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 : EC1602
Submitter : Miss. Katherine Kirkland Date & Time: 10/31/2005 01:10:31
Organization : Miss. Katherine Kirkland
Category : Academia
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?
B. If it could, would it be able to do so as practical matter and, if so, how?
no, at least not fiscally practical
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?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
circumstances in which there is a high instance of abuse