Government Prosecutions of Compounded Drugs Schemes
In the past several years, the federal government has focused investigative and enforcement resources on pharmacies that compound drugs, and the marketers, doctors and pharmacists involved. Criminal and civil actions have been brought for violations based on statutes prohibiting kickbacks, fraud and false claims. A compounded drug is one that is supposed to be tailored to a particular patient’s needs. These compounds are legitimately prescribed and used by very young or older patients that have difficulty swallowing pills, patients that cannot tolerate dyes used in pills or patients with certain allergies. Most are topical creams for pain or scars, or specialized vitamins. While these compounded drugs are not approved by the Food and Drug Administration (FDA), they are subject to regulation and enforcement actions by a variety of state and federal agencies.