FDA finalizes nonprescription drug rule: 5 notes

Becker's Healthcare January 2, 2025
Alexandra Murphy

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:

1. 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.
2. The rule aims to “increase options for applicants to develop and market safe and effective nonprescription drug products,”...

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