The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an additional condition for nonprescription use (ACNU). The proposed rule is intended to increase options for the development and marketing of safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.
The 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.
Need for the Proposed Rule
The FDA recognizes the potential benefit of providing consumers with access to additional types of nonprescription drug products, such as some drug products that are currently available only by prescription.
Currently, nonprescription drug products are limited to drugs that can be labeled with sufficient information for consumers to appropriately self-select and use the drug product. For certain drug products, limitations of labeling present challenges for adequate communication of information needed for consumers to appropriately self-select or use the drug product without the supervision of a healthcare provider.
Nonprescription Drug with an Additional Condition for Nonprescription Use (ACNU)
Under the proposed rule, when labeling alone is not sufficient to ensure that the consumer can appropriately self-select, appropriately use, or both, a drug product correctly in a nonprescription setting, an applicant may submit an application proposing an ACNU that a consumer must successfully fulfill to obtain the nonprescription drug product with an ACNU.
An ACNU is one or more FDA-approved conditions that an applicant of a nonprescription drug product must implement to ensure consumers’ appropriate self-selection or appropriate actual use, or both, of the nonprescription drug product without the supervision of a healthcare practitioner. For example, an applicant could propose an ACNU that requires a consumer to respond with specific answers to a set of questions on a self-selection test available by either a mobile application (“app”) or an automated telephone response system in order to purchase the nonprescription drug product.
Major Provisions of the Proposed Rule
- Establish the requirements for a new drug application (NDA) or abbreviated new drug application (ANDA) for a nonprescription drug product with an ACNU, including the requirement to submit a separate application for approval
- Clarify that an ACNU would constitute a meaningful difference between a prescription drug product and a nonprescription drug product containing the same active ingredient; allowing both products to be simultaneously marketed even if they do not have other meaningful differences
- Specify that the FDA would refuse to approve an NDA or ANDA for a nonprescription drug product with an ACNU if the application fails to meet the applicable requirements or if the applicant is unable to demonstrate that labeling alone is insufficient to ensure that the consumer can appropriately self-select or appropriately actually use, or both, a drug product correctly in a nonprescription setting
- Establish postmarketing reporting requirements for a nonprescription drug product with an ACNU
- · Federal Register Notices
- Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)
- Draft Guidance: Innovative Approaches for Nonprescription Drug Products (Docket No. FDA-2018-D-2281)
The proposed rule is available for public comment for 120 days. Comments should be submitted to docket FDA-2021-N-0862 on Regulations.gov.
The FDA encourages comments and questions to be submitted to the docket so that the agency can fully consider all feedback.
For questions related to proposed rule:
(855) 543-3784, or