For each drug being manufactured, repacked, relabeled, or salvaged for commercial distribution at an establishment at the time of initial registration, drug listing information must be submitted no later than 3 calendar days after the initial registration of the establishment.
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, and the National Drug Code
§ 207.45 When, after initial registration of an establishment, must drug listing information be submitted?
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FDA guidance that cites § 207.45
- Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors 18 May 2022
Amendment history
Federal Register documents that created or amended this section.
- 81 FR 60212 31 Aug 2016