21 CFR 211.208
Drug product salvaging
21 CFR 211.208 is the regulation titled “Drug product salvaging” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 207.17, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 12022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 211.208 (eCFR, as of Sep 1, 2026)
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 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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.208.
- 21 CFR 207.17Who must register?1 letter cites both
- 21 CFR 211.100Written procedures; deviations1 letter cites both
- 21 CFR 211.165Testing and release for distribution1 letter cites both
- 21 CFR 211.188Batch production and control records1 letter cites both
- 21 CFR 211.192Production record review1 letter cites both
- 21 CFR 211.22Responsibilities of quality control unit1 letter cites both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1 letter cites both
Latest letters citing it
The letter citing 21 CFR 211.208 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.