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 : EC1626
Submitter : Mrs. Ellen Chmiel Date & Time: 10/31/2005 01:10:36
Organization : Mrs. Ellen Chmiel
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?
Not necessary. Stop stalling. We want this issue free of political delay.
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?

Same question as #1. No need to answer.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
It's the FDA that seems confused. No there's no significant confusion.
C. If so, would a rulemaking on this issue help dispet that confusion?
I don't know since I don't see any confusion.
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?
Probably. No pharmacist wants to lose his/her license. Isn't this prescription merely a double dose of birth control pill?
B. If it could, would it be able to do so as practical matter and, if so, how?
Again, pharmacists don't want to lose their license and using them is the only way to enforce rules
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?
I see no need for this. What's the rational? It will just cost more to have them in one package.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Makes little difference either way. What are you quibbling about? This question makes no sense.
GENERAL
GENERAL
I am a practicing Roman Catholic and I will not force my standards on someone who does not subscribe to them. The world has enough unwanted babies.