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