New FDA Proposal Would Expand Access to Nonprescription Medications

A new proposal by the FDA lays out new requirements to expand the use of a non-prescription drug to additional conditions while maintaining non-prescription status. If the agency finds that a product’s labeling is too unclear, drugmakers can set conditions for non-prescription use instead of making the drug prescription only.

According to the FDA, “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”

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(Source: PR Newswire, June 27th, 2022)