A sponsor of a nonprescription drug product may seek to market a prescription drug product as nonprescription. A sponsor of a prescription drug product may initiate this change in marketing status through the NDA process. This change in the marketing status is commonly referred to as a Prescription-to-Nonprescription (RX-to-OTC) switch.
Types of Rx-to-OTC Switches
There are two types of Rx-to-OTC switches: full switch or partial switch.
- Full switch: A sponsor switches the drug product covered under the NDA to nonprescription marketing status in its entirety. To initiate a full switch, a sponsor submits an efficacy supplement to an approved NDA or a 505(b)(2) application. After a full switch, the drug is only available as a nonprescription drug.
- Partial switch: A sponsor partially switches some of the conditions of use (e.g. indications) to nonprescription marketing status, while retaining others within a prescription status. To initiate a partial switch, a sponsor submits a new NDA. After a partial switch, the drug is available as a prescription drug for certain conditions of use and a nonprescription drug for other conditions of use.
Data Supporting an Rx-to-OTC Switch
An application or efficacy supplement to an application for an Rx-to-OTC switch should contain both efficacy and safety data demonstrating that the drug product is safe to use in the nonprescription setting. Efficacy and safety data to support an Rx-to-OTC switch may include data from randomized, controlled clinical trials submitted in the original NDA for the prescription drug; and new randomized, controlled clinical trials. Additionally, the applicant must provide data that demonstrate consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional. The applicant must also provide post-marketing safety surveillance data.
Approval of an Rx-to-OTC Switch
FDA will approve an Rx-to-OTC switch application when FDA determines that the previous prescription status is “not necessary for the protection of the public health by reason of the drug’s toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and . . . the drug is safe and effective for use in self-medication as directed in proposed labeling.” See 21 CFR 310.200(b).
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- FAQs on the Regulatory Process of Over-the-Counter (OTC) Drugs
- Label Comprehension Studies for Nonprescription Drug Products guidance document
- Self-Selection Studies for Nonprescription Drug Products guidance document
- Prescription to Over-the-Counter (OTC) Switch List