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.