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 : EC260
Submitter : Dr. Laura Roller Date & Time: 09/20/2005 02:09:59
Organization : University of Utah
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
1.
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?
Possibly
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?
If the medication is kept behind the counter of the pharmacy. This also allows for important interventions & counseling by the pharmacist. Most pharmacists won't impose their personal beliefs on the patients.
B. If it could, would it be able to do so as practical matter and, if so, how?
You put pseudoephedrine behind the counter. The pharmacist checks an ID & counsels the patients.
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?
New concept, but if it's behind the counter, the pharmacist can distinguish when it needs a prescription (i.e. patient does not meet OTC criteria) or not.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If the product is NOT kept behind the pharmacy counter, not sure what use the prescription has.
GENERAL
GENERAL
Perspective as a doctor of pharmacy. Thank you.