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 : EC1082
Submitter : Ms. Jennifer Sloan Date & Time: 10/27/2005 10:10:50
Organization : Ms. Jennifer Sloan
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Certain OTC drugs must be sold by a pharmacist and are only available to individuals over a certain age (e.g., psuedoephedrine products, nicotine products, etc.). Why not use this same method for distributing EC without a prescription to women over 16 years of age?