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 : EC2094
Submitter : Mr. Trey McAtee Date & Time: 10/31/2005 06:10:34
Organization : Mr. Trey McAtee
Category : Individual Consumer
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?
Please grant clearance to OTC emergency contraception. This is a vital step to ensuring fewer abortions as well as providing for the health care of women.