President Biden Dec. 2 signed into law a bill intended to remove barriers that have impeded research into the potential health benefits of marijuana and cannabidiol (CBD).

The Medical Marijuana and Cannabidiol Research Expansion Act, Pub. L. No. 117-215, establishes DEA registration processes for practitioners conducting marijuana research and manufacturers of marijuana for research purposes. The processes include deadlines for DEA action on the registration applications.

The statute also directs the agency to register manufacturers and distributors of marijuana and CBD that are involved in the commercial production of FDA-approved drugs that contain marijuana or a marijuana derivative.

The measure (H.R. 8454) passed the House on July 26 by a vote of 325 to 95. The Senate approved the legislation without amendment by a voice vote on Nov. 16.

Practitioner Registration To Conduct Research

The statute directs the DEA to register a practitioner to conduct research with marijuana if:

• the applicant’s research protocol has been reviewed and allowed by the FDA, by the National Institutes of Health (NIH) or another federal agency funding the research, or under the DEA regulations on research protocols (21 C.F.R. §1301.18) and research on Schedule I substances (21 C.F.R. §1301.32); and
• the applicant has demonstrated to the DEA that effective procedures to safeguard against diversion are in place, “including demonstrating that the security measures are adequate for storing the quantity of marijuana the applicant would be authorized to possess.”

The DEA may deny the application only if it determines that issuing the registration would be inconsistent with the public interest (21 U.S.C. §823(f)(1)).

The first of the five statutory public interest factors, the recommendation of the appropriate state licensing board or professional disciplinary authority, would be considered by the DEA if the state requires practitioners conducting research to register with a state board or other authority.

The DEA must either approve the registration or request more information from the applicant within 60 days. If more information is requested, the agency must approve or deny the application within 30 days after receiving the supplemental information. If the application is denied, the DEA must provide a written explanation of the reasons for the denial.

Research Protocols

Also under the statute, a practitioner registered with the DEA to conduct research with marijuana may amend or supplement the research protocol without notice to or review by the agency if the registrant does not change:

• the quantity or type of marijuana or CBD;
• the source of the marijuana or CBD; or
• the conditions under which the marijuana or CBD is stored, tracked or administered.

The statute specifies procedures for the registrant and the DEA to follow in cases where a registrant wants to change the type of marijuana or CBD, to address additional security measures, or to change the quantity of marijuana needed for the research.

The FDA retains its authority over the research protocols, including (1) the method of administration or the dosing of the marijuana or CBD and (2) the number of individuals or patients involved in the research.

The DEA must promulgate regulations covering these research protocol provisions by December 2023.

Registration for Manufacturers of Marijuana for Research

For applications to manufacture marijuana for research purposes, when the DEA places a notice in the Federal Register to increase the number of registered entities manufacturing marijuana to supply researchers, the agency has 60 days to approve the application or ask for additional information.

In its registration application, the manufacturer must document that it will limit the transfer and sale of marijuana to DEA-registered researchers and for purposes of preclinical research or clinical investigations pursuant to an FDA investigational new drug application (IND).

The manufacturer also must document that:

• it will transfer or sell marijuana only with the DEA’s prior written consent;
• it has completed the application and review process for the bulk manufacture of Schedule I controlled substances;
• it has established and begun operation of a process for storing and handling Schedule I controlled substances (including the statute’s inventory control and monitoring security requirements); and
• it has satisfied any state marijuana manufacturing licensing requirements.

Once the DEA has received any supplemental information that it has requested, the agency has 30 days to approve or deny the manufacturer’s application. The DEA must supply a written explanation for an application denial.

Ensuring a Supply of Marijuana for Research

The statute also requires the DEA to work with the FDA to assess annually “whether there is an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes.”

If the supply is found not to be adequate and uninterrupted, the DEA must within 60 days of the finding report to Congress on the factors contributing to the supply issues, the expected impacts on ongoing research protocols, and the steps that the agency will take to restore the supply.

Security

Researchers must store the marijuana and its components in “a securely locked, substantially constructed cabinet.”

Any additional security measures imposed by the DEA must be consistent with those that apply to practitioners conducting research on Schedule I and Schedule II controlled substances that have “a similar risk of diversion and abuse.”

No Interdisciplinary Review

The statute prohibits the Department of Health and Human Services (HHS) from reinstating a review process under which the Public Health Service (PHS) had reviewed non-federally funded research protocols involving marijuana.

The PHS review had been instituted in May 1999 with publication of a guidance document titled “Guidance on Procedures for the Provision of Marijuana for Medical Research.” In June 2015, HHS eliminated the PHS review process after finding that it overlapped the FDA’s IND process (80 Fed. Reg. 35960).

The statute bars HHS from requiring any additional review of scientific protocols that is applicable only to marijuana research.

Medical Research on Cannabidiol

“An appropriately registered covered institution of higher education, practitioner, or manufacturer may manufacture, distribute, dispense, or process marijuana or cannabidiol … for purposes of medical research for drug development or subsequent commercial production,” the statute provides.

The legislation specifies that these activities are permitted notwithstanding any provisions of the Controlled Substances Act, the Safe and Drug-Free Schools and Communities Act, or any other federal law.

DEA Registration for Commercial Production of Drugs

The statute also requires the DEA to provide registrations for applicants that manufacture or distribute CBD or marijuana for purposes of the commercial production of FDA-approved drugs derived from marijuana.

The registration process must follow the requirements of the Controlled Substances Act (21 U.S.C. §823(a), 21 U.S.C. §823(b)).

Doctor-Patient Relationship

In addition, the statute specifies that it is not a violation of the Controlled Substances Act for a state-licensed physician to discuss the potential harms and benefits of treatments using marijuana derivatives, including CBD, with the legal guardians of children who are the physician’s patients.

When talking with adult patients or their legal guardians, a physician may discuss the potential harms and benefits of marijuana as well as marijuana derivatives, including CBD, as treatments.

Federal Report

The statute also directs HHS to work with the NIH and other relevant federal agencies to prepare a report on (1) the potential therapeutic effects of CBD or marijuana on serious medical conditions, including intractable epilepsy, and (2) the barriers associated with researching marijuana and CBD in states that have legalized the use of such substances.

The report must be submitted by December 2023 to the Senate Caucus on International Narcotics Control, the Senate Health, Education, Labor and Pensions Committee, the Senate Judiciary Committee, the House Energy and Commerce Committee, and the House Judiciary Committee.