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
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?
no
B. If it could, would it be able to do so as practical matter and, if so, how?
no, at least not fiscally practical
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
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