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 : EC888
Submitter : Mrs. Barbara Rine Date & Time: 10/17/2005 11:10:14
Organization : Mrs. Barbara Rine
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 leave well enough alone. Things are complicated enough, if a drug needs to have a prescription, it needs a prescription. If a drug does not need a prescription, it does not need a prescription.