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