How can a prescription (Rx) drug be converted to OTC status?

The correct process for converting a prescription drug to over-the-counter (OTC) status involves a supplemental New Drug Application (NDA). This regulatory pathway is crucial because it requires submitting scientific evidence to the FDA demonstrating that the drug can be used safely and effectively without a healthcare professional's supervision. The application must provide comprehensive data regarding the drug's safety profile, side effects, and labeling, and demonstrate that consumers can understand how to use the product appropriately without direct medical supervision.

The supplemental NDA specifically addresses changes in the drug's marketing status and provides the necessary documentation for review by the FDA. If approved, the drug can then be marketed as an OTC product, allowing broader access while ensuring consumer safety.

Other options listed, such as a public announcement or annual review, do not align with the formal regulatory processes defined by the FDA for converting prescription drugs to OTC status. Removing a drug from the market or simply declaring it OTC without following established procedures lacks the robust consumer safety and efficacy review required in the transition from prescription to OTC.