|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 :||EC589|
|Submitter :||Miss. Peggy Napier||Date & Time:||10/12/2005 06:10:54|
|Organization :||Miss. Peggy Napier|
|Category :||Individual Consumer|
| 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?|
| Dear Sirs;
I strongly urge the FDA to do its job in protecting the public from unsafe over the counter medications. Releasing the morning after pill for over the counter purchase would be a disaster. There would be absolutely no way to ensure that it was not distributed to minors and or abused. Don't you think we have enough problems already with over the counter drugs being abused? As an example, lets take the drugs which contain ephedrine which are used to make crystal meth. Additionally, it is a parents right to decide what drugs their children are administered. If the over the counter sale of this drug is permitted, parental authority will once again be undermined with their teenagers and even younger children.