Prescription to Nonprescription Switch MAPP

CDER has published a Manual of Policies and Procedures (MAPP), “Prescription to Nonprescription Switches and Abbreviated New Drug Applications,” describing the policies and procedures for the Office of Generic Drugs (OGD) when a reference-listed drug switches from prescription to nonprescription marketing status. The MAPP specifically describes the procedures for OGD to send notifications to approved ANDA holders about the need to submit additional information, including updated labeling, for the ANDA for prescription to nonprescription switches.

The document applies to full prescription to nonprescription switches after FDA has determined that there is no clinically meaningful difference between the generic drug product that is the subject of an approved ANDA and a drug product that was switched to nonprescription status under an approved NDA. It does not apply to partial prescription to nonprescription switches or unapproved ANDAs.