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 : EC845
Submitter : Mrs. Dorothy Perron Date & Time: 10/13/2005 10:10:54
Organization : Mrs. Dorothy Perron
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?
Enforcement would be very difficult. Young girls would just heve their older frends provide for them. Also there is the possibility of reselling ilegally.