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FDA Releases New Guidance for Compounding Animal Drugs from Bulk Drug Substances

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June 24, 2015

Animal Compounders Fear the End is Near & Begin to Fight Their Losing Battle

A few weeks ago the FDA released their latest guidance, #230 Guidance for Industry Compounding Animal Drugs from Bulk Drug Substances and animal compounders are very concerned at what this means for their futures. All guidances reflect the current thinking of the FDA, even though they are not “law” they are implemented as such because if you do not adhere you can be cited or worse. But why are they so concerned? Aren’t these guidances meant to put stricter rules in place to protect patient safety? Most think so, not all.

Any facility that is not a 503B should be very concerned. We’ve read the guidance, many times in fact, but we are not rushing out a newsletter to ask vets to put a stop to this madness. In fact this guidance points to everything that 503B facilities have been saying since the FDCA was passed.

Some large vet compounders would have you believe that “The proposed guidance also would eliminate office use of compounded medications that you do not compound yourself, in strict compliance with the same standards required of the professional compounding pharmacies from which the vast majority of veterinarians obtain compounded medications. (86% of veterinary practices compound “never, rarely or occasionally.”)” This is only true for facilities that are not registered and inspected by the FDA. All 503B facilities will continue to be allowed to do office use in those states which allow it and in which they are licensed to do so.

Let the fearmongering begin. The FDA isn’t trying to prevent veterinarians from being able to treat their patients, in fact all they wish to do is hold animal drug compounders to the same standards that they hold compounders of human drugs, and why not? Wouldn’t you want that, another level of quality assurance and confidence in the drugs that we use to treat man’s best friend?

Again, a large vet compounder’s CEO says, “The proposed FDA Guidance is brief but represents a full-frontal attack on the practice of veterinary medicine. Thank you in advance for doing your part to defeat this misguided and dangerous attempt by FDA to interfere with your medical judgment, your ability to access compounded medications for office use, your practice and your patients’ health.” We hear, “..please help us save our business, we don’t want to be subject to FDA inspections, we like things the way they are, leave us alone.”

First they came for the Manufacturers, and I did not speak out—
Because I was not a Manufacturer.
Then they came for the Compounders of Human Drugs, and I did not speak out—
Because I was not a Compounder of Human Drugs.
Then they came for me—and there was no one left to speak for me.

Subjecting yourself to stricter regulations and cGMP are things that can only make things better for all parties involved. Instead of fearing the worst, try and see how this may improve the quality of the medications you will receive doing business with registered and inspected FDA 503B outsourcing facilities, such as your partner, KRS Global Biotechnology where “Quality is Our Promise.”

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