21 C.F.R. § 207.54

Current through May 31, 2024

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

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.

21 C.F.R. §207.54