Wednesday, July 11, 2012

Compounding controversy Are renegades ruining the industry for legitimate compounders?

Although this article by Denise Steffanus appeared in 2008 in the Throughbreed Times Magazine, it is still relevant today:

Compounding controversy
Are renegades ruining the industry for legitimate compounders?

COMPOUNDED drugs benefit veterinary medicine when they are formulated properly and used for
appropriate medical purposes. No one involved on either side of the ongoing controversy over compounding denies their importance in a veterinarian’s armamentarium. The
legality of their manufacture and distribution, and how carefully and ethically they are produced, are the issues. The biggest issue is piracy—producing a knockoff of a commercially available, United States Food and Drug Administration-approved product. Because they are produced
illegally, these products have no quality control or safety testing, and in many instances, the raw materials needed to make them are proprietary to the drug manufacturer that developed the FDA-approved product. So renegade compounders must substitute whatever material they can
find, wherever in the world they can get it, to make these knockoffs, which
often do not work or can be outright dangerous.
Knockoffs are cheaper for the consumer to buy than medications produced by drug manufacturers, which must factor in the cost of research, development, and quality manufacturing processes to recoup their investments so they can continue to manufacture the drugs. Renegade compounders, who do not have to shoulder these costs, can garner a huge profit from these knockoffs while still undercutting the price for the commercially available product. 
The simplest way to determine if a compounding pharmacy is operating within ethical and scientific boundaries is to ask the pharmacist to compound a knockoff, such as counterfeit GastroGard ulcer medication.

To read the remainder of the article, click here.  Note the case mentioned at the end of the article has already been decided and a link to it is on the left side.

The article also contains these useful tips for selecting a compounder:

VETERINARIANS are urged to use the following criteria when selecting a compounding pharmacy:
• Ask the pharmacy if it will make you a knockoff of a commercially
available, United States Food and Drug Administration-approved medication. If so, do not use that pharmacy;
• Know the pharmacist and his or her background in pharmacy and in the veterinary industry;
• Choose a pharmacy that has a reputation for quality and that has been active in the veterinary industry long enough to be time-tested;
• Talk to other veterinarians who have established such relationships;
• If possible, visit the pharmacy and establish a one-on-one relationship with the pharmacist and support personnel.—Denise Steffanus

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