June 27, 2022: “The U.S. FDA issued a proposed rule titled, “Nonprescription Drug Product with an Additional Condition for Nonprescription Use,” which is intended to broaden the range of marketed nonprescription drugs available to consumers, empowering them to self-treat certain common conditions and improving public health.
“Nonprescription drug products play a vital role in America’s healthcare system, as millions of people use them to self-manage health conditions every day,” said FDA Commissioner Robert M. Califf, M.D.
“As part of the FDA’s ongoing efforts to improve public health, this proposal can broaden the types of drugs that can be approved as nonprescription—increasing availability of drugs that would otherwise only be available by prescription.”
Nonprescription drug products are used by consumers without the supervision of a health care professional and require the ability of the consumer to determine that they have the condition for which the drug is to be used, and to appropriately use the drug.
Consumers are likely familiar with the “Drug Facts Labeling” on nonprescription drug packaging as the primary source for information about a product’s intended use, directions for use, and important safety information, all designed in understandable language that is tested for consumer comprehension.
The proposed rule, if finalized, would expand options for consumers by establishing the requirements for a drug company that submits a new application to bring a nonprescription drug product to market with an additional condition for nonprescription use.
Under the proposed rule, when the FDA finds that labeling alone is not sufficient to ensure that the consumer can appropriately self-select and use a drug product in a nonprescription setting, an applicant may submit an application proposing an additional condition for nonprescription use that a consumer must successfully fulfill to obtain the nonprescription drug product.
An additional condition for nonprescription use is one or more FDA-approved conditions that an applicant of a nonprescription drug product must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers of the nonprescription drug product.
For example, an applicant could propose an additional condition for nonprescription use that requires a consumer to respond with specific answers to a set of questions on a self-selection test available by either a phone “app” or an automated telephone response system in order to purchase the nonprescription drug product.
Under the proposed rule, if the FDA finds that the additional condition for nonprescription use will permit appropriate self-selection and/or appropriate actual use of the product, and consumers can use the product safely and effectively without the supervision of a healthcare practitioner, it may approve the product for nonprescription use with the additional condition for nonprescription use.
As with all proposals, the safety of patients remains a top priority.
The FDA encourages public comment for this proposed rule. The comment period will end 120 days after the date of publication in the Federal Register.
After the comment period closes, the FDA will review and consider comments as it develops the final rule. The timing of the final rule will depend on the number and substance of the comments.
For more information on the proposed rule, visit the Nonprescription Drug Product with an Additional Condition for Nonprescription Use Proposed Rule webpage.
Related Information
- Guidance: Innovative Approaches for Nonprescription Drug Products
- Guidance: Self-Selection Studies for Nonprescription Drug Products”
