The Food and Drug Administration published a final rule establishing requirements for a nonprescription drug product with an additional condition for nonprescription use, to take effect Jan. 27. 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.
NCPA commented on FDA’s proposed rule in November 2022. The FDA disagreed with NCPA’s comment that such drugs should be sold only after consultation with a pharmacist, citing patient access concerns.
However, the agency did address NCPA’s concerns regarding administrative burden on pharmacies, stating that while a pharmacist or other individual may voluntarily submit a report of an ACNU failure to 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.
