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 : EC851
Submitter : Ms. Lynne Garcia Date & Time: 10/13/2005 10:10:43
Organization : Ms. Lynne Garcia
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! This drug is not suited to casual, over the counter use.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, there is confusion of the Act in general. Your questions are confusing as well. The public is ignorant of these issues because the terms you employ do not engage public debate. Simplify and you will that the public is concerned with the issue.
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, if a presecription is required, the pharmacist would be forced to follow the letter of the law.