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]