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 : EC45
Submitter : Mrs. Theresa Lohman Date & Time: 09/01/2005 04:09:33
Organization : Planned Parenthood
Category : Health Professional
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?
Possibly if the consumer had to ask for it (at the pharmacy counter) and show picture ID to purchase it.
B. If it could, would it be able to do so as practical matter and, if so, how?
See above