ regs/ sp-a. for more
information. The DEA has worked with the DOT to facilitate this process in an
effort to ensure maximum participation in the collection of controlled
substances for secure and responsible disposal, and the DEA will continue to
work with the DOT to facilitate registrant compliance with all applicable laws
and regulations. For these purposes, it should be noted that sealed collection
receptacle inner liners may be transported inside of a shipping container that
is labeled and packaged for transport with the necessary notice requirements
applicable to hazardous waste under the DOT's PHMSA.

[2] Issue: One commenter asked whether or not law enforcement must comply with
the DOT's PHMSA requirements for transporting collected substances that may
contain hazardous materials.

Response: It is not within the DEA's expertise or authority to opine on the
applicability of DOT regulations. However, the DEA believes that the DOT's
Hazardous Materials Regulations apply to entities that place hazardous materials
in commercial transportation, and not government vehicles operated by government
personnel solely for non-commercial purposes. However, State and local
governments may have different regulations that do apply to government entities
or law enforcement. The DEA encourages these entities to consult the DOT as well
as their State and local governments for specific guidance on transporting
collected substances that may contain hazardous materials.

[3] Issue: Commenters asked the DEA whether or not collected substances must be
destroyed as hazardous waste under the EPA's Resource Conversation and Recovery
Act (RCRA).

Response: It is not within the DEA's expertise or authority to opine what
pharmaceutical controlled substances could be hazardous waste subject to EPA
regulations. The DEA does not have the authority to regulate hazardous waste and
thus cannot advise on whether or not collected substances must be destroyed as
hazardous waste pursuant to RCRA. However, the DEA has worked with the EPA at
various stages of this rulemaking, and the DEA continues to work with the EPA to
ensure the secure and responsible disposal of controlled substances, including
those that may be considered hazardous waste. The DEA believes that there is a
small portion of pharmaceuticals that are regulated as hazardous waste, and an
even smaller portion of pharmaceuticals that are regulated as both controlled
substances and hazardous waste. However, pharmaceutical controlled substances
that are collected directly from ultimate users via mail-back programs or
collection receptacles may fall under RCRA's Household Hazardous Waste
Exemption; if so, EPA RCRA regulations would not apply in those instances. The
DEA acknowledges that some state and local regulations may be more stringent.

The DEA is working with the EPA to ensure that this final rule will enable LTCF
residents to responsibly, securely, and safely dispose of controlled substances
that may also be considered hazardous waste. Collected substances from LTCFs may
pose a unique challenge since the EPA currently uses a bifurcated system to
determine whether pharmaceutical waste from LTCFs must be treated as hazardous
waste under the RCRA. If the waste is generated by the resident, it does not
have to be treated as hazardous waste and is exempt under the Household
Hazardous Waste Exemption. If the waste is generated by the LTCF, it must be
treated as hazardous waste unless it is otherwise exempt. Hazardous waste
generated by LTCFs may be exempt if Start Printed Page 53555the LTCF is a
“conditionally-exempt small quantity generator.” To qualify under such
exemption, the LTCF must generate less than or equal to 100 kilograms of
non-acute hazardous waste, and less than or equal to one kilogram of acute
hazardous waste on a monthly basis. The DEA believes that most LTCFs may qualify
under this conditional exemption. Also, the DEA acknowledges that many
pharmaceuticals that are recognized as acute hazardous waste (e.g., blood
thinners) are non-controlled substances. The DEA hopes that authorized
collectors and LTCFs will collaborate to minimize the impact that disposing of
such pharmaceuticals may have on collection efforts by separating these
non-controlled substances from controlled substances to be deposited into
collection receptacles.

The EPA is aware of the concerns regarding collected substances at LTCFs, and
according to the Fall 2013 Regulatory Agenda, the EPA is currently drafting
regulations to address hazardous waste pharmaceuticals, including the small
group of pharmaceutical controlled substances that the EPA classifies as
hazardous waste under the RCRA, when discarded. According to the Regulatory
Agenda, the EPA's proposal, “Management Standards for Hazardous Waste
Pharmaceuticals,” may propose to “revise the regulations to improve management
and disposal of hazardous waste pharmaceuticals,” and clarify regulation of
reverse distribution. The abstract for the proposal may be viewed at
www.reginfo.gov. Interested persons are encouraged to follow the progress of
this pending regulatory action.

The DEA encourages authorized collectors and others to seek guidance directly
from the EPA, and the DEA encourages such persons to consult www.epa.gov for
more information. All drug disposal and destruction must be conducted in a
manner consistent with this rule and all other applicable Federal, State,
tribal, and local laws and regulations.

R. TRANSPORTING COLLECTED SUBSTANCES (3 ISSUES)

[1] Issue: One commenter indicated that transporting collected substances
directly to the destruction location will be virtually impossible because
drivers must stop for rest breaks.

Response: The DEA recognizes that transportation to destruction facilities may
occur over long distances. The requirement to transport collected substances
directly to the destruction facility means that the collected substances should
be constantly moving towards their final destruction destination and unnecessary
or unrelated stops, and stops of an extended duration should not occur. The
final rule in §§ 1317.05(b)(4) and 1317.95(c)(1) is modified to specify this
requirement, which is designed to reduce the opportunities for diversion.

[2] Issue: Several commenters were concerned that this rule will change their
existing transport procedures that were already approved by their local SAC.

Response: In promulgating this rule, the DEA carefully considered the impact of
these changes to existing procedures and is requiring the minimum procedures
necessary to ensure safe and secure means of transporting controlled substances.
The rule provides a nationwide standard, and allows non-practitioners the
flexibility to determine the best method of transportation considering their own
individual circumstances while also ensuring accountability and reducing theft
and diversion risks. Any previous waivers, Memorandums of Understanding, or
Memorandums of Agreement issued in accordance with § 1307.21 shall be superseded
by this final rule once it becomes effective. However, practitioners may seek
assistance from their local SAC pursuant to § 1317.05(a)(4).

[3] Issue: Other commenters sought guidance on whether or not the DEA will limit
the quantity of controlled substances that may be transported, and whether or
not there will be additional requirements for interstate transport of collected
substances.

Response: This final rule does not impose any transportation quantity limits or
any requirements specific to interstate transport of controlled substances.

S. MISCELLANEOUS COMMENTS (2 ISSUES)

[1] Issue: Approximately eight commenters asked the DEA to expand the rule to
include procedures for controlled substances that have been “partially
administered” or “partially dispensed.” These commenters referred to
institutional settings where transdermal patches are used, as these used patches
may contain residual amounts of controlled substances.

Response: As previously discussed, destruction of the residual amounts of
controlled substances administered by a practitioner to a patient that remain in
the delivery apparatus (in this instance, the transdermal patch) must continue
to be recorded in accordance with existing § 1304.22(c). In accordance with the
revised § 1304.21, these destructions are not required to be recorded on DEA
Form 41. All disposals of inventory must be accomplished in accordance with
§ 1317.05(a), and all other applicable recordkeeping and inventory requirements.

[2] Issue: One commenter indicated that §§ 1317.15 and 1317.95 may conflict in
that § 1317.15 allows for storage by a reverse distributor while § 1317.95 does
not.

Response: The DEA has reviewed the relevant portions of this rule and determined
that §§ 1317.15 and 1317.95 do not conflict. Section 1317.15 encompasses the
wider topic of reverse distributor activities, including the acquisition and
storage of controlled substances from other registrants, whereas § 1317.95 deals
exclusively with the actual destruction process and the procedures that are
required for destruction once substances are in the possession and control of
the reverse distributor (including securely stored substances).

IV. REGULATORY ANALYSES

REGULATORY FLEXIBILITY ACT

The Administrator, in accordance with the Regulatory Flexibility Act of 1980
(RFA) (5 U.S.C. 601-612), has reviewed this rule and by approving it certifies
that it will not have a significant economic impact on a substantial number of
small entities. In developing this rule, the DEA considered numerous
alternatives for each requirement and method of collection and evaluated the
impact of this rule on small entities. The DEA has concluded that the rule will
not have a significant economic impact on a substantial number of small
entities. The DEA updated the economic impact analysis after considering
comments made by the public in response to the NPRM. The updated economic impact
analysis of the final rule may be viewed in the rulemaking docket at
www.regulations.gov.

In developing this rule, the DEA considered several options for both registrant
and non-registrant disposal and reverse distributor destruction requirements.
The DEA analyzed alternative methodology approaches keeping in mind its
obligations under the CSA. The DEA considered three options for non-registrant
disposal: (1) “Single Collection,” which would permit non-registrants to utilize
only one method of collection to dispose of their lawfully possessed controlled
substances; (2) “Open Collection,” which would authorize any person to collect
controlled substances from ultimate users for disposal, regardless of their
status as a registrant; and (3) Start Printed Page 53556“Multiple Collection,”
which would authorize non-registrants to utilize more than one method of
collection to transfer controlled substances for the purpose of disposal to law
enforcement and certain registrants. In addition, the DEA considered two options
for registrant disposal: (1) “Retain Existing Regulations,” which would make no
changes to the existing registrant disposal regulations (§§ 1307.12 and
1307.21); and (2) “Establish Consistent National Standards,” which would
eliminate existing regulations on the disposal of controlled substances
(§§ 1307.12 and 1307.21) and promulgate a new part that would comprehensively
outline the process and procedure for the disposal of controlled substances by
registrants and non-registrants.

Finally, the DEA considered four options for reverse distributors: (1) “On-site
Requirement,” which would require reverse distributors to have and utilize an
on-site method of destruction; (2) “Prompt Requirement,” which would require
reverse distributors, like all other registrants, to promptly destroy controlled
substances; (3) “No Requirement,” which would retain the current destruction
standard and would not put a deadline on when reverse distributors must destroy
controlled substances acquired for destruction; and (4) “No Later Than 30
Calendar Day Requirement,” which would require reverse distributors to destroy
controlled substances received for the purpose of destruction no later than 30
calendar days from receipt. The DEA performed a qualitative analysis of each of
these alternatives and selected the “Multiple Collection” option for
non-registrant disposal, the “Establish Consistent National Standards” option
for registrant disposal, and the “No Later than 30 Calendar Day Requirement”
option for reverse distributors.

In accordance with the RFA, the DEA evaluated the impact of this rule on small
entities. While all 1.5 million DEA registrants must comply with the rule as it
relates to the disposal of pharmaceutical controlled substances, only a small
subset of the registrants are associated with activities where the rule imposes
new mandatory requirements or provides options for voluntary activities.
Therefore, the DEA examined the impact of two mandatory provisions in the rule:
The 30-day destruction requirement for reverse distributors and the two employee
transportation requirement for manufacturers, distributors, and reverse
distributors. Additionally, the DEA estimated the level of voluntary
participation in collection activities in accordance with the rule and the
resulting cost impact.

The mandatory provisions and voluntary participation activities are estimated to
affect 53,533 entities (439 manufacturers, 585 distributors, 55 reverse
distributors, 656 narcotic treatment programs (NTPs), 3,068 hospitals/clinics,
29,582 pharmacies, and 19,148 long term care facilities (LTCFs). Of the 53,533
affected entities, 50,714 (423 manufacturers, 555 distributors, 38 reverse
distributors, 610 NTPs, 1,346 hospitals/clinics, 29,328 pharmacies, and 18,414
long term care facilities), or 94.7% are estimated to be small entities.

Both the 30-day destruction and the two employee transportation requirements
associated with the mandatory portions of the rule will apply to the 55 reverse
distributors that receive controlled substances from other registrants for
disposal, of which 38 were estimated to be small entities. The potential
increase in destruction, transport, travel, and labor cost associated with these
two requirements was analyzed for each of the 38 small entities. Additionally,
reverse distributors with on-site destruction facilities may receive
authorization to voluntarily operate a mail-back program. The DEA estimates that
the three small reverse distributors with on-site destruction facilities will
each operate a mail-back program. The DEA does not estimate that any reverse
distributors will operate collection receptacles at their registered locations
because of the small numbers of employees that work at those locations. However,
reverse distributors will be impacted by the destruction of controlled
substances from collection receptacles that are transferred to them for
destruction. The total estimated cost of the mandatory portions and voluntary
participation aspects of the rule was compared to the estimated annual revenue
for each of the small reverse distributors. The economic impact of the mandatory
portion and voluntary participation aspects of this rule is estimated to be
significant, greater than one percent of annual revenue, for two (5%) of 38
affected small businesses.

The two-person transportation requirement associated with the mandatory portions
of the rule also affects 423 small manufacturers and 555 small distributors that
transport to reverse distributors or to an unregistered, off-site location for
destruction. The potential increase in labor cost associated with the two-person
requirement was analyzed for manufacturers and distributors. Additionally, a
small number of manufacturers and distributors are estimated to volunteer to
operate collection receptacles at their registered locations primarily for use
by their employees. However, the DEA believes that manufacturers and
distributors will not operate collection receptacles at their registered
locations unless they believe there will be a benefit to them for the service.
The economic impact of the mandatory portion and voluntary participation aspects
of this rule is estimated to be significant for none (0.0%) of the 423 small
manufacturers and none (0.0%) of the 555 small distributors.

The rule also permits certain other registrant categories to voluntarily conduct
collection activities. The DEA estimates some retail pharmacies,
hospitals/clinics with on-site pharmacies, and NTPs will voluntarily participate
as collectors by operating collection receptacles at their locations. Some
retail pharmacies and hospitals/clinics with an on-site pharmacy are also
estimated to operate collection receptacles at LTCFs. The level of participation
and operating costs were estimated to determine the number of small entities
with impact greater than 1% of revenue.

In summary, the DEA estimates that zero (0.0%) of the 423 small manufacturers,
zero (0.0%) of the 555 small distributors, two (5.0%) of 38 small reverse
distributors, 62 (10.2%) of the small NTPs, zero (0.0%) of the 1,349 small
hospitals/clinics, 810 (2.8%) of the 29,328 small pharmacies, and zero (0.0%) of
the 18,414 small long term care facilities may be significantly impacted by this
rule (that is, where the annual cost is estimated to be greater than 1% of
annual revenue). But DEA emphasizes that these estimates are entirely dependent
on the level of voluntary participation by these entities. All of the provisions
relating to collection activities by manufacturers, distributors, NTPs,
hospitals/clinics, pharmacies, and LTCFs are completely voluntary and these
entities would be free to choose whether or not to participate based on their
own review of the cost to them and the anticipated benefits in providing
collection receptacles.

In total, the DEA estimates that 874 (1.7%) of the 50,714 affected small
entities may be significantly affected by this rule. The DEA's assessment of
economic impact by size category indicates that the rule will not have a
significant effect on a substantial number of these small business entities.

In accordance with the RFA (5 U.S.C. 605(b)), the Administrator hereby certifies
that this rulemaking has been Start Printed Page 53557drafted consistent with
the RFA, that a regulatory analysis on the effects or impacts of this rulemaking
on small entities has been done, and that the rule will not have a significant
economic impact on a substantial number of small entities.

EXECUTIVE ORDERS 12866 AND 13563

This rule was developed in accordance with the principles of Executive Orders
12866 and 13563. Based on the completed economic analysis, the DEA does not
anticipate that this rulemaking will have an annual effect on the economy of
$100 million or more or adversely affect, in a material way, the economy, a
sector of the economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or communities. An
economic analysis of the final rule can be found in the rulemaking docket at
www.regulations.gov. Public comment was received in public meetings held on
January 19-20, 2011, and through a solicitation for comment in the NPRM to help
inform and develop these rules. Although not an economically significant rule,
this rule on the disposal of controlled substances has been reviewed by the
Office of Management and Budget (OMB).

The DEA has determined that reverse distributors currently destroy controlled
substances within the “No Later than 30 Calendar Day” requirement the majority
of the time. However, it is recognized that there may be instances when reverse
distributors do not currently meet this requirement. Additionally, many
manufacturers, distributors, and reverse distributors currently employ two
persons to transport controlled substances for destruction. However, it is
recognized that there may be instances when manufacturers, distributors, and
reverse distributors do not currently meet this requirement. For these
instances, the DEA estimated the cost to accommodate the requirements and has
determined the cost is not a significant economic impact.

Moreover, the DEA estimated a range of costs of voluntary participation for
manufacturers, distributors, reverse distributors, narcotic treatment programs,
hospitals/clinics with an on-site pharmacy, and retail pharmacies that may
participate to collect ultimate user pharmaceutical controlled substances.

In summary, the DEA estimates that the annual total cost to the economy as a
result of the rule is $2,719,319 for the mandatory provisions of this rule and
the total annualized cost of the mandatory provisions and the voluntary
participation aspects of the rule ranges from $44,896,787 to $73,222,427. The
DEA estimates the highest cost in any given year occurs in the first year,
ranging from $45,282,242 to $99,075,339. Accordingly, the DEA does not
anticipate that this rulemaking will have an annual effect on the economy of
$100 million or more or adversely affect in a material way the economy, a sector
of the economy, productivity, competition, jobs, the environment, public health
or safety, or State, local, or tribal governments or communities.

Since the aspects of the rule that facilitate non-registrant disposal are
completely voluntary (not mandated), manufacturers, distributors, reverse
distributors, narcotic treatment programs, hospitals/clinics with an on-site
pharmacy, and retail pharmacies may become collectors if they choose to engage
in the voluntary activities based on its own evaluation of costs and benefits
(tangible and intangible). For the purposes of this analysis, the DEA assumes
that an entity will volunteer to perform the activities to facilitate
non-registrant disposal only if there is a net zero or positive benefit to the
entity. For example, a pharmacy may derive tangible benefits, such as additional
revenue from increased retail traffic to the pharmacy. Collectors may also
derive tangible benefits such as public safety and good will from their
collection activities. Any collector that chooses to engage in these voluntary
activities can decide to cease these activities at any time. Therefore, for the
purposes of this analysis, the DEA estimates that the cost of the voluntary
participation aspects of this rule are offset by the benefits of the voluntary
participation aspects of this rule and have a net zero economic impact. The
total cost of the mandatory provisions and voluntary participation aspects of
the rule ($73,222,427 at the highest voluntary participation rate) is compared
to the benefit of this rule. In evaluating the costs and benefits of the rule,
the annual cost of the rule is compared with the anticipated reduction in the
growth rate of costs associated with diversion of controlled substances into the
illicit market. The cost-benefit analysis uses the costs associated with the
nonmedical use of prescription opioids, $8.6 billion in 2001 [7] and $53.4
billion in 2006.[8] These are conservative estimates of the rapidly growing
total cost associated with diversion of controlled substances into the illicit
market. Although there is a lack of evidence to quantify the cost savings or
public health impacts of the rule, the DEA believes that this rule reduces the
growth in the cost of the diversion of controlled substances into the illicit
market by at least $44.9 to $73.2 million annually and, therefore, this rule
will have positive net economic benefits, including benefits related to the
health and safety of the citizens and residents of the United States.

PAPERWORK REDUCTION ACT

Pursuant to § 3507(d) of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501 et seq.), the DEA has identified the following collections of information
related to this rule and has submitted these collection requests to the OMB for
review and approval. This rule implements the Disposal Act, in addition to
reorganizing and consolidating existing regulations on disposal into a
comprehensive regulatory framework for the destruction of controlled substances.
In accordance with the CSA, which establishes a closed system of distribution
for all controlled substances, registrants are required to make a biennial
inventory and maintain, on a current basis, a complete and accurate record of
each controlled substance manufactured, received, sold, delivered, or otherwise
disposed of. 21 U.S.C. 827(a) and 958. These records must be in accordance with
and contain such relevant information as may be required by regulations
promulgated by the DEA. 21 U.S.C. 827(b)(1).

In this rule, the DEA revises existing, and adds a minimum amount of new,
registrant recordkeeping requirements. These requirements are consistent with
requirements already required by statute and regulation.

TITLE: IMPLEMENTATION OF REGISTRANT RECORDKEEPING REQUIREMENTS PURSUANT TO THE
CSA, 21 U.S.C. 827

The records that registrants are required to maintain pursuant to law are a
vital component of the DEA's enforcement and control responsibilities—such
records alert the DEA to problems of diversion and ensure that the system of
controlled substances distribution is open only to legitimate handlers of such
substances.

The DEA is revising the information that reverse distributors are currently
required to record for clarity and consistency, and adding a minimum amount of
new requirements. For all controlled substance records, reverse distributors
will be required to maintain their existing business records so that Start
Printed Page 53558the record of receipt is maintained with the corresponding
record of return or destruction. By maintaining all relevant business records
together, the DEA will be able to trace each substance received by a reverse
distributor from its acquisition to its disposition, whether by destruction or
return to the manufacturer.

The DEA estimates that there will be 60 respondents to this information
collection and that their estimated frequency of response will vary because, in
accordance with 21 U.S.C. 827 and 958, registrants make an initial and biennial
inventory and maintain, on a current basis, a complete and accurate record of
each controlled substance manufactured, received, sold, delivered, or otherwise
disposed of. Under existing law, reverse distributors are required to maintain,
for at least two years, inventory records and records of controlled substances
received, delivered, destroyed, or returned to the manufacturer. The annual hour
burden for recordkeeping for reverse distributors is estimated to increase by 34
hours due to the requirements in this final rule, and the annualized cost to
respondents is estimated to be $719. The DEA is also modifying information that
registrants are required to record in the return and recall process. The DEA is
eliminating the previous rule on return and recall, § 1307.12, and implementing
separate rules on the return and recall of controlled substances for registrants
and non-registrants in part 1317. The return and recall recordkeeping
requirements reflect these changes.

The DEA estimates that the universe of potential respondents to this information
collection will be 1,511,389 respondents (all registrants may transfer
controlled substances for return or recall). The DEA estimates that the
frequency of response will vary, because, in accordance with 21 U.S.C. 827(a),
registrants must make an initial and biennial inventory and maintain, on a
current basis, a complete and accurate record of each controlled substance
manufactured, received, sold, delivered, or otherwise disposed of. Because
registrants are already required to maintain records in accordance with 21
U.S.C. 827(a)-(b), the DEA anticipates that the annual hour burden will not be
increased by this rule.

The DEA is implementing new recordkeeping requirements for registrants that
collect controlled substances from ultimate users and other non-registrants in
accordance with the new authority provided in the Disposal Act. The
implementation of the Disposal Act regulations will provide ultimate users,
LTCFs, and other non-registrants safe and convenient options to transfer
controlled substances for the purpose of disposal: Take-back events, mail-back
programs, and collection receptacles. Registered manufacturers, distributors,
reverse distributors, narcotic treatment programs, hospitals/clinics with an
on-site pharmacy, and retail pharmacies may obtain authorization from the DEA to
be a collector pursuant to § 1317.40. A collector is a registered manufacturer,
distributor, reverse distributor, narcotic treatment program, hospital/clinic
with an on-site pharmacy, or retail pharmacy that is authorized under this rule
to receive a pharmaceutical controlled substance from an ultimate user for the
purpose of destruction, as defined in part 1300. The DEA is requiring
information that collectors must record based on the particular ultimate user
collection method implemented (i.e., mail-back program or collection
receptacle).

The DEA estimates that the universe of potential participants to this
information collection will be 87,736 respondents (Manufacturers—536,
Distributors—829, Reverse Distributors—60, Narcotic Treatment Programs—1,332,
Hospitals/Clinics—15,953, Retail Pharmacies—69,026).[9] However, the DEA
estimates that the participants to this information collection will be 54,457
respondents (Manufacturers—107, Distributors—166, Reverse Distributors—10,
Narcotic Treatment Programs—999, Hospitals/Clinics—2862, Retail
Pharmacies—34,513, and an additional 15,800 hospitals/clinics and retail
pharmacies operating collection receptacles at LTCFs). The DEA estimates that
the frequency of response will vary, because, in accordance with 21 U.S.C.
827(a), registrants must make an initial and biennial inventory and maintain, on
a current basis, a complete and accurate record of each controlled substance
manufactured, received, sold, delivered, or otherwise disposed of. The DEA
notes, however, that the option to become a collector is voluntary and no entity
is required to establish or operate a disposal program as a collector. While the
authorization to collect is a new activity, the DEA has estimated the level of
participation. The estimated 54,457 respondents are estimated to have an
annualized hour burden of 89,406 with an estimated annualized cost of
$1,670,064. The DEA will continue to monitor and analyze the potential burden of
the new requirements imposed by this rule.

The DEA is authorizing reverse distributors to acquire controlled substances
from law enforcement and authorized collectors that have acquired controlled
substances from ultimate users and other non-registrants. The DEA is also
authorizing distributors to acquire controlled substances from authorized
collectors that collect controlled substances from ultimate users. The DEA is
requiring these reverse distributors and distributors to maintain complete and
accurate records, in accordance with part 1304, of controlled substances
received, delivered, or otherwise transferred for the purpose of destruction.

The DEA estimates that the universe of potential respondents to this information
collection will be 889 respondents (Distributors—829, Reverse Distributors—60).
The DEA estimates that the frequency of response will vary, because, in
accordance with 21 U.S.C. 827(a), registrants must make an initial and biennial
inventory and maintain, on a current basis, a complete and accurate record of
each controlled substance manufactured, received, sold, delivered, or otherwise
disposed of. The authorization for reverse distributors to acquire controlled
substances collected by law enforcement and collectors, and the authorization
for distributors to acquire controlled substances from collectors, is new.
Although the DEA has estimated the level of participation, the DEA is unable to
estimate the number of information collection events because destruction of
multiple acquisitions of controlled substances can be on a single form. The
DEA's initial estimate for the annual hour burden is 472 hours (32 minutes per
event), with an estimated annualized cost of $10,037. The DEA will continue to
analyze the potential burden of the new requirements imposed by this rule.

TITLE: REGISTRANT RECORD OF CONTROLLED SUBSTANCES DESTROYED—DEA FORM 41

OMB Control Number: 1117-0007.

Form Number: DEA Form 41.

The records that registrants are required to maintain pursuant to law are a
vital component of the DEA's enforcement and control responsibilities—such
records alert the DEA to diversion and ensure that the system of controlled
substances distribution is open only to legitimate handlers of such substances.
The DEA is requiring registrants involved in the destruction of controlled
substances to record certain information. The record Start Printed Page 53559of
destruction must include the signature of the two employees of the registrant
that witnessed the destruction, in addition to other information about the
controlled substance disposed of and the method of destruction utilized. The DEA
is modifying existing DEA Form 41 to record the destruction of controlled
substances that remain in the closed system of distribution and to account for
registrant destruction of controlled substances collected from ultimate users
and other non-registrants outside the closed system pursuant to the Disposal
Act. DEA Form 41 has previously been approved by the OMB and assigned OMB
control number 1117-0007. In accordance with the CSA, registrants that destroy
controlled substances and utilize DEA Form 41 will be required to keep and make
available the information in the specified format, for at least two years, for
inspection and copying by officers or employees of the United States authorized
by the Attorney General. 21 U.S.C. 827(b).

The DEA estimates that there will be 87,736 respondents (Manufacturers—536,
Distributors—829, Reverse Distributors—60, Narcotic Treatment Programs—1,332,
Hospitals/Clinics—15,953, Retail Pharmacies—69,026) to this information
collection. The number of respondents (87,736) represents the total number of
registrants in business activities that are most likely to destroy controlled
substances. The DEA estimates that the frequency of response will vary, because
in accordance with 21 U.S.C. 827(a), registrants must maintain, on a current
basis, a complete and accurate record of each controlled substance manufactured,
received, sold, delivered, or otherwise disposed of, and, as a result, will make
a record of destruction each time they destroy a controlled substance. The DEA
estimates that the average time per response will be 30 minutes and that the
total annual burden will be 43,868 hours, with an estimated total annual cost
burden of $928,247.

EXECUTIVE ORDER 12988

This rule meets the applicable standards set forth in §§ 3(a) and 3(b)(2) of
Executive Order 12988 to eliminate ambiguity, minimize litigation, establish
clear legal standards, and reduce burden.

EXECUTIVE ORDER 13132

This rulemaking does not preempt or modify any provision of State law, impose
enforcement responsibilities on any State or diminish the power of any State to
enforce its own laws. Accordingly, this rulemaking does not have federalism
implications warranting the application of Executive Order 13132.

NATIONAL ENVIRONMENTAL POLICY ACT (NEPA)

This rule provides options for the collection of controlled substances by
registrants and non-registrants consistent with DEA regulations and Federal,
State, tribal, and local laws and regulations. Provision of these options is
intended to result in increased collection and destruction of unused controlled
substances and thereby prevent diversion of such unused substances to illicit
uses and result in collection and destruction of larger quantities in economical
and environmentally sound manners. This rule establishes legal requirements for
the handling of controlled substances. Destruction of controlled substances must
be consistent with Federal, State, tribal and local laws and regulations.

The DEA and registrants have disposed of controlled substances since passage of
the CSA. By regulation, the U.S. Department of Justice categorically excluded
the DEA from further NEPA analysis with respect to regulations relating to the
storage and destruction of controlled substances. This rule does not authorize
any new methods of storage, transportation, or destruction of controlled
substances, but is limited to the procedures and records pertaining to the
collection of controlled substances for destruction. Accordingly, this proposed
rule does not significantly affect the quality of the human environment. The DEA
has, therefore, determined that this rule does not have significant individual
or cumulative effects on the human environment and is excluded from detailed
analysis pursuant to 28 CFR part 61, Appendix B.

UNFUNDED MANDATES REFORM ACT

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C.
1501 et seq.), on the basis of information contained in the “Regulatory
Flexibility Act” section above, the DEA has determined and certifies pursuant to
the UMRA that this action would not result in any Federal mandate that may
result “in the expenditure by State, local, and tribal governments, in the
aggregate, or by the private sector, of $100,000,000 or more (adjusted for
inflation) in any one year. . . .” Therefore, neither a Small Government Agency
Plan nor any other action is required under provisions of the UMRA of 1995.

EXECUTIVE ORDER 13175

This rule does not have tribal implications warranting the application of
Executive Order 13175. The rule does not have substantial direct effects on one
or more Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.

CONGRESSIONAL REVIEW ACT

This rule is not a major rule as defined by the Congressional Review Act (5
U.S.C. 804). This rule will not result in an annual effect on the economy of
$100,000,000 or more, a major increase in costs or prices, or have significant
adverse effects on competition, employment, investment, productivity,
innovation, or the ability of United States-based companies to compete with
foreign based companies in domestic and export markets.

RULE TEXT

Start List of Subjects

LIST OF SUBJECTS

21 CFR PART 1300

* Chemicals
* Drug traffic control

21 CFR PART 1301

* Administrative practice and procedure
* Drug traffic control
* Security measures

21 CFR PART 1304

* Drug traffic control
* Reporting and recordkeeping requirements

21 CFR PART 1305

* Drug traffic control

21 CFR PART 1307

* Drug traffic control

21 CFR PART 1317

* Drug traffic control
* Security measures

End List of Subjects

For the reasons stated in the preamble, the DEA amends 21 CFR chapter II as
follows:

Start Part

PART 1300—DEFINITIONS

End Part Start Amendment Part

1-2. The authority citation for part 1300 is revised to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).

End Authority Start Amendment Part

3. In § 1300.01, amend paragraph (b) as follows:

End Amendment Part Start Amendment Part

a. Revise the introductory text;

End Amendment Part Start Amendment Part

b. Add a definition of “Collection” in alphabetical order;

End Amendment Part Start Amendment Part

c. Revise the last sentence in the definition of “Freight forwarding facility”;

End Amendment Part Start Amendment Part

d. Add a definition of “Reverse distribute” in alphabetical order; and Start
Printed Page 53560

End Amendment Part Start Amendment Part

e. Revise the definition of “Reverse distributor”.

End Amendment Part

The revisions and additions read as follows:

§ 1300.01
Definitions relating to controlled substances.
* * * * *

(b) As used in parts 1301 through 1308, 1312, and 1317 of this chapter, the
following terms shall have the meanings specified:

* * * * *

Collection means to receive a controlled substance for the purpose of
destruction from an ultimate user, a person lawfully entitled to dispose of an
ultimate user decedent's property, or a long-term care facility on behalf of an
ultimate user who resides or has resided at that facility. The term collector
means a registered manufacturer, distributor, reverse distributor, narcotic
treatment program, hospital/clinic with an on-site pharmacy, or retail pharmacy
that is authorized under this chapter to so receive a controlled substance for
the purpose of destruction.

* * * * *

Freight forwarding facility * * * For purposes of this definition, a
distributing registrant is a person who is registered with the Administration as
a manufacturer, distributor (excluding reverse distributor), and/or importer.

* * * * *

Reverse distribute means to acquire controlled substances from another
registrant or law enforcement for the purpose of:

(1) Return to the registered manufacturer or another registrant authorized by
the manufacturer to accept returns on the manufacturer's behalf; or

(2) Destruction.

Reverse distributor is a person registered with the Administration as a reverse
distributor.

* * * * *
Start Amendment Part

4. Add § 1300.05 to read as follows:

End Amendment Part
§ 1300.05
Definitions relating to the disposal of controlled substances.

(a) Any term not defined in this part or elsewhere in this chapter shall have
the definition set forth in section 102 of the Act (21 U.S.C. 802).

(b) As used in part 1317 of this chapter, the following terms shall have the
meanings specified:

Employee means an employee as defined under the general common law of agency.
Some of the factors relevant to the determination of employee status include:
The hiring party's right to control the manner and means by which the product is
accomplished; the skill required; the source of the instrumentalities and tools;
the location of the work; the duration of the relationship between the parties;
whether the hiring party has the right to assign additional projects to the
hired party; the extent of the hired party's discretion over when and how long
to work; the method of payment; the hired party's role in hiring and paying
assistants; whether the work is part of the regular business of the hiring
party; whether the hiring party is in business; the provision of employee
benefits; and the tax treatment of the hired party. Other applicable factors may
be considered and no one factor is dispositive. The following criteria will
determine whether a person is an employee of a registrant for the purpose of
disposal: The person is directly paid by the registrant; subject to direct
oversight by the registrant; required, as a condition of employment, to follow
the registrant's procedures and guidelines pertaining to the handling of
controlled substances; subject to receive a performance rating or performance
evaluation on a regular/routine basis from the registrant; subject to
disciplinary action by the registrant; and required to render services at the
registrant's registered location.

Law enforcement officer means a person who is described in paragraph (1), (2) or
(3) of this definition:

(1) Meets all of the following criteria:

(i) Employee of either a law enforcement agency, or law enforcement component of
a Federal agency;

(ii) Is under the direction and control of a Federal, State, tribal, or local
government;

(iii) Acting in the course of his/her official duty; and

(iv) Duly sworn and given the authority by a Federal, State, tribal, or local
government to carry firearms, execute and serve warrants, make arrests without
warrant, and make seizures of property;

(2) Is a Veterans Health Administration (VHA) police officer authorized by the
Department of Veterans Affairs to participate in collection activities conducted
by the VHA; or

(3) Is a Department of Defense (DOD) police officer authorized by the DOD to
participate in collection activities conducted by the DOD.

Non-retrievable means, for the purpose of destruction, the condition or state to
which a controlled substance shall be rendered following a process that
permanently alters that controlled substance's physical or chemical condition or
state through irreversible means and thereby renders the controlled substance
unavailable and unusable for all practical purposes. The process to achieve a
non-retrievable condition or state may be unique to a substance's chemical or
physical properties. A controlled substance is considered “non-retrievable” when
it cannot be transformed to a physical or chemical condition or state as a
controlled substance or controlled substance analogue. The purpose of
destruction is to render the controlled substance(s) to a non-retrievable state
and thus prevent diversion of any such substance to illicit purposes.

On-site means located on or at the physical premises of the registrant's
registered location. A controlled substance is destroyed on-site when
destruction occurs on the physical premises of the destroying registrant's
registered location. A hospital/clinic has an on-site pharmacy when it has a
pharmacy located on the physical premises of the registrant's registered
location.

Start Part

PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF
CONTROLLED SUBSTANCES

End Part Start Amendment Part

5. The authority citation for part 1301 is revised to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952,
953, 956, 957, 958, 965.

End Authority Start Amendment Part

6. In § 1301.13, revise paragraphs (e)(1)(i) and (ii) to read as follows:

End Amendment Part
§ 1301.13
Application for registration; time for application; expiration date;
registration for independent activities; application forms, fees, contents and
signature; coincident activities.
* * * * *

(e) * * *

(1)Start Printed Page 53561

Expand Table

Business activityControlled substancesDEA application formsApplication fee
($)Registration period (years)Coincident activities allowed(i)
ManufacturingSchedules I-VNew—225 Renewal—225a3,0471Schedules I-V: May
distribute that substance or class for which registration was issued; may not
distribute any substance or class for which not registered. Schedules II-V:
May conduct chemical analysis and preclinical research (including quality
control analysis) with substances listed in those schedules for which
authorization as a mfr. was issued.(ii) DistributingSchedules I-VNew—225
Renewal—225a1,5231May acquire Schedules II-V controlled substances from
collectors for the purposes of
destruction. * * * * * * *

* * * * *
Start Amendment Part

7. In § 1301.25, revise paragraph (i) to read as follows:

End Amendment Part
§ 1301.25
Registration regarding ocean vessels, aircraft, and other entities.
* * * * *

(i) Controlled substances acquired and possessed in accordance with this section
shall be distributed only to persons under the general supervision of the
medical officer employed by the owner or operator of the vessel, aircraft, or
other entity, except in accordance with part 1317 of this chapter.

Start Amendment Part

8. Revise § 1301.51 to read as follows:

End Amendment Part
§ 1301.51
Modification in registration.

(a) Any registrant may apply to modify his/her registration to authorize the
handling of additional controlled substances or to change his/her name or
address by submitting a written request to the Registration Unit, Drug
Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01
of this chapter for the current mailing address. Additionally, such a request
may be submitted on-line at www.DEAdiversion.usdoj.gov.

(1) The request shall contain:

(i) The registrant's name, address, and registration number as printed on the
certificate of registration;

(ii) The substances and/or schedules to be added to the registration or the new
name or address; and

(iii) A signature in accordance with § 1301.13(j).

(2) If the registrant is seeking to handle additional controlled substances
listed in Schedule I for the purpose of research or instructional activities,
the registrant shall attach three copies of a research protocol describing each
research project involving the additional substances, or two copies of a
statement describing the nature, extent, and duration of such instructional
activities, as appropriate.

(b) Any manufacturer, distributor, reverse distributor, narcotic treatment
program, hospital/clinic with an on-site pharmacy, or retail pharmacy registered
pursuant to this part, may apply to modify its registration to become authorized
as a collector by submitting a written request to the Registration Unit, Drug
Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01
of this chapter for the current mailing address. Additionally, such request may
be submitted on-line at www.DEAdiversion.usdoj.gov.

(1) The request shall contain:

(i) The registrant's name, address, and registration number as printed on the
certificate of registration;

(ii) The method(s) of collection the registrant intends to conduct (collection
receptacle and/or mail-back program); and

(iii) A signature in accordance with § 1301.13(j).

(2) If a hospital/clinic with an on-site pharmacy or retail pharmacy is applying
for a modification in registration to authorize such registrant to be a
collector to maintain a collection receptacle at a long-term care facility in
accordance with § 1317.80 of this chapter, the request shall also include the
name and physical location of each long-term care facility at which the
hospital/clinic with an on-site pharmacy, or the retail pharmacy, intends to
operate a collection receptacle.

(c) No fee shall be required for modification. The request for modification
shall be handled in the same manner as an application for registration. If the
modification of registration is approved, the Administrator shall issue a new
certificate of registration (DEA Form 223) to the registrant, who shall maintain
it with the old certificate of registration until expiration.

Start Amendment Part

9. In § 1301.52, revise the last sentence of paragraph (c) and add paragraph (f)
to read as follows:

End Amendment Part
§ 1301.52
Termination of registration; transfer of registration; distribution upon
discontinuance of business.
* * * * *

(c) * * * Any controlled substances in his/her possession may be disposed of in
accordance with part 1317 of this chapter.

* * * * *

(f) Any registrant that has been authorized as a collector and desires to
discontinue its collection of controlled substances from ultimate users shall
notify the Administration of its intent by submitting a written notification to
the Registration Unit, Drug Enforcement Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this chapter for the current mailing address.
Additionally, such notice may be submitted on-line at
www.DEAdiversion.usdoj.gov. When ceasing collection activities of an authorized
mail-back program, the registrant shall provide the Administration with the
name, registered address, and registration number of the collector that will
receive the remaining mail-back packages in accordance with § 1317.70(e)(3) of
this chapter.

Start Amendment Part

10. In § 1301.71, add paragraph (f) to read as follows:

End Amendment Part
§ 1301.71
Security requirements generally.
* * * * *

(f) A collector shall not employ, as an agent or employee who has access to or
influence over controlled substances acquired by collection, any person who has
been convicted of any felony offense relating to controlled substances or who,
at any time, had an application for registration with DEA denied, had a DEA
registration revoked or suspended, Start Printed Page 53562or has surrendered a
DEA registration for cause. For purposes of this subsection, “for cause” means
in lieu of, or as a consequence of, any Federal or State administrative, civil,
or criminal action resulting from an investigation of the individual's handling
of controlled substances.

Start Amendment Part

11. In § 1301.72, revise paragraph (a) introductory text to read as follows:

End Amendment Part
§ 1301.72
Physical security controls for non-practitioners; narcotic treatment programs,
and compounders for narcotic treatment programs; storage areas.

(a) Schedules I and II. Raw material, bulk materials awaiting further
processing, finished products which are controlled substances listed in Schedule
I or II (except GHB that is manufactured or distributed in accordance with an
exemption under section 505(i) of the Federal Food Drug and Cosmetic Act which
shall be subject to the requirements of paragraph (b) of this section), and
sealed mail-back packages and inner liners acquired in accordance with part 1317
of this chapter, shall be stored in one of the following secured areas:

* * * * *
Start Amendment Part

12. In § 1301.74, add paragraph (m) to read as follows:

End Amendment Part
§ 1301.74
Other security controls for non-practitioners; narcotic treatment programs and
compounders for narcotic treatment programs.
* * * * *

(m) A reverse distributor shall not employ, as an agent or employee who has
access to or influence over controlled substances, any person who has been
convicted of any felony offense relating to controlled substances or who, at any
time, had an application for registration with the DEA denied, had a DEA
registration revoked or suspended, or has surrendered a DEA registration for
cause. For purposes of this subsection, “for cause” means in lieu of, or as a
consequence of, any Federal or State administrative, civil, or criminal action
resulting from an investigation of the individual's handling of controlled
substances.

Start Amendment Part

13. In § 1301.75, redesignate paragraphs (c) and (d) as paragraphs (d) and (e)
and add a new paragraph (c) to read as follows:

End Amendment Part
§ 1301.75
Physical security controls for practitioners.
* * * * *

(c) Sealed mail-back packages and inner liners collected in accordance with part
1317 of this chapter shall only be stored at the registered location in a
securely locked, substantially constructed cabinet or a securely locked room
with controlled access, except as authorized by § 1317.80(d).

* * * * *
Start Amendment Part

14. In § 1301.76, revise paragraph (c) to read as follows:

End Amendment Part
§ 1301.76
Other security controls for practitioners.
* * * * *

(c) Whenever the registrant distributes a controlled substance (without being
registered as a distributor as permitted in §§ 1301.13(e)(1), 1307.11, 1317.05,
and/or 1317.10 of this chapter), he/she shall comply with the requirements
imposed on non-practitioners in § 1301.74(a), (b), and (e).

* * * * *
Start Part

PART 1304—RECORDS AND REPORTS OF REGISTRANTS

End Part Start Amendment Part

15. The authority citation for part 1304 is revised to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and 965, unless
otherwise noted.

End Authority Start Amendment Part

16. Amend § 1304.03 by revising the first and second sentences of paragraph (a)
to read as follows:

End Amendment Part
§ 1304.03
Persons required to keep records and file reports.

(a) Every registrant, including collectors, shall maintain the records and
inventories and shall file the reports required by this part, except as exempted
by this section. Any registrant that is authorized to conduct other activities
without being registered to conduct those activities, pursuant to §§ 1301.22(b),
1307.11, 1307.13, or part 1317 of this chapter, shall maintain the records and
inventories and shall file the reports required by this part for persons
registered or authorized to conduct such activities. * * *

* * * * *
Start Amendment Part

17. In § 1304.04, add paragraph (a)(3) to read as follows:

End Amendment Part
§ 1304.04
Maintenance of records and inventories.

(a) * * *

(3) A collector that is authorized to maintain a collection receptacle at a
long-term care facility shall keep all records required by this part relating to
those collection receptacles at the registered location, or other approved
central location.

* * * * *
Start Amendment Part

18. In § 1304.11, revise paragraphs (e) introductory text and (e)(2) and (3) and
add paragraphs (e)(6) and (7) to read as follows:

End Amendment Part
§ 1304.11
Inventory requirements.
* * * * *

(e) Inventories of manufacturers, distributors, registrants that reverse
distribute, importers, exporters, chemical analysts, dispensers, researchers,
and collectors. Each person registered or authorized (by §§ 1301.13, 1307.11,
1307.13, or part 1317 of this chapter) to manufacture, distribute, reverse
distribute, dispense, import, export, conduct research or chemical analysis with
controlled substances, or collect controlled substances from ultimate users, and
required to keep records pursuant to § 1304.03 shall include in the inventory
the information listed below.

* * * * *

(2) Inventories of distributors. Each person registered or authorized to
distribute controlled substances shall include in the inventory the same
information required of manufacturers pursuant to paragraphs (e)(1)(iii) and
(iv) of this section.

(3) Inventories of registrants that reverse distribute. Each person registered
or authorized to reverse distribute controlled substances shall include in the
inventory, the following information:

(i) The name of the substance, and

(ii) The total quantity of the substance:

(A) For controlled substances in bulk form, to the nearest metric unit weight
consistent with unit size;

(B) For each controlled substance in finished form: Each finished form of the
substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid
ounce or milliliter); the number of units or volume of each finished form in
each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
the number of commercial containers of each such finished form (e.g., four
100-tablet bottles or six 3-milliliter vials); and

(C) For controlled substances in a commercial container, carton, crate, drum, or
other receptacle that has been opened: If the substance is listed in Schedule I
or II, make an exact count or measure of the contents; or if the substance is
listed in Schedule III, IV, or V, make an estimated count or measure of the
contents, unless the container holds more than 1,000 tablets or capsules in
which case an exact count of the contents shall be made; or

(iii) For controlled substances acquired from collectors and law enforcement:
The number and size (e.g., five 10-gallon liners, etc.) of sealed inner liners
on hand, or

(iv) For controlled substances acquired from law enforcement: the Start Printed
Page 53563number of sealed mail-back packages on hand.

* * * * *

(6) Inventories of dispensers and researchers. Each person registered or
authorized to dispense or conduct research with controlled substances shall
include in the inventory the same information required of manufacturers pursuant
to paragraphs (e)(1)(iii) and (iv) of this section. In determining the number of
units of each finished form of a controlled substance in a commercial container
that has been opened, the dispenser or researcher shall do as follows:

(i) If the substance is listed in Schedules I or II, make an exact count or
measure of the contents; or

(ii) If the substance is listed in Schedule III, IV, or V, make an estimated
count or measure of the contents, unless the container holds more than 1,000
tablets or capsules in which case he/she must make an exact count of the
contents.

(7) Inventories of collectors. Each registrant authorized to collect controlled
substances from ultimate users shall include in the inventory the following
information:

(i) For registrants authorized to collect through a mail-back program, the
record shall include the following information about each unused mail-back
package and each returned mail-back package on hand awaiting destruction:

(A) The date of the inventory;

(B) The number of mail-back packages; and

(ii) For registrants authorized to collect through a collection receptacle, the
record shall include the following information about each unused inner liner on
hand and each sealed inner liner on hand awaiting destruction:

(A) The date of the inventory;

(B) The number and size of inner liners (e.g., five 10-gallon liners, etc.);

Start Amendment Part

19. In § 1304.21, revise paragraphs (a), (c), and (d) and add paragraph (e) to
read as follows:

End Amendment Part
§ 1304.21
General requirements for continuing records.

(a) Every registrant required to keep records pursuant to § 1304.03 shall
maintain, on a current basis, a complete and accurate record of each substance
manufactured, imported, received, sold, delivered, exported, or otherwise
disposed of by him/her, and each inner liner, sealed inner liner, and unused and
returned mail-back package, except that no registrant shall be required to
maintain a perpetual inventory.

* * * * *

(c) Separate records shall be maintained by a registrant for each independent
activity and collection activity for which he/she is registered or authorized,
except as provided in § 1304.22(d).

(d) In recording dates of receipt, importation, distribution, exportation, other
transfers, or destruction, the date on which the controlled substances are
actually received, imported, distributed, exported, otherwise transferred, or
destroyed shall be used as the date of receipt, importation, distribution,
exportation, transfer, or destruction (e.g., invoices, packing slips, or DEA
Form 41).

(e) Record of destruction. In addition to any other recordkeeping requirements,
any registered person that destroys a controlled substance pursuant to
§ 1317.95(d), or causes the destruction of a controlled substance pursuant to
§ 1317.95(c), shall maintain a record of destruction on a DEA Form 41. The
records shall be complete and accurate, and include the name and signature of
the two employees who witnessed the destruction. Except, destruction of a
controlled substance dispensed by a practitioner for immediate administration at
the practitioner's registered location, when the substance is not fully
exhausted (e.g., some of the substance remains in a vial, tube, or syringe after
administration but cannot or may not be further utilized), shall be properly
recorded in accordance with § 1304.22(c), and such record need not be maintained
on a DEA Form 41.

Start Amendment Part

20. In § 1304.22, revise the section heading, introductory text, and paragraph
(e) and add paragraph (f) to read as follows:

End Amendment Part
§ 1304.22
Records for manufacturers, distributors, dispensers, researchers, importers,
exporters, registrants that reverse distribute, and collectors.

Each person registered or authorized (by §§ 1301.13(e), 1307.11, 1307.13, or
part 1317 of this chapter) to manufacture, distribute, dispense, import, export,
reverse distribute, destroy, conduct research with controlled substances, or
collect controlled substances from ultimate users, shall maintain records with
the information listed in paragraphs (a) through (f) of this section.

* * * * *

(e) Records for registrants that reverse distribute. Each person registered or
authorized to reverse distribute controlled substances shall maintain records
with the following information for each controlled substance:

(1) For controlled substances acquired for the purpose of return or recall to
the manufacturer or another registrant authorized by the manufacturer to accept
returns on the manufacturer's behalf pursuant to part 1317 of this chapter:

(i) The date of receipt; the name and quantity of each controlled substance
received; the name, address, and registration number of the person from whom the
substance was received; and the reason for return (e.g., recall or return); and

(ii) The date of return to the manufacturer or other registrant authorized by
the manufacturer to accept returns on the manufacturer's behalf; the name and
quantity of each controlled substance returned; the name, address, and
registration number of the person from whom the substance was received; the
name, address, and registration number of the registrant to whom the substance
was returned; and the method of return (e.g., common or contract carrier).

(2) For controlled substances acquired from registrant inventory for destruction
pursuant to § 1317.05(a)(2), (b)(2), and (b)(4) of this chapter:

(i) The date of receipt; the name and quantity of each controlled substance
received; and the name, address, and registration number of the person from whom
the substance was received; and

(ii) The date, place, and method of destruction; the name and quantity of each
controlled substance destroyed; the name, address, and registration number of
the person from whom the substance was received; and the name and signatures of
the two employees of the registrant that witnessed the destruction.

(3) The total quantity of each controlled substance shall be recorded in
accordance with the following:

(i) For controlled substances in bulk form: To the nearest metric unit weight or
volume consistent with unit size;

(ii) For controlled substances in finished form: Each finished form (e.g.,
10-milligram tablet or 10-milligram concentration per fluid ounce or
milliliter); the number of units or volume of finished form in each commercial
container (e.g., 100-tablet bottle or 3-milliliter vial); and the number of
commercial containers of each such finished form (e.g., four 100-tablet bottles
or six 3-milliliter vials); and

(iii) For controlled substances in a commercial container, carton, crate, drum,
or other receptacle that has been opened: If the substance is listed in Start
Printed Page 53564Schedule I or II make an exact count or measure of the
contents; or if the substance is listed in Schedule III, IV, or V, make an
estimated count or measure of the contents, unless the container holds more than
1,000 tablets or capsules in which case an exact count of the contents shall be
made.

(4) For each sealed inner liner acquired from collectors or law enforcement and
each sealed mail-back package acquired from law enforcement pursuant to
§ 1317.55 of this chapter:

(i) The number of sealed inner liners acquired from other persons, including the
date of acquisition, the number and, for sealed inner liners the size (e.g.,
five 10-gallon liners, etc.), of all sealed inner liners and mail-back packages
acquired to inventory, the unique identification number of each sealed inner
liner and mail-back package, and the name, address, and, for registrants, the
registration number of the person from whom the sealed inner liners and
mail-back packages were received, and

(ii) The date, place, and method of destruction; the number of sealed inner
liners and mail-back packages destroyed; the name, address, and, for
registrants, the registration number of the person from whom the sealed inner
liners and mail-back packages were received; the number and, for sealed inner
liners the size (e.g., five 10-gallon liners, etc.), of all sealed inner liners
and mail-back packages destroyed; the unique identification number of each
sealed inner liner and sealed mail-back package destroyed; and the name and
signatures of the two employees of the registrant that witnessed the
destruction.

(5) For all records, the record of receipt shall be maintained together with the
corresponding record of return or destruction (DEA Form 41).

(f) Records for collectors. Each person registered or authorized to collect
controlled substances from ultimate users shall maintain the following records:

(1) Mail-Back Packages:

(i) For unused packages that the collector makes available to ultimate users and
other authorized non-registrants at the collector's registered address: The date
made available, the number of packages, and the unique identification number of
each package;

(ii) For unused packages provided to a third party to make available to ultimate
users and other authorized non-registrants: The name of the third party and
physical address of the location receiving the unused packages, date sent, and
the number of unused packages sent with the corresponding unique identification
numbers;

(iii) For sealed mail-back packages received by the collector: Date of receipt
and the unique identification number on the individual package; and

(iv) For sealed mail-back packages destroyed on-site by the collector: Number of
sealed mail-back packages destroyed, the date and method of destruction, the
unique identification number of each mail-back package destroyed, and the names
and signatures of the two employees of the registrant who witnessed the
destruction.

(2) Collection receptacle inner liners:

(i) Date each unused inner liner acquired, unique identification number and size
(e.g., 5-gallon, 10-gallon, etc.) of each unused inner liner acquired;

(ii) Date each inner liner is installed, the address of the location where each
inner liner is installed, the unique identification number and size (e.g.,
5-gallon, 10-gallon, etc.) of each installed inner liner, the registration
number of the collector, and the names and signatures of the two employees that
witnessed each installation;

(iii) Date each inner liner is removed and sealed, the address of the location
from which each inner liner is removed, the unique identification number and
size (e.g., 5-gallon, 10-gallon, etc.) of each inner liner removed, the
registration number of the collector, and the names and signatures of the two
employees that witnessed each removal;

(iv) Date each sealed inner liner is transferred to storage, the unique
identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each sealed
inner liner stored, and the names and signatures of the two employees that
transferred each sealed inner liner to storage;

(v) Date each sealed inner liner is transferred for destruction, the address and
registration number of the reverse distributor or distributor to whom each
sealed inner liner was transferred, the unique identification number and the
size (e.g., 5-gallon, 10-gallon, etc.) of each sealed inner liner transferred,
and the names and signatures of the two employees that transferred each sealed
inner liner to the reverse distributor or distributor; and

(vi) For sealed inner liners destroyed on-site by the collector: The same
information required of reverse distributors in paragraph (e)(4)(ii) of this
section.

Start Amendment Part

21. In § 1304.25, revise the section heading and paragraphs (a)(9) and (b)(9) to
read as follows:

End Amendment Part
§ 1304.25
Records for treatment programs that compound narcotics for treatment programs
and other locations.
* * * * *

(a) * * *

(9) The quantity disposed of by destruction, including the reason, date, and
manner of destruction.

(b) * * *

(9) The number of units of finished forms and/or commercial containers destroyed
in any manner by the registrant, including the reason, date, and manner of
destruction.

Start Amendment Part

22. Amend § 1304.33 by revising the section heading and paragraph (f) and adding
paragraph (g) to read as follows:

End Amendment Part
§ 1304.33
Reports to Automation of Reports and Consolidated Orders System (ARCOS).
* * * * *

(f) Exceptions. (1) A registered institutional practitioner that repackages or
relabels exclusively for distribution or that distributes exclusively to (for
dispensing by) agents, employees, or affiliated institutional practitioners of
the registrant may be exempted from filing reports under this section by
applying to the ARCOS Unit of the Administration.

(2) Registrants that acquire recalled controlled substances from ultimate users
pursuant to § 1317.85 of this chapter may report as a single transaction all
recalled controlled substances of the same name and finished form (e.g., all
10-milligram tablets or all 5-milligram concentration per fluid ounce or
milliliter) received from ultimate users for the purpose of reporting
acquisition transactions.

(g) Exemptions. (1) Collectors that acquire controlled substances from ultimate
users are exempt from the ARCOS reporting requirements only with respect to
controlled substances collected through mail-back programs and collection
receptacles for the purpose of disposal.

(2) Reverse distributors and distributors that acquire controlled substances
pursuant to § 1317.55(a) or (b) of this chapter are exempt from the ARCOS
reporting requirements in this section with regard to any controlled substances
acquired pursuant to § 1317.55(a) or (b) of this chapter.

* * * * *
Start Part

PART 1305—ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES

End Part Start Amendment Part

23. The authority citation for part 1305 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.

End Authority Start Amendment Part

24. In § 1305.03, add paragraphs (e), (f), and (g) to read as follows:

End Amendment Part
§ 1305.03
Distributions requiring a Form 222 or a digitally signed electronic order.
* * * * *
Start Printed Page 53565

(e) Deliveries to an authorized DEA registrant by an ultimate user, a long-term
care facility on behalf of an ultimate user who resides or has resided at that
facility, or a person authorized to dispose of the ultimate user decedent's
property.

(f) Distributions to reverse distributors and distributors by collectors and law
enforcement pursuant to § 1317.55 of this chapter.

(g) Deliveries of controlled substances from ultimate users for the purpose of
recalls pursuant to § 1317.85 of this chapter.

Start Part

PART 1307—MISCELLANEOUS

End Part Start Amendment Part

25. The authority citation for part 1307 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise noted.

End Authority Start Amendment Part

26. In § 1307.11, revise section heading and remove and reserve paragraph
(a)(2).

End Amendment Part

The revision reads as follows:

§ 1307.11
Distribution by dispenser to another practitioner.
* * * * *
§ 1307.12
[Removed]
Start Amendment Part

27. Remove § 1307.12.

End Amendment Part Start Amendment Part

28. Revise § 1307.13 to read as follows:

End Amendment Part
§ 1307.13
Incidental manufacture of controlled substances.

Any registered manufacturer who, incidentally but necessarily, manufactures a
controlled substance as a result of the manufacture of a controlled substance or
basic class of controlled substance for which he is registered and has been
issued an individual manufacturing quota pursuant to part 1303 of this chapter
(if such substance or class is listed in Schedule I or II) shall be exempt from
the requirement of registration pursuant to part 1301 of this chapter and, if
such incidentally manufactured substance is listed in Schedule I or II, shall be
exempt from the requirement of an individual manufacturing quota pursuant to
part 1303 of this chapter, if such substances are disposed of in accordance with
part 1317 of this chapter.

§ 1307.21
[Removed]
Start Amendment Part

29. Remove § 1307.21.

End Amendment Part Start Amendment Part

30. In § 1307.22, revise the section heading and the first sentence to read as
follows:

End Amendment Part
§ 1307.22
Delivery of surrendered and forfeited controlled substances.

Any controlled substance surrendered by delivery to the Administration under
part 1317 of this chapter or forfeited pursuant to section 511 of the Act (21
U.S.C. 881) may be delivered to any department, bureau, or other agency of the
United States or of any State upon proper application addressed to the Office of
Diversion Control, Drug Enforcement Administration.

* * * * *
Start Amendment Part

31. Add part 1317 to read as follows:

End Amendment Part Start Part

PART 1317—DISPOSAL

1317.01 Scope. Subpart A—Disposal of Controlled Substances by Registrants
1317.05 Registrant disposal. 1317.10 Registrant return or recall. 1317.15
Reverse distributor registration requirements and authorized activities. Subpart
B—Disposal of Controlled Substances Collected From Ultimate Users and Other
Non-Registrants 1317.30 Authorization to collect from non-registrants. 1317.35
Collection by law enforcement. 1317.40 Registrants authorized to collect and
authorized collection activities. 1317.55 Reverse distributor and distributor
acquisition of controlled substances from collectors or law enforcement. 1317.60
Inner liner requirements. 1317.65 Take-back events. 1317.70 Mail-back programs.
1317.75 Collection receptacles. 1317.80 Collection receptacles at long-term care
facilities. 1317.85 Ultimate user delivery for the purpose of recall or
investigational use of drugs. Subpart C—Destruction of Controlled Substances
1317.90 Methods of destruction. 1317.95 Destruction procedures.
Start Authority

Authority: 21 U.S.C. 821, 822, 823, 827, 828, 871(b), and 958.

End Authority
§ 1317.01
Scope.

This part sets forth the rules for the delivery, collection, and destruction of
damaged, expired, returned, recalled, unused, or otherwise unwanted controlled
substances that are lawfully possessed by registrants (subpart A) and
non-registrants (subpart B). The purpose of such rules is to provide prompt,
safe, and effective disposal methods while providing effective controls against
the diversion of controlled substances.

SUBPART A—DISPOSAL OF CONTROLLED SUBSTANCES BY REGISTRANTS

§ 1317.05
Registrant disposal.

(a) Practitioner inventory. Any registered practitioner in lawful possession of
a controlled substance in its inventory that desires to dispose of that
substance shall do so in one of the following ways:

(1) Promptly destroy that controlled substance in accordance with subpart C of
this part using an on-site method of destruction;

(2) Promptly deliver that controlled substance to a reverse distributor's
registered location by common or contract carrier pick-up or by reverse
distributor pick-up at the registrant's registered location;

(3) For the purpose of return or recall, promptly deliver that controlled
substance by common or contract carrier pick-up or pick-up by other registrants
at the registrant's registered location to: The registered person from whom it
was obtained, the registered manufacturer of the substance, or another
registrant authorized by the manufacturer to accept returns or recalls on the
manufacturer's behalf; or

(4) Request assistance from the Special Agent in Charge of the Administration in
the area in which the practitioner is located.

(i) The request shall be made by submitting one copy of the DEA Form 41 to the
Special Agent in Charge in the practitioner's area. The DEA Form 41 shall list
the controlled substance or substances which the registrant desires to dispose.

(ii) The Special Agent in Charge shall instruct the registrant to dispose of the
controlled substance in one of the following manners:

(A) By transfer to a registrant authorized to transport or destroy the
substance;

(B) By delivery to an agent of the Administration or to the nearest office of
the Administration; or

(5) In the event that a practitioner is required regularly to dispose of
controlled substances, the Special Agent in Charge may authorize the
practitioner to dispose of such substances, in accordance with subparagraph
(a)(4) of this section, without prior application in each instance, on the
condition that the practitioner keep records of such disposals and file periodic
reports with the Special Agent in Charge summarizing the disposals. The Special
Agent in Charge may place such conditions as he/she deems proper on practitioner
procedures regarding the disposal of controlled substances.

(b) Non-practitioner inventory. Any registrant that is a non-practitioner in
lawful possession of a controlled substance in its inventory that desires to
dispose of that substance shall do so in one of the following ways:Start Printed
Page 53566

(1) Promptly destroy that controlled substance in accordance with subpart C of
this part using an on-site method of destruction;

(2) Promptly deliver that controlled substance to a reverse distributor's
registered location by common or contract carrier or by reverse distributor
pick-up at the registrant's registered location;

(3) For the purpose of return or recall, promptly deliver that controlled
substance by common or contract carrier or pick-up at the registrant's
registered location to: The registered person from whom it was obtained, the
registered manufacturer of the substance, or another registrant authorized by
the manufacturer to accept returns or recalls on the manufacturer's behalf; or

(4) Promptly transport that controlled substance by its own means to the
registered location of a reverse distributor, the location of destruction, or
the registered location of any person authorized to receive that controlled
substance for the purpose of return or recall as described in paragraph (b)(3)
of this section.

(i) If a non-practitioner transports controlled substances by its own means to
an unregistered location for destruction, the non-practitioner shall do so in
accordance with the procedures set forth at § 1317.95(c).

(ii) If a non-practitioner transports controlled substances by its own means to
a registered location for any authorized purpose, transportation shall be
directly to the authorized registered location and two employees of the
transporting non-practitioner shall accompany the controlled substances to the
registered destination location. Directly transported means the substances shall
be constantly moving towards their final location and unnecessary or unrelated
stops and stops of an extended duration shall not occur.

(c) Collected controlled substances. Any collector in lawful possession of a
controlled substance acquired by collection from an ultimate user or other
authorized non-registrant person shall dispose of that substance in the
following ways:

(1) Mail-back program. Upon receipt of a sealed mail-back package, the collector
shall promptly:

(i) Destroy the package in accordance with subpart C of this part using an
on-site method of destruction; or

(ii) Securely store the package and its contents at the collector's registered
location in a manner consistent with § 1301.75(c) of this chapter (for
practitioners), or in a manner consistent with the security requirements for
Schedule II controlled substances (for non-practitioners) until prompt on-site
destruction can occur.

(2) Collection receptacles. Upon removal from the permanent outer container, the
collector shall seal it and promptly:

(i) Destroy the sealed inner liner and its contents;

(ii) Securely store the sealed inner liner and its contents at the collector's
registered location in a manner consistent with § 1301.75(c) of this chapter
(for practitioners), or in a manner consistent with § 1301.72(a) of this chapter
(for non-practitioners) until prompt destruction can occur; or

(iii) Securely store the sealed inner liner and its contents at a long-term care
facility in accordance with § 1317.80(d).

(iv) Practitioner methods of destruction. Collectors that are practitioners
(i.e., retail pharmacies and hospitals/clinics) shall dispose of sealed inner
liners and their contents by utilizing any method in paragraph (a)(1), (a)(2),
or (a)(4) of this section, or by delivering sealed inner liners and their
contents to a distributor's registered location by common or contract carrier
pick-up or by distributor pick-up at the collector's authorized collection
location.

(v) Non-practitioner methods of destruction. Collectors that are
non-practitioners (i.e., manufacturers, distributors, narcotic treatment
programs, and reverse distributors) shall dispose of sealed inner liners and
their contents by utilizing any method in paragraph (b)(1), (b)(2), or (b)(4) of
this section, or by delivering sealed inner liners and their contents to a
distributor's registered location by common or contract carrier or by
distributor pick-up at the collector's authorized collection location for
destruction. Freight forwarding facilities may not be utilized to transfer
sealed inner liners and their contents.

§ 1317.10
Registrant return or recall.

(a) Each registrant shall maintain a record of each return or recall transaction
in accordance with the information required of manufacturers in
§ 1304.22(a)(2)(iv) of this chapter.

(b) Each registrant that delivers a controlled substance in Schedule I or II for
the purpose of return or recall shall use an order form in the manner described
in part 1305 of this chapter.

(c) Deliveries for the purpose of return or recall may be made through a freight
forwarding facility operated by the person to whom the controlled substance is
being returned provided that advance notice of the return is provided and
delivery is directly to an agent or employee of the person to whom the
controlled substance is being returned.

§ 1317.15
Reverse distributor registration requirements and authorized activities.

(a) Any person that reverse distributes a controlled substance shall be
registered with the Administration as a reverse distributor, unless exempted by
law or otherwise authorized pursuant to this chapter.

(b) A reverse distributor shall acquire controlled substances from a registrant
pursuant to §§ 1317.05 and 1317.55(a) and (c) in the following manner:

(1) Pick-up controlled substances from a registrant at the registrant's
registered location or authorized collection site; or

(2) Receive controlled substances delivered by common or contract carrier or
delivered directly by a non-practitioner registrant.

(i) Delivery to the reverse distributor by an authorized registrant directly or
by common or contract carrier may only be made to the reverse distributor at the
reverse distributor's registered location. Once en route, such deliveries may
not be re-routed to any other location or person, regardless of registration
status.

(ii) All controlled substance deliveries to a reverse distributor shall be
personally received by an employee of the reverse distributor at the registered
location.

(1) Immediately store the controlled substance, in accordance with the security
controls in parts 1301 and 1317 of this chapter, at the reverse distributor's
registered location or immediately transfer the controlled substance to the
reverse distributor's registered location for secure storage, in accordance with
the security controls in parts 1301 and 1317 of this chapter, until timely
destruction or prompt return of the controlled substance to the registered
manufacturer or other registrant authorized by the manufacturer to accept
returns or recalls on the manufacturer's behalf;

(2) Promptly deliver the controlled substance to the manufacturer or another
registrant authorized by the manufacturer to accept returns or recalls on the
manufacturer's behalf; or

(3) Timely destroy the controlled substance in a manner authorized in subpart C
of this part.

(d) A reverse distributor shall destroy or cause the destruction of any
controlled substance received for the purpose of destruction no later than 30
calendar days after receipt.

Start Printed Page 53567

SUBPART B—DISPOSAL OF CONTROLLED SUBSTANCES COLLECTED FROM ULTIMATE USERS AND
OTHER NON-REGISTRANTS

§ 1317.30
Authorization to collect from non-registrants.

(a) The following persons are authorized to collect controlled substances from
ultimate users and other non-registrants for destruction in compliance with this
chapter:

(1) Any registrant authorized by the Administration to be a collector pursuant
to § 1317.40; and

(2) Federal, State, tribal, or local law enforcement when in the course of
official duties and pursuant to § 1317.35.

(b) The following non-registrant persons in lawful possession of a controlled
substance in Schedules II, III, IV, or V may transfer that substance to the
authorized persons listed in paragraph (a) of this section, and in a manner
authorized by this part, for the purpose of disposal:

(1) An ultimate user in lawful possession of a controlled substance;

(2) Any person lawfully entitled to dispose of a decedent's property if that
decedent was an ultimate user who died while in lawful possession of a
controlled substance; and

(3) A long-term care facility on behalf of an ultimate user who resides or
resided at such long-term care facility and is/was in lawful possession of a
controlled substance, in accordance with § 1317.80 only.

§ 1317.35
Collection by law enforcement.

(a) Federal, State, tribal, or local law enforcement may collect controlled
substances from ultimate users and persons lawfully entitled to dispose of an
ultimate user decedent's property using the following collection methods:

(1) Take-back events in accordance with § 1317.65;

(2) Mail-back programs in accordance with § 1317.70; or

(3) Collection receptacles located inside law enforcement's physical address.

(b) Law enforcement that conducts a take-back event or a mail-back program or
maintains a collection receptacle should maintain any records of removal,
storage, or destruction of the controlled substances collected in a manner that
is consistent with that agency's recordkeeping requirements for illicit
controlled substances evidence.

(c) Any controlled substances collected by law enforcement through a take-back
event, mail-back program, or collection receptacle should be stored in a manner
that prevents the diversion of controlled substances and is consistent with that
agency's standard procedures for storing illicit controlled substances.

(d) Any controlled substances collected by law enforcement through a take-back
event, mail-back program, or collection receptacle should be transferred to a
destruction location in a manner that prevents the diversion of controlled
substances and is consistent with that agency's standard procedures for
transferring illicit controlled substances.

(e) Law enforcement that transfers controlled substances collected from ultimate
users pursuant to this part to a reverse distributor for destruction should
maintain a record that contains the following information: If a sealed inner
liner as described in § 1317.60 is used, the unique identification number of the
sealed inner liner transferred, and the size of the sealed inner liner
transferred (e.g., 5-gallon, 10-gallon, etc.); if a mail-back package as
described in § 1317.70 is used, the unique identification number of each
package; the date of the transfer; and the name, address, and registration
number of the reverse distributor to whom the controlled substances were
transferred.

§ 1317.40
Registrants authorized to collect and authorized collection activities.

(a) Manufacturers, distributors, reverse distributors, narcotic treatment
programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies that
desire to be collectors shall modify their registration to obtain authorization
to be a collector in accordance with § 1301.51 of this chapter. Authorization to
be a collector is subject to renewal. If a registrant that is authorized to
collect ceases activities as a collector, such registrant shall notify the
Administration in accordance with § 1301.52(f) of this chapter.

(b) Collection by registrants shall occur only at the following locations:

(1) Those registered locations of manufacturers, distributors, reverse
distributors, narcotic treatment programs, hospitals/clinics with an on-site
pharmacy, and retail pharmacies that are authorized for collection; and

(2) Long-term care facilities at which registered hospitals/clinics or retail
pharmacies are authorized to maintain collection receptacles.

(1) Receive and destroy mail-back packages pursuant to § 1317.70 at an
authorized registered location that has an on-site method of destruction;

(2) Install, manage, and maintain collection receptacles located at their
authorized collection location(s) pursuant to §§ 1317.75 and 1317.80; and

(3) Promptly dispose of sealed inner liners and their contents as provided for
in § 1317.05(c)(2).

§ 1317.55
Reverse distributor and distributor acquisition of controlled substances from
collectors or law enforcement.

(a) A reverse distributor is authorized to acquire controlled substances from
law enforcement that collected the substances from ultimate users. A reverse
distributor is authorized to acquire controlled substances collected through a
collection receptacle in accordance with §§ 1317.75 and 1317.80.

(b) A distributor is authorized to acquire controlled substances collected
through a collection receptacle in accordance with §§ 1317.75 and 1317.80.

(c) A reverse distributor or a distributor that acquires controlled substances
in accordance with paragraph (a) or (b) of this section shall:

(1) Acquire the controlled substances in the manner authorized for reverse
distributors in § 1317.15(b)(1) and (2);

(2) Dispose of the controlled substances in the manner authorized for reverse
distributors § 1317.15(c) and (d); and

(3) Securely store the controlled substances in a manner consistent with the
security requirements for Schedule II controlled substances until timely
destruction can occur.

§ 1317.60
Inner liner requirements.

(a) An inner liner shall meet the following requirements:

(1) The inner liner shall be waterproof, tamper-evident, and tear-resistant;

(2) The inner liner shall be removable and sealable immediately upon removal
without emptying or touching the contents;

(3) The contents of the inner liner shall not be viewable from the outside when
sealed;

(4) The size of the inner liner shall be clearly marked on the outside of the
liner (e.g., 5-gallon, 10-gallon, etc.); and

(5) The inner liner shall bear a permanent, unique identification number that
enables the inner liner to be tracked.

(b) Access to the inner liner shall be restricted to employees of the collector.

(c) The inner liner shall be sealed by two employees immediately upon removal
from the permanent outer container and the sealed inner liner shall not be
opened, x-rayed, analyzed, or otherwise penetrated.

Start Printed Page 53568
§ 1317.65
Take-back events.

(a) Federal, State, tribal, or local law enforcement may conduct a take-back
event and collect controlled substances from ultimate users and persons lawfully
entitled to dispose of an ultimate user decedent's property in accordance with
this section. Any person may partner with law enforcement to hold a collection
take-back event in accordance with this section.

(b) Law enforcement shall appoint a law enforcement officer employed by the
agency to oversee the collection. Law enforcement officers employed and
authorized by the law enforcement agency or law enforcement component of a
Federal agency conducting a take-back event shall maintain control and custody
of the collected substances from the time the substances are collected from the
ultimate user or person authorized to dispose of the ultimate user decedent's
property until secure transfer, storage, or destruction of the controlled
substances has occurred.

(c) Each take-back event should have at least one receptacle for the collection
of controlled substances. The collection receptacle should be a securely locked,
substantially constructed container with an outer container and a removable
inner liner as specified in § 1317.60 of this chapter. The outer container
should include a small opening that allows contents to be added to the inner
liner, but that does not allow removal of the inner liner's contents.

(d) Only those controlled substances listed in Schedule II, III, IV, or V that
are lawfully possessed by an ultimate user or person entitled to dispose of an
ultimate user decedent's property may be collected. Controlled and
non-controlled substances may be collected together and be comingled, although
comingling is not required.

(e) Only ultimate users and persons entitled to dispose of an ultimate user
decedent's property in lawful possession of a controlled substance in Schedule
II, III, IV, or V may transfer such substances to law enforcement during the
take-back event. No other person may handle the controlled substances at any
time.

§ 1317.70
Mail-back programs.

(a) A mail-back program may be conducted by Federal, State, tribal, or local law
enforcement or any collector. A collector conducting a mail-back program shall
have and utilize at their registered location a method of destruction consistent
with § 1317.90 of this chapter.

(b) Only those controlled substances listed in Schedule II, III, IV, or V that
are lawfully possessed by an ultimate user or person lawfully entitled to
dispose of an ultimate user decedent's property may be collected. Controlled and
non-controlled substances may be collected together and be comingled, although
comingling is not required.

(c) Collectors or law enforcement that conduct a mail-back program shall make
packages available (for sale or for free) as specified in this paragraph to
ultimate users and persons lawfully entitled to dispose of an ultimate user
decedent's property, for the collection of controlled substances by common or
contract carrier. Any person may partner with a collector or law enforcement to
make such packages available in accordance with this section. The packages made
available shall meet the following specifications:

(1) The package shall be nondescript and shall not include any markings or other
information that might indicate that the package contains controlled substances;

(2) The package shall be water- and spill-proof; tamper-evident; tear-resistant;
and sealable;

(3) The package shall be preaddressed with and delivered to the collector's
registered address or the participating law enforcement's physical address;

(4) The cost of shipping the package shall be postage paid;

(5) The package shall have a unique identification number that enables the
package to be tracked; and

(6) The package shall include instructions for the user that indicate the
process for mailing back the package, the substances that can be sent, notice
that packages may only be mailed from within the customs territory of the United
States (the 50 States, the District of Columbia, and Puerto Rico), and notice
that only packages provided by the collector will be accepted for destruction.

(d) Ultimate users and persons lawfully entitled to dispose of an ultimate user
decedent's property shall not be required to provide any personally identifiable
information when mailing back controlled substances to a collector. The
collector or law enforcement may implement a system that allows ultimate users
or persons lawfully entitled to dispose of an ultimate user decedent's property
to notify the collector or law enforcement that they are sending one of the
designated packages by giving the unique identification number on the package.

(e) A collector that conducts a mail-back program pursuant to paragraph (a)
shall:

(1) Accept only those controlled substances contained within packages that the
collector made available for the collection of controlled substances by mail and
packages that are lawfully forwarded to the collector pursuant to paragraph
(e)(3) of this section.

(2) Within three business days of receipt, notify the Field Division Office of
the Administration in their area of the receipt of a package that likely
contains controlled substances that the collector did not make available or did
not agree to receive pursuant to subparagraph (e)(3) of this section.

(3) When discontinuing activities as a collector or ceasing an authorized
mail-back program:

(i) Make a reasonable effort to notify the public prior to discontinuing such
activities or ceasing the authorized mail-back program; and

(ii) Obtain the written agreement of another collector that has and utilizes at
its registered location a method of destruction consistent with § 1317.90 of
this chapter to receive all remaining mail-back packages that were disseminated
but not returned and arrange for the forwarding of only such packages to that
location.

(f) Only law enforcement officers employed by the law enforcement agency or law
enforcement component of a Federal agency and employees of the collector shall
handle packages received through an authorized mail-back program. Upon receipt
of a mail-back package by a collector conducting a mail-back program, the
package shall not be opened, x-rayed, analyzed, or otherwise penetrated.

§ 1317.75
Collection receptacles.

(a) Collectors or Federal, State, tribal, or local law enforcement may manage
and maintain collection receptacles for disposal.

(b) Only those controlled substances listed in Schedule II, III, IV, or V that
are lawfully possessed by an ultimate user or other authorized non-registrant
person may be collected. Controlled and non-controlled substances may be
collected together and be comingled, although comingling is not required.

(c) Collectors shall only allow ultimate users and other authorized
non-registrant persons in lawful possession of a controlled substance in
Schedule II, III, IV, or V to deposit such substances in a collection receptacle
at a registered location. Collectors shall not permit an ultimate user to
transfer such substance to any person for any reason. Once a substance has been
deposited into a collection receptacle, the substance shall not be counted,
Start Printed Page 53569sorted, inventoried, or otherwise individually handled.

(d) Collection receptacles shall be securely placed and maintained:

(1) Inside a collector's registered location, inside law enforcement's physical
location, or at an authorized long-term care facility;

(2) At a registered location, be located in the immediate proximity of a
designated area where controlled substances are stored and at which an employee
is present (e.g., can be seen from the pharmacy counter). Except as follows:

(i) At a hospital/clinic: A collection receptacle shall be located in an area
regularly monitored by employees, and shall not be located in the proximity of
any area where emergency or urgent care is provided;

(ii) At a narcotic treatment program: A collection receptacle shall be located
in a room: That does not contain any other controlled substances and is securely
locked with controlled access;

(iii) At a long-term care facility: A collection receptacle shall be located in
a secured area regularly monitored by long-term care facility employees.

(e) A controlled substance collection receptacle shall meet the following design
specifications:

(1) Be securely fastened to a permanent structure so that it cannot be removed;

(2) Be a securely locked, substantially constructed container with a permanent
outer container and a removable inner liner as specified in § 1317.60 of this
chapter;

(3) The outer container shall include a small opening that allows contents to be
added to the inner liner, but does not allow removal of the inner liner's
contents;

(4) The outer container shall prominently display a sign indicating that only
Schedule II-V controlled and non-controlled substances, if a collector chooses
to comingle substances, are acceptable substances (Schedule I controlled
substances, controlled substances that are not lawfully possessed by the
ultimate user, and other illicit or dangerous substances are not permitted); and

(f) Except at a narcotic treatment program, the small opening in the outer
container of the collection receptacle shall be locked or made otherwise
inaccessible to the public when an employee is not present (e.g., when the
pharmacy is closed), or when the collection receptacle is not being regularly
monitored by long-term care facility employees.

(g) The installation and removal of the inner liner of the collection receptacle
shall be performed by or under the supervision of at least two employees of the
authorized collector.

§ 1317.80
Collection receptacles at long-term care facilities.

(a) A long-term care facility may dispose of controlled substances in Schedules
II, III, IV, and V on behalf of an ultimate user who resides, or has resided, at
such long-term care facility by transferring those controlled substances into an
authorized collection receptacle located at that long-term care facility. When
disposing of such controlled substances by transferring those substances into a
collection receptacle, such disposal shall occur immediately, but no longer than
three business days after the discontinuation of use by the ultimate user.
Discontinuation of use includes a permanent discontinuation of use as directed
by the prescriber, as a result of the resident's transfer from the long-term
care facility, or as a result of death.

(b) Only authorized retail pharmacies and hospitals/clinics with an on-site
pharmacy may install, manage, and maintain collection receptacles at long-term
care facilities and remove, seal, transfer, and store, or supervise the removal,
sealing, transfer, and storage of sealed inner liners at long-term care
facilities. Collectors authorized to install, manage, and maintain collection
receptacles at long-term care facilities shall comply with all requirements of
this chapter, including §§ 1317.60, 1317.75, and 1317.80.

(c) The installation, removal, transfer, and storage of inner liners shall be
performed either: By or under the supervision of one employee of the authorized
collector and one supervisor-level employee of the long-term care facility
(e.g., a charge nurse or supervisor) designated by the authorized collector; or,
by or under the supervision of two employees of the authorized collector.

(d) Upon removal, sealed inner liners may only be stored at the long-term care
facility for up to three business days in a securely locked, substantially
constructed cabinet or a securely locked room with controlled access until
transfer in accordance with § 1317.05(c)(2)(iv).

(e) Neither a hospital/clinic with an on-site pharmacy nor a retail pharmacy
shall operate a collection receptacle at a long-term care facility until its
registration has been modified in accordance with § 1301.51 of this chapter.

§ 1317.85
Ultimate user delivery for the purpose of recall or investigational use of
drugs.

(a) In the event of a product recall, an ultimate user in lawful possession of a
controlled substance listed in Schedule II, III, IV, or V may deliver the
recalled substance to the manufacturer of the substance or another registrant
authorized by the manufacturer to accept recalled controlled substances on the
manufacturer's behalf.

(b) An ultimate user who is participating in an investigational use of drugs
pursuant to 21 U.S.C. 355(i) and 360b(j) and wishes to deliver any unused
controlled substances received as part of that research to the registered
dispenser from which the ultimate user obtained those substances may do so in
accordance with regulations promulgated by the Secretary of Health and Human
Services pursuant to 21 U.S.C. 355(i) and 360b(j).

SUBPART C—DESTRUCTION OF CONTROLLED SUBSTANCES

§ 1317.90
Methods of destruction.

(a) All controlled substances to be destroyed by a registrant, or caused to be
destroyed by a registrant pursuant to § 1317.95(c), shall be destroyed in
compliance with applicable Federal, State, tribal, and local laws and
regulations and shall be rendered non-retrievable.

(b) Where multiple controlled substances are comingled, the method of
destruction shall be sufficient to render all such controlled substances
non-retrievable. When the actual substances collected for destruction are
unknown but may reasonably include controlled substances, the method of
destruction shall be sufficient to render non-retrievable any controlled
substance likely to be present.

(c) The method of destruction shall be consistent with the purpose of rendering
all controlled substances to a non-retrievable state in order to prevent
diversion of any such substance to illicit purposes and to protect the public
health and safety.

§ 1317.95
Destruction procedures.

The destruction of any controlled substance shall be in accordance with the
following requirements:

(a) Transfer to a person registered or authorized to accept controlled
substances for the purpose of destruction. If the controlled substances are
transferred to a person registered or authorized to accept the controlled
substances for the purpose of destruction, two employees of the transferring
registrant shall load and Start Printed Page 53570unload or observe the loading
and unloading of any controlled substances until transfer is complete.

(b) Transport to a registered location. If the controlled substances are
transported by a registrant to a registered location for subsequent destruction,
the following procedures shall be followed:

(1) Transportation shall be directly to the registered location (the substances
shall be constantly moving towards their final location and unnecessary or
unrelated stops and stops of an extended duration shall not occur);

(2) Two employees of the transporting registrant shall accompany the controlled
substances to the registered location;

(3) Two employees of the transporting registrant shall load and unload or
observe the loading and unloading of the controlled substances until transfer is
complete;

(c) Transport to a non-registered location. If the controlled substances are
transported by a registrant to a destruction location that is not a registered
location, the following procedures shall be followed:

(1) Transportation shall be directly to the destruction location (the substances
shall be constantly moving towards their final destruction location and
unnecessary or unrelated stops and stops of an extended duration shall not
occur);

(2) Two employees of the transporting registrant shall accompany the controlled
substances to the destruction location;

(3) Two employees of the transporting registrant shall load and unload or
observe the loading and unloading of the controlled substances;

(4) Two employees of the transporting registrant shall handle or observe the
handling of any controlled substance until the substance is rendered
non-retrievable; and

(5) Two employees of the transporting registrant shall personally witness the
destruction of the controlled substance until it is rendered non-retrievable.

(d) On-site destruction. If the controlled substances are destroyed at a
registrant's registered location utilizing an on-site method of destruction, the
following procedures shall be followed:

(1) Two employees of the registrant shall handle or observe the handling of any
controlled substance until the substance is rendered non-retrievable; and

(2) Two employees of the registrant shall personally witness the destruction of
the controlled substance until it is rendered non-retrievable.

End Part Start Signature

Dated: August 25, 2014.

Michele M. Leonhart,

Administrator.

End Signature End Supplemental Information

FOOTNOTES

1. All of the comments submitted, except two comments, are available for public
inspection online at www.regulations.gov. Two comments are not posted (at the
commenters' request) in order to protect confidential business information.

Back to Citation

2. 21 U.S.C. 822(c)(3) and 957(b)(1)(C) except “ultimate users” who possess
substances for purposes referenced in 21 U.S.C. 802(25); however, “ultimate
user” is defined in 21 U.S.C. 802(27).

Back to Citation

3. It is unlawful to knowingly or intentionally manufacture, distribute,
dispense, or possess with the intent to manufacture, distribute, or dispense, a
controlled substance without the appropriate registration. 21 U.S.C. 841(a).

Back to Citation

4. The terms “disposal,” “dispose,” or “disposition” appear several times in
the CSA and its implementing regulations, but are not defined. For example, in
the CSA, see 21 U.S.C. 822(g); 824(f)-(g); 826(c), (e)-(f); 827(a)(3), (d)(1);
842(a)(7); 853(n); 880(a)(2); 881(e)(1); 958(d)(6); and in the CFR, see 21 CFR
1307.21(b) and 1304.22(a)(2)(ix). The term “net disposal,” however, is defined
at 21 CFR 1300.01(b). As used, the terms refer to a variety of activities that
ultimately result in eliminating the availability of controlled substances for
use. For example, within the meaning of the CSA, a controlled substance can be
“disposed of” by destruction, return, recall, sale, or through the manufacturing
process. The Disposal Act allows an ultimate user to deliver a lawfully obtained
controlled substance to another person “for the purpose of disposal.” The DEA
believes that the ultimate user disposal authorized by the Disposal Act includes
the transfer or delivery of controlled substances for purposes of destruction,
return, and recall. Such ultimate user activities are consistent with the intent
to remove unused, unwanted, tainted, and expired substances from households and
out of the reach of children and teenagers thereby reducing the risk of
diversion and protecting the public health and safety. As used in this Final
Rule, the DEA uses the terms “disposal” and “dispose” to generally refer to the
wide range of activities that result in controlled substances being unavailable
for further use. When necessary to specify a particular activity within the
disposal process, the particular activity is identified (e.g., transfer,
deliver, collect/collection, return, recall, and destroy/destruction).

Back to Citation

5. The Attorney General's delegation of authority to the DEA may be found at 28
CFR 0.100.

Back to Citation

6. Definitions and terms specific to particular comment categories, such as
“Law Enforcement” and “Long-Term Care Facilities (LTCFs),” are located in those
specific sections.

Back to Citation

7. Clin. J. Pain (The Clinical Journal of Pain), Volume 22, Number 8, October
2006.

Back to Citation

8. Clin. J. Pain (The Clinical Journal of Pain), Volume 27, Number 3,
March/April 2011.

Back to Citation

9. The universe of potential participants includes all registrants that could
potentially become collectors. It is likely that this estimate will be adjusted
downward once the DEA obtains more information.

Back to Citation

[FR Doc. 2014-20926 Filed 9-8-14; 8:45 am]

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