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 : EC1946
Submitter : Mrs. Ventura Quijas Date & Time: 10/31/2005 04:10:46
Organization : Mrs. Ventura Quijas
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, it seems illogical to market an active ingredient simultaneously in both a prescription drug product and an OTC drug product. Either the drug is safe and should be sold OTC and not as a prescription drug or it is not safe without professional oversight and should only be sold as a prescription drug. After all, isn't it safety that is at issue here?