“Prescription” v. “Recommendation”: How State Medical Marijuana Laws May Insulate Treating Physicians From Liability Under The Controlled Substances Act
As of today, twenty states and the District of Columbia have legalized marijuana for medicinal purposes. (A complete list of the states which have legalized marijuana use, including summaries of each state’s use laws can be found here.) While the nationwide debate has focused on how the patchwork of laws in the United States treats patient use and commercial dispensaries, physicians must also assess their potential liabilities when recommending or prescribing marijuana for their patients.
As we have previously reported, despite changing state legislation, federal law still lists marijuana as a Schedule I controlled substance under the Controlled Substances Act (“CSA”); 21 U.S.C § 801 et seq. Schedule I controlled substances are subject to the most strict regulation under the CSA because the federal government has determined that these substances have a “high potential for abuse,” “no currently accepted medical use in treatment in the United States, “ and a “lack of accepted safety” for “use under medical supervision.” See 21 U.S.C. § 812(b)(1). The CSA prohibits physicians from prescribing Schedule I drugs. Under the CSA, Schedule I drugs may only be dispensed in the United States through strictly-controlled, federally-approved research programs.
In order to prescribe a controlled substance, a physician must first register with the Attorney General of the United States. However, the CSA also confers authority on the Attorney General to revoke a physician’s registration for a variety of reasons, including if the physician “has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest. . . .” See 21 U.S.C. § 824(a)(4). In determining whether a physician has acted “inconsistent with the public interest,” the Attorney General may consider a physician’s “compliance with applicable State, Federal, or local laws relating to controlled substances.” See 21 U.S.C. § 823(f). Thus, because marijuana is a Schedule I substance that the CSA makes unlawful to possess, use, or distribute, a physician prescribing medicinal marijuana pursuant to State law could subject himself to federal criminal penalties and revocation of his registration to dispense controlled substances. However, as explained below, physician liability under federal law may turn on whether doctors can be properly classified as “prescribing” marijuana for patient use.
Pursuant to the CSA and its implementing regulations, a “prescription” is defined as “an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user.” See 21 C.F.R. § 1300.01. However, many states with medicinal marijuana laws, including California, Massachusetts, Michigan, Maine, Colorado, and Illinois do not authorize their physicians to “prescribe” marijuana as that term is defined under state law or the CSA. Instead, these states provide that a patient’s treating physician “recommend” or “certify” that the patient qualifies for participation in the state’s medicinal marijuana program. In addition, these recommendations or certifications are not designed to allow patients to directly obtain marijuana. Instead, patients gain access to medicinal marijuana solely through registration with the state and purchase the product through state licensed dispensaries. Put simply, the physician’s role is limited to evaluating whether, in the physician’s medical opinion, a patient qualifies for participating in the state sanctioned marijuana program.
In Conant v. Walters, 309 F.3d 629 (9th Cir. 2002), a case analyzing California’s Compassionate Use Act, the Ninth Circuit found that the recommendation of marijuana use by a treating physician to a patient cannot serve as the sole basis for revoking or suspending the physician’s registration to dispense controlled substances under the CSA. In Conant, the Ninth Circuit made clear that a doctor’s recommendation that a patient use a controlled substance is not the same as a prescription for a controlled substance, and without more, would fall outside of the scope of aiding and abetting or conspiracy to commit a violation of the CSA.
As explained in greater detail in the decision, a doctor’s recommendation of marijuana could lead to several lawful and legitimate responses, including lawful use of medicinal marijuana through a federally-approved experimental therapy program or travel to a country where marijuana is legally dispensed. Moreover, the Ninth Circuit found that the mere possibility that illegal conduct could occur was too attenuated to justify a restriction on the free speech rights of doctors and patients. Thus, the Ninth Circuit found that the First Amendment prohibited the government policy which threatened to punish physicians for recommending to a patient the medical use of marijuana on the ground that the recommendation might encourage illegal conduct by the patient. Therefore, at least as it stands in the Ninth Circuit, recommendation alone cannot serve as a basis for liability under the CSA. As medicinal marijuana statutes proliferate in states outside of the Ninth Circuit, it remains to be seen whether other Circuits will adopt the Ninth Circuit’s interpretation.
Fuerst Ittleman David & Joseph, PL will continue to watch for the latest developments in the regulation of the marijuana industry. The attorneys at Fuerst Ittleman David & Joseph, PL have extensive experience in the areas of administrative law, anti-money laundering, food & drug law, tax law and litigation, constitutional law, regulatory compliance, white collar criminal defense and litigating against the U.S. Department of Justice. If you are a physician or marijuana-related business, or if you seek further information regarding the steps which your business must take to become or remain compliant, you can reach an attorney by emailing us at firstname.lastname@example.org or by calling us at 305.350.5690.