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 : EC587
Submitter : Ms. Christine Buonopane Date & Time: 10/12/2005 06:10:30
Organization : Ms. Christine Buonopane
Category : Individual Consumer
Issue Areas/Comments
Plan B should not become available over the counter. This would pave the way for under age or otherwise misinformed individuals to use the drug, to possibly ignore the prescription instructions and also could lead to misuse such as purchasing then reselling to individuals at an inflated price. This drug could also be used to convince an otherwise unwilling participant to engage in sexual behavior.