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 : EC837
Submitter : Ms. Rhia Perkins Date & Time: 10/13/2005 10:10:56
Organization : Ms. Rhia Perkins
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?
Plan B should be available over the counter, without a prescription and preferably without having to see a pharmacist.
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?
Plan B should be available over the counter, without a prescription and preferably without having to see a pharmacist.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Plan B should be available over the counter, without a prescription and preferably without having to see a pharmacist.
C. If so, would a rulemaking on this issue help dispet that confusion?
Plan B should be available over the counter, without a prescription and preferably without having to see a pharmacist.
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?
Plan B should be available over the counter, without a prescription and preferably without having to see a pharmacist.
B. If it could, would it be able to do so as practical matter and, if so, how?
Plan B should be available over the counter, without a prescription and preferably without having to see a pharmacist.
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?
Plan B should be available over the counter, without a prescription and preferably without having to see a pharmacist.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Plan B should be available over the counter, without a prescription and preferably without having to see a pharmacist.
GENERAL
GENERAL
Plan B should be available over the counter, without a prescription and preferably without having to see a pharmacist.