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 : EC667
Submitter : Mrs. Cynthia Raschke Date & Time: 10/12/2005 06:10:05
Organization : Mrs. Cynthia Raschke
Category : Individual Consumer
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?
Probably not.
Making Plan B over the counter would create numerous problems especially with regard to keeping it out of the hands of minors. The FDA has no mechanism for enforcing a regulation that prohibits sale to minors.