Code of Maine Rules › 18 - DEPARTMENT OF ADMINISTRATIVE AND FINANCIAL SERVICES › 691 - OFFICE OF MARIJUANA POLICY › Chapter 4 - Marijuana Manufacturing Facilities › Section 691-4-1 - Administration

Current through 2024-29, July 17, 2024
1.1 - Purpose and Scope This rule is
				promulgated to establish standards and procedures related to manufacturing
				marijuana, marijuana concentrate, and marijuana products. This rule implements
				requirements of 22 MRS, chapter 558-C, including a marijuana track and trace
				system, and establishes minimum standards for manufacturing marijuana and
				marijuana products for medical use, including requirements for facility
				registration, requirements for engaging in marijuana extraction using
				inherently hazardous substances, staff qualifications, and security and
				testing. This rule protects public health and assures safe practices related to
				marijuana manufacturing, requiring a level of competency of facility personnel
				and appropriate equipment to process and extract marijuana. This rule
				establishes the form and content of initial and renewal applications for
				certification. This rule is in addition to the requirements of 10-144
Code of Maine Rules
("CMR"), chapter 122,
Maine
				Medical Use of Marijuana Program Rule.
In case of any inconsistencies
				between this rule and Chapter 122, this rule controls.
(APA Office Note:
				10-144 chapter 122 has been relocated to 18-691 chapter 2.)
1.2 - Authority 22 558-C.
1.3 - Definitions For the purposes of this
				rule, the definitions included in this rule are in addition to the MRS, chapter
				definitions contained in 22 MRS, chapter 558-C; unless the context otherwise
				indicates, the following terms have the following meanings:
1.
Audit
means a systematic and
				independent examination of facilities, equipment, personnel, training,
				procedures, record-keeping, data validation, data management and reporting
				aspects of a system to determine whether quality assurance, quality control and
				technical activities are being conducted as planned. An audit is conducted to
				determine whether these activities will effectively achieve quality objectives.
2.
Act
means the
Maine Medical Use of Marijuana Act
.
3.
Assistant
means a person paid
				to perform a service for a caregiver, dispensary, manufacturing facility or
				marijuana testing facility, whether as an employee or independent contractor,
				whose services include direct or indirect contact with marijuana or marijuana
				products.
4.
Cannabidiol
				(CBD)
is Chemical Abstracts Service number 13956-29-1.
5.
Certificate of analysis
means
				the document prepared by a testing facility that documents the analytical
				testing performed and results produced by the testing laboratory for a specific
				marijuana sample or product.
6.
Department
means the Department of Administrative and Financial
				Services.
7.
Exempt
				caregiver
means a natural person who is a caregiver for no more than two
				family members or members of the caregiver's household, is exempt from
				registration pursuant to
				22
				MRS §2423-A(3)(C) and
				may not possess more than 8 pounds of marijuana.
8.
Extraction
means a process of
				extracting marijuana concentrate from marijuana using water, lipids, gases,
				solvents or other chemicals or chemical processes. The use of inherently
				hazardous substances in marijuana extraction is restricted by this rule.
9.
Harvested marijuana
means plant material harvested from a mature marijuana plant, except the stalk,
				leaves and roots of the plant that are not used for a qualifying patient's
				medical use. Harvested marijuana includes marijuana concentrate and marijuana
				products.
10.
Homogeneous
means manufactured in a manner that results in the
				amount of marijuana or marijuana concentrate and cannabinoids within the
				product being consistent and reasonably equally dispersed throughout the
				product or throughout each portion of the product or concentrate; or a sample
				representative of the whole.
11.
Inherently hazardous substance
("IHS") means a liquid chemical; a
				compressed gas; carbon dioxide (CO2); or a commercial
				product that has a flash point at or lower than 38 degrees Celsius or 100
				degrees Fahrenheit, including, but not limited to, butane, propane and diethyl
				ether. For the purposes of this Rule, inherently hazardous substances include
				the potentially hazardous extraction methods listed at Section 4.1.2(B) and
				excludes any form of alcohol or ethanol. A person or entity extracting
				marijuana is authorized to use only inherently hazardous substances approved by
				this rule.
12
Inherently
				hazardous substance registration
means a valid registration issued by
				the Department authorizing a tier 1 or tier 2 manufacturing facility, patient,
				caregiver, dispensary, or freestanding entity to engage in extraction using the
				inherently hazardous substances approved by the Department only and that do not
				exceed thresholds established for required testing.
13.
Local authorization
means
				authorization from a municipality in accordance with
				22 MRS
				§2429-D.
14.
Manifest form
means a
				record, either paper or electronic, required by the Department for a registered
				caregiver, dispensary, or licensed facility to document the possession and
				transfer of the marijuana or marijuana product on the premises, tracking all
				inventory, acquisition, sales and waste disposal.
15.
Manufacturing facility
means a registered tier 1 or tier 2 manufacturing facility or a person or
				entity authorized to engage in marijuana extraction using IHS under
				
				22 MRS §2423-F.
16.
Manufacture or manufacturing
means the production, blending, infusing, compounding or other preparation of
				marijuana concentrate and marijuana products by a registered manufacturing
				facility, or by a patient, caregiver or dispensary as authorized under 22 MRS,
				chapter 558-C. Manufacturing includes, but is not limited to, marijuana
				extraction or preparation by means of chemical synthesis. "Manufacturing or
				manufacture" does not include cultivation.
17.
Marijuana concentrate
means
				the resin extracted from any part of a marijuana plant and every compound,
				manufacture, salt, derivative, mixture or preparation from such resin,
				including, but not limited to hashish.
18.
Marijuana
means the leaves,
				stems, flowers and seeds of all species of the plant genus Cannabis, whether
				growing or not, used for medical purposes and conduct authorized under 22 MRS,
				chapter 558-C.
19.
Marijuana
				product
means a product composed of marijuana, or marijuana concentrate
				and other ingredients that is intended for medical use. "Marijuana product"
				includes, but is not limited to, an edible marijuana product, a marijuana
				inhalant, a marijuana ointment and a marijuana tincture. "Marijuana product"
				does not include marijuana concentrate.
20.
Marijuana testing facility
means an entity licensed by the Department and certified to test medical use
				marijuana, including concentrates and products containing marijuana, for
				research and development purposes and to analyze contaminants in, and the
				potency and cannabinoid profile of, marijuana samples and products containing
				marijuana cultivated in accordance with 22 MRS, chapter 558-C.
21.
Patient
means a qualifying
				patient, or a visiting qualifying patient, who is 18 years of age or older, and
				possesses a valid written certification for the medical use of marijuana
				obtained pursuant to
				22 MRS
				§2423-B or a valid out-of-state
				credential for the medical use of marijuana pursuant to
				22
				MRS §2423-D.
22.
Person
means any
				individual, firm, partnership, joint venture, association, corporation, limited
				liability company, estate, trust, business trust, receiver, syndicate, or any
				other group or combination acting as a unit, and the plural as well as the
				singular.
23.
Premises
means the structure or structures and land specified in the application for
				registration that is owned, leased, or otherwise held under the control of the
				applicant or registrant where conduct related to marijuana manufacturing takes
				place. The premises must be a contiguous area and may only be occupied by one
				registrant, unless otherwise permitted by statute and this rule.
24.
Registration certificate
means a document containing a unique registry identification number that
				permits the manufacturing of marijuana and marijuana products for medical
				use.
25.
Registry
				identification card
means a photographic identification card issued by
				the Department to an individual who is authorized to manufacture marijuana or
				marijuana products for medical use, in the capacity of or in the employ of a
				patient, caregiver, dispensary or manufacturing facility. For the purposes of
				these rules, the Department may issue a registry identification card to any
				person who holds an active and valid Individual Identification Card issued
				under Maine's Adult Use Marijuana Program authorized by 28-B MRS, chapter
				1.
26.
Sample
means a
				portion of marijuana or marijuana product containing marijuana regulated under
				this rule that may be analyzed for testing or for research and development
				purposes.
27.
Sampler
means a person authorized to collect samples of marijuana and marijuana
				products.
28.
Sampling
				date
means the date that a sample was collected from the manufacturer,
				in order to be reported as such, when reporting the sample results to marijuana
				testing facility clients.
29.
Tetrahydrocannabinol (THC
and
delta-9 THC
) is
				substance defined in Chemical Abstracts Service number 1972-08-3.
30.
Track and trace system
means
				the record-keeping required and approved by the Department for registered
				caregivers, dispensaries, and manufacturing facilities to monitor inventory and
				transfers of marijuana for medical use for compliance purposes.
Visitor
means any person, other than officer, assistant, or employee of the
				manufacturing facility, who enters into any areas of the manufacturing facility
				where marijuana is manufactured or stored.