Which option is NOT one of the three steps listed for Rx-to-OTC switch pathways?

Which option is NOT one of the three steps listed for Rx-to-OTC switch pathways?

• A. Approve marketing by the state
• B. Submit Supplemental NDA
• C. Petition FDA
• D. Amend drug Monograph

Answer: (A)

The process relies on actions governed by FDA to change a prescription drug to over-the-counter status. The steps involved are federal actions: petition FDA to initiate the switch, submit a Supplemental NDA to obtain OTC status for an already marketed Rx drug, or amend the drug monograph so OTC sales are permitted. Approving marketing by the state is not part of this FDA-driven pathway, because state-level approvals do not determine a drug’s federal OTC status. So the option involving state approval is not a recognized step in Rx-to-OTC switch pathways.

The process relies on actions governed by FDA to change a prescription drug to over-the-counter status. The steps involved are federal actions: petition FDA to initiate the switch, submit a Supplemental NDA to obtain OTC status for an already marketed Rx drug, or amend the drug monograph so OTC sales are permitted. Approving marketing by the state is not part of this FDA-driven pathway, because state-level approvals do not determine a drug’s federal OTC status. So the option involving state approval is not a recognized step in Rx-to-OTC switch pathways.