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 : EC804
Submitter : Mrs. Denise Morningstar Date & Time: 10/13/2005 08:10:11
Organization : Mrs. Denise Morningstar
Category : Individual Consumer
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No. A drug should only have one type of delivery. Either it is by prescription or OTC. How can it possibly be both.
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?
There is no way the FDA could possibly control the use of a drug by a subpopulation, such as under age children. How could you possibly prevent an adult male from purchasing and giving to an under age girl the morning after pill. You would be taking the possible life of a child in your hands.
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?