230-RICR-80-05-1
230-RICR-80-05-1. Rules and Regulations Related to the Medical Marijuana Program Administered by the Office of Cannabis Regulation at the Department of Business Regulation (version Technical Revision, 01/01/2017 to 03/25/2020)
1.1 General Provisions
A. Definitions and References
1. “Act” shall refer to
Chapter 21-28.6 of the Rhode Island General Laws entitled “The
Edward O. Hawkins and Thomas C. Slater Medical Marijuana Act,” as
amended, including amendment by the 2016 Public Laws, Chapter 142
(Budget Article 14).
2. “DBR” shall refer to
the Rhode Island Department of Business Regulation or its successor
agency. R.I. Gen. Laws § 21-28.6-3(6).
3. “DOH” shall refer to
the Rhode Island Department of Health or its successor agency. R.I.
Gen. Laws § 21-28.6-3(7).
4. “RISP” shall refer to
the Rhode Island Department of Public Safety, Division of State
Police, or its successor agency. R.I. Gen. Laws § 21-28.6-3(8).
5. “DBR Regulations” shall
refer to these Regulations, the Rules and Regulations Related to the
Medical Marijuana Program Administered by the Department of Business
Regulation, as the same may be amended from time to time.
6. “DOH Regulations” shall
refer to the Rules and Regulations Related to the Medical Marijuana
Program Administered by the Department of Health, 216-RICR-20-10-3,
as the same may be amended from time to time, and the DOH Testing
Regulations, when adopted.
7. “DOH Testing Regulations”
shall refer to the testing requirements, standards, and procedures
for conduct of testing through “approved third party testing
providers” to be promulgated by DOH, as the same may be amended
from time to time. The DOH Testing Regulations will apply to
licensed cultivators, registered compassion centers, and approved
third party testing providers performing independent testing on the
medical marijuana and marijuana products of the compassion centers
and licensed cultivators for tetrahydrocannabinol (THC) and
cannabidiol (CBD) concentrations and traces of contaminants such as
pesticides and for any other results mandated by DOH, and will
obligate compassion centers and, if applicable, licensed cultivators
to ensure testing compliance and “testing compliance tracking.”
Specific authority for said regulations is found at R.I. Gen. Laws §
21-28.6-12(f)(10) and § 21-28.6-16(f). The DOH Testing Regulations
may require compassion centers and/or licensed cultivators to pay the
costs associated with testing their product.
8. “Marijuana and marijuana
products” shall refer to marijuana, as defined in the Rhode Island
Uniform Controlled Substances Act, R.I. Gen. Laws § 21-28-1.02(26),
and is deemed to specifically include the following subcategories:
a. “Mature marijuana plant,”
which shall refer to a marijuana plant that has flowers or buds that
are readily observable by an unaided visual examination. R.I. Gen.
Laws § 21-28.6-3(14).
b. “Seedling,” which shall
refer to a marijuana plant with no observable flowers or buds. R.I.
Gen. Laws § 21-28.6-3(20).
c. “Plant,” which shall
refer collectively to both and/or independently to either “mature
marijuana plants” and “seedlings,” as the context requires.
d. “Unusable marijuana,”
which shall refer to marijuana seeds, stalks, seedlings, and unusable
roots. R.I. Gen. Laws § 21-28.6-3(21).
e. “Usable marijuana,”
which shall refer to the dried leaves and flowers of the marijuana
plant, and any mixture or preparation thereof, but does not include
the seeds, stalks, and roots of the plant. R.I. Gen. Laws §
21-28.6-3(22).
f. “Dried usable marijuana,”
which shall refer to the dried leaves and flowers of the marijuana
plant after the wet harvested leaves and flowers of the marijuana
plant have undergone the drying process. R.I. Gen. Laws §
21-28.6-3(9); DOH Regulations 216-RICR-20-10-3.3(A)(10).
g. “Wet marijuana,” which
shall refer to the harvested leaves and flowers of the marijuana
plant before they have reached a dry usable state. R.I. Gen. Laws §
21-28.6-3(23). Pursuant to DOH Regulations § 1.30, marijuana that
has been dried to a usable state shall be assumed to have yielded
twenty percent (20%) of the weight of the wet marijuana.
h. “Marijuana infused
products,” which shall refer to product infused with medical
marijuana or an extract of medical marijuana that is intended for use
or consumption other than by smoking, including but not limited to
ointments, oils tinctures, and edible products (hereinafter referred
to as “infused edible product”). See DOH Regulations
216-RICR-20-10-3.3(A)(15).
i. “Concentrate,”
synonymous with “extract,” is any type of marijuana product that
is refined from usable plant material into a more purified form of
usable marijuana including but not limited to hash, supercritical CO2
oil, butane hash oil, shatter, budder, wax, tinctures, infused
butter, infused oils, and rosin.
9. Tetrahydrocannabinol is
abbreviated herein as “THC.”
10. Cannabidiol is abbreviated
herein as “CBD.”
11. “Medical Marijuana
Program Tracking System” shall refer to any system(s) designated by
DBR and DOH designed and used to record and track all “seed to
sale” activities and transactions with unique identifiers. The
Medical Marijuana Program Tracking System may also be used for
registration, licensing, and tagging applications, renewals, change
of information, and communications, as well as to record and/or
report any other additional information directed by DBR or DOH.
12. “Seed to sale” shall
refer to all medical marijuana program regulated activities and
transactions from point of origin to the point of sale. Seed to sale
activities and transactions include but are not limited to: all
cultivation, harvest, processing, manufacturing, and packaging and
labeling; all purchases, acquisitions or third party supply of
marijuana; all sales and dispensing transactions, any other transfers
of marijuana as permitted by the Act and any and all applicable
regulations promulgated thereto; any instances of destruction of
marijuana; and testing compliance tracking.
13. All other terms used
herein shall have the same meanings at set forth in the Act,
including particularly the definitions under R.I. Gen. Laws §
21-28.6-3, and as may be further defined within the DBR Regulations
and the DOH Regulations.
B. Limitations on Scope of the
Rhode Island Medical Marijuana Program
1. The scope of these DBR
Regulations is limited to authorized activities under the Rhode
Island Medical Marijuana Program and does not extend to any
acquisition, possession, cultivation, manufacture, delivery,
transfer, transportation, or sale for non-medical purposes. See R.I.
Gen. Laws § 21-28.6-3(15)(defining “medical use”) and R.I. Gen.
Laws § 21-28.6-2(5)(legislative findings making distinction between
medical and non-medical use).
2. The protections and
immunities for participation in the Rhode Island Medical Marijuana
Program set forth in R.I. Gen. Laws §§ 21-28.6-4 (patient and
caregivers), 21-28.6-12(h)(compassion centers), and
21-28.6-16(m)(cultivators) do not apply to any activities beyond the
borders of the state of Rhode Island.
C. DBR’s Role in
Administration of the Rhode Island Medical Marijuana Program
1. DBR is responsible for the
administrative functions required to implement the provisions of the
Act and the DBR Regulations related to compassion centers, licensed
cultivators, and cooperative cultivations, including but not limited
to l icensing, operational requirements, and enforcement. See R.I.
Gen. Laws § 42-14-2(a)(4).
2. DBR and DOH have jointly
determined that DBR will primarily administer all aspects of the
medical marijuana plant tag program to fulfill the state obligation
to monitor and verify compliance with the statutory requirements that
patient cardholders electing to grow and primary caregiver
cardholders do not exceed plant limits, properly tag all permitted
plants, and do not grow at more than one location. See R.I. Gen.
Laws § 21-28.6-15 and § 21-28.6-4; DOH Regulations
216-RICR-20-10-3.6.3(B)(1).
D. DBR General Rulemaking
Authority
R.I. Gen. Laws § 42-14-17
provides that DBR may promulgate such rules and regulations as are
necessary and proper to carry out the duties assigned to it by any
provision of law.
E. Procedural Rules
Enforcement hearings shall be
handled in accordance with Department of Business Regulation Central
Management Regulation 2 entitled Rules of Procedure for
Administrative Hearings and the Rhode Island Administrative
Procedures Act, R.I. Gen. Laws § 42-35-1 et seq .
F. Acceptance of Electronic
Records and Signatures
In accordance with the
Uniform Electronic Transactions Act (UETA), R.I. Gen. Laws §
42-127.1-1 et seq ., DBR may determine whether, and the extent
to which, it will accept electronic records, documents,
notifications, and signatures from other persons or entities where
the Act or DBR administered regulations refer to written records,
documents, notifications, and signatures.
1.2 Compassion Center Registration
Application and Licensing Provisions
A. Authority
R.I. Gen. Laws §
21-28.6-12(b)(1)(i) authorizes DBR to promulgate regulations
regarding the form and content of registration and renewal
applications for compassion centers.
B. Compassion Center
Application and Registration Timeline
1. Applications for compassion
centers may only be submitted to DBR for consideration during an open
application period announced by DBR. Open application periods will
only be announced upon revocation, relinquishment, or expiration of
an existing compassion center, as provided in R.I. Gen. Laws §§
21-28.6-12(b)(7)(ii), 21-28.6-12(b)(8), and 21-28.6-12(d)(3).
2. Upon notification of an
approval of an application from DBR, the approved applicant must take
reasonable and documented efforts to complete the prerequisites for
issuance of the registration which steps are detailed in § 1.2(E) of
this Part. If such efforts take longer than nine (9) months, the
approved applicant must show good cause to DBR why additional time
should be granted and the application approval should not be
rescinded.
3. Once the registration has
been issued by DBR, the compassion center must take reasonable and
documented efforts to launch compassion center activities, which for
purposes of this paragraph shall mean actual medical marijuana
cultivation, processing, packaging, manufacturing, authorized sales
and/or other medical marijuana activities requiring a compassion
center pursuant to the Act. If such efforts take longer than one (1)
year, the compassion center must show good cause to DBR why the
license should not be revoked for non-use.
C. Application for Compassion
Center Registration
1. DBR will evaluate
applicants based upon the information provided by applicants on the
application forms/submissions and otherwise obtained during the
application process.
2. Each application for a
compassion center shall be on such forms and through such submission
mechanisms as designated by DBR and shall include:
a. A non-refundable
application fee set by R.I. Gen. Laws § 21-28.6-12(c)(1)(i) ($250).
b. The applicant’s legal and
any d/b/a name(s), certificate of incorporation under R.I. Gen. Laws
§ 7-6-36 or certificate of authority under § 7-6-70, articles of
incorporation and bylaws, and, if applicable, documentation of
recognition as a tax-exempt organization by the US Internal Revenue
Service.
c. A business plan, including
scope of activities, budget and resource narratives, and timeline for
initiating operations.
d. The proposed physical
location of the compassion center (by plat and lot number, mailing
address, etc.), if a precise location has been determined. This may
also include one additional location to be used for the secure
cultivation of medical marijuana. If a precise physical location has
not been determined, a description of the general location(s) where
it may be sited, if approved, and the expected schedule for
purchasing or leasing said location(s). Regarding the proposed
physical location(s), the applicant shall submit:
(1) Evidence of compliance or
preliminary determination of compatibility of the location(s) with
the local zoning laws.
(2) Evidence that the physical
locations are not located within one thousand feet (1,000’) of the
property line of a preexisting public or private school in compliance
with R.I. Gen. Laws § 21-28.6-12(f)(2). For the purposes of this
paragraph, “private school” shall be deemed to refer to any
nonpublic institution of elementary or secondary (K-12th Grade)
education, accredited or recognized as a private school by the
department of elementary and secondary education or the school
committee of the city or town having jurisdiction over private
schools. For purposes of this paragraph, the 1000 foot distance
shall be measured from the secured compassion center premises, which
shall include allotted outdoor areas (such as parking and loading
areas), to the property line of the school, which shall include the
school building, land, and appurtenances.
(3) A draft diagram of the
proposed facilities, including where within the facility the medical
marijuana will be cultivated, stored, processed, packaged,
manufactured and dispensed, and where security alarms and cameras and
surveillance recording storage will be located, and showing the
location of the facility relative to streets and other public areas.
(4) A description of objective
parameters (such as distances from streets and public areas) and/or
proposed measures (such as black-out window shades) that ensure that
marijuana at the premises shall not be visible from the street or
other public areas.
(5) Evidence of either
ownership of property or agreement by owner of property to allow the
operation of a compassion center on the property, including the
cultivation and/or sale of medical marijuana, if property has already
been purchased or leased at the time of the application.
e. The legal name, current
address, and date of birth of each principal officer, director or
member of the compassion center.
f. A list of all persons or
entities (legal names and current addresses) having direct or
indirect authority over the management or policies of the compassion
center.
g. If a compassion center will
have a management agreement in place, it shall also include a copy of
the management agreement or management agreement proposal and a list
of persons who have any ownership interest or operational control
over the management company.
h. A list of all persons or
business entities (legal names and current addresses) having any
ownership interest in the applicant entity, whether direct or
indirect.
i. If the compassion center
premises and/or other operational assets will be owned or leased by a
person or entity other than the applicant, the legal name and current
address of such person or entity and a list of all persons or
entities (legal names and current addresses) having any ownership
interest in such entity, whether direct or indirect.
j. The legal names and current
addresses of all creditors holding a security interest in the
premises and/or other assets to be used in the compassion center
operations, if any.
k. Tax Affidavit in accordance
with R.I. Gen. Laws § 5-76-1 et seq.
l. Other written materials
which will allow DBR to determine the compassion center’s ability
to comply with the review criteria contained in R.I. Gen. Laws §
21-28.6-12(c)(3).
m. All other information
required by DBR as described in the application form.
3. Only applications which DBR
has determined to be complete (i.e., adequately address all
application requirements above) shall be eligible for review. An
applicant who submits an incomplete application shall receive written
notification from DBR regarding the specific deficiencies and shall
be allowed to resubmit additional material to address these
deficiencies within a reasonable timeframe.
D. Compassion Center
Application Review Criteria
DBR shall utilize the
criteria specified in R.I. Gen. Laws § 21-28.6-12(c)(3) of the Act
to review applications for a registration certificate to operate a
compassion center.
E. Prerequisites to Issuance
of Compassion Center Registration and Commencement of Operations
1. If an applicant seeking to
operate a compassion center is notified that its application has been
approved by DBR, it shall complete the below steps before a
registration certificate authorizing operation of a compassion center
will be issued.
2. Annual Compassion Center
Registration Fee: The annual registration fee set by R.I. Gen. Laws
§ 21-28.6-12(c)(5)(i)($5000) must be paid.
3. Final Information and
Documentation to be Supplied: The applicant must provide any updates
to previously submitted application information and the following
additional items to DBR:
a. A sufficient description of
the final physical location of the compassion center (by plat and lot
number, mailing address, etc.). This shall include any additional
address to be used for the secure cultivation of medical marijuana
(if applicable).
b. Evidence of complete
compliance of the facility with the local zoning laws in the form of
a letter from an authorized zoning official of the municipality and
certification by an authorized officer of the applicant as to
compliance with any other applicable local ordinances.
c. Unless already provided at
time of initial application, evidence that all of the physical
addresses to be utilized as a compassion center or for the secure
cultivation of medical marijuana are not located within one thousand
feet (1,000’) of the property line of a preexisting public or
private school. See § 1.2(C)(2)(d)(2) of this Part.
d. A current Certificate of
Occupancy (or equivalent document) to demonstrate compliance with the
relevant provisions of Chapters 28.1 and 27.3 of Title 23 of the R.I.
General Laws [Fire Safety Code and State Building Code, respectively]
for each physical address to be utilized as a compassion center or
for the secure cultivation of medical marijuana.
e. Evidence of either
ownership of property or agreement by owner of property to allow the
operation of a compassion center on the property, including the
cultivation and/or sale of medical marijuana.
f. A final diagram of the
proposed facilities, including where within the facilities the
medical marijuana will be cultivated, stored, processed, packaged,
manufactured and dispensed, and where security alarms and cameras and
surveillance recording storage will be located, and showing the
location of the facilities relative to streets and other public
areas.
g. The name, address and date
of birth of any person who will be an agent, employee or volunteer of
the compassion center at its inception.
h. Evidence of completion of
divestiture plan pursuant to § 1.2(E)(6)(e) of this Part.
4. In accordance with R.I.
Gen. Laws § 21-28.6-12(f)(5), request that RISP visit the compassion
center to inspect the facility security and make any recommendations
regarding the security of the facility and its personnel within ten
(10) business days prior to the initial opening of the compassion
center and any alternative cultivation site.
5. DBR Pre-Registration
Inspection
Before a compassion center
registration will be issued, a DBR inspection is required. Approved
applicants should contact DBR to coordinate said inspection. Nothing
in this paragraph should be construed as limiting inspections at an
earlier time in addition to the final pre-registration inspection.
6. Divestiture of Prohibited
Material Financial Interest and Control
a. A compassion center and
“key persons” thereof may not have any “material financial
interest or control” in another compassion center, a cultivator, or
a licensed cooperative cultivation or vice versa. See R.I. Gen. Laws
§ 21-28.6-12(c)(1)(iii)(limiting a compassion center to one
additional location to cultivate its marijuana); R.I. Gen. Laws §
21-28.6-12(b)(1)(ii)(DBR minimum oversight over compassion centers);
R.I. Gen. Laws § 21-28.6-16(i)(cultivator to be licensed at one
location only); R.I. Gen. Laws § 21-28.6-16(b)(2)(DBR minimum
oversight over cultivators); R.I. Gen. Laws § 21-28.6-3(4)(i) and
R.I. Gen. Laws § 21-28.6-3(12)(separately defining “compassion
center” and “licensed cultivator,” respectively); R.I. Gen.
Laws § 21-28.6-14(a)(10)(DBR authority to regulate operations of
licensed cooperative cultivations); R.I. Gen. Laws §
21-28.6-4(q)(qualifying patient and primary caregiver cardholders may
only grow at one location).
b. R.I. Gen. Laws §
21-28.6-12(f)(10) authorizes regulations regarding testing of medical
marijuana and marijuana product cultivated and/or manufactured by
compassion centers, which will include ensuring the independence of
third party testing providers. Accordingly, a compassion center may
not have any material financial interest or control in a Rhode Island
DOH-approved third party testing provider and vice versa.
c. “Material financial
interest or control” shall mean: i) any ownership interest,
regardless of the size of the holding, and including any ownership
interest through a subsidiary or affiliate; ii) trusteeship,
mortgage, guarantor, endorser or surety relationship, or loan
relationship, except that loan relationship for the purposes of this
definition shall exclude accounts payable and accounts receivable on
account of a medical marijuana purchase order; iii) any other
beneficial financial interest such that the holder bears the risk of
loss (other than as an insurer) or has an opportunity to gain profit
from the operation or sale of the regulated medical marijuana
business; iv) operational control, including but not limited to
interlocking directors or officers or through a management agreement.
d. “Key persons” shall
mean officers, directors, and any persons with managing or
operational control.
e. Therefore, if a compassion
center application is approved and any prohibited material financial
interest or control has been identified by DBR or is otherwise known
to the compassion center applicant, such interest or control must be
divested prior to issuance of the compassion center registration
certificate. The plan of divestiture shall be filed with DBR.
f. The duty to divest
prohibited material financial interests and control is a continuing
obligation of registration.
7. Registry Identification
Card Requirements
Before commencement of
operations, all principal officers, board members, employees, agents,
and volunteers of the compassion center must apply for a registry
identification card and submit to a national criminal background
check as provided in § 1.3 of this Part. Such individuals may be
hired, appointed, or retained prior to receiving a registry
identification card, but may not begin engagement in medical
marijuana cultivation, storage, processing, packaging, manufacturing,
transport, dispensing or other medical marijuana activities requiring
registration pursuant to the Act until receipt of the card.
F. DBR Post-Registration
Inspection of Operations and Inventory
After the compassion center
registration is issued, the compassion center shall notify DBR when
it obtains inventory and commences operations. DBR may conduct a
post-licensure inspection upon this commencement of operations,
including but not limited to inspection for compliance of medical
marijuana and marijuana product inventory with the tagging and
tracking requirements set forth in § 1.4(E) of this Part. Nothing
in this paragraph shall be construed to limit DBR’s general
inspection powers as delineated in § 1.4(K) of this Part.
G. Changes in Location, Floor
Plan, Ownership and Control of Compassion Center; Continuing Duty to
Update Application Information; Discontinuation of or Failure to
Launch Compassion Center Activities
1. A registration certificate
authorizing operation of a compassion center shall not be assigned or
otherwise transferred to other persons or locations.
2. A compassion center shall
provide DBR with a written notice of any change described below at
least sixty (60) calendar days prior to the proposed effective date
of the change:
a. A change in ownership of
the compassion center.
b. Change in the membership of
a board of directors or board of trustees.
c. Change in corporate
officer.
d. Merger, dissolution, or
entity conversion.
e. Entering into a management
agreement, changing management companies, and/or material changes to
an existing management agreement.
f. Changes in the approved
premises location for cultivation and/or sale of medical marijuana.
g. Change to approved premises
floor plan.
h. Proposed premises
expansion.
3. Unless the compassion
center provides timely notification of the above changes and receives
prior DBR approval or waiver of the requirement of prior notice and
approval (for example a non-material change in ownership or emergency
situation as determined by DBR), the registration certificate shall
be void and returned to DBR.
4. As to any proposed change
of ownership or to a management agreement that will effect a change
of majority control and/or decision-making authority with respect to
the operation of the compassion center or as to any proposed change
in an approved premises location for the cultivation and/or sale of
medical marijuana, DBR may require the compassion center to follow
the process for a new application, which may include a new
application fee and/or hearing.
5. For updates in information
other than the categories requiring sixty (60) calendar days prior
notice, the compassion center has a continuing obligation to update,
amend and/or correct any information requested and/or submitted in
the application process within ten (10) business days after any
change in the information submitted and/or any material change in
circumstances related to the application. This includes timely
notification and divestiture if a prohibited interest as delineated
in § 1.2(E)(6) of this Part is acquired by operation of law.
6. If the compassion center
proposes to alter the final floor plan previously submitted and
approved, the compassion center must first submit a renovation plan
for DBR approval 60 (sixty) calendar days prior to commencement of
construction. The renovation plan must specifically address quality
control procedures for the protection of medical marijuana and
medical marijuana products from any contamination during the
construction process and further address any other criteria DBR
requires.
7. In addition to the
requirements of paragraph 6 above, any expansion of the approved
premises further requires explanation by the compassion center that
the request to expand is justified by the projected needs of
qualifying patients. See R.I. Gen. Laws § 21-28.6-12(i)(1).
8. The registration
certificate shall be void and returned to DBR if the compassion
center discontinues its operation, unless the discontinuance is on a
temporary basis approved by DBR. Once a registration certificate is
issued, the compassion center must take reasonable and documented
efforts to launch compassion center activities. If such efforts take
longer than one (1) year, the compassion center must show good cause
to DBR why the registration certificate should not be revoked.
H. Annual Renewal
1. Compassion center
registrations shall be issued for one year terms.
2. Annual renewals shall be
submitted on such forms and include such information as prescribed by
DBR.
3. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(d)(2), DBR’s review of compassion center renewal
applications shall include consideration of whether the compassion
center is adequately providing patients with access to medical
marijuana at reasonable rates.
4. An annual inspection shall
be part of the annual renewal process.
1.3 Compassion Center Cardholder
Registry Identification Card Provisions
A. Compassion Center
Cardholder Definitions
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-3(4)(ii), “compassion center cardholder” includes all
principal officers, board members, employees, agents, and volunteers
associated with the compassion center.
2. “Agent” of a compassion
center shall include, but not be limited to, “testing agents.”
3. “Testing agent” shall
mean an employee of an approved third party testing provider who
performs independent testing of medical marijuana and/or marijuana
products of the compassion center in accordance with the DOH Testing
Regulations, once adopted.
B. Registry Identification
Card Requirement, Eligibility, Annual Fee and Application
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(c)(6), all principal officers, board members,
employees, agents, and volunteers of a compassion center must apply
for compassion center registry identification cards.
2. Each compassion center
shall maintain a current list of all compassion center cardholders
associated with that compassion center.
3. Compassion center
cardholders shall be at least twenty-one (21) years old.
4. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(c)(6), DBR hereby sets the non-returnable,
non-refundable annual fee for a compassion center registry
identification card, including each initial application and
subsequent annual renewal, at one hundred dollars ($100.00).
5. Applications pursuant to
this section shall be on such forms and through such submission
mechanisms as directed by DBR.
6. Eligibility for the
compassion center “volunteer” designation shall be limited to
persons whose volunteer activities and use of compassion center
resources is strictly limited to participation in educational
programming conducted for compassion center cardholders and
registered qualifying patients, primary caregivers, and authorized
purchasers. Volunteers shall not be permitted to be otherwise
involved in the growth, cultivation, weighing, packaging or labeling,
manufacturing, processing, dispensing or sale of medical marijuana.
C. Criminal Background Checks
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(c)(7), all compassion center cardholders will be
subject to a national criminal background check as part of their
application for a compassion center registry identification card
(hereinafter also referred to in this section as “applicants”).
2. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(c)(7), DBR shall deny an application for registration
if the background check reveals the applicant has been convicted of a
felony drug offense or has entered a plea of nolo contendere for a
felony drug offense and received a sentence of probation, unless the
applicant successfully petitions for an exception pursuant to §
1.3(C)(8) of this Part.
3. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(c)(7)(i), applicants shall apply to RISP for a national
criminal identification records check that shall include fingerprints
submitted to the Federal Bureau of Investigation.
4. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(c)(7)(i), upon the discovery of a felony drug offense
conviction or a plea of nolo contendere for a felony drug offense
with a sentence of probation, RISP shall inform the applicant, in
writing, of the nature of the felony.
5. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(c)(7)(i), upon discovery of disqualifying information,
RISP shall notify DBR, in writing, without disclosing the nature of
the felony, that a felony drug offense conviction or a plea of nolo
contendere for a felony drug offense with probation has been found.
6. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(c)(7)(ii), in those situations in which no felony drug
offense conviction or plea of nolo contendere for a felony drug
offense with probation has been found, RISP shall inform the
applicant and DBR, in writing, of this fact.
7. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(c)(7)(iii), applicants shall be responsible for any
expense associated with the national criminal background check with
fingerprints.
8. R.I. Gen. Laws §
21-28.6-12(c)(7) provides DBR with discretion to grant a compassion
center registry identification card if the disqualifying offense was
for conduct that occurred prior to the enactment of the Act or that
was prosecuted by an authority other than the state of Rhode Island
and for which the Act would otherwise have prevented a conviction.
To seek relief from criminal background disqualification pursuant to
R.I. Gen. Laws § 21-28.6-12(c)(7), the applicant must make the
request for relief to the DBR in writing, setting forth in detail why
the Act would have prevented a conviction, including all applicable
court records and legal documents. The DBR may conduct a hearing on
the issue and, if so, the applicant shall bear the burden of proof to
show why the relief should be granted.
9. R.I. Gen. Laws §
21-28.6-12(c)(7) provides that the compassion center will be notified
in writing of the purpose for denying a compassion center cardholder
application. DBR shall limit its disclosure of the purpose to a
statement of the fact that disqualifying information was found,
without revealing to the compassion center any further detail of the
offense.
10. DBR will not require a
person subject to a national criminal background check under this
subsection to undergo such a check more than once every two (2)
years, unless a more frequent time frame is mandated and/or agreed to
as part of a license disciplinary action.
D. Issuance of the Compassion
Center Registry Identification Card
1. Once the application is
approved by DBR, the principal officer, board member, agent,
volunteer or employee of the compassion center is responsible for
getting a registry identification card from DOH.
2. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(c)(6), the registry identification card shall contain:
a. The name, address and date
of birth of the person.
b. The legal name of the
compassion center that the individual is affiliated with.
c. The category of the
person’s affiliation: principal officer, board member, employee,
agent, or volunteer.
d. The date of issuance and
expiration date of the registry identification card.
e. A random registry
identification number.
f. A photograph.
E. Expiration and Renewal of
Compassion Center Registry Identification Cards
Pursuant to R.I. Gen. Laws §
21-28.6-12(c)(8), compassion center registry identification cards
shall expire one year after issuance. Renewal applications shall be
on such forms and through such submission mechanisms as directed by
DBR.
F. Change in Name or Address;
Lost/Stolen Cards
1. In accordance with R.I.
Gen. Laws § 21-28.6-12(c)(9), a compassion center cardholder shall
notify DBR of any change in his or her name or address within ten
(10) business days of such change. A compassion center cardholder
who fails to notify DBR of any of these changes may be subject to a
fine up to one hundred fifty dollars ($150).
2. In accordance with R.I.
Gen. Laws § 21-28.6-12(c)(10), changes in name and/or address
require the compassion center cardholder to remit a ten dollar
($10.00) fee to DBR. Upon receipt of the notice and fee, DBR will
prompt DOH to issue an updated registry identification card. The
compassion center cardholder shall be responsible for getting the
updated registry identification card from DOH.
3. In accordance with R.I.
Gen. Laws § 21-28.6-12(c)(11), if a compassion center cardholder
loses his or her registry identification card (which would
particularly include a card suspected to be stolen), he or she shall
notify DBR and submit a ten dollar ($10.00) fee within ten (10)
business days of losing the registry identification card. Upon
receipt of the notice and fee, DBR will prompt DOH to issue a
replacement registry identification card. The compassion center
cardholder shall be responsible for getting the replacement registry
identification card from DOH.
G. Duty to Notify DBR of
Disqualifying Criminal Information
Pursuant to R.I. Gen. Laws §
21-28.6-12(c)(13), a compassion center cardholder shall notify DBR of
any disqualifying criminal convictions as defined in § 21-4
28.6-12(c)(7). Such notification must be made in writing within ten
(10) business days.
H. Termination of Compassion
Center Registry Identification Card
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(i), a person found to have dispensed marijuana to a
non-cardholder or in excess of the statutory limits is not eligible
to be a compassion center cardholder, and such person's registry
identification card shall be immediately revoked.
2. If a compassion center
cardholder violates any other provisions of the Act, DBR Regulations,
or DOH Regulations, his or her registry identification card may be
suspended/revoked as determined by DBR pursuant to R.I. Gen. Laws §
21-28.6-12(c)(14).
3. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(f)(3), when a compassion center cardholder ceases work
with a compassion center, whether voluntarily or involuntarily or
upon the compassion center closing, his or her registry
identification card shall be null and void. See also R.I. Gen. Laws
§ 21-28.6-12(c)(8). In that situation, the compassion center and/or
the compassion center cardholder shall notify DBR and the registry
identification card shall be returned to DBR within ten (10) business
days. No hearing shall be necessary to render the card null and void
in this situation. In addition to being null and void, a penalty of
up to one hundred and fifty dollars ($150) may be assessed for
failure to return the card within the ten (10) day period.
1.4 Compassion Center Operational
Provisions
A. State Medical Marijuana
Program Tracking System
Upon direction by the DBR and
in accordance with R.I. Gen. Laws § 21-28.6-12(g)(3), each
compassion center shall be required to utilize the state approved
Medical Marijuana Program Tracking System to document and monitor
compliance with the Act, the DBR Regulations, and the DOH
Regulations, including but not limited to seed to sale and point of
sale tracking, dispensing limits and the patient information privacy
protections, inventory supply tracking, adherence to restrictions on
third party supply and sources of marijuana and marijuana products
and transfers thereof off the registered premises, and all testing
compliance tracking. Compassion centers may be required to pay costs
associated with use of the Medical Marijuana Program Tracking System
which may be assessed on an annual, monthly, per use, or per volume
basis and payable to the state or to its approved vendor.
B. Permitted and Prohibited
Sources of Marijuana; Contract Requirement
1. A compassion center can
only legally purchase or otherwise receive marijuana from a Rhode
Island licensed cultivator as authorized by R.I. Gen. Laws §
21-28.6-16(e), which has a “formal agreement” requirement.
2. “Formal agreement”
requirements shall be as follows: A written executed contract or
purchase order shall be required for all sales from a licensed
cultivator to a compassion center and shall contain the following
minimum terms: a) date of execution/placement of the
contract/purchase order, b) description and amount of product to be
sold; c) the total and per unit price of the product to be sold; d)
the specific date or date range not spanning more than thirty (30)
calendar days for fulfillment of the order and delivery or pickup; e)
the payment due date, as specifically agreed between the parties, but
if no date is specifically agreed to, payment shall be made within
sixty (60) calendar days of delivery or pickup. Contracts/purchase
orders pursuant to this paragraph may not be modified but may be
cancelled or voided by the creation of a new replacement
contract/purchase order.
3. In accordance with R.I.
Gen. Laws § 21-28.6-4(c) and (i), a compassion center cannot
purchase or otherwise receive marijuana from any qualifying patient
cardholder or primary caregiver after December 31, 2016. This
prohibition extends to purchases and transfers from cooperative
cultivations.
C. Permitted and Prohibited
Sales and Transfers
1. Sales to qualifying
patients, directly or through their caregivers or authorized
purchasers, are only permitted if those qualifying patients,
caregivers, or authorized purchasers are registered with DOH. For
such sales, a compassion center shall be strictly bound by the
dispensing limits of R.I. Gen. Laws § 21-28.6-12(g). Sales for
delivery to a qualifying patient cardholder’s residence are deemed
permitted provided that such sales comply with § 1.4(J)(3)(e) of
this Part.
2. A compassion center is
permitted to transfer or transport medical marijuana and marijuana
products to a Rhode Island licensed cultivator only if the
transfer/transport is pursuant to a written contract or purchase
order for the cultivator to process the medical marijuana into a
product to be furnished back to the compassion center.
3. Any transfer to or from a
third party testing provider shall be in accordance with the DOH
Testing Regulations, once adopted.
4. Unless specifically
permitted by this section, no other compassion center sales or
transfers of marijuana or marijuana products are permitted.
D. Inventory Limit
Pursuant to R.I. Gen. Laws §
21-28.6-12(i)(1), a compassion center must limit its inventory of
seedlings, plants, and usable marijuana to reflect the projected
needs of qualifying patients.
E. Medical Marijuana and
Marijuana Product Tagging for Compassion Centers
1. The compassion center shall
properly use tags with unique identifiers through the Medical
Marijuana Program Tracking System, or if prior to the implementation
of the Marijuana Program Tracking System, DBR will advise the
compassion center of acceptable alternative inventory tagging and
tracking systems and protocols. In such a case, any references to
the Medical Marijuana Program Tracking System in this section shall
be deemed to include the acceptable alternatives.
2. Compassion centers must
ensure that medical marijuana is marked with Medical Marijuana
Program Tracking System unique identifier tags through each stage of
production the compassion center is undertaking, from seed
propagation through packaging, as may be applicable.
3. Medical Marijuana Program
Tracking System unique identifier tags shall contain the following
information and/or technical functions:
a. DBR registration number.
b. Unique identifier(s) (such
as barcodes and/or numerical/alphabetical codes) that track marijuana
product through each stage of production.
c. Registered premises
location.
d. Any other information or
technical functions DBR deems appropriate (such as radio frequency
identification).
4. Medical Marijuana Program
Tracking System unique identifier tags shall not be altered or
duplicated.
5. Unique identifier tags
shall be placed in a manner so as to clearly display their
association with a particular plant, plant material, or product, such
as affixed to the plant itself, on the growing receptacle, or in the
growing medium, by labeling drying racks and other receptacles that
wet marijuana dries on, by affixing the tag to the stalk for drying
on the stalk, on a label affixed to a storage/transport package
and/or retail-ready package, and other reasonable means.
6. The unique identifier tags
may not be transferred or assigned except when affixed to marijuana
plants, wet marijuana, or usable marijuana which is being
sold/transferred/transported in accordance with § 1.4(B), (C), and
(J)(3) of this Part.
7. Return of unique identifier
tags by the compassion center upon revocation or abandonment of the
license shall be specifically governed by DBR order or agreement
which may include coordinated efforts with law enforcement. Disposal
of unique identifier tags by the compassion center as may be required
by DBR, such as in the regular course of tagging if different stages
will require different tag forms or such as recall of tags due to new
technology, shall be handled in accordance with further instructions
provided by DBR.
F. Inventory Control
1. Upon direction by DBR, each
compassion center shall utilize the state approved Medical Marijuana
Program Tracking System for all inventory tracking from seed to sale
as further defined herein.
2. If the compassion center is
notified by DBR that the Medical Marijuana Program Tracking System is
not available, the compassion center will be provided with direction
as to alternative inventory control measures, which may include but
are not necessarily limited to the compassion center being directed
to:
a. Conduct an initial
comprehensive inventory of all medical marijuana, including usable
marijuana available for dispensing, marijuana plants and seedlings,
unusable marijuana, and wet marijuana, at each authorized location on
the date the compassion center first dispenses medical marijuana or
as of another date certain set by DBR.
b. Conduct subsequent
comprehensive inventories at intervals not to exceed twenty-four (24)
months from the date of the previous comprehensive inventory.
c. Conduct a monthly inventory
review of stored, usable marijuana, seedlings, plants, and wet
marijuana.
3. Upon request, DBR may
require a compassion center to conduct and provide the results of
alternative inventory control measures outlined above, regardless of
the availability and use of the Medical Marijuana Program Tracking
System.
G. Minimum Security
Requirements
1. Authority
R.I. Gen. Laws §
21-28.6-12(b)(1)(iv) authorizes DBR to promulgate regulations
regarding the minimum security requirements for compassion centers.
2. General Security
Requirements
a. Each compassion center
shall implement appropriate security and safety measures to deter and
prevent the unauthorized entrance into areas containing marijuana and
the theft of marijuana.
b. Use or carry of firearms on
the premises and/or perimeter of the compassion center is a
prohibited form of security, except by security guards licensed by
the Office of the Rhode Island Attorney General pursuant to R.I. Gen.
Laws § 5-5.1-13 and who are under written contract to provide
security services to the compassion center and by law enforcement
personnel during duty.
c. The outside perimeter of
the compassion center retail premises shall be well-lighted at all
times. For any alternative cultivation only site, the premises may
be equipped with motion activated lighting acceptable to DBR.
d. Except for persons whose
visit falls within § 1.4(G)(2)(e) of this Part below, any person who
does not have a valid compassion center registry identification card
who enters any area where marijuana and marijuana products are grown,
cultivated, stored, weighed, packaged, processed, manufactured or
sold shall be considered a “visitor” and must be escorted at all
times by a compassion center registry identification card holder.
The compassion must maintain a visitor log for any such activity as
detailed in § 1.4(G)(6)(d) of this Part.
e. Registered qualifying
patients, primary caregivers, and authorized purchasers are only
permitted within point of sale areas. In such areas, the compassion
center shall ensure that all marijuana and marijuana products are
kept behind the sales counter or other partition and make reasonable
efforts to limit the number of registered qualifying patients,
primary caregivers, and authorized purchasers present in relation to
the number of compassion center cardholders to assure adequate
monitoring and control of point of sale area activities.
f. Each compassion center
shall ensure that the storage of marijuana and any marijuana products
is in a locked area, meaning that at all points of ingress and
egress, the compassion center shall ensure the use of a working
commercial-grade door lock.
3. Security Alarm Requirements
a. Each compassion center
shall have a fully operational security alarm system at each
authorized physical address that will provide suitable protection
against theft and diversion, including alarms at all outside
perimeter entry points and outside perimeter windows.
b. A fully operational
security alarm system may include a combination of hard-wired systems
and systems interconnected with a radio frequency method such as
cellular or private radio signals that emit or transmit a remote or
local audible, visual, or electronic signal; motion detectors,
pressure switches, duress alarms (a silent system signal generated by
the entry of a designated code into the arming station to indicate
that the user is disarming under duress); panic alarms (an audible
system signal to indicate an emergency situation); and hold-up alarms
(a silent system signal to indicate that a robbery is in progress).
c. A fully operational
security alarm system shall at a minimum provide for immediate
automatic or electronic notification to alert municipal and/or state
law enforcement agencies or public safety personnel to an
unauthorized breach or attempted unauthorized breach of security at
the compassion center or any other authorized physical address and to
any loss-of-electrical support backup system to the security alarm
system.
d. Each compassion center
shall establish a protocol for the testing and maintenance of the
security alarm system, which shall at a minimum provide for a
maintenance inspection/test of the alarm system for each authorized
location at intervals not to exceed thirty (30) calendar days from
the previous inspection/test and prompt completion of all necessary
repairs to ensure the proper operation of the alarm system.
e. If the compassion center
suffers a failure of the security alarm system, due to loss of
electrical support, mechanical function, or otherwise, that is
expected to exceed an eight (8) hour period, in addition to the
notice requirements provided in § 1.4(G)(3)(c) and (G)(7) of this
Part, the compassion center must also close the authorized physical
address(es) impacted by the failure/malfunction until the security
alarm system has been restored to full operation, or, if approved by
DBR, provide alternative security.
4. Video Surveillance
Requirements
Each compassion center must
have a fully operational video surveillance and camera recording
system with appropriate protocols, which shall, at a minimum, comply
with the below requirements:
a. Video surveillance
equipment shall, at a minimum, consist of digital or network video
recorders, video monitors, and digital archiving devices capable of
playback quality sufficient to identify and monitor all individuals
(including sufficient clarity of facial features) and activities in
the monitored areas.
b. The recording system must
record in digital format.
c. The date and time must be
embedded on the recording without significantly obscuring the
picture. Time is to be measured in Eastern Standard Time.
d. All video surveillance
systems must be equipped with a failure notification system that
provides prompt notification of any surveillance interruption and/or
the complete failure of the surveillance system. Said
notification must be routed to compassion center personnel
specifically designated by management and to DBR.
e. All video surveillance
equipment shall have sufficient battery backup to support a minimum
of four (4) hours of recording in the event of a power outage.
f. Video recordings must be
archived in a format and maintained in a manner that ensures
authentication of the recording as legitimately-captured video and
guarantees that no alteration of the recorded image has taken place.
g. Remote access to a
continuous live feed video on a real time basis must be available at
all times to compassion center personnel specifically designated by
management and to DBR. Additionally, all video surveillance
records and recordings must be made available upon request to DBR.
DBR employees and representatives will hold video surveillance
records and recordings of point-of-sale areas confidential except for
authorized release in accordance with applicable law.
h. The system must include a
color printer or similar equipment capable of printing still photos
of a quality sufficient to identify individuals and activities in the
monitored areas.
i. Camera coverage is required
for all areas where marijuana and marijuana products are grown,
cultivated, stored, weighed, packaged, processed, manufactured or
sold, including all areas of ingress and egress thereto,
point-of-sale areas, security rooms (as defined below), all points of
ingress and egress to the exterior of the compassion center, and any
computer or other digital access points.
j. Camera views of required
coverage areas shall be continuously recorded twenty (24) hours a
day, (7) seven days per week.
k. All surveillance recordings
must be kept for a minimum of sixty (60) calendar days.
l. Surveillance recording
equipment and all video surveillance records and recordings must be
housed in a designated, locked and secured room or other enclosure
with access limited to compassion center personnel specifically
authorized by management (the “security room”). The compassion
center must keep on site a current list of all authorized employees
and service personnel who have access to the security room and a
video surveillance equipment maintenance activity log.
m. If the compassion center
suffers a failure of the video surveillance system, due to loss of
electrical support, mechanical function, or otherwise, that is
expected to exceed an eight (8) hour period, in addition to the
notice requirements provided in § 1.4(G)(7) of this Part, the
compassion center must also close the authorized physical address(es)
impacted by the failure/malfunction until the video surveillance
system has been restored to full operation, or, if approved by DBR,
provide alternative premises monitoring.
5. Emergency Plan
The compassion center shall
develop and maintain an emergency plan with procedures to be followed
to prevent and, if not prevented, to adequately address and mitigate
consequences of theft or burglary or attempts thereof, fire, natural
disasters, and other emergencies, including cybersecurity and data
breach procedures to prevent a compromise of the integrity of the
Medical Marijuana Program Tracking System. The plan shall include
training for employees on crime prevention and personal safety
techniques.
6. Security-Related
Record-Keeping
The compassion center shall
maintain the following documentation on-site and with digital back-up
for a period of at least twenty-four (24) months after the event:
a. Inventory records
including, at a minimum, the date the inventory was conducted, a
summary of the inventory findings and the name, signature and title
of the individual who conducted the inventory.
b. All records of maintenance,
inspections, and tests of the security alarm and video surveillance
systems and of servicing, modifications, or upgrades performed on
said systems. These records shall include, at a minimum, the date of
the action, a summary of the action(s) performed and the purpose
therefor, and the name, signature and title of the individual who
performed the action(s).
c. Emergency notification
reports as required by § 1.4(G)(7) of this Part.
d. Visitor logs which shall
include the name of each visitor, the date and time of the beginning
and end of the visit, the reason for the visit (i.e. maintenance,
authorized pickup, etc.), the name of the escorting compassion center
registry identification cardholder.
7. Emergency Notifications and
Reports
a. Compassion centers shall
provide notification of emergency events to DBR and municipal and/or
state law enforcement as outlined below.
b. Immediately upon discovery
of the event, the compassion center shall provide telephone
notification to the appropriate municipal and/or state law
enforcement authorities regarding any of the following “emergency
events”:
(1) Theft or burglary or an
attempt thereof.
(2) Any fire.
(3) A natural disaster that
results in the destruction of or damage to medical marijuana or
marijuana products.
(4) A failure of the security
alarm system or video surveillance system, due to loss of electrical
support, mechanical function, or otherwise, that is expected to
exceed an eight (8) hour period.
(5) A security alarm
activation.
(6) Any other event which
requires response by law enforcement or public safety personnel.
c. The compassion center shall
provide e-mail notification to DBR immediately upon discovery of any
data breach or cybersecurity threat to the Medical Marijuana Program
Tracking System, and within twenty-four (24) hours of discovery of
any other emergency event as defined above. A follow-up telephone
notification to DBR shall be provided no later than the next business
day.
d. The compassion center shall
submit a follow-up written report to DBR within five (5) business
days for each emergency event. The written report shall include, at
a minimum, a description of the event(s), identification of known or
suspected cause(s) for the event(s), any corrective action(s) taken
to prevent a recurrence, and the name, title, and signature of the
individual preparing the report.
e. Any notification and report
of an emergency event required to be made to DBR pursuant to these
DBR Regulations shall be made using the mailing address, telephone
number, and/or e-mail address provided by DBR to approved licensees.
f. Upon written direction to
the compassion center, DBR may require that the written and telephone
notifications and reporting must be replaced or supplemented by
notifications and reporting through the Medical Marijuana Program
Tracking System or any other electronic system or means DBR mandates
the compassion center to utilize.
H. Record-Keeping and
Reporting
1. Authority
R.I. Gen. Laws §
21-28.6-12(b)(1)(iii) authorizes DBR to promulgate regulations
regarding the minimum record-keeping requirements for compassion
centers.
2. Operations Manual
Each compassion center shall
develop, implement, and maintain on the premises an operations manual
which addresses, at a minimum, the following subject areas and
requirements:
a. Procedures for the
organization, administration, command, and control of the compassion
center (including but not limited to organizational chart, chain of
command protocols, etc.).
b. Procedures for safely
dispensing medical marijuana only to registered qualifying patients,
registered primary caregivers, and authorized purchasers, including
procedures for verifying authenticity of registry identification
cards and other forms of identification.
c. Procedures to ensure
accurate record-keeping, including protocols to ensure that all
acquisitions, dispensing, and sales of marijuana are logged into the
Medical Marijuana Program Tracking System on a real time basis and
that all dispensing and sales transactions to registered qualifying
patients, primary caregivers, and authorized purchases adhere to the
limits for usable marijuana prescribed by statute and the marijuana
product equivalency limits set by the DOH regulations, and procedures
on proper training and use of the Medical Marijuana Program Tracking
System and any other tracking system used by the compassion center.
d. Records retention policies.
e. Ethics and compliance
policies.
f. Alcohol and drug free work
place policy.
g. If applicable, medical
marijuana manufacturing protocols, safety measures, and training
information.
h. Odor control and mitigation
plan.
i. A description of the
compassion center’s outreach activities to registered qualifying
patients, registered primary caregivers, and authorized purchasers.
j. Customer service protocols.
3. Personnel Records
Each compassion center shall
maintain a personnel record for each employee, agent or volunteer for
a period of at least six (6) months after termination of the
individual’s affiliation with the compassion center. Said
personnel record shall contain the following minimum documentation
and information:
a. An application for
employment or to volunteer or offers to provide services as an agent.
b. An employment or engagement
description detailing duties, responsibilities, authority,
qualifications and supervision.
c. If applicable, a copy of
any employment or engagement contract or, for volunteers, volunteer
agreement.
d. A record of any
disciplinary action taken.
e. Documentation of all
required training, which shall include a signed statement from the
individual indicating the date, time and place he or she received
said training, topics discussed, and the name and title of
presenters.
4. Additional Records to be
Maintained
In addition to all other
specific record-keeping requirements of the Act, the DBR Regulations,
and the DOH Regulations, the compassion center shall maintain the
following records for a minimum of five (5) years:
a. All contracts and purchase
orders with licensed cultivators, including documentation of any
cancelled contracts or purchased orders and any contracts and
purchase orders voided by replacement contracts.
b. Invoices and any supporting
documentation of all marijuana purchases, acquisitions, transfers,
and payments.
c. Contracts pertaining to the
security alarm and security camera systems.
d. Contracts with vendors,
including any approved third party testing providers.
e. All records normally
retained for tax purposes.
5. Storage of Records
Records pertaining to
transactions occurring within the last six (6) months shall be stored
on the registered premises. Records dating further back may be
stored off the premises with DBR’s approval.
6. Responsibility for Loss of
Records and Data
The compassion center shall
exercise due diligence and reasonable care in preserving and
maintaining all required records to guard against loss of records and
data, including cybersecurity of electronically-maintained records.
I. Product Packaging and
Labeling Requirements
1. Authority and Applicability
a. These product packaging and
labeling requirements for compassion centers are promulgated pursuant
to R.I. Gen. Laws § 21-28.6-12(f)(11). These requirements were
developed jointly with DOH.
b. Compassion centers shall
have ninety (90) calendar days from the effective date of these
regulations to comply with these requirements.
c. Any container or packaging
containing usable marijuana or marijuana product, including both
retail-retail ready packaging and product otherwise packaged for the
purpose of storage and/or authorized transport, must:
(1) Protect the product from
contamination.
(2) Not impart any toxic or
deleterious substance to the usable marijuana or marijuana product.
(3) Contain the Inventory
tracking ID number assigned by the Medical Marijuana Program Tracking
System or, if prior to the Medical Marijuana Program Tracking
System’s implementation, an inventory tracking ID number generated
from an alternative inventory tracking system approved by DBR.
(4) Be labeled with the
quantity of the product.
d. The remainder of these
product packaging and labeling requirements only apply to
retail-ready product packaging and labeling.
e. Compliance with these
product packaging and labeling requirements shall include the
requirement that retail-ready product complies with the DOH Testing
Regulation, once adopted.
f. While a compassion center
is permitted to purchase medical marijuana and medical marijuana
products from a Rhode Island licensed cultivator pursuant to a
written contract/purchase order, including final products that have
already been packaged, labeled, and/or tested, the compassion center
is responsible for ensuring the integrity of the product, compliance
of the packaging and labeling, including particularly that the
products have the correct composition and profiles that are
advertised/indicated in the label.
2. Packaging and labeling
shall not:
a. Make any false or
misleading statements including particularly any statements regarding
health or physical benefits to the consumer and the composition and
profiles that are advertised/indicated in the label.
b. Resemble the trademarked,
characteristic or product-specialized packaging of any commercially
available snack, baked good, or beverage.
c. Contain any statement,
artwork, or design that could reasonably mislead any reasonably
prudent person to believe that the package contains anything other
than medical marijuana or marijuana product.
d. Contain any seal, flag,
crest, coat of arms, or other insignia that could reasonably mislead
any reasonably prudent person to believe that the product has been
endorsed or manufactured by the State of Rhode Island or any agency
thereof or municipality within.
3. Packaging for medical
marijuana and marijuana products sold at retail shall be opaque,
light-resistant, and tamper-evident.
4. Packaging and labeling
shall not be designed such that it would be attractive to children.
This requires the packing and labeling be in black and white only,
have no animal characters, and does not contain the word “candy.”
5. Medical marijuana and
marijuana products sold at retail must be packaged in manner that is
“child-resistant,” which for purposes of these Regulations shall
mean that the packaging is designed and constructed to be
significantly difficult for children under five years of age to open.
Approved methods include but are not limited to:
a. Solid or liquid marijuana
products may be packaged in plastic four mil or greater in thickness
and be heat sealed with no easy-open tab, dimple, corner, or flap.
b. Liquid marijuana products
may also be packaged in a bottle and sealed using a metal crown cork
style bottle cap or other similar sealing method pre-approved by DBR.
6. For solid edible marijuana
products with more than one serving size in the outer package, each
serving must be packaged individually and placed in a child-resistant
outer package.
7. For liquid edible marijuana
products with more than one serving in the package, a measuring cap
or dropper must be included in the package with the product.
8. All medical marijuana and
marijuana products when sold at retail must include a label affixed
to the package containing the following information, prominently
displayed and in a clear and legible English language font:
a. The business or trade name
of the selling compassion center.
b. Inventory tracking ID
number assigned by the Medical Marijuana Program Tracking System or,
if prior to the Medical Marijuana Program Tracking System’s
implementation, an inventory tracking ID number generated from an
alternative inventory tracking system approved by DBR.
c. Date of final packaging,
and, if applicable, the recommended expiration or “use by” date.
d. Total weight in ounces and
grams or volume as appropriate. Weight and volume must be determined
using accurately calibrated equipment which equipment must also
comply with any other applicable state laws.
e. Total estimated amount of
THC and total estimated amount of CBD.
f. For edible marijuana
products, a list of all ingredients used.
g. A statement that discloses
all pesticides applied to the marijuana plants and growing medium
during production and processing.
h. If solvents were used,
statement that discloses the type of extraction method, including any
solvents, gases, or other chemicals or compounds used to produce or
that are added to the extract.
i. Any applicable instructions
for use and safe storage.
9. All medical marijuana and
marijuana products when sold at retail must include a label affixed
to the package containing the following warnings, prominently
displayed and in a clear and legible English language font. For
products other than edibles and topical applications, these warnings
may be on an insert provided with the packaging.
a. “Warning: Marijuana has
intoxicating effects and may be habit forming and addictive. The
intoxicating effects of marijuana may be delayed by up to two hours.”
b. “Warning: Do not operate
a vehicle or machinery under its influence.”
c. “Warning: There may be
health risks associated with consumption of marijuana.”
d. “Warning: For use only by
adults twenty-one and older. Keep out of reach of children.”
e. “Warning: Marijuana
should not be used by women that are pregnant or breast feeding.”
f. “Warning: Do not take
this product across state lines.”
g. “Warning: For medical use
by a registered patient only. Not for resale.”
h. “Warning: This product is
not certified to be free of contaminants.”
i. For product to be smoked,
“Warning: Smoking is hazardous to your health.”
j. If applicable, a warning
regarding use or contact with any nuts or other known allergens as
defined in the federal Food Allergen Labeling and Consumer Protection
Act of 2004, as administered by the federal Food and Drug
Administration.
10. Notwithstanding any of the
product labeling requirements set forth in § 1.4(H) of this Part,
application may be made to DBR for approval to affix a two inch (2”)
by two inch (2”) logo or graphic, which may be colored, for the
purpose of identifying the compassion center selling and/or the
cultivator producing the product.
J. Other Compassion Center
Operation Requirements
1. Authority
R.I. Gen. Laws §
21-28.6-12(b)(1)(ii) authorizes DBR to promulgate regulations
regarding the minimum oversight requirements for compassion centers.
The requirements set forth in this section are promulgated in
accordance with that statutory duty of general regulatory supervision
over the compassion centers.
2. Use on Premises Prohibited
Compassion centers shall not
permit the use of marijuana or marijuana products on the premises of
the compassion center, including any parking areas that are
designated for compassion center clients or otherwise within the
control of the compassion center.
3. Transportation of Medical
Marijuana to and from a Compassion Center; Home Delivery
Transportation
a. “Authorized transports”
of marijuana and marijuana products to and from compassion centers
are limited to approved patient home delivery plans under §
1.4(J)(3)(e) of this Part and transports to and from licensed
cultivators for transactions authorized under § 1.4(C)(2) of this
Part.
b. “Registered/licensed
facility” shall refer to a either a registered compassion center or
licensed cultivator that is party to an “authorized transport,”
as the context requires.
c. “Authorized transport
vehicle” means a vehicle meeting the following criteria:
(1) The vehicle bears no
markings that indicate that the vehicle is being used to transport
marijuana nor indicates the name of the registered/licensed facility.
(2) The vehicle is equipped
with a global positioning system monitoring device that is monitored
by the originating registered/licensed facility during an authorized
transport.
(3) The vehicle has a locked
storage compartment within which the marijuana and marijuana product
being transported is secured.
d. “Detailed transport
manifest” refers to a manifest which DBR may require be generated
through and/or maintained in the Medical Marijuana Program Tracking
System and that shall include the following minimum information:
(1) Departure date and
approximate time of departure.
(2) Names, location addresses,
and registration/license numbers of the originating and receiving
registered/licensed facilities.
(3) If for transport to a
registered qualifying patient pursuant to an approved patient home
delivery plan, the patient registry identification card number and
any such other information pursuant to approved delivery plan.
(4) Product name or
descriptions and quantities (by weight or unit) of each product to be
delivered to each specific destination location(s).
(5) Arrival date and
approximate time of arrival.
(6) Delivery vehicle make and
model and license plate number.
(7) Names, registry
identification card numbers, and signatures of the delivery persons.
e. If a compassion center
proposes to offer home delivery service of usable marijuana or
marijuana products to a Rhode Island registered patient’s
residence, it shall submit a comprehensive proposed patient home
delivery plan to DBR for its review and pre-approval, detailing how
the program will assure compliance with the Act, the DBR Regulations,
and the DOH Regulations. The patient home delivery plan must include
satisfactory cardholder verification procedures to ensure delivery is
made to requested qualifying patients and in authorized amounts. The
patient home delivery plan must include how the compassion center
will comply with point of sale tracking requirements for patient home
delivery transactions. Patient home delivery services, if approved,
are subject to the requirement that payment must be made prior to or
within one (1) business day of delivery to the patient.
f. The originating
registered/licensed facility shall ensure that all delivery times and
routes are randomized.
g. Authorized transports may
only be made by cardholders affiliated with the particular
registered/licensed facility that is the source or recipient party to
an authorized transaction. Authorized transports must be in
compliance with one of the following minimum requirements: (i) an
authorized transport may use a single authorized transport vehicle so
long as it is operated/occupied by a minimum of two authorized
transport cardholders and is subject to the requirement that at least
one such cardholder shall remain in the authorized transport vehicle
at all times; or (ii) an authorized transport may use two or more
authorized transport vehicles that are operated/occupied by
authorized transport cardholders provided the authorized transport
vehicles are traveling together at all times during the authorized
transport.
h. During all authorized
transports, the delivery persons must have on their persons their
compassion center or licensed cultivator registry identification
cards and the detailed transport manifest.
i. Any authorized transport
vehicle carrying marijuana and marijuana products shall travel
directly from the originating registered/licensed facility to the
receiving registered/licensed facility. Any compassion center
authorized transport vehicle carrying marijuana and marijuana
products to patients pursuant to an approved patient home delivery
plan shall only stop at the patient addresses listed on the detailed
transport manifests. In case of an emergency stop, a detailed
written account must be maintained describing the reason for the
event, the duration, the location, any activities occurring during
the stop, and any personnel exiting the vehicle during the stop.
j. Authorized transports shall
be conducted in such a manner as to ensure that marijuana and
marijuana products are secured and safe at all times during
transport, which includes, but is not limited to, the requirements
that marijuana is not visible from outside the authorized transport
vehicle at that any ingestible marijuana products that are perishable
are adequately refrigerated, if necessary.
k. Prior to leaving the
originating registered/licensed facility for an authorized transport
to another registered/licensed facility, the originating
registered/licensed facility must weigh, inventory, and account for
on video all marijuana and marijuana product to be transported.
l. For authorized transports
to and from a licensed cultivator, the transport manifest shall be
accompanied by a copy of any contract/purchase order for which the
transport is being made and documentation of the actual payment date,
if prepaid.
m. The detailed transport
manifest shall be prepared by the originating registered/licensed
facility and transmitted in advance to the receiving facility. Both
facilities shall retain copies of detailed transport manifests as
part of their record retention responsibilities.
n. Within eight (8) hours of
after arrival at the destination registered/licensed facility, the
receiving party shall re-weigh, re-inventory, and account on video
for all marijuana and marijuana product transported.
o. Both the originating and
recipient registered/licensed facilities shall timely adjust their
records to reflect in its records the completed authorized transport
of marijuana, including logging such information in the Medical
Marijuana Program Tracking System. All records and entries in the
Medical Marijuana Program Tracking System shall be easily reconciled,
by product name and quantity, with the applicable detailed transport
manifest. Any unusual discrepancies in the quantity described in the
detailed transport manifest and the quantities received shall be
reported to DBR and municipal and/or state law enforcement within
(24) hours.
p. Any vehicle accidents,
diversions, or losses during authorized transports of marijuana shall
be reported to DBR and law enforcement as an “emergency event”
pursuant to § 1.4(G)(7) of this Part.
q. Transportation to or from a
third party testing provider shall be in accordance with the DOH
Testing Regulations, once adopted.
4. Manufacturing and
Extraction
a. Any manufacturing method
using a solvent extraction process must be approved by DBR. If the
manufacturing method uses a flammable/combustible material or heat
source, the method must also be approved by the State Fire Marshall
and/or local fire department.
b. Only registered compassion
center employees and agents may manufacture marijuana products on the
premises. A registered volunteer may do so only as part of
educational programming under the direct supervision of a registered
compassion center employee.
c. The compassion center must
maintain written standard operating procedures for each manufacturing
process, including step-by-step instructions.
d. The compassion center must
ensure that for each manufacturing process, all safety and sanitary
equipment appropriate for that manufacturing process, including any
personal protective equipment, is provided to any authorized
compassion center cardholder who will be involved in that
manufacturing process.
e. All medical marijuana
product manufacturing areas must be adequately lit during
manufacturing, cleaning, or other use.
f. All work surfaces on which
medical marijuana products are manufactured and the walls and floors
in the areas in which such products are manufactured shall be
non-porous, non-absorbent, and easily cleanable.
g. No eating or smoking shall
be permitted in the manufacturing area.
h. The compassion center must
provide a training manual and instructional training on each
manufacturing process to any authorized compassion center cardholder
who will be involved in that manufacturing process.
5. Required Patient Outreach
Activities
The compassion center’s
outreach activities to registered qualifying patients, registered
primary caregivers, and authorized purchasers shall, at a minimum,
include:
a. Providing each new
registered qualifying patient who visits the compassion center with a
frequently asked questions sheet that explains the limitations on the
right to use medical marijuana under state law in accordance with
R.I. Gen. Laws § 21-28.6-12(f)(9).
b. Providing a list of
ingestion options for usable marijuana.
c. Providing applicable usage
techniques and any corresponding safety information to registered
qualifying patients.
d. Communicating potential
side effects.
e. Upon the request of DOH
and/or DBR, e-mailing or otherwise disseminating information to
compassion center clients regarding changes in the medical marijuana
program.
6. Required Employee, Agent,
and Volunteer Training.
In accordance with R.I. Gen.
Laws § 21-28.6-12(f)(14), each compassion center shall develop,
implement and maintain on the premises an on-site training
curriculum, or enter into contractual relationships with outside
resources capable of meeting employee, agent and volunteer training
needs. Each employee, agent or volunteer, at the time of his or her
initial appointment and every year thereafter, shall receive, at a
minimum, training in the following:
a. Professional conduct,
ethics, and state and federal laws regarding patient confidentiality.
b. Informational developments
in the field of medical use of marijuana.
c. The proper use of security
measures and controls that have been adopted.
d. Training on use of the
Medical Marijuana Program Tracking System and any other tracking
systems used by the compassion center for persons responsible for
using the system.
e. Specific procedural
instructions for responding to an emergency, including robbery or
violent accident.
7. Minimum Sanitation and
Workplace Safety Conditions
a. The compassion center shall
be maintained in a safe, sanitary, and clean manner, with all
operations in the cultivation, receiving, inspecting, transporting,
segregating, preparing, manufacturing, packaging, and storing of
medical marijuana and marijuana products conducted in accordance with
adequate sanitation principles, as further detailed below.
b. The facility must meet the
following minimum specifications:
(1) Adequate supply of potable
hot and cold water.
(2) Non-porous, non-absorbent
and easily cleanable floors, walls, and ceilings in areas where
marijuana is cultivated, manufactured, and stored.
(3) Lavatory facilities that
are readily-accessible to employees and that comply with the Rhode
Island State Plumbing Code Regulation.
(4) Adequate hand-washing
area(s): hand washing sinks with effective hand-cleaning and
sanitizing preparations (such as soap dispensers) and disposable
towels or an air dryer for hands.
(5) Adequate screening or
other protection against the entry of pests and environmental
contaminants.
c. All mechanical and
electrical equipment shall be maintained in a safe operating
condition.
d. Waste disposal equipment
shall be adequate and removal schedules timely so as to minimize the
risk of contamination to medical marijuana and marijuana products,
including the risk of the waste becoming an attractant, harborage, or
breeding place for pests.
e. All waste (including all
liquid, chemical, hazardous, pesticide, manufacturing solvent and
chemical waste) must be stored, secured, and managed in accordance
with all applicable federal, state, and local statutes, regulations,
ordinances, or other legal requirements. Specific instructions for
safe destruction of any marijuana required to be destroyed and proper
disposal of medical marijuana waste are provided in § 1.4(J)(10) of
this Part.
f. Floors, walls, and ceilings
shall be kept clean and in good repair, free from dust, debris, mold,
mildew, and other contaminants and potentially hazardous materials.
g. Lavatory facilities and
hand washing areas shall be kept clean and sanitary and in working
condition at all times.
h. Toxic cleaning compounds,
sanitizing agents, and other chemicals shall be identified, held,
stored and disposed of in a manner that protects against
contamination of medical marijuana and marijuana products and in a
manner that is in accordance with any applicable local, state, or
federal law, rule, regulation, or ordinance.
i. The compassion center shall
comply with all relevant statutes, regulations, and requirements
administered by the Federal Occupational Safety and Health
Administration (OSHA), including but not necessarily limited to
standards for toxic and flammable compounds and air contaminants.
j. All persons working in
direct contact with medical marijuana and marijuana products shall
conform to hygienic practices while on duty, including but not
limited to maintaining adequate personal cleanliness and washing
hands thoroughly in an adequate hand-washing area before starting
work and at any other time when the hands may have become soiled or
contaminated.
k. Any person whose medical
condition, as determined by medical examination or as observed by a
supervisor, poses or reasonably appears to pose a risk of
contamination of medical marijuana and/or medical marijuana products
shall be excluded from medical marijuana operations until the
condition is cleared. Medical conditions posing a risk of
contamination include but are not necessarily limited to open
lesions, including boils, sores, or infected wounds, or any other
abnormal source of microbial infection.
l. The compassion center shall
not permit the entry of any animal into the premises. Service
animals (as defined in the Americans with Disabilities Act) are
exempted from this prohibition.
m. In addition to the safety
and sanitary equipment including personal protective equipment that
the compassion center is required to furnish its employees involved
in marijuana manufacturing and extraction pursuant to § 1.4(J)(4)(D)
of this Part, the compassion center must also furnish its employees
with proper safety equipment for other types of work assigned as part
of the compassion center operations.
8. Odor Control and Mitigation
a. Cultivation area(s) shall
have ventilation and filtration systems installed that prevent
medical marijuana plant odors from exiting the interior of the
structure to an extent that would significantly alter the
environmental odor outside, while addressing the potential for mold.
b. The ventilation and
filtration system, along with any plumbing improvements, shall be
installed in compliance with all applicable codes and ordinances,
including obtaining any necessary permits, and inspected by the
municipality.
c. Measures to assure
compliance with this section shall be documented in an odor control
and mitigation plan acceptable to DBR.
9. Pesticide Use and Records
a. The cultivation process
shall use best practices to limit contamination of medical marijuana
and marijuana products, including but not limited to mold, mildew,
fungus, bacterial diseases, rot, pests, pesticides, and any other
contaminant identified as posing potential harm.
b. The use of pesticides on
marijuana plants in Rhode Island by registered compassion centers
will not be considered a violation of these regulations provided that
the product must satisfy all of the following criteria:
(1) The product must be a
“minimum risk pesticide” under 40 C.F.R. § 152.25(f), as the
same may be amended from time to time.
(2) The product must be
labelled for use on “all plants,” “other plants,” bedding
plants, unspecified plants, or unspecified crops.
(3) The label must not
prohibit indoor or greenhouse use, as applicable.
(4) All active ingredients
must be eligible for food use as determined by the federal
Environmental Protection Agency (EPA). See EPA’s Active
Ingredients Eligible for Minimum Risk Pesticide Products (last
updated December 2015), as the same may be updated and/or amended
from time to time.
https://www.epa.gov/sites/production/files/2015-12/documents/minrisk-active-ingredients-tolerances-2015-12-15.pdf.
(5) All inert/other
ingredients must be eligible for food use. See EPA’s Inert
Ingredients Eligible for FIFRA 25(b) Pesticide Products (last updated
December 2015), as the same may be updated and/or amended from time
to time. See
https://www.epa.gov/sites/production/files/2016-07/documents/section25b_inerts.pdf.
(6) The product must be a
currently registered pesticide product eligible for sale in Rhode
Island as determined by the Rhode Island Department of Environmental
Management. To verify a product’s registration in Rhode Island,
please consult the online National Pesticide Information Retrieval
System through the Center for Environmental and Regulatory
Information Systems.
http://npirspublic.ceris.purdue.edu/state/state_menu.aspx?state=RI.
(7) The product must be used
in accordance with any and all use instructions on the label.
c. No application of
pesticides shall be made after the vegetative stage of growth of the
cannabis plant. The vegetative stage of growth should be determined
by visual buds or flower or by proxy of the plant receiving less than
eighteen (18) hours of light in a twenty-four (24) hour period.
d. Pesticides shall be
identified, held, stored and disposed of in a manner that protects
against contamination of medical marijuana and marijuana products and
in a manner that is in accordance with any applicable local, state,
or federal law, rule, regulation, or ordinance.
e. As a DBR record-keeping
requirement, compassion centers must keep detailed records of any
pesticide products used and application regiments, including video
recording during pesticide applications which must cease if there is
a failure or disruption of the video surveillance system. This
record-keeping requirement is independent of that required of
commercial pesticide applicators by the Rhode Island Department of
Environmental Management, and is intended to apply in addition to
that requirement, where relevant.
10. Safe Disposal of Medical
Marijuana Waste and Safe Destruction of Usable Medical Marijuana
a. Marijuana and marijuana
product waste (including all liquid, chemical, hazardous, pesticide,
manufacturing solvent and chemical waste containing any traces of
marijuana) must be stored, secured, and managed in accordance with
all applicable federal, state, and local statutes, regulations,
ordinances, or other legal requirements.
b. Prior to disposal,
marijuana and marijuana product waste must be made unusable and any
marijuana plant material made indistinguishable from other plant
material. This may be accomplished by grinding and incorporating the
marijuana plant waste with other non-consumable solid waste or other
ground materials so the resulting mixture is at least fifty percent
non-marijuana waste by volume. Other methods to render marijuana
waste unusable must be approved by DBR before implementing.
Marijuana waste rendered unusable following an approved method may be
delivered to a licensed solid waste disposal facility in Rhode Island
for final disposition or disposed of in an alternative manner
approved by DBR.
c. Destruction of marijuana
and marijuana materials other than waste generated in the regular
course of processing and/or manufacturing (such as destruction of
whole plants, wet, or usable marijuana that are found to be in excess
of statutory possession limits or destruction of a contaminated batch
of medical marijuana product) shall be in a manner acceptable to DBR,
which may include consultation with law enforcement.
d. Destruction of marijuana
and marijuana materials upon revocation or abandonment of the license
shall be specifically governed by DBR order or agreement and/or
coordinated efforts with law enforcement.
e. Compassion centers must
maintain accurate and comprehensive records regarding waste material
that accounts for, reconciles, and evidences all waste activity
related to the disposal of marijuana and marijuana products
(including any waste material produced through the trimming or
pruning of a marijuana plant prior to harvest). DBR may mandate
storage of any such records or summaries of such records to be
through the Medical Marijuana Program Tracking System or any other
electronic system DBR designates.
K. Inspections and Audits;
Enforcement Actions
1. Compassion centers are
subject to reasonable inspection by DBR and DOH. DBR and DOH and
their authorized representatives have authority to enter a compassion
center premises at reasonable times and to inspect in a reasonable
manner, the premises and all equipment, materials, containers, and
other things therein, including without limitation all records,
files, financials, sales, transport, pricing and employee data,
research, papers, processes, controls and to inventory any stock of
marijuana, labels, containers, paraphernalia and other materials and
products. During any inspection, DBR and DOH may review the
compassion center's confidential records, including its dispensing
records, which shall track transactions according to identifying
information for the patient, primary caregiver, and/or authorized
purchaser. Dispensing records for patient cardholders shall be
tracked by registry identification numbers only to protect their
confidentiality. See R.I. Gen. Laws § 21-28.6-12(e).
2. DBR may review and audit
the books and records of compassion centers to ascertain compliance
with the Act, the DBR Regulations, and/or the DOH Regulations,
including continued satisfaction of the statutory criteria considered
in granting a compassion center license. The compassion center must
make such books and records immediately available for reviewing and
copying by DBR and DOH. DBR may retain an independent auditor to act
as its agent for purposes of this section, the cost of which shall be
borne by the compassion center.
3. Nothing herein shall be
interpreted to limit the real time access of DBR and DOH to
information stored in the Medical Marijuana Program Tracking System
consistent with the Act.
4. Pursuant to R.I. Gen. Laws
§ 21-28.6-12(d)(5) and § 21-28.6-12(b)(1), a compassion center's
registration certificate may be suspended/revoked if the compassion
center is in violation of the laws of Rhode Island, including the
Act, DBR Regulations, or DOH Regulations.
5. If a principal officer,
board member, employee, agent, or volunteer affiliated with a
compassion center violates the Act, the DBR Regulations, and/or the
DOH Regulations when acting in their capacity as a principal officer,
board member, employee, agent, or volunteer of the compassion center,
the compassion center may be subject to suspension/revocation for
failure to exercise adequate supervision.
1.5 Licensed Cultivator
Application and Licensing Provisions
A. Authority
R.I. Gen. Laws §
21-28.6-16(b)(1) authorizes DBR to promulgate regulations regarding
the form and content of licensing and renewal applications for
licensed cultivators.
B. Licensed Cultivator
Application and License Timeline
1. Licensed cultivator
applications may be submitted to DBR for consideration through April
30, 2017. The application period will be re-opened each subsequent
year during the months of January, February, and March. DBR reserves
the right to modify the application periods based on patient and
program need. DBR also reserves the right to issue regulations
limiting the number and/or classes of new licenses available for
application based on the projected needs of the Rhode Island Medical
Marijuana Program population. See R.I. Gen. Laws § 21-28.6-16
(location and possession restrictions, regulation of licensing and
oversight requirements).
2. Upon notification of
approval of an application from DBR, the approved applicant must take
reasonable and documented efforts to complete the prerequisites for
issuance of the license which steps are detailed in § 1.5(E) of this
Part. If such efforts take longer than nine (9) months, the approved
applicant must show good cause to DBR why additional time should be
granted and the application approval should not be rescinded.
3. Once the license has been
issued, the licensed cultivator must take reasonable and documented
efforts to launch licensed cultivator activities, which for purposes
of this paragraph shall mean actual medical marijuana cultivation,
processing, packaging, manufacturing, and/or other medical marijuana
activities requiring a cultivator license pursuant to the Act. If
such efforts take longer than six (6) months, the licensed cultivator
must show good cause to DBR why the license should not be revoked for
non-use.
C. Classes of Cultivator
Licenses
1. Cultivator licenses shall
be divided into the following categories:
License
Class
Size
of Facility*
Micro-license
0
- 2,500 sq. ft.
Class
A
0
- 5000 sq. ft.
Class
B
5,001
- 10,000 sq. ft.
Class
C
10,001
- 15,000 sq. ft.
Class
D
15,001
- 20,000 sq. ft.
2. For facilities over 20,000
sq. ft., please contact DBR prior to submitting the application.
3. For the period of one (1)
year from the effective date of these regulations, only
Micro-license, Class A, and Class B applications will be accepted.
An applicant who is considering eventually applying to operate a
larger facility may detail any such plan on the application.
4. Facility size shall be
determined as a total of any area where marijuana will be cultivated,
stored, processed, packaged, and/or manufactured.
5. An authorized officer of
the applicant shall certify the square footage calculation.
D. Application for Cultivator
License
1. DBR will evaluate
applicants based upon the information provided by applicants on the
application forms/submissions and otherwise obtained during the
application process.
2. Each application for a
licensed cultivator shall be on such forms and through such
submission mechanisms as designated by DBR.
3. All categories of
cultivator applications shall be accompanied by a non-refundable
application fee of five-thousand dollars ($5000).
4. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(i), cultivators shall only be licensed at a single
location registered with DBR and RISP, must abide by all local
ordinances, including zoning ordinances, and may be subject to any
additional location restrictions promulgated by DBR. With respect to
local zoning, medical marijuana cultivation may fall within various
zoning use categories including without limitation the following
zoning use categories: agricultural uses (such as greenhouse
and nursery), industrial uses (light and general), manufacturing
and processing (such as factory) or specific medical
marijuana related use categories. Whether medical marijuana
cultivation is a permitted use, prohibited use or allowed by special
use permit within these or any other use categories is
determined by local zoning authorities. Furthermore, in accordance
with R.I. Gen. Laws § 21-28.6-16(i):
a. Only one cultivator license
will be issued per structural building.
b. The application must
contain the following minimum information:
(1) The proposed physical
location of the licensed cultivator (by plat and lot number, mailing
address, etc.), if a precise location has been determined. If a
precise physical location has not been determined, a description of
the general location(s) where it may be sited, if approved, and the
expected schedule for purchasing or leasing said location(s).
(2) Approximate calculation of
the square footage of the proposed facility.
(3) Evidence of the location’s
compliance or preliminary determination of compatibility with the
local zoning laws.
(4) Evidence that the physical
location is not located within one thousand feet (1,000’) of the
property line of a preexisting public or private school. For the
purposes of this paragraph, “private school” shall be deemed to
refer to any nonpublic institution of elementary or secondary (K-12th
Grade) education, accredited or recognized as a private school by the
department of elementary and secondary education or the school
committee of the city or town having jurisdiction over private
schools. For purposes of this paragraph, the 1000 foot distance
shall be measured from the secured cultivator premises, which shall
include allotted outdoor areas (such as parking and loading areas),
to the property line of the school, which shall include the school
building, land, and appurtenances.
(5) A draft diagram of the
proposed facility, including where within the facility the medical
marijuana will be cultivated, stored, processed, packaged, and/or
manufactured, and where security alarms and cameras and surveillance
recording storage will be located, and showing the location of the
facility relative to streets and other public areas.
(6) A description of objective
parameters (such as distances from streets and public areas) and/or
proposed measures (such as black-out window shades) that ensure that
marijuana at the premises shall not be visible from the street or
other public areas.
(7) Evidence of either
ownership of property or agreement by owner of property to allow the
operation of a licensed cultivator on the property, if property has
already been purchased or leased at the time of the application.
5. The application shall also
provide the following minimum information:
a. The applicant’s legal and
any d/b/a name(s), certificate of incorporation or organization in
Rhode Island or certificate of authority to transact business in
Rhode Island, articles of incorporation or organization, and bylaws
or operating agreement.
b. A business plan, including
scope of activities, budget and resource narratives, and timeline for
initiating operations.
c. The legal name, current
address, and date of birth of each officer and director or
member/manager of the applicant.
d. A list of all persons or
business entities (legal names and current addresses) that currently
have or are expected to have direct or indirect authority over the
management or policies of the applicant.
e. If the applicant proposes
to have a management agreement in place, it shall also include a copy
of the management agreement or management agreement proposal and a
list of persons who have any ownership interest or operational
control over the management company.
f. A list of all persons or
business entities (legal names and current addresses) having any
ownership interest in the applicant entity, whether direct or
indirect.
g. If the cultivator premises
and/or other operational assets will be owned or leased by a person
or entity other than the applicant, the legal name and current
address of any such person or entity and a list of all persons or
entities (legal names and current addresses) having any ownership in
such entity, whether direct or indirect.
h. The legal names and current
addresses of all creditors holding a security interest in the
premises and/or other assets to be used in the cultivator operations,
if any.
i. Tax Affidavit in accordance
with R.I. Gen. Laws § 5-76-1 et seq.
j. All other information
required by DBR as described in the application form, including for
example experience and regulatory history of the applicant and its
key personnel.
6. Only applications which DBR
has determined to be complete (i.e., adequately address all
application requirements above) shall be eligible for review. An
applicant who submits an incomplete application shall receive written
notification from DBR regarding the specific deficiencies and shall
be allowed to resubmit additional material to address these
deficiencies within a reasonable timeframe without additional
application fees.
E. Prerequisites to Issuance
of Cultivator License and Commencement of Operations
1. If an applicant seeking to
operate as a licensed cultivator is notified that its application has
been approved by DBR, it shall complete the below steps before a
cultivator license will be issued.
2. Annual Cultivator License
Fees
The annual license fee shall
be determined by the below table and must be paid in full before a
license will be issued.
License
Class
Annual
License Fee
Micro-license
$5,000.00
Class
A
$20,000.00
Class
B
$35,000.00
Class
C
$50,000.00
Class
D
$80,000.00
3. Final Information and
Documentation to be Supplied
The applicant must provide
any updates to previously submitted application information and the
following additional items to DBR:
a. A sufficient description of
the final physical location of the cultivator premises (by plat and
lot number, mailing address, etc.).
b. Evidence of complete
compliance of the facility with the local zoning laws in the form of
a letter from an authorized zoning official of the municipality and
certification by an authorized officer of the applicant as to
compliance with any other applicable local ordinances. See §
1.5(D)(4) of this Part.
c. Unless already provided at
time of initial application, evidence that the physical location for
the cultivator premises is not located within one thousand feet
(1,000’) of the property line of a preexisting public or private
school. See § 1.5(D)(4)(b)(4) of this Part.
d. A current Certificate of
Occupancy (or equivalent document) to demonstrate compliance of the
cultivator facility with the relevant provisions of Chapters 28.1 and
27.3 of Title 23 of the R.I. General Laws [Fire Safety Code and State
Building Code, respectively].
e. Evidence of either
ownership of property or agreement by owner of property to allow the
operation of a licensed cultivator on the property.
f. A final diagram of the
facility, including where marijuana will be cultivated, stored,
processed, packaged, and manufactured, and where security alarms and
cameras and surveillance recording storage will be located.
g. The legal name, current
address, and date of birth of any person who will be an employee or
agent of the cultivator at its inception.
h. Evidence of completion of
divestiture plan pursuant to § 1.5(E)(5)(e) of this Part and other
individual relinquishment requirements pursuant to § 1.5(E)(5)(f) of
this Part.
4. DBR Pre-License Inspection
Before a cultivator license
will be issued, a DBR inspection is required. Approved applicants
should contact DBR to coordinate said inspection. Nothing in this
paragraph should be construed as limiting inspections at an earlier
time in addition to the final pre-license inspection.
5. Divestiture of Prohibited
Material Financial Interest and Control
a. A licensed cultivator and
“key persons” thereof may not have any “material financial
interest or control” in another licensed cultivator, a compassion
center, or a licensed cooperative cultivation or vice versa. See
R.I. Gen. Laws § 21-28.6-12(c)(1)(iii)(limiting a compassion center
to one additional location to cultivate its marijuana); R.I. Gen.
Laws § 21-28.6-12(b)(1)(ii)(DBR minimum oversight over compassion
centers); R.I. Gen. Laws § 21-28.6-16(i)(cultivator to be licensed
at one location only); R.I. Gen. Laws § 21-28.6-16(b)(2)(DBR minimum
oversight over cultivators); R.I. Gen. Laws § 21-28.6-3(4)(i) and
R.I. Gen. Laws § 21-28.6-3(12)(separately defining “compassion
center” and “licensed cultivator,” respectively); R.I. Gen.
Laws § 21-28.6-14(a)(10)(DBR authority to regulate operations of
licensed cooperative cultivations); R.I. Gen. Laws §
21-28.6-4(q)(qualifying patient and primary caregiver cardholders may
only grow at one location).
b. R.I. Gen. Laws §
21-28.6-16(f) authorizes regulations regarding testing of medical
marijuana and marijuana product cultivated and/or manufactured by
licensed cultivators, which will include ensuring the independence of
third party testing providers. Accordingly, a licensed cultivator
may not have any material financial interest or control in a Rhode
Island DOH-approved third party testing provider and vice versa.
c. “Material financial
interest or control” shall mean: i) any ownership interest,
regardless of the size of the holding, and including any ownership
interest through a subsidiary or affiliate; ii) trusteeship,
mortgage, guarantor, endorser or surety relationship, or loan
relationship, except that loan relationship for the purposes of this
definition shall exclude accounts payable and accounts receivable on
account of a medical marijuana purchase order; iii) any other
beneficial financial interest such that the holder bears the risk of
loss (other than as an insurer) or has an opportunity to gain profit
from the operation or sale of the regulated medical marijuana
business; iv) operational control including but not limited to
interlocking directors or officers or through a management agreement.
d. “Key persons” shall
mean officers, directors, LLC managers/members and any persons with
managing or operational control.
e. Therefore, if a licensed
cultivator application is approved and any prohibited material
financial interest or control has been identified by DBR or is
otherwise known to the licensed cultivator applicant, such interest
or control must be divested prior to issuance of the cultivator
license. The plan of divestiture shall be filed with DBR.
f. If applicable, before
issuance of the cultivator license, the cultivator applicant entity
and its officers, directors or managers/members, and any other person
with an ownership or controlling interest must relinquish any
caregiver registrations or cooperative cultivation licenses held in
order to comply with R.I. Gen. Laws § 21-28.6-16(a).
g. The duty to divest
prohibited material financial interests and control is a continuing
obligation of licensure.
6. Registry Identification
Card Requirements
Before issuance of the
cultivator license, all officers, directors or managers/members,
employees, and agents must apply for a registry identification card
and submit to a national criminal background check as provided in §
1.6 of this Part. Such individuals may be hired, appointed, or
retained prior to receiving a registry identification card, but may
not begin engagement in medical marijuana cultivation, storage,
processing, packaging, manufacturing, transport, or other medical
marijuana activities requiring a licensed cultivator license pursuant
to the Act until receipt of the card.
F. DBR Post-Licensure
Inspection of Operations and Inventory
After the cultivator license
is issued, the licensed cultivator shall notify DBR when it obtains
inventory and commences operations. DBR may conduct a post-licensure
inspection upon this commencement of operations, including but not
limited to inspection for compliance of medical marijuana and
marijuana product inventory with the tagging and tracking
requirements set forth in § 1.7(D) of this Part. Nothing in this
paragraph shall be construed to limit DBR’s general inspection
powers as delineated in § 1.7(J) of this Part.
G. Changes in Location, Floor
Plan, Ownership and Control of Licensed Cultivator; Continuing Duty
to Update Application Information; Discontinuation of or Failure to
Launch Licensed Cultivator Activities
1. A cultivator license shall
not be assigned or otherwise transferred to other persons or
locations, unless pre-approved in accordance with the below
paragraphs.
2. A licensed cultivator shall
provide DBR with a written notice of any change described below at
least sixty (60) calendar days prior to the proposed effective date
of the change:
a. A change in ownership of
the licensed cultivator.
b. Change in the membership of
a board of directors, board of trustees, or managers/members.
c. Change in corporate
officer.
d. Merger, dissolution, or
entity conversion.
e. Entering into a management
agreement, changing management companies, and/or material changes to
an existing management agreement.
f. Changes in the approved
licensed cultivator premises.
g. Change to approved premises
floor plan.
h. Proposed premises
expansion.
3. Unless the licensed
cultivator provides timely notification of the above changes and
receives prior DBR approval or waiver of the requirement of prior
notice and approval (for example a non-material change in ownership
or emergency situation as determined by DBR), the license shall be
void and returned to DBR.
4. As to any proposed change
of ownership or to a management agreement that will effect a change
of majority control and/or decision-making authority with respect to
the operation of the licensed cultivator or as to any proposed change
in an approved licensed cultivator premises location, DBR may require
the licensed cultivator to follow the process for a new application,
which may include a new application fee. Additionally, any increase
in the size of the facility that causes the facility to be
reclassified based on the license fee structure set forth in §
1.5(E)(2) of this Part shall require payment of the difference
between the paid fee and the fee applicable to the new classification
of the facility. DBR, in its sole discretion, may prorate the fee
increase or may offer a rebate for a size decrease.
5. For updates in information
other than the categories requiring sixty (60) calendar days prior
notice, the licensed cultivator has a continuing obligation to
update, amend and/or correct any information requested and/or
submitted in the application process within ten (10) business days
after any change in the information submitted and/or any material
change in circumstances related to the application. This includes
timely notification and divestiture if a prohibited interest as
delineated in § 1.5(E)(5) of this Part is acquired by operation of
law.
6. If the licensed cultivator
proposes to alter the final floor plan previously submitted and
approved, the licensed cultivator must first submit a renovation plan
for DBR approval sixty (60) calendar days prior to commencement of
construction. The renovation plan must specifically address quality
control procedures for the protection of medical marijuana and
medical marijuana products from any contamination during the
construction process and further address any other criteria DBR
requires.
7. The cultivator license
shall be void and returned to DBR if the licensed cultivator
discontinues its operation, unless the discontinuance is on a
temporary basis approved by DBR.
H. Annual Renewal
1. Cultivator licenses shall
be issued for one year terms.
2. Annual renewals shall be
submitted on such forms and include such information as prescribed by
DBR.
3. An annual inspection shall
be part of the annual renewal process.
1.6 Licensed Cultivator Cardholder
Registry Identification Card Provisions
A. Cultivator Cardholder
Definitions
1. “Licensed cultivator
cardholder” includes all officers, directors or managers/members,
employees, and agents who have been issued a registry identification
for their association with the licensed cultivator.
2. “Agent” of a licensed
cultivator shall include, but not be limited to, “testing agents.”
3. “Testing agent” shall
mean an employee of an approved third party testing provider who
performs independent testing of medical marijuana and/or marijuana
products of the licensed cultivator in accordance with the DOH
Testing Regulations, once adopted.
B. Registry Identification
Card Requirement, Eligibility, Annual Fee and Application
1. All officers, directors or
managers/members, employees, and agents of the licensed cultivator
must apply for cultivator registry identification cards.
2. Each licensed cultivator
shall maintain a current list of all licensed cultivator cardholders
associated with the licensed cultivator.
3. Licensed cultivator
cardholders shall be at least twenty-one (21) years old.
4. There shall be a one
hundred dollars ($100.00) non-returnable, non-refundable annual fee
for a licensed cultivator registry identification card, including
each initial application and subsequent annual renewal.
5. Applications pursuant to
this section shall be on such forms and through such submission
mechanisms as directed by DBR.
C. Criminal Background Checks
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(k), the cultivator applicant is subject to a national
criminal background check. This shall include all officers,
directors or managers/members, employees, and agents of the licensed
cultivator (hereinafter also referred to in this section as
“applicants”).
2. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(k)(2), disqualifying information is defined as a felony
drug offense conviction or a plea of nolo contendere for a felony
drug offense with a sentence of probation.
3. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(k), the national criminal identification records check
shall include fingerprints submitted to the Federal Bureau of
Investigation. Application for said records check may be made to the
Bureau of Criminal Identification of the Department of Attorney
General, RISP, or the local police department.
4. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(k) and § 21-28.6-16(k)(2), upon the discovery of any
disqualifying information, the office that conducted the records
check (the Bureau of Criminal Identification of the Department of
Attorney General, RISP, or the local police department) shall issue a
letter to the applicant disqualifying the applicant and informing the
applicant of the nature of the disqualifying information.
5. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(k) and § 21-28.6-16(k)(2), upon discovery of any
disqualifying information, the office that conducted the records
check (the Bureau of Criminal Identification of the Department of
Attorney General, RISP, or the local police department) shall notify
DBR, in writing of the fact that disqualifying information has been
discovered thus disqualifying the applicant.
6. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(k)(1), in those situations in which no felony drug
offense conviction or plea of nolo contendere for a felony drug
offense with probation has been found, the office that conducted the
records check (the Bureau of Criminal Identification of the
Department of Attorney General, RISP, or the local police department)
shall inform the applicant and DBR, in writing, of this fact.
7. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(k)(2), the applicant shall be responsible for any
expense associated with the national criminal background check with
fingerprints.
8. DBR will not require a
person subject to a national criminal background check under this
subsection to undergo such a check more than once every two (2)
years, unless a more frequent time frame is mandated and/or agreed to
as part of a license disciplinary action.
D. Issuance of the Cultivator
Cardholder Registry Identification Card
1. Once the licensed
cultivator cardholder application is approved by DBR, each approved
officer, director or manager/member, employee, or agent of the
licensed cultivator is responsible for getting a registry
identification card from DOH.
2. The registry identification
card shall contain:
a. The name, address and date
of birth of the person.
b. The legal name of the
licensed cultivator that the individual is affiliated with.
c. The category of the
person’s affiliation: officer, director or manager/member,
employee, or agent.
d. The date of issuance and
expiration date of the registry identification card.
e. A random registry
identification number.
f. A photograph.
E. Expiration and Renewal of
Cultivator Cardholder Registry Identification Cards
Cultivator cardholder
registry identification cards shall expire one year after issuance.
Renewal applications shall be on such forms and through such
submission mechanisms as directed by DBR.
F. Change in Name or Address;
Lost/Stolen Cards
1. In accordance with R.I.
Gen. Laws § 21-28.6-16(l)(1), a licensed cultivator cardholder shall
notify DBR of any change in his or her name or address within ten
(10) business days of such change. A licensed cultivator cardholder
who fails to notify DBR of any of these changes may be subject to a
fine up to one hundred fifty dollars ($150).
2. In accordance with R.I.
Gen. Laws § 21-28.6-16(l)(2), changes in name and/or address require
the licensed cultivator cardholder to remit a ten dollar ($10.00) fee
to DBR. Upon receipt of the notice and fee, DBR will prompt DOH to
issue an updated registry identification card. The licensed
cultivator cardholder shall be responsible for getting the updated
registry identification card from DOH.
3. In accordance with R.I.
Gen. Laws § 21-28.6-16(l)(3),if a licensed cultivator cardholder
loses his or her registry identification card (which would
particularly include a card suspected to be stolen), he or she shall
notify DBR and submit a ten dollar ($10.00) fee within ten (10)
business days of losing the registry identification card. Upon
receipt of the notice and fee, DBR will prompt DOH to issue a
replacement registry identification card. The licensed cultivator
cardholder shall be responsible for getting the replacement registry
identification card from DOH.
G. Duty to Notify DBR of
Disqualifying Criminal Information
In accordance with R.I. Gen.
Laws § 21-28.6-16(l)(3), a licensed cultivator cardholder shall
notify DBR of any disqualifying criminal convictions as defined in §
21-28.6-16(k)(2). Such notification must be made in writing within
ten (10) business days.
H. Termination of Cultivator
Cardholder Registry Identification Card.
1. If a licensed cultivator
cardholder violates R.I. Gen. Laws § 21-28.6-16 (entitled “Licensed
Cultivator”) or any portion of the DBR Regulations or DOH
Regulations which regulate licensed cultivators and licensed
cultivator cardholders, his or her registry identification card may
be suspended/revoked or subject to a fine as determined by DBR
pursuant to R.I. Gen. Laws § 21-28.6-16(e).
2. When a licensed cultivator
cardholder ceases work with a licensed cultivator, whether
voluntarily or involuntarily or upon the licensed cultivator closing,
his or her registry identification card shall be null and void. In
that situation, the licensed cultivator and/or the licensed
cultivator cardholder shall notify DBR and the registry
identification card shall be returned to DBR within ten (10) business
days. No hearing shall be necessary to render the card null and void
in this situation. In addition to being null and void, a penalty of
up to one hundred and fifty dollars ($150) may be assessed for
failure to return the card within the ten (10) day period.
1.7 Licensed Cultivator
Operational Provisions
A. State Medical Marijuana
Program Tracking System
Upon direction by the DBR,
each licensed cultivator shall be required to utilize the state
approved Medical Marijuana Program Tracking System to document and
monitor compliance with the Act, the DBR Regulations, and the DOH
Regulations, including but not limited to seed to sale tracking,
inventory supply tracking, adherence to restrictions on third party
supply and sources of marijuana and marijuana products and transfers
thereof off the licensed premises, and all testing compliance
tracking. Licensed cultivators may be required to pay costs
associated with use of the Medical Marijuana Program Tracking System
which may be assessed on an annual, monthly, per use, or per volume
basis and payable to the state or to its approved vendor.
B. Limitation on Sales and
Transfers; Contract Requirements
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(e), licensed cultivators shall only sell medical
marijuana and marijuana products to Rhode Island registered
compassion centers. As part of such sales transactions, the licensed
cultivator may transfer and transport medical marijuana and medical
marijuana products to a registered compassion center. A licensed
cultivator may only receive medical marijuana and marijuana products
from a Rhode Island registered compassion center if the receipt is
pursuant to a written contract or purchase order for the cultivator
to process the medical marijuana into a product to be furnished back
to the compassion center.
2. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(e), all marijuana and marijuana products possessed by a
cultivator in excess of the permitted ”uncommitted inventory” as
defined and delineated in § 1.7(C)(3) of this Part must be under
“formal agreement” to be purchased by a compassion center.
3. “Formal agreement”
requirements shall be as follows: An executed written contract or
purchase order shall be required for all sales from a licensed
cultivator to a compassion center and shall contain the following
minimum terms: a) date of execution/placement of the
contract/purchase order, b) description and amount of product to be
sold; c) the total and per unit price of the product to be sold; d)
the specific date or date range not spanning more than (30) calendar
days for fulfillment of the order and delivery or pickup; e) the
payment due date, as specifically agreed between the parties, but if
no date is specifically agreed to, payment shall be made within sixty
(60) calendar days of delivery or pickup. Contracts/purchase orders
pursuant to this paragraph may not be modified but may be cancelled
or voided by the creation of a new replacement contract/purchase
order.
4. In furtherance of the
intent of R.I. Gen. Laws § 21-28.6-16(e) and pursuant to its minimum
oversight rulemaking authority under R.I. Gen. Laws §
21-28.6-16(b)(2), DBR deems the sale and/or transfer of marijuana or
marijuana products, with or without consideration, to any other party
that is not a Rhode Island registered compassion center, including
any transfer between licensed cultivators, to be prohibited.
5. Any transfer to or from a
third party testing provider shall be in accordance with the DOH
Testing Regulations, once adopted.
6. Unless specifically
permitted by § 1.7 of this Part, no other licensed cultivator sales
or transfers of marijuana or marijuana products are permitted.
C. Inventory Limitations;
Sources of Inventory
1. Marijuana Plant Inventory
a. Prior to the implementation
of the Medical Marijuana Tracking System, micro-licensees may not
possess more than fifty (50) mature marijuana plants and fifty (50)
seedlings which must be properly tagged and tracked in accordance
with acceptable alternative tagging and tracking under § 1.7(D) of
this Part.
b. Prior to the implementation
of the Medical Marijuana Tracking System, Class A cultivator
licensees may not possess more than two hundred and fifty (250)
mature marijuana plants and two hundred and fifty (250) seedlings
which must be properly tagged and tracked in accordance with
acceptable alternative tagging and tracking under § 1.7(D) of this
Part.
c. Prior to the implementation
of the Medical Marijuana Tracking System, Class B cultivator
licensees will be limited to five hundred (500) mature marijuana
plants and five hundred (500) seedlings which must be properly tagged
and tracked in accordance with acceptable alternative tagging and
tracking under § 1.7(D) of this Part.
d. After implementation of the
Medical Marijuana Tracking System, licensed cultivators will not be
subject to a numerical possession limit for marijuana plants,
provided every plant is properly tagged and tracked in the Medical
Marijuana Tracking System.
2. Wet Marijuana Inventory
Licensed cultivators will not
be subject to a numerical possession limit for the amount of wet
marijuana provided the cultivator complies with the following:
a. All wet marijuana is tagged
and tracked in accordance with the cultivator tagging and tracking
requirements provided in § 1.7(D) of this Part.
b. All wet marijuana must be
stored in an environment conducive to the drying process and may not
be stored in an environment that artificially prolongs the drying
process or preserves marijuana in an unusable wet state.
3. Usable Marijuana Inventory
a. Pursuant to its authority
under R.I. Gen. Laws § 21-28.6-16(d), DBR establishes limits on the
amount of “uncommitted inventory” of usable marijuana a licensed
cultivator may possess based on licensed facility size as provided in
the below table. “Uncommitted inventory” shall refer to
marijuana and marijuana product not under formal agreement to be
purchased by a compassion center.
License
class by size per § 1.5(C)(1) of this Part
Pounds
of dried usable marijuana
OR
10
mg THC units of infused edible product
OR
Grams
of concentrate
OR
any combined amount of dried usable marijuana, infused edible
product, and/or concentrate that does not equate to more than the
maximum limit of dried usable marijuana in pounds
Micro-license
2.5
max
OR
3,320
max
OR
308
max
OR’’
Class
A
5
max
OR
6,640
max
OR
616
max
OR
?
Class
B
10
max
OR
13,280
max
OR
1,232
max
OR
?
Class
C
15
max
OR
19,920
max
OR
1,848
max
OR
?
Class
D
20
max
OR
26,560
max
OR
2,464
max
OR
?
b. The above uncommitted inventory limits are
derived from the equivalency conversions delineated in DOH
Regulations, Appendix A. To any extent these equivalency conversions
are inconsistent with the DOH Regulations, the DOH Regulations shall
be controlling. Limits for combined inventory of marijuana in mixed
forms shall be calculated as a total equivalent to the maximum limit
of dried usable marijuana in pounds in accordance with the
equivalency conversions factors delineated in DOH Regulations,
Appendix A.
c. In accordance with R.I.
Gen. Laws § 21-28.6-16(e), all marijuana and marijuana product that
exceeds the amount of uncommitted inventory permitted by the above
chart must be under formal agreement to be purchased by a compassion
center. If such excess marijuana is not under formal agreement to be
purchased, the cultivator will have forty-five (45) calendar days to
sell the excess to a compassion center or destroy the excess in
accordance with the destruction guidelines in § 1.7(I)(9) of this
Part.
d. Formal agreement
requirements are set forth in § 1.7(B)(3) of this Part.
4. Sources of inventory for
licensed cultivators shall be limited to “legally pre-existing
inventory” and “clone cutting procurement” as delineated below.
a. Legally Pre-Existing
Inventory: If a licensed cultivator or its officers, directors,
members/managers, or employees possessed medical marijuana plants in
compliance with the provisions of the Act before the license was
granted, such marijuana plants may be transferred to the licensed
cultivator inventory as a one-time transaction upon licensure
provided such marijuana plants are properly tagged and tracked in
compliance with § 1.7(D) of this Part. Except as provided in the
preceding sentence, transfers of marijuana and marijuana product
between the licensed cultivator and its officers, directors,
members/managers, and/or employees is strictly prohibited.
b. Clone Cutting Procurement:
A licensed cultivator may acquire marijuana plant cuttings to use as
clones for plant development (“clone cuttings”) not more than
once per month in a single transaction of not more than twelve (12)
clone cuttings from a “non-affiliated licensed cooperative
cultivation.” The clone cuttings may be no longer than eight (8)
inches in length, and may not contain observable buds or flower. A
licensed cultivator who acquires clone cuttings must immediately tag
such clone cuttings and track them in accordance with the tagging and
tracking requirements set forth in § 1.7(D) of this Part. A
licensed cultivator must keep records of all clone cutting
procurements as required by DBR. “Non-affiliated licensed
cooperative cultivation” requirements are further delineated in §
1.8(O) of this Part.
D. Medical Marijuana and
Marijuana Product Tagging for Cultivators
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(d), every marijuana plant possessed by a licensed
cultivator must be accompanied by a medical marijuana tag.
2. Properly using tags with
unique identifiers through the Medical Marijuana Program Tracking
System, payment of the annual license fee, and compliance with the
requirements of this subsection shall be deemed to satisfy the
requirements of R.I. Gen. Laws § 21-28.6-16(d).
3. If a licensed cultivator
begins to operate prior to the implementation of the Marijuana
Program Tracking System, DBR will advise the cultivator of acceptable
alternative inventory tagging and tracking systems and protocols. In
such a case, any references to the Medical Marijuana Program Tracking
System in this section shall be deemed to include the acceptable
alternatives.
4. Cultivators must ensure
that medical marijuana is marked with Medical Marijuana Program
Tracking System unique identifier tags through each stage of
production the cultivator is undertaking, from seed propagation
through packaging, as may be applicable.
5. Medical Marijuana Program
Tracking System unique identifier tags shall contain the following
information and/or technical functions:
a. DBR license number.
b. Unique identifier(s) (such
as barcodes and/or numerical/alphabetical codes) that track marijuana
product through each stage of production.
c. Licensed premises location.
d. Any other information or
technical functions DBR deems appropriate (such as radio frequency
identification).
6. Medical Marijuana Program
Tracking System unique identifier tags shall not be altered or
duplicated.
7. Unique identifier tags
shall be placed in a manner so as to clearly display their
association with a particular plant, plant material, or product, such
as affixed to the plant itself, on the growing receptacle, or in the
growing medium, by labeling drying racks and other receptacles that
wet marijuana dries on, by affixing the tag to the stalk for drying
on the stalk, on a label affixed to a storage/transport package
and/or retail-ready package, and other reasonable means.
8. The unique identifier tags
may not be transferred or assigned except when affixed to marijuana
plants, wet marijuana, or usable marijuana which is being
sold/transferred/ transported in accordance with § 1.7(B) and (I)(3)
of this Part.
9. Return of unique identifier
tags by a licensed cultivator upon revocation or abandonment of the
license shall be specifically governed by DBR order or agreement
and/or coordinated efforts with law enforcement. Disposal of unique
identifier tags by a licensed cultivator as may be required by DBR,
such as in the regular course of tagging if different stages will
require different tag forms or such as recall of tags due to new
technology, shall be handled in accordance with further instructions
provided by DBR.
10. In addition to any and all
other disciplinary actions and civil and criminal penalties
authorized by the Act and the DBR Regulations in the event that a
licensed cultivator fails to comply with the unique identifier tags
provisions for licensed cultivators set forth above, the licensed
cultivator is subject to a fine between twenty-five dollars ($25) and
five-thousand dollars ($5,000) per mature marijuana plant that does
not have the required unique identifier tag. See R.I. Gen. Laws §
21-28.6-15(b)(4)(untagged plants exceeding limits set by R.I. Gen.
Laws § 21-28.6-16 subject to minimum of the tag fee that would be
paid by a cardholder ($25), leaving discretion to DBR to establish a
maximum penalty); R.I. Gen. Laws § 21-28.6-16 (authorizing DBR to
limit licensed cultivator inventory).
E. Inventory Control
1. Upon direction by DBR, each
licensed cultivator shall utilize the state approved Medical
Marijuana Program Tracking System for all inventory tracking from
seed to sale as further defined herein.
2. If the licensed cultivator
is notified by DBR that the Medical Marijuana Program Tracking System
is not available, the licensed cultivator will be provided with
direction as to alternative inventory control measures, which may
include but are not necessarily limited to the licensed cultivator
being directed to:
a. Conduct an initial
comprehensive inventory of all medical marijuana, including usable
marijuana available for sale, marijuana plants and seedlings,
unusable marijuana, and wet marijuana, as of a date certain set by
DBR.
b. Conduct subsequent
comprehensive inventories at intervals not to exceed twenty-four (24)
months from the date of the previous comprehensive inventory.
c. Conduct a monthly inventory
review of stored, usable marijuana, seedlings, plants, and wet
marijuana.
3. Upon request, DBR may
require the licensed cultivator to conduct and provide the results of
alternative inventory control measures outlined above, regardless of
the availability and use of the Medical Marijuana Program Tracking
System.
F. Minimum Security
Requirements
1. Authority
R.I. Gen. Laws §
21-28.6-16(b)(4) authorizes DBR to promulgate regulations regarding
the minimum security requirements for licensed cultivators.
2. General Security
Requirements
a. Each licensed cultivator
shall implement appropriate security and safety measures to deter and
prevent the unauthorized entrance into areas containing marijuana and
the theft of marijuana.
b. Use or carry of firearms on
the premises and/or perimeter of the licensed cultivator is a
prohibited form of security, except by security guards licensed by
the Office of the Rhode Island Attorney General pursuant to R.I. Gen.
Laws § 5-5.1-13 and who are under written contract to provide
security services to the licensed cultivator and by law enforcement
personnel during duty.
c. The outside perimeter of
the licensed cultivator shall have adequate lighting to deter theft
which may include motion activated lighting acceptable to DBR.
d. Within any area where
marijuana and marijuana products are grown, cultivated, stored,
weighed, packaged, processed, or manufactured, any person who does
not have a valid licensed cultivator registry identification card
shall be considered a “visitor” and must be escorted at all times
by a licensed cultivator registry identification card holder. The
licensed cultivator must maintain a visitor log for any such activity
as detailed in § 1.7(F)(6)(c) of this Part.
e. Each licensed cultivator
shall ensure that the storage of marijuana and any marijuana products
is in a locked area, meaning that at all points of ingress and
egress, the licensed cultivator shall ensure the use of a working
commercial-grade door lock.
3. Security Alarm Requirements
a. Each licensed cultivator
shall have a fully operational security alarm system at the premises
that will provide suitable protection against theft and diversion,
including alarms at all outside perimeter entry points and outside
perimeter windows.
b. A fully operational
security alarm system may include a combination of hard-wired systems
and systems interconnected with a radio frequency method such as
cellular or private radio signals that emit or transmit a remote or
local audible, visual, or electronic signal; motion detectors,
pressure switches, duress alarms (a silent system signal generated by
the entry of a designated code into the arming station to indicate
that the user is disarming under duress); panic alarms (an audible
system signal to indicate an emergency situation); and hold-up alarms
(a silent system signal to indicate that a robbery is in progress).
c. A fully operational
security alarm system shall at a minimum provide for immediate
automatic or electronic notification to alert municipal and/or state
law enforcement agencies or public safety personnel to an
unauthorized breach or attempted unauthorized breach of security at
the licensed cultivator premises and to any loss-of-electrical
support backup system to the security alarm system.
d. Each licensed cultivator
shall establish a protocol for the testing and maintenance of the
security alarm system, which shall at a minimum provide for a
maintenance inspection/test of the alarm system for each authorized
location at intervals not to exceed thirty (30) calendar days from
the previous inspection/test and prompt completion of all necessary
repairs to ensure the proper operation of the alarm system.
e. If the licensed cultivator
premises suffers a failure of the security alarm system, due to loss
of electrical support, mechanical function, or otherwise, that is
expected to exceed an eight (8) hour period, in addition to the
notice requirements provided in § 1.7(F)(3)(c) and (F)(7) of this
Part, the licensed cultivator must also close the licensed cultivator
premises until the security alarm system has been restored to full
operation, or, if approved by DBR, provide alternative security
measures.
4. Video Surveillance
Requirements
Each licensed cultivator must
have a fully operational video surveillance and camera recording
system with appropriate protocols, which shall, at a minimum, comply
with the below requirements:
a. Video surveillance
equipment shall, at a minimum, consist of digital or network video
recorders, video monitors, and digital archiving devices capable of
playback quality sufficient to identify and monitor all individuals
(including sufficient clarity of facial features) and activities in
the monitored areas.
b. The recording system must
record in digital format.
c. The date and time must be
embedded on the recording without significantly obscuring the
picture. Time is to be measured in Eastern Standard Time.
d. All video surveillance
systems must be equipped with a failure notification system that
provides prompt notification of any surveillance interruption and/or
the complete failure of the surveillance system. Said
notification must be routed to licensed cultivator personnel
specifically designated by management and to DBR.
e. All video surveillance
equipment shall have sufficient battery backup to support a minimum
of four (4) hours of recording in the event of a power outage.
f. Video recordings must be
archived in a format and maintained in a manner that ensures
authentication of the recording as legitimately-captured video and
guarantees that no alteration of the recorded image has taken place.
g. Remote access to a
continuous live feed video on a real time basis must be available at
all times to licensed cultivator personnel specifically designated by
management and to DBR. Additionally, all video surveillance
records and recordings must be made available upon request to DBR.
h. The system must include a
color printer or similar equipment capable of printing still photos
of a quality sufficient to identify individuals and activities in the
monitored areas.
i. Camera coverage is required
for all areas where marijuana and marijuana products are grown,
cultivated, stored, weighed, packaged, processed, or manufactured,
including all areas of ingress and egress thereto, security rooms (as
defined below), all points of ingress and egress to the exterior of
the licensed cultivator, and any computer or other digital access
points.
j. Camera views of required
coverage areas shall be continuously recorded twenty (24) hours a
day, (7) seven days per week.
k. All surveillance recordings
must be kept for a minimum of sixty (60) calendar days.
l. Surveillance recording
equipment and all video surveillance records and recordings must be
housed in a designated, locked and secured room or other enclosure
with access limited to licensed cultivator personnel specifically
authorized by management (the “security room”). The licensed
cultivator must keep on site a current list of all authorized
employees and service personnel who have access to the security room
and a video surveillance equipment maintenance activity log.
m. If the licensed cultivator
suffers a failure of the surveillance system, due to loss of
electrical support, mechanical function, or otherwise, that is
expected to exceed an eight (8) hour period, in addition to the
notice requirements provided in § 1.7(F)(4)(d) and § 1.7(F)(7) of
this Part, the licensed cultivator must also close the licensed
cultivator premises until the video surveillance system has been
restored to full operation, or, if approved by DBR, provide
alternative premises monitoring.
5. Emergency Plan
The licensed cultivator shall
develop and maintain an emergency plan with procedures to be followed
to prevent and, if not prevented, to adequately address and mitigate
consequences of theft or burglary or attempts thereof, fire, natural
disasters, and other emergencies, including cybersecurity and data
breach procedures to prevent a compromise of the integrity of the
Medical Marijuana Program Tracking System. The plan shall include
training for employees on crime prevention and personal safety
techniques.
6. Security-Related
Record-Keeping
The licensed cultivator shall
maintain the following documentation on-site and with digital back-up
for a period of at least twenty-four (24) months after the event:
a. Inventory records
including, at a minimum, the date the inventory was conducted, a
summary of the inventory findings and the name, signature and title
of the individual who conducted the inventory.
b. All records of maintenance,
inspections, and tests of the security alarm and video surveillance
systems and of servicing, modifications, or upgrades performed on
said systems. These records shall include, at a minimum, the date of
the action, a summary of the action(s) performed and the purpose
therefor, and the name, signature and title of the individual who
performed the action(s).
c. Visitor logs which shall
include the name of each visitor, the date and time of the beginning
and end of the visit, the reason for the visit (i.e. maintenance,
authorized pickup, etc.), the name of the escorting licensed
cultivator registry identification cardholder.
d. Emergency notification
reports as required by § 1.7(F)(7) of this Part.
7. Emergency Notifications and
Reports
a. Licensed cultivators shall
provide notification of emergency events to DBR and municipal and/or
state law enforcement as outlined below.
b. Immediately upon discovery
of the event, the licensed cultivator shall provide telephone
notification to the appropriate municipal and/or state law
enforcement authorities regarding any of the following “emergency
events:”
(1) Theft or burglary or an
attempt thereof.
(2) Any fire.
(3) A natural disaster that
results in the destruction of or damage to medical marijuana or
marijuana products.
(4) A failure of the security
alarm system or video surveillance system, due to loss of electrical
support, mechanical function, or otherwise, that is expected to
exceed an eight (8) hour period.
(5) A security alarm
activation.
(6) Any other event which
requires response by law enforcement or public safety personnel.
c. The licensed cultivator
shall provide e-mail notification to DBR immediately upon discovery
of any data breach or cybersecurity threat to the Medical Marijuana
Program Tracking System, and within twenty-four (24) hours of
discovery of any other emergency event as defined above. A follow-up
telephone notification to DBR shall be provided no later than the
next business day.
d. The licensed cultivator
shall submit a follow-up written report to DBR within five (5)
business days for each emergency event. The written report shall
include, at a minimum, a description of the event(s), identification
of known or suspected cause(s) for the event(s), any corrective
action(s) taken to prevent a recurrence, and the name, title, and
signature of the individual preparing the report.
e. Any notification and report
of an emergency event required to be made to DBR pursuant to these
DBR Regulations shall be made using the mailing address, telephone
number, and/or e-mail address provided by DBR to approved licensees.
f. Upon written direction to
the licensed cultivator, DBR may require that the written and
telephone notifications and reporting must be replaced or
supplemented by notifications and reporting through the Medical
Marijuana Program Tracking System or any other electronic system or
means DBR mandates the licensed cultivator to utilize.
G. Record-Keeping and
Reporting
1. Authority
R.I. Gen. Laws §
21-28.6-16(b)(3) authorizes DBR to promulgate regulations regarding
the minimum record-keeping requirements for licensed cultivators.
2. Operations Manual
Each licensed cultivator
shall develop, implement, and maintain on the premises an operations
manual which addresses, at a minimum, the following subject areas and
requirements:
a. Procedures for the
organization, administration, command, and control of the licensed
cultivator (including but not limited to organizational chart, chain
of command protocols, etc).
b. Procedures to ensure
accurate record-keeping, including protocols to ensure that all
acquisitions and authorized sales of marijuana are logged into the
Medical Marijuana Program Tracking System on a real time basis and
procedures on proper training and use of the Medical Marijuana
Program Tracking System and any other tracking system used by the
licensed cultivator.
c. Records retention policies.
d. Ethics and compliance
policies.
e. Alcohol and drug free work
place policy.
f. If applicable, medical
marijuana manufacturing protocols, safety measures, and training
information.
g. Odor control and mitigation
plan.
3. Personnel Records
Each licensed cultivator
shall maintain a personnel record for each employee or agent for a
period of at least six (6) months after termination of the
individual’s affiliation with the license cultivator. Said
personnel record shall contain the following minimum documentation
and information:
a. An application for
employment or offers to provide services as an agent.
b. An employment or engagement
description detailing duties, responsibilities, authority,
qualifications and supervision.
c. If applicable, a copy of
any employment or engagement.
d. A record of any
disciplinary action taken.
e. Documentation of all
required training, which shall include a signed statement from the
individual indicating the date, time and place he or she received
said training, topics discussed, and the name and title of
presenters.
4. Additional Records to be
Maintained
In addition to all other
specific record-keeping requirements of the Act, the DBR Regulations,
and the DOH Regulations, the licensed cultivator shall maintain the
following records for a minimum of five (5) years:
a. All contracts and purchase
orders with compassion centers, including documentation of any
cancelled contracts or purchased orders and any contracts and
purchase orders voided by replacement contracts.
b. Invoices and any supporting
documentation of all marijuana purchases, acquisitions, sales,
transfers, and payments.
c. Contracts pertaining to the
security alarm and security camera systems.
d. Contracts with vendors,
including any approved third party testing providers.
e. All records normally
retained for tax purposes.
5. Storage of Records
Records pertaining to
transactions occurring within the last six (6) months shall be stored
on the registered premises. Records dating further back may be
stored off the premises with DBR’s approval.
6. Responsibility for Loss of
Records and Data
The licensed cultivator shall
exercise due diligence and reasonable care in preserving and
maintaining all required records to guard against loss of records and
data, including cybersecurity of electronically-maintained records.
H. Product Packaging and
Labeling Requirements
1. Authority and Applicability
a. These product packaging and
labeling requirements for licensed cultivators are promulgated
pursuant to R.I. Gen. Laws § 21-28.6-16(g). These requirements were
developed jointly with DOH.
b. Licensed cultivators shall
have ninety (90) calendar days from the effective date of these
regulations to comply with these requirements.
c. Any container or packaging
containing usable marijuana or marijuana product, including both
retail-retail ready packaging and product otherwise packaged for the
purpose of storage and/or authorized transport, must:
(1) Protect the product from
contamination.
(2) Not impart any toxic or
deleterious substance to the usable marijuana or marijuana product.
(3) Contain the Inventory
tracking ID number assigned by the Medical Marijuana Program Tracking
System or, if prior to the Medical Marijuana Program Tracking
System’s implementation, an inventory tracking ID number generated
from an alternative inventory tracking system approved by DBR.
(4) Be labeled with the
quantity of the product.
d. The remainder of these
product packaging and labeling requirements only apply to
retail-ready product packaging and labeling. Such requirements only
apply to a licensed cultivator if the licensed cultivator is engaged
in retail-ready product packaging and/or labeling services as part of
the services provided for sale of a retail-ready product to a
compassion center pursuant to a written contract/purchase order.
e. Compliance with these
product packaging and labeling requirements shall include the
requirement that the licensed cultivator confirms before retail-ready
packaging/labeling that the product complies with the DOH Testing
Regulation, once adopted.
2. Packaging and labeling
shall not:
a. Make any false or
misleading statements including particularly any statements regarding
health or physical benefits to the consumer and the composition and
profiles that are advertised/indicated in the label.
b. Resemble the trademarked,
characteristic or product-specialized packaging of any commercially
available snack, baked good, or beverage.
c. Contain any statement,
artwork, or design that could reasonably mislead any reasonably
prudent person to believe that the package contains anything other
than medical marijuana or marijuana product.
d. Contain any seal, flag,
crest, coat of arms, or other insignia that could reasonably mislead
any reasonably prudent person to believe that the product has been
endorsed or manufactured by the State of Rhode Island or any agency
thereof or municipality within.
3. Packaging for retail-ready
medical marijuana and marijuana products shall be opaque,
light-resistant, and tamper-evident.
4. Packaging and labeling
shall not be designed such that it would be attractive to children.
This requires the packing and labeling be in black and white only,
have no animal characters, and does not contain the word “candy.”
5. Retail-ready medical
marijuana and marijuana products must be packaged in manner that is
“child-resistant,” which for purposes of these Regulations shall
mean that the packaging is designed and constructed to be
significantly difficult for children under five years of age to open.
Approved methods include but are not limited to:
a. Solid or liquid marijuana
products may be packaged in plastic four mil or greater in thickness
and be heat sealed with no easy-open tab, dimple, corner, or flap.
b. Liquid marijuana products
may also be packaged in a bottle and sealed using a metal crown cork
style bottle cap or other similar sealing method pre-approved by DBR.
6. For solid edible marijuana
products with more than one serving size in the outer package, each
serving must be packaged individually and placed in a child-resistant
outer package.
7. For liquid edible marijuana
products with more than one serving in the package, a measuring cap
or dropper must be included in the package with the product.
8. All retail-ready medical
marijuana and marijuana products must include a label affixed to the
package containing the following information, prominently displayed
and in a clear and legible English language font:
a. The business or trade name
of the selling compassion center.
b. Inventory tracking ID
number assigned by the Medical Marijuana Program Tracking System or,
if prior to the Medical Marijuana Program Tracking System’s
implementation, an inventory tracking ID number generated from an
alternative inventory tracking system approved by DBR.
c. Date of final packaging,
and, if applicable, the recommended expiration or “use by” date.
d. Total weight in ounces and
grams or volume as appropriate. Weight and volume must be determined
using accurately calibrated equipment which equipment must also
comply with any other applicable state laws.
e. Total estimated amount of
THC and total estimated amount of CBD.
f. For edible marijuana
products, a list of all ingredients used.
g. A statement that discloses
all pesticides applied to the marijuana plants and growing medium
during production and processing.
h. If solvents were used,
statement that discloses the type of extraction method, including any
solvents, gases, or other chemicals or compounds used to produce or
that are added to the extract.
i. Any applicable instructions
for use and safe storage.
9. All retail-ready medical
marijuana and marijuana products must include a label affixed to the
package containing the following warnings, prominently displayed and
in a clear and legible English language font. For products other
than edibles and topical applications, these warnings may be on an
insert provided with the packaging.
a. “Warning: Marijuana has
intoxicating effects and may be habit forming and addictive. The
intoxicating effects of marijuana may be delayed by up to two hours.”
b. “Warning: Do not operate
a vehicle or machinery under its influence.”
c. “Warning: There may be
health risks associated with consumption of marijuana.”
d. “Warning: For use only by
adults twenty-one and older. Keep out of reach of children.”
e. “Warning: Marijuana
should not be used by women that are pregnant or breast feeding.”
f. “Warning: Do not take
this product across state lines.”
g. “Warning: For medical use
by a registered patient only. Not for resale.”
h. “Warning: This product
is not certified to be free of contaminants.”
i. For product to be smoked,
“Warning: Smoking is hazardous to your health.”
j. If applicable, a warning
regarding use or contact with any nuts or other known allergens as
defined in the federal Food Allergen Labeling and Consumer Protection
Act of 2004, as administered by the federal Food and Drug
Administration.
10. Notwithstanding any of the
product labeling requirements set forth in § 1.7(H) of this Part,
application may be made to DBR for approval to affix a two inch (2”)
by two inch (2”) logo or graphic, which may be colored, for the
purpose of identifying the compassion center selling and/or the
cultivator producing the product.
I. Other Licensed Cultivator
Operation Requirements
1. Authority
R.I. Gen. Laws §
21-28.6-16(b)(2) authorizes DBR to promulgate regulations regarding
the minimum oversight requirements for licensed cultivators. The
requirements set forth in this section are promulgated in accordance
with that statutory duty of general regulatory supervision over the
licensed cultivators.
2. Use on Premises Prohibited
Use of marijuana or marijuana
products on the premises of the licensed cultivator is strictly
prohibited.
3. Transportation of Medical
Marijuana to and from Licensed Cultivators
a. “Authorized transports”
of marijuana and marijuana products to and from licensed cultivators
are limited to transports authorized in § 1.7 of this Part.
b. “Registered/licensed
facility” shall refer to a either a licensed cultivator or
registered compassion center that is party to an “authorized
transport,” as the context requires.
c. “Authorized transport
vehicle” means a vehicle meeting the following criteria:
(1) The vehicle bears no
markings that indicate that the vehicle is being used to transport
marijuana nor indicates the name of the registered/licensed facility.
(2) The vehicle is equipped
with a global positioning system monitoring device that is monitored
by the originating registered/licensed facility during an authorized
transport.
(3) The vehicle has a locked
storage compartment within which the marijuana and marijuana product
being transported is secured.
d. “Detailed transport
manifest” refers to a manifest which DBR may be required to be
generated through and/or maintained in the Medical Marijuana Program
Tracking System and that shall include the following minimum
information:
(1) Departure date and
approximate time of departure.
(2) Names, location addresses,
and registration/license numbers of the originating and receiving
registered/licensed facilities.
(3) Product name or
descriptions and quantities (by weight or unit) of each product to be
delivered to each specific destination location(s).
(4) Arrival date and
approximate time of arrival.
(5) Delivery vehicle make and
model and license plate number.
(6) Names, registry
identification card numbers, and signatures of the delivery persons.
e. The originating
registered/licensed facility shall ensure that all delivery times and
routes are randomized.
f. Authorized transports may
only be made by cardholders affiliated with the particular
registered/licensed facility that is the source or recipient party to
an authorized transaction. Authorized transports must be in
compliance with one of the following minimum requirements: (i) an
authorized transport may use a single authorized transport vehicle so
long as it is operated/occupied by a minimum of two authorized
transport cardholders and is subject to the requirement that at least
one such cardholder shall remain in the authorized transport vehicle
at all times; or (ii) an authorized transport may use two or more
authorized transport vehicles that are operated/occupied by
authorized transport cardholders provided the authorized transport
vehicles are traveling together at all times during the authorized
transport.
g. During all authorized
transports, the delivery persons must have on their persons their
licensed cultivator or compassion center registry identification
cards and the detailed transport manifest.
h. Any authorized transport
vehicle carrying marijuana and marijuana products shall travel
directly from the originating registered/licensed facility to the
receiving registered/licensed facility. In case of an emergency
stop, a detailed written account must be maintained describing the
reason for the event, the duration, the location, any activities
occurring during the stop, and any personnel exiting the vehicle
during the stop.
i. Authorized transports shall
be conducted in such a manner as to ensure that marijuana and
marijuana products are secured and safe at all times during
transport, which includes, but is not limited to, the requirements
that marijuana is not visible from outside the authorized transport
vehicle at that any ingestible marijuana products that are perishable
are adequately refrigerated, if necessary.
j. Prior to leaving the
originating registered/licensed facility for an authorized transport
to another registered/licensed facility, the originating
registered/licensed facility must weigh, inventory, and account for
on video all marijuana and marijuana product to be transported.
k. For authorized transports
to and from a compassion center, the transport manifest shall be
accompanied by a copy of any contract/purchase order for which the
transport is being made and documentation of the actual payment date,
if prepaid.
l. The detailed transport
manifest shall be prepared by the originating registered/licensed
facility and transmitted in advance to the receiving facility. Both
facilities shall retain copies of detailed transport manifests as
part of their record retention responsibilities.
m. Within eight (8) hours of
after arrival at the destination registered/licensed facility, the
receiving party shall re-weigh, re-inventory, and account on video
for all marijuana and marijuana product transported.
n. Both the originating and
recipient registered/licensed facilities shall timely adjust their
records to reflect in its records the completed authorized transport
of marijuana, including logging such information in the Medical
Marijuana Program Tracking System. All records and entries in the
Medical Marijuana Program Tracking System shall be easily reconciled,
by product name and quantity, with the applicable detailed transport
manifest. Any unusual discrepancies in the quantity described in the
detailed transport manifest and the quantities received shall be
reported to DBR and municipal and/or state law enforcement within
(24) hours.
o. Any vehicle accidents,
diversions, or losses during authorized transports of marijuana shall
be reported to DBR and law enforcement as an “emergency event”
pursuant to § 1.7(F)(7) of this Part.
p. Transportation to or from a
third party testing provider shall be in accordance with the DOH
Testing Regulations, once adopted.
4. Manufacturing and
Extraction
a. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(h), licensed cultivators are not permitted to
manufacture marijuana using a solvent extraction process that
includes the use of a compressed, flammable gas as a solvent.
b. Any other manufacturing
method using a solvent extraction process must be approved by DBR.
If the manufacturing method uses a flammable/combustible material or
heat source, the method must also be approved by the State Fire
Marshall and/or local fire department.
c. Only registered cultivator
employees and agents may manufacture marijuana products on the
premises.
d. The licensed cultivator
must maintain written standard operating procedures for each
manufacturing process, including step-by-step instructions.
e. The licensed cultivator
must ensure that for each manufacturing process, all safety and
sanitary equipment appropriate for that manufacturing process,
including any personal protective equipment, is provided to any
authorized cultivator cardholder who will be involved in that
manufacturing process.
f. All medical marijuana
product manufacturing areas must be adequately lit during
manufacturing, cleaning, or other use.
g. All work surfaces on which
medical marijuana products are manufactured and the walls and floors
in the areas in which such products are manufactured shall be
non-porous, non-absorbent, and easily cleanable.
h. No eating or smoking shall
be permitted in the manufacturing area.
i. The licensed cultivator
must provide a training manual and instructional training on each
manufacturing process to any authorized cultivator cardholder who
will be involved in that manufacturing process.
5. Required Employee and Agent
Training
Each employee and agent of
the licensed cultivator shall receive, at the time of his or her
initial appointment and every year thereafter, at a minimum, training
in the following:
a. The proper use of security
measures and controls that have been adopted and instruction on the
licensed cultivator’s emergency plan.
b. The use of the Medical
Marijuana Program Tracking System and any other tracking systems used
by the licensed cultivator for persons responsible for using the
system.
6. Minimum Sanitation and
Workplace Safety Conditions
a. The licensed cultivator
facility shall be maintained in a safe, sanitary, and clean manner,
with all operations in the cultivation, receiving, inspecting,
transporting, segregating, preparing, manufacturing, packaging, and
storing of medical marijuana and marijuana products conducted in
accordance with adequate sanitation principles, as further detailed
below.
b. The facility must meet the
following minimum specifications:
(1) Adequate supply of potable
hot and cold water.
(2) Non-porous, non-absorbent
and easily cleanable floors, walls, and ceilings in areas where
marijuana is cultivated, manufactured, and stored.
(3) Lavatory facilities that
are readily-accessible to employees and that comply with the Rhode
Island State Plumbing Code Regulation.
(4) Adequate hand-washing
area(s): hand washing sinks with effective hand-cleaning and
sanitizing preparations (such as soap dispensers) and disposable
towels or an air dryer for hands.
(5) Adequate screening or
other protection against the entry of pests and environmental
contaminants.
c. All mechanical and
electrical equipment shall be maintained in a safe operating
condition.
d. Waste disposal equipment
shall be adequate and removal schedules timely so as to minimize the
risk of contamination to medical marijuana and marijuana products,
including the risk of the waste becoming an attractant, harborage, or
breeding place for pests.
e. All waste (including all
liquid, chemical, hazardous, pesticide, manufacturing solvent and
chemical waste) must be stored, secured, and managed in accordance
with all applicable federal, state, and local statutes, regulations,
ordinances, or other legal requirements. Specific instructions for
safe destruction of any marijuana required to be destroyed and proper
disposal of medical marijuana waste are provided in § 1.7(I)(9) of
this Part.
f. Floors, walls, and ceilings
shall be kept clean and in good repair, free from dust, debris, mold,
mildew, and other contaminants and potentially hazardous materials.
g. Lavatory facilities and
hand washing areas shall be kept clean and sanitary and in working
condition at all times.
h. Toxic cleaning compounds,
sanitizing agents, and other chemicals shall be identified, held,
stored and disposed of in a manner that protects against
contamination of medical marijuana and marijuana products and in a
manner that is in accordance with any applicable local, state, or
federal law, rule, regulation, or ordinance.
i. The licensed cultivator
shall comply with all relevant statutes, regulations, and
requirements administered by the Federal Occupational Safety and
Health Administration (OSHA), including but not necessarily limited
to standards for toxic and flammable compounds and air contaminants.
j. All persons working in
direct contact with medical marijuana and marijuana products shall
conform to hygienic practices while on duty, including but not
limited to maintaining adequate personal cleanliness and washing
hands thoroughly in an adequate hand-washing area before starting
work and at any other time when the hands may have become soiled or
contaminated.
k. Any person whose medical
condition, as determined by medical examination or as observed by a
supervisor, poses or reasonably appears to pose a risk of
contamination of medical marijuana and/or medical marijuana products
shall be excluded from medical marijuana operations until the
condition is cleared. Medical conditions posing a risk of
contamination include but are not necessarily limited to open
lesions, including boils, sores, or infected wounds, or any other
abnormal source of microbial infection.
l. The licensed cultivator
shall not permit the entry of any animal into the premises. Service
animals (as defined in the Americans with Disabilities Act) are
exempted from this prohibition.
m. In addition to the safety
and sanitary equipment including personal protective equipment that
the licensed cultivator is required to furnish its employees involved
in marijuana manufacturing and extraction pursuant to § 1.7(I)(4)(e)
of this Part, the licensed cultivator must also furnish its employees
with proper safety equipment for other types of work assigned as part
of the licensed cultivator operations.
7. Odor Control and Mitigation
a. Cultivation area(s) shall
have ventilation and filtration systems installed that prevent
medical marijuana plant odors from exiting the interior of the
structure to an extent that would significantly alter the
environmental odor outside, while addressing the potential for mold.
b. The ventilation and
filtration system, along with any plumbing improvements, shall be
installed in compliance with all applicable codes and ordinances,
including obtaining any necessary permits, and inspected by the
municipality.
c. Measures to assure
compliance with this section shall be documented in an odor control
and mitigation plan acceptable to DBR.
8. Pesticide Use and Records
a. The cultivation process
shall use best practices to limit contamination of medical marijuana
and marijuana products, including but not limited to mold, mildew,
fungus, bacterial diseases, rot, pests, pesticides, and any other
contaminant identified as posing potential harm.
b. The use of pesticides on
marijuana plants in Rhode Island by licensed cultivator will not be
considered a violation of these regulations provided that the product
must satisfy all of the following criteria:
(1) The product must be a
“minimum risk pesticide” under 40 C.F.R. § 152.25(f), as the
same may be amended from time to time.
(2) The product must be
labelled for use on “all plants,” “other plants,” bedding
plants, unspecified plants, or unspecified crops.
(3) The label must not
prohibit indoor or greenhouse use, as applicable.
(4) All active ingredients
must be eligible for food use as determined by the federal
Environmental Protection Agency (EPA). See EPA’s Active
Ingredients Eligible for Minimum Risk Pesticide Products (last
updated December 2015), as the same may be updated and/or amended
from time to time.
https://www.epa.gov/sites/production/files/2015-12/documents/minrisk-active-ingredients-tolerances-2015-12-15.pdf.
(5) All inert/other
ingredients must be eligible for food use. See EPA’s Inert
Ingredients Eligible for FIFRA 25(b) Pesticide Products (last updated
December 2015), as the same may be updated and/or amended from time
to time.
https://www.epa.gov/sites/production/files/2016-07/documents/section25b_inerts.pdf.
(6) The product must be a
currently registered pesticide product eligible for sale in Rhode
Island as determined by the Rhode Island Department of Environmental
Management. To verify a product’s registration in Rhode Island,
please consult the online National Pesticide Information Retrieval
System through the Center for Environmental and Regulatory
Information Systems. See
http://npirspublic.ceris.purdue.edu/state/state_menu.aspx?state=RI.
(7) The product must be used
in accordance with any and all use instructions on the label.
c. No application of
pesticides shall be made after the vegetative stage of growth of the
cannabis plant. The vegetative stage of growth should be determined
by visual buds or flower or by proxy of the plant receiving less than
eighteen (18) hours of light in a twenty-four (24) hour period.
d. Pesticides shall be
identified, held, stored and disposed of in a manner that protects
against contamination of medical marijuana and marijuana products and
in a manner that is in accordance with any applicable local, state,
or federal law, rule, regulation, or ordinance.
e. As a DBR record-keeping
requirement, licensed cultivators must keep detailed records of any
pesticide products used and application regiments, including video
recording during pesticide applications which must cease if there is
a failure or disruption of the video surveillance system. This
record-keeping requirement is independent of that required of
commercial pesticide applicators by the Rhode Island Department of
Environmental Management, and is intended to apply in addition to
that requirement, where relevant.
9. Safe Disposal of Medical
Marijuana Waste and Safe Destruction of Usable Medical Marijuana
a. Marijuana and marijuana
product waste (including all liquid, chemical, hazardous, pesticide,
manufacturing solvent and chemical waste containing any traces of
marijuana) must be stored, secured, and managed in accordance with
all applicable federal, state, and local statutes, regulations,
ordinances, or other legal requirements.
b. Prior to disposal,
marijuana and marijuana product waste must be made unusable and any
marijuana plant material made indistinguishable from other plant
material. This may be accomplished by grinding and incorporating the
marijuana plant waste with other non-consumable solid waste or other
ground materials so the resulting mixture is at least fifty percent
non-marijuana waste by volume. Other methods to render marijuana
waste unusable must be approved by DBR before implementing.
Marijuana waste rendered unusable following an approved method may be
delivered to a licensed solid waste disposal facility in Rhode Island
for final disposition or disposed of in an alternative manner
approved by DBR.
c. Destruction of marijuana
and marijuana materials other than waste generated in the regular
course of processing and/or manufacturing (such as destruction of
whole plants, wet, or usable marijuana that are found to be in excess
of statutory possession limits or destruction of a contaminated batch
of medical marijuana product) shall be in a manner acceptable to DBR,
which may include consultation with law enforcement.
d. Destruction of marijuana
and marijuana materials upon revocation or abandonment of the license
shall be specifically governed by DBR order or agreement and/or
coordinated efforts with law enforcement.
e. Licensed cultivators must
maintain accurate and comprehensive records regarding waste material
that accounts for, reconciles, and evidences all waste activity
related to the disposal of marijuana and marijuana products
(including any waste material produced through the trimming or
pruning of a marijuana plant prior to harvest). DBR may mandate
storage of any such records or summaries of such records to be
through the Medical Marijuana Program Tracking System or any other
electronic system DBR designates.
J. Inspections and Audits;
Enforcement Actions
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(j), licensed cultivators are subject to reasonable
inspection by DBR. Accordingly, DBR and its authorized
representatives have authority to enter a licensed cultivator
premises at reasonable times and to inspect in a reasonable manner,
the premises and all equipment, materials, containers, and other
things therein, including without limitation all records, files,
financials, sales, transport, pricing, and employee data, research,
papers, processes, controls and to inventory any stock of marijuana,
labels, containers, paraphernalia and other materials and products.
2. DBR may review and audit
the books and records of a licensed cultivator to ascertain
compliance with the Act, the DBR Regulations, and/or the DOH
Regulations. The licensed cultivator must make such books and
records immediately available for reviewing and copying by DBR. DBR
may retain an independent auditor to act as its agent for purposes of
this section, the cost of which shall be borne by the licensed
cultivator.
3. Nothing herein shall be
interpreted to limit the real time access of DBR and DOH to
information stored in the Medical Marijuana Program Tracking System
consistent with the Act.
4. Pursuant to R.I. Gen. Laws
§ 21-28.6-16(e), if a licensed cultivator violates R.I. Gen. Laws §
21-28.6-16 (entitled “Licensed Cultivator”) or any portion of the
DBR Regulations or DOH Regulations which regulate licensed
cultivators and licensed cultivator cardholders, DBR may
suspend/revoke a cultivator license and/or impose an administrative
penalty, as determined by DBR. Pursuant to R.I. Gen. Laws §
21-28.6-16(l)(5), if a licensed cultivator violates any other
provision of the Act, the DBR Regulations, or the DOH Regulations,
the cultivator license may be suspended/revoked.
5. If an officer, director or
manager/member, employee, or agent affiliated with a licensed
cultivator violates the Act, the DBR Regulations, and/or the DOH
Regulations when acting in their capacity as an officer, director or
manager/member, employee, or agent of the licensed cultivator, the
licensed cultivator may be subject to suspension/revocation and/or
administrative penalties for failure to exercise adequate
supervision.
1.8 Cooperative Cultivation
Provisions
A. Authority and Effective
Date
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(10), DBR is charged with promulgating regulations
governing the licensing and operation of cooperative cultivations,
and may promulgate regulations that set a fee for a cooperative
cultivation license.
2. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(1), cooperative cultivations (defined below) must
apply to obtain a license from DBR effective January 1, 2017. For
cooperative cultivations in existence prior to January 1, 2017 that
have submitted a completed cooperative license application no later
than January 1, 2017, the cooperative cultivation may continue its
operations until its license application is acted upon by DBR.
B. Cooperative Cultivation
Definitions
1. “Cooperative cultivation”
shall mean two (2) or more qualifying patient or primary caregiver
cardholders that elect to cooperatively cultivate marijuana in the
same dwelling unit or commercial unit within the limits and subject
to the requirements of a cooperative cultivation license under the
Act and these regulations. This excludes the situations of two (2)
or more qualifying patient or primary caregiver cardholder(s) who are
primary residents of the same dwelling unit where the medical
marijuana plants are grown and who do not elect to grow together
within the limits and subject to the requirements of a cooperative
cultivation license under the Act and these regulations; provided
nothing herein should be deemed to absolve persons in such a
situation from complying with the requirements that all medical
marijuana plants must be properly tagged and not exceed the plant
limits of R.I. Gen. Laws § 21-28.6-4(q)(if election to grow as a
licensed cooperative cultivation is not made, no more than
twenty-four (24) plants may be grown at a single dwelling unit or
commercial unit). See also R.I. Gen. Laws § 21-28.6-14(entitled
“Cooperative Cultivations”); R.I. Gen. Laws §
21-28.6-3(10)(defining “dwelling unit”); R.I. Gen. Laws §
21-28.6-3(3)(defining “commercial unit”).
2. “Licensed cooperative
cultivation” shall mean a cooperative cultivation that is required
to obtain a license from DBR pursuant to R.I. Gen. Laws § 21-28.6-14
and shall include both “licensed residential cooperative
cultivations” and “licensed non-residential cooperative
cultivations.”
3. “Licensed residential
cooperative cultivation” shall mean a licensed cooperative
cultivation in a location zoned for residential use and that complies
with the provisions of § 1.8(F)(3) of this Part.
4. “Licensed non-residential
cooperative cultivation” shall mean a licensed cooperative
cultivation that complies with the provisions of § 1.8(F)(4) of this
Part.
C. Licensed Cooperative
Cultivation “Member” Requirements and Restrictions
1. “Member” of a licensed
cooperative cultivation means any qualifying patient or primary
caregiver with a registry identification card in good standing with
DOH who has elected to grow cooperatively with the other members at
the cooperative cultivation premises.
2. No other person other than
a “member” may participate in the management or operation of the
cooperative cultivation or exert any direct or indirect authority
over the management or operations of the cooperative cultivation.
3. If the cooperative
cultivation organizes as a legal entity, then any directors/officers
and managers/members must be “members” of the cooperative
cultivation as defined above.
4. All “members” of a
licensed cooperative cultivation must be listed on the application.
5. No “member” of a
licensed cooperative cultivation may grow medical marijuana at any
location other than the licensed cooperative cultivation premises.
R.I. Gen. Laws § 21-28.6-4(q).
D. Cooperative Cultivation
Application and License Fees
1. There shall be a
non-refundable application fee of fifty dollars ($50) for initial
cooperative cultivation license applications.
2. The annual license fee for
residential cooperative cultivations shall be two hundred and fifty
dollars ($250).
3. The annual license fee for
non-residential cooperative cultivations shall be five hundred
dollars ($500).
4. These annual license fees
shall be in addition to the individual qualifying patient and primary
caregiver registration fees and medical marijuana plant tag fees.
E. General Application
Requirements for Cooperative Cultivation Licenses
1. Each initial application
for a cooperative cultivation license shall be on such forms and
through such submission mechanisms as designated by DBR and shall
include:
a. The signature of the
individual identified as being primarily responsible for the license
(“primary applicant”) and one designee.
b. A list of the legal name of
each qualified patient cardholder and/or primary caregiver cardholder
that is or will be a member of the cooperative cultivation and for
each such person, their DOH registry identification card number, date
of birth, a mailing address and phone and/or e-mail address at which
they can be best reached.
c. If the cooperative
cultivation chooses to be organized as a legal entity for legal
purposes without the intent of generating profit, the cooperative
cultivation must also provide the following information regarding any
such legal entity:
(1) Legal and any d/b/a
name(s), certificate of incorporation or organization in Rhode Island
or certificate of authority to transact business in Rhode Island,
articles of incorporation or organization, and bylaws or operating
agreement.
(2) The legal name, DOH
registry identification card number, date of birth, of any and all
directors/officers or managers/members of the cooperative
cultivation, including a mailing address and phone and/or e-mail
address at which they can be best reached.
d. Tax Affidavit in accordance
with R.I. Gen. Laws § 5-76-1 et seq. filled out by the “primary
applicant” or legal entity who will hold the license, if approved.
e. Evidence of compliance with
location-specific initial application requirements and security plan
requirement as detailed in § 1.8(F)(6) and 1.8(G) of this Part,
respectively.
2. Only initial applications
which DBR has determined to be complete (i.e., adequately address all
application requirements above) shall be eligible for review. A
primary applicant who submits an incomplete initial application shall
receive written notification from DBR regarding the specific
deficiencies and shall be allowed to resubmit additional material to
address these deficiencies within a reasonable timeframe.
3. When a primary applicant
for a licensed cooperative cultivation is notified that the
application has been approved by DBR, he or she shall complete the
below steps before a license authorizing operation of cooperative
cultivation will be issued:
a. Pay the annual license fee
set forth in § 1.8(D) of this Part above.
b. Provide any updates to
previously submitted application information.
c. Provide evidence of
compliance with final location-specific application requirements as
detailed in § 1.8(F)(7) of this Part.
d. For non-residential
licensed cooperative cultivations, provide a copy of the security
plan as required by § 1.8(G) of this Part.
e. Provide evidence of
completion of divestiture plan pursuant to § 1.8(H) of this Part.
F. Cooperative Cultivation
Location Restrictions and Location-Specific Application Requirements
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(3), a single structural building may only have one
cooperative cultivation operating in it. This precludes a structural
building with multiple units from having more than one unit with a
cooperative cultivation operating in it, unless a single cooperative
cultivation has been approved by DBR to occupy two or more connected
units provided any such approved occupation of multiple units does
not increase the applicable medical marijuana possession limits.
2. Cooperative cultivation
licenses will only be issued for “secure indoor facilities.” The
secure indoor facility shall satisfy the following parameters:
a. Enclosed area with four
walls and a roof.
b. Equipped with locks and any
other appropriate security devices that limit access to the members
of the cooperative cultivation. Locks and devices must be sufficient
to discourage theft, unauthorized entrance, and access by persons
under eighteen (18).
c. Marijuana is not visible
from the street or other public areas. See R.I. Gen. Laws §
21-28.6-14(a)(4).
3. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(7)(ii), a licensed residential cooperative
cultivation must have displayed prominently on the premises an
affidavit by a licensed electrician that the cultivation has been
inspected and is in compliance with any applicable state or municipal
housing and zoning codes for the municipality where the licensed
residential cooperative cultivation is located.
4. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(7)(i), a licensed non-residential cooperative
cultivation must have displayed prominently on the premises
documentation from the municipality where the single location is
located that the location and the cultivation has been inspected by
the municipal building and/or zoning official and the municipal fire
department and is in compliance with any applicable state or
municipal housing and zoning codes.
5. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(8), licensed cooperative cultivations must report
the location of the licensed cooperative cultivation to RISP.
Cooperative cultivation licensees and applicants may designate DBR to
report the location to RISP on their behalf through the application
process. If the cooperative cultivation licensee or applicant will
self-report, DBR will verify with RISP that they did in fact
correctly report the cooperative cultivation location. This
reporting shall be made before a cooperative cultivation license is
issued.
6. Location-Specific Initial
Application Requirements. In order to enable DBR to ascertain
compliance with the above location restrictions, the initial
application for the cooperative cultivation license must contain the
following information regarding the proposed physical location for
the cooperative cultivation licensed premises:
a. A sufficient description of
the location (by plat and lot number, mailing address, etc.).
b. A description of objective
parameters (such as approximate distances from streets and public
areas) and/or proposed measures (such as black-out window shades)
that ensure that marijuana at the premises shall not be visible from
the street or other public areas.
c. Evidence of either
ownership of property by the primary applicant person or legal entity
applicant (as applicable) or any qualified patient or primary
caregiver cardholder that has been listed as associated with the
cooperative cultivation applying for the license, or agreement by
owner of property to allow the operation of a licensed cooperative
cultivation on the property.
7. Location-Specific Final
Application Requirements: If an applicant for a licensed cooperative
cultivation is notified that the application has been approved by
DBR, it shall complete the below steps before a license authorizing
operation of cooperative cultivation will be issued:
a. For residential cooperative
cultivation license applicants, submit an affidavit by a licensed
electrician that the location and cultivation (if the cultivation
predates the licensing requirement) has been inspected and is in
compliance with any applicable state or municipal housing and zoning
codes for the municipality where the licensed residential cooperative
cultivation is located.
b. For non-residential
cooperative cultivation license applicants, submit:
(1) Documentation from the
municipal building and/or zoning official and the municipal fire
department indicating that the location and the cultivation (if the
cultivation predates the licensing requirement) has been inspected by
and is in compliance with any applicable state or municipal housing
and zoning codes.
(2) A draft diagram of the
premises, including where within the facility the medical marijuana
will be grown, stored, and processed, and showing the location of the
facility relative to streets and other public areas.
c. For all cooperative
cultivations, residential or non-residential, provide any updates to
previously submitted application information regarding the location.
d. For all cooperative
cultivations, residential or non-residential, contact DBR to
coordinate the pre-license DBR inspection. Nothing in this paragraph
should be construed as limiting inspections at an earlier time in
addition to the final pre-license inspection.
G. Security Plan Requirement -
For Non-Residential Cooperative Cultivation License Applicants Only
1. Non-residential cooperative
cultivation license applicants must submit and approved licensees
must maintain a security plan that meets the below general criteria.
2. Security and safety
measures (such as locks and lighting) shall be sufficiently designed
to deter and prevent theft of marijuana.
3. The security plan must
include an emergency plan component with procedures to be followed to
prevent and, if not prevented, to adequately address and mitigate
consequences of theft or burglary or attempts thereof, fire, natural
disasters, and other emergencies.
4. Use or carry of firearms on
the premises and/or perimeter of the non-residential cooperative
cultivation is a prohibited form of security, except by security
guards licensed by the Office of the Rhode Island Attorney General
pursuant to R.I. Gen. Laws § 5-5.1-13 and who are under written
contract to provide security services to the non-residential
cooperative cultivation and by law enforcement personnel during duty.
H. Divestiture of Prohibited
Material Financial Interest and Control
1. A licensed cooperative
cultivation and “key persons” thereof may not have any “material
financial interest or control” in another licensed cooperative
cultivation, a compassion center, or a licensed cultivator or vice
versa. See R.I. Gen. Laws § 21-28.6-12(c)(1)(iii)(limiting a
compassion center to one additional location to cultivate its
marijuana); R.I. Gen. Laws § 21-28.6-12(b)(1)(ii)(DBR minimum
oversight over compassion centers); R.I. Gen. Laws §
21-28.6-16(i)(cultivator to be licensed at one location only); R.I.
Gen. Laws § 21-28.6-16(b)(2)(DBR minimum oversight over
cultivators); R.I. Gen. Laws § 21-28.6-3(4)(i) and R.I. Gen. Laws §
21-28.6-3(12)(separately defining “compassion center” and
“licensed cultivator,” respectively); R.I. Gen. Laws §
21-28.6-14(a)(10)(DBR authority to regulate operations of licensed
cooperative cultivations); R.I. Gen. Laws § 21-28.6-4(q)(qualifying
patient and primary caregiver cardholders may only grow at one
location).
2. “Material financial
interest or control” shall mean: i) any ownership interest,
regardless of the size of the holding, and including any ownership
interest through a subsidiary or affiliate; ii) trusteeship,
mortgage, guarantor, endorser or surety relationship, or loan
relationship, except that loan relationship for the purposes of this
definition shall exclude accounts payable and accounts receivable on
account of a medical marijuana purchase order; iii) any other
beneficial financial interest such that the holder bears the risk of
loss (other than as an insurer) or has an opportunity to gain profit
from the operation or sale of the regulated medical marijuana
business; iv) operational control including but not limited to
interlocking directors or officers or through a management agreement.
3. “Key persons” shall
mean officers, directors, LLC managers/members and any persons with
managing or operational control.
4. Therefore, if a licensed
cooperative cultivation application is approved and any prohibited
material financial interest or control has been identified by DBR or
is otherwise known to the applicant, such interest or control must be
divested prior to issuance of the cooperative cultivation license.
The plan of divestiture shall be filed with DBR.
5. The duty to divest
prohibited material financial interests and control is a continuing
obligation of licensure.
I. Prior Notice of Material
Changes; Continuing Duty to Update Application; Change in Location
1. A licensed cooperative
cultivation shall provide DBR with written notice of any change
described below at least ten (10) business days prior to the proposed
effective date of the change:
a. Any disassociation of a
member from the licensed cooperative cultivation.
b. Any new member of the
licensed cooperative cultivation.
2. A licensed cooperative
cultivation shall provide DBR with written notice of any change
described below at least sixty (60) calendar days prior to the
proposed effective date of the change:
a. If organized as a legal
entity, any change in such legal entity’s organization (e.g. change
in legal form from corporation to limited liability company, change
in the board of directors for corporation, change in managers/members
for limited liability companies, etc.)
b. Any request for change in
the licensed and inspected location.
3. For updates in information
other than the categories requiring the above delineated prior
notice, the licensed cooperative cultivation has a continuing
obligation to update, amend and/or correct any information requested
and/or submitted in the application process within ten (10) business
days of any change in the information submitted and/or any material
change in circumstances related to the application.
4. Requests for change in the
licensed and inspected location for the cooperative cultivation
require following the location-specific application requirements set
forth in § 1.8(F) of this Part and no move may take place unless the
request is approved by DBR after satisfaction of those application
requirements. If a move is approved, the DBR will provide specific
instructions for movement of medical marijuana, which may involve
consultation with law enforcement.
J. Licensed Residential
Cooperative Cultivation Possession Limits
1. Marijuana plants possessed
by a licensed residential cooperative cultivation are limited to the
number of plants that are properly tagged in compliance with all
provisions of § 1.9 of this Part and as specifically capped in
accordance with § 1.9(D)(5) of this Part.
2. Possession of usable
marijuana by a licensed residential cooperative cultivation is
limited to the lesser of: (a) ten (10) ounces of dried usable
marijuana as capped by R.I. Gen. Laws § 21-28.6-14(6)(ii); and (b)
the aggregate total maximum amount of dried usable marijuana that all
members of the cooperative cultivation are permitted to possess
pursuant to R.I. Gen. Laws § 21-28.6-4(a), (e), and (o). Possession
under this paragraph may include any combination of dried usable,
edible, or concentrate marijuana that when calculated for total
aggregate equivalency amount to dried usable marijuana does not
exceed the maximum limit of this paragraph. Possession limits for
marijuana possessed in mixed forms shall be calculated as a total
equivalent to the maximum limit of dried usable marijuana in pounds
in accordance with the equivalency conversion factors delineated in
Appendix A of the DOH Regulations. This paragraph was developed
jointly with DOH.
3. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(6)(ii), possession of wet marijuana by a licensed
residential cooperative cultivation is limited to the lesser of: (a)
fifty (50) ounces of wet marijuana (which, based on the conversion
factors adopted in Appendix A of the DOH Regulations, is the
equivalent of ten (10) ounces of dried usable marijuana as capped by
R.I. Gen. Laws § 21-28.6-14(6)(ii)); and (b) the aggregate total
maximum amount of wet marijuana that all members of the cooperative
cultivation are permitted to possess. This paragraph was developed
jointly with DOH.
K. Licensed Non-Residential
Cooperative Cultivation Possession Limits
1. Marijuana plants possessed
by a licensed non-residential cooperative cultivation are limited to
the number of plants that are properly tagged in compliance with all
provisions of § 1.9 of this Part and as specifically capped in
accordance with § 1.9(D)(6) of this Part.
2. Possession of usable
marijuana by a licensed non-residential cooperative cultivation is
limited to the lesser of: (a) ten (10) ounces of dried usable
marijuana as capped by R.I. Gen. Laws § 21-28.6-14(6)(i); and (b)
the aggregate total maximum amount of dried usable marijuana or its
edible or concentrate equivalent that all members of the cooperative
cultivation are permitted to possess pursuant to R.I. Gen. Laws §
21-28.6-4(a), (e), and (o). Possession under this paragraph may
include any combination of dried usable, edible, or concentrate
marijuana that when calculated for total aggregate equivalency amount
to dried usable marijuana does not exceed the maximum limit of this
paragraph. Possession limits for marijuana possessed in mixed forms
shall be calculated as a total equivalent to the maximum limit of
dried usable marijuana in pounds in accordance with the equivalency
conversion factors delineated in Appendix A of the DOH Regulations.
This paragraph was developed jointly with DOH.
3. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(6)(i), possession of wet marijuana by a licensed
non-residential cooperative cultivation shall be limited to the
lesser of: (a) fifty (50) ounces of wet marijuana (which, based on
the conversion factors adopted in Appendix A of the DOH Regulations,
is the equivalent of ten (10) ounces of dried usable marijuana as
capped by R.I. Gen. Laws § 21-28.6-14(6)(i)); and (b) the aggregate
total maximum amount of wet marijuana that all member of the
cooperative cultivation are permitted to possess. This paragraph
was developed jointly with DOH.
L. Odor Control and Mitigation
Licensed cooperative
cultivations shall take any and all reasonable efforts to prevent
marijuana plant odors from exiting the interior of the approved
structure to an extent that would significantly alter the
environmental odor outside. For example, such reasonable efforts may
include ventilation and filtration systems.
M. Manufacturing
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-4(s), patient and primary caregiver cardholders are
prohibited from the manufacture of marijuana using a solvent
extraction process that includes the use of a compressed, flammable
gas as a solvent. This prohibition extends to licensed cooperative
cultivations.
2. Any other manufacturing
method using a solvent extraction process must be approved by DBR.
If the manufacturing method uses a flammable/combustible material or
heat source, the method must also be approved by the State Fire
Marshall and/or local fire department. The licensed cooperative
cultivation must provide any information and documentation as
required to consider any such requests for approval.
N. Safe Disposal of Medical
Marijuana Waste and Safe Destruction of Usable Medical Marijuana
1. Marijuana and marijuana
product waste (including all liquid, chemical, hazardous, pesticide,
manufacturing solvent and chemical waste containing any traces of
marijuana) must be stored, secured, and managed in accordance with
all applicable federal, state, and local statutes, regulations,
ordinances, or other legal requirements.
2. Prior to disposal,
marijuana and marijuana product waste must be made unusable and any
marijuana plant material made indistinguishable from other plant
material. This may be accomplished by grinding and incorporating the
marijuana plant waste with other non-consumable solid waste or other
ground materials so the resulting mixture is at least fifty percent
non-marijuana waste by volume. Other methods to render marijuana
waste unusable must be approved by DBR before implementing.
Marijuana waste rendered unusable following an approved method may be
delivered to a licensed solid waste disposal facility in Rhode Island
for final disposition or disposed of in an alternative manner
approved by DBR.
3. Destruction of marijuana
and marijuana materials other than waste generated in the regular
course of processing and/or manufacturing (such as destruction of
whole plants, wet, or usable marijuana that are found to be in excess
of statutory possession limits or destruction of a contaminated batch
of medical marijuana product) shall be in a manner acceptable to DBR,
which may include consultation with law enforcement.
4. Destruction of marijuana
and marijuana materials upon revocation or abandonment of the license
shall be specifically governed by DBR order or agreement and/or
coordinated efforts with law enforcement.
5. In addition to the above
requirements, non-residential cooperative cultivations must also
maintain accurate and comprehensive records regarding waste material
that accounts for, reconciles, and evidences all waste activity
related to the disposal of marijuana and marijuana products
(including any waste material produced through the trimming or
pruning of a marijuana plant prior to harvest).
O. Prohibited and Permitted
Sales and Transfers
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-4(c) and (i), a qualifying patient cardholder or primary
caregiver is prohibited from selling, giving, or distributing
marijuana to a compassion center after December 31, 2016. This
prohibition extends to sales and transfers by licensed cooperative
cultivations.
2. Clone Cutting Procurement
a. § 1.7(C)(4)(b) of this
Part permits a licensed cultivator to acquire from a “non-affiliated
licensed cooperative cultivation” not more than twelve (12)
marijuana plant cuttings in a single monthly transaction to use as
clones for plant development (“clone cuttings”). Such clone
cuttings may be no longer than eight (8) inches in length, and may
not contain observable buds or flower.
b. For purposes of the
provisions of these regulations regarding clone cutting procurement,
a “non-affiliated licensed cooperative cultivation” shall refer
to a licensed cooperative cultivation that does not have any members
who are also officers, directors, managers/members, employees, or
agents of the licensed cultivator which the licensed cooperative
cultivation would be supplying with clone cuttings.
c. Each licensed cooperative
cultivation that elects to supply clone cuttings as permitted by
these regulations is limited to supplying no more than two (2)
licensed cultivators per month and must keep records of all clone
cutting procurements as required by DBR.
3. Except for clone cutting
procurements as permitted above, transfer of medical marijuana and
medical marijuana products for consideration by the licensed
cooperative cultivation or any of its members is strictly limited to
transfer amongst members of that cooperative cultivation and to
transfer by caregiver members to their associated patients.
P. Documentation Required to
be Posted on the Premises
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(7)(iii), the cooperative cultivation license issued
by DBR must be displayed prominently on the premises. The license
displayed shall be the document printed for the most recent renewal
period.
2. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(5), each member of the licensed cooperative
cultivation shall sign a written acknowledgement of the limitations
of the right to use and possess marijuana for medical purposes in
Rhode Island. Said acknowledgment shall be on such forms as directed
by DBR. This documentation must be displayed prominently in the
cooperative cultivation premises.
3. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(7)(i), a licensed non-residential cooperative
cultivation must have the municipal inspection/compliance
documentation (as further described in § 1.8(F)(4) of this Part)
displayed prominently on the premises.
4. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(7)(ii), a licensed residential cooperative
cultivation must have the licensed electrician inspection/compliance
affidavit (as further described in § 1.8(F)(3) of this Part)
displayed prominently on the premises.
5. As used in this section,
the requirement of documentation being “displayed prominently”
shall be deemed satisfied by posting the documentation on a wall with
clear visibility and access within or immediately outside the
premises.
Q. Compliance Standards
1. Licensed cooperative
cultivations must be organized and operated in a manner to ensure
compliance with all relevant state and local laws and regulations and
to safeguard against diversion of marijuana to illicit markets.
2. The person identified as
the primary applicant and the designee of the licensed cooperative
cultivation shall each be responsible for the verification that each
member of the cooperative cultivation is the holder of a valid and
active qualified patient or primary caregiver registry identification
card. This includes keeping on the premises copies of the qualified
patient or primary caregiver cardholder cards printed for the most
recent renewal period.
R. Inspections and Enforcement
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(a)(6)(v), cooperative cultivations are subject to
reasonable inspection by DBR for the purposes of enforcing applicable
provisions of the Act, the DBR Regulations, and the DOH Regulations.
Because the Act and the DBR Regulations require inspections for
compliance with applicable state and local zoning, housing, and fire
codes, DBR may be accompanied by state or local officials authorized
to determine compliance with said codes as part of its inspection
pursuant to this section.
2. Pursuant to R.I. Gen. Laws
§ 21-28.6-14(b), any violation of any applicable provision of the
Act, the DBR Regulations, or the DOH Regulations may result in the
revocation or suspension of the cooperative cultivation license.
Administrative fines may also be assessed in accordance with R.I.
Gen. Laws § 21-28.6-15 (entitled “Medical Marijuana Plant Tags”)
and § 1.9(N) of this Part herein.
3. Nothing in this section
shall alter or impair the ability of law enforcement to confiscate
excess, untagged, and/or invalidly tagged marijuana plants and
revoked and/or otherwise invalid plant tags in accordance with
applicable criminal law and procedures.
S. Medical Marijuana Plant Tag
Procedures Upon Termination of Cooperative Cultivation License
1. Subject to paragraph 2
below, upon termination of a cooperative cultivation license, whether
by voluntary dissolution and surrender of license or by revocation of
the license by DBR, the cooperative cultivation shall destroy all
medical marijuana and plants and return each and every medical
marijuana plant tag associated with the cooperative cultivation
within ten (10) business days of license termination.
2. If an individual registered
patient or primary caregiver cardholder has medical marijuana, plants
and associated tags tied to a cooperative cultivation grow location
and the cooperative cultivation license for that location is
surrendered or revoked, the individual can only retain the medical
marijuana, plants and associated tags that are associated with their
individual registration (up to the individual maximum number of
plants) if the individual’s registration as a patient or caregiver
is still in good standing with DOH. A qualifying individual shall
follow the following steps prior to transportation of any marijuana
plants.
a. The individual must apply
to DBR for transfer of the marijuana plant tags to a new location, on
such forms and through such mechanisms as DBR designates.
b. Then, DBR will verify with
DOH the continued validity of the registry identification card(s) for
which the tags were issued as well as confirm the registration of the
new grow location.
c. Once the change of location
application is processed, the transport shall be conducted in the
time period prescribed and be accompanied by a DBR receipt.
1.9 Medical Marijuana Plant Tag
Program
A. Scope of Section
1. This section applies to
patient cardholders who have chosen to grow medical marijuana for
themselves as an alternative to use of a caregiver or compassion
center and to all caregiver cardholders.
2. Eligibility for medical
marijuana plant tags: only persons for whom DOH has approved an
application as a qualified patient or primary caregiver and issued a
registry photo identification card to the applicant; or, for
qualified patients and primary caregivers who are renewing their
medical marijuana registration, for whom DOH has approved the renewal
application of the qualified patient or primary caregiver and issued
a registry photo identification card to the applicant.
3. Patient and caregiver
cardholders who have elected to cooperatively cultivate are further
subject to all requirements of § 1.8 of this Part regulating
licensed cooperative cultivations.
4. Medical marijuana tagging
and tracking requirements for licensed cultivators are set forth in §
1.7(D) of this Part.
B. Administration of Plant Tag
Program
DBR and DOH have jointly
determined that DBR will primarily administer all aspects of the
medical marijuana plant tag program in order to fulfill the state
obligation to monitor and verify compliance with the statutory
requirements that cardholders electing to grow do not exceed plant
limits, properly tag all permitted plants, and do not grow at more
than one location. This Section shall be deemed to be promulgated
jointly with DOH. See R.I. Gen. Laws § 21-28.6-15 and § 21-28.6-4;
DOH Regulations 216-RICR-20-10-3.6.3(B)(1).
C. Plant Tag Program Timeline
and Basic Guidelines
1. Pursuant to §
21-28.6-15(a) of the Act, effective April 1, 2017, every marijuana
plant possessed by a qualified patient or primary caregiver
cardholder must be accompanied by a physical medical marijuana plant
tag purchased through DBR and issued by DOH. Plant tags being issued
by DOH shall mean the following:
a. DOH has approved the
application of the qualified patient or primary caregiver and issued
a registry photo identification card to the applicant; or for
qualified patients and primary caregivers who are renewing their
medical marijuana registration, DOH has approved the renewal
application of the qualified patient or primary caregiver and issued
a registry photo identification card to the applicant.
b. DBR verifies with DOH the
status of the card and any information submitted on the DBR plant tag
purchasing form in accordance with § 21-28.6-15(a)(2) of the Act.
For plant tags issued to qualified patient cardholders after January
1, 2019, DBR will verify both the status of the card and the election
to grow with DOH in accordance with § 21-28.6-15(a)(3).
c. The plant tag set fee is
paid to DBR and the plant tag is distributed by DBR to the qualified
patient or primary caregiver cardholder.
2. Pursuant to R.I. Gen. Laws
§ 21-28.6-15(a)(1), medical marijuana plant tags will be sold in
“tag sets” of one plant tag for a mature plant and one plant tag
for a seedling.
3. No later than April 1,
2017, all qualified patient cardholders who choose to grow for
themselves must obtain at least one (1) medical marijuana plant tag
set and enough plant tag sets to properly tag every marijuana plant
in their lawful possession (up to the maximum number of tags that may
be issued pursuant to § 1.9(D)(2) of this Part below).
4. No later than April 1,
2017, all primary caregiver cardholders must obtain at least one (1)
medical marijuana plant tag set for each qualified patient cardholder
to whom the primary caregiver cardholder is connected through DOH’s
registration process and enough plant tag sets to properly tag every
marijuana plant in their lawful possession (up to the maximum number
of tags that may be issued pursuant to § 1.9(D)(3) and (D)(4) of
this Part below).
5. Qualified patient
cardholders who register with DOH after April 1, 2017 and who choose
to grow for themselves must obtain at least one (1) medical marijuana
plant tag set within ten (10) business days of receiving their
registry identification card from DOH. Such patients are further
responsible for obtaining any additional medical marijuana plant tag
sets necessary and may not legally possess medical marijuana plants
until such time as the plant tags are obtained.
6. Primary caregiver
cardholders who register with DOH after April 1, 2017, must obtain at
least one (1) medical marijuana plant tag set for each qualified
patient cardholder to whom the primary caregiver cardholder is
connected through DOH’s registration process within ten (10)
business days of receiving their registry identification card from
DOH. Such caregivers are further responsible for obtaining any
additional medical marijuana plant tag sets necessary and may not
legally possess medical marijuana plants until such time as the plant
tags are obtained.
7. Any primary caregiver
cardholder who becomes connected with any additional qualified
patient cardholder(s) through DOH’s registration process after
April 1, 2017, must obtain at least one (1) medical marijuana plant
tag set for each additional qualified patient cardholder within ten
(10) business days of said connection. Such caregivers are further
responsible for obtaining any additional medical marijuana plant tag
sets necessary and may not legally possess any additional medical
marijuana plant(s) until such time as the plant tags are obtained.
8. Every member of a licensed
cooperative cultivation must be in compliance with the above minimum
tag requirements as a condition of the cooperative cultivation
license.
D. Maximum Number of Plant Tag
Sets
1. The maximum number of
medical marijuana plant tag sets that can be purchased from DBR
corresponds to the maximum number of mature plants that may be
possessed by the purchaser under the Act.
2. A qualified patient
cardholder may purchase no more than twelve (12) medical marijuana
plant tag sets (comprised of twelve (12) mature plant tags and twelve
(12) seeding tags for a total of twenty-four (24) medical marijuana
plant tags), which corresponds to the possession limits of twelve
(12) mature plants and twelve (12) seedlings set by R.I. Gen. Laws §
21-28.6-4(a) and § 21-28.6-4(f), respectively.
3. A primary caregiver
cardholder connected with one (1) qualified patient cardholder
through DOH’s registration process may purchase no more than twelve
(12) medical marijuana plant tag sets (comprised of twelve (12)
mature plant tags and twelve (12) seedling tags for a total of
twenty-four (24) medical marijuana plant tags), which corresponds to
the possession limits of twelve (12) mature plants per qualified
patient cardholder and twelve (12) seedlings derived from R.I. Gen.
Laws § 21-28.6-4(e) and § 21-28.6-4(f), respectively.
4. A primary caregiver
cardholder connected with at least two (2) and up to five (5)
qualified patient cardholders through DOH’s registration process
may purchase no more than twenty-four (24) medical marijuana plant
tag sets (comprised of twenty-four (24) mature plant tags and
twenty-four (24) seedling tags for a total of forty-eight (48)
medical marijuana plant tags), which corresponds to the possession
limits of twenty-four (24) mature plants and twenty-four (24)
seedlings set by R.I. Gen. Laws § 21-28.6-4(e) and § 21-28.6-4(f),
respectively.
5. A residential cooperative
cultivation formed by two (2) or more qualified patient and/or
primary caregiver cardholders may purchase no more than twenty-four
(24) medical marijuana plant tag sets (comprised of twenty-four (24)
mature plant tags and twenty-four (24) seedling tags for a total of
forty-eight (48) medical marijuana plant tags), which corresponds to
the possession limits of twenty-four (24) mature plants and
twenty-four (24) seedlings set by R.I. Gen. Laws §
21-28.6-14(a)(6)(ii).
6. A non-residential
cooperative cultivation may purchase plant tag sets of no more than
the lesser of: (a) forty-eight (48) medical marijuana plant tag sets
(comprised of forty-eight (48) mature plant tags and forty-eight (48)
seedling tags for a total of ninety-six (96) medical marijuana plant
tags), which corresponds to the maximum possession limits for a
non-residential cooperative cultivation of forty-eight (48) mature
plants and forty-eight (48) seedlings set by R.I. Gen. Laws §
21-28.6-14(a)(6)(i); and (b) the number of medical marijuana plant
tag sets which would correspond to the total maximum amount of mature
plants that each individual qualified patient cardholder and each
individual primary caregiver cardholder growing at the cooperative
cultivation is permitted to grow under the mature plant and seedling
possession limits delineated above.
E. Plant Tag Fees
1. R.I. Gen. Laws §
21-28.6-15(a)(1) mandates that DBR charge an annual fee for each
medical marijuana plant tag set which shall include one plant tag for
a mature medical marijuana plant and one plant tag for a seedling.
Pursuant to the mandate, DBR hereby establishes the below annual fee
schedule.
2. Qualifying patient
cardholder - Twenty-five dollars ($25) per plant tag set.
3. Reduced-registration
patient - The fee shall be waived for patients for which DOH has
determined qualification for reduced-registration due to income or
disability status, as may be periodically determined by DOH.
4. Primary caregiver
cardholder - Twenty-five dollars ($25) per plant tag set.
5. Caregiver registered with
DOH to grow for reduced-registration patient(s) - The fee shall be
adjusted for caregivers registered with DOH to grow for one (1) to
five (5) qualifying patient cardholder(s) for which DOH has
determined qualification for reduced- registration due to income or
disability status. Specifically:
a. If a primary caregiver is
registered with DOH to grow for reduced-registration patients only,
the plant tag fees shall be waived entirely.
b. If a primary caregiver is
registered with DOH to grow for one (1) or more reduced-registration
patients and one (1) or more full-registration patients, the primary
caregiver shall be required to purchase at least one (1) plant tag
set per full-registration patient at the rate of twenty-five dollars
($25) per plant tag set. In this case, the remainder of the plant
tag sets up to the numerical limits delineated herein may be obtained
with a fee waiver; provided, however, that no more than twelve (12)
fee-waived plant tag sets may be obtained per reduced-registration
patient.
c. If a primary caregiver has
used the plant tag fee reductions cited above and then at any point
prior to the next plant tag renewal date that primary caregiver is in
the position of having no associations with any reduced-registration
patients, the primary caregiver shall take one of the following
actions within ten (10) business days:
(1) Register with DOH to grow
for one (1) or more other reduced-registration patients;
(2) Register with DOH to grow
for one (1) or more full-registration patients and pay the balance of
what would have been paid had the plant tag sets been obtained or
renewed with no reduced-registration patients; or
(3) If not registered with DOH
to grow for any other existing or new patients within ten (10)
business days, destroy the marijuana plants and then also return the
plant tags within an additional ten (10) business day period.
F. Applications and Processes
for Obtaining and Renewing Plant Tags
1. Applications to obtain
medical marijuana plant tags pursuant to this Section and to renew
said plant tags shall be on such forms and through such submission
mechanisms as directed by DBR.
2. Required application
information shall include, but is not necessarily limited to, the
registry identification number of the applicant, and, if the
applicant is a caregiver, the registry identification number(s) of
the patient(s) the caregiver applicant is authorized to grow for, a
sufficiently specific identification of the single grow location
selected by the applicant, and current contact information.
3. Before issuing medical
marijuana plant tags, DBR will verify with DOH the validity of the
applicant’s registry identification card and, if the applicant is a
caregiver, the validity of the registry identification card(s) of the
patient(s) the caregiver applicant is authorized to grow for as well
as confirm the registration of the grow location in accordance with
R.I. Gen. Laws § 21-28.6-15(a)(2) and R.I. Gen. Laws §
21-28.6-15(a)(3).
4. DBR will provide further
guidance on the mechanism for paying the plant tag set fees for
initial applications and annual renewal.
5. DBR will provide further
guidance on the mechanism for receiving plant tags from DBR,
including information about pick up schedule and authorization.
G. Conditions for Obtaining
and Maintaining Plant Tags
1. The rules in this
subsection are deemed to be continuing conditions for obtaining and
maintaining medical marijuana plant tags.
2. A medical marijuana plant
tag holder may not grow marijuana at more than one location. R.I.
Gen. Laws § 21-28.6-4(q).
3. Medical marijuana plant
tags will only be issued under the express and continuing condition
that they will only be used for plants that are stored in a “secure
indoor structure.” The secure indoor structure shall satisfy the
following parameters:
a. Enclosed area with four
walls and a roof.
b. Equipped with locks and any
other appropriate security devices that limit access to the
individual authorized to grow the marijuana. Locks must be
sufficient to discourage theft and unauthorized entrance.
c. Marijuana is not visible
from the street or other public areas.
d. Reasonable efforts must be
taken to prevent marijuana plant odors from exiting the building to
an extent that would significantly alter the environmental odor
outside.
e. For licensed cooperative
cultivations, consult § 1.8(F) of this Part, for any additional
location restrictions and/or security requirements.
4. Medical marijuana plant
tags may only be used by the individual and/or licensed cooperative
cultivation to whom and at the location for which they were issued.
They may not be transferred or assigned.
5. Medical marijuana plant
tags shall not be altered or duplicated.
6. As a continuing condition
of holding plant tags, plant tag holders may not pursue any marijuana
transaction that is in violation of the Act, including pursuing such
a transaction by online advertising.
H. Plant Tag Data
1. Medical marijuana plant
tags shall be printed with, electronically embedded with, or
otherwise contain the following plant tag data:
a. Unique numerical or
alpha-numerical identifiers:
(1) For a qualified patient
cardholder who is growing individually, the identifier shall
correspond to his or her DOH patient registry identification card
number.
(2) For a primary caregiver
cardholder who is growing individually, the identifier shall
correspond to his or her DOH caregiver registry identification card
number and the number(s) of the qualified patient cardholder(s) he or
she is registered with DOH to grow for.
(3) For cooperative
cultivations, the medical marijuana plant tag shall contain
identifiers that correspond to both the DBR license number for the
cooperative cultivation as well as the DOH registry identification
card numbers for the qualified patient cardholders and/or primary
caregiver cardholders and their associated patients forming the
cooperative cultivation.
b. Expiration date of the
plant tag.
c. Registered or licensed grow
location.
d. Designation as to whether
the medical marijuana plant tag is for a mature plant or seedling.
e. Any other information DBR
deems appropriate that is not subject to the patient privacy
provisions of the Act.
2. DBR and DOH will have
access to the above medical marijuana plant tag data, through the
Medical Marijuana Program Tracking System, or, if the System is not
available, through other data sharing mechanisms.
I. Placement of Plant Tags
Plant tags shall be placed in
a manner so as to clearly display their association with a particular
plant, such as affixed to the plant itself, on the growing
receptacle, or in the growing medium.
J. Duty to Update Application
Information; Approved Transports of Tagged Medical Marijuana Plants
1. The medical marijuana plant
tag holder has a continuing obligation to update all application
information in a timely manner. Contact information (legal name,
physical and mailing address, phone number, e-mail address, etc.)
must be updated no later than three (3) business days after the
change.
2. Change of information
regarding the grow location must be provided to DBR at least ten (10)
business days before the change.
3. Medical marijuana plant
tags do not authorize transport of marijuana plants outside the
borders of the state of Rhode Island under any circumstances.
4. Medical marijuana plant
tags are non-transferrable to another location within the state of
Rhode Island unless the steps outlined in this section are followed.
5. If an individual qualified
patient cardholder or primary caregiver cardholder who is not growing
as part of a cooperative cultivation needs to change his or her
registered grow location, the individual shall follow the following
steps prior to transportation of any marijuana plants:
a. The individual must apply
to DBR for transfer of the marijuana plant tags, on such forms and
through such mechanisms as DBR designates.
b. Then, DBR will verify with
DOH the continued validity of the registry identification card(s) for
which the tags were issued as well as confirm the registration of the
new grow location.
c. Once the change of location
application is processed, the transport shall be conducted within the
time period prescribed and accompanied by a DBR receipt.
6. The medical marijuana plant
tag procedures surrounding any change in grow location for a
cooperative cultivation and transportation of the plants of an
individual patient or caregiver upon dissolution or disassociation
with the cooperative cultivation is addressed in § 1.9(R) of this
Part.
K. Lost and Stolen Tags and
DBR-Mandated Tag Replacement
1. Any stolen or lost medical
marijuana plant tags must be reported to DBR and law enforcement
within one (1) business day that the tag holder becomes aware of the
theft or loss of the tags.
2. The circumstances
surrounding the loss or theft must be disclosed to DBR.
3. If DBR determines that the
loss or theft of the tags is the result of improper tag use in
violation of these regulations or the Act, then DBR may refuse to
issue replacement tags.
4. For any periodic recall of
tags by DBR (circumstances such as wearing out, new technology,
etc.), no replacement cost will be assessed to the tag holder.
L. DBR Processes for
Monitoring and Verifying Compliance with Tagging Requirements and
Marijuana Plant Possession Limits
1. If DBR has reasonable
grounds to believe that a medical marijuana plant tag holder, a
primary caregiver who has not obtained or renewed tags, or a
qualified patient cardholder who has made an election to grow who has
not obtained or renewed tags, may be in violation of the tagging
requirements and/or plant possession limits set forth in the Act
and/or these regulations, the below steps may be taken to verify
compliance or prompt the person to come into compliance.
2. First Written Notice: A
written notice may be sent to the person explaining the tagging
requirements and plant possession limits set forth in the Act and
these regulations and why the DBR has reason to believe the person
may be out of compliance and outlining the information the person may
provide and/or the action(s) the person may take to verify or come
into compliance. The recipient will have ten (10) business days from
the date of mailing to reply to this notice.
3. Second Written Notice: If
the recipient fails to respond to the first written notice with
information that verifies compliance or fails to take the necessary
actions to come into compliance, a second written notice may be sent
and the recipient will have an additional ten (10) business days from
the date of mailing to reply.
4. Alternative Contact
Attempt: If the recipient fails to respond to the second written
notice with information that verifies compliance or fails to take the
necessary actions to come into compliance, the DBR may attempt to
contact the person utilizing other contact methods through
information provided on any tag purchasing form submitted to DBR
(e.g. telephone) or other contact information reasonably obtained by
DBR (e.g. public telephone listings).
5. Reasonable Inspection: If
an alternative contact attempt has been unsuccessful or, if after ten
(10) business days following an alternative contact, the person has
not yet provided information that verifies compliance or taken the
necessary actions to come into compliance, then the person may be
subject to reasonable inspection by DBR to ensure compliance with the
tagging requirements and plant possession limits set forth in the Act
and these regulations. DBR shall make an effort to schedule
inspections in advance.
M. Revocation of Medical
Marijuana Plant Tags
1. R.I. Gen. Laws §
21-28.6-15(b)(1) authorizes DBR to revoke medical marijuana plant
tags for violation of any provision of the Act, the DBR Regulations,
or the DOH Regulations.
2. Grounds for revocation of
medical marijuana plant tags shall include, but are not limited to,
failure to maintain or timely renew the required underlying
qualifying patient, primary caregiver, or cooperative cultivation
registration or license, as applicable, which is a legal prerequisite
to obtaining the medical marijuana plant tag and being able to grow
medical marijuana under the Act; having excess and/or untagged
plants; misrepresentation in applying for plant tags; permitting
unauthorized use of tags by another party; growing in more than one
location; and transferring plants from the registered grow location
without complying with the rules for said transport.
3. If DOH revokes the
registration of a primary caregiver due to disqualifying criminal
information as delineated in the Act or for any other reason, that
primary caregiver’s medical marijuana plant tags shall be
automatically and immediately revoked by DBR.
4. If DOH revokes the
registration of a patient for any reason, any medical marijuana plant
tags issued to that patient and/or issued to any caregiver registered
with DOH to grow for that patient shall be automatically and
immediately revoked by DBR.
5. Before medical marijuana
plant tags are revoked pursuant to this section, the tag holder will
be given ten (10) business days advance notice to destroy the
marijuana plants that were previously associated with the plant tags
and to then return said plant tags within the 10 day timeframe.
6. The fact that a patient or
primary caregiver is a member of a cooperative cultivation shall not
in any way preclude revocation of their medical marijuana plant tags
as provided in this subsection.
N. Administrative Penalties
1. Pursuant to R.I. Gen. Laws
§ 21-28.6-15(b)(3), as to any patient cardholder, primary caregiver
cardholder, or licensed cooperative cultivation who is found to have
mature marijuana plants that are within the relevant possession
limits of the Act but which do not have valid medical marijuana tags,
DBR may impose an administrative penalty up to the total fee that
would be paid by a cardholder or licensee who purchased medical
marijuana plant tags for such plants in compliance with the Act.
2. Pursuant to R.I. Gen. Laws
§ 21-28.6-15(b)(4), as to any patient cardholder, primary caregiver
cardholder, or licensed cooperative cultivation who is found to have
mature marijuana plants that exceed the relevant possession limits of
the Act, DBR may impose an administrative penalty of no less than the
total fee that would be paid by a cardholder or licensee who
purchased medical marijuana plant tags for such plants in compliance
with the Act, which fee is twenty five dollars ($25) assessed per
plant. DBR hereby sets the maximum administrative penalty at five
thousand dollars ($5,000) assessed per plant. Within the $25 - $5000
fine which may be assessed per plant under this paragraph, DBR adopts
the following schedule:
Number
of plants exceeding the relevant possession limits of the Act
Fine
assessed per plant
1
- 3 plants over limit
$25
assessed per plant
4
- 8 plants over limit
$100
assessed per plant
9
- 12 plants over limit
$250
assessed per plant
13
- 15 plants over limit
$1000
assessed per plant
16
- 24 plants over limit
$2500
assessed per plant
25
or more plants over limit
$5000
assessed per plant
O. Criminal Penalties and Law
Enforcement
1. R.I. Gen. Laws §
21-28.6-15(b)(4) provides that any administrative penalties for
possession of marijuana plants in excess of the numerical limits of
the Act may be in addition to the criminal penalties provided for by
§ 21-33 28.6-9, subsection (c) of which provides for arrest and
prosecution under Chapter 28 of Title 21 (the “Rhode Island
Controlled Substances Act”).
2. Nothing in this section
shall alter or impair the ability of law enforcement to confiscate
excess, untagged, and/or invalidly tagged marijuana plants and
revoked and/or otherwise invalid plant tags in accordance with
applicable criminal law and procedures.
3. DBR may notify law
enforcement if it reasonably believes a tag holder is engaged in a
material violation of the Act or these regulations.
4. Law enforcement may be
granted access to the Medical Marijuana Program Tracking System to
verify the validity of plant tags and tag data, or, if the System is
not available, through other data sharing mechanisms, in accordance
with applicable law.
P. Return of Plant Tags
1. When return of tags is
required by these regulations, the medical marijuana plants
associated with those tags shall be destroyed prior to the required
return date.
2. A patient shall return his
or her medical marijuana plant tags to DBR within ten business (10)
business days of any of the following occurrences: a) election to no
longer grow medical marijuana for himself or herself, b) voluntary
surrender of the registry identification card, or c) revocation of
the registry identification card.
3. A primary caregiver shall
return all medical marijuana plant tags associated with a particular
patient within ten (10) business days of any of the following
occurrences concerning that patient: a) death, b) termination of the
relationship with the primary caregiver, c) voluntary surrender of
the registry identification card, or d) revocation of the registry
identification card. If during such ten (10) business day period,
the primary caregiver re-associates with another qualified patient
cardholder through DOH and re-associates the tags to the other
existing or new patient by registry identification number through
DBR, the plant tags need not be returned.
4. A primary caregiver shall
return each and every medical marijuana plant tag within ten (10)
business days of his or her voluntary surrender of or DOH’s
revocation of his or her registry identification card.
5. The fact that a patient or
primary caregiver is a member of a cooperative cultivation shall not
in any way relieve his or her individual medical marijuana plant tag
return obligations under this subsection.
6. DBR will provide a person
returning medical marijuana plant tags with a receipt documenting the
return.
7. For additional provisions
regarding return of tags associated with licensed cooperative
cultivations, consult § 1.8(S) of this Part.
1.10 Severability
If any provision of the DBR
Regulations, or the application thereof to any person or
circumstance, is held to be invalid, such invalidity shall not affect
other provisions or application of the DBR Regulations which can be
given effect without the invalid provision or application, and to
this end the provisions are declared to be severable.