Compounding pharmacies in the eye of investigative storm

A blue door with two small holes in it.In the last year or so there have been a number of stories in the media about investigations into wrongdoing by compounding pharmacies, marketing companies and physicians.

At last count there were nearly 100 federal investigations underway for what the feds believe are questionable financial relationships involving these three entities.

In some instances, physicians are being enticed to write prescriptions for compounded medications in exchange for a share of the profits. In other instances, doctors are being solicited by marketing companies to enroll their patients in pain cream studies in exchange for remuneration.

Enforcement agencies allege that telemarketers promote these medications and market them directly to patients, using physicians or nurse practitioners to essentially rubber stamp needed prescriptions in exchange for payment.

And, the stakes are high since many of these compounded medications come with big price tags – some in the thousands of dollars per prescription. Another reason such arrangements raise red flags for investigators.

Although there are legitimate arrangements being forged between physicians and pharmacies with advice from legal counsel, some of these relationships are relatively new territory. Physicians, pharmacy owners and pharmacists are at risk of federal and state criminal and licensure prosecutions. Awareness of the laws regulating these relationships and taking steps to ensure you are not in violation is imperative.

The federal Anti-kickback statute prohibits individuals or entities from offering or paying, or from soliciting or receiving, remuneration to induce prescriptions reimbursed by federal healthcare programs (i.e. Tricare, Medicare, Medicaid).

Many states, including Florida, also have antifraud and abuse and anti-referral laws (i.e. the Florida Patient Self Referral Act and the Florida Anti-kickback Statute) and many medical and pharmacy boards have their own regulations relating to referral practices.

There is no doubt that compounding pharmacies provide a vital service to patients by making medications they otherwise might not be able to obtain. However, heightened scrutiny of these compounded medications by federal and state regulatory agencies into the financial arrangements being made to prescribe compounded medications have resulted in a growing number of providers and pharmacies being caught up in fraud and abuse investigations.

It is imperative for anyone – compounding pharmacy, physician or marketer – who is contacted by an investigator to seek immediate legal counsel.

The Health Law Offices of Anthony C. Vitale has been representing clients under investigation for 25 years. The firm conducts confidential defense investigations and will take you through the process in an effort to reduce or eliminate criminal, civil, licensure and administrative liability.

We can be reached at 305 358-4500 or email us at

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The Health Law Offices of Anthony C. Vitale