§207.54. What listing information must a registrant submit for a drug that it salvages?
21 C.F.R. § 207.54
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.
The NDC assigned to the drug immediately before the drug is received by the registrant for salvaging;
The lot number and expiration date of the salvaged drug product; and
The name and Unique Facility Identifier for each establishment where the registrant salvages the drug.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.
Source
Source: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.