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 H—Holding and Distribution

21 C.F.R. § 211.142

Warehousing procedures

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Written procedures describing the warehousing of drug products shall be established and followed. They shall include:

(a) Quarantine of drug products before release by the quality control unit.

(b) Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected.

Notes of Decisions
Cited in 3 cases (1 in the last 5 years), 1996–2023 · leading case: Liberatore, James v. Melville Corp, 168 F.3d 1326 (D.C. Cir. 1999).
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Liberatore, James v. Melville Corp, 168 F.3d 1326 (D.C. Cir. 1999). “21 C.F.R. § 211.142 (b). Failure to comply results in adulterated drugs as defined by Section 501 of the Food, Drug, and Cosmetic Act, 21 U.”
United States v. Argent Chem. Labs., Inc., 93 F.3d 572 (9th Cir. 1996). “137 ; holding and distribution procedures, 21 C.F.R. §§ 211.142 , 211.150; laboratory controls, 21 C.”
Ellis v. CVS Health Corp., No. 2:16-cv-01582 (E.D. Pa. May 2, 2023). “Plaintiff focuses on 21 C.F.R. § 211.142 , but that section deals with warehousing and storage, rather than distribution, so it does not regulate the actions at issue here.”
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