|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 :||EC639|
|Submitter :||Mrs. Bonnie Sager||Date & Time:||10/12/2005 06:10:25|
|Organization :||Mrs. Bonnie Sager|
|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. The product should not be sold over the counter. period.
Much less by prescription.
| 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?|
| A product with an active ingredient such as Plan B, is unsafe
whether for under or over 16 year olds. This is not a good,
safe, and humane product.
|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 think it would be impossible.|
|B. If it could, would it be able to do so as practical matter and, if so, how?|
| This would necessitate time-consuming checking of identification,
etc. and lengthier waits for customers. Moreover, identity is
not that difficult to counterfeit.