21 CFR § 207.45 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?

Current through Sep 8, 2026 · Read all of Part 207

⚠ 2 pending changes to Part 207

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.

← § 207.41 Who must list drugs and what drugs must they list?§ 207.49 What listing information must a registrant submit for a drug it manufactures? →