Wyoming MPJE (Pharmacy Jurisprudence) Practice Exam

Which of the following is NOT a way for a prescription drug to become OTC?

1. Drug company submits a NDA

2. FDA issues a recall

3. FDA grants an exception based on relative safety of the drug

4. The Nonprescription Drug Advisory Committee recommends a drug be OTC

The correct answer is: Drug company submits a NDA

When a drug company submits a New Drug Application (NDA) for a prescription drug, it is seeking approval from the FDA to market the drug as a prescription medication. The FDA issues a recall when there is a safety concern with a drug that is already on the market, indicating that it is not eligible to become an over-the-counter (OTC) drug. The FDA can grant an exception for a prescription drug to be sold over-the-counter based on its relative safety compared to other medications. The Nonprescription Drug Advisory Committee can recommend a prescription drug be made available over-the-counter if they determine that it is safe and effective for self-use without the need for a healthcare provider's prescription. Therefore, the correct answer is option A because the submission of a New Drug Application is the process by which drugs are initially approved for use as prescription medications.