Non-prescription Drug Product with an Additional Condition for Non-prescription Use

The FDA is proposing to establish norms for a non-prescription medication with an additional condition for non-prescription use (ACNU). If implemented, the proposed rule would establish requirements for a non-prescription drug product with an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers who are not under the supervision of a healthcare practitioner.

Non-prescription drug products are currently only allowed to contain medications that can be labelled with enough information to allow consumers to appropriately self-select and use the drug product. When it comes to certain drug products, labelling restrictions present challenges for sufficient communication of information needed for consumers to appropriately self-select or use the drug product without the supervision of a healthcare practitioner for specific drug products.

By expanding the range of non-prescription drug options available to consumers, the proposed rule may improve public health by providing applicants with more options for developing and marketing safe and effective non-prescription drug products.

If adopted, the proposed rule would establish specifications for non-prescription medication containing an ACNU. Non-prescription drug products approved with an ACNU would continue to be subject to the same evidentiary requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and current FDA regulations for proving safety and efficacy.

An applicant would be required to submit a new application for the approval of a non-prescription drug product with an ACNU rather than an addition to an application previously authorised as a prescription medicine. NDA applicants would now be required to present a description of the ACNU and accompanying documentation, in addition to any applicable existing application requirements.

If medication items were more readily available, consumers may cure a variety of medical conditions without the help of a doctor by using non-prescription medicines and an ACNU.



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