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 : EC1773
Submitter : Mr. Mark Shemanski Date & Time: 10/31/2005 03:10:23
Organization : Mr. Mark Shemanski
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?
Plain and simple it should be made easily available as an OTC, so women don't have to run up against a pharmacist who "doesn't believe" and wont' fill their prescription.