21 CFR § 226.1

21 CFR · Food and Drugs

§ 226.1 — Current good manufacturing practice.

21 CFR § 226.1

TitleTitle 21: Food and Drugs PartPart 226: Current Good Manufacturing Practice for Type a Medicated Articles

SourceeCFR (current through Apr 9, 2026)

This text of 21 C.F.R. § 226.1 (Current good manufacturing practice.) is published on Counsel Stack Legal Research, covering United States primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

21 C.F.R. § 226.1 (2026).

Text

§ 226.1 Current good manufacturing practice.

(a)The criteria in §§ 226.10 through 226.115, inclusive, shall apply in determining whether the methods used in, or the facilities and controls used for the manufacture, processing, packing, or holding of a Type A medicated article(s) conform to or are operated or administered in conformity with current good manufacturing practice to assure that a Type A medicated article(s) meets the requirements of the act as to safety, and has the identity and strength, and meets the quality and purity characteristics which it purports or is represented to possess, as required by section 501(a)(2)(B) of the act. The regulations in this part 226 permit the use of precision, automatic, mechanical, or electronic equipment in the production of a Type A medicated

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§ 226.1 Current good manufacturing practice.

(a) The criteria in §§ 226.10 through 226.115, inclusive, shall apply in determining whether the methods used in, or the facilities and controls used for the manufacture, processing, packing, or holding of a Type A medicated article(s) conform to or are operated or administered in conformity with current good manufacturing practice to assure that a Type A medicated article(s) meets the requirements of the act as to safety, and has the identity and strength, and meets the quality and purity characteristics which it purports or is represented to possess, as required by section 501(a)(2)(B) of the act. The regulations in this part 226 permit the use of precision, automatic, mechanical, or electronic equipment in the production of a Type A medicated article(s) when adequate inspection and checking procedures or other quality control procedures are used to assure proper performance.

(b) In addition to maintaining records and reports required in this part, Type A medicated articles requiring approved NADAs are subject to the requirements of § 514.80 of this chapter. Similarly, Type A medicated articles listed in the index are subject to the requirements of § 516.165 of this chapter.

[40 FR 14031, Mar. 27, 1975, as amended at 68 FR 15364, Mar. 31, 2003; 72 FR 69120, Dec. 6, 2007]