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 : EC2198
Submitter : Mr. James Cunningham Date & Time: 10/31/2005 06:10:05
Organization : Mr. James Cunningham
Category : Individual Consumer
Issue Areas/Comments
1
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?
You have not given me enough information to effectively and intelligently answer this question. The "detailed description"is not very detailed.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
No. There should always be different packaging for OTC products vs prescription-only products.
GENERAL
GENERAL
There is no excuse for not making emergency contraception available as an OTC product. My daughter was raped last year and could have benefitted from the peace of mind such a product could have provided.