915 Ky. Admin. Regs. 2:020

Current through Register Vol. 51, No. 7, January 1, 2025

Section 915 KAR 2:020 - Supply limits and equivalency formula

RELATES TO: KRS Chapter 218B

NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing supply limits and an equivalency formula for medicinal cannabis. This administrative regulation establishes the supply limits and equivalency formula for the Kentucky Medical Cannabis Program.

Section 1. Medicinal Cannabis Supply Limits.

(1) For the purpose of establishing supply limits for the Kentucky Medical Cannabis Program:

(a) A daily supply of medicinal cannabis for cardholders consists of 3.75 grams of raw plant material, 1 gram of concentrate, or 130 milligrams of delta-9 tetrahydrocannabinol (THC) infused into a medicinal cannabis product, such as an edible, pill, capsule, oil, liquid, or tincture;

(b) An uninterrupted ten (10) day supply of medicinal cannabis for cardholders consists of 37.5 grams of raw plant material, 9.5 grams of concentrate, or 1,300 milligrams of THC infused into a medicinal cannabis product; and

(c) An uninterrupted thirty (30) day supply of medicinal cannabis for cardholders consists of 112 grams of raw plant material, 28 grams of concentrate, or 3,900 milligrams of THC infused into a medicinal cannabis product.

(2) The following non-consumable medicinal cannabis products shall not count toward a patient's supply limits:

(a) Ointments;

(b) Soaps;

(c) Lotions; and

(d) Other topical agents.

(3) In making recommendations for dosage of medicinal cannabis, 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 established in this section 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. If a medicinal cannabis practitioner makes the determination to increase the qualified patient's dosage above the thirty (30) day supply limit, the medicinal cannabis practitioner shall:

(a) Document the dosage recommendation and the rationale in the qualified patient's medical record; and

(b) Document the dosage recommendation and the rationale in the qualified patient's written certification in the state's designated medicinal cannabis practitioner registry.

(4) Beginning January 1, 2026, the cabinet shall annually review the supply limits established in this section to determine if any adjustments should be made. In making this determination, the cabinet shall consider standards and procedures that have been found to be best practices relative to the use of medicinal cannabis, any scientific research studies regarding dosage and the health effects of medicinal cannabis, and any input from the Board of Physicians and Advisors, the Kentucky Board of Medical Licensure, the Kentucky Board of Nursing, and the Kentucky Center for Cannabis.

Section 2. Standards for Determining Equivalency.

(1) The following potency equivalency formula shall be used for determining the amount of raw plant material that medicinal cannabis products are considered the equivalent to:

(a) Step 1. Weight of raw plant material (in grams) x average THC potency percentage of raw plant material = amount of concentrate (in grams).

(b) Step 2. Convert amount of concentrate in grams to milligrams.

(c) Step 3. Amount of concentrate (in milligrams) x average THC potency percentage of concentrate = preliminary amount of THC infused medicinal cannabis products (in milligrams).

(d) Step 4. Preliminary amount of THC infused medicinal cannabis products (in milligrams) / 5 = final amount of THC infused medicinal cannabis products (in milligrams).

(2) In Step 4 of the equivalency formula, the preliminary amount of THC infused medicinal cannabis products (in milligrams) is reduced by a factor of five (5) based on pharmacokinetic equivalency research showing one (1) milligram of THC in edible form is equivalent to approximately five (5) milligrams of THC in inhalable form.

(3) For example:

(a) 28 grams of raw plant material x 25% average THC potency = 7 grams of concentrate.

(b) 7 grams is equivalent to 7,000 milligrams.

(c) 7,000 milligrams of concentrate x 70% average THC potency = 4,900 milligrams.

(d) 4,900 milligrams / 5 = 980 milligrams of THC infused medicinal cannabis products.

915 KAR 2:020

50 Ky.R. 2128; eff. 8/28/2024.

STATUTORY AUTHORITY: KRS 218B.140