Schedules 1 and 2 of the Federal list of controlled substances are reserved for drugs with “a high potential for abuse” — LSD, MDMA, heroin, marijuana/THC, cocaine, amphetamine, etc. Failure to comply with regulatory controls over these substances is a Federal offense. What is less well understood is that the same regulatory controls and/or penalties can extend to unscheduled/unlisted substances that are later determined to be “substantially similar” in chemical structure and/or pharmacological effects to Schedule 1 or 2 drugs. One of the major current challenges at the interface of chemistry and law is how to interpret the Controlled Substance Analogue Enforcement Act, and more particularly how to determine if one substance is “substantially similar” to another substance in terms of its chemical structure and/or its pharmacological effects. No definition or standard is provided for “substantially similar” in the Federal statutes or scientific literature. This presentation will include observations compiled from dozens on Federal Analogue cases, including the US Supreme Court case of McFadden v. United States, and a conceptual construct and personal opinion on what “substantially similar” should mean in the context of Federal regulatory controls governing the boundary between legal and illegal drug discovery.

What is substantially similar? Interpreting federal law governing unscheduled drug-like chemicals that are substantially similar to listed controlled substances

253rd National Meeting (2017)

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