So shouldn't the FDA and state boards of pharmacy being looking at all compounding pharmacies' tax returns and financial records? Are is that going to the extreme? Should we simply look to the volume produced and sold for deteriming who is high risk and needs to be immediately inspected and closely watched. What if the company is simply mass producing but doing it in volumes of 10-12 injectibles at a time so as to try to go unnoticed? However, that mom and pop pharmacies actually produces more preparations and makes more money than NECC did? What about the mom and pop compound pharmacy who does everything right, buys the right powders, test, etc, and has to charge a higher price for the same product to make a profit even though it is a smaller profit that another company? So do we look at gross profit or net profit, or both? How does the FDA and the state boards of pharmacy catch those high risk compounders that might not otherwise be on the radar?
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
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3 comments:
The state boards of pharmacy are not Elliot Ness and "The Untouchables". They're not going to get access to IRS tax returns, much less know what to do with the information if they did get it.
How do you find these "rogue compounding pharamcies"? Easy. Go to conferences such as A4M (anti-aging medicine), AMMG (anti-aging medicine), ACAM (alternative medicine), ASBP (weight loss), (and whatever veterinary medicine conferences there are) - where these pharmacies hold exhibit booths and offer kickbacks to physicians (and veterinarians) to prescribe their compounded drugs and/or dispense them in their offices.
If a compounding pharmacy is big enough to go to a national conference to hold an exhibit booth, then odds are, it's big enough to be doing manufacturing.
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Kenneth Woliner, MD
www.holisticfamilymed.com
Very good point about the national conferences.
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