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Latest NewsApril 1, 2025 ACNU Final Rule Delayed Until May 27, 2025 The Food and Drug Administration stated that the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule’s effective date has been delayed from March 21 to May 27, 2025. The FDA originally issued the final rule in December 2024. A nonprescription drug product with an ACNU is a drug product that could be marketed without a prescription if an applicant (i.e., the drug manufacturer) 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 FDA says the final rule is meant 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. In the December 2024 final rule, the FDA disagreed with comments that such drugs should be sold only after consultation with a pharmacist, citing patient access concerns. However, the agency did address concerns regarding administrative burden on pharmacies, stating that while a pharmacist or other individual may voluntarily submit a report of an ACNU failure to the FDA’s reporting systems, the rule requires the applicant of the nonprescription drug product with an ACNU to submit reports of an ACNU failure. Therefore, unless they are applicants for the relevant drug product, pharmacies are not required under the rule to report ACNU failures. [Nonprescription Drug Product With an Additional Condition for Nonprescription Use. FDA Fed Reg Vol. 90, No. 56 at 13533. 25 Mar 2025; Nonprescription Drug Product With an Additional Condition for Nonprescription Use. FDA Fed Reg Vol. 89, No. 247 at 105288. 26 Dec 2024.]
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