N.Y. Comp. Codes R. & Regs. tit. 10 § 1004.12

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

Section 1004.12 - Requirements for dispensing facilities

(a) Medical marihuana products shall not be dispensed or handled unless an individual with an active New York State pharmacist license, as defined in article 137 of the Education Law, who has completed a four-hour course pursuant to section 1004.1 of this part, is on the premises and supervising the activity within the facility.

(b) Dispensing facilities shall only sell approved medical marihuana products, related products necessary for the approved forms of administration of medical marihuana, and items that promote health and well-being subject to disapproval of the department and only in such a manner as does not increase risks of diversion, theft or loss of approved medical marihuana products or risk physical, chemical or microbial contamination or deterioration of approved medical marihuana products.

(c) No approved medical marihuana products shall be vaporized or consumed on the premises of a dispensing facility.

(d) Dispensing facilities shall not dispense approved medical marihuana products to anyone other than a certified patient or designated caregiver.

(e) When dispensing approved medical marihuana products, the dispensing facility shall:

(1) not dispense an amount greater than a 30 day supply to a certified patient, and not until the patient has exhausted all but a seven day supply provided pursuant to any previously dispensed medical marihuana product by any registered organization;

(2) ensure that medical marihuana product packaging shall not be opened by dispensing facility staff;

(3) provide a patient specific log of medical marihuana 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;

(4) ensure the prescription monitoring program registry is consulted pursuant to 3343-a and section 3364 of the Public Health Law, prior to any sales transactions and dispensing of any approved medical marihuana products by the facility.

(f) 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 marihuana storage areas and areas within the dispensing facility where security equipment and recordings are stored shall be restricted to:

(1) registered organization employees;

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

(i) The dispensing facility shall maintain a visitor log, which shall include the name of the visitor, date, time and purpose of the visit. The visitor log shall be available to the department at all times during operating hours and upon request.

(ii) If an unforeseen circumstance requires the presence of a visitor and makes it impractical for the dispensing facility to obtain a waiver pursuant to this part, the dispensing facility shall record in the visitor log, the name of the visitor, date, time, purpose of the visit and the facts upon which the access was granted.

(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.

(i) The dispensing facility 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 department at all times during operating hours and upon request.

(g) The dispensing facility shall affix to the approved medical marihuana product package a patient specific dispensing label approved by the department, that is easily readable, and firmly affixed and includes:

(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 facility 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 marihuana; and

(7) the expiration date of the product once opened pursuant to section 1004.11(m)(1) of this Part.

(h) The dispensing facility shall place the approved medical marihuana product in a plain outer package when dispensing to the patient or designated caregiver.

(i) The dispensing facility shall ensure that each patient receives approved medical marihuana product from no more than two distinct lots for any 30-day supply dispensed.

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

(1) the medical marihuana product and brand;

(2) a list of any excipients used;

(3) a warning if there is any potential for allergens in the medical marihuana product;

(4) contraindications;

(5) more specific dosage directions and instructions for administration;

(6) warning of adverse effects and/or any potential dangers stemming from the use of medical marihuana;

(7) instructions for reporting adverse effects as may be determined by the department;

(8) a warning about driving, operation of mechanical equipment, child care or making important decisions while under the influence of medical marihuana;

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

(10) advice on how to keep the medical marihuana product secure;

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

(12) language stating that unwanted, excess, or contaminated medical marihuana product must be disposed of according to section 1004.20 of this Part; and

(13) 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 facility shall store the medical marihuana product in a manner to ensure that there is no contamination or deterioration of the medical marihuana product or its packaging.

(l) If an approved medical marihuana product is returned to the dispensing facility, the dispensing facility shall:

(1) dispose of such product pursuant to section 1004.24 of this part;

(2) provide the following information to the department:

(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 brand and form being returned;

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

(v) the reason for the return;

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

(vii) any other information required by the department;

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

N.Y. Comp. Codes R. & Regs. Tit. 10 § 1004.12

Adopted, New York State Register April 15, 2015/Volume XXXVII, Issue 15, eff. 4/15/2015

Amended New York State Register December 27, 2017 /Volume XXXIX, Issue 52, eff. 12/27/2017