N.Y. Comp. Codes R. & Regs. tit. 9 § 113.13

Current through Register Vol. 46, No. 45, November 2, 2024

Section 113.13 - Requirements for Dispensing Sites

(a) Medical cannabis products at a dispensing site shall only be dispensed by authorized employees, twenty-one (21) years of age or older, of the registered organization, under the in-person supervision of an individual with an active New York State pharmacist license as defined in Article 137 of the Education Law, who has completed at minimum a two (2) hour course pursuant to this Part.

(b) Dispensing sites shall only sell approved medical cannabis products, related products necessary for the administration of medical cannabis, and items that promote health and well-being subject to disapproval of the Office.

(c) Dispensing sites may display, in secure, locked cases, samples of each medical cannabis product offered for sale. Authorized employees may remove samples from the display case and provide it to the medical cannabis certified patient or designated caregiver for inspection, provided the patient or caregiver may not consume or otherwise use or remove the sample from the dispensing site.

(d) No medical cannabis products shall be vaporized or consumed on the premises of a dispensing site.

(e) Dispensing sites shall not dispense medical cannabis products to anyone other than a certified patient, designated caregiver, research license holder, or unless such registered organization, pursuant to Article 4 of the Cannabis Law, is authorized by the Office to sell cannabis for adult use for retail sale.

(f) When dispensing medical cannabis, the dispensing site shall:

(1) not dispense any medical cannabis to a certified patient, unless the certified patient presents the dispensing site with:

(i) a valid certification from a practitioner, as defined in Article 1 of the Cannabis Law, and issued in accordance with, Article 3 of the Cannabis Law, which shall also serve as the certified patient's registry card; and

(ii) a valid government-issued photo identification, which the dispensing site shall use to validate that such patient is eighteen (18) years of age or older and capable of consent as documented on the certification, provided that, such government-issue photo identification, is issued by:

(a) the New York State commissioner of motor vehicles;

(b) the federal government of the United States;

(c) any United States territory;

(d) the District of Columbia;

(e) a state, commonwealth, or local government within the United States;

(f) a post-secondary educational institution regulated by the New York State Department of Education or another state; or

(g) or a provincial government of the dominion of Canada;

(2) use the patient certification number as the registry identification when a registry identification number is required;

(3) not dispense any medical cannabis product to a designated caregiver, unless such caregiver presents a certification in accordance with section 113.3 of this Part and a form of photo identification of such caregiver issued pursuant to this section.

(4) not dispense an amount greater than a sixty (60) day supply to a certified patient, and not until the patient has exhausted all but a seven (7) day supply provided pursuant to any previously dispensed medical cannabis by any registered organization;

(5) ensure that medical cannabis product packaging shall not be opened by dispensing site staff;

(6) provide a patient-specific log of medical cannabis products (brand, administration form, and dosage, and dates dispensed and any return of product) to the patient, the patient's designated caregiver, if applicable, or the patient's practitioner upon request;

(7) ensure the prescription monitoring program registry is consulted pursuant to 3343-a Public Health Law and section 34 Article 3 of the Cannabis Law prior to any sales transactions and dispensing of any medical cannabis products by the facility.

(g) The registered organization shall be responsible for maintaining the confidentiality of patients and the integrity of the security of the facility at all times. Access to medical cannabis storage areas and areas within the dispensing site where security equipment and recordings are stored shall be restricted to:

(1) registered organization employees;

(2) employees of the Office or its authorized representatives;

(3) emergency personnel responding to an emergency, and;

(4) other persons authorized by a manager of the registered organization for the sole purpose of maintaining the operations of the facility.

(h) The dispensing site shall maintain a visitor log of all persons, other than registered organization employees or emergency personnel responding to an emergency, that access these secured areas, which shall include the name of the visitor, date, time and purpose of the visit. The visitor log shall be available to the Office at all times during operating hours and upon request.

(i) The dispensing site shall affix to the medical cannabis product package a patient specific dispensing label, that is easily readable, and firmly affixed and includes the following information:

(1) the name and registry identification number of the certified patient and designated caregiver, if any;

(2) the certifying practitioner's name;

(3) the dispensing site name, address and phone number;

(4) the dosing and administration instructions;

(5) the quantity and date dispensed;

(6) any recommendation or limitation by the practitioner as to the use of medical cannabis; and

(7) the expiration date of the product once opened pursuant to section 113.12(p)(2) of this Part, if not included on the cannabis product label pursuant to section 113.12 of this Part.

(j) The dispensing site shall include with each product package dispensed to a patient, a package safety insert. Information provided shall include but not be limited to:

(1) the medical cannabis product;

(2) contraindications;

(3) specific dosage directions and instructions for administration based on the medical cannabis product form, including but not limited to onset of effect and duration of action;

(4) warning of adverse events and/or any potential dangers stemming from the use of medical cannabis;

(5) instructions for reporting adverse events as may be determined by the Office;

(6) a warning about driving, operation of mechanical equipment, or making important decisions while taking medical cannabis;

(7) information on tolerance, dependence and withdrawal and substance abuse, how to recognize what may be problematic usage of medical cannabis and obtain appropriate services or treatment;

(8) language stating that the medical cannabis product must be kept secure at all times, and out of sight and reach of children and pets;

(9) language stating that the certified patient may not distribute any medical cannabis product to anyone else;

(10) language stating that unwanted, excess, or contaminated medical cannabis product must be disposed of in accordance with the requirements set forth in section 113.21 of this Part; and

(11) language stating that "This product has not been analyzed by the FDA. There is limited information on the side effects of using this product and there may be associated health risks."

(k) The dispensing site shall store the medical cannabis product in a manner to ensure that there is no contamination or deterioration of the medical cannabis product or its packaging.

(l) If a medical cannabis product is returned to the dispensing site, the dispensing site shall:

(1) dispose of such product pursuant to section 113.25 of this Part;

(2) retain the following information for at least five (5) years and make available to the Office upon request:

(i) the name and registry identification number of the certified patient for whom the product was dispensed;

(ii) the date of the return;

(iii) the product being returned;

(iv) the quantity and/or weight being returned;

(v) the reason for the return;

(vi) the name of the dispensing site employee accepting the return; and

(vii) any other information required by the Office;

(3) ensure the returned medical cannabis product is securely stored, separate from working inventory while awaiting disposal.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 113.13

Adopted New York State Register February 22, 2023/Volume XLV, Issue 08, eff. 2/22/2023