Nonprescription Drug Product with an Additional Condition for Nonprescription Use

 

December 23, 2024 - FDA is announcing the final rule, Nonprescription Drug Product with an Additional Condition for Nonprescription Use. The final rule establishes requirements for a nonprescription drug product that has an additional condition for nonprescription use (ACNU). The final rule is intended to increase options for consumer access to appropriate, safe, and effective drug products, which could improve public health.

What Are Nonprescription Drugs?

FDA regulates nonprescription drugs to ensure that they are safe and effective for their intended use. Nonprescription drugs are available to consumers without a prescription and can be safely and effectively used without the supervision of a healthcare provider. Nonprescription drugs have long provided an efficient, low-cost way for Americans to manage every-day health needs, and they play an increasingly vital role in our healthcare system. Nonprescription drugs include drugs for allergies, pain, fever, and many more indications. Nonprescription drugs can be purchased in many online and retail outlets including pharmacies, grocery stores, and convenience stores.

What is a Nonprescription Drug Product with an ACNU?

ACNU stands for Additional Condition for Nonprescription Use. Consumers must successfully complete an extra step to see if the drug is right for them before buying or using a nonprescription drug with an ACNU. This extra step makes sure that consumers can correctly choose and/or use the right drug product on their own without first consulting a health care professional. An example of an extra step could be a questionnaire to determine if the drug is right for you.

How Will Consumers Know that a Product is a Nonprescription Drug with an ACNU?

Right now, there are no FDA-approved nonprescription drugs with an ACNU. However, in the future, the information on the label of the nonprescription drug with an ACNU will alert consumers. 

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For additional information, consumers can read more at 7 Things to Know about ACNU.

Why Does FDA Need an ACNU Rule?

FDA recognizes the benefit of providing consumers with options for additional types of nonprescription drugs, such as some drugs that are currently available only by prescription and that treat chronic diseases or conditions. The rule is expected to broaden the types of nonprescription drugs available to consumers. 

Without the ACNU rule, the label of the nonprescription drug product must have information that consumers need to choose whether the drug is right for them (self-select) and to use the drug appropriately. The ACNU rule provides a way for drug companies developing a drug product for nonprescription use to address the label limitations that otherwise exist for nonprescription drugs – where the label itself needs to have enough information on it that people can determine if the product is right for them (self-select) and how to appropriately use the product without the supervision of a healthcare provider. 

Specifically, under the final rule, a drug company may propose to have an ACNU for the drug when the label on its own cannot, by itself, provide all the information consumers need to appropriately select or use the drug on their own in the nonprescription setting.  

Related Information

• FDA issues final rule to broaden types of nonprescription drugs available to consumers
• 7 Things to know about ACNU
• Federal Register Notices
  • Final Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
  • Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)
• Final Regulatory Impact Analysis
• Drug Application Process for Nonprescription Drugs

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