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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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closed 1341d ago
Consumer Healthcare Products Association filings
2

Activity

Consumer Healthcare Products Association filed 2 comments on this docket between Jul 28, 2022 and Nov 23, 2022. 15 other organizations filed here. The comment window closed 1341d ago.

What Consumer Healthcare Products Association filed (2)

Nov 23, 2022· Comment from Consumer Healthcare Products Association (CHPA)· FDA-2021-N-0862-0181

CHPA comments on the ACNU proposed rule.

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Jul 28, 2022· Comment from Consumer Healthcare Products Association· FDA-2021-N-0862-0033

Filed on regulations.gov — full text not in the inline record.

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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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