21 CFR § 207.54 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

§ 207.54 What listing information must a registrant submit for a drug that it salvages?

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

⚠ 2 pending changes to Part 207

A registrant who also relabels or repacks a drug that it salvages must list the drug it relabels or repacks in accordance with § 207.53 rather than in accordance with this section. A registrant who performs only salvaging with respect to a drug must provide the following listing information for that drug.

(a) The NDC assigned to the drug immediately before the drug is received by the registrant for salvaging;

(b) The lot number and expiration date of the salvaged drug product; and

(c) The name and Unique Facility Identifier for each establishment where the registrant salvages the drug.

← § 207.53 What listing information must a registrant submit for a drug that it repacks or relabels?§ 207.55 What additional drug listing information may FDA require? →