Weiss Zarett Brofman | Sonnenklar & Levy, P.C. | Attorneys At Law

High Quality Services And Personal Attention


On Behalf of | Apr 1, 2012 | Healthcare Law

The United States is currently experiencing an epidemic of diversion of lawful prescription drugs.  It is now recognized that prescription drugs are the most often abused drugs in the United States. Diversion takes place when otherwise lawful prescription drugs are “diverted” to persons for whom the drugs were not intended.  Diversion also takes place when a patient uses medications beyond the medical necessity for which they were prescribed; that is, the patient obtains and uses the drugs to satiate dependency or addiction. In addition, a provider who prescribes or otherwise obtains controlled substances for his/her own use is another unfortunate example of diversion.

In an effort to stem the tide of diversion, authorities– including the Drug Enforcement Administration (“DEA”) and state licensing boards–are looking at the health care provider as the enabler of diversion.  The Rx is considered the launch pad for diversion and health care providers who are licensed to prescribe are now looked upon as the gatekeepers.

It is generally recognized that physicians and other health care providers licensed to prescribe, dispense and/or administer controlled substances (collectively referred to as “practitioners”) can do so without running afoul of the law.  However, instances of these practitioners being prosecuted, basically as drug dealers, are on the rise. Ever wonder why these prosecutions occur? It is because the provider has forfeited what is known as “practitioner immunity”.  This article will explore the basis of that forfeiture and how to avoid losing this protection.

The Controlled Substances Act (“CSA”), 21 U.S.C. 801-971, and its corresponding and implementing regulations, 21 C.F.R. part 1300 et seq., mandate that the DEA prevent, detect and investigate the diversion of legally manufactured controlled substances, while at the same time ensuring that there are adequate supplies to meet the legitimate medical needs for such substances in the United States.  The controlled substances are divided into five schedules and are found at 21 C.F.R. 1308.11 through 1308.15.  The different schedules–and the placement of a drug within a particular schedule–is based on whether the controlled substance has a currently accepted medical use in treatment in the United States, as well as on the drug’s  potential for abuse and causing of dependence.

Federal and state laws prohibit the unlawful distribution of controlled substances. For example, under federal law, 21 U.S.C. 841 makes it unlawful for any person knowingly or intentionally to manufacture, distribute or dispense, or possess with intent to manufacture, distribute or dispense, a controlled substance.  In order to be able to perform their jobs and not run afoul of these types of laws, practitioners are covered by what is loosely referred to as “practitioner immunity”; that is, they are exempt from laws prohibiting the unlawful distribution of drugs when they legitimately perform their role.  This rule is longstanding, and is contained in 21 C.F.R. 1306.04(a), which states that a prescription for a controlled substance is not effective unless it is “issued for a legitimate medical purpose by an individual practitioner in the usual course of his professional practice.” The regulation also sets forth when practitioner immunity is forfeited.  The person issuing a prescription which is not issued in the usual course of professional treatment shall be subject “to the penalties provided for violations of the provisions of law related to controlled substances.”

The United States Supreme Court reinforced and elaborated on these rules in Gonzales v. Oregon, 546 U.S. 243, (2006), stating  that “the prescription r