Current through Register 1531, September 27, 2024
(1) In addition to the general operational
requirements for Marijuana Establishments required under
935
CMR 500.105 and security requirements
provided in
935 CMR
500.110, Marijuana Product Manufacturers
shall comply with additional operational requirements required under 935 CMR
500.130.
(2) Production of Edibles
shall take place in compliance with the following:
(a) All Edibles shall be prepared, handled,
and stored in compliance with the sanitation requirements in
105 CMR 590.000:
State Sanitary Code Chapter X: Minimum Sanitation Standards for Food
Establishments, and with the requirements for food handlers specified
in
105 CMR 300.000:
Reportable Diseases, Surveillance, and Isolation and
Quarantine Requirements; and
(b) Any Marijuana Product that is made to
resemble a typical food or Beverage product shall be packaged and labelled as
required by
935
CMR 500.105(5) and
(6).
(3) A Marijuana Product Manufacturer shall
meet all applicable environmental laws, regulations, permits and other
applicable approvals including, but not limited to, those related to water
quality and quantity, wastewater, solid and hazardous waste management and air
pollution control, including prevention of odor and noise pursuant to 310 CMR
7:00: Air Pollution Control, and to use additional best
management practices as determined by the Commission in consultation with the
working group established under St. 2017, c. 55, § 78(b) or applicable
departments or divisions of the EOEEA to reduce energy and water usage, engage
in energy conservation and mitigate other environmental impacts.
(4) A Marijuana Product Manufacturer selling
or otherwise Transferring Marijuana to another Marijuana Establishment shall
provide documentation of its compliance, or lack thereof, with the testing
requirements of
935 CMR
500.160, and standards established by the
Commission for the conditions, including time and temperature controls,
necessary to protect Marijuana Products against physical, chemical, and
microbial contamination as well as against deterioration of finished products
during storage and transportation.
(a) A
Product Manufacturer shall retain all records of purchases from any
manufacturer or supplier of any ingredient, additive, device, component part or
other materials obtained by the Product Manufacturer in relation to the
manufacturing of Marijuana Vaporizer Devices and such records shall be made
available to the Commission on request.
(b) A Marijuana Product Manufacturer shall
maintain records of the name and business address of the manufacturer of any
cartridge, battery, atomizer coil, hardware or other component of Marijuana
Vaporizer Products manufactured by the Licensee. Further, the Product
Manufacturer shall, on request by the Commission, identify the materials used
in the device's atomizer coil (e.g., titanium, titanium alloy,
quartz, copper, nichrome, kanthal, or other specified material) or state if
such information cannot be reasonably ascertained.
(c) A copy of the Certificate of Analysis for
each thickening agent, thinning agent or terpene infused or incorporated into a
Marijuana Vaporizer Device during production shall be retained by a Product
Manufacturer and provided as a part of a wholesale transaction with any
Marijuana Retailer, MTC or Delivery Operator.
(d) A Product Manufacturer that wholesales
Marijuana Vaporizer Devices to a Marijuana Retailer, MTC or Delivery Operator
shall provide the recipient with the information insert required by
935
CMR 500.105(5)(c) or the
necessary information to produce such an insert and the appropriate labeling
information required by
935 CMR
500.000; provided, however, that White Labeling of
Marijuana Vaporizer Devices is explicitly prohibited.
(5) In addition to the written operating
policies required under
935
CMR 500.105(1), a Marijuana
Product Manufacturer shall maintain written policies and procedures for the
production or distribution of Marijuana Products as applicable, which shall
include, but not be limited to:
(a) Methods
for identifying, recording, and reporting diversion, theft, or loss, and for
correcting all errors and inaccuracies in inventories. The policies and
procedures, at a minimum, shall comply with
935
CMR 500.105(8);
(b) Policies and procedures for handling
voluntary and mandatory recalls of Marijuana Products. Such procedures shall be
adequate to deal with recalls due to any action initiated at the request or
order of the Commission, and any voluntary action by a Marijuana Establishment
to remove defective or potentially defective Marijuana Products from the
market, as well as any action undertaken to promote public health and
safety;
(c) Policies and procedures
for ensuring that any outdated, damaged, deteriorated, mislabeled, or
contaminated Marijuana or Marijuana Products are segregated from other
Marijuana and destroyed. Such procedures shall provide for written
documentation of the disposition of the Marijuana or Marijuana Products. The
policies and procedures, at a minimum, shall comply with
935
CMR 500.105(12);
(d) Policies and procedures for
transportation. The policies and procedures, at a minimum, shall comply with
935
CMR 500.105(13);
(e) Policies and procedures to reduce energy
and water usage, engage in energy conservation and mitigate other environmental
impacts. The policies and procedures, at a minimum, shall comply with
935
CMR 500.105(15);
(f) Policies and procedures for the Transfer,
acquisition, or sale of Marijuana Products between Marijuana Establishments,
and if applicable, MTCs and CMOs;
(g) Policies and procedures to ensure that
all Edibles are prepared, handled, and stored in compliance with the sanitation
requirements in
105 CMR 590.000:
State Sanitary Code Chapter X: Minimum Sanitation Standards for Food
Establishments, and with the requirements for food handlers specified
in
105 CMR 300.000:
Reportable Diseases, Surveillance, and Isolation and Quarantine
Requirements;
(h) Policies
and procedures for maintaining a product catalogue identifying all types of
Marijuana Products actively manufactured at the facility. The catalog shall
include a description of the product, photograph or illustration, packaging
design, and dosage amounts, including expected Cannabinoid Profile;
(i) Policies and procedures for ensuring
safety in all processing activities and the related uses of extraction
equipment in compliance with the standards set forth in
527 CMR 1.00: The
Massachusetts Comprehensive Fire Safety Code;
(j) Policies and procedures for developing
and providing Vendor Samples to a Marijuana Retailer. Policies and procedures
shall include methods by which the Marijuana Product Manufacturer will
adequately track, record, and document all Vendor Samples developed on, or
provided from, the licensed Premises in satisfaction of 935 CMR
500.130(8);
(k) Policies and
procedures for developing and providing Quality Control Samples to employees
for the purpose of ensuring product quality and determining whether to make the
product available to sell. Policies and procedures shall include methods by
which the Marijuana Product Manufacturer will adequately track, record, and
document all Quality Control Samples developed on, or provided from, the
licensed Premises in satisfaction of 935 CMR 500.130(8). Policies and
procedures shall further prohibit consumption of Quality Control Samples on the
licensed Premises; and
(l) Policies
and procedures for White Labeling on behalf of any Delivery Operator. Marijuana
Product Manufacturers shall retain all Wholesale Agreements entered into with
Delivery Operators and shall make them available to the Commission upon
request.
(6)
Product Database. In addition to the requirement to
establish policies and procedures for maintaining a product catalogue under 935
CMR 500.130(5)(h), a Marijuana Product Manufacturer, after receiving a
Provisional License but prior to receiving a Certificate to Commence
Operations, shall provide the following information about the Finished
Marijuana Products it intends to produce and make available at wholesale to a
Marijuana Retailer or Delivery Operator prior to commencement of operations.
This information may be used by the Commission for its Product Database.
(a) The Marijuana Product Manufacturer shall
provide the following:
1. Marijuana Product
type;
2. Marijuana Product Brand
Name;
3. List of direct
ingredients;
4. List of indirect
ingredients;
5. Serving size,
including a description of what constitutes a serving size for a product that
is not already a single serving;
6.
Potency;
7. A photograph of a
Finished Marijuana Product, against a white background, outside of but next to
the Marijuana Product's packaging, including any external or internal
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), and where an Edible cannot be stamped, for
example, due to size or a coating, the photograph of the Edible outside of, but
next to, its external and internal packaging, such as the wrapper, and labeling
information for the Edible;
8. A
photograph of the Marijuana Product, against a white background, inside the
packaging; and
9. A list of
Marijuana Products to be sold based on anticipated or executed agreements
between the Marijuana Product Manufacturer and Marijuana Retailer or Delivery
Operator.
(b)
Photographs shall be submitted in a form and manner determined by the
Commission.
(c) A Marijuana Product
Manufacturer shall provide the information required under 935 CMR 500.130(6)(a)
for each Marijuana Product that it produces prior to the product being made
available for sale through a licensed Marijuana Retailer, MTC or Delivery
Operator and shall update the information whenever a substantial change to the
product information occurs. Substantial changes, including changes to
information listed in 935 CMR 500.130(6)(a)1.through 9., shall be submitted to
the Commission for inclusion in the Product Database prior to the transfer of
the Marijuana Product.
(7) Notwithstanding a stricter municipal or
state regulation, a Marijuana Product Manufacturer shall identify the method of
extraction (e.g., Butane, Propane, CO2) on a physical posting
at all entrances of the Marijuana Establishment. The Posting shall be a minimum
of 12" x 12" and identify the method of extraction in lettering no smaller than
one inch in height. A Marijuana Product Manufacturer shall post a copy of a
permit to keep, store, handle or otherwise use flammable and combustible at
each place of operation within the facility.
(8)
Vendor Samples .
(a) A Marijuana Product Manufacturer may
provide a Vendor Sample of a Marijuana Product to a Marijuana Retailer, or
Delivery Operator, Provision of a Vendor Sample under 935 CMR 500.130(8) shall
not be considered a prohibited practice under
935
CMR
500.105(4)(b)20.
(b) Vendor Samples provided under 935 CMR
500.130(8):
1. May not be consumed on any
licensed Premises;
2. May not be
sold to another licensee or Consumer;
3. Shall be tested in accordance with
935 CMR
500.160; and
4. Shall be transported in accordance with
935
CMR 500.105(13). A Marijuana
Product Manufacturer may include Vendor Samples with other Marijuana Products
intended for transportation to an individual Marijuana Retailer or Delivery
Operator.
(c)
Vendor Sample limits. A Marijuana Product Manufacturer
is limited to providing the following aggregate amounts of Vendor Samples to an
individual Marijuana Retailer or Delivery Operator in a calendar month period:
1. Five grams of Marijuana concentrate or
extract including, but not limited to, tinctures;
2. Five hundred milligrams of Edibles whereby
the serving size of each individual sample does not exceed five milligrams and
otherwise satisfies the potency levels set forth in
935 CMR
500.150(4); and
3. Five units of sale per Cannabis product
line and no more than six individual Cannabis product lines. For purposes of
935 CMR 500.130(8), a Cannabis product line shall mean items bearing the same
Stock Keeping Unit Number.
(d) All Vendor Samples received from a
Marijuana Cultivator pursuant to
935
CMR 500.120(13) that are
used to manufacture a Marijuana Product shall be assigned a unique, sequential
alphanumeric identifier and entered into the Seed-to-sale SOR in a form and
manner to be determined by the Commission, and further, shall be designated as
"Vendor Sample";
(e) All Vendor
Samples provided by a Marijuana Product Manufacturer under 935 CMR 500.130(8)
shall be assigned a unique, sequential alphanumeric identifier and entered into
the Seed-to-sale SOR in a form and manner to be determined by the Commission
and shall further be designated as "Vendor Sample";
(f) Vendor Samples provided under 935 CMR
500.130(8) shall have a legible, firmly Affixed label on which the wording is
no less than
1/16 inch in size
containing at minimum the following information:
1. A statement that reads: "VENDOR SAMPLE NOT
FOR RESALE";
2. The name and
registration number of the Marijuana Product Manufacturer;
3. The quantity, net weight, and type of
Marijuana Product contained within the package; and
4. A unique sequential, alphanumeric
identifier assigned to the Production Batch associated with the Vendor Sample
that is traceable in the Seed-to-sale SOR.
(9)
Quality Control
Samples.
(a) A Marijuana Product
Manufacturer may provide a Quality Control Sample of Marijuana Product to its
employees for the purpose of ensuring product quality and determining whether
to make the product available to sell. Provision of a Quality Control Sample
under 935 CMR 500.130(9) shall not be considered a prohibited practice under
935
CMR
500.105(4)(b)20.
(b) Quality Control Samples provided to
employees under 935 CMR 500.130(9):
1. May
not be consumed on the licensed Premises;
2. May not be sold to another licensee or
Consumer; and
3. Shall be tested in
accordance with
935 CMR
500.160.
(c)
Quality Control Sample
Limits. A Marijuana Product Manufacturer is limited to providing
the following aggregate amounts of Quality Control Samples to all employees in
a calendar month period:
1. Five grams of
Marijuana concentrate or extract including, but not limited to,
tinctures;
2. Five hundred
milligrams of Edibles whereby the serving size of each individual sample does
not exceed five milligrams and otherwise satisfies the potency levels set forth
in
935 CMR
500.150(4); and
3. Five units of sale per Cannabis product
line and no more than six individual Cannabis product lines. For purposes of
935 CMR 500.130(8), a Cannabis product line shall mean items bearing the same
Stock Keeping Unit Number.
(d) All Quality Control Samples provided
under 935 CMR 500.130(8) shall be assigned a unique, sequential alphanumeric
identifier and entered into the Seed-to-sale SOR in a form and manner to be
determined by the Commission, and further, shall be designated as "Quality
Control Sample."
(e) Quality
Control Samples provided under 935 CMR 500.130(9) shall have a legible, firmly
Affixed label on which the wording is no less than
1/16 inch in size
containing at minimum the following information:
1. A statement that reads: "QUALITY CONTROL
SAMPLE NOT FOR RESALE";
2. The name
and registration number of the Marijuana Product Manufacturer;
3. The quantity, net weight, and type of
Marijuana flower contained within the package; and
4. A unique sequential, alphanumeric
identifier assigned to the Production Batch associated with the Quality Control
Sample that is traceable in the Seed-to-sale SOR.
(f) Upon providing a Quality Control Sample
to an Employee, the Marijuana Product Manufacturer shall record:
1. The reduction in quantity of the total
weight or item count under the unique alphanumeric identifier associated with
the Quality Control Sample;
2. The
date and time the Quality Control Sample was provided to the
Employee;
3. The agent registration
number of the employee receiving the Quality Control Sample; and
4. The name of the Employee as it appears on
their agent registration card.