The Controlled Substances Act

In the United States, the federal Controlled Substances Act (CSA) controls substances that are psychoactive or otherwise have abuse potential. The CSA controls all stages of the manufacturing and supply chain, and all handlers (including “ultimate users,” such as patients). The extent or stringency of these controls is largely determined by a substance's classification in one of five schedules for controlled substances. Classification depends on a substance's medical effectiveness and abuse potential (21 USC 812). The general rule is that a substance and products derived from that substance are in the same schedule.

The criteria for substances in Schedule I are no currently accepted medical use in the United States, high potential for abuse, and lack of accepted safety for use of the drug or other substance under medical supervision. These substances include marijuana and its cannabinoid components, THCs, ibogaine, mescaline, psilocybin, peyote, heroin, and d-Lysergic acid diethylamide (LSD).

The criteria for substances in Schedule II are currently accepted medical use in the United States, high potential for abuse, and abuse of the drug or other substances that may lead to severe psychological or physical dependence. Schedule II substances include most opioids (e.g., oxycodone) and stimulants (e.g., methylphenidate). Opium and coca leaves also are listed in Schedule II because approved medications (e.g., morphine) were already on the market in 1970, when the CSA was enacted.

Like drugs in Schedule II, drugs in Schedules III–V have a currently accepted medical use in the United States. In addition, they have lower abuse potential when compared with drugs in the preceding schedule. The phrase “currently accepted medical use in the United States” is not defined in the CSA or in its implementing regulations. However, the Drug Enforcement Agency (DEA) has developed the following five criteria, all of which must be satisfied: (1) the drug's chemistry must be known and reproducible, (2) there must be adequate safety studies, (3) there must be adequate and well-controlled studies proving efficacy, (4) the drug must be accepted by qualified experts, and (5) the scientific evidence must be widely available.

These criteria have been upheld by federal courts (Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C.Cir. 1994)). In addition, FDA approval of a product is sufficient to establish its “currently accepted medical use.” By contrast, state laws authorizing the use of cannabis for medical purposes and the prevalence of anecdotal reports do not satisfy this statutory standard. [DOJ, DEA, Denial of Petition To Initiate Proceedings To Reschedule Marijuana, 21 C.F.R. 40552 at p. 40567 (July 8, 2011)].

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