|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 :||EC1635|
|Submitter :||Mrs. Joy Eller||Date & Time:||10/31/2005 01:10:08|
|Organization :||Mrs. Joy Eller|
|Category :||Health Professional|
| 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?|
Please note that OTC has been proven safe time and again in other countries, and I see no good reason to continue to deny women acces to it over the counter and without a prescription in the United States. Politics should not unduly play with human life but be of a help toward better living for all. Please clear the way today.