C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS › Subpart K—Returned and Salvaged Drug Products

21 C.F.R. § 211.204

Returned drug products

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Returned drug products shall be identified as such and held. If the conditions under which returned drug products have been held, stored, or shipped before or during their return, or if the condition of the drug product, its container, carton, or labeling, as a result of storage or shipping, casts doubt on the safety, identity, strength, quality or purity of the drug product, the returned drug product shall be destroyed unless examination, testing, or other investigations prove the drug product meets appropriate standards of safety, identity, strength, quality, or purity. A drug product may be reprocessed provided the subsequent drug product meets appropriate standards, specifications, and characteristics. Records of returned drug products shall be maintained and shall include the name and label potency of the drug product dosage form, lot number (or control number or batch number), reason for the return, quantity returned, date of disposition, and ultimate disposition of the returned drug product. If the reason for a drug product being returned implicates associated batches, an appropriate investigation shall be conducted in accordance with the requirements of § 211.192. Procedures for the holding, testing, and reprocessing of returned drug products shall be in writing and shall be followed.

Notes of Decisions
Cited in 1 case, 2005–2005 · leading case: Am. Home Assur. Co. v. Merck & Co., Inc., 386 F. Supp. 2d 501 (S.D.N.Y. 2005).
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Am. Home Assur. Co. v. Merck & Co., Inc., 386 F. Supp. 2d 501 (S.D.N.Y. 2005). “Merck also argues in its opposition papers, but not in its initial motion for summary judgment or its reply brief, that at least some of the Prototype Claims would be deemed unfit for use under a reasonable interpretation of 21 C.F.R. § 211.204 ("Section 211.204"). That…”
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