21 C.F.R. § 210.2

Applicability of current good manufacturing practice regulations

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(a) The regulations in this part and in parts 211, 213, 225, and 226 of this chapter as they may pertain to a drug; in parts 600 through 680 of this chapter as they may pertain to a biological product for human use; and in part 1271 of this chapter as they are applicable to a human cell, tissue, or cellular or tissue-based product (HCT/P) that is regulated as a drug (subject to premarket review under an application submitted under section 505 of the act or under a biologics license application under section 351 of the Public Health Service Act); shall be considered to supplement, not supersede, each other, 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, the regulation specifically applicable to the drug product in question shall supersede the more general.

(b) If a person engages in only some operations subject to the regulations in this part and in parts 211, 213, 225, 226, 600 through 680, and 1271 of this chapter, and not in others, that person need only comply with those regulations applicable to the operations in which the person is engaged.

(c) An investigational drug for use in a phase 1 study, as described in § 312.21(a) of this chapter, is subject to the statutory requirements set forth in 21 U.S.C. 351(a)(2)(B). The production of such drug is exempt from compliance with the regulations in part 211 of this chapter. However, this exemption does not apply to an investigational drug for use in a phase 1 study once the investigational drug has been made available for use by or for the sponsor in a phase 2 or phase 3 study, as described in § 312.21(b) and (c) of this chapter, or the drug has been lawfully marketed. If the investigational drug has been made available in a phase 2 or phase 3 study or the drug has been lawfully marketed, the drug for use in the phase 1 study must comply with part 211.

[69 FR 29828, May 25, 2004, as amended at 73 FR 40462, July 15, 2008; 74 FR 65431, Dec. 10, 2009; 89 FR 51769, June 18, 2024]

Notes of Decisions

Cited in 4 cases (1 in the last 5 years), 1980–2026 · leading case: United States v. Merck & Co., 44 F. Supp. 3d 581 (E.D. Pa. 2014).

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United States v. Merck & Co., 44 F. Supp. 3d 581 (E.D. Pa. 2014). “21 C.F.R. § 210.2 . Manufacturers are required to test for safety, purity, and potency of every lot of the vaccine to be sold.”

Cmty. Nutrition Inst. v. Bergland, 493 F. Supp. 488 (D.D.C. 1980). “29, 1980) (to be codified in 21 C.F.R. §§ 210.2 , 210.15b, 220.2, 220.”

Merix Pharm. Corp. v. Clinical Supplies Mgmt., Inc., 59 F. Supp. 3d 865 (N.D. Ill. 2014). “Reply at 2 (quoting 21 C.F.R. § 210.2 (a)). But that does not mean that task-specific regulations apply equally to all manufacturers, processors, packers, and holders of drug products.”

Shareholder Rep. Servs., LLC v. Alexion Pharm., Inc. (Del. Ch. 2026). · cites it 5× “The excerpt differs from 21 C.F.R. § 210.2 (c) in that it appears to provide a blanket exemption from the requirements imposed by Part 211, while the codified amendment provides that “this exemption does not apply to an investigational drug for use in a phase 1 study once the…”

— 21 C.F.R. § 210.2(c) — 1 case

Shareholder Rep. Servs., LLC v. Alexion Pharm., Inc. (Del. Ch. 2026). “The excerpt differs from 21 C.F.R. § 210.2 (c) in that it appears to provide a blanket exemption from the requirements imposed by Part 211, while the codified amendment provides that “this exemption does not apply to an investigational drug for use in a phase 1 study once the…”

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