Current through Register 1531, September 27, 2024
(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:
b. A government
issued identification card;
c. A
military identification card; or
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(a1/2)(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
(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.