21 CFR 211.208 - Drug product salvaging.

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§ 211.208 Drug product salvaging.
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.

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 211 after this date.

  • 2013-11-20; vol. 78 # 224 - Wednesday, November 20, 2013
    1. 78 FR 69604 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; extension of comment period for the proposed rule and for its information collection provisions.
      The FDA is extending the comment period for the proposed rule referenced in the Summary. Submit either electronic or written comments on the notice of proposed rulemaking by November 22, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by November 22, 2013 (see the “Paperwork Reduction Act of 1995” section).
      21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211