2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC133
Submitter : Dr. Allison Korell Date & Time: 09/20/2005 01:09:28
Organization : University of Minnesota
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Plan B should be immediately available for OTC use. If you want to limit it's use to those above a certain age, simply have the pharmacist or his/her representative ID purchasers. This is just what we do for cigarettes and alcohol. This drug is safer than aspirin, tylenol, and sudafed... all of which have unrestricted OTC sales.