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 : EC879
Submitter : Mrs. Linda McLaughlin Date & Time: 10/17/2005 10:10:20
Organization : Mrs. Linda McLaughlin
Category : Health Professional
Issue Areas/Comments
1.
C. If so, would a rulemaking on this issue help dispet that confusion?
NO
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!
B. If it could, would it be able to do so as practical matter and, if so, how?
NO
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?
NO
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When they are sold to the population that is not legally entitled to purchase it. Who is going to enforce this? The clerk at the pharmacy that checks out the person buying the product? Will only the pharmacist be allowed to sell the product? Will they have to require a picture ID? Will they be allowed to sell it to men?
GENERAL
GENERAL
There are to many places where this product can be misused, and there is no agency or person to hold responsible if it is not purchased or used inappropriately. What is to prevent a pregnant girl to use it other than directed? At least with a physician prescribing it, there is some simblance of assessment for appropriate use and the posibility of some education as to its affects and side affects. There is WAY to much probability of misuse of this product as an Over The Counter item.