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 : EC631
Submitter : Mrs. B Lang Date & Time: 10/12/2005 06:10:15
Organization : Mrs. B Lang
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?
I don't think it would be in the best interest of a person if a drug that is prescription should be sold over the counter. it is a prescription that has been tested and should remain a prescription
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
yes, I don't think it should be so confusing for comsumers. Layman terms would better serve the public.
C. If so, would a rulemaking on this issue help dispet that confusion?
possible
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?
this is very confusing