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 : EC591
Submitter : Mrs. Mary Theoret Date & Time: 10/12/2005 06:10:15
Organization : Mrs. Mary Theoret
Category : Drug Industry
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?
This type of pill should be illegal as it would be used to commit murder!
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?
This type of pill should be illegal as it would be used to commit murder!
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
This type of pill should be illegal as it would be used to commit murder!
C. If so, would a rulemaking on this issue help dispet that confusion?
This type of pill should be illegal as it would be used to commit murder!
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 type of pill should be illegal as it would be used to commit murder!
B. If it could, would it be able to do so as practical matter and, if so, how?
This type of pill should be illegal as it would be used to commit murder!
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?
This type of pill should be illegal as it would be used to commit murder!
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
This type of pill should be illegal as it would be used to commit murder!
GENERAL
GENERAL
This type of pill should be illegal as it would be used to commit murder!