Md. Code Regs. 10.62.01.01

Current through Register Vol. 51, No. 7, April 5, 2024

Section 10.62.01.01 - Definitions

A. In this subtitle, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Ancillary business agent" means an owner, a member, an employee, a volunteer, an officer, or a director of an ancillary business that is registered with the Commission to transport, deliver, or dispose of medical cannabis or green waste.

(2) "Association" means employment or volunteer status at a licensed grower, licensed processor, or licensed dispensary.

(3) Batch.

(a) "Batch" means all of the plants of the same variety of medical cannabis that have been:

(i) Grown, harvested, and processed together; and

(ii) Exposed to substantially similar conditions throughout cultivation and processing.

(b) "Batch" includes all of the processed materials produced from those plants.

(4) "Bona fide provider-patient relationship" means a treatment or counseling relationship between a provider and a patient in which the provider has:

(a) Reviewed the patient's relevant medical records and completed an in person assessment of the patient's medical history and current medical condition;

(b) Created and maintained records of the patient's condition in accord with medically accepted standards; and

(c) A reasonable expectation that the provider will monitor the progress of the patient while using medical cannabis and take any medically indicated action:

(i) To provide follow-up care to the patient;

(ii) Regarding the efficacy of the use of medical cannabis as a treatment of the patient's severe or debilitating medical condition; and

(iii) Regarding any adverse event associated with the use of medical cannabis.

(5) Caregiver.

(a) "Caregiver" means an individual 21 years old or older designated by a patient who has agreed to assist with a qualifying patient's medical use of medical cannabis.

(b) "Caregiver" means, for a qualifying patient younger than 18 years old:

(i) A parent or legal guardian; and

(ii) Not more than two additional adults designated by the parent or legal guardian.

(6) "Central Repository" means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.

(7) "Certifying provider" has the meaning stated in Health-General Article, §13-3301(d), Annotated Code of Maryland.

(8) Commission" means the Natalie M. LaPrade Medical Cannabis Commission.

(9) "Contractor" means any individual or entity who holds a contract for goods or services, including a prime contractor, subcontractor, or independent contractor.

(10) "Control" means the authority to direct:

(a) The management of a business through independent and unilateral decisions that guide the business; or

(b) The operation of the technical aspects of the business.

(11) "Criminal history record information" has the meaning provided by Criminal Procedure Article, § 10-201(d)(3), Annotated Code of Maryland.

(12) "Disadvantaged equity applicant" means an applicant who:

(a) Is a member of any of the following minority groups:

(i) African American - an individual having origin in any of the black racial groups of Africa;

(ii) American Indian/Native American - an individual having origins in any of the original peoples of North America and who is a documented member of a North American tribe, band, or otherwise has a special relationship with the United States or a state through treaty, agreement, or some other form of recognition. This includes an individual who claims to be an American Indian/Native American and who is regarded as such by the American Indian/Native American community of which the individual claims to be a part, but does not include an individual of Eskimo or Aleutian origin;

(iii) Asian - an individual having origins in the Far East, Southeast Asia, or the Indian subcontinent, and who is regarded as such by the community of which the individual claims to be a part;

(iv) Hispanic - an individual of Mexican, Puerto Rican, Cuban, Central or South American, or other Spanish culture or origin, regardless of race, and who is regarded as such by the community of which the individual claims to be a part; or

(v) Women - a woman, regardless of race or ethnicity; and

(b) Meets the following requirements:

(i) Has a personal net worth that does not exceed $1,713,333, as adjusted annually for inflation according to the Consumer Price Index; or

(ii) Is a disadvantaged owner of a certified minority business enterprise as defined in State Finance and Procurement Article, § 14-301(d), Annotated Code of Maryland.

(13) "Dispensary agent" means an owner, a member, an employee, a volunteer, an officer or a director of a licensed dispensary.

(14) Diversity Plan.

(a) "Diversity plan" means a detailed written plan, including objectives, timetables, and evaluation metrics that describes the steps an applicant will take to ensure that a business will promote the meaningful inclusion of diverse groups.

(b) "Diversity plan" includes the following information:

(i) The diversity status of each owner, investor, employee, and contractor;

(ii) Strategies for obtaining a diverse group of owners, investors, employees, including executive and managerial positions, and contractors;

(iii) Internal numerical diversity goals adopted by the applicant;

(iv) A plan for diversity-related outreach or events the applicant will conduct to support its diversity goals in ownership, investment, management, employment, and contracting;

(v) Proposed timelines and benchmarks for achieving the diversity goals outlined in the plan; and

(vi) Any other information that demonstrates the applicant's commitment to ownership, investment, management, employment, and contracting diversity.

(15) "Drive-through dispensing" means a method of dispensing medical cannabis through a window or other opening in the exterior wall of a dispensary that enables a registered dispensary agent to provide services to a qualifying patient or registered caregiver who drives a vehicle to the dispensary without a:

(a) Registered dispensary agent leaving the dispensary service area; or

(b) Qualifying patient or registered caregiver leaving their vehicle.

(16) "Economically disadvantaged area" means a geographic area, identified by the Commission, which meets three or more of the following criteria:

(a) A median income that is 80 percent or less of the average median household income in the State;

(b) An unemployment rate that is at least 150 percent of the unemployment rate in the State;

(c) A health uninsured rate that is at least 150 percent of the health uninsured rate in the State;

(d) A food stamp or Supplemental Nutrition Assistance Plan rate that is at least 150 percent of the food stamp or Supplemental Nutrition Assistance Plan rate in the State; and

(e) A poverty rate that is at least 150 percent of the poverty rate in the State.

(17) Edible Cannabis Product.

(a) "Edible cannabis product" means a medical cannabis product intended for human consumption by oral ingestion, in whole or in part.

(b) "Edible cannabis product" includes medical cannabis products that dissolve or disintegrate in the mouth.

(c) "Edible cannabis product" does not include any:

(i) Medical cannabis concentrate;

(ii) Medical cannabis-infused product, including an oil, a wax, an ointment, a salve, a tincture, a capsule, a suppository, a dermal patch, or a cartridge; or

(iii) Other dosage form that is recognized by the United States Pharmacopeia, the National Formulary, or the Food and Drug Administration and is approved by the Commission.

(18) "Fund" means the Natalie M. LaPrade Medical Cannabis Commission Fund.

(19) "Green waste" means unauthorized, misbranded, contaminated, unused, surplus, returned, or out-of-date medical cannabis or product containing medical cannabis.

(20) "Independent testing laboratory" means a facility, entity, or site that offers or performs tests of medical cannabis and products containing medical cannabis:

(a) Accredited as operating to ISO standard 17025 by an accreditation body:

(i) Operating in accordance with the International Organization for Standardization (ISO) standard ISO/IEC 17011; and

(ii) That is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA); and

(iii) That is independent from all other persons involved in the Maryland cannabis industry; and

(b) Registered with the Commission.

(21) "Inspector" means any member of the Commission or any State employee or contractor designated by the Commission to carry out an inspection under this subtitle.

(22) "Law enforcement agency" means a governmental police force, sheriff's office, security force, or law enforcement organization of the State, a county, or a municipal corporation that by statute, ordinance, or common law is authorized to enforce the general criminal laws of the State.

(23) "Licensed dispensary" means an entity licensed by the Commission that acquires, possesses, repackages, processes, transfers, transports, sells, distributes, or dispenses, products containing medical cannabis, related supplies, related products including tinctures, aerosols, oils, or ointments, or educational materials for use by a qualifying patient or caregiver.

(24) "Licensed grower" means an entity that cultivates, manufactures, packages or distributes medical cannabis to licensed processors, licensed dispensaries or registered independent testing laboratories.

(25) "Licensed premises" means the locations at which a licensed grower, licensed processor, or licensed dispensary operates.

(26) "Licensed processor" means an entity licensed by the Commission that:

(a) Transforms the medical cannabis into another product or extract; and

(b) Packages and labels medical cannabis.

(27) "Lot" means all of a medical cannabis finished product that is uniform, that is intended to meet specifications, and that is manufactured, packaged, or labeled together during a specified time period according to a single lot record.

(28) "Management agreement" means an agreement between a licensee and a third party under which the third party receives control of the business in exchange for a fee, financial interest, or a percentage of the licensee's revenue.

(29) Medical Cannabis.

(a) "Medical cannabis" means all parts of any plant of the genus cannabis, whether growing or not, including:

(i) The seeds of the plant;

(ii) The resin extracted from any part of the plant; and

(iii) Any compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin including tetrahydrocannabinol (THC) and all other naturally produced cannabinoid derivatives, whether produced directly or indirectly by extraction.

(b) "Medical cannabis " does not include:

(i) Hemp, as defined in Agriculture Article, § 14-101, Annotated Code of Maryland;

(ii) Mature stalks of the plant or fiber produced from the mature stalks;

(iii) Oil or cake made from the seeds of the plant;

(iv) Any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks, fiber, oil, or cake; or

(v) The sterilized seed of the plant that is incapable of germination.

(30) "Medical cannabis concentrate" means a product derived from medical cannabis that is kief, hashish, bubble hash, oil, wax, or other product, produced by extracting cannabinoids from the plant through the use of:

(a) Solvents;

(b) Carbon dioxide; or

(c) Heat, screens, presses or steam distillation.

(31) "Medical cannabis finished product" means any usable cannabis, medical cannabis concentrate, edible cannabis product, product containing a medical cannabis concentrate, or any other type of medical cannabis-infused product intended to be packaged and labeled for release to a qualifying patient without further processing.

(32) Medical Cannabis - Infused Product.

(a) "Medical cannabis - infused product" means oil, wax, ointment, salve, tincture, capsule, suppository, dermal patch, cartridge or other product containing medical cannabis concentrate or usable cannabis that has been processed so that the dried leaves and flowers are integrated into other material.

(b) "Medical cannabis - infused product" does not include an edible cannabis product as that term is defined in this section.

(33) "Medical cannabis grower agent" means an owner, an employee, a volunteer, an officer, or a director of a licensed grower.

(34) "Owner" means a person or entity with an ownership interest.

(35) "Ownership interest" means an equity interest in a licensed grower, processor, or dispensary, including in its shares or stock.

(36) Personal Net Worth.

(a) "Personal net worth" means the net value of the assets of an individual remaining after total liabilities are deducted, including the individual's share of assets held jointly or as community property with the individual's spouse.

(b) "Personal net worth" does not include:

(i) The individual's ownership interest in the applicant or a certified minority business enterprise;

(ii) The individual's equity in his or her primary place of residence; or

(iii) The cash value of any qualified retirement savings plans or individual retirement accounts.

(37) "Principal officer" means a board member, president, vice president, secretary, treasurer, partner, officer, or managing member, or any other person with a profit sharing, financial interest, or revenue sharing arrangement, including a person with the authority to control a licensed medical cannabis grower, processor, or dispensary.

(38) "Processing" means the manufacture of usable medical cannabis into a medical cannabis concentrate, or manufacture of a medical cannabis-infused product.

(39) "Qualifying patient" means an individual who:

(a) Lives in the State and:

(i) Has been provided with a written certification by a certifying provider in accordance with a bona fide provider-patient relationship; and

(ii) If younger than 18 years old, has a caregiver; or

(b) Is physically in the State and:

(i) Has been provided with a written certification by a certifying provider in accordance with a bona fide provider-patient relationship;

(ii) Is admitted to a Joint Commission accredited medical facility;

(iii) Will be dispensed medical cannabis at the medical facility during an inpatient stay;

(iv) Will complete the treatment with medical cannabis prior to release; and

(v) If younger than 18 years old, has a caregiver.

(40) "Registered dispensary agent" means a dispensary agent who is registered by the Commission in accordance with COMAR 10.62.26.

(41) "Registered grower agent" means a medical cannabis grower agent who is registered by the Commission in accordance with COMAR 10.62.09.

(42) "Registered processor agent" means a medical cannabis processor agent who is registered by the Commission in accordance with COMAR 10.62.20.

(43) "Secure medical cannabis transport vehicle" means a vehicle owned or leased by a licensee or an ancillary business as defined in COMAR 10.62.18.01B(1) for the purpose of transporting medical cannabis that:

(a) Meets the criteria specified in COMAR 10.62.18;

(b) Is equipped with:

(i) A secure area within the body or compartment of the vehicle containing solid or locking metal partitions, cages, or high strength shatterproof acrylic; or

(ii) Locked and secure storage containers anchored to the inside of the vehicle;

(c) Conceals medical cannabis, products containing medical cannabis, or locked and secure storage containers so they are not visible or identifiable from outside of the vehicle; and

(d) Is registered with the Commission.

(44) "Serious adverse event" means an undesirable experience associated with the use of medical cannabis where the outcome was death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly/birth defect; required intervention to prevent permanent impairment or damage, or any other important medical event.

(45) "Shipment identification number" means a unique identification number created by the shipping licensee to track a shipment of products containing cannabis.

(46) "Variety" means the name of a cultivar or varietal of medical cannabis used by a licensed grower to consistently identify and control medical cannabis from batch to batch.

(47) "Written certification" means a certification that is issued by a certifying provider for a qualifying patient with whom the provider has a bona fide provider-patient relationship.

(48) "30-day supply" means:

(a) 120 grams of usable cannabis unless the provider determines this amount would be inadequate to meet the medical needs of the qualifying patient; or

(b) In the case of a medical cannabis-infused product, 36 grams of A9-Tetrahydrocannabinol (THC) unless the provider determines this amount would be inadequate to meet the medical needs of the qualifying patient.

Md. Code Regs. 10.62.01.01

Regulation .01 adopted effective 42:18 Md. R. 1176, eff.9/14/2015; amended effective 45:25 Md. R. 1201, eff. 12/17/2018;amended effective 46:6 Md. R. 346, eff. 3/25/2019; amended effective 46:16 Md. R. 688, eff. 8/12/2019; amended effective 47:10 Md. R. 519, eff. 5/18/2020; amended effective 48:8 Md. R. 309, eff. 4/19/2021; amended effective 48:23 Md. R. 980, eff. 11/15/2021; amended effective 50:8 Md. R. 339, eff. 5/1/2023