# Nonprescription Drug Product With an Additional Condition for Nonprescription Use
> **Food and Drug Administration** · Final rule. · Published 2024-12-26 · Effective 2025-01-27 · 89 FR 105288
## Document
- **Document number:** 2024-30261
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 89 FR 105288
- **CFR reference:** 21 CFR 201
- **Publication date:** 2024-12-26
- **Effective date:** 2025-01-27
- **HHS docket:** Docket No. FDA-2021-N-0862
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2024/12/26/2024-30261/nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use)
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