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 E—Control of Components and Drug Product Containers and Closures

21 C.F.R. § 211.80

General requirements

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(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed.

(b) Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination.

(c) Bagged or boxed components of drug product containers, or closures shall be stored off the floor and suitably spaced to permit cleaning and inspection.

(d) Each container or grouping of containers for components or drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected).

Notes of Decisions
Cited in 6 cases (1 in the last 5 years), 1981–2024 · leading case: United States v. Radix Labs., Inc., & Premchand Girdhari, 963 F.2d 1034 (7th Cir. 1992).
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United States v. Radix Labs., Inc., & Premchand Girdhari, 963 F.2d 1034 (7th Cir. 1992). “§ 351 (a)(2)(B); see also 21 C.F.R. 211.80(a) and 211.184. Tracking was impossible at the Esmond Road plant since production records did not exist.”
Nat'l Ass'n of Pharm. Mfrs. v. Dep't of Health & Human Servs., 586 F. Supp. 740 (S.D.N.Y. 1984). “21 C.F.R. § 211.80 (a) (1983). 34 . See Administrative Record, Comments of NAP and NAPM, pp.”
United States v. Richlyn Labs., Inc., 827 F. Supp. 1145 (E.D. Pa. 1992). “See Generally: 21 C.F.R. §§ 211.80 , 211.100, 211.101, 211.”
United States v. Richlyn Labs., Inc., 822 F. Supp. 268 (E.D. Pa. 1993). “See Generally: 21 C.F.R. §§ 211.80 , 211.100, 211.101, 211.”
United States v. Jamieson-McKames Pharm., Inc., 651 F.2d 532 (8th Cir. 1981). “Specifically, 21 C.F.R. § 211.80 describes proper record-keeping procedures for packaging and labeling operations.”
United States of Am. v. Merck KGaA (D. Mass. 2024). · cites it 2× “See 21 C.F.R. § 211.80 . These regulations require, inter alia, that “[c]omponents and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination.”
— 21 C.F.R. § 211.80(a) — 1 case
United States v. Radix Labs., Inc., & Premchand Girdhari, 963 F.2d 1034 (7th Cir. 1992). “§ 351 (a)(2)(B); see also 21 C.F.R. 211.80(a) and 211.184. Tracking was impossible at the Esmond Road plant since production records did not exist.”
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