The Department of Justice (DOJ) May 16 released its long-anticipated notice of proposed rulemaking (NPRM) that would transfer marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA).

The NPRM was published in the Federal Register May 21 (89 Fed. Reg. 44597).

The release of the NPRM was the latest step in a process initiated in October 2022, when President Biden asked the DOJ and the Department of Health and Human Services (HHS) to initiate a scientific review of the scheduling of marijuana under the CSA.

In announcing his request, Biden noted that Schedule I is “the classification meant for the most dangerous substances.”

“This is the same schedule as for heroin and LSD, and even higher than the classification of fentanyl and methamphetamine — the drugs that are driving our overdose epidemic,” Biden noted.

In August 2023, HHS recommended that marijuana be controlled in Schedule III, based on findings corresponding to the criteria for placing a controlled substance in Schedule III (21 U.S.C. §812(b)(3)).

The DEA has not yet made a determination as to its views of the appropriate schedule for marijuana, the DOJ noted in the preamble to the NPRM. “DEA believes that additional information arising from this rulemaking will further inform the findings regarding the appropriate schedule for marijuana,” the department said in the preamble.

Eight-Factor Analysis

The NPRM includes a detailed recounting of HHS’s scientific and medical determinations with respect to the eight factors that HHS and the DOJ must consider when recommending or determining whether a drug should be controlled and, if so, under what schedule (21 U.S.C. §811(c)):

• the drug’s actual or relative potential for abuse;
• scientific evidence of the drug’s pharmacological effect, if known;
• the state of current scientific knowledge regarding the drug or other substance;
• its history and current pattern of abuse;
• the scope, duration and significance of the abuse;
• what, if any, risk there is to the public health;
• the drug’s psychic or physiological dependence liability; and
• whether the substance is an immediate precursor to a substance already controlled.

Reclassification Standards

Marijuana has been a Schedule I controlled substance ever since the CSA was enacted in 1970.

The DEA and HHS last considered the issue of whether to reschedule marijuana in 2016. At the time, HHS said that marijuana should remain in Schedule I because it met the three criteria for placement there.

Under CSA, Schedule I controlled substances are those that have:

• a high potential for abuse;
• no currently accepted use in treatment in the United States (i.e., no currently accepted medical use (CAMU)); and
• a lack of accepted safety for use of the substance under medical supervision.

By contrast, under the statute, Schedule III controlled substances are drugs:

• that have a potential for abuse that is less than the abuse potential of substances in Schedule I and Schedule II;
• that have a CAMU; and
• abuse of which may lead to low or moderate physical dependence or high psychological dependence.

HHS, DOJ Determinations

The DOJ’s NPRM included HHS’s three findings regarding the appropriate schedule in which to place marijuana, which tracked the three criteria for inclusion of the substance in Schedule III:

• the substance’s abuse potential;
• whether the substance has a CAMU; and
• the safety or dependence potential of the substance.

For purposes of initiating the rulemaking proceedings, the DOJ concurred with HHS’s recommendations and concluded that:

• marijuana has a potential for abuse less than the drugs or other substances in Schedules I and II;
• there is a CAMU for marijuana; and
• the abuse of marijuana may lead to moderate or low physical dependence, depending on the frequency and degree of marijuana exposure.

‘Currently Accepted Medical Use’

Since 1992, the DEA has determined that a controlled substance has a CAMU only if (1) the FDA has approved the drug for marketing under the Federal Food, Drug, and Cosmetic Act (FD&C Act), or (2) the drug meets a five-part test that tracks the “core standards developed under the [FD&C Act]” (57 Fed. Reg. 10499).

Under the five-part test, a controlled substance has a CAMU if:

1. the drug’s chemistry is known and reproducible;
2. there are adequate safety studies;
3. there are adequate and well-controlled studies proving efficacy;
4. the drug is accepted by qualified experts; and
5. scientific evidence about the drug is widely available.

In its August 2023 recommendation, HHS concluded that, whether or not a drug was approved by the FDA or satisfied the DEA’s five-part test, a drug could have a CAMU if it satisfied a new two-part test — i.e.:

1. if licensed health care providers have “widespread current experience with medical use” of the drug “in accordance with implemented state-authorized programs, where the medical use is recognized by entities that regulate the practice of medicine”; and
2. if there is “some credible scientific support for at least one of the medical uses.”

In the preamble to the final rule, the DOJ noted that since 1996, 38 states, the District of Columbia and four U.S. territories have legalized the use of medical marijuana. Moreover, since fiscal year 2015, Congress has annually adopted an appropriations rider that prohibits the DOJ from using funds to prevent states, territories and the District of Columbia from implementing their own medical marijuana laws.

OLC Legal Memorandum

After receiving the HHS recommendation, Attorney General Merrick Garland asked for advice from the DOJ’s Office of Legal Counsel (OLC) on three important issues.

• Determining CAMU. In an April 11 memorandum, the OLC concluded that the DEA’s five-part test for determining whether a drug has a CAMU “is impermissibly narrow” and that satisfying HHS’s new two-part test “is sufficient to establish that a drug has a CAMU even if the drug has not been approved by FDA and would not satisfy DEA’s five-part test.”
• Status of HHS recommendations. The OLC also determined that the HHS CAMU recommendation was not binding on the DEA, but that the DEA must accord HHS’s scientific and medical determinations “significant deference” and that the DEA cannot undertake a de novo assessment of HHS’s findings.
• Effect of Single Convention. Under 21 U.S.C. §811(d)(1), the DEA must control a drug under the schedule that is most effective to carry out its obligations under the 1961 United Nations Single Convention on Narcotic Drugs, which covers marijuana. The OLC concluded that neither the Single Convention nor the CSA requires the DEA to place marijuana in Schedule I or Schedule II.

Criminal Prohibitions Would Remain

In the preamble to the NPRM, the DOJ said that if marijuana is transferred into Schedule III, “the manufacture, distribution, dispensing and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA” (21 U.S.C. §§841-844).

Treaty Obligations

In the NPRM, the DOJ said that as part of the rulemaking the DEA “will consider the marijuana-specific controls that would be necessary to meet U.S. obligations” under both the Single Convention and the Convention on Psychotropic Substances if marijuana is rescheduled to Schedule III.

To the extent that new regulations are needed to comply with the treaties if marijuana is rescheduled, the department added, the DEA “will seek to finalize any such regulations as soon as possible.”

Comments on the NPRM are due by July 22 and may be submitted online (Docket No. DEA-1362).