(a) The regulations set forth in this part and in parts 211, 213, 225, and 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.
(b) The failure to comply with any regulation set forth in this part and in parts 211, 213, 225, and 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.
(c) Owners and operators of establishments engaged in the recovery, donor screening, testing (including donor testing), processing, storage, labeling, packaging, or distribution of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in § 1271.3(d) of this chapter, that are drugs (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act), are subject to the donor-eligibility and applicable current good tissue practice procedures set forth in part 1271 subparts C and D of this chapter, in addition to the regulations in this part and in parts 211, 225, and 226 of this chapter. Failure to comply with any applicable regulation set forth in this part, in parts 211, 225, and 226 of this chapter, in part 1271 subpart C of this chapter, or in part 1271 subpart D of this chapter with respect to the manufacture, processing, packing or holding of a drug, renders an HCT/P adulterated under section 501(a)(2)(B) of the act. Such HCT/P, as well as the person who is responsible for the failure to comply, is subject to regulatory action.
[43 FR 45076, Sept. 29, 1978, as amended at 69 FR 29828, May 25, 2004; 74 FR 65431, Dec. 10, 2009; 89 FR 51769, June 18, 2024]
Notes of Decisions
United States v. Richlyn Labs., Inc., 827 F. Supp. 1145 (E.D. Pa. 1992).
· cites it 3× “: 21 C.F.R. §§ 210.1 , 211.1. Regular and continuing training of all employees and personnel in current good manufacturing practices by qualified individuals is also expected.”
United States v. Barr Labs., Inc., 812 F. Supp. 458 (D.N.J. 1993).
· cites it 2× “21 C.F.R. § 210.1 (b). 9. Congress recognizes the United States Pharmacopeia (“USP”), a nonprofit corporation which develops drug product standards with the help of professionals from academia, the medical community, the pharmaceutical industry and the FDA, as an official…”
Liberatore, James v. Melville Corp, 168 F.3d 1326 (D.C. Cir. 1999).
“§ 351 , see 21 C.F.R. § 210.1 (b), and the violator is subject to a fine, imprisonment up to one year, or both.”
United States v. Merck & Co., 44 F. Supp. 3d 581 (E.D. Pa. 2014).
“12 (b); 21 C.F.R. § 210.1 et seq., and duties to the National Vaccine Program and the Vaccine Injury Compensation Program.”
United States v. Richlyn Labs., Inc., 822 F. Supp. 268 (E.D. Pa. 1993).
· cites it 2× “: 21 C.F.R. §§ 210.1 , 211.1. Regular and continuing training of all employees and personnel in current good manufacturing practices by qualified individuals is also expected.”
United States v. Premo Pharm. Labs., Inc., 511 F. Supp. 958 (D.N.J. 1981).
“FDA’s Good Manufacturing Practice (GMP) regulations, 21 C.F.R. § 210.1 et seq. (1980), are not sufficient to avoid the need for preclearance.”
In-Possession, Cantrell Drug Co. v. United States (In re Cantrell Drug Co.), 585 B.R. 555 (Bankr. E.D. Ark. 2018).
“See 21 C.F.R. § 210.1 (a) (2011) ("The regulations set forth in this part and in parts 211, 225, and 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing,…”
— 21 C.F.R. § 210.1(a) — 2 cases
United States v. Richlyn Labs., Inc., 827 F. Supp. 1145 (E.D. Pa. 1992).
“: 21 C.F.R. §§ 210.1 , 211.1. Regular and continuing training of all employees and personnel in current good manufacturing practices by qualified individuals is also expected.”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.