Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter C - Drugs: General |
Subpart D - Listing |
§ 207.54 - What listing information must a registrant submit for a drug that it salvages?
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§ 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.