218B.140 Electronic monitoring system required capabilities -- Administrative
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/ky/218b-140A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
regulations -- Medicinal cannabis adverse drug effects reporting system --
Medicinal Cannabis Advisory Pamphlet.
(1)No later than July 1, 2024, the cabinet shall:
(a)Ensure that the electronic monitoring system established pursuant to KRS
218A.202 is designed or configured to enable:
1. Medicinal cannabis practitioners to record the issuance of written
certifications to qualified patients, as required by KRS 218B.050;
2. The cabinet and state licensing boards to monitor the issuance of written
certifications by medicinal cannabis practitioners;
3. Cabinet personnel, law enforcement personnel, and dispensary agents to
verify the validity of registry identification cards issued by the cabinet
by entering a registry identification number to determine whether or not
the identification number corresponds with a current, valid registry
identification card. The system shall only disclose whether the
identification card is valid and whether the cardholder is a registered
qualified patient, visiting qualified patient, or designated caregiver;
4. Law enforcement personnel and dispensary agents to access medicinal
cannabis sales data recorded by dispensary agents pursuant to KRS
218B.110;
5. Dispensary agents to record the amount of medicinal cannabis that is
dispensed to a cardholder during each transaction as required by KRS
218B.110; and
6. The sharing of dispensing data recorded by dispensary agents pursuant
to KRS 218B.110 with all dispensaries in real time;
(b)Ensure that the electronic monitoring system established pursuant to KRS
218A.202 is designed to facilitate the tracking of medicinal cannabis from the
point of cultivation to the point of sale to cardholders; and
(c)Promulgate administrative regulations in accordance with KRS Chapter 13A
to establish:
1. Procedures for the issuance, renewal, suspension, and revocation of
registry identification cards, including the creation of a standardized:
a. Written certification form; and
b. Application form which the cabinet shall require to be notarized;
2. Procedures for the issuance and revocation of registry identification
cards;
3. Procedures for the issuance, renewal, suspension, and revocation of
cannabis business licenses, including the creation of a uniform licensure
application form which the cabinet shall require to be notarized and
minimal performance standards for a biennial accreditation process with
all such procedures subject to the requirements of KRS Chapters 13A
and 13B;
4. A convenience fee to be assessed and collected by dispensaries for
visiting qualified patients who do not possess a valid registry
identification card issued by the cabinet and who purchase medicinal
cannabis with an out-of-state registry identification card and
documentation of having been diagnosed with a qualifying medical
condition. The convenience fee established pursuant to this
subparagraph shall not exceed fifteen dollars ($15) per transaction; 5. In collaboration with the Board of Physicians and Advisors:
a. A definition of the amount of medicinal cannabis or delta-9
tetrahydrocannabinol that constitutes a daily supply, an
uninterrupted ten
(10)day supply, and an uninterrupted thirty
day supply of medicinal cannabis; and
b. The amount of raw plant material that medicinal cannabis products
are considered to be equivalent to; 6. A process by which a medicinal cannabis practitioner may recommend,
and a registered qualified patient or his or her designated caregiver may
legally purchase and possess, an amount of medicinal cannabis in excess
of the thirty
(30)day supply of medicinal cannabis, if the medicinal
cannabis practitioner reasonably believes that the standard thirty
day supply would be insufficient in providing the patient with
uninterrupted therapeutic or palliative relief; 7. Provisions governing the following matters related to cannabis
businesses with the goal of protecting against diversion and theft,
without imposing any undue burden that would make cannabis business
operations unreasonable or impractical on cannabis businesses or
compromising the confidentiality of cardholders:
a. Recordkeeping and inventory control requirements, including the
use of the electronic monitoring systems established pursuant to
KRS 218A.202;
b. Procedures for the verification and validation of a registry
identification card, or its equivalent, that was issued pursuant to
the laws of another state, district, territory, commonwealth, or
insular possession of the United States that allows for the use of
medicinal cannabis in the jurisdiction of issuance;
c. Security requirements for safety compliance facilities, processors,
producers, dispensaries, and cultivators, which shall include at a
minimum lighting, video security, alarm requirements, on-site
parking, and measures to prevent loitering;
d. Procedures for the secure transportation, including delivery
services provided by dispensaries, and storage of medicinal
cannabis by cannabis business licensees and their employees or
agents;
e. Employment and training requirements for licensees and their
agents, including requiring each licensee to create an identification
badge for each of the licensee's agents or employees; and
f. Restrictions on visits to licensed cultivation and processing
facilities, including requiring the use of visitor logs; 8. Procedures to establish, publish, and annually update a list of varieties
of cannabis that possess a low but effective level of
tetrahydrocannabinol, including the substance cannabidiol, by
comparing percentages of chemical compounds within a given variety
against other varieties of cannabis; 9. A rating system that tracks the terpene content of at least the twelve
major terpenoids within each strain of cannabis available for medicinal
use within the Commonwealth; 10. Requirements for random sample testing of medicinal cannabis to
ensure quality control, including testing for cannabinoids, terpenoids,
residual solvents, pesticides, poisons, toxins, mold, mildew, insects,
bacteria, and any other dangerous adulterant; 11. Requirements for licensed cultivators, producers, and processors to
contract with an independent safety compliance facility to test the
medicinal cannabis before it is sold at a dispensary. The cabinet may
approve the safety compliance facility chosen by a cultivator, producer,
or processor and require that the safety compliance facility report test
results for a designated quantity of medicinal cannabis to the cultivator,
producer, or processor and cabinet; 12. Standards for the operation of safety compliance facilities which may
include:
a. Requirements for equipment;
b. Personnel qualifications; and
c. Requiring facilities to be accredited by a relevant certifying entity; 13. Standards for the packaging and labeling of medicinal cannabis sold or
distributed by cannabis businesses which shall comply with 15 U.S.C.
secs. 1471 to 1476 and shall include:
a. Standards for packaging that requires at least a two
(2)step
process of initial opening;
b. A warning label which may include the length of time it typically
takes for the product to take effect, how long the effects of the
product typically last, and any other information deemed
appropriate or necessary by the cabinet;
c. The amount of medicinal cannabis the product is considered the
equivalent to;
d. Disclosing ingredients, possible allergens, and certain bioactive
components, including cannabinoids and terpenoids, as determined
by the cabinet;
e. A nutritional fact panel;
f. Opaque, child-resistant packaging;
g. A requirement that all raw plant material packaged or sold in this
state be marked or labeled as "NOT INTENDED FOR
CONSUMPTION BY SMOKING";
h. A requirement that medicinal cannabis products be clearly marked
with an identifiable and standardized symbol indicating that the
product contains cannabis;
i. A requirement that all medicinal cannabis product packaging
include an expiration date; and
j. A requirement that medicinal cannabis products and their
packaging not be visually reminiscent of major brands of edible
noncannabis products or otherwise present an attractive nuisance
to minors;
14. Health and safety requirements for the processing of medicinal cannabis
and the indoor cultivation of medicinal cannabis by licensees;
15. Restrictions on:
a. Additives to medicinal cannabis that are toxic, including vitamin E
acetate, or increase the likelihood of addiction; and
b. Pesticides, fertilizers, and herbicides used during medicinal
cannabis cultivation which pose a threat to human health and
safety;
16. Standards for the safe processing of medicinal cannabis products created
by extracting or concentrating compounds from raw plant material;
17. Standards for determining the amount of unprocessed raw plant material
that medicinal cannabis products are considered the equivalent to;
18. Restrictions on advertising, marketing, and signage in regard to
operations or establishments owned by licensees necessary to prevent
the targeting of minors;
19. The requirement that evidence-based educational materials regarding
dosage and impairment be disseminated to registered qualified patients,
visiting qualified patients, and designated caregivers who purchase
medicinal cannabis products;
20. Policies governing insurance requirements for cultivators, dispensaries,
processors, producers, and safety compliance facilities; and
21. Standards, procedures, or restrictions that the cabinet deems necessary
to ensure the efficient, transparent, and safe operation of the medicinal
cannabis program, except that the cabinet shall not promulgate any
administrative regulation that would impose an undue burden or make
cannabis business operations unreasonable or impractical.
(2)No later than January 1, 2025, the cabinet shall:
(a)Establish a medicinal cannabis adverse drug effects reporting system for the
purpose of allowing cardholders to report adverse drug effects via telephone
or online; and
(b)In collaboration with the Board of Physicians and Advisors, produce the
Medicinal Cannabis Advisory Pamphlet which shall include but not be limited
to:
1. Information on the risks, dangers, and possible side effects of the use of
medicinal cannabis;
2. Information on the medicinal cannabis adverse drug effects reporting
system and how to report adverse drug effects; and
3. A detachable signature page which shall be:
a. Signed by a cardholder each time he or she receives a copy of the
Medicinal Cannabis Advisory Pamphlet as required under KRS
218B.110(2)(d); and
b. Retained by the dispensary for a period of at least thirty-six
months.
(3)The cabinet shall provide each licensed dispensary with an adequate number of
Medicinal Cannabis Advisory Pamphlets to ensure that the dispensary is able to
comply with the requirements of KRS 218B.110(2)(d).
(4)Except as provided in KRS 218B.035(1)(g), 218B.095(2)(b), 218.110(2)(e),
218B.115(2), 218B.120(3), and subsection (1)(c)10., 13., 15., and 16. of this
section, the cabinet shall not restrict or limit methods of delivery, use, or
consumption of medicinal cannabis or the types of products that may be acquired,
produced, processed, possessed, sold, or distributed by a cannabis business.
(5)If a need for additional cannabis cultivation in this state is demonstrated by
cannabis businesses or the cabinet's own analysis, the cabinet may through the
promulgation of administrative regulations increase the cultivation area square
footage limits for either cultivators or producers, or both by up to three
(3)times the
limits established in KRS 218B.105 and 218B.120. Any increase in the cultivation
square footage limits adopted by the cabinet pursuant to this section shall not result
in an increase in the licensure application or renewal fees established by the cabinet.
(6)When promulgating administrative regulations under this section, the cabinet shall
consider standards, procedures, and restrictions that have been found to be best
practices relative to the use and regulation of medicinal cannabis.