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 : EC848
Submitter : Dr. Harnath Holmes Date & Time: 10/13/2005 10:10:20
Organization : Dr. Harnath Holmes
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
B. If it could, would it be able to do so as practical matter and, if so, how?
yes, look at how we sell alcohol, tobacco, adult magazines, firearms etc. If they have a drivers license they are at least 16 years old

Otherwise keep it behind the counter.
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?
none
GENERAL
GENERAL
This product should be approved for OTC sale.