March 2007 The FDA has been increasing oversight of compounding pharmacists and is sending out warning letters to pharmacists about their practicing habits when the agency feels it is appropriate. The International Academy of Compounding Pharmacists, in its Winter 2007 newsletter, offered nine ways to minimize the chance that the FDA will take law enforcement action against a pharmacy, including ensuring that the preparations compounded are significantly different than commercially available drug products; refraining from giving unsolicited samples to a physician; avoiding supplying physicians with compounded medications that are being resold to patients outside the physician's office; and compounding products using active ingredients that are components of FDA-approved medications or that have USP monographs. The Academy mentions that filling prescriptions such as domperidone or polidoconol (FJN note: topical preparation to treat varicose veins) greatly increases the risk of FDA enforcement action. There you have it. Domperidone, according to the FDA, is right up there being abused by compounding pharmacists just like a schlerosing product for varicose veins. Why the FDA once again is targeting domperidone is beyond me. I do know that actions at the FDA can be greatly driven by just one Consumer Safety Officer, who can wield a lot of power. The FDA just doesn't seem to get it that the Supreme Court just afforded compounding pharmacists protection from the FDA in most compounding matters. I do not know how much compounding pharmacists have been intimidated by this. Frank J. Nice, Pharmacist, DPA, CPHP _________________________________________________________________ More photos, more messages, more storage—get 2GB with Windows Live Hotmail. http://imagine-windowslive.com/hotmail/?locale=en-us&ocid=TXT_TAGHM_migration_HM_mini_2G_0507 *********************************************** Archives: http://community.lsoft.com/archives/LACTNET.html Mail all commands to [log in to unmask] To temporarily stop your subscription: set lactnet nomail To start it again: set lactnet mail (or [log in to unmask]) To unsubscribe: unsubscribe lactnet or ([log in to unmask]) To reach list owners: [log in to unmask]