2023 Maine Revised Statutes › TITLE 22: HEALTH AND WELFARE › Subtitle 2: HEALTH › Part 5: FOODS AND DRUGS › Chapter 558-C: MAINE MEDICAL USE OF CANNABIS ACT › 22 §2423-F. Cannabis manufacturing facilities

§2423-F. Cannabis manufacturing facilities
A person may not manufacture cannabis products or cannabis concentrate or engage in cannabis extraction except as provided in this chapter.   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
1.  Tier 1 manufacturing facility.
A tier 1 manufacturing facility registered pursuant to subsection 8 may engage in the activities authorized under subsection 4 in accordance with rules adopted pursuant to subsection 10 and may possess up to 40 pounds of harvested cannabis.
[PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
2.  Tier 2 manufacturing facility.
A tier 2 manufacturing facility registered pursuant to subsection 8 may engage in the activities authorized under subsection 4 in accordance with rules adopted pursuant to subsection 10 and may possess up to 200 pounds of harvested cannabis.
[PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
3.  Authorization for extraction using inherently hazardous substances.
This subsection governs the authority of a person to engage in cannabis extraction using inherently hazardous substances in accordance with subsection 5.
A. A qualifying patient, caregiver, registered dispensary or manufacturing facility may engage in cannabis extraction using inherently hazardous substances if the person can produce, upon demand of the department:
(1) Certification from a professional engineer licensed in this State of the safety of the equipment used for cannabis extraction and the location of the equipment and the professional engineer's approval of the standard operating procedures for the cannabis extraction;
(2) Documentation from a professional engineer licensed in this State or a state or local official authorized to certify compliance that the equipment used for cannabis extraction and the location of the equipment comply with state law and all applicable local and state building codes, electrical codes and fire codes, including the chapters of the most recent National Fire Protection Association Fire Code relating to cannabis extraction facilities;
(3) Documentation from the manufacturer of the cannabis extraction system or a professional engineer licensed in this State showing that a professional grade, closed-loop extraction system that is capable of recovering the solvents used to produce cannabis concentrate is used by the person; and
(4) Evidence that the person has provided notice to the department of the person's intent to engage in cannabis extraction using inherently hazardous substances and the location where the cannabis extraction will occur prior to engaging in cannabis extraction using inherently hazardous substances.
A person that intends to engage in cannabis extraction using inherently hazardous substances shall notify the department of that intention prior to engaging in cannabis extraction using inherently hazardous substances. The department may deny an application of a person authorized under this paragraph to register pursuant to rules adopted under subsection 10 if the person did not notify the department in accordance with this paragraph.   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
B. A person that is not a qualifying patient, caregiver or dispensary and that meets the requirements of a person authorized under paragraph A, pays the fee required by section 2425‑A, subsection 10 and meets the requirements of rules adopted under subsection 10 is authorized to engage in cannabis extraction using inherently hazardous substances and may possess up to 40 pounds of harvested cannabis in accordance with subsection 5.   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
[PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
4.  Authorized conduct; manufacturing facilities.
A registered manufacturing facility:
A. May manufacture cannabis products and cannabis concentrate for medical use using any method that does not involve an inherently hazardous substance, except that a registered manufacturing facility may manufacture cannabis concentrate using inherently hazardous substances if authorized under subsection 3;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
B. May obtain harvested cannabis from a qualifying patient, a caregiver or a registered dispensary and may transfer cannabis products and cannabis concentrate to the person that provided the harvested cannabis used to manufacture the cannabis product or cannabis concentrate;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
C. May transfer samples to a cannabis testing facility for testing;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
D. May conduct testing of cannabis products or cannabis concentrate manufactured by the facility for research and development purposes;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
E. May receive reasonable compensation for manufacturing cannabis products or cannabis concentrate;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
F. Shall dispose of harvested cannabis used in the manufacturing process in a manner that prevents its diversion to persons not authorized to possess harvested cannabis possessed by the facility and in accordance with rules adopted by the department; and   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
G. May hire any number of assistants who are 21 years of age or older to assist in performing the duties of the manufacturing facility.   [PL 2021, c. 367, §8 (AMD).]
[PL 2021, c. 367, §8 (AMD); PL 2021, c. 669, §5 (REV).]
5.  Authorized conduct; extraction using inherently hazardous substances.
A person that is authorized to engage in cannabis extraction using inherently hazardous substances pursuant to subsection 3:
A. May engage in cannabis extraction to produce cannabis concentrate for medical use;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
B. May obtain harvested cannabis from a qualifying patient, a caregiver or a dispensary and may transfer cannabis concentrate to the person that provided the harvested cannabis used to produce the cannabis concentrate;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
C. May transfer samples to a cannabis testing facility for testing;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
D. May conduct testing of cannabis concentrate produced by the person for research and development purposes;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
E. May receive reasonable compensation for producing cannabis concentrate;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
F. Shall dispose of harvested cannabis used in the extraction process in a manner that prevents its diversion to persons not authorized to possess harvested cannabis possessed by the person and in accordance with rules adopted by the department; and   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
G. May hire any number of assistants who are 21 years of age or older to assist in performing the activities authorized under this subsection, except that a qualifying patient authorized under subsection 3 may not hire an assistant.   [PL 2021, c. 367, §9 (AMD).]
Notwithstanding the authorizations established in this subsection, a person that is authorized to engage in cannabis extraction using inherently hazardous substances pursuant to subsection 3 shall comply with any rules adopted pursuant to subsection 10.
[PL 2021, c. 367, §9 (AMD); PL 2021, c. 669, §5 (REV).]
6.  Retail sale prohibited.
A registered manufacturing facility or a person authorized to engage in cannabis extraction using inherently hazardous substances under subsection 3 may not engage in retail sales of cannabis products or cannabis concentrate unless the person is authorized to engage in retail sales under this chapter.
[PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
7.  Food establishment license required to manufacture food products.
A registered manufacturing facility or a person authorized to produce cannabis concentrate using inherently hazardous substances may not manufacture edible cannabis products or cannabis tinctures unless licensed pursuant to section 2167.
[PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
8.  Registration requirements.
This subsection governs registration requirements of a manufacturing facility or a person authorized to engage in cannabis extraction using inherently hazardous substances under subsection 3 and the officer or director or assistant of the facility or person.
A. In accordance with rules adopted under subsection 10, the department shall register and issue a registration certificate with a registry identification number to a manufacturing facility or a person authorized to engage in cannabis extraction within 30 days to the facility or person if the facility or person provides:
(1) The annual fee required pursuant to section 2425‑A, subsection 10;
(2) The legal name of the facility or person and, if incorporated, evidence of incorporation and evidence that the corporation is in good standing with the Secretary of State;
(3) The physical address of the facility or person or the physical address where an applicant who is an individual will engage in the activities authorized under this section. If the facility or person changes its physical location, or if a person registered under this subsection changes the location at which the person engages in activities authorized under this section, the facility or person shall notify the department of the new location; and
(4) The name, address and date of birth of each officer or director of the facility or person.   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
B. In accordance with rules adopted under subsection 10, the department shall issue registry identification cards to the officer or director or assistant of a registered manufacturing facility or person authorized to engage in cannabis extraction using inherently hazardous substances within 5 business days of approving an application or renewal under this subsection. A registry identification card is required to be issued to an officer or director or assistant of a registered manufacturing facility or person authorized to engage in cannabis extraction using inherently hazardous substances. A registry identification card expires one year after the date of issuance. A registry identification card issued under this paragraph must contain:
(1) The name of the cardholder;
(2) The date of issuance and expiration date of the registry identification card; and
(3) A random identification number that is unique to the cardholder.
The department may not issue a registry identification card to an officer or director or assistant of a registered manufacturing facility or person authorized to engage in cannabis extraction using inherently hazardous substances who has been convicted of a disqualifying drug offense. The department shall conduct a criminal history record check of each person, officer or director or assistant subject to this subsection on an annual basis.
If the department determines not to issue a registry identification card for a person, officer or director or assistant, the department shall notify the registered manufacturing facility or person authorized to engage in cannabis extraction using inherently hazardous substances in writing of the reason for denying the registry identification card.   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
[PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
9.  Packaging and labeling requirements.
A manufacturing facility shall package and label its cannabis products and cannabis concentrate prior to transfer from the manufacturing facility in a form intended for use or consumption by a qualifying patient in tamper-evident packaging and with a label that includes the following information:
A. The registry identification number of the manufacturing facility;   [PL 2019, c. 331, §17 (RPR).]
B. Information that allows the provider of the cannabis to the manufacturing facility to confirm that the cannabis provided was used to manufacture the cannabis product or cannabis concentrate transferred back to that provider;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
C. Ingredients other than material derived from cannabis plants contained in the cannabis product or cannabis concentrate; and   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
D. Any chemicals, solvents or other substances used to manufacture the cannabis product or cannabis concentrate.   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
[PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
10.  Rulemaking.
The department shall adopt routine technical rules as defined in Title 5, chapter 375, subchapter 2‑A, except that, beginning July 1, 2021, rules adopted pursuant to this subsection are major substantive rules as defined in Title 5, chapter 375, subchapter 2‑A, governing manufacturing facilities, including but not limited to:
A. Requirements for the registration of a manufacturing facility and an officer or director or assistant of a registered manufacturing facility;   [PL 2019, c. 331, §17 (RPR).]
B. Requirements for engaging in cannabis extraction using inherently hazardous substances;   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
C. Manufacturing facility officer or director qualification requirements;   [PL 2019, c. 331, §17 (RPR).]
D. Required security for manufacturing facilities;   [PL 2019, c. 331, §17 (RPR).]
E. Requirements of a disposal plan for harvested cannabis used in the manufacturing process; and   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
F. Minimum record-keeping requirements.   [PL 2021, c. 367, §10 (AMD).]
G. [PL 2019, c. 331, §17 (RP).]
The failure of the department to adopt rules under this subsection does not prevent a person authorized pursuant to subsection 3, paragraph A from engaging in conduct authorized under this section.
[PL 2021, c. 367, §10 (AMD); PL 2021, c. 387, §5 (AMD); PL 2021, c. 669, §5 (REV).]
11.  Multiple authorizations.
A manufacturing facility or person registered pursuant to subsection 8 may also be a qualifying patient, a caregiver or a registered dispensary. A manufacturing facility or person authorized to possess cannabis under this chapter may possess the amount allowed for that manufacturing facility or person in addition to the possession amount allowed under this section if the manufacturing facility or person is registered pursuant to this section. The cannabis possessed must be distinguishable with respect to the purposes for which it is authorized to be possessed.
[PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
12.  Record keeping.
A registered manufacturing facility or person authorized to engage in cannabis extraction using inherently hazardous substances under subsection 3 shall maintain records of all transactions in accordance with section 2430‑G.
[PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
13.  Colocation of facilities.
A manufacturing facility that is also licensed as an adult use cannabis products manufacturing facility under Title 28‑B, chapter 1 may manufacture cannabis products and cannabis concentrate for adult use within the same facility in which the licensee also manufactures cannabis products or cannabis concentrate for medical use pursuant to this chapter. The following items or areas within the shared facility may be shared for both manufacturing pursuant to this chapter and pursuant to Title 28‑B, chapter 1:
A. Manufacturing-related and nonmanufacturing-related equipment, except that manufacturing-related equipment may not be simultaneously used for manufacturing pursuant to this chapter and pursuant to Title 28‑B, chapter 1;   [PL 2019, c. 331, §17 (RPR).]
B. Manufacturing-related and nonmanufacturing-related supplies or products not containing harvested cannabis and the storage areas for those supplies or products; and   [PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
C. General office space, bathrooms, entryways and walkways.   [PL 2019, c. 331, §17 (RPR).]
[PL 2019, c. 331, §17 (RPR); PL 2021, c. 669, §5 (REV).]
14.  Immunity.
[PL 2019, c. 331, §17 (RP).]
SECTION HISTORY
PL 2017, c. 447, §15 (NEW). PL 2017, c. 452, §9 (NEW). PL 2019, c. 331, §17 (RPR). PL 2021, c. 367, §§8-10 (AMD). PL 2021, c. 387, §5 (AMD). PL 2021, c. 669, §5 (REV).