935 CMR, § 501.130 - Additional Operational Requirements for Handling and Testing Marijuana and for Production of MIPs
(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 shall comply with
additional operational requirements required under
935
CMR 501.130.
(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 in 105 CMR 500.000: Good Manufacturing Practices for
Food, and with the requirements for food handlers specified in 105 CMR
300.000: Reportable Diseases, Surveillance, and Isolation and
Quarantine Requirements; and
(b) Any Edible that is made to resemble a
typical food or beverage product shall be packaged in an opaque package and
labeled as required by
935
CMR 501.105(5)(c).
(3) An MTC engaged in product
manufacturing operations 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) An
MTC selling or otherwise Transferring Marijuana to another MTC or Marijuana
Establishment shall provide documentation of its compliance, or lack thereof,
with the testing requirements of
935
CMR 501.160, 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) An MTC
shall retain all records of purchases from any manufacturer or supplier of any
ingredient, additive, device, component part or other materials obtained by the
MTC in relation to the manufacturing of Marijuana Vaporizer Devices and such
records shall be made available to the Commission on request.
(b) An MTC 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 MTC 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 an MTC and provided as a part of a wholesale transaction
with any MTC or Marijuana Retailer .
(d) An MTC that wholesales Marijuana
Vaporizer Devices to an MTC or Marijuana Retailer shall provide the recipient
with the information insert required by
935
CMR 501.105(5)(c) or the
necessary information to produce such an insert and the appropriate labeling
information required by 935 CMR 501.000.
(5) Written policies and procedures for the
production and distribution of Marijuana , 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 501.105(8);
(b) A procedure for handling voluntary and
mandatory recalls of Marijuana . Such procedure 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 an MTC to remove defective or potentially defective
Marijuana from the market, as well as any action undertaken to promote public
health and safety;
(c) A procedure
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 501.105(12);
(d) Policies and procedures for
transportation and Patient or Personal Caregiver patient delivery;
(e) Policies and procedures for the Transfer ,
acquisition, or sale of Marijuana between MTCs, and if applicable, Marijuana
Establishments and CMOs;
(f)
Policies and procedures to ensure that all Edibles are prepared, handled, and
stored in compliance with the sanitation requirements in 105 CMR 500.000:
Good Manufacturing Practices for Food, and with the
requirements for food handlers specified in 105 CMR 300.000: Reportable
Diseases, Surveillance, and Isolation and Quarantine Requirements;
and
(g) 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:
Massachusetts Comprehensive Fire Code.
(6)
Product
Database
. An MTC engaged in product manufacturing operations,
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 prior to commencement of operations.
This information may be used by the Commission for its Product Database .
(a) The MTC 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 MTC and
another MTC or Marijuana Establishment.
(b) Photographs shall be submitted in a form
and manner determined by the Commission.
(c) An MTC shall provide the information
required under
935
CMR 501.130(6)(a) for each
Marijuana Product that it produces prior to the product being made available
for sale and shall update the information whenever a substantial change to the
product information occurs. Substantial changes, including changes to
information listed in
935
CMR 501.130(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, an MTC shall identify the method of extraction
(e.g., Butane, Propane, CO2) on a
physical posting at all entrances of the MTC. 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. An MTC shall post a copy of a permit to keep, store, handle
or otherwise use flammable and combustible material at each place of operation
within the facility.
(8) Except for
a Registered Qualifying Patient or Personal Caregiver , who are not subject to
935
CMR 501.105, only a licensed MTC is permitted
to produce MIPs. Unless otherwise authorized by the Commission, an MIP
production facility of an MTC may produce MIPs for only that MTC, and up to two
additional MTCs under an entity.
Notes
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