N.Y. Comp. Codes R. & Regs. tit. 9 § 113.12

Current through Register Vol. 46, No. 36, September 4, 2024

Section 113.12 - Manufacturing Requirements for Medical Cannabis Products

(a) Requirements for extraction. Unless otherwise approved in writing by the Office, a registered organization may only use the methods, equipment, solvents, gases and mediums set forth in this section when creating cannabis extracts and only in a manner exhibiting minimal potential for human health related toxicity.

(1) All extraction processes and activities must:

(i) be conducted by employees adequately trained in the operation of the extraction equipment to be utilized, as well as the emergency plan for incidents;

(ii) demonstrate control of all sources of ignition, and occur in a spark-free environment where appropriate for the type of extraction method used;

(iii) ensure proper ventilation;

(iv) have ongoing equipment monitoring and maintain a record of regular maintenance of equipment based on equipment specifications;

(v) follow all applicable fire, safety and building codes, regulations, laws and guidance in the use and storage of solvents, including but not limited to, maximum quantities to be held onsite;

(vi) evidence the purity of any chemical solvents used and make any certificate of analysis or other documentation evidencing such purity and shall make such evidence readily available to employees and to the Office upon request.

(2) Unless a registered organization obtains prior written approval from the Office, extraction shall only be conducted using the following methods:

(i) use of mechanical extraction methods, such as screens or presses, or heat, steam distillation, ice water and other methods without employing solvents or gases;

(ii) use of a professional grade, closed-loop CO2 gas extraction system that is of a supply equivalent to food or beverage grade of at least 99.5 percent purity;

(iii) Ethanol, provided that all ethanol 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);

(iv) use of a volatile solvent or hydrocarbon extraction method, provided that the method:

(a) utilizes a commercial, professional grade closed-loop system designed to recover the solvent;

(b) utilizes the following permissible volatile solvent-based or hydrocarbon extraction substances, which must be accompanied by a certificate of analysis which establishes that said substances have a minimum purity level of 99 percent:

(1) Butane;

(2) Propane;

(3) A different volatile solvent or hydrocarbon with prior written approval by the Office prior to use;

(c) In addition, for all proposed volatile solvent based or hydrocarbon extraction, a registered organization shall submit to the Office, prior to receiving approval to commence extraction operations, documentation which demonstrates, to the satisfaction of the Office, the following additional requirements for all designated extraction equipment, rooms, or other areas where volatile solvents used for extraction are handled or stored:

(1) final certification letter from a licensed professional engineer or registered architect which certifies the completed installation of a professionally designed, commercially manufactured extraction system, that is compliant with all applicable state or local fire, safety or building codes;

(2) a letter or equivalent document as determined by the Office from the municipal jurisdiction's fire marshal, local building code authority, or its equivalent, stating that the facility is approved to conduct the proposed activities and that the registered organization has demonstrated compliance with all applicable fire codes and/or regulations; and

(3) a certificate of occupancy, or equivalent document, from the local building official that all permits for extraction related rooms or areas have been closed as applicable.

(b) A registered organization shall only produce medical cannabis products according to the following requirements:

(1) each medical cannabis product, 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 phytocannabinoid profile. The concentration of the following phytocannabinoids, at a minimum, must be reported:

(i) tetrahydrocannabinol (THC);

(ii) tetrahydrocannabinol acid (THCA);

(iii) cannabidiol (CBD);

(iv) cannabinadiolic acid (CBDA);

(v) any other marketed phytocannabinoid;

(vi) any other phytocannabinoid component at > 0.2 percent of the phytocannabinoid profile; and

(vii) terpenoid content, if the registered organization will be marketing or advertising terpenoid content, or including terpenoid content as a part of the medical cannabis product labeling.

(2) the final medical cannabis product shall not contain less than ninety (90) percent, nor more than 110 percent, of the concentration of total THC or total CBD, as indicated on the label. However:

(i) where the total THC concentration is less than five (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 five (5) milligrams per dose, the concentration of total CBD shall be within 0.5 milligrams per dose; and

(iii) unless otherwise approved by the Office, the concentration of total THC and CBD in milligrams per single dose for any sample of a product submitted for testing must be within twenty-five (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 products with a specified total THC and CBD concentration less than two (2) milligrams per single dose, the concentration of each sample for that low concentration phytocannabinoid shall be within 0.5 milligrams per dose of the mean concentration.

(3) the registered organization shall offer and make available to patients at least one (1) medical cannabis product that has a low THC and a high CBD content (e.g., a 1:20 ratio of THC to CBD);

(4) the registered organization shall offer and make available at least one (1) medical cannabis product that has approximately equal amounts of THC and CBD;

(5) for each medical cannabis product offered, the registered organization shall utilize a name that complies with the requirements of section 113.12(k) of this Part; and

(6) each registered organization shall have a manufacturing schedule that ensures the ability to produce adequate supply of any offered medical cannabis product, unless otherwise allowed by the Office, to ensure continuity of care for certified patients;

(c) Excipients for all forms of administration must be demonstrated safe for use in the proposed form. All vaporized and inhaled medical cannabis products shall meet the following additional requirements:

(1) unless prior written approval of the Office is received, medical cannabis vaporization devices for concentrates shall be a closed system with a pre-filled single-use cartridge that attaches to a rechargeable battery, or a single-use product;

(2) electronic vaporization devices shall have internal or external temperature controls to prevent combustion and have a heating element made of inert material such as glass, ceramic or stainless steel and not plastic or rubber;

(3) except for cannabis or hemp-derived terpenes, excipients and ingredients must be pharmaceutical grade unless otherwise approved by the Office, and shall not include:

(i) synthetic terpenes;

(ii) polyethylene glycol (PEG);

(iii) vitamin E acetate;

(iv) medium chain triglycerides (MCT oil);

(v) medicinal compounds;

(vi) illegal or controlled substances;

(vii) artificial food coloring;

(viii) benzoic acid;

(ix) diketones; and

(x) any other compound or ingredient as determined by the Office;

(4) not contain any flavors or flavoring agents, except for cannabis-derived or hemp-derived terpenes; and

(d) A registered organization shall:

(1) use good agricultural practices (GAPs);

(2) use good manufacturing practices (GMPs) and demonstrate compliance with GMP by submitting to the Office proof of a qualified third-party GMP audit of the registered organization's extraction and/or manufacturing facility operations and any related certification or audit report within one year of commencing operations and be maintained for the duration of the registration;

(3) conform to all applicable laws and rules of New York State;

(4) use water from a public water supply or present a plan, approved by the Office, 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;

(5) 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 6 NYCRR section 325.2(b);

(6) process the leaves and flowers of the female cannabis plant only, in a safe and sanitary manner;

(7) perform visual inspection of the harvested plant material to ensure there is no mold, mildew, pests, rot or gray or black plant material;

(8) have a separate secure area for temporary storage of any medical cannabis or medical cannabis product that needs to be destroyed; and

(9) 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.

(e) Production of any medical cannabis 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 cannabis and medical cannabis 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.

(f) Medical cannabis products shall be limited to the following forms of administration:

(1) metered liquid or oil preparations;

(2) solid and semisolid preparations (e.g. capsules, chewable and effervescent tablets, lozenges);

(3) metered ground plant preparations;

(4) whole flower;

(5) topical forms and transdermal patches; or

(6) any other form approved by the Board.

(g) Medical cannabis may not be incorporated into food or beverage products by the registered organization, unless approved by the Board

(h) The registered organization shall identify each lot of medical cannabis product with a lot unique identifier.

(i) The registered organization shall package the final form of the medical cannabis 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 Office, by the certified patient or designated caregiver, designated caregiver facility, an authorized cannabis research license holder, or by the registered organization for internal quality control testing or disposal.

(j) Medical Cannabis Product Packaging Minimum Standards.

(1) A medical cannabis product package shall:

(i) be packaged and labeled in its final form at the manufacturing facility;

(ii) be easily readable and firmly affixed to the package;

(iii) be child-resistant unless otherwise approved by the Office;

(iv) be tamper-evident;

(v) fully enclose the product, minimize oxygen exposure and prevent the contamination and/or degradation of the medical cannabis product; and

(vii) not impart any toxic or deleterious substance onto the medical cannabis product.

(2) Unless otherwise approved by the Office, a registered organization shall maintain a copy of the certificate showing that each medical cannabis package into which the registered organization places medical cannabis products is child-resistant and complies with the requirements of 16 CFR § 1700.15 for Poison Prevention Packaging Standards and 16 CFR § 1700.20 for Testing Procedure for Special Packaging.

(3) An exit package is optional and is not required to be labeled but may include the registered organization's name or logo, provided that the name or logo complies with the provisions of subdivision 113.12(k) of this section.

(4) Registered organizations shall implement a recycling program for medical cannabis product packaging.

(5) Claims about recyclable or recycled content packaging shall comply with Title 16 of the Code of Federal Regulations relating to Commercial Practices, Part 260 regarding Guides for the Use of Environmental Marketing Claims.

(k) Medical Cannabis Product Packaging Prohibitions.

(1) A medical cannabis product package shall not:

(i) be opened or the original seal be broken except for quality testing at an approved laboratory, for adverse event investigations, by the Office, by the certified patient or designated caregiver, designated caregiver facility, an authorized cannabis research license holder, or by the registered organization for internal quality control testing or disposal, unless otherwise approved by the Office;

(ii) contain any pictures, images, or graphics, other than what may be required by the Board;

(iii) contain any features that emit scent or sound;

(iv) contain any features that change or alter a package's appearance through technology, other than for anti-counterfeiting purposes;

(v) be made attractive to individuals under twenty-one (21) by using or including:

(a) Cartoons;

(b) Bubble-type or other cartoon-like font;

(c) Bright colors that are "neon" in appearance;

(d) Similarities to products or words that refer to products that are commonly associated with or marketed in a manner so as to be attractive to individuals under twenty-one (21), including but not limited to, any imitation of food, candy, soda, drinks, cookies, or cereal, in labeling, packaging, advertising, or marketing;

(e) Terms "candy" or "candies" or variants in spelling such as "kandy" or "kandeez";

(f) Symbols, images, characters, public figures, phrases, toys, or games that are commonly used to market products to individuals under the age of twenty-one (21); or

(g) Images of individuals who could reasonably appear to be under the age of twenty-one (21).

(vi) use any term or variants in the spelling of any term describing a medical condition;

(vii) be made of single-use plastic, unless containing a minimum 25% post-consumer recycled content. The Board may waive this requirement upon good cause shown; and

(viii) violate any additional requirements as set out by the Office.

(l) Cannabis Product Labeling Minimum Standards

(1) Registered organizations shall ensure that the principal packaging display panel shall have a white background with black text containing the following information:

(i) the medical cannabis product form, and brand designation;

(ii) a list of all ingredients in descending order of predominance by weight in the medical cannabis product - both active and inactive. The ingredient list must include and separately list, in bold, any major allergens set forth in the Food Allergen Labeling and Consumer Protection Act of 2004, Title 21, as it relates to Food and Drugs, of the U.S. Code § 343, for misbranded food.

(iii) milligrams per dose of total THC (THC + THCA x 0.877), total CBD (CBD + CBDA x 0.877) content;

(iv) milligrams per package of total THC (THC + THCA x 0.877) and total CBD (CBD + CBDA x 0.877)

(v) any other marketed phytocannabinoids in milligrams per dose and milligrams per package;

(vi) the amount of total THC (THC + THCA x 0.877) and any other marketed phytocannabinoids as a percentage of volume, unless otherwise exempted by the Office;

(vii) the total quantity or volume included in the package;

(viii) the medical cannabis product lot unique identifier (lot number or bar code);

(ix) the date of expiration of the unopened medical cannabis product based on stability studies in accordance with paragraph 113.12(p)(2) of this section;

(x) use by date once the medical cannabis product is opened if not included on the dispensing label pursuant to 113.12(p)(1) of this section;

(xi) the proper storage conditions;

(xii) the name, address and registration number of the registered organization;

(xiii) language stating:

(a) "Keep secured at all times.";

(b) "May not be resold or transferred to another person.";

(c) "This product might impair the ability to drive.";

(d) "Medical cannabis 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.";

(e) "KEEP PRODUCT AWAY FROM CHILDREN (unless the medical cannabis product is being given to the child under a practitioner's care). In case of accidental ingestion or overconsumption, contact the poison control hotline 1-800-222-1222 or call 9-1-1."

(f) "This product is for medicinal use only. This product should not be consumed during pregnancy or while nursing except on the advice of the certifying practitioner, and in the case of a nursing parent, including the infant's pediatrician."; and

(g) For topical products: "For external use only".

(xiv) a scannable bar code or QR code linked to a downloadable certificate of analysis for the medical cannabis product or linked to a website where the certificate of analysis can be downloaded. A registered organization shall provide a physical or paper certificate of analysis which includes, but is not limited to, the quality, safety and clinical strength of the medical cannabis product manufactured or dispensed by the registered organization directly to certified patients or their designated caregivers upon their request, in accordance with section 34 of the Cannabis Law;

(xv) any solvent used to produce the medical cannabis product, if applicable; and

(xvi) any other information required by the Board.

(2) Required labeling on the medical cannabis package must be:

(i) in text no smaller than 6-point font;

(ii) clearly written or printed and visible to consumers;

(iii) in Times New Roman, Calibri, Arial, or Helvetica; and

(iv) in the English language. In addition to the required labeling in English, licensees may include an additional, accurate foreign language translation on the package that otherwise complies with this Part.

(3) The information required pursuant to section 113.12(l)(1) of this Part must be unobstructed and conspicuous. A registered organization may include the required information by printing the information directly onto the medical cannabis package or by affixing multiple labels with the information to the package, provided none of the information is obstructed. For example, and not by means of limitation, the information may appear on labels that may be accordion, expandable, extendable, or layered to accommodate labeling of small packages.

(4) Any research licensee conducting research approved by the Board involving human subjects shall comply with all packaging and labeling requirements, unless the licensee receives prior written approval for a waiver of specific packaging or labeling requirements in connection with any research approved by the Board. The waiver may extend to a registered organization providing medical cannabis or medical cannabis products for an approved research study.

(m) Medical Cannabis Product Labeling Prohibitions; No medical cannabis product package shall display any content or be labeled in any manner that:

(1) is made attractive to individuals under twenty-one (21) as set forth in section 113.12(k)(1)(v) of this Part;

(2) includes any false or misleading statements;

(3) includes the term "organic";

(4) includes the term "craft";

(5) causes a reasonable consumer confusion as to whether the medical cannabis product is trademarked, marked or labeled in a manner that violates any federal trademark law or regulation;

(6) depicts cannabis, cannabis products, or paraphernalia;

(7) promotes overconsumption or consumption contrary to a certifying practitioner or pharmacist's recommendation;

(8) depicts a child or other person reasonably appearing to be under the age of twenty-one (21); and

(9) violates additional prohibitions as set out by the Office.

(n) For each lot of medical cannabis product produced by the registered organization, a predetermined number of final medical cannabis products shall be collected and submitted, in a manner approved by the Office, for final product testing to an independent laboratory/laboratories permitted by the Board. The registered organization must review the testing results provided by the independent laboratory/laboratories to verify that the concentration of cannabinoids is consistent with the form of medical cannabis and verify that contaminants do not exceed limits, as defined by the Office, prior to the medical cannabis product being released from the manufacturer to any dispensing site.

(o) Any lot not meeting the minimum testing standards for contaminants, shall be rejected and destroyed by the registered organization in accordance with section 113.25 of this Part, notwithstanding a medical cannabis flower product lot that has not met the minimum testing standards for microbial testing and has passed all remaining contaminant testing. A registered organization may remediate and repurpose medical cannabis flower products provided that;

(1) the lot must be resubmitted for laboratory testing in a manner set forth in section 113.12(n) of this Part;

(2) after completing the required analyses of a representative sample obtained from a remediated or repurposed medical cannabis lot, the laboratory shall report the results to the Office within two (2) business days;

(3) a medical cannabis flower product lot may only be remediated or repurposed for extraction once. If the lot fails to meet minimum testing standards for contaminants after the remediation or repurposing process, the entire lot shall be destroyed by the registered organization in accordance with section 113.25 of this Part;

(4) when a failed medical cannabis flower lot is not remediated or reprocessed in any way it cannot be retested. Any subsequent testing results produced without remediation of the failed batch will not supersede the initial regulatory testing results.

(5) Any lot not meeting the minimum standards or specifications for product consistency shall be reported to the Office and not dispensed by a registered organization without prior written approval from the Office.

(6) The registered organization shall keep and maintain records documenting submission of medical cannabis products to approved laboratories as required herein, and the results of the laboratory testing. The registered organization shall provide the Office with such records upon request.

(p) The registered organization shall demonstrate the stability of each medical cannabis product produced by testing both the unopened and opened product in accordance with section 113.15(i) of this Part:

(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 site, in the patient's home and for samples retained for future testing.

(q) Registered organization shall not prepare or produce any medical cannabis products that contains:

(1) synthetic cannabis additives;

(2) artificially derived phytocannabinoid; or

(3) phytocannabinoid not produced by a registered organization by extraction in an approved manufacturing facility.

(r) In the manufacturing of medical cannabis products, a registered organization may use hemp grown pursuant to the New York State Department of Agriculture and Markets, or hemp extracts derived from hemp, processed or manufactured in accordance with the Office's cannabinoid hemp program, in accordance with applicable federal, state and local laws and regulations;

(s) The registered organization's approved standard operating procedure for the aforementioned activities must be followed, unless otherwise approved by the Office.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 113.12

Adopted New York State Register February 22, 2023/Volume XLV, Issue 08, eff. 2/22/2023