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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 (Final Rule)

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 (Final Rule)

This final rule amends our longstanding regulations governing drug establishment registration and drug listing. The amendments are aimed at modernizing these regulations and improving efficiency and reliability for us and drug manufacturers.

The rule makes clear that the establishment registration and listing obligation rests with persons who manufacture, repack, relabel, or salvage drug products. The rule does not require persons who act only as private label distributors of drug products to register establishments or list drugs, but allows them to submit drug listing information as agents acting on behalf of persons who manufacture, repack, relabel, or salvage drug products. The final rule also supports implementation of the electronic prescribing provisions of the MMA and the availability of current drug labeling information through DailyMed.

All incremental costs from the final rule are one-time costs, except for registrants' annually recurring costs of certifying no change to listings upon annual registration for part 207 registrants.

Regulatory Impact Analysis

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 (Final Rule) (PDF - 564KB)

Federal Register: 81 FR 60169, August 31, 2016

Docket: FDA-2005-N-0464