Sunday, August 10, 2014

Violations 101: The Troubling Illegal World of the Compounding Pharmacy Industry

August 10, 2014
Sue Richmond

The list will probably grow with time.  It is a list that I came up with after having done the blog since 2011 and all the information I have learned from my research, mostly from information found on the Internet in plain view for everyone to find.  In some cases compounding pharmacists have boldly made incriminating statements whether knowingly or unknowingly.  These are the illegal areas that I have seen the compounding pharmacists, pharmacies, doctors and veterinarians involved in.  Many overlap. For example Medicaid Fraud often includes kickbacks.  I have made it very generic rather than specific as to each state and federal law.  Again there are good compounders; not all are violating the laws. But it clear that prosecutors and attorney have a wide range of tools available to them. 

Human Doping with Illegal Hormones and Peptides
Animal Doping with Illegal Substances
Making Commercially Available drugs in Human and Animal Compounds for "convenience" and claiming medically necessary
Health Care Fraud--
Medicaid and Medicare Fraud
Worker's Compensation Fraud
Private Insurance Fraud
"Partnering" formally and informally with clinics and doctors and drug device companies in violations of kickback laws and fraudulent or illegal billing
Making totally "new drugs" through compounding and avoiding laws in the U.S. required for health and safety (manufacturing, not registering as an outsourcing facility, prescription may appear to be patient specific but it is the same formula prepared for multiple people across the U.S.--doctor/pharmacy may have what appears to be legitimate documentation but in truth it is a business reason for prescription and not a valid, specific medical reason for that specific person or animal)
Failing to comply with regulations and laws in place to protect the safety and health of the public such as not doing proper test, using the same chain for the powders, formulas, training, testing which creates a greater risk for errors, manipulation, and conflicts of interest
Tax Law Violations
OSHA Violations
Environmental Violations
Misbranding
Adulterated Drugs
Kickbacks/False Claims Act
False Advertising
Negligence to Murder (depending on scienter or state of mind required to injury or kill or injure a person)/Possibly even assault/battery under some definitions as has been used against doctors in some jurisdictions
Health Care Conspiracy
Controlled Substance Law Violations

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