How to obtain FDA registration?
A pharmaceutical establishment obtains FDA registration by identifying its regulated activities, securing the required facility identifiers, and submitting establishment information electronically through FDA’s drug registration and listing system. Registration must be accompanied by accurate drug listings where applicable and does not constitute FDA approval.
Answer
The FDA registration process depends on the regulated product category. For human pharmaceutical establishments, manufacturers, repackers, relabelers, and certain other facilities generally submit registration information through the Electronic Drug Registration and Listing System.
A pharmaceutical establishment should generally:
• Determine whether its activities require registration under section 510 of the FD&C Act and 21 CFR Part 207.
• Obtain or verify the FDA-recognized Unique Facility Identifier and associated facility information.
• Identify the legal owner, physical manufacturing site, business operations, and responsible contacts.
• For a foreign establishment, appoint a U.S. agent and provide information on known U.S. importers where required.
• Prepare an establishment-registration submission in Structured Product Labeling format.
• Submit the information through an FDA-supported electronic channel, such as CDER Direct or the Electronic Submissions Gateway.
• Submit required drug-listing records for products manufactured, repacked, relabeled, salvaged, or commercially distributed.
• Verify that the facility and listings appear accurately in the applicable FDA databases.
Drug establishments must renew registration annually, generally between October 1 and December 31, and update changed registration or listing information within the applicable regulatory timeframe.
FDA does not issue a general pharmaceutical “approval certificate” merely because a facility is registered. Registration, drug listing, an NDC, and assignment of an FDA Establishment Identifier do not demonstrate that FDA has inspected, certified, endorsed, or approved either the establishment or its products.
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