The switching policy of the FDA allows it to review prescription drugs and evaluate their suitability as OTC products. This statement is:

• A. True
• B. False
• C. Not Applicable
• D. Cannot Determine

Answer: (A)

The key idea is that the FDA has an explicit review pathway to determine if a prescription drug can be sold over the counter. The agency evaluates whether a drug can be used safely by consumers without a clinician, ensuring that dosing, indications, warnings, and labeling are clear and adequate for self-use. If the evidence shows safety and appropriate use with OTC labeling, the drug can be switched to OTC status through an approved labeling change or a formal OTC monograph process. This is precisely why the statement is true: the FDA does review prescription drugs to assess their suitability for OTC sale. For example, many allergy medicines and some acid reducers have moved from Rx to OTC after such evaluation.