Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs
Requires establishments that manufacture, repack, relabel or salvage drugs to register with FDA and to list the drugs they handle, with annual registration renewal and defined update cycles for listing data. Foreign establishments importing into the US must also identify a US agent.
Always verify against the current published text before relying on it for a submission or inspection.
Scope & applicability
Drug establishments, domestic and foreign, including contract manufacturers and API sites. It is the obligation that makes a site visible to FDA for inspection scheduling and import screening — separate from product approval, and separate again from the device regime in 21 CFR Part 807.
Key requirements
- Registration of each establishment, with annual renewal during the defined registration period
- Drug listing with National Drug Code information, and updates on the prescribed schedule
- Designation of a US agent for foreign establishments
- Electronic submission of registration and listing information unless a waiver is granted
Implementation tips
- Registration lapses quietly and stops supply as effectively as a failed batch — put expiry and renewal lead time in a register with a named owner, not in someone’s calendar
- A site or process change should trigger the question of which registrations describe the site as it was
21 CFR Part 207: frequently asked questions
Quick answers to common questions about 21 CFR Part 207.
What is 21 CFR Part 207?
21 CFR Part 207 — Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs — is a regulation issued by the Food and Drug Administration (United States). Requires establishments that manufacture, repack, relabel or salvage drugs to register with FDA and to list the drugs they handle, with annual registration renewal and defined update cycles for listing data. Foreign establishments importing into the US must also identify a US agent.
Who does 21 CFR Part 207 apply to?
Drug establishments, domestic and foreign, including contract manufacturers and API sites. It is the obligation that makes a site visible to FDA for inspection scheduling and import screening — separate from product approval, and separate again from the device regime in 21 CFR Part 807.
What are the key requirements of 21 CFR Part 207?
FDA 21 CFR Part 207 requires, among other things: Registration of each establishment, with annual renewal during the defined registration period; Drug listing with National Drug Code information, and updates on the prescribed schedule; Designation of a US agent for foreign establishments; Electronic submission of registration and listing information unless a waiver is granted.
When was 21 CFR Part 207 last updated?
The current version of 21 CFR Part 207 dates from November 2016.