The Act is part of a federal attempt to streamline the research process for medical marijuana and provide more attainable security requirements
The medical marijuana and cannabidiol Research Expansion Act (MMCREA), enacted at the US federal level on December 2, 2022, streamlined a new and separate registration process for registered entities to facilitate research on marijuana.1
Prior to the the MMCREA, the drug development and approval process for marijuana and cannabidiol was much more complex because of their inclusions under Schedule I of the Controlled Substances Act (CSA). Schedule I substances have no accepted medical use, limited safety data, and a high potential for abuse.2
The primary focus of MMCREA is the cultivation of research-grade medical marijuana. Prior to 2022, the federal government allowed only a single entity—the National Center for Natural Products Research at the University of Mississippi—to develop research-grade medical marijuana. This can include cannabinoids, cannabis-derived compounds, or cannabis-related compounds that contain greater than 0.3% tetrahydrocannabinol (THC) based on a dry-weight basis.3
The MMCREA begins with Section 101, titled Marijuana Research Applications. Section 101 amends the CSA by redesignating various paragraphs to allow the US attorney general to register a practitioner to conduct research with marijuana (including any derivative, preparation, extract, and compound) if the research application is approved and reviewed by a federal agency that funds scientific research, the US Secretary of Health and Human Services (HHS), or the Drug Enforcement Administration (DEA), and adheres to regulations of Schedule I substances research. Researchers must also have safeguards in place to prevent diversion. The attorney general has 60 days to approve the application or request supplemental information. If supplemental information is submitted, the application must be approved or denied within 30 days. However, this amendment applies only to research applications by practitioners.1
Sections 103 and 104, titled Applications to Manufacture Marijuana for Research, and Adequate and Uninterrupted Supply, respectively, both help ensure a steady, consistent supply of research-grade marijuana. Section 103 allows the attorney general to place a notice in the Federal Register to increase registered bulk manufacturers. The attorney general is then required to review any completed manufacturer applications within the same time-line as outlined for research applications.
Furthermore, Section 202, titled Registration for the Commercial Production and Distribution of FDA-Approved Drugs, directs the attorney general to register any applicant seeking to distribute or manufacture marijuana or cannabidiol for production of an FDA-approved drug.1
Lastly, Section 104 requires the attorney general to consult with the secretary of HHS to annually assess whether there is an adequate and uninterrupted supply of marijuana for research purposes. Based on their joint determination, the attorney general will report to Congress whether the supply was deemed adequate or inadequate, the impact of supply on ongoing research, and steps that will be taken to restore supply if needed.1
Taken together, these sections allow for approved manufacturers to sell or transfer research-grade marijuana for use in clinical research trials; help guarantee that research grade marijuana is more readily available for research use; and allow approved manufacturers to distribute, dispense, or possess research-grade marijuana for commercial production or drug development research.1
Section 105 of MMCREA, titled Security Requirements, eases the requirement that marijuana or its components must be stored in a securely locked, substantially constructed cabinet with any other security measures required to safeguard against diversion of Schedule I controlled substances as described in the CSA section 202(c). This lightened requirement will allow for more clinical and research settings to maintain more realistic, but necessary, marijuana diversion safeguards.1
Even with the MMCREA, however, the complexities continue. As of April 2023, medical marijuana has become legalized in 38 states and the District of Columbia, and recreational use has been approved in 23 states and the District of Columbia.4 Regulations at the state level may or may not include product testing, packaging, and labeling requirements. Labeling specifics may include potency, health risks associated with its use, and/or the marijuana strain. Packaging requirements may include the use of tamper resistant and childproof material. Therefore, until regulations are approved at the federal level, varying regulation among states can impose risk for consumers.3
The MMCREA was the beginning of a federal attempt to streamline the research process for medicinal marijuana and cannabidiol, ensure adequate supply for research purposes, and provide more attainable security requirements. This will, in time, allow for more research to be conducted on the substances’ potential health care uses, risks, benefits, more precise dosing ranges, and interactions with other medications.1
As medical marijuana becomes a more researched pharmaceutical option, pharmacists need to be prepared to counsel patients or make recommendations regarding its use, benefits, and risks to optimize patient outcomes. Pharmacists can have a critical role in monitoring patient use, monitoring potential interactions with other medications, identifying and dispensing the appropriate dose, and ensuring appropriate potential uses.
About the Authors
Abbey F. Carr is a PharmD candidate at the College of Pharmacy at the University of Kentucky in Lexington.
Joseph L. Fink III, JD, DSC (HON), BSPHARM, FAPHA, is a professor emeritus of pharmacy law and policy and the former Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.