In May, the US Department of Justice published proposed rules in the US Federal Register to reschedule marijuana from Schedule I to Schedule III, pursuant to the Controlled Substances Act.1,2 The move initiated a 62-day public comment period, which is required in the formal federal rulemaking process and marks the first time since 1970 that material changes are potentially taking place in national marijuana legislation.2
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The DEA will be accepting public comments until July 22, 2024.1 The notice for public comment does not propose a firm deadline for when the DEA is expected to review the comments before a final rule.
In October 2022, the Biden administration issued an executive order that had the effect of directing agencies to “expeditiously review” the possibility of reclassifying marijuana, which started the new initiative.3
About the Author
Ned Milenkovich, PharmD, JD, is chair of the health care law practice at Much Shelist, P.C., and is the former vice chairman of the Illinois State Board of Pharmacy.
In August 2023, after reviewing information including data from states with legal cannabis programs, the Department of Health and Human Services (HHS) concluded that marijuana has a “currently accepted use” and recommended reclassifying it as a Schedule III drug. HHS considered 8 factors, including the drug’s actual or relative potential for abuse; scientific evidence of its pharmacological effect; current scientific knowledge about the drug; marijuana’s history and current pattern of abuse; the scope, duration, and significance of abuse; potential risk to public health; potential addiction; and whether cannabis is an immediate precursor of a substance that is already controlled.4
Whereas Schedule I drugs are illegal with no accepted medical indication, Schedule III drugs do have medical uses and include anabolic steroids, ketamine, and testosterone, which are legally available and obtained through a valid prescription.5
Over half of the states have regulated marijuana with 24 states and Washington, DC, making marijuana legal for recreation and another 14 making it legal for medical use.6 Nevertheless, there is ongoing speculation that the DEA continues to resist rescheduling.7
The DEA stated that if marijuana is reclassified to Schedule III, the regulatory controls for Schedule III substances, marijuana-specific requirements, and additional controls to meet US treaty obligations would apply. The DEA added that the manufacture, distribution, dispensing, and possession of marijuana would still be subject to the criminal prohibitions of the Controlled Substances Act. Drugs containing substances defined as “marijuana” under the Controlled Substances Act would also remain subject to prohibitions in the Federal Food, Drug, and Cosmetic Act.1
Schedule III drugs are still controlled substances and subject to laws and regulations, and individuals who traffic them illegally could still face federal criminal prosecution.1 An amendment to the Controlled Substances Act would be required for marijuana to be completely descheduled, and there are currently no moves to do this.
Critics note that if marijuana is rescheduled, US cannabis dispensaries would be required to register with the DEA like regular pharmacies and fulfill strict reporting and recordkeeping requirements, that the DEA probably doesn’t have the bandwidth to manage. However, the cannabis industry would not be subject to Internal Revenue Service Code Section 280E, which prevents marijuana businesses from taking certain deductions on their federal tax returns.8
[[{“value”:”Pharmacists could play a major role in answering patient questions and
providing counseling about cannabis”}]] Read More
