Methadone's Regulatory Thicket

35 Pages Posted: 12 Sep 2022

See all articles by Laura Stanley

Laura Stanley

George Washington University - GW Regulatory Studies Center

Bridget C.E. Dooling

The Ohio State University

Date Written: August 13, 2022


Methadone is an effective treatment for opioid use disorder, which makes it a key tool to address the opioid crisis. Paradoxically, regulations—particularly at the federal level, which is the focus of this Article—greatly limit access to methadone when it is used to treat opioid use disorder. As policymakers consider how to support treatment, it is important to understand which changes regulators can make on their own and which changes would require an act of Congress.

This Article analyzes four sets of regulations that are barriers to treatment for opioid use disorder with methadone. First, patient care regulations limit who may provide treatment, who may receive it, how much methadone patients may take home, and more. Second, the prohibition on prescribing methadone—as opposed to dispensing it directly—requires patients to travel to their opioid treatment program, rather than a pharmacy, to collect their medicine. Third, methadone’s categorization as a Schedule II controlled substance limits it further. Fourth, entry barriers and operating costs depress the supply of treatment providers.

Working through each group or regulations, this Article finds that in almost every instance, federal regulators have clear statutory authority to amend or remove these barriers. It also explains how agencies can make changes. This includes determining which changes to make, a complex policy decision. This Article clarifies that federal agencies have discretion to lower barriers and improve access to methadone treatment for opioid use disorder. How will they use it?

Suggested Citation

Stanley, Laura and Dooling, Bridget C.E., Methadone's Regulatory Thicket (August 13, 2022). Annals of Health Law, Vol. 32, No. 1, (Forthcoming 2023), Available at SSRN: or

Laura Stanley

George Washington University - GW Regulatory Studies Center ( email )

Bridget C.E. Dooling (Contact Author)

The Ohio State University ( email )

Columbus, OH
United States

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