Title: Section 1004.11 - Manufacturing requirements for approved medical marihuana products
1004.11 Manufacturing requirements for approved medical marihuana products
(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 (CO2, 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% 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 §321 is available for copying and inspection at the Regulatory Affairs Unit, New York State Department of Health, Corning Tower, Empire State Plaza, Albany, New York 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 toinsecticides, 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, 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 five hundred two 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.
(o) The registered organization’s approved standard operating procedure for the aforementioned activities must be followed, unless otherwise approved by the department.
VOLUME E (Title 10)