935 Mass. Reg. 501.140

Current through Register 1518, March 29, 2024

Section 501.140 - Additional Operational Requirements for Patient Sales

(1) In addition to the general operational requirements for MTCs required under 935 CMR 501.105 and security requirements provided in 935 CMR 501.110, MTCs engaged in patient sales shall comply with additional operational requirements for MTCs under 935 CMR 501.140.

(2)Verification of Patient and Caregiver Certification

(a) Upon entry into an MTC by a Registered Qualifying Patient or Personal Caregiver, or arrival at a residence for delivery to a Registered Qualifying Patient of Personal Caregiver, an MTC or Marijuana Courier Agent shall immediately inspect the Patient's or caregiver's temporary or annual Registration Card and proof of government-issued identification.

1. The government-issued identification card shall contain a name, photograph, and date of birth, and shall be limited to one of the following:

a. A driver's license;

b. A government issued identification card;

c. A military identification card; or

d. A passport.

2. An MTC may dispense only to a Registered Qualifying Patient who has a current valid certification with the Commission or Other Jurisdictions that permit the medical use of marijuana or their Personal Caregiver. Pursuant to 935 CMR 501.010(8), a Certifying Healthcare Provider shall have defined the calendar day length of valid certification of a Qualifying Patient.

3. Qualifying Patients younger than 18 years old do not have to have a separate means of identification to enter an MTC.

4. A Qualifying Patient younger than 18 years old cannot enter an MTC without their Caregiver.

(b) An MTC shall make interpreter services available that are appropriate to the population served, including for the visually and hearing impaired. Such services may be provided by any effective means.

(3)Patient Allotment.

(a) For a Registered Qualifying Patient certified for 60 days or longer, the amount of Marijuana dispensed, including Marijuana contained in MIPs, shall be no more than a 60-day supply in each 60-day period as defined in 935 CMR 501.002 (e.g., a Patient with a 60-day supply of ten ounces who is certified for 90 days may receive up to ten ounces in the first 60 days and five ounces in the remaining 30 days, while a Patient certified for 180 days may receive up to ten ounces in each 60-day period).

(b) For a Registered Qualifying Patient whose Certifying Healthcare Provider has determined that he or she requires a 60-day supply other than ten ounces in accordance with 935 CMR 501.010(9), the amount of Marijuana dispensed, including Marijuana contained in MIPs, shall be adjusted accordingly so that the amount of Marijuana dispensed, including Marijuana contained in MIPs, shall be no more than a 60-day supply as certified by the Certifying Healthcare Provider in each 60-day period.

(c) A Registered Qualifying Patient may possess up to 12 flowering plants and up to 12 Vegetative plants, excluding Clones and cuttings. If one or more Qualifying Patients collectively require more than this amount at one residence in order to maintain a 60-day supply, then a Hardship Cultivation Registration is required.

(4)Unauthorized Sales and Right to Refuse Sales.

(a) An MTC shall refuse to sell Marijuana to any Registered Qualifying Patient or Personal Caregiver who is unable to produce a temporary or an annual Registration Card and valid proof of identification, or who does not have a valid certification in the Commission supported interoperable database.

(b) An MTC shall refuse to dispense to a Registered Qualifying Patient or Personal Caregiver if in the opinion of the MTC agent, the Patient or the public would be placed at risk. In any instance of denial, an MTC shall notify the Patient's Certifying Healthcare Provider within 24 hours.

(c) An MTC may not sell to a Patient or caregiver an amount of Marijuana or Marijuana Products that would exceed the Patient's 60-day Supply.

(d) An MTC is prohibited from selling Marijuana Products containing nicotine.

(e) An MTC is prohibited from selling Marijuana Products containing alcohol, if sales of such alcohol would require licensure pursuant to M.G.L. c. 138.

(5)Recording Sales.

(a) An MTC shall only utilize a point-of-sale system approved by the Commission.

A retailer is prohibited from utilizing software or other methods to manipulate or alter sales data.

1. An MTC shall conduct a monthly analysis of its equipment and sales data to determine that no software has been installed that could be utilized to manipulate or alter sales data and that no other methodology has been employed to manipulate or alter sales data. The MTC shall use industry best practices to ensure its analysis does not compromise system security.

An MTC shall maintain records that it has performed the monthly analysis and produce it on request to the Commission. If a retailer determines that software has been installed for the purpose of manipulation or alteration of sales data or other methods have been utilized to manipulate or alter sales data:

2. It shall immediately disclose the information to the Commission;

3. It shall cooperate with the Commission in any investigation regarding manipulation or alteration of sales data; and

4. Take such other action directed by the Commission to comply with 935 CMR 501.105.

(b) An MTC shall adopt separate accounting practices at the point-of-sale for Marijuana and Marijuana Product sales, and non-Marijuana sales.

(c) For non-Marijuana sales, an MTC shall comply with Massachusetts tax laws, and DOR rules and regulations including, but not limited to, 830 CMR 62C.25.1: Record Retention, and DOR Directive 16-1 regarding recordkeeping requirements.

(d) At the point of sale, and in a form and manner determined by the Commission, an MTC shall comply with tracking requirements in 935 CMR 501.015(3) and (4) including, but not limited to, Qualifying Patient and, where applicable, Personal Caregiver information, and amount of medical-use Marijuana or MIPs sold.

(e) An MTC shall accurately track and maintain these records for no less than one year, except as otherwise provided in 935 CMR 501.140(5)(e) for taxable non-Marijuana sales, and shall be readily available to the Commission or its representatives on request. Such records shall include:

1. Date and time of transaction;

2. Name and agent registration number of the MTC Agent conducting the transaction;

3. Specific name, strength, dose, quantity, and type of Marijuana and MIPs sold during the transaction;

4. Name of Patient, and where applicable, Personal Caregiver, receiving the Marijuana, MIPs or Marijuana accessory or other taxable non-Marijuana item; and

5. Any other additional information the Commission may deem necessary.

(f) The Commission may audit and examine the point-of-sale system used by an MTC in order to ensure compliance with 935 CMR 501.140(5);

(6)Patient Education.

(a) An MTC shall provide educational materials about Marijuana to Registered Qualifying Patients and their Personal Caregivers.

1. An MTC shall have an adequate supply of up to date educational material available for distribution.

2. Educational materials shall be available in languages accessible to all Patients served by the MTC, including for the visually and hearing impaired.

3. Such materials shall be made available for inspection by the Commission upon request.

(b) The educational material shall include at least the following:

1. A warning that Marijuana has not been analyzed or approved by the FDA, that there is limited information on side effects, that there may be health risks associated with using Marijuana, and that it should be kept away from children;

2. A warning that when under the influence of Marijuana, driving is prohibited by M.G.L. c. 90, § 24, and machinery should not be operated;

3. Information to assist in the selection of Marijuana, describing the potential differing effects of various strains of Marijuana, as well as various forms and routes of administration;

4. Materials offered to Registered Qualifying Patients and their Personal Caregivers to enable them to track the strains used and their associated effects;

5. Information describing proper dosage and titration for different routes of administration. Emphasis shall be on using the smallest amount possible to achieve the desired effect. The impact of potency shall also be explained;

6. A discussion of tolerance, dependence, and withdrawal;

7. Facts regarding substance abuse signs and symptoms, as well as referral information for substance abuse treatment programs;

8. A statement that Registered Qualifying Patients may not distribute Marijuana to any other individual, and that they shall return unused, excess, or contaminated product to the MTC from which they purchased the product, for disposal; and

9. Any other information required by the Commission.

(c) The educational material cannot include:

1. Any statement, design, representation, picture, or illustration that encourages or represents the use of Marijuana for any purpose other than to treat a Debilitating Medical Condition or related symptoms;

2. Any statement, design, representation, picture, or illustration that encourages or represents the recreational use of Marijuana;

3. Advertising, marketing, and branding that asserts that its products are safe, or represent that its products have curative or therapeutic effects, other than labeling required pursuant to M.G.L. c. 94G, § 4(a½)(xxvi), unless supported by substantial evidence or substantial clinical data with reasonable scientific rigor as determined by the Commission; and

4. Any statement, design, representation, picture, or illustration portraying anyone younger than 21 years old.

(7)Testing. No Marijuana Product, including Marijuana, may be sold or otherwise marketed for adult use that is not capable of being tested by Independent Testing Laboratories, except as allowed under 935 CMR 501.000. The product shall be deemed to comply with the standards required under 935 CMR 501.160.

Potency levels derived from the Cannabinoid Profile, including the amount of delta-nine-tetrahydrocannabinol ([DELTA]9-THC) and other Cannabinoids, contained within Finished Marijuana or Marijuana Product to be sold or otherwise marketed shall be recorded in the Seed-to-sale SOR.

(8) Repackaging. Repackaged Marijuana shall comply with the labeling and packaging requirements under 935 CMR 501.105(5) and 500.105(6).

(9)Advance Contactless Order Fulfillment.

(a) An MTC may allow for advance ordering of Marijuana and Marijuana Products by telephone, website or Third-party Platform, which shall be available for inspection prior to commencing operations and on request.

(b) MTCs may fulfill advance orders through contactless means by not requiring contact between a Qualified Patient or Personal Caregiver and Registered Marijuana Agent.

(c) Any physical unit used for the purpose of the fulfillment of an advance contactless order (order) shall ensure that access to orders of Marijuana or Marijuana Products is limited to the Qualifying Patient or Personal Caregiver who placed the advance order.

(d) Any physical unit used for the purpose of order fulfillment of Marijuana or Marijuana Products shall be located within the MTC building and bolted or otherwise permanently affixed to the MTC Premises.

(e) An MTC that adopts a contactless means of fulfilling orders shall have a written operations plan which shall be submitted to the Commission prior to commencing these operations and on request. The plan shall include a detailed description of how the MTC will ensure that advance contactless order fulfillment complies with the requirements of:

1.935 CMR 501.105(3)(b) and (c) for the safe storage of Marijuana and Marijuana Products;

2.935 CMR 501.110(1)(a) for the purposes of limiting access to Qualifying Patient or Personal Caregivers;

3.935 CMR 501.110(5)(a)4. for the video surveillance of all advance contactless orders; and

4.935 CMR 501.140(8).

(f) Orders placed in advance may not be retained in a physical unit used for the purpose of contactless order fulfillment overnight or outside of business hours.

(10)Product Database. An MTC engaged in patient sales that purchases wholesale Marijuana Products from another licensed Marijuana Product Manufacturer for the purpose of Repackaging Marijuana Products for sale to a Qualifying Patient shall provide the Commission with the following information. This information may be used by the Commission for its Product Database.

(a) The MTC shall provide the following:

1. A photograph of a finished Marijuana Product outside of but next to the Marijuana Product's packaging; provided however, that where single servings of a multi-serving product are unable to be easily identified because of its form, a description of what constitutes a single serving shall be provided (e.g., a single serving is a 1" x 1" square);

2. A photograph of the Marijuana Product inside packaging; and

3. The name of the MTC or Marijuana Establishment Product Manufacturer that produced the Marijuana Product.

(b) Photographs submitted shall be electronic files in a JPEG format with a minimum photo resolution of 640 x 480 and print resolution of 300 DPI. Photographs shall be against a white background.

(c) The MTC shall provide the information required under 935 CMR 501.140(8) for each Marijuana Product it Repackages for sale prior to the product being made available for sale and shall update the information whenever a substantial change to packaging or label of the Marijuana Product occurs. For purposes of 935 CMR 501.140(10)(c), a substantial change shall be a change to the physical attributes or content of the package or label.

(11)Sale of Marijuana Vaporizer Devices.

(a) MTCs offering Marijuana Vaporizer Devices for sale to Registered Qualifying Patients shall include signage at the point of sale, that is legible and enlarged and contains the following statements:

1. "Marijuana Vaporizer Devices have been tested for Vitamin E Acetate and other contaminants, with no adverse findings. WARNING: Vaporizer Devices may contain ingredients harmful to health when inhaled."

2. "Patients shall have access to the test results of Marijuana Vaporizer Devices including copies of any Certificates of Analysis provided be the device's manufacturer."

(b) MTCs shall provide a physical insert to Registered Qualifying Patients that accompanies all purchased Marijuana Vaporizer Devices that states, including capitalization and emphasis, the following: "Marijuana Vaporizer Devices have been tested for Vitamin E Acetate and other contaminants, with no adverse findings. WARNING: Vaporizer Devices may contain ingredients harmful to health when inhaled."

(c) The sale of disposable and reusable vaporizer pens and devices shall be accompanied by a product insert identifying the materials used in the vaporizer device's atomizer coil (e.g., titanium, titanium alloy, quartz, copper, nichrome, kanthal, or other specified material), and manufacturer identification of the device hardware, cartridge, battery and other components;

(d) An MTC shall make available the information contained in 935 CMR 501.105(5)(c)6. in the product description at the point of sale and as part of any product list posted on the MTC's website or Third-party Technology Platforms or applications employed for preordering or delivery.

(e) An MTC shall retain all records of purchases from any supplier of any ingredient, additive, device, component part or other materials provided to the MTC about Marijuana Vaporizer Devices sold at MTCs. Such records shall be made available to the Commission upon request.

(12)Physical Separation of Marijuana and MIPs or Marijuana Products for Medical or Adult Use. A CMO shall provide for physical separation between medical and adult use sales areas. Separation may be provided by a temporary or semi permanent physical barrier, such as a stanchion, that, in the opinion of the Commission, adequately separates sales areas of MIPs for medical use from sales areas of Marijuana Products for adult use for the purpose of patient confidentiality.

(a) A CMO shall provide for separate lines for sales of Marijuana or MIPs for medical use from Marijuana Products for adult use within the sales area, provided that the holder of a patient registration card may use either line and may not be limited only to the medical use line, so long as the CMO can record the patient's transaction in accordance with 935 CMR 501.105(5)(d).

(b) A CMO shall additionally provide a patient consultation area, an area that is separate from the sales floor that is enclosed to allow privacy and for confidential visual and auditory consultation with Qualifying Patients.

(c) A CMO's patient consultation area shall have signage stating, "Consultation Area". The private consultation area shall be separate from the sales area. It shall be accessible by a Qualifying Patient or caregiver without having to traverse a Limited Access Area.

(d) A CMO shall use best efforts to prioritize Patient and caregiver identification verification and physical entry into its retail area.

(13)Patient Supply.

(a) A CMO shall ensure access to a sufficient quantity and variety of Marijuana Products, including Marijuana, for Patients registered under 935 CMR 501.000.

1. Where the CMO has been open and dispensing for a period of less than six months, the license shall reserve 35% of the MTC's Marijuana Products.

2. Where the CMO has been open and dispensing for a period of six months or longer, the licensee shall maintain a quantity and variety of Marijuana Products for Patients registered under 935 CMR 501.000, sufficient to meet the demand indicated by an analysis of sales data collected by the Licensee during the preceding six months in accordance with 935 CMR 500.140(5): Recording Sales and 935 CMR 501.140(5).

(b) Marijuana products reserved for patient supply shall, unless unreasonably impracticable, reflect the actual types and strains of Marijuana Products documented during the previous six months. If a substitution shall be made, the substitution shall reflect as closely as possible the type and strain no longer available.

(c) On a biannual basis, the CMO shall submit to the Commission an inventory plan to reserve a sufficient quantity and variety of medical use Marijuana Products for Registered Qualifying Patients, based on reasonably anticipated patient needs as documented by sales records over the preceding six months. On each occasion that the supply of any product within the reserved patient supply is exhausted and a reasonable substitution cannot be made, the CMO shall submit a report to the Commission in a form determined by the Commission.

(d) Marijuana Products reserved for patient supply shall be either maintained on-site at the retailer or easily accessible at another location operated by the Licensee and transferable to the retailer location within 48 hours of notification that the on-site supply has been exhausted. CMOs shall perform audits of available patient supply on a weekly basis and retain those records for a period of six months.

(e) The Commission shall, consistent with 935 CMR 500.301 or 501.301, inspect and audit CMOs to ensure compliance with 935 CMR 500.140: Additional Operating Requirements for Retail Sales. The Commission may, in addition to the issuance of a deficiency statement under 935 CMR 500.310: Deficiency Statements or 935 CMR 501.310 and a plan of correction under 935 CMR 500.320: Plans of Correction or 935 CMR 501.320, demand that the CMO take immediate steps to replenish its reserved patient supply to reflect the amounts required under 935 CMR 500.140(15)(a) or 935 CMR 501.140(13)(a). Failure to adequately address a deficiency statement or follow a plan of correction shall result in administrative action by the Commission pursuant to 935 CMR 500.450: Marijuana Establishment License: Grounds for Suspension, Revocation and Denial of Renewal Applications, and 935 CMR 500.500: Hearings and Appeals of Actions on Licenses or 935 CMR 501.450 and 501.500.

(f) CMOs may transfer Marijuana Products reserved for medical-use to adult-use within a reasonable period of time prior to the date of expiration provided that the product does not pose a risk to health or safety.

(14)Prohibition on Monopolies.

(a) It shall be a violation of 935 CMR 501.000 for any MTC to monopolize or attempt to monopolize, or combine or conspire with any other person or entity including, but not limited, to a Third-party Technology Platform Provider, to monopolize any part of licensed activities authorized under 935 CMR 501.000.

(b) It shall be a violation of 935 CMR 501.000 for any MTC engaged in activities authorized under 935 CMR 501.000 to make a contract for services with a Third-party Technology Platform Provider for the listing of a MTC's Marijuana or Marijuana Products on the condition, agreement or understanding that the parties to the contract shall not deal in Marijuana or Marijuana Products, either generally or specific brands or categories of Finished Marijuana Products, of a competitor or competitors of the parties where the effect of such contract or such condition, agreement or understanding may be to lessen substantially competition or tend to create a monopoly in any activity engaged in under 935 CMR. 501.000.