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 : EC745
Submitter : Miss. Dina Meyer Date & Time: 10/13/2005 08:10:25
Organization : Texas House of Representatives
Category : State Government
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.
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?
It might be helpful to list the act so that the public can read if for themselves.
C. If so, would a rulemaking on this issue help dispet that confusion?
What is "dispet"? We don't need a rule on this.
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?
No, unless there is some registry put in place for each person who buys it. Which would require the pharmacy staff to be involved by looking at the buyer's ID.
B. If it could, would it be able to do so as practical matter and, if so, how?
See above.
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.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I don't think they should be sold in the same packaging nor in the same form.