Data / Federal rules / 2024-13190
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
The Food and Drug Administration published this final rule in the Federal Register on June 18, 2024. It took effect on December 18, 2025.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.
Key facts
- Document number
- 2024-13190
- Type
- Final rule
- Action
- Final rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- June 18, 2024
- Takes effect
- December 18, 2025
- Dates
- This rule is effective December 18, 2025, except for the amendments to Sec. Sec. 4.2 (amendatory instruction 2), 4.3 (amendatory instruction 3), and 4.4 (amendatory instruction 4) (21 CFR 4.2, 4.3, and 4.4), which are effective February 2, 2026. The incorporation by reference of certain material listed in this rule has been approved by the Director of the Federal Register as of February 2, 2026.
- Docket
- Docket No. FDA-2021-N-1333
- Regulation ID (RIN)
- 0910-AH96
- Code of Federal Regulations
- 21 CFR 4; 21 CFR 16; 21 CFR 201; 21 CFR 210; 21 CFR 211; 21 CFR 213; 21 CFR 230; 21 CFR 314; 21 CFR 514
- Topics
- Administrative practice and procedure; Animal drugs; Biologics; Confidential business information; Drugs; Human cells and tissue-based products; Incorporation by reference; Labeling; Laboratories; Medical devices; Packaging and containers; Prescription drugs; Reporting and recordkeeping requirements; Warehouses
- Pages
- 46
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on administrative practice and procedure · Rules on animal drugs · Rules on biologics · Published in June 2024
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.