Does the switch of Plan B create a third class of drugs?
No. Sponsors of switch applications can and should feel free to explore new or different approaches to moving prescription medicines over the counter. There are recent examples in which an application sponsor has voluntarily committed to innovative distribution and educational mechanisms for a product. Supplemental educational materials, web site information centers, etc., are examples of some of the innovative approaches being used by OTC companies to ensure their consumers have access to even more resources for safe and effective self medication.Duramed’s application for the switch of Plan B (levonorgestrel), 0.75 mg, is the most recent and prominent example of this. The application voluntarily set up a system whereby consumers 18 and over can purchase the product without a prescription and requires a prescription for consumers under 18. The company agreed to limit distribution through pharmacists-only becase the product is labeled for prescription use by women under 18. Federal law
