21 CFR 211.208
Drug product salvaging. This section left the CFR when the QMSR took effect on Feb 2, 2026; the text below is as of Feb 1, 2026.
- Inspections citing it: 9
- Of those classified, ended OAI: 43%
- Last cited: FY2023
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Regulation Text
eCFR, as of Feb 1, 2026Drug 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 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.
Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR