CFR section
21 CFR 211.208: Drug product salvaging
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart K-Returned and Salvaged Drug Products
Key facts
| Citation | 21 CFR 211.208 |
|---|---|
| Section | Drug product salvaging |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart K-Returned and Salvaged Drug Products |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Biologics, Drugs, Food/Cosmetics |
| Regulation text (excerpt) | 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… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.