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
2
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.
3
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.
GENERAL
GENERAL
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.