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 A—General Provisions

21 C.F.R. § 211.1

Scope

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs and medical gases as defined in § 213.3(b)(12) of this chapter) for administration to humans or animals.

(b) The current good manufacturing practice regulations in this chapter as they pertain to drug products; in parts 600 through 680 of this chapter, as they pertain to drugs that are also biological products for human use; and in part 1271 of this chapter, as they are applicable to drugs that are also human cells, tissues, and cellular and tissue-based products (HCT/Ps) and 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); supplement and do not supersede the regulations in this part unless the regulations explicitly provide otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, or in parts 600 through 680 of this chapter, or in part 1271 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general.

(c) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under parts 110 and 117 of this chapter, and where applicable, parts 113 through 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.

[43 FR 45077, Sept. 29, 1978, as amended at 62 FR 66522, Dec. 19, 1997; 69 FR 29828, May 25, 2004; 74 FR 65431, Dec. 10, 2009; 80 FR 56168, Sept. 17, 2015; 89 FR 51769, June 18, 2024]
Notes of Decisions
Cited in 8 cases (2 in the last 5 years), 1978–2026 · leading case: Livingston v. Wyeth, Inc., 520 F.3d 344 (4th Cir. 2008).
Sort: Relevance Newest Treatment
Livingston v. Wyeth, Inc., 520 F.3d 344 (4th Cir. 2008). · cites it 2× “" 21 C.F.R. § 211.1 . In addition to specific mandates, such as requiring workers to wear clean clothing during drug production, see id.”
Supernus Pharm., Inc. v. TWi Pharm., Inc., 265 F. Supp. 3d 490 (D.N.J. 2017). “Because 21 C.F.R. § 211.1 (a) requires that experimental drugs pass FDA .”
United States v. Articles of Drug Consisting of the Following: 27/1000 Tablet Bottles, More or Less, Labeled in Part: 1000 Tablets Colchicine, 442 F. Supp. 1236 (S.D.N.Y. 1978). “The evidence conclusively establishes that Consolidated, in the preparation and repacking of its dihycon and colchicine, did not conform to current good manufacturing practice as defined in 21 C.F.R. § 211.1 (a) which states that the “criteria in §§ 211.”
Mohr v. Targeted Genetics, Inc., 690 F. Supp. 2d 711 (C.D. Ill. 2010). “, 21 C.F.R. § 211.1 (“regulations in this part contain the minimum *727 current good manufacturing practice for preparation of drug products for administration to humans and animals”).”
United States v. Argent Chem. Labs., Inc., 93 F.3d 572 (9th Cir. 1996). “72 ; production and process controls, 21 C.F.R. §§ 211.1 GO-211.115; packaging and labeling controls, 21 C.”
Torrent Pharma, Inc. v. Priority Healthcare Distrib., Inc. (Del. Super. Ct. 2022). “14 See 21 C.F.R. § 211.1 (a) (2015). 15 Id. § 211.”
Shareholder Rep. Servs., LLC v. Alexion Pharm., Inc. (Del. Ch. 2026). “130 (citing to Phase 1 Guidance); Phase 1 Guidance § III (“[I]f an investigational drug has already been manufactured by an IND sponsor for use during phase 2 or phase 3 clinical trials or has been lawfully marketed, manufacture of such a drug must comply (21 CFR 211.1) with 21…”
Boudreault v. Chesapeake Biological Labs., Inc., 19 Mass. L. Rptr. 484 (Mass. Super. Ct. 2005). “While the plaintiff has not set out any policy in Massachusetts upon which to base his public policy exception, he points out that the FDA can dictate public policy, more specifically the policies *486 set forth in 21 C.F.R. §211.1 . Similarly to the plaintiff in Wright ,…”
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.