Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 62 - NATALIE M. LAPRADE MEDICAL CANNABIS COMMISSION › Chapter 10.62.01 - Definitions › Section 10.62.01.01 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
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.