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 : EC668
Submitter : Mrs. Anna Vrankar Date & Time: 10/12/2005 06:10:17
Organization : Mrs. Anna Vrankar
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?
No, if an active ingredient needs the supervision of a physician because of potential side effects, drug interactions, or because there might be physical conditions which would render taking such an ingredient unsafe, it should remain "prescription only"
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, see above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
no
C. If so, would a rulemaking on this issue help dispet that confusion?
only if the rule made it clear that if a prescription is required, it is universally required.
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! Is the ban on tobacco sales to minors enforeceable? Absolutely not.
B. If it could, would it be able to do so as practical matter and, if so, how?
NO
GENERAL
GENERAL
Please protect our children's health! Keep these potentially dangerous prescription drugs available by prescription only