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 : EC706
Submitter : Mr. Abraham Weaver Date & Time: 10/12/2005 06:10:03
Organization : Mr. Abraham Weaver
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Making a product "over the counter" to one population and prescription to another may create a serious problem with regard to control of the substance. Much like many minor have ready access to tobacco products through older friends, etc., an OTC product of this sort would be very easy to procure.