The FDA has finalized a rule that establishes requirements for nonprescription drug products with additional conditions for nonprescription use (ACNU).
Set to take effect Jan. 27, 2025, the rule aims to expand access to nonprescription drugs while ensuring consumers can self-select and use them appropriately.
Here are five notes:
- The FDA's final rule defines a nonprescription drug product with an ACNU as one that could be marketed without a prescription if the manufacturer implements an additional condition to ensure appropriate self-selection or actual use by consumers without the supervision of a healthcare provider.
- The rule aims to "increase options for applicants to develop and market safe and effective nonprescription drug products," according to a Dec. 23 news release from the agency.
- The rule does not affect nonprescription products marketed under an approved marketing application or over-the-counter monograph.
- The National Community Pharmacists Association commented on the rule, expressing concerns about the lack of required pharmacy consultation before selling ACNU products stating, "Unless they are applicants for the relevant drug product, pharmacies are not required under the rule to report ACNU failures."
- The Consumer Healthcare Products Association also raised concerns about the "simultaneous marketing" provision stating: "We remain extremely concerned that the simultaneous marketing provision within the rule will blunt the incentive to pursue the ACNU pathway and would ultimately undermine public health goals."