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In this section: Human Drug Compounding
 * Human Drug Compounding
    * Compounding Quality Center of Excellence
    * Compounding Laws and Policies
    * Regulatory Policy Information
    * Compounding Risk Alerts
    * Compounding Oversight and Compliance Actions
    * Compounding: Inspections, Recalls, and other Actions
    * Information for Outsourcing Facilities
    * Registered Outsourcing Facilities
    * Bulk Drug Substances Used in Compounding
    * Consumer and Health Care Professional Information
    * Compounding Information for States
    * Compounding Research
   
   

 1. Home
 2. Drugs
 3. Guidance, Compliance, & Regulatory Information
 4. Human Drug Compounding
 5. Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act

 1. Human Drug Compounding


BULK DRUG SUBSTANCES USED IN COMPOUNDING UNDER SECTION 503B OF THE FD&C ACT

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Outsourcing facilities, which operate under section 503B of the Federal Food,
Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes
a bulk drug substance unless:

 1. the bulk drug substance appears on a list identifying bulk drug substances
    for which there is a clinical need (the 503B bulks list), or
 2. the drug product compounded from such bulk drug substance appears on FDA’s
    drug shortage list at the time of compounding, distribution and dispensing.

Bulk drug substances must be accompanied by a valid certificate of analysis and
must have been manufactured by an establishment registered with FDA under
section 510 of the FD&C Act. In addition, if an applicable United States
Pharmacopeia (USP) or National Formulary monograph exists, bulk drug substances
must comply with the monograph.

The agency urges compounders to know your bulks supplier.


DEVELOPING THE 503B BULKS LIST

The agency solicited nominations for bulk drug substances for inclusion on the
503B bulks list and is evaluating them. FDA issued a final guidance in March
2019, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under
Section 503B of the Federal Food, Drug, and Cosmetic Act, that describes FDA’s
interpretation of the statutory term, “bulk drug substance for which there is a
clinical need,” and factors FDA intends to consider when determining whether to
include a bulk drug substance on the 503B bulks list.

See the 503B bulks list, which will continue to be updated as other bulk drug
substances are added to or excluded from the list.


COLLABORATIVE AGREEMENTS TO HELP INFORM FDA’S DEVELOPMENT OF THE 503B BULKS LIST

FDA is engaging in two cooperative agreements with research partners to help
inform the agency’s evaluation of bulk drug substances nominated for use in
compounding under section 503B.

FDA is working with the University of Maryland Center of Excellence in
Regulatory Science and Innovation (CERSI) on a project entitled, “Clinical Use
of Drugs Including Bulk Drug Substances Nominated for Use in Compounding by
Outsourcing Facilities.” This project involves research related to certain bulk
drug substances nominated for use in compounding under section 503B, including
how drugs compounded with the substances have currently and historically been
used in clinical practice. FDA expects that this project will provide valuable
information for it to consider when assessing whether there is a clinical need
to compound using bulk drug substances that have been nominated for the 503B
bulks list, and generally help information agency decision-making, stakeholders,
and the public.

FDA is working with the Johns Hopkins University CERSI on a project entitled,
“Bulk Drug Substances Used to Compound Drugs for Patients with Autism Spectrum
Disorder (ASD).” This project involves researching information about certain
bulk drug substances that are used to compound drug products for patients with
ASD. Information from the project will help FDA evaluate whether there is a
clinical need for use of a bulk drug substance in compounding under section
503B, and help to promote public input as well as stakeholder understanding and
discussion.

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INTERIM POLICY ON COMPOUNDING DRUGS USING BULK DRUG SUBSTANCE

FDA issued a revised final guidance in January 2017, Guidance for Industry,
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of
the Federal Food, Drug, and Cosmetic Act, which is in place while the FDA
develops the 503B bulks list. The guidance describes conditions under which the
agency does not intend to take action against outsourcing facilities that
compound drug products from bulk drug substances that cannot otherwise be used
in compounding under section 503B. FDA issued this guidance document to avoid
unnecessary disruption to patient treatment while FDA evaluates the bulk drug
substances nominated for use in compounding under section 503B of the FD&C Act.

The guidance documents describe three categories of bulk drug substances
nominated by the public for use in compounding. The categories are:

 * Category 1 – These substances may be eligible for inclusion on the 503B bulks
   list, were nominated with sufficient information for FDA to evaluate them,
   and do not appear on any other list. FDA does not intend to take action
   against an outsourcing facility for compounding drugs using bulk drug
   substances identified in Category 1 provided that the conditions described in
   the guidance document are met.
 * Category 2 – These are bulk drug substances that were nominated with
   sufficient supporting information for FDA to evaluate them, but FDA has
   identified significant safety risks relating to the use of these substances
   in compounding pending further evaluation. Drug products compounded using
   these substances are not eligible for the policy described for the substances
   in Category 1. FDA would consider taking action against an outsourcing
   facility for compounding drug products with this bulk drug substance under
   its general enforcement policies. See Safety Risks Associated with Certain
   Bulk Drug Substances Nominated for Use in Compounding for the substances and
   a summary of the identified safety risks.
 * Category 3 – These substances may be eligible for inclusion on the 503B bulks
   list, but were nominated with insufficient supporting information for FDA to
   evaluate them. The substances are not eligible for the policy that applies to
   substances in Category 1. FDA would consider taking action against an
   outsourcing facility for compounding drug products with this bulk drug
   substance under its general enforcement policies. These bulk drug substances
   can be re-nominated with sufficient supporting information through Bulk Drug
   Substances That Can Be Used To Compound Drug Products in Accordance With
   Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a
   Public Docket.

FDA intends to update these categories to reflect any new nominations or other
changes on a periodic basis. Sign up to receive email updates on compounding.

 

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   CONTENT CURRENT AS OF:
   
   02/20/2020

 * 

 * Human Drug Compounding
    * Compounding Quality Center of Excellence
    * Compounding Laws and Policies
    * Regulatory Policy Information
    * Compounding Risk Alerts
    * Compounding Oversight and Compliance Actions
    * Compounding: Inspections, Recalls, and other Actions
    * Information for Outsourcing Facilities
    * Registered Outsourcing Facilities
    * Bulk Drug Substances Used in Compounding
    * Consumer and Health Care Professional Information
    * Compounding Information for States
    * Compounding Research
   
   




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