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 : EC100
Submitter : Ms. Cindy Neels MPH, RD Date & Time: 09/20/2005 10:09:36
Organization : Lahey Clinic
Category : Health Professional
Issue Areas/Comments
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
Yes, by requiring identification such as a drivers' license for non-prescription sales.
B. If it could, would it be able to do so as practical matter and, if so, how?
See A.
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
Yes, if sold at the pharmacy counter where identification could be checked.
I strongly support FDA's committment to making safe and effective contraceptive products available to women and men who choose to use them. I believe allowing non-precription sale of Plan B for women over age 16 would be am appropriate action to reach this goal.