21 CFR 210.1
Status of current good manufacturing practice regulations
21 CFR 210.1 is the regulation titled “Status of current good manufacturing practice regulations” in 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. Since 2021, 41 FDA warning letters have cited it.
- Letters citing it
- 41 since 2021
- Jan 1 to Oct 30, 2026
- 8 against 10 on the same dates in 2025
- Most often cited with
- 21 CFR 200.10, in 41 letters
- Closed out
- 10% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 210.1 (eCFR, as of Sep 1, 2026)
(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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 210.1.
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers41 letters cite both
- 21 CFR 211.192Production record review31 letters cite both
- 21 CFR 201.115New drugs or new animal drugs30 letters cite both
- 21 CFR 211.113Control of microbiological contamination29 letters cite both
- 21 CFR 211.42Design and construction features28 letters cite both
- 21 CFR 211.100Written procedures; deviations14 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit11 letters cite both
- 21 CFR 211.165Testing and release for distribution10 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 210.1 that FDA posted most recently.
- DrugsView SCA Pharmaceuticals, LLCCompounded sterile drug productsIssuedSep 14, 2026PostedOct 13, 2026
- DrugsView Pine Pharmaceuticals, LLCsterile compounded drug productsIssuedAug 7, 2026PostedOct 6, 2026
- DrugsView Empower Clinic Services, LLC dba Empower Pharmacycompounded semaglutide and tirzepatide products, including TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML), SEMAGLUTIDE/CYANOCOBALAMIN (1…IssuedSep 18, 2026PostedSep 22, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.