Today, the U.S. Food and Drug Administration issued a final rule establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU).
A nonprescription drug product with an ACNU is a drug product that could be marketed without a prescription if the drug company implements an additional condition to ensure appropriate self-selection (consumers being able to choose whether the drug is right for them), appropriate actual use, or both, by consumers without the supervision of a health care provider. An example of an “additional condition” could be a questionnaire to determine if the drug product is right for the consumer.
The final rule is intended to increase options for pharmaceutical companies to develop and market nonprescription drug products and increase consumer access to appropriate, safe, and effective drug products, which could improve public health. FDA recognizes the benefit of providing consumers with options for additional types of nonprescription drug products, such as some drugs that are currently available only by prescription and that treat certain chronic diseases or conditions. The rule is expected to broaden the types of nonprescription drug products available to consumers.
Today’s rule does not impact nonprescription drug products marketed under an approved marketing application or over-the-counter monograph.
Additional Information
- For more information on the final rule, visit the ACNU webpage.
- Learn more in 7 Things to Know About the Nonprescription Drug Product with an Additional Condition for Nonprescription Use Final Rule.
Posted in Drugs, FDA and USDA Regulatory Update.