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In this section: Drug Approvals and Databases
 * Drug Approvals and Databases
   
    * Resources for Information | Approved Drugs

 1. Home
 2. Drugs
 3. Development & Approval Process | Drugs
 4. Drug Approvals and Databases
 5. Drug Establishments Current Registration Site

 1. Drug Approvals and Databases


DRUG ESTABLISHMENTS CURRENT REGISTRATION SITE

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The drug establishments current registration site is a publication of currently
registered establishments which manufacture, prepare, propagate, compound or
process drugs that are distributed in the U.S. or offered for import to the U.S.

This file is updated each business day. Any establishment is automatically
removed from the database if its registration is inactivated by FDA due to a
compliance case. Registrations that expire, deregister or are otherwise dropped
from submission are also removed from the database.

Establishments must be registered within five days of beginning operations.
Additionally, establishments must renew registration annually between October 1
and December 31 of each year.

Establishments that send initial or annual registrations during the October 1 to
December 31 period are considered registered until the end of following calendar
year. Any registration submission received outside of this timeframe does not
extend the registration expiration date beyond the current calendar year.

 * Example 1: A new, updated or annual establishment registration structured
   product labeling (SPL) is received on October 1, 2020. Registration is
   current through December 31, 2021.
 * Example 2: A new, updated or annual establishment registration SPL is
   received on September 30, 2020. Registration is current through December 31,
   2020. The updated establishment registration must be submitted between
   October 1, 2020, and December 31, 2020 to remain current through December 31,
   2021.


DOWNLOAD AND SEARCH

 * Drug establishment registration search
 * Drug establishment annual registration status download file (zip format)
 * Drug establishment annual registration status (Excluded) download file (zip
   format) (New)


ABOUT THE REGISTRATION DATABASE

 * This database does not contain establishments registered as human drug
   compounding outsourcing facilities
   * An outsourcing facility may appear in the database if it also registered
     under other business operations
 * This database does not contain wholesale drug distributors and third-party
   logistics providers that report licensure annually to the FDA as required by
   the Drug Supply Chain Security Act
   * See wholesale distributor and third party logistics providers
     reporting for more information


QUESTIONS

Contact eDRLS@fda.hhs.gov with questions on the electronic registration and
listing requirements. See points of contact for drug registration and listing
for more information.


   CONTENT CURRENT AS OF:
   
   12/18/2020

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 * Drug Approvals and Databases
   
    * Resources for Information | Approved Drugs




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