Current through Register Vol. 46, No. 12, March 20, 2024
(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.