Who determines when a prescription medicine should be switched to OTC status?

Technically, anyone could submit a Citizen’s Petition to FDA to switch a product from Rx to OTC status. However, the holder of the approved new drug application (NDA)—the company that developed the drug for prescription use—knows the most about the drug and is in the best position to determine whether and under what circumstances it would be appropriate to request a switch.

FDA should consult with the NDA holder about whether the switch process should be initiated, but the sponsor needs to develop the evidence and drive the switch process to manage the risk of prematurely or inappropriately removing prescription safeguards.

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