Drug product salvaging as per USFDA CFR 211.208

Drug product salvaging as per USFDA CFR 211.208

Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation due to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace.

Whenever there is a question about whether drug products have been subjected to such conditions, salvaging operations may be conducted only if there is

(a) Evidence from laboratory tests and assays (including animal feeding studies where applicable) that the drug products meet all applicable standards of identity, strength, quality, and purity, and

(b) Evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage conditions as a result of the disaster or accident.

Organoleptic examinations shall be acceptable only as supplemental evidence that the drug products meet appropriate standards of identity, strength, quality, and purity.

Records including name, lot number, and disposition shall be maintained for drug products subject to this section.

Reference:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211