Data / Federal rules / 2024-30261
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The Food and Drug Administration published this final rule in the Federal Register on December 26, 2024. It took effect on January 27, 2025.
SpecStream is the live web data engine for teams and agents. It reads every rule and proposed rule in the Federal Register each morning, and this page is that reading. Name your industry once and new rules, comment deadlines and effective dates arrive in your sheet, CRM, Slack or agent as they are published.
What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). A nonprescription drug product with an ACNU is a drug product that could be marketed without a prescription if an applicant implements an additional condition to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a practitioner licensed by law to administer such drug. The final rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products and increase consumer access to appropriate, safe, and effective drug products, which could improve public health.
Key facts
- Document number
- 2024-30261
- Type
- Final rule
- Action
- Final rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- December 26, 2024
- Takes effect
- January 27, 2025
- Dates
- This rule is effective January 27, 2025.
- Docket
- Docket No. FDA-2021-N-0862
- Regulation ID (RIN)
- 0910-AH62
- Code of Federal Regulations
- 21 CFR 201; 21 CFR 314
- Topics
- Administrative practice and procedure; Confidential business information; Drugs; Labeling; Reporting and recordkeeping requirements
- Significant
- Yes, under Executive Order 12866
- Pages
- 44
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on administrative practice and procedure · Rules on confidential business information · Rules on drugs · Published in December 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.