More on FDA Drug Compounding Oversight Bill--Do Not Compound List

By Edward Lamb, About.com GuideNovember 7, 2012

Commenting yesterday on the proposed Verifying Authority and Legality in Drug (VALID) Compounding Act, I neglected to mention one of the bill's major provisions.

I apologize for this oversight in describing possible changes to pharmacy compounding oversight. My only real explanation for doing so is that I can hardly believe the draft of the VALID Compounding Act calls on the U.S. Food and Drug Administration to "create and maintain a 'Do Not Compound' list of drugs that are not safe or effective when compounded and make the list available to the public and state regulators."

The problem with requiring such a thing is that the list already exists in the form of Schedule I maintained by the U.S. Drug Administration under the Controlled Substances Act.

Here's what I mean:

• Drug compounding is literally the making of medication doses.
• Any medication dose that would be unsafe to make by compounding would, therefore, be unsafe to make in any manner.
• A drug would be defined as unsafe almost exclusively on the grounds that it causes harm to users without producing health benefits.
• Schedule I controlled substances are, by law (though not consensus), drugs and other chemicals determined to cause harm without producing recognized health benefits.
• Pharmaceutical manufacturers are already barred by law from making products containing Schedule I drugs, as are compounding pharmacists or pharmacy technicians.

I normally temper my criticisms in these blog posts for fear of overstating my case. But I can see no need for, nor logic in, asking the FDA to draw up and publicize a Do Not Compound list. The contents of any such list are already widely available to anyone with knowledge of, and commitment to, making safe medications on industrial or individual scales.

Can you see any purpose in a Do Not Compound list?


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