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Date: | Sat, 19 May 2007 01:46:48 +0000 |
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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
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