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.
What this does not cover
stated in the document's own scope- Registration and listing do not denote approval. Under § 207.77, a representation that a drug is approved or legally marketable because it is registered, listed or has an NDC is misleading and constitutes misbranding.
- Medical-device establishments register and list under 21 CFR Part 807, not Part 207.
- Private label distributors that do not themselves manufacture, repack, relabel or salvage drugs are not required to register, although they must have labeler codes.
- Exemption from registration under § 207.13 does not relieve a person of other statutory or regulatory obligations.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 207 requires drug establishments to register with FDA and to list the drugs they make, and it governs the National Drug Code (NDC). Registration tells FDA who is manufacturing, repacking, relabeling and salvaging drugs and where those operations take place; listing gives FDA a current inventory of the drugs those establishments place into commercial distribution. It covers human drugs, including those regulated under a biologics license application, and animal drugs, at domestic establishments and at foreign establishments whose drugs are imported or offered for import into the United States.
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.
Legal basis & how it acquires force
Part 207 is a binding FDA regulation in Title 21 of the Code of Federal Regulations, implementing section 510 of the Federal Food, Drug, and Cosmetic Act. Its current form was published at 81 FR 60212 on 31 August 2016. Information must be submitted electronically and, with stated exemptions, must comply with 21 CFR Part 11. eCFR flags an amendment to § 207.33, the National Drug Code section, published at 91 FR 10770 on 5 March 2026, so the NDC text should be read against the Federal Register as well as the codified version.
Document structure
| Part | Covers |
|---|---|
| Subpart A — General | Definitions, purpose, who the part covers and who is exempt, such as qualifying pharmacies |
| Subpart B — Registration | Who must register, the 5-day deadline for domestic establishments, required information, and annual review between 1 October and 31 December |
| Subpart C — National Drug Code | The NDC’s labeler, product and package segments, what changes require a new NDC, and restrictions on its use |
| Subpart D — Listing | Who must list which drugs, the information required, and review and update each June and December |
| Subparts E–F — Electronic format and miscellaneous | Electronic submission and waivers, the official contact and United States agent, legal status of registration, and public disclosure |
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
International alignment
Part 207 is the drug-side counterpart of 21 CFR Part 807, which covers establishment registration and device listing for manufacturers and initial importers of devices. The NDC assigned under it is the number 21 CFR 201.2 requests, though does not require, on drug labels. In the EU the comparable controls are the manufacturing and wholesale-distribution authorisations under Directive 2001/83/EC, which are authorisations an applicant must qualify for — Article 41 lists the requirements for a manufacturing authorisation — rather than a registration of what already exists.
21 CFR Part 207: frequently asked questions
Quick answers to common questions about 21 CFR Part 207.
When must a new drug establishment register with FDA?
A domestic establishment must register no later than 5 calendar days after it begins to manufacture, repack, relabel or salvage a drug. A foreign establishment must register before its drug is imported or offered for import into the United States.
How often must registration and listing be updated?
Registration information is reviewed and updated annually between 1 October and 31 December, with certain changes — such as closing an establishment or changing the official contact or US agent — due within 30 calendar days. Listing information is reviewed and updated each June and December.
Does a foreign establishment need a US agent?
Yes. Under § 207.69, registrants of foreign establishments must designate a single United States agent who resides or maintains a place of business in the United States and is physically present there, not a mailbox or answering service.
Does an NDC mean FDA has approved a drug?
No. Section 207.77 states that assignment of an NDC, inclusion in FDA’s drug database or registration does not denote approval, and that representing otherwise is misleading and constitutes misbranding.