Chapter 19. Cannabis Research
Regulation .01 Academic Research.LinkCopy Citation
A.
An entity eligible to register with the Administration for the purpose of conducting a bona fide research project relating to the uses, properties, or composition of cannabis includes:
(1)
An institution of higher education;
(2)
A related medical facility; or
(3)
An affiliated biomedical research firm.
B.
Academic research institutions and entities shall operate in accordance with Alcoholic Beverages and Cannabis Article, §36-701, Annotated Code of Maryland.
C.
Registration.
(1)
An entity qualified under §A of this regulation shall submit an application to the Administration that includes:
(a)
The name of the primary researcher;
(b)
The expected duration of the research project;
(c)
The primary objectives of the research project, scope of work, and potential application(s) of the research findings;
(d)
An application fee as specified in COMAR 14.17.21; and
(e)
If applicable, a detailed budget.
(2)
Registrations under this regulation shall be valid until:
(a)
There is a change in the research project;
(b)
The institution withdraws the registration; or
(c)
30 days have elapsed from the expected duration of the research project and the Administration has not been notified of any change or extension to the research project.
D.
Modifications.
(1)
The registered entity shall report any modifications to the scope, researcher, or any other information submitted as part of the application within 30 days to the Administration.
(2)
The registered entity may continue to conduct research under this regulation while awaiting Administration approval of any modifications.
Regulation .02 Research and Development.LinkCopy Citation
A.
The Administration may register an entity to grow, process, test, or transfer cannabis for the purposes of research and development.
B.
An entity under §A of this regulation shall conduct research and development only for the purposes under Alcoholic Beverages and Cannabis Article, §36-702, Annotated Code of Maryland.
C.
Registration.
(1)
An entity shall submit an application to the Administration that includes:
(a)
The name of the primary researcher or entity;
(b)
The address the research will be primarily taking place;
(c)
The research purpose; and
(d)
An application fee as specified in COMAR 14.17.21.
(2)
Registrations under this regulation shall be valid for 2 years and may be renewed for additional 2 year terms in a manner determined by the Administration.
D.
Research and development entities under this regulation shall otherwise comply with Alcoholic Beverages and Cannabis Article, §36-702, Annotated Code of Maryland, and the following requirements:
(1)
The study shall be conducted in conformity with study protocols provided and any additional Administration guidance;
(2)
The entity shall notify the Administration of any adverse events reported by study participants within 48 hours of the study’s primary researcher being made aware of the adverse event;
(3)
Within 30 days, the entity or primary researcher shall update the Administration with any changes to the study protocols, including but not limited to:
(a)
Scope;
(b)
Researcher;
(c)
Number of participants;
(d)
Study duration; and
(e)
Products used;
(4)
The entity may continue to conduct research under this regulation while awaiting Administration approval of any changes to the study protocols;
(5)
The entity or primary researcher shall provide documentation of Institutional Review Board or Institutional Animal Care and Use Committee, whichever is applicable, approval prior to the beginning of the study;
(6)
An entity shall track the cannabis used for research and development in the seed-to-sale tracking system;
(7)
A batch or lot of cannabis originally used or processed for research and development purposes:
(a)
May not be used in the processing of cannabis sold to a licensed dispensary; and
(b)
Shall be destroyed and logged as green waste; and
(8)
An entity shall maintain a record of all research and development tests for at least 2 years and provide copies of the test results to the Administration, upon request.
E.
Edible Cannabis Product Development. An entity that processes edible cannabis products for research and development shall:
(1)
Quarantine each batch or lot in a quarantine area and label each batch or lot with a distinctive label; and
(2)
Process the cannabis for research and development during a time that does not overlap with the processing of any cannabis that will be intended for distribution.
F.
Limited Testing for Edible Cannabis Product Development.
(1)
An entity may conduct the research and development testing on the entity’s premises or through an independent testing laboratory.
(2)
If an independent testing laboratory conducts the research and development testing on the edible cannabis product, the laboratory shall clearly mark any certificate of analysis or reporting of test results with “R&D TESTING ONLY” on the header and footer of the report in 20-point white font and a red background.
(3)
The cannabis product shall be categorized as “Work in Process” in the seed-to-sale tracking system.
(4)
Any edible cannabis product transferred from the premises for research and development testing shall:
(a)
Be packaged in accordance with COMAR 14.17.18.05;
(b)
Be labeled with the statements:
(i)
“CAUTION: THIS PRODUCT IS FOR APPROVED R&D USAGE ONLY.”; and
(ii)
“This product has not been approved by the Administration and is intended for research and development purposes only.”;
(c)
Identify the name and telephone number of the entity who manufactured the product; and
(d)
Include a unique identifying number.
Regulation .03 Inspections and Controls.LinkCopy Citation
A.
The Administration may inspect entities registered under this chapter to ensure compliance with:
(1)
Alcoholic Beverages and Cannabis Article, Title 36, Annotated Code of Maryland;
(2)
This subtitle;
(3)
Any other violation of State, federal, or local:
(a)
Law;
(b)
Regulations; or
(c)
Ordinances.
B.
Inspections under this regulation may be announced or unannounced.
C.
The Administration may issue identification cards for individuals associated with research entities registered under this chapter.
Regulation .04 Reporting Requirements.LinkCopy Citation
A.
The registrant shall submit to the Administration:
(1)
An annual report on the progress and status of any research project; and
(2)
A final report of the findings of the research project to the Administration within 30 days of the completion of the research project.
B.
The final report shall include a summary of the research findings and their applications.
C.
A published article or document on the research project may serve as the final report.
D.
Approval is required by the Administration prior to publication of any findings.
Regulation .05 Prohibitions.LinkCopy Citation
A.
Entities registered under this regulation may not dispense, sell, sample, or otherwise distribute cannabis or cannabis products to individuals outside of the scope the defined research project.
B.
Entities registered under this regulation may not otherwise operate in a manner that gives the appearance of the growing, processing, or dispensing of cannabis or cannabis products by a licensee.
C.
Entities registered under this regulation may not perform research activities outside of Maryland.
Chapter annotations
Authority: Alcoholic Beverages and Cannabis Article, §§36-202, 36-701, and 36-702, Annotated Code of Maryland
History: Effective date:
History: Regulations .01—.05 adopted as an emergency provision effective July 1, 2023 (50:14 Md. R. 559); emergency status expired June 30, 2024
History: Regulations .01—.05 adopted as an emergency provision effective June 7, 2024 (51:14 Md. R. 676)
History: Regulations .01—.05 adopted effective July 22, 2024 (51:14 Md. R. 678)
History: Regulation .02F amended effective April 14, 2025 (52:7 Md. R. 324)