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FDARulemakingFDA-2021-N-0862

Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule

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Sep 25, 2025
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American Pharmacists Association (APhA) filings
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Activity

American Pharmacists Association (APhA) filed 1 comment on this docket between Nov 25, 2022 and Nov 25, 2022. 15 other organizations filed here. The comment window closed 1341d ago.

What American Pharmacists Association (APhA) filed (1)

Nov 25, 2022· Comment from American Pharmacists Association (APhA)· FDA-2021-N-0862-0191

Please see attached comment letter submitted on behalf of the American Pharmacists Association. Thank you.

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Abstract

The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.

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Co-filers (15)

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Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule (FDA) — American Pharmacists Association (APhA) | OpenPolis