KRS § 218B.140 — KY Code / Title XVIII / Chapter 218B / Section 218B.140
218B.140 Electronic monitoring system required capabilities -- Administrative regulations -- Medicinal cannabis adverse drug effects reporting system -- Medicinal Cannabis Advisory Pamphlet
Status: in_force

218B.140 Electronic monitoring system required capabilities -- Administrative

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 (30)

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 (30)

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 (12)

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 (36)

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.