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 : EC718
Submitter : Mr. Michael Kreis Date & Time: 10/12/2005 06:10:36
Organization : Mr. Michael Kreis
Category : Health Professional
Issue Areas/Comments
as a Physician Assistant, I do not understand the logic of thios. The liabilities alone could be staggering. And all for a misled social agenda. I hope that the FDA thinks and uses common sense or the consequences could be tragic. Please don't allow this "medication" to be sold over the counter....M. Kreis, PA-C