Wyoming MPJE (Pharmacy Jurisprudence) Practice Exam

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Which method is NOT a way for a prescription drug to become OTC?

  1. Appending to an FDA petition

  2. FDA grants an exception

  3. Drug company submits a NDA

  4. Nonprescription Drug Advisory Committee recommendations

The correct answer is: Appending to an FDA petition

Appending to an FDA petition is not a method for a prescription drug to become over-the-counter (OTC). In the process of switching a drug from prescription to OTC status, the FDA may consider various factors including safety, efficacy, potential for misuse, and the drug's labeling. However, simply appending a drug to an FDA petition does not inherently lead to reclassification as an OTC medication. The correct processes involve FDA granting an exception, a drug company submitting a New Drug Application (NDA) for OTC status, or receiving recommendations from the Nonprescription Drug Advisory Committee.

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