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 : EC603
Submitter : Ms. Estelle padawer Date & Time: 10/12/2005 06:10:12
Organization : Ms. Estelle padawer
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?
B. If it could, would it be able to do so as practical matter and, if so, how?
If there are no medical contra-indications for use by younger girls, Plan B should be available over the counter for ALL ages. This would be better than waiting to have an abortion.
Sadly we now know that incest is not rare; the victims need all the help we can give them.