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 : EC563
Submitter : Mrs. Rosemary Woerner Date & Time: 10/12/2005 06:10:59
Organization : Mrs. Rosemary Woerner
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
NO. No active ingredients should be simultaneously marketed as both prescription and OTC.
1.
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?
NO
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
NO
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?
It would be difficult, if not impossible.
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?
NO, they should not.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Always inappropriate.