Current through Register Vol. 46, No. 39, September 25, 2024
(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.
