|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 :||EC716|
|Submitter :||Mr. Joseph R Hager||Date & Time:||10/12/2005 06:10:09|
|Category :||Individual Consumer|
| 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?|
| NO! 1. There is no way to control the dispensing that "medicine" if packaged the same.
2. As a parent, I object to a "birth control" drug being made available as an over the counter drug for my daughter under the age of 18 because I am still responsible for her health and safety, and her development, and a birth control drug available to her over the counter would usurp my parental authority.
3. Allowing an active medicinal ingredient simultaneously marketed in both a prescription drug and an OTC drug product would leave the use of the drug open to misuse/abuse.
| A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?|
|No! See above answer.|
|B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?|
|Not able to make a knowledgeable response.|
|C. If so, would a rulemaking on this issue help dispet that confusion?|
| 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?|
| I say that the pharmicist/pharmacy/store is in danger of being prosecuted because they unintentionally/inadvertantly sell an OTC drug to some one who was authorized the drug only by prescription.|
|B. If it could, would it be able to do so as practical matter and, if so, how?|
| 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?|
|Are you asking a legal question of non-legally trained people?|
|B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?|
|Without a parent's approval.|