18- 691 C.M.R. ch. 4, § 2

Current through 2024-18, May 1, 2024

Section 691-4-2 - Authorized Manufacturing; Patient, Caregiver and Dispensary Conduct

2.1 - Authorized Marijuana Manufacturing

2.1.1.Limited Authorization. A person or entity may not manufacture marijuana products or marijuana concentrate for medical use, including all forms and derivatives of the cannabis plant cultivated under 22 MRS, chapter 558-C, in whole or in part, except as explicitly authorized by and in accordance with this rule.

A. A qualifying patient, caregiver or registered dispensary may manufacture marijuana to produce marijuana product and marijuana concentrate for medical use as authorized in accordance with this rule, including limits on possessing and transferring marijuana and marijuana products for medical use.

B. A person or entity who is not a qualifying patient, caregiver or dispensary is required to apply for manufacturing facility registration to be authorized to manufacture marijuana for medical use. The person or entity not otherwise authorized to possess and manufacture marijuana for medical use may apply for a tier 1 or tier 2 manufacturing facility registration.

C. A caregiver or dispensary must apply for a manufacturing facility registration to manufacture marijuana for medical use on behalf of another caregiver or dispensary or to manufacture marijuana that is donated or acquired by wholesale.

D. An inherently hazardous substances registration (IHS registration) is required for any person or entity using inherently hazardous substances to extract marijuana, including a qualifying patient, exempt caregiver, or a freestanding person or entity. A tier 1 or 2 manufacturing facility is only authorized to extract with inherently hazardous substances if it also has an IHS registration.

E. Any natural person, including but not limited to officers or directors and assistants or employees, involved in manufacturing under these rules is required to hold a registry identification card as specified under 22 MRS §2425-A(2) and 22 MRS §2423-F(8)(B).

2.1.2.Permissible and Impermissible Activities. A person or entity manufacturing marijuana for medical use, whether or not required to register, must comply with all relevant Department rules.

A. No qualifying patient, caregiver, dispensary manufacturing facility or IHS registrant may employ or be a person who is under 21 years of age.

B. Manufacturing must be performed in a manner that results in the amount of marijuana and cannabinoid content within the portion or part of the product containing marijuana or marijuana concentrate being homogeneous throughout the product and consistent with product labeling.

C. Manufacturing edible products containing marijuana for medical use requires compliance with 22 MRS §2429-C, except that patients who manufacture edible products only for themselves, and exempt caregivers who manufacture edible products for their family members, or members of their household, in accordance with Department rules, are exempt.

D. A registered caregiver, dispensary, tier 1 manufacturing facility or tier 2 manufacturing facility producing an edible marijuana product must obtain a food establishment license.

E. Manufacturing-related equipment may not be used to simultaneously manufacture medical use marijuana with marijuana cultivated under the Marijuana Legalization Act, 28-B MRS, chapter 1.

F. A person or entity manufacturing marijuana under this rule must utilize reliable instruments and devices suitable for the weighing of the amount and kind of material to be weighed to uniformly and consistently calculate and report the amount of all forms of marijuana for medical use on the premises. The Department may require a statement of measurement or amount and investigate variations from the declared weight or counts for compliance purposes.

(1) Units of harvested marijuana weight must be declared and expressed in pounds, kilograms, grams or milligrams.

(2) Units of liquid measure must be declared and expressed in liters or milliliters.

(3) Units must be expressed in terms of the largest whole unit with any remainder being in decimal fractions of the unit.

(4) Whole numbers may be used in the statement of count for plants, packages and servings per package.

(5) Pursuant to 22 MRS §2430-E(4), the calculation of the weight of marijuana that is not dried may be adjusted by a percentage to reasonably account for moisture content of the marijuana that is in need of further manufacturing. The date of harvest and conditions are factors to consider for weight.

(6) A calculation of the weight of marijuana in a marijuana product may not include ingredients in the product other than marijuana, except that the weight of marijuana concentrate must be included whether the marijuana concentrate is possessed by itself or within a marijuana product.

G. No registered caregiver, dispensary or manufacturing facility may produce any marijuana manufactured product or marijuana concentrate in the distinct shape of a human, animal or fruit, or a shape that bears the likeness or contains the characteristics of a realistic or fictional human, animal, or fruit, including artistic, caricature, or cartoon renderings.

H. No registered caregiver, dispensary, or manufacturing facility may transfer or offer to transfer a marijuana manufactured product or marijuana concentrate that did not pass a test required by the Department and performed by a licensed marijuana testing facility.

I. Any marijuana, marijuana product or concentrate that fails a test required by the Department to verify or analyze the potency or the presence of residual solvents or other potential contaminants may not be dispensed unless remediated and the subsequent sample passes required testing.

J. Only approved inherently hazardous substances may be used by a person or entity registered with the Department. No Class 1 solvents may be used to manufacture marijuana.

2.2 - Qualifying Patient Authorized Manufacturing

A. A qualifying patient, who is not a visiting patient, may possess up to eight pounds of marijuana for medical use. A visiting qualifying patient may possess no more than two and one-half ounces of marijuana obtained from a registered caregiver or dispensary in a 15-day period.

B. A qualifying patient, including a visiting patient, may prepare marijuana, marijuana concentrate and marijuana products for medical use using the marijuana cultivated pursuant to 22 MRS, chapter 558-C.

C. A qualifying patient may manufacture extracts or concentrates using only generally safe extraction methods and potentially hazardous extraction methods using ethanol, including solutions of ethanol and potable water (See Section 4.1 ). Any other extraction methods are prohibited unless a registration to use inherently hazardous substances is obtained in accordance with this rule.

D. A qualifying patient, including a visiting patient, may provide marijuana cultivated under Chapter 558-C to an appropriately registered caregiver, dispensary or manufacturing facility for that caregiver, dispensary or facility to manufacture a product or concentrate on behalf of the qualifying patient.

E. A qualifying patient may not sell marijuana, or be otherwise compensated for furnishing marijuana to another person, or for assisting in the preparation of a marijuana product for, or on behalf of, another person. A qualifying patient, except a visiting patient, may furnish up to two and one-half ounces of marijuana to another qualifying patient if nothing is transferred in return or provided to the qualifying patient as compensation or remuneration.

2.3 - Caregiver Authorized Manufacturing

2.3.1.Exempt Caregiver Authorized Manufacturing.

A. An exempt caregiver may prepare marijuana, marijuana concentrate and marijuana products for medical use using the marijuana cultivated pursuant to 22 MRS, chapter 558-C for a family member or member of the caregiver's household. The caregiver may manufacture extracts or concentrates using only generally safe extraction methods and potentially hazardous extraction methods using ethanol, including solutions of ethanol and potable water (see Section 4.1 ). Any other extraction methods or solvents are prohibited unless a registration to use inherently hazardous extraction methods is obtained in accordance with this rule.

(1) An exempt caregiver may not possess any more than eight pounds of harvested marijuana for medical use, including marijuana contained in marijuana manufactured products and concentrated marijuana concentrate.

(2) An exempt caregiver is prohibited from assisting more than two qualifying patients.

(3) An exempt caregiver using inherently hazardous substances must obtain an inherently hazardous substance registration from the Department.

(4) An exempt caregiver may accept a limited amount of marijuana for medical use, as authorized under Chapter 558-C, to assist a qualifying patient who is a member of the caregiver's family or household.

(5) Any caregiver who manufactures marijuana or marijuana concentrate on behalf of another caregiver or dispensary must apply for a tier1 or tier 2 manufacturing facility registration.

B. An exempt caregiver producing edible products containing marijuana for medical use is not required to obtain a food establishment license in accordance with 22 MRS §2152, if the caregiver is providing the manufactured product only to the qualifying patient who is a family or household member.

(1) An exempt caregiver is restricted to transferring no more than two and one-half ounces of marijuana to a qualifying patient at one time, except that, if the patient is a visiting qualifying patient, the caregiver is limited to transferring no more than two and one-half ounces to that visiting patient during a 15-day period.

(2) An exempt caregiver may provide marijuana cultivated for medical use to registered caregiver, dispensary or tier 1 or tier 2 manufacturing facility to produce, on behalf of the caregiver, a marijuana product or concentrate for a qualifying patient who is a member of that caregiver's family or household.

(3) An exempt caregiver is permitted to be compensated for providing marijuana for medical use to a qualifying patient who is a member of the caregiver's family or household. A caregiver exempt from registration may not be compensated for cultivating or furnishing marijuana plants, product or concentrate to anyone other than a family or household member.

2.3.2.Registered Caregiver Authorized Manufacturing. A registered caregiver must electronically enroll in the track and trace system chosen by the Department and pay required costs. Costs to use the monitoring system may include the vendor's monthly license fee(s) and individual charges for identification tags that may be required to properly identify marijuana plants and marijuana products or concentrates. The registered caregiver must also comply with data collection and reporting requirements of the track and trace system implemented by the Department for all inventory and transfers.

A. A registered caregiver is permitted to possess and manufacture the total amount of marijuana produced by the registered caregiver's cultivation under Chapter 558-C. A registered caregiver may manufacture marijuana the caregiver cultivated under Chapter 558-C to produce marijuana products and marijuana concentrate for medical use. The registered caregiver may manufacture extracts or concentrates using only generally safe extraction methods and potentially hazardous extraction methods using ethanol, including solutions of ethanol and potable water (see Section 4.1 ). Any other extraction methods or solvents are prohibited unless a registration to use inherently hazardous substances is obtained in accordance with this rule.

B. A registered caregiver may provide marijuana for medical use to an appropriately registered caregiver, dispensary or tier 1 or tier 2 manufacturing facility to produce, on behalf of the registered caregiver, a marijuana product or concentrate for a qualifying patient.

(1) A registered caregiver who provides a qualifying patient prepared marijuana or marijuana product or concentrate manufactured using only the medical use marijuana cultivated by the caregiver and not using inherently hazardous substances is not required to register as a manufacturing facility.

(2) A registered caregiver using inherently hazardous substances to extract marijuana must obtain an inherently hazardous substance registration from the Department.

(3) A registered caregiver who manufactures marijuana and marijuana concentrate on behalf of another caregiver or dispensary is required to apply for a tier 1 or tier 2 manufacturing facility registration.

C. A registered caregiver is responsible for ensuring all marijuana plants, manufactured marijuana and marijuana concentrate are packaged and labeled in accordance with 22 MRS §§2429-A and 2430-G.

D. As part of a wholesale transaction, a registered caregiver may, in accordance with 22 MRS §2423-A(2) (K-1), acquire marijuana as inventory from another registered caregiver or dispensary. All marijuana plants, manufactured marijuana and marijuana concentrate must be stored securely, labeled for content, and accounted for in the track and trace system required by the Department.

(1) The registered caregiver is required to obtain a tier 1 or tier 2 manufacturing facility registration if the registered caregiver manufactures wholesale marijuana or further processes wholesale or donated marijuana on behalf of another caregiver or dispensary.

(2) The registered caregiver is not required to obtain a tier 1 or tier 2 manufacturing facility registration if the caregiver acquires, in wholesale, or by donation, marijuana, marijuana product or concentrate from a source authorized under Chapter 558-C and no further manufacturing is done by the registered caregiver to provide that marijuana to a qualifying patient for medical use.

E. A registered caregiver producing edible products containing the marijuana for medical use is required to obtain a food establishment license in accordance with 22 MRS §2152 and comply with any required testing and all applicable food safety standards.

F. A registered caregiver may conduct testing on manufactured marijuana for research and development purposes. Only the analysis conducted by a licensed marijuana testing facility may be reported for testing required by the Department.

2.4 - Dispensary Authorized Manufacturing To assist qualifying patients with medical use of marijuana, a registered dispensary is permitted to possess and manufacture all marijuana produced from the plants cultivated by the dispensary under 22 MRS, chapter 558-C for a qualifying patient's medical use.

A. A registered dispensary that manufactures marijuana for medical use must comply with tracking and record requirements established by 22 MRS §2430-G; and must establish credentials for and utilize any track and trace system implemented by the Department whenever such a system takes effect.

B. A dispensary manufacturing only the medical use marijuana cultivated by that dispensary and not using inherently hazardous substances is not required to register as manufacturing facility.

C. A dispensary is required to register as a tier 1 or tier 2 manufacturing facility if the dispensary manufactures on behalf of a caregiver, another dispensary, or manufacturing facility using marijuana provided to the dispensary by donation or wholesale transaction.

D. The dispensary is not required to obtain a manufacturing facility registration if the dispensary acquires marijuana for medical use from a source authorized under 22 MRS, chapter 558-C and no further manufacturing by the dispensary is needed for the dispensary to provide that marijuana to a qualifying patient.

E. A dispensary using inherently hazardous substances in marijuana extraction must obtain an inherently hazardous substance registration from the Department.

F. A dispensary that does not have an inherently hazardous substances registration may manufacture extracts or concentrates using only generally safe extraction methods and potentially hazardous extraction methods using ethanol, including solutions of ethanol and potable water.

G. The dispensary is permitted to dispense up to two and one-half ounces of harvested marijuana to a qualifying patient in one transaction, except that a dispensary assisting a visiting qualifying patient may not dispense more than two and one-half ounces of harvested marijuana to the visiting qualifying patient during a 15-day period. All transactions must be documented.

H. The registered dispensary is responsible for ensuring all marijuana plants, manufactured marijuana and marijuana concentrate are labeled and packaged in accordance with 22 MRS §§2429-A and 2430-G.

I. If the dispensary is manufacturing edible products containing marijuana, the dispensary is required to obtain a food establishment license in accordance with 22 MRS §2152 and comply with any required testing and all applicable food safety standards.

J. A dispensary may conduct testing on manufactured marijuana for research and development purposes. Only the analysis conducted by a licensed marijuana testing facility may be reported for testing required by the Department.

18- 691 C.M.R. ch. 4, § 2