Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S. agent and importers at the time of registration.
The FDA relies on registration and listing information for administering many key programs, including:
- Post-marketing surveillance;
- Potential user fee assessments;
- Monitoring of drug shortages and availability; and
- Determining products that are being marketed without an approved application.
Regulations governing drug establishment registration and listing have long appeared in 21 CFR Part 207 (human drugs, animal drugs, and certain human biologics). In August 2016, FDA published a final rule amending these regulations. This rule updates these regulations with recent statutory amendments and current practice.
For information and instructions on the electronic submission process, please refer to our eDRLS Instructions webpage.
Features of 21 CFR 207
Mandatory electronic submission of registration and listing information (rather than submission of information on paper forms) provides:
- Greater clarity that registration and listing obligations rest with persons who physically manufacture, repack, or relabel drugs (and not with persons who merely act as distributors or formulators, for example);
- Minor adjustments to the timing and substance of information submitted to register and list;
- Greater clarity that listing information must be reviewed and updated if necessary every June and December. Additionally, if no changes to product listing information have occurred since the last update, then the registrant must certify that no changes have occurred;
- Updates to provisions governing public disclosure of registration and listing information submitted to FDA; and
- Renewed emphasis that National Drug Codes (NDCs) should not appear on the labels of non-drug products.
When Does the New Rule Take Effect?
The final rule includes a table of compliance dates for various provisions of the rule. Registrants are encouraged to come into compliance as soon as possible but are given up to two years after the rule’s effective date to adjust their practices. FDA will make certain adjustments to business practices consistent with the rule, but will likely do this in 2017 after the October-December 2016 annual reregistration period.
- Human Drug Compounding Registration And Product Reporting Procedures
- Human Drug Establishment Registration and Drug Listing Compliance Course
- 21 CFR Part 207 – Provides the applicable section of the Code of Federal Regulations detailing registration of producers of drugs and listing of drugs in commercial distribution
- Section 510 of the Food Drug and Cosmetic Act – This section of the Act requires manufacturers, repackers, and re-labelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution to the FDA.