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 : EC777
Submitter : Mr. John Long Date & Time: 10/13/2005 08:10:39
Organization : Mr. John Long
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
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?
Maybe
C. If so, would a rulemaking on this issue help dispet that confusion?
Probably not
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?
Highly doubtful
B. If it could, would it be able to do so as practical matter and, if so, how?
Not likely
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?
Matter of law
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If it was stocked on shelves with OTC products
GENERAL
GENERAL
This is a highly dangerous drug, with many deaths already documented relating with its use. It is not safe even as a prescription.