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 : EC758
Submitter : Ms. Anna Schmidt, RN Date & Time: 10/13/2005 08:10:17
Organization : Ms. Anna Schmidt, RN
Category : Health Professional
Issue Areas/Comments
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?
see comments below
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, a minor child could easily acquire the drug from an older sibling, friend, or adult who may not necessarily have the child's best interest in mind. Any drug that has potentially serious side effects should not be readily available to minors.