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 : EC1153
Submitter : Ms. Erin O'Hanlon-Keys Date & Time: 10/27/2005 04:10:38
Organization : Ms. Erin O'Hanlon-Keys
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?
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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?
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B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
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C. If so, would a rulemaking on this issue help dispet that confusion?
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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?
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B. If it could, would it be able to do so as practical matter and, if so, how?
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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?
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B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
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GENERAL
GENERAL
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