Data / Federal rules / 2025-04978
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The Food and Drug Administration published this final rule in the Federal Register on March 25, 2025. It took effect on December 26, 2024.
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What the agency says
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule, entitled "Nonprescription Drug Product With an Additional Condition for Nonprescription Use," (ACNU) was delayed until March 21, 2025. Additional time is needed for review; therefore, the delay is extended for an additional 60 days.
Key facts
- Document number
- 2025-04978
- Type
- Final rule
- Action
- Final rule; delay of effective date
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- March 25, 2025
- Takes effect
- December 26, 2024
- Dates
- As of March 21, 2025, the effective date for the final rule published December 26, 2024, (89 FR 105288), is further delayed to a new effective date of May 27, 2025.
- Docket
- Docket No. FDA-2021-N-0862
- Regulation ID (RIN)
- 0910-AH62
- Code of Federal Regulations
- 21 CFR 201; 21 CFR 314
- Significant
- Yes, under Executive Order 12866
- Pages
- 2
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Published in March 2025
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.