(1)
Written Operating Procedures. Every MTC shall have
and follow a set of detailed written operating procedures. If the MTC has an
additional location, it shall develop and follow a set of such operating
procedures for that facility. A CMO shall have written operating procedures
that comply with both 935 CMR
501.105(1) and
500.105(1):
Written Operating Procedures and may do so by having two sets
of written operating procedures applicable to each medical-use and adult-use
operations or having one set of written operating procedures, provided it
complies with both medical-use and adult-use requirements. Operating procedures
shall include, but need not be limited to, the following:
(a) Security measures in compliance with
935
CMR
501.110.
(b) Employee security policies, including
personal safety and crime prevention techniques.
(c) A description of the MTC's hours of
operation and after hours contact information, which shall be provided to the
Commission, made available to
Law Enforcement Authorities on request, and
updated pursuant to
935 CMR
501.101(1)(c)11.
(d) Storage and waste disposal of
Marijuana
in compliance with 935 CMR
501.105(11) and 501.105(12).
(e) Description of the various strains of
Marijuana to be cultivated and dispensed, and the form(s) in which Marijuana
will be dispensed.
(f) Price list
for
Marijuana, MIPs, and any other available products, and alternate price
lists for Patients with documented
Verified Financial Hardship as required by
935 CMR
501.050(1)(h).
(g)
Procedures to ensure accurate recordkeeping, including inventory protocols for
Transfer and inventory and procedures for integrating a secondary electronic
system with the Seed-to-sale SOR.
(h) Plans for quality control, including
product testing for contaminants in compliance with 935 CMR
501.160.
(i) A staffing plan and staffing records in
compliance with 935 CMR
501.105(9)(d).
(j) Emergency procedures, including a
disaster plan with procedures to be followed in case of fire or other
emergencies.
(k) Alcohol, smoke,
and drug free workplace policies.
(l) A plan describing how Confidential
Information and other records required to be maintained confidentially will be
maintained.
(m) A policy for the
immediate dismissal of any
MTC Agent who has:
1. Diverted Marijuana, which shall be
reported to Law Enforcement Authorities and to the Commission;
2. Engaged in unsafe practices with regard to
operation of the MTC, which shall be reported to the Commission; or
3. Been convicted or entered a guilty plea,
plea of nolo contendere, or admission to sufficient facts of a
felony drug offense involving distribution to a minor in the Commonwealth, or a
like violation of the laws of any Other Jurisdiction.
(n) A list of all board of directors, members
and Executives of an MTC, and Members, if any, of the Licensee, shall be made
available on request by any individual. This requirement may be fulfilled by
placing this information on the MTC's website.
(o) Policies and procedure for the handling
of cash on MTC Premises including, but not limited to, storage, collection
frequency, and transport to financial institution(s), to be available on
inspection.
(p) The standards and
procedures by which the MTC determines the price it charges for
Marijuana, and
a record of the prices charged, including the MTC's policies and procedures for
the provision of
Marijuana to Registered Qualifying Patients with
Verified
Financial Hardship without charge or at less than the market price, as required
by 935 CMR
501.050(1)(h).
(q)
Policies and procedures for energy efficiency and conservation that shall
include:
1. Identification of potential
energy use reduction opportunities (including, but not limited to, natural
lighting, heat recovery ventilation and energy efficiency measures), and a plan
for implementation of such opportunities;
2. Consideration of opportunities for
renewable energy generation including, where applicable, submission of building
plans showing where energy generators could be placed on the site, and an
explanation of why the identified opportunities were not pursued, if
applicable;
3. Strategies to reduce
electric demand (such as lighting schedules, active load management and energy
storage); and
4. Engagement with
energy efficiency programs offered pursuant to M.G.L. c. 25, § 21, or
through municipal lighting plants.
(r) Policies and procedures to promote
workplace safety consistent with the standards set forth under the Occupational
Safety and Health Act of 1970, 29 U.S.C. §
651,
et seq.,
including the general duty clause whereby each employer:
1. shall furnish to each of its employees
employment and a place of employment which are free from recognized hazards
that are causing or are likely to cause death or serious physical harm to its
employees;
2. shall comply with
occupational safety and health standards promulgated under 29 U. S.C. §
651,
et seq. Each
employee shall comply with occupational
safety and health standards and all rules, regulations, and orders issued
pursuant to 29 U.S.C. §
651,
et seq., which are
applicable to the
employee's own actions and conduct.
All current and updated regulations and references at 29 CFR
Parts 1903, 1904, 1910, 1915,1917,1918,1926,1928, and 1977 are incorporated by
reference, and applicable to all places of employment covered by 935 CMR
501.000.
(s) A
description of the MTC's patient education activities in accordance with 935
CMR
501.140(6).
(3)
Handling of
Marijuana
.
(a) An MTC shall
Process Marijuana in a safe and sanitary manner. An MTC shall
Process the
leaves and flowers of the female
Marijuana plant only, which shall be:
1. Well cured and free of seeds and
stems;
2. Free of dirt, sand,
debris, and other foreign matter;
3. Free of contamination by mold, rot, other
fungus, pests and bacterial diseases and satisfying the sanitation requirements
in 105 CMR
500.000:
Good Manufacturing Practices for Food, and
if applicable, 105 CMR
590.000:
State Sanitary Code Chapter X: Minimum
Sanitation Standards for Food Establishments;
4. Prepared and handled on food-grade
stainless steel tables with no contact with MTC Agents' bare hands;
and
5. Packaged in a secure
area.
(b) All MTCs,
including those that develop,
Repackage, or
Process non-Edible MIPs, shall
comply with the following sanitary requirements:
1. Any
MTC Agent whose job includes contact
with
Marijuana or non-Edible MIPs, including cultivation, production, or
packaging, is subject to the requirements for food handlers specified in 105
CMR
300.000:
Reportable Diseases, Surveillance, and Isolation and
Quarantine Requirements;
2. Any
MTC Agent working in direct contact
with preparation of
Marijuana or nonEdible MIPs shall conform to sanitary
practices while on duty, including:
a.
Maintaining adequate personal cleanliness; and
b. Washing hands thoroughly in an adequate
hand washing area before starting work, and at any other time when hands may
have become soiled or contaminated.
c. Hand washing facilities shall be adequate
and convenient and shall be furnished with running water at a suitable
temperature.
3. Hand
washing facilities shall be located in the MTC in Production Areas and where
good sanitary practices require employees to wash and/or sanitize their hands,
and shall provide effective hand-cleaning and sanitizing preparations and
sanitary towel service or suitable drying devices;
4. There shall be sufficient space for
placement of equipment and storage of materials as is necessary for the
maintenance of sanitary operations;
5. Litter and waste shall be properly
removed, disposed of so as to minimize the development of odor, and minimize
the potential for the waste attracting and harboring pests. The operating
systems for waste disposal shall be maintained in an adequate manner pursuant
to 935 CMR
501.105(12);
6. Floors,
walls, and ceilings shall be constructed in such a manner that they may be
adequately kept clean and in good repair;
7. There shall be adequate safety lighting in
all Processing and storage areas, as well as areas where equipment or utensils
are cleaned;
8. Buildings,
fixtures, and other physical facilities shall be maintained in a sanitary
condition;
9. All contact surfaces,
including utensils and equipment, shall be maintained in a clean and sanitary
condition. Such surfaces shall be cleaned and sanitized as frequently as
necessary to protect against contamination, using a sanitizing agent registered
by the US Environmental Protection Agency (EPA), in accordance with labeled
instructions. Equipment and utensils shall be so designed and of such material
and workmanship as to be adequately cleanable;
10. All toxic items shall be identified,
held, and stored in a manner that protects against contamination of Marijuana
and MIPs. Toxic items may not be stored in an area containing products used in
the cultivation of Marijuana. The Commission may require an MTC to demonstrate
the intended and actual use of any toxic items found on the Premises;
11. An MTC's water supply shall be sufficient
for necessary operations. Any private water source shall be capable of
providing a safe, potable, and adequate supply of water to meet the MTC's
needs;
12. Plumbing shall be of
adequate size and design, and adequately installed and maintained to carry
sufficient quantities of water to required locations throughout the MTC.
Plumbing shall properly convey sewage and liquid disposable waste from the MTC.
There shall be no cross-connections between the potable and wastewater
lines;
13. An MTC shall provide its
employees with adequate, readily accessible toilet facilities that are
maintained in a sanitary condition and in good repair;
14. Products that can support the rapid
growth of undesirable microorganisms shall be held in a manner that prevents
the growth of these microorganisms;
15. Storage and transportation of finished
products shall be under conditions that will protect them against physical,
chemical, and microbial contamination as well as against deterioration of them
or their container; and
16. All
vehicles and transportation equipment used in the transportation of
Marijuana
Products or
Edibles requiring temperature control for safety shall be designed,
maintained, and equipped as necessary to provide adequate temperature control
to prevent the
Marijuana Products or
Edibles from becoming unsafe during
transportation, consistent with applicable requirements pursuant to
21 CFR
1.908(c).
(c) All MTCs shall comply with
sanitary requirements during the development or
Processing of
Edibles. All
Edibles shall be prepared, handled, and stored in compliance with the
sanitation requirements in 105 CMR
590.000:
State Sanitary Cpde Chapter
X - Minimum Sanitation Standards for Food Establishments.
(d) All
Marijuana in the
process of
cultivation, production, preparation, transport, or analysis shall be housed
and stored in such a manner as to prevent diversion, theft, or loss.
1. Such items shall be accessible only to the
minimum number of specifically authorized MTC Agents essential for efficient
operation;
2. Such items shall be
returned to a secure location immediately after completion of the process or at
the end of the scheduled business day; and
3. If a manufacturing process cannot be
completed at the end of a working day, the Processing area or tanks, vessels,
bins, or bulk containers containing Marijuana shall be securely locked inside
an area or building that affords adequate security.
4. Unless otherwise authorized by the
Commission, a CMO shall comply with
935
CMR
500.105(3):
Requirements for the Handling of Marijuana and 935 CMR
501.105(3).
(4)
Advertising Requirements.
(a)
Permitted
Practices.
1. A Marijuana
Establishment may develop a Brand Name to be used in labeling, signage, and
other materials; provided however, that use of medical symbols, images of
Marijuana or Marijuana Products, or related Paraphernalia, images that are
appealing to persons younger than 21 years old, and colloquial references to
Marijuana and Cannabis are prohibited from use in the Brand Name
2. Brand Name Sponsorship of a charitable,
sporting or similar event, so long as the following conditions are met:
a. Sponsorship of the event is limited to the
Brand Name.
b. Any advertising at
or in connection with such an event is prohibited, unless such advertising is
targeted to entrants or participants reasonably expected to be 21 years of age
or older, as determined by reliable, current audience composition data, and
reasonable safeguards have been employed to prohibit advertising from targeting
or otherwise reaching entrants or participants reasonably expected to be
younger than 21 years old, as determined by reliable, current audience
composition data; unless such advertising is targeted to entrants or
participants reasonably expected to be 21 years of age or older, as determined
by reliable, current audience composition data, and reasonable safeguards have
been employed to prohibit advertising from targeting or otherwise reaching
entrants or participants reasonably expected to be younger than 21 years old,
as determined by reliable, current audience composition data;
3. An MTC engaging in
Brand Name
Sponsorship under 935 CMR
501.105(4)(a)2. shall retain documentation of
reliable, reasonable audience composition data that is the basis for allowing
any such
advertising or branding for a period of one year, or longer if
otherwise required by the Commission, or a court or agency with
jurisdiction.
4. An MTC may
display, in secure, locked cases, samples of each product offered for sale and
subject to the requirements of
935
CMR
501.110 for
Marijuana Treatment Centers.
These display cases may be transparent. An authorized
MTC Agent may remove a
sample of
Marijuana from the case and provide it to the
Registered Qualifying
Patient for inspection, provided the
Registered Qualifying Patient may not
consume or otherwise use the sample, unless otherwise authorized in 935 CMR
501.000.
5. The MTC may post prices
in the store and may respond to questions about pricing. The MTC shall provide
a catalogue or a printed list of the prices and strains of Marijuana available
at the MTC to Registered Qualifying Patients and may post the same catalogue or
printed list on its website and in the retail store.
6. An MTC may engage in reasonable
advertising practices that are not otherwise prohibited in 935 CMR
501.105(4)(b) that do not jeopardize the public health, welfare or safety of
the general public or promote the diversion of
Marijuana or
Marijuana use in
individuals younger than 21 years old or otherwise promote practices
inconsistent with the purposes of M.G.L. c. 94G or 94I. Any such
advertising
created for viewing by the public shall include the statement "Please Consume
Responsibly", in a conspicuous manner on the face of the advertisement and
shall include a minimum of two of the following warnings in their entirety in a
conspicuous manner on the face of the advertisement:
a. "This product may cause impairment and may
be habit forming";
b. "Marijuana
can impair concentration, coordination and judgment. Do not operate a vehicle
or machinery under the influence of this drug";
c. "There may be health risks associated with
consumption of this product"; or
d.
"Marijuana should not be used by women who are pregnant or
breastfeeding".
(b)
Prohibited
Practices. The following
advertising activities are prohibited:
1. Advertising in such a manner that is
deemed to be is deceptive, misleading, false or fraudulent, or that tends to
deceive or create a misleading impression, whether directly or by omission or
ambiguity;
2. Advertising by means
of television, radio, internet, mobile applications, social media, or other
electronic communication, billboard or other outdoor advertising, or print
publication, unless at least 85% of the audience is reasonably expected to be
21 years of age or older or comprised of individuals with debilitating
conditions, as determined by reliable and current audience composition
data;
3. Advertising, including
statements by a Licensee, that makes any false or statements concerning other
Licensees and the conduct and products of such other Licensees that is
deceptive, misleading, false or fraudulent, or that tends to deceive or create
a misleading impression, whether directly or by omission or
ambiguity;
4. Advertising on any
billboards or any other public signage which fails to comply with all state
laws and local ordinances;
5.
Installation of any illuminated signage or external signage beyond the period
of 30 minutes before sundown until closing; provided however, that the
Commission may further specify minimum signage requirements;
6. The use of vehicles equipped with radio or
loudspeakers for the advertising of Marijuana or Marijuana Products;
7. The use of radio or loudspeaker equipment
in any MTC for the purpose of attracting attention to the sale of Marijuana or
Marijuana Products;
8. Operation of
any website of an MTC that fails to verify that the entrant is a Qualifying
Patient or Caregiver or the entrant is 21 years of age or older;
9. Use of unsolicited pop-up advertisements
on the internet or text message; unless the advertisement is a mobile device
application installed on the device by the owner of the device who is a
Qualifying Patient or Caregiver or 21 years of age or older and includes a
permanent and easy opt-out feature;
10. Any advertising, including the use of
Brand Names, of an improper or objectionable nature including, but not limited
to, the use or language or images offensive or disparaging to certain
groups;
11. Any advertising solely
for the promotion of Marijuana or Marijuana Products on MTC Branded Goods
including, but not limited to, clothing, cups, drink holders, apparel
accessories, electronic equipment or accessories, sporting equipment, novelty
items and similar portable promotional items;
12. Advertising on or in public or private
vehicles and at bus stops, taxi stands, transportation waiting areas, train
stations, airports, or other similar transportation venues including, but not
limited to, vinyl-wrapped vehicles or signs or logos on transportation vehicles
not owned by the MTC;
13. The
display of signs or other printed material advertising any brand or kind of
Marijuana or Marijuana Products that are displayed on the exterior of any
licensed Premises;
14. Advertising
of the price of
Marijuana or
Marijuana Products, except as permitted above
pursuant to 935 CMR
501.105(4)(a)5.;
15. Display of Marijuana or Marijuana
Products so as to be clearly visible to a person from the exterior of an
MTC;
16. Advertising, marketing or
branding including 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;
(c) The
Commission shall maintain and make available a list of all MTCs, their
dispensing location, and their contact information.
(d) Nothing in 935 CMR
501.105(4) prohibits
an MTC from using a mark provided by the Commission which uses images of
Marijuana.
(e) CMOs shall comply
with the requirements of each
935
CMR
500.105(4):
Advertising Requirements and 935 CMR
501.105(4) with respect
to the applicable
license. A CMO may develop a single marketing campaign;
provided, however, it shall apply the most restrictive requirements applicable
under either
license.
(5)
Labeling of Marijuana and Marijuana Products
.
(a)
Labeling of Marijuana Not
Sold as a Marijuana Product . Prior to
Marijuana being sold or
Transferred, an MTC shall ensure the placement of a legible, firmly
Affixed
label on which the wording is no less than
1/
16 of an inch in
size on each package of
Marijuana that it makes available for retail sale. The
Affixed label shall contain at a minimum the following information, but may not
include a Qualifying Patient's name:
1. The
name and registration number, telephone number, email address of the MTC that
produced the Marijuana, together with the retail Licensee's business telephone
number, electronic mail address, and website information, if any;
2. The date that the MTC packaged the
contents and a statement of which Licensee performed the packaging;
3. A batch number, sequential serial number,
and bar code when used, to identify the batch associated with manufacturing and
Processing;
4. Net weight or volume
in U.S. customary or metric units, listed in that order;
5. The full Cannabinoid Profile of the
Marijuana contained within the package, including THC and other Cannabinoid
levels;
6. A statement and a seal
certifying that the product has been tested for contaminants, that there were
no adverse findings, and the date of testing in accordance with M.G.L c. 94G,
§ 15;
7. This statement,
including capitalization: "This product has not been analyzed or approved by
the FDA. There is limited information on the side effects of using this
product, and there may be associated health risks. Marijuana use during
pregnancy and breast-feeding may pose potential harms. It is against the law to
drive or operate machinery when under the influence of this product. KEEP THIS
PRODUCT AWAY FROM CHILDREN.";
8.
The following symbol or easily recognizable mark issued by the Commission that
indicates the package contains
Marijuana:
Click to view
image
9. The
following symbol or other easily recognizable mark issued by the Commission
that indicates that the product is harmful to children:
Click to view
image
10.935 CMR
501.105(5)(a) may not apply to
Marijuana packaged for transport of wholesale
cultivated
Marijuana in compliance with 935 CMR
501.105(13); provided however,
that the MTC is responsible for compliance with 935 CMR
501.105(5) for all
Marijuana Products sold or displayed to Patients.
(b)
Labeling of
Edibles
. Prior to
Edibles being sold or Transferred, the MTC shall
place a legible, firmly
Affixed label on which the wording is no less than
1/
16 of an inch in
size on each Edible that it prepares for retail sale or wholesale. The
Affixed
label shall contain at a minimum the following information, but may not include
a Qualifying Patient's name:
1. The name and
registration number of the Marijuana Product Manufacturer that produced the
Marijuana Product, together with the Marijuana Product Manufacturer's business
telephone number, e-mail address and website information, if any;
2. The name of the Marijuana
Product;
3. Refrigeration of the
product is required, as applicable;
4. Total net weight or volume in U.S.
customary and metric units, listed in that order, of the Marijuana
Product;
5. The number of servings
in the Marijuana Product and the specific weight in milligrams of a serving
size;
6. The type of Marijuana used
to produce the product, including what, if any, Processing technique or
solvents were used;
7. A list of
ingredients, including the full Cannabinoid Profile of the Marijuana contained
within the Marijuana Product, including the amount of
delta-nine-tetrahydrocannabinol ([DELTA]9-THC) and other Cannabinoids in the
package and in each serving of a Marijuana Product as expressed in absolute
terms and as a percentage of volume;
8. The amount, in grams, of sodium, sugar,
carbohydrates and total fat per serving;
9. The date of creation and the recommended
"use by" or expiration date which may not be altered or changed;
10. A batch number, sequential serial number
and bar codes when used, to identify the batch associated with manufacturing
and Processing;
11. Directions for
use of the Marijuana Product;
12. A
statement and a seal that the product has been tested for contaminants, that
there were no adverse findings, and the date of testing in accordance with
M.G.L. c. 94G, § 15;
13. A
warning if nuts or other Known Allergens are contained in the
product;
14. This statement,
including capitalization: "The impairment effects of edible products may be
delayed by two hours or more. This product has not been analyzed or approved by
the FDA. There is limited information on the side effects of using this
product, and there may be associated health risks. Marijuana use during
pregnancy and breast-feeding may pose potential harms. It is against the law to
drive or operate machinery when under the influence of this product. KEEP THIS
PRODUCT AWAY FROM CHILDREN.";
15.
The following symbol or easily recognizable mark issued by the Commission that
indicates the package contains
Marijuana:
Click to view
image
16. The
following symbol or other easily recognizable mark issued by the Commission
that indicates that the product is harmful to children:
Click to view
image
17.935 CMR
501.105(5)(b) shall apply to
Edibles produced by an MTC for transport to
another
Licensee in compliance with 935 CMR
501.105(8) and shall be in addition
to any regulation regarding the appearance of
Edibles under
935 CMR
501.150.
(c)
Labeling of Marijuana
Concentrates and Extracts. Prior to
Marijuana concentrates or
extracts being sold or Transferred, the MTC shall place a legible, firmly
Affixed label on which the wording is no less than
1/
16 of an inch in
size on each
Marijuana concentrate container that it prepares for retail sale
or wholesale. The
Affixed label shall contain at a minimum the following
information, but may not include a Qualifying Patient's name:
1. The name and registration number of the
Marijuana Product Manufacturer that produced the Marijuana Product, together
with the Marijuana Product Manufacturer's business telephone number and e-mail
address;
2. The name of the
Marijuana Product;
3. Product
identity, including the word "concentrate" or "extract", as
applicable;
4. Total net weight or
volume expressed in U.S. customary units and metric units, listed in that
order, of a Marijuana Product;
5.
If applicable, the number of servings in the Marijuana Product and the specific
weight in milligrams of a serving size;
6. The type of Marijuana used to produce the
product, including what, if any, Processing technique or solvents were
used;
7. A list of ingredients
including, but not limited to, the full
Cannabinoid Profile of the
Marijuana
contained within the
Marijuana Product, including the amount of
delta-nine-tetrahydrocannabinol ([DELTA]9-THC) and other Cannabinoids in the
package and in each serving of a
Marijuana Product as expressed in absolute
terms and as a percentage of volume, and the amount of specific additives
infused or incorporated during the manufacturing
process, whether active or
inactive including, but not limited to, thickening agents, thinning agents, and
specific terpenes, expressed in absolute terms and as a percentage of volume;
a. For
Marijuana Vaporizer Devices,
identification of specific additives shall include, but not be limited to, any
additives identified on the FDA's Inactive Ingredient Database for "Respiratory
(inhalation)" or "Oral" routes of administration and based on dosage form as an
aerosol product or inhalant. The FDA Inactive Ingredient Database is available
at
https://www.fda.gov/media/72482/download
. If the FDA database or its equivalent is no longer available, licensees shall
use the database identified by the Commission.
b. For Marijuana Vaporizer Devices produced
using only cannabis-derived terpenes, the following statement: "This product
was produced using only cannabis-derived terpenes."
c. For Marijuana Vaporizer Devices produced
using terpenes other than cannabis-derived terpenes, the following statement:
"This product was produced using terpenes derived from sources other than
cannabis."
8. The date of
creation and the recommended "use by" or expiration date;
9. A batch number, sequential serial number,
and bar code when used, to identify the batch associated with manufacturing and
Processing;
10. Directions for use
of the Marijuana Product;
11. A
statement and a seal that the product has been tested for contaminants, that
there were no adverse findings, and the date(s) of testing in accordance with
M.G.L. c. 94G, § 15. Marijuana Products that are required to undergo more
than one screening shall list all applicable dates of testing;
12. A warning if nuts or other Known
Allergens are contained in the product;
13. This statement, including capitalization:
"This product has not been analyzed or approved by the FDA. There is limited
information on the side effects of using this product, and there may be
associated health risks. Marijuana use during pregnancy and breast-feeding may
pose potential harms. It is against the law to drive or operate machinery when
under the influence of this product. KEEP THIS PRODUCT AWAY FROM
CHILDREN.";
14. The following
symbol or easily recognizable mark issued by the Commission that indicates the
package contains
Marijuana:
Click to
view image
15.
The following symbol or other easily recognizable mark issued by the Commission
that indicates that the product is harmful to children:
Click to
view image
16.935
CMR
501.105(5)(c) shall apply to
Marijuana concentrates and extracts produced
by an MTC for transport to another
Licensee in compliance with 935 CMR
501.105(13).
(d)
Labeling of Marijuana Infused Tinctures, Topicals or Other
Non-edible Marijuana-infused Products. Prior to
Marijuana-infused
Tinctures, topicals or other non-edible
Marijuana-infused Products being sold
or Transferred the MTC shall place a legible, firmly
Affixed label on which the
wording is no less than
1/
16 of an inch in
size on each container of
Marijuana-infused Product that it prepares for retail
sale or wholesale. The
Affixed label shall contain at a minimum the following
information, but may not include a Qualifying Patient's name:
1. The name and registration number of the
MTC that produced the Marijuana Product, together with the MTC's business
telephone number, e-mail address and website information, if any;
2. The Marijuana Product's
identity;
3. The type of Marijuana
used to produce the product, including what, if any, Processing technique or
solvents were used;
4. A list of
ingredients, including the full Cannabinoid Profile of the Marijuana contained
within the Marijuana Product, including the amount of delta-nine-tetrahy
drocannabinol ([DELTA]9-THC) and other Cannabinoids in the package and in each
serving of a Marijuana Product as expressed in absolute terms and as a
percentage of volume;
5. Total net
weight or volume as expressed in U.S. customary units and metric units, listed
in that order, of the Marijuana Product;
6. If applicable, the number of servings in
the Marijuana Product and the specific weight in milligrams of a serving
size;
7. The date of product
creation;
8. A batch number,
sequential serial number, and bar code when used, to identify the batch
associated with manufacturing and Processing;
9. Directions for use of the Marijuana
Product;
10. A statement and a seal
that the product has been tested for contaminants, that there were no adverse
findings, and the date of testing in accordance with M.G.L. c. 94G, §
15;
11. A warning if nuts or other
Known Allergens are contained in the product;
12. This statement, including capitalization:
"This product has not been analyzed or approved by the FDA. There is limited
information on the side effects of using this product, and there may be
associated health risks. Marijuana use during pregnancy and breast-feeding may
pose potential harms. It is against the law to drive or operate machinery when
under the influence of this product. KEEP THIS PRODUCT AWAY FROM
CHILDREN.";
13. The following
symbol or easily recognizable mark issued by the Commission that indicates the
package contains
Marijuana:
Click to
view image
14.
The following symbol or other easily recognizable mark issued by the Commission
that indicates that the product is harmful to children:
Click to
view image
15.935
CMR
501.105(5)(d) shall apply to
Marijuana-infused Tinctures and topicals
produced by an MTC for transport to another
Licensee in compliance with 935 CMR
501.105(8).
(e)
Labeling of Repackaged Marijuana
. Prior to Repackaged
Marijuana being sold, the Retailer shall place a legible, firmly
Affixed label
on which the wording is no less than
1/
16 inch in size
on each container of
Marijuana that it prepares for retail sale.
1. The
Affixed label shall contain at a
minimum the following information, but may not include a Qualifying Patient's
name:
a. The name and registration number of
the Cultivator that produced the Marijuana;
b. Business or trade name of licensee that
packaged the product, if different from the Cultivator;
c. Date of Harvest;
d. Type of Marijuana or name of
strain;
e. The full Cannabinoid
Profile of the Marijuana contained within the Repackaged Product, including the
amount of delta-nine-tetrahydrocannabinol ([DELTA]9-THC) and other Cannabinoids
in the package;
f. Weight in grams
of usable marijuana used in product;
g. A batch number, sequential serial number,
and bar code when used, to identify the batch associated with manufacturing and
Processing;
h. A statement and a
seal that the product has been tested for contaminants, that there were no
adverse findings, and the date of testing in accordance with M.G.L. c. 94G,
§ 15;
i. This statement,
including capitalization: "This product has not been analyzed or approved by
the FDA. There is limited information on the side effects of using this
product, and there may be associated health risks. Marijuana use during
pregnancy and breast-feeding may pose potential harms. It is against the law to
drive or operate machinery when under the influence of this product. KEEP THIS
PRODUCT AWAY FROM CHILDREN.";
j.
The following symbol or easily recognizable mark issued by the Commission that
indicates the package contains
Marijuana:
Click to
view image
k. The
following symbol or other easily recognizable mark issued by the Commission
that indicates that the product is harmful to children:
Click to
view image
2. In circumstances where the labeling of the
Marijuana Product is unreasonable or impractical, the MTC may include the
labeling information on a peel-back label or may place the product in a sealed
bag with an insert or additional, easily readable label firmly Affixed to that
bag.
(f) In circumstances
where the labeling of the Marijuana Product is unreasonable or impractical, the
MTC may include the labeling information on a peel-back label or may place the
product in a take-away bag with an insert or additional, easily readable placed
within that bag.
(g) CMOs shall
comply with the labeling requirements in
935
CMR
500.105(5) for all
adult-use sales and 935 CMR
501.105(5) for all medical-use sales.
(6)
Packaging of
Marijuana and Marijuana Products
.
(a)
Child-resistant
Packaging. MTCs engaged in product manufacturing operations shall
ensure that all
Marijuana and
Marijuana Products that are provided for sale to
Registered Qualifying Patients shall be sold in child-resistant packaging. To
comply with 935 CMR
501.105(6), Licensees shall ensure:
1. That to the extent it is not
Unreasonably
Impracticable for the specific type of product,
Marijuana Products are packaged
in containers that are:
a. Opaque and plain in
design;
b. Do not use bright
colors, cartoon characters and other features designed to appeal to
minors;
c. Resealable for any
Marijuana Product intended for more than a single use or containing multiple
servings; and
d. Certified by a
qualified child-resistant packaging testing firm that the packaging complies
with the most recent poison prevention packaging regulations of the U.S.
Consumer Product Safety Commission as included at 16 CFR
1700.
2. That where compliance with the
requirements of child-resistant packaging is deemed to be
Unreasonably
Impracticable or too challenging for Patients to maneuver,
Marijuana Products
shall be placed in an packaging that is:
a.
Capable of being resealed after it has been opened; and
b. Includes the following statement,
including capitalization, in at least ten-point Times New Roman, Helvetica or
Arial font: "KEEP OUT OF REACH OF CHILDREN".
(b)
Limits on Packaging
Design. Packaging for
Marijuana or
Marijuana Products sold or
displayed to Patients, including any label or imprint
Affixed to any packaging
containing
Marijuana or
Marijuana Products or any exit packages, may not be
attractive to minors. Packaging is explicitly prohibited from:
1. Imitating or having a semblance to any
existing branded consumer products, including foods and beverages, that do not
contain Marijuana;
2. Featuring
cartoons;
3. Featuring a design,
brand or name that resembles a non-Cannabis consumer product of the type that
is typically marketed to minors;
4.
Featuring symbols or celebrities that are commonly used to market products to
minors;
5. Featuring images of
minors; and
6. Featuring words that
refer to products that are commonly associated with minors or marketed to
minors.
(c)
Packaging of Multiple Servings.
1. Packaging for Marijuana Products sold or
displayed for Registered Qualifying Patients in multiple servings shall include
the following statement on the exterior of the package in a printed font that
is no smaller than ten-point Times New Roman, Helvetica or Arial, including
capitalization: "INCLUDES MULTIPLE SERVINGS."
2. Packaging for
Marijuana Products in solid
form sold or displayed for Registered Qualifying Patients in multiple servings
shall allow a
Registered Qualifying Patient to easily perform the division into
single servings.
a. Edibles in a solid form
shall be easily and permanently scored to identify individual
servings.
b. Notwithstanding 935
CMR
501.105(6)(c)2.a., where a product is unable, because of its form, to be
easily and permanently scored to identify individual servings, the product
shall be packaged in a single serving size. The determination of whether a
product can be easily and permanently scored shall be decided by the Commission
consistent with sub-regulatory guidelines established by the Commission and
provided to Licensees.
(d) Each single serving of an Edible
contained in a multiple-serving package may be marked, stamped or otherwise
imprinted with the symbol issued by the Commission under 935 CMR
501.105(5)
that indicates that the single serving is a
Marijuana Product.
(e) Serving size shall be determined by the
MTC.
(f) CMOs shall comply with the
packaging requirements in
935
CMR
500.105(6):
Packaging of Marijuana and Marijuana Products for adult use
sales or 935 CMR
501.105(6) for medical use sales.
(7)
Packaging and Labeling
Pre-approval. Prior to
Marijuana or
Marijuana Product being sold
at an MTC, a CMO, a
Licensee or
License Applicant may submit an application for
packaging and label approval to the Commission. An application for preapproval
may be submitted at any time prior to
Marijuana or
Marijuana Product being sold
or at any time a substantive change is made to the packaging or labeling of
Marijuana or
Marijuana Product. The Commission shall charge a fee for packaging
and labeling preapproval pursuant to
935 CMR
501.005.
(a) Packaging and labeling preapproval review
shall be limited to the physical attributes of, and statutorily required
warnings on, the packaging and label, including but not limited to legibility,
but may not include a review of specific
Independent Testing Laboratory test
results required pursuant to 935 CMR
501.105(5). The packaging and labeling
preapproval
process shall be in addition to the requirements of 935 CMR
501.105(5) and (6).
(b) In addition
to an application for packaging and labeling preapproval in a form and manner
determined by the Commission, an applicant for preapproval shall submit
electronic files of the following to the Commission:
1. For packaging preapproval, two images of
the packaging, one depicting the front of the packaging and one depicting the
back of the packaging. Photographs 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.
2. For labeling preapproval, one image of
each label requested for review. Photographs 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 Commission shall make
every effort to make a preapproval determination based on information
submitted. In the event that a preapproval determination is unable to be made
conclusively based on submitted photographs, the Commission may request to view
the packaging or label in person or through a video conference. Any such
request by the Commission shall be made to the applicant electronically or in
writing.
(8)
Inventory.
(a)
Subject to
Marijuana or
Marijuana Products being entered into the Seed-to-sale
SOR, a
Marijuana Establishment may
Transfer product to an MTC, and an MTC may
Transfer product to a
Marijuana Establishment as long as there is no violation
of the dosing limitations set forth in
935 CMR
500.150(4):
Dosing
Limitations or the limitations on total MTC inventory as set forth in
935 CMR
501.105(8)(m). Such Transfers cannot violate provisions protecting
patient supply under
935 CMR
501.140(12). An MTC shall
limit its
Transfer of inventory of seeds, plants, and
Usable Marijuana to
reflect the projected needs of Registered Qualifying Patients.
(b) Real-time inventory shall be maintained
as specified by the Commission and in 935 CMR
501.105(8)(c) and (d) including,
at a minimum, an inventory of
Marijuana plants,
Marijuana plant seeds and
Clones in any phase of development such as
Propagation,
Vegetation, and
Flowering,
Marijuana ready for dispensing, all MIPs, and all damaged,
defective, expired, or contaminated
Marijuana and MIPs awaiting
disposal.
(c) An MTC shall:
1. Establish inventory controls and
procedures for the conduct of inventory reviews, and comprehensive inventories
of Marijuana and MIPs in the process of cultivation, and finished, stored
Marijuana;
2. Conduct a monthly
inventory of Marijuana in the process of cultivation and finished, stored
Marijuana;
3. Conduct a
comprehensive annual inventory at least once every year after the date of the
previous comprehensive inventory; and
4. Promptly transcribe inventories if taken
by use of an oral recording device.
(d) The record of each inventory shall
include, at a minimum, the date of the inventory, a summary of the inventory
findings, and the names, signatures, and titles of the individuals who
conducted the inventory.
(e) An MTC
shall attach plant tags to all Marijuana, Clones, and plants and attach package
tags to all Finished Marijuana and Marijuana Products, and track all Marijuana
seeds, Clones, plants, and Marijuana Products, using a Seed-to-sale methodology
in a form and manner to be approved by the Commission.
(f) The failure to enter inventory into the
Seed-to-sale SOR may result in the suspension or revocation of an MTC
License.
(g) The use of the
Seed-to-sale SOR does not preclude an MTC from using a secondary electronic
tracking system so long as it complies with 935 CMR
501.105(8). The MTC shall
seek approval from the Commission, in a form and manner determined by the
Commission, to integrate its secondary system with the Seed-to-sale
SOR.
(h) Prior to the point of
sale, an MTC shall specify the suggested retail price for any Marijuana or
Marijuana Product intended for patient sale.
(i) An MTC shall limit its inventory of
seeds, plants, and Usable Marijuana to reflect the projected needs of
Registered Qualifying Patients.
(j)
An MTC may acquire
Marijuana and
Marijuana Product from or distribute
Marijuana
or
Marijuana Product to another MTC or
Marijuana Establishment in accordance
with
935 CMR
501.140(8) and subject to
the following:
1. The distribution and
acquisition of Marijuana and Marijuana Product, including MIPs, to and from all
other MTCs does not exceed, cumulatively, 45% of the MTC's total annual
inventory of Marijuana as measured by weight, or for Marijuana Product,
including MIPs, as measured by its combined dry weight equivalent in Marijuana
concentrate; except that such requirement shall not apply to CMOs;
and
2. A documented emergency
occurs such as loss of crop, vandalism, or theft, or other circumstance as
approved by the Commission.
(k) Any distribution and acquisition of
Marijuana and MIPs shall be tracked in the Seed-to-sale SOR in a form and
manner determined by the Commission. Any distribution of Marijuana and MIPs
that is not tracked in the Seed-to-sale SOR may result in the suspension or
revocation of an MTC License or other administrative action.
(l) An MTC may not engage in a
transfer of
inventory that would violate the provisions protecting patient supply under
935 CMR
501.140(12).
(m) A CMO shall implement procedures for
electronic separation of medical-and adult-use Marijuana, MIPs, and Marijuana
Products in the Seed-to-sale SOR.
(n) A CMO shall designate whether Marijuana
or MIPs, or Marijuana Products are intended for sale for adult use or medical
use through the SOR. Products shall be transferred to the appropriate license
within the Seed-to-sale SOR prior to sale. After the point of sale, there shall
be a reconciliation of that inventory in the SOR.
(9)
Recordkeeping.
Records of an MTC shall be available for inspection by the Commission, on
request. The financial records of an MTC shall be maintained in accordance with
generally accepted accounting principles. Written records that are required and
are subject to inspection include, but are not limited to, all records required
in any section of 935 CMR
501.000 in addition to the following:
(a) Operating procedures as required by 935
CMR
501.105(1);
(b) Inventory
records as required by 935 CMR
501.105(8)(d);
(c) Seed-to-sale Electronic Tracking System
records for all
Marijuana and MIPs as required by 935 CMR
501.105(8)(e);
(d) The following
personnel records:
1. Job descriptions for
each employee and volunteer position, as well as organizational charts
consistent with the job descriptions;
2. A personnel record for each MTC and
Laboratory Agent. Such records shall be maintained for at least 12 months after
termination of the individual's affiliation with the MTC and shall include, at
a minimum, the following:
a. All materials
submitted to the Commission pursuant to
935
CMR
501.029 and
501.030;
b. Documentation of verification of
references;
c. The job description
or employment contract that includes duties, authority, responsibilities,
qualifications, and supervision;
d.
Documentation of all required training, including training regarding privacy
and confidentiality requirements, and the signed statement of the individual
indicating the date, time, and place he or she received said training and the
topics discussed, including the name and title of presenters;
e. A copy of the application that the MTC
submitted to the Commission on behalf of any prospective MTC agent;
f. Documentation of periodic performance
evaluations;
g. Notice of completed
Responsible Vendor Training Program and in-house training for MTC Agents
required under 935 CMR
501.105(2); and
h. A record of any disciplinary action
taken.
3. A staffing plan
that will demonstrate accessible business hours and safe cultivation
conditions;
4. Personnel policies
and procedures, including, at a minimum, the following:
a. Code of ethics;
b. Whistle-blower policy; and
5. All background check reports obtained in
accordance with M.G.L. c. 6, § 172,
935
CMR
501.029,
935 CMR
501.030, and 803 CMR
2.00:
Criminal
Offender Record Information (CORI);
(e) Business records, which shall include
manual or computerized records of:
1. Assets
and liabilities;
2. Monetary
transactions;
3. Books of accounts,
which shall include journals, ledgers, and supporting documents, agreements,
checks, invoices, and vouchers;
4.
Sales records that indicate the name of the Registered Qualifying Patient or
Personal Caregiver to whom Marijuana has been dispensed, including the
quantity, form, and cost;
5. Salary
and wages paid to each employee, stipend paid to each board of directors
member, and any executive compensation, bonus, benefit, or item of value paid
to any individual affiliated with an MTC, including Persons or Entities Having
Direct or Indirect Control over the MTC.
(f) Waste disposal records as required under
935 CMR
501.105(12); and
(g)
Following closure of an MTC, all records shall be kept for at least two years
at the expense of the MTC and in a form and location acceptable to the
Commission.
(12)
Waste
Disposal.
(a) All recyclables and
waste, including organic waste composed of or containing Finished Marijuana and
MIPs, shall be stored, secured, and managed in accordance with applicable state
and local statutes, ordinances, and regulations. All exterior waste receptacles
located on the MTC's Premises shall be locked and secured to prevent
unauthorized access.
(b) Liquid
waste containing
Marijuana or by-products of
Marijuana Processing shall be
disposed of in compliance with all applicable state and federal requirements
including, but not limited to, for discharge of pollutants into surface water
or groundwater (Massachusetts Clean Waters Act, M.G.L. c. 21, §§ 26
through 53; 314 CMR
3.00:
Surface Water Discharge Permit
Program; 314 CMR
5.00:
Groundwater Discharge Permit
Program; 314 CMR
12.00:
Operation, Maintenance and
Pretreatment Standards for Wastewater Treatment Works and Indirect
Dischargers; the Federal Clean Water Act,
33 U.S.C.
1251
et seq., the National
Pollutant Discharge Elimination System Permit Regulations at 40 CFR Part
122,
314 CMR
7.00:
Sewer System Extension and Connection Permit
Program), or stored pending disposal in an industrial wastewater
holding tank in accordance with 314 CMR
18.00:
Industrial Wastewater
Holding Tank and Container Construction, Operation, and Record Keeping
Requirements.
(c) Organic
material, recyclable material and solid waste generated at an MTC shall be
redirected or disposed of as follows:
1.
Organic and recyclable material shall be redirected from disposal in accordance
with the waste disposal bans described at
310
CMR
19.017:
Waste
Bans.
2. To the greatest
extent feasible:
a. Any recyclable material as
defined in
310
CMR
16.02:
Definitions shall
be recycled in a manner approved by the Commission; and
b. Any
Marijuana containing organic material
as defined in
310
CMR
16.02:
Definitions shall
be ground up and mixed with other organic material as defined in
310
CMR
16.02 at the MTC such that the resulting
mixture renders any
Marijuana unusable for its original purpose. Once such
Marijuana has been rendered unusable, the organic material may be composted or
digested at an aerobic or anaerobic digester at an operation that complies with
the requirements of 310 CMR
16.00:
Site Assignment Regulations for
Solid Waste Facilities.
3. Solid waste containing Marijuana generated
at an MTC shall be ground up and mixed with other solid waste at the MTC such
that the resulting mixture renders any Marijuana unusable for its original
purpose. Once such Marijuana has been rendered unusable, the resulting solid
waste may be brought to a solid waste transfer facility or a solid waste
disposal facility (e.g., landfill or incinerator) that holds a
valid permit issued by the Department of Environmental Protection or by the
appropriate agency in the jurisdiction in which the facility is
located.
(d) No fewer
than two MTC Agents shall witness and document how the solid waste or organic
material containing
Marijuana is handled on-site including, but not limited to,
the grinding up, mixing, storage and removal from the MTC in accordance with
935
CMR
501.105(12). When
Marijuana Products or waste is disposed or handled, the MTC shall create and
maintain an electronic record of the date, the type and quantity disposed or
handled, the manner of disposal or other handling, the location of disposal or
other handling, and the names of the two MTC Agents present during the disposal
or other handling, with their signatures. An MTC shall keep these records for
at least three years. This period shall automatically be extended for the
duration of any disciplinary action and may be extended by an order of the
Commission.
(13)
Transportation Between MTCs.
(a)
General
Requirements.
1. A licensed MTC
shall be licensed to transport its
Marijuana and
Marijuana Products to other
licensed establishments, including
Marijuana Establishments, except as
otherwise provided in
935
CMR
501.105(13).
2. Marijuana Products may only be transported
between licensed MTCs by registered MTC Agents.
3. A
Marijuana Transporter licensed pursuant
to 935 CMR
500.050(9)
may
Transfer Marijuana and
Marijuana
Products to or from an MTC.
4. The
originating and receiving licensed MTCs shall ensure that all transported
Marijuana Products are linked to the Seed-to-sale SOR. For the purposes of
tracking, seeds and Clones will be properly tracked and labeled in a form and
manner determined by the Commission.
5. Any Marijuana Product that is
undeliverable or is refused by the destination MTC shall be transported back to
the originating establishment.
6.
All vehicles transporting
Marijuana Products shall be staffed with a minimum of
two MTC Agents. At least one agent shall always remain with the vehicle when
the vehicle contains
Marijuana or
Marijuana Products.
a. Notwithstanding
935
CMR
501.105(13)(a)6., an
Independent Testing Laboratory shall ensure that all vehicles operated by the
Independent Testing Laboratory or a
Marijuana Transporter used solely for
transporting
Marijuana or
Marijuana Products for testing purposes in accordance
with 935 CMR
501.160 that contain
Marijuana and
Marijuana Products with a total Wholesale value in excess of
$5,000 in the vehicle are staffed with a minimum of two Agents.
b. Notwithstanding
935
CMR
501.105(13)(a)6., for
all vehicles transporting
Marijuana or
Marijuana Products solely for testing
purposes in accordance with
935
CMR
501.160 that contain
Marijuana and
Marijuana Products with a total Wholesale value of $5,000 or less in the
vehicle, an
Independent Testing Laboratory or
Marijuana Transporter may staff
the vehicle with one Agent.
7. Prior to leaving an MTC for the purpose of
transporting Marijuana Products, the originating MTC shall weigh or count
inventory, and account for, on video, all Marijuana Products to be
transported.
8. Within eight hours
after arrival at the destination MTC, the destination MTC shall re-weigh or
re-count inventory, and account for, on video, all Marijuana Products
transported.
9. When videotaping
the weighing, counting, inventorying, and accounting of Marijuana Products
before transportation or after receipt, the video shall show each product being
weighed, the weight, and the manifest.
10. Marijuana Products shall be packaged in
sealed, labeled, and tamper or child-resistant packaging prior to and during
transportation.
11. In the case of
an emergency stop during the transportation of
Marijuana Products, a log shall
be maintained describing the reason for the stop, the duration, the location,
and any activities of personnel exiting the vehicle. Licensees shall comply
with applicable requirements of
935
CMR
501.110(9).
12. An MTC transporting Marijuana Products
shall ensure that all transportation times and routes are randomized.
13. An MTC transporting Marijuana Products
shall ensure that all transport routes remain within the
Commonwealth.
14. All vehicles and
transportation equipment used in the transportation of
Cannabis Products or
Edibles requiring temperature control for safety shall be designed, maintained,
and equipped as necessary to provide adequate temperature control to prevent
the
Cannabis products or
Edibles from becoming unsafe during transportation,
consistent with applicable requirements pursuant to
21 CFR
1.908(c).
15. All vehicles shall be equipped with a
video system that includes one or more video cameras in the storage area of the
vehicle and one or more video cameras in the driver area of the vehicle and
which shall remain operational at all times during the entire transportation
process and which shall have:
a. The ability
to produce a clear color still photo whether live or recorded; and
b. A date and time stamp embedded in all
recordings which shall always be synchronized and set correctly and may not
significantly obscure the picture.
(b)
Reporting
Requirements.
1. MTC agents shall
document and report any unusual discrepancy in weight, count, or inventory to
the Commission and Law Enforcement Authorities not more than 24 hours of the
discovery of such a discrepancy.
2.
MTC agents shall report to the Commission and Law Enforcement Authorities any
vehicle accidents, diversions, losses, or other reportable incidents that occur
during transport, not more than 24 hours of such accidents, diversions, losses,
or other reportable incidents.
(c)
Vehicles.
1. A vehicle used for transporting
Marijuana
Products shall be:
a. Exclusively owned or
leased by the MTC or otherwise licensed by the Commission as a Third-party
Transporter;
b. Properly
registered, inspected, and insured in the Commonwealth (documentation of such
status shall be maintained as records of the MTC, and shall be made available
to the Commission on request);
c.
Equipped with an alarm system approved by the Commission; and
d. Equipped with functioning heating and air
conditioning systems appropriate for maintaining correct temperatures for
storage of Marijuana Products.
2. Marijuana Products may not be visible from
outside the vehicle.
3. Any vehicle
used to transport or deliver Marijuana or Marijuana Products must comply with
applicable Massachusetts Registry of Motor Vehicles (RMV) requirements, but may
not include any additional external marking that indicate the vehicle is being
used to transport or deliver Marijuana or Marijuana Products.
4. When transporting Marijuana Products, no
other products may be transported or stored in the same vehicle.
5. No firearms may be located within the
vehicle or on an MTC Agent.
(d)
Storage
Requirements.
1. Marijuana
Products shall be transported in a secure, locked storage compartment that is a
part of the vehicle transporting the Marijuana Products.
2. The storage compartment shall be
sufficiently secure that it cannot be easily removed.
3. If an MTC is transporting Marijuana
Products for more than one licensed MTC at a time, the Marijuana Products for
each Licensee shall be kept in a separate locked storage compartment during
transportation and separate manifests shall be maintained for each
MTC.
4. If an MTC is transporting
Marijuana Products to multiple other establishments, it may seek the
Commission's permission to adopt reasonable alternative safeguards.
(e)
Communications.
1.
Any vehicle used to transport
Marijuana Products shall contain a global
positioning system (GPS) monitoring device that is:
a. Not a mobile device that is easily
removable;
b. Attached to the
vehicle at all times that the vehicle contains Marijuana Products;
c. Monitored by the MTC during transport of
Marijuana Products; and
d. Inspected
by the Commission prior to initial transportation of Marijuana Products, and
after any alteration to the locked storage compartment.
2. Each MTC Agent transporting Marijuana
Products shall always have access to a secure form of communication with
personnel at the originating location when the vehicle contains Marijuana and
Marijuana Products.
3. Secure types
of communication include, but are not limited to:
a. Two-way digital or analog radio (UHF or
VHF);
b. Cellular phone; or
c. Satellite
phone.
4. When choosing a
type of secure communications, the following shall be taken into consideration:
a. Cellular signal coverage;
b. Transportation area;
c. Base capabilities;
d. Antenna coverage; and
e. Frequency of transportation.
5. Prior to, and immediately after
leaving the originating location, the MTC Agents shall use the secure form of
communication to contact the originating location to test communications and
GPS operability.
6. If
communications or the GPS system fail while on route, the MTC Agents
transporting Marijuana Products shall return to the originating location until
the communication system or GPS system is operational.
7. The MTC Agent or Agents transporting
Marijuana Products shall contact the originating location when leaving any
scheduled location or making any unscheduled stops.
8. The originating location shall have an MTC
Agent assigned to monitoring the GPS unit and secure form of communication, who
shall log all official communications with MTC Agents transporting Marijuana
Products.
(f)
Manifests.
1. An MTC
shall complete a manifest prior to transporting Marijuana or Marijuana Products
between Marijuana Establishments or an MTC. An MTC may utilize a physical or
electronic manifest during the transportation of Marijuana or Marijuana
Products.
2. Prior to transport,
the manifest shall be securely transmitted to the destination MTC by facsimile
or email.
3. On arrival at the
destination MTC, an
MTC Agent at the destination MTC shall compare the manifest
produced by the agents who transported the
Marijuana Products to the copy
transmitted by facsimile or email. This manifest shall, at a minimum, include:
a. The originating MTC name, address, and
registration number;
b. The names
and registration numbers of the agents who transported the Marijuana
Products;
c. The name and
registration number of the MTC Agent who prepared the manifest;
d. The destination MTC name, address, and
registration number;
e. A
description of the Marijuana Products being transported, including the weight
and form or type of product;
f. The
mileage of the transporting vehicle at departure from originating MTC and
mileage on arrival at destination MTC, as well as mileage on return to
originating MTC;
g. The date and
time of departure from originating MTC and arrival at destination MTC for each
transportation;
h. A signature line
for the MTC Agent who receives the Marijuana Products;
i. The inventory weight or count before
departure and on receipt;
j. The
date and time that the transported products were reweighed and
re-inventoried;
k. The name of the
MTC Agent at the destination MTC who reweighed and re-inventoried products; and
l. The vehicle make, model and
license plate number.
4.
The manifest shall be maintained within the vehicle during the entire
transportation
process, until the delivery is completed.
a. If utilizing a physical copy of the
manifest, the licensed MTC Agent must be able to access the physical copy at
any time during transportation.
b.
If utilizing an electronic manifest, the licensed MTC Agent must be able to
access the electronic manifest at any time during transportation.
5. An MTC shall retain all
transportation manifests for no less than one year and make them available to
the Commission on request.
(g)
Requirements for
Agents.
1. Each employee or
agent transporting or otherwise handling Marijuana Products for an MTC shall be
registered as an MTC Agent and have a driver's license in good standing issued
by the Massachusetts Registry of Motor Vehicles for all classes of vehicle the
MTC agent will operate for the MTC prior to transporting or otherwise handling
Marijuana Products.
2. An MTC Agent
shall carry his or her Agent Registration Card at all times when transporting
Marijuana Products and shall produce his or her Agent Registration Card to the
Commission or Law Enforcement Authorities on request.
(h) MTCs engaged in transportation operations
shall use best management practices to reduce energy and water usage, engage in
energy conservation and mitigate other environmental impacts.
(i) A CMO can transport adult use and medical
use Marijuana and Marijuana Products if it is appropriately licensed to do so.
Where a CMO is transporting both adult use and medical use Marijuana, MIPs and
Marijuana Products, the CMO shall comply with the more restrictive security
provisions.
(19)
Prohibitions.
(a) Unless otherwise authorized by the
Commission, an MTC may not dispense, deliver, or otherwise
transfer Marijuana
to a
person other than a
Registered Qualifying Patient or to his or her
Personal Caregiver, to another MTC or to a laboratory as provided for in
935
CMR
501.105(13).
(b) Unless otherwise authorized by the
Commission, an MTC may not acquire
Marijuana or
Marijuana plants, except
through the cultivation of
Marijuana by that MTC or another MTC as specified in
935
CMR
501.105(13); provided,
however that an MTC may acquire
Marijuana seeds, cuttings or genetic plant
material. Cuttings or genetic plant material may only be acquired within 90
days of receiving a final
Certificate of Licensure, or such other time period
approved by the Commission and otherwise as authorized under
935
CMR
501.105(13).
(c) Unless authorized by the Commission, an
MTC is prohibited from acquiring, possessing, cultivating, delivering,
Transferring, transporting, supplying, or dispensing Marijuana for any purpose
except to assist Registered Qualifying Patients.
(d) An MTC may not give away any
Marijuana
except as required pursuant to
935
CMR
501.050(1)(g). An MTC
may not provide any samples of
Marijuana.
(e) An MTC may not receive orders for
Marijuana in any manner other than from a Registered Qualifying Patient or
Personal Caregiver in person at the MTC, except in the cases of delivery, in
which an order may be received by telephone or through a password-protected,
internet-based platform.
(f) An MTC
may not fill orders for
Marijuana in any manner other than to a
Registered
Qualifying Patient or
Personal Caregiver in
person at the MTC, except in the
case of delivery, in which an order may be delivered only to the
Residence of a
Registered Qualifying Patient or
Personal Caregiver or the
Caregiving
Institution of a
Registered Qualifying Patient. The Qualifying Patient or
caregiver receiving the delivery shall possess a temporary or an annual
Registration Card and valid photo identification as required pursuant to
935
CMR
501.140(2). An MTC is
prohibited from delivering adult use
Marijuana.
(g) Unless authorized by the Commission, an
MTC may not sell any products other than Marijuana, including MIPs and
Marijuana seeds, and other Marijuana Accessories and products such as
vaporizers that facilitate the use of Marijuana for medical purposes.
(h) Consumption of Marijuana on the Premises
or grounds of any MTC is prohibited; provided, however, that an MTC may
administer medical use Marijuana for the purposes of teaching use of
vaporizers, or demonstration of use of other products as necessary. An MTC is
prohibited from administering adult use Marijuana.
(i) An MTC may not adulterate Marijuana,
including with psychoactive additives or other illegal substances.
(j) An MTC may not sell
Marijuana to a
Registered Qualifying Patient with a
Hardship Cultivation Registration or to
his or her
Personal Caregiver(s); provided however, that the MTC may sell seeds
to such individuals or gift seeds pursuant to 935 CMR
501.105(19)(1)(g).