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 : EC367
Submitter : Mrs. Jacquie Stratton Date & Time: 09/20/2005 04:09:58
Organization : Utah Valley State College
Category : Health Professional
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?
yes
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?
yes
B. If it could, would it be able to do so as practical matter and, if so, how?
It seems this could be handled in thae same manner as sales of liquor and tabacco. both admittedly have abuses and are hard to actually requlate
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?
Tabacco and alcohol are sold this way- so yes