Current through Register Vol. 46, No. 52, December 24, 2024
(a)
Definitions.
Wherever used in this Part, the following terms shall have
the following meanings:
(1)
Approved medical marihuana product is the final manufactured
product delivered to the patient that represents a specific brand with a
defined cannabinoid content and active and inactive ingredients, prepared in a
specific dosage and form, to be administered as recommended by the
practitioner.
(2)
Brand means a defined medical marihuana product that has a
homogenous and uniform cannabinoid concentration (total THC and total CBD) and
product quality, produced according to an approved and stable processing
protocol and shall have the same inactive ingredients as that defined for that
form of the brand.
(3)
Form of medical marihuana shall be a type of a medical
marihuana product approved by the commissioner and shall refer to the final
preparation of an approved medical marihuana brand; for example, an extract in
oil for sublingual administration, an extract for vaporization or an extract in
a capsule for ingestion.
(4)
Lot means a quantity of a medical marihuana extraction product
that has a homogenous and uniform cannabinoid concentration and product
quality, produced according to an approved and stable processing protocol
specific to that brand and form of medical marihuana product, during the same
cycle of manufacture.
(5)
Lot unique identifier (lot number or bar code) means any
distinctive combination of letters, numbers, or symbols, or any combination of
them, from which the complete history of manufacturing, testing, holding,
distribution or recall of a lot of medical marihuana product can be
determined.
(6)
Manufacturing shall include, but not be limited to
cultivation, harvesting, extraction (or other processing), packaging and
labeling.
(b) A
registered organization shall use either carbon dioxide (CO, super-critical) or
alcohol for cannabinoid extraction and shall only perform extraction of the
leaves and flowers of female marihuana plants. A registered organization shall
only use carbon dioxide that is of a supply equivalent to food or beverage
grade of at least 99.5 percent purity; and alcohol used shall be of a grade
that meets or exceeds specifications of official compendiums as defined in
section
321 of title 21 of the United States Code
(USC).
21 USC section
321 is available for copying and inspection
at the Regulatory Affairs Unit, New York State Department of Health, Corning
Tower, Empire State Plaza, Albany, NY 12237. A registered organization shall
obtain prior written approval from the department if it seeks to use other
extraction methods.
(c) A
registered organization shall only produce such forms of medical marihuana as
approved by the department according to the following requirements:
(1) Each registered organization may
initially produce up to five brands of medical marihuana product with prior
approval of the department. These brands may be produced in multiple forms as
approved by the commissioner. Thereafter, additional brands may be approved by
the department.
(2) Each medical
marihuana product brand, in its final form, shall be defined as having a
specific concentration of total Tetrahydrocannabinol (THC) and total
Cannabidiol (CBD) and shall have a consistent cannabinoid profile. The
concentration of the following cannabinoids, at a minimum, must be reported:
(i) Tetrahydrocannabinol (THC);
(ii) Tetrahydrocannabinol acid
(THCA);
(iii)
Tetrahydrocannabivarin (THCV);
(iv)
Cannabidiol (CBD);
(v)
Cannabinadiolic acid (CBDA);
(vi)
Cannabidivarine (CBDV);
(vii)
Cannabinol (CBN);
(viii)
Cannabigerol (CBG);
(ix)
Cannabichromene (CBC);
(x) Any
other cannabinoid component at > 0.2 percent, for which there is a certified
standard available at a customary cost.
(3) The final medical marihuana product shall
not contain less than 90 percent or more than 110 percent of the concentration
of total THC or total CBD indicated on the label for this brand and shall have
no more than 10mg total THC per dose.
However:
(i) Where
the total THC concentration is less than 5 milligrams per dose, the
concentration of total THC shall be within 0.5 milligrams per dose;
(ii) Where the total CBD concentration is
less than 5 milligrams per dose, the concentration of total CBD shall be within
0.5 milligrams per dose; and
(iii)
the concentration of total THC and CBD in milligrams per single dose for each
sample of a brand lot submitted for testing must be within 25 percent of the
mean concentration of total THC and CBD in milligrams per single dose for that
submitted lot with the exception that, for brands with a specified total THC
and CBD concentration less than 2 milligrams per single dose, the concentration
of each sample for that low concentration cannabinoid shall be within 0.5
milligrams per dose of the mean concentration.
(4) The registered organization shall offer
and make available to patients at least one brand that has a low THC and a high
CBD content (e.g., a 1:20 ratio of THC to CBD).
(5) The registered organization shall offer
and make available at least one brand that has approximately equal amounts of
THC and CBD.
(6) For each brand
offered, the registered organization shall only utilize a distinct name which
has been approved by the department, consisting of only letters and/or numbers.
The name shall not be coined or fanciful, and may not include any street, slang
or other name. No reference shall be made to any specific medical
condition.
(7) Each registered
organization shall ensure the availability of at least a one year supply of any
offered brand unless otherwise allowed by the department.
(d) The registered organization shall not add
any additional active ingredients or materials to any approved medical
marihuana product that alters the color, appearance, smell, taste, effect or
weight of the product unless it has first obtained prior written approval of
the department. Excipients must be pharmaceutical grade and approved by the
department.
(e) A registered
organization shall:
(1) use good agricultural
practices (GAPs) and must conform to all applicable laws and rules of New York
State;
(2) use water from a public
water supply or present a plan, approved by the department, which demonstrates
the ability to obtain sufficient quantities of water of equal or greater
quality as that from a public water supply and to monitor the quality of such
water on an ongoing basis;
(3) upon
prior written notice to the department, only use pesticides that are registered
by the New York State Department of Environmental Conservation or that
specifically meet the United States Environmental Protection Agency
registration exemption criteria for Minimum Risk Pesticides, and only in
accordance with section
325.2(b) of title
6 of the NYCRR;
(4) process the
leaves and flowers of the female plant only, in a safe and sanitary
manner;
(5) perform visual
inspection of the harvested plant material to ensure there is no mold, mildew,
pests, rot or gray or black plant material;
(6) have a separate secure area for temporary
storage of any medical marihuana or medical marihuana product that needs to be
destroyed; and
(7) provide
continual environmental monitoring for temperature, ventilation and humidity at
all locations in the manufacturing facility where unprocessed leaf and flower
material is stored, until further extraction or other processing is
completed.
(f) Production
of any approved medical marihuana product shall be in accordance with general
sanitary conditions. Poisonous or toxic materials, including but not limited to
insecticides, rodenticides, detergents, sanitizers, caustics, acids and related
cleaning compounds must be stored in a separate area from the marihuana and
medical marihuana products in prominently and distinctly labeled containers,
except that nothing herein precludes the convenient availability of detergents
or sanitizers to areas where equipment, containers and utensils are washed and
sanitized.
(g) Approved medical
marihuana products shall be limited to the forms of administration approved by
the Department, including but not limited to:
(1) metered liquid or oil
preparations;
(2) solid and
semisolid preparations (e.g. capsules, chewable and effervescent tablets,
lozenges);
(3) metered ground plant
preparations; and
(4) topical forms
and transdermal patches.
(5)
medical marihuana may not be incorporated into food products by the registered
organization, unless approved by the commissioner.
(6) Smoking is not an approved route of
administration.
(h) The
registered organization shall package the final form of the approved medical
marihuana product at the manufacturing site. The original seal shall not be
broken except for quality testing at an approved laboratory, for adverse event
investigations, by the department, or by the certified patient or designated
caregiver, or by the registered organization for internal quality control
testing or disposal.
(i) The
registered organization shall package the approved medical marihuana product
such that it is child-resistant, tamper-proof/tamper-evident, light-resistant,
and in a resealable package that minimizes oxygen exposure.
(j) The registered organization shall
identify each lot of approved medical marihuana product with a lot unique
identifier.
(k) Each approved
medical marihuana product shall be affixed with a product label. Medical
marihuana product labels shall be approved by the department prior to use. Each
product label shall be applied at the manufacturing facility, be easily
readable, firmly affixed and include:
(1) the
name, address and registration number of the registered organization;
(2) the medical marihuana product form and
brand designation;
(3) the single
dose THC and CBD content for the product set forth in milligrams
(mg);
(4) the medical marihuana
product lot unique identifier (lot number or bar code);
(5) the quantity included in the
package;
(6) the date
packaged;
(7) the date of
expiration of the unopened product, based on stability studies in accordance
with section
1004.11(m)(2) of
this title, or a tentative expiration date approved by the
department;
(8) the proper storage
conditions;
(9) language stating:
(i) "Medical marihuana products must be kept
in the original container in which they were dispensed and removed from the
original container only when ready for use by the certified patient";
(ii) "Keep secured at all times";
(iii) "May not be resold or transferred to
another person";
(iv) "This product
might impair the ability to drive";
(v) "KEEP THIS PRODUCT AWAY FROM CHILDREN
(unless medical marihuana product is being given to the child under a
practitioner's care"); and
(vi)
"This product is for medicinal use only. Women should not consume during
pregnancy or while breastfeeding except on the advice of the certifying
practitioner, and in the case of breastfeeding mothers, including the infant's
pediatrician."
(l) For each lot of medical marihuana product
produced, the registered organization shall submit a predetermined number of
final medical marihuana products (e.g., sealed vials or
capsules; with the number of samples submitted, based on statistical analysis,
determined to be representative of the lot) to an independent
laboratory/laboratories approved by the department. The laboratory verifying
the cannabinoid content shall be approved for the analysis of medical marihuana
product by the department in accordance with section
502 of the
Public Health Law and Subpart 55-2 of this Title. Such laboratory, or approved
laboratories cumulatively, shall certify the medical marihuana product lot as
passing all contaminant testing and verify that the content is consistent with
the brand prior to the medical marihuana product being released from the
manufacturer to any dispensing facility.
(1)
Any lot not meeting the minimum standards or specifications for safety shall be
rejected and destroyed by the registered organization in accordance with
section 1004.24 of this Part.
(2) Any lot not meeting the minimum standards
or specifications for brand consistency shall be reported to the department and
not dispensed by a registered organization without prior written approval from
the department.
(3) The registered
organization shall keep and maintain records documenting submission of medical
marihuana products to approved laboratories as required herein, and the results
of the laboratory testing. The registered organization shall provide the
department with such records upon request.
(m) The registered organization shall
demonstrate the stability of each approved medical marihuana product produced
(each brand in each form) by testing both the unopened and opened product at an
approved laboratory in accordance with section
1004.14(h) of
this Title:
(1) the stability of opened
products shall be validated under the conditions (light, temperature and
humidity), specified for storage of the product and an expiration date for
opened product shall be determined;
(2) the stability of unopened products
(e.g., sealed packages or vials) shall be validated by ongoing
stability testing and an expiration date for unopened products shall be
determined.
(3) specifications
regarding storage conditions must address storage at the manufacturing facility
once the package is sealed, during transport, at the dispensing facility, in
the patient's home and for samples retained for future testing.
(n) No synthetic marihuana
additives nor any cannabinoid preparation not produced by a registered
organization in an approved manufacturing facility shall be used in the
production of any medical marihuana product; provided, however, that a
registered organization may use hemp, or extracts derived from hemp, grown and
processed under the authority of the New York State Department of Agriculture
and Markets in the manufacturing of medical marihuana products.
(o) The registered organization's approved
standard operating procedure for the aforementioned activities must be
followed, unless otherwise approved by the department.
