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  5. Drug Establishments Current Registration Site
  1. Drug Approvals and Databases

Drug Establishments Current Registration Site

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.

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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

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.

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