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 : EC586
Submitter : Mr. Gregory Doran Date & Time: 10/12/2005 06:10:08
Organization : Mr. Gregory Doran
Category : Individual Consumer
Issue Areas/Comments
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
No. You would NOT be able to inforce or prevent the illegal usage until the persons are injured by its usage. Let alone even for a 17 year old consumer may not be sufficiently informed of the risks of the drug. The greater fear is anyone using the drug without sufficient knowledge of the risks of the drug including the psychological predisposition (desperation) and postdisposition (negative side affects). Requiring a prescription will require the patient to confront their physician for advice and allow the physiscian to properly educate the patient on its safe usage if it is safe for that patient.