TerraLex Cross-Border Guide to Cannabis Guide

Yes – See the Official Compilation of Codes, Rules and Regulations of the State of New York – Title 10, Chapter XIII, Part 1004 and Subpart 55-2

§1004.5 Application for initial registration as a registered organization. (a) No person or entity shall produce, grow or sell medical marijuana or hold itself out as a New York State registered organization unless it has complied with article 33 of the public health law and this part and is registered by the department.

(b) In order to operate as a registered organization, an entity shall file an application on forms or in a manner prescribed by the commissioner. The application shall be signed by the chief executive officer duly authorized by the board of a corporate applicant, or a general partner or owner of a proprietary applicant. The application shall set forth or be accompanied by the following:

1. The name, address, phone and email address of the applicant;

2. Identification of all real property, buildings and facilities that will be used in manufacturing, as defined in Section 1004.11 of this part, and dispensing of the medical marijuana products;

3. Identification of all equipment that will be used to carry out the manufacturing, processing, transportation, distributing, sale and dispensing activities described in the application and operating plan;

4. An operating plan that includes a detailed description of the applicant’s manufacturing processes, transporting, distributing, sale and dispensing policies or procedures. The operating plan shall also include:

   • (i) A detailed description of any devices used with approved medical marijuana products to be offered or sold by the registered organization;
   • (ii) Policies and procedures related to security and control measures that will be in place to prevent diversion, abuse, and other illegal or unauthorized conduct relating to medical marijuana and are consistent with provisions set forth in this part;
   • (iii) A standard operating procedure manual for all methods used from cultivation of the medical marijuana through packaging, sealing and labeling of each lot of medical marijuana product. The procedures shall include use of good agricultural practices (GAPs) and must conform to all applicable laws and rules of New York State. Standard operating procedures shall be able to be validated to demonstrate that the applicant will be able to produce and dispense consistent and reproducible medical marijuana product such that, for each form of each brand produced, there is homogeneity, absence of contamination and reproducibility of the brand profile in each lot as defined in section 1004.11 of this part.
   • (iv) Quality assurance plans, including but not limited to plans to detect, identify and prevent dispensing errors;
   • (v) Policies and procedures to document and investigate approved medical marijuana product returns, complaints and adverse events, and to provide for rapid voluntary or involuntary recalls of any lot of medical marijuana product. Such policies and procedures shall include a plan for any retesting of returned approved medical marijuana products, storage and disposal of marijuana and any manufactured medical marijuana products not passing requirements, and a requirement that adverse events and total recalls are reported to the department within twenty-four hours of their occurrence;
   • (vi) A quality assurance program to track contamination incidents and document the investigated source of such incidents, and the appropriate corrective action(s) taken.
   • (vii) Detailed description of plans, procedures and systems adopted and maintained for tracking, record keeping, record retention and surveillance systems, relating to all medical marijuana at every stage including cultivating, possessing of marijuana, and manufacturing, delivery, transporting, distributing, sale and dispensing by the proposed registered organization. proposed hours of operation for the manufacturing and dispensing facilities;

5. Copies of the organizational and operational documents of the applicant, including but not limited to, as applicable: the certificate of incorporation, bylaws, articles of organization, partnership agreement, operating agreement and other applicable documents and agreements, and all amendments thereto;

6. The name, residence address and title of each of the board members, officers, managers, owners, partners, principal stakeholders, directors and any person or entity that is a member of the applicant. Each such person (if an individual, or lawful representative, if a legal entity) shall submit an affidavit with the application setting forth:

   • (i) Any position of management or ownership during the preceding ten years of a ten percent or greater interest in any other business, located in or outside New York State, manufacturing or distributing drugs; and
   • (ii) Whether such person or any such business has been convicted of a felony or had a registration or license suspended or revoked in any administrative or judicial proceeding. In addition, any managers who may come in contact with or handle medical marijuana, including medical marijuana products, shall be subject to a fingerprinting process as part of a criminal history background check in compliance with the procedures established by Division of Criminal Justice Services and submission of the applicable fee;

7. Documentation that the applicant has entered into a labor peace agreement, as required by subdivision one of section thirty-three hundred sixty five of the public health law, with a bona-fide labor organization that is actively engaged in representing or attempting to represent the applicant’s employees. The maintenance of such a labor peace agreement shall be an ongoing material condition of registration;

8. A statement that the applicant is able to comply with all applicable state and local laws and regulations relating to the activities in which it intends to engage under the registration;

9. Copies of all applicable executed and proposed deeds, leases, and rental agreements or executed option contracts related to the organization’s real property interests, that shows that the applicant possesses or has the right to use sufficient land, buildings, and other premises as specified in the application and equipment to properly carry on the activities for which registration is sought. In the alternative, the applicant shall post a bond of not less than two million dollars; provided, however, that if the applicant posts a bond in lieu of providing the documentation requested herein, the applicant’s submission of the applicable executed deeds, leases and rental agreements shall be required prior to the issuance of a registration to the applicant, if selected; and, provided further that whenever any applicant proposes to lease premises for the activities described in its operating plan, the lease agreement shall clearly set forth as a purpose the manufacturing and/or dispensing of medical marijuana, as applicable, and include the following language:

   • “The landlord acknowledges that its rights of reentry into the premises set forth in this lease do not confer on it the authority to manufacture and/or dispense on the premises medical marijuana in accordance with article 33 of the Public Health Law and agrees to provide the New York State Department of Health, Mayor Erastus Corning 2nd Tower, The Governor Nelson A. Rockefeller Empire State Plaza, Albany, N.Y. 12237, with notification by certified mail of its intent to reenter the premises or to initiate dispossess proceedings or that the lease is due to expire, at least 30 days prior to the date on which the landlord intends to exercise a right of reentry or to initiate such proceedings or at least 60 days before expiration of the lease.”

10. A financial statement setting forth all elements and details of any business transactions connected with the application, including but not limited to all agreements and contracts for consultation and/or arranging for the assistance in preparing the application;

11. Architectural program and sketches of the applicant’s proposed manufacturing and dispensing facility(ies) including the following:

    • (i) Site plans;
    • (ii) Schematic architectural and engineering design drawings and single line sketches in an appropriate scale showing the relationship of various buildings to each other, room configurations, major exit corridors, exit stair locations, and circulation along with existing buildings if additions or alterations are part of the project;
    • (iii) Outline specifications for the type of construction proposed including a description of energy sources, type and location of engineering systems proposed for heating, cooling, ventilation and electrical distribution, water supply and sewage;
    • (iv) A security plan indicating how the applicant will comply with the requirements of article 33 of the Public Health Law, this part and any other applicable law, rule, or regulation; and
    • (v) The registered organization shall submit detailed floor plans indicating the activities performed in each area and security plans (physical and cyber) consistent with the requirements of section 1004.13 of this part.

12. A construction timetable;

13. A statement as to whether the applicant, any controlling person of the applicant, any manager, any sole proprietor applicant, any general partner of a partnership applicant, any officer and member of the board of directors of a corporate applicant, and corporate general partner had a prior discharge in bankruptcy or was found insolvent in any court action;

14. If any controlling person of the applicant, any manager, any sole proprietor applicant, any general partner of a partnership applicant, any officer and member of the board of directors of a corporate applicant, or corporate general partner or a combination of such persons collectively, maintains a ten percent interest or greater in any firm, association, foundation, trust, partnership, corporation, or other entity or if such entity maintains a ten percent interest or greater in the applicant, and such entity will or may provide goods, leases, or services to the registered organization, the value of which is or would be five hundred dollars or more within any one year, the name and address of the entity shall be disclosed together with a description of the goods, leases or services and the probable or anticipated cost to the registered organization;

15. If the applicant is a corporate subsidiary or affiliate of another corporation, disclosure of the parent or affiliate corporation including the name and address of the parent or affiliate, the primary activities of the parent or affiliate, the interest in the applicant held by the parent or affiliate and the extent to which the parent will be responsible for the financial and contractual obligations of the subsidiary;

16. The most recent financial statement of the applicant prepared in accordance with generally accepted accounting principles (GAAP) applied on a consistent basis and certified by an independent certified public accountant, including a balance sheet as of the end of the applicant’s last fiscal year and income statements for the past two fiscal years, or such shorter period of time as the applicant has been in operation;

17. If construction, lease, rental or purchase of the manufacturing or dispensing facility has not been completed, a statement indicating the anticipated source and application of the funds to be used in such purchase, lease, rental or construction;

18. A staffing plan for staff involved in activities related to the cultivation of marijuana, the manufacturing and/or dispensing of approved medical marijuana products and/or staff with oversight responsibilities for such activities, which shall include:

    • (i) A senior staff member with a minimum of one (1) year experience in good agricultural practices (GAP);
    • (ii) A quality assurance officer who shall exercise oversight of the organization’s practices and procedures and who has documented training and experience in quality assurance and quality control procedures;
    • (iii) A requirement that all staff be twenty-one (21) years of age or older;
    • (iv) A requirement that all staff involved in the manufacturing be trained in and conform to general sanitary practices; and
    • (v) Policies and procedures to ensure that the proposed registered organization shall not employ anyone who would come in contact with or handle medical marijuana who has been convicted of any felony of sale or possession of drugs, narcotics, or controlled substances in accordance with the requirements of section thirty-three hundred sixty-four of the public health law.

19. Any other information as may be required by the commissioner.

(c ) An application under this section may be amended while the matter is pending before the commissioner, if approved by the commissioner upon good cause shown.

(d) The applicant shall verify the truth and accuracy of the information contained in the application. The department, in its discretion, may reject an application if it determines that information contained therein is not true and accurate.

§1004.6 Consideration of registered organization applications.

(a) Applicants for approval to operate as registered organizations shall submit an application to the department, containing the information required in §1004.5, in a manner and format determined by the department.

1. Applications shall be accompanied by a non-refundable application fee in the amount of $10,000.

2. The registration fee for the registration period shall be $200,000. Applicants shall submit the registration fee by certified check at the time of submission of the application. The registration fee shall be returned to the applicant if the applicant is not granted a registration under this part.

3. Only applications completed in accordance with this part as determined by the department and for which the application and registration fees have been submitted shall be considered if submitted in a timely manner. The department shall return the certified check for $200,000 to all applicants who are not granted a registration.

(b) The department shall initially register up to five applicants as registered organizations. In deciding whether to grant an application, or amendment to a registration, the department shall consider whether:

1. The applicant will be able to manufacture approved medical marijuana products, each with a consistent cannabinoid profile (the concentration of total tetrahydrocannabinol (THC) and total cannabidiol (CBD) will define the brand) and each able to pass the required quality control testing;

2. The applicant will produce sufficient quantities of approved medical marijuana products as necessary to meet the needs of certified patients;

3. The applicant will be able to maintain effective control against diversion of marijuana and medical marijuana products;

4. The applicant will be able to comply with all applicable state and local laws and regulations;

5. The applicant is ready, willing and able to properly carry on the activities set forth in this part;

6. The applicant possesses or has the right to use sufficient real property, buildings and equipment to properly carry on the activity described in its operating plan;

7. It is in the public interest that such registration be granted;

8. The number of registered organizations in an area will be adequate or excessive to reasonably serve the area, including whether there is sufficient geographic distribution across the state;

9. The moral character and competence of board members, officers, managers, owners, partners, principal stakeholders, directors, and members of the applicant’s organization; the applicant has entered into a labor peace agreement with a bona-fide labor organization, as defined in section thirty-three hundred sixty of the public health law, that is actively engaged in representing or attempting to represent the applicant’s employees; and evaluation of the applicant’s proposed operating plan and suitability of the proposed manufacturing and dispensing facilities, including but not limited to the suitability of the location and architectural and engineering design of the proposed facilities. Department approval of the applicant’s operating plan and architectural and engineering design of the proposed facilities shall be required for issuance of a registration.

(c ) The applicant shall allow reasonable access to the department and/or its authorized representatives for the purpose of conducting an on-site survey or inspection of the applicant’s proposed manufacturing and/or dispensing facilities.

(d) If the commissioner is not satisfied that the applicant should be issued a registration, he or she shall notify the applicant in writing of those factors upon which further evidence is required. Within 30 days of the receipt of such notification, the applicant may submit additional material to the commissioner or demand a hearing, or both.

(e) An application may be amended to allow the registered organization to relocate within the state or to add or delete permitted registered organization activities or facilities. The department shall consider whether to grant or deny the application for amendment of the registration utilizing the criteria set forth in subdivision (b) of this section. The fee for such amendment shall be two hundred fifty dollars.

Registrations issued shall be valid for two years from the date of issuance. To facilitate renewals of registrations, the commissioner may upon the initial application for a registration, issue some registrations which may remain valid for a period of time greater than two years, but not exceeding an additional eleven months. The registration fee will be prorated for the additional time exceeding two years.

§1004.7 Applications for renewal of registration as registered organization

(a) An application to renew any registration issued under this part shall be filed with the department not more than six months nor less than four months prior to the expiration thereof. If a renewal application is not filed at least four months prior to the expiration thereof, the department may determine that the registration shall have expired and become void on such expiration date.

(b) Applications shall be accompanied by a non-refundable application fee in the amount of $10,000. Applications shall also be accompanied by a registration fee in the amount of $200,000 made by certified check. Only applications completed in accordance with this part as determined by the department and for which the application and registration fees have been submitted shall be considered if submitted in a timely manner. The registration fee shall be returned to the applicant if the applicant is not granted a renewal registration under this section.

(c ) The application for renewal shall include such information prepared in the manner and detail as the commissioner may require, including but not limited to:

1. Any material change as determined by the department in the information, circumstances or factors listed in section 1004.5 of this part;

2. Every known complaint, charge or investigation, pending or concluded during the period of the registration, by any governmental or administrative agency with respect to:

   • (i) Each incident or alleged incidence involving the theft, loss, or possible diversion of medical marijuana manufactured, distributed, or dispensed by the registered organization; and
   • (ii) Compliance by the applicant with local or state laws, or regulations of the department, including but not limited to, with respect to any substance listed in section thirty-three hundred six of the public health law;

3. Information concerning the applicant’s ability to carry on the manufacturing and distributing activity for which it is registered, including but not limited to approved medical marijuana product shortages or wait lists occurring during the registration period; and

4. A summary of quality assurance testing for all medical marijuana products produced in the prior year including but not limited to the percentage of lots of each brand and form passing all required testing, the percentage of lots failing contaminant testing, the percentage of lots failing brand requirements, all recalls of product lots and all adverse events reported.

(d) The department shall consider applications for renewal in accordance with the criteria set forth in section thirty-three hundred sixty-five of the public health law.

(e) If the department determines that the applicant’s registration should not be renewed, the department shall serve upon the applicant or his or her attorney of record, in person or by registered or certified mail, an order directing the applicant to show cause why his or her application for renewal should not be denied. The order shall specify in detail the respects in which the applicant has not satisfied the department that the registration should be renewed.

1. Within ten (10) business days of receipt of such an order, the applicant may submit additional material to the department or demand a hearing, or both. If a hearing is demanded, the commissioner shall fix a date as soon as reasonably practicable.

2. If the applicant fails to submit additional material to the department within ten (10) business days as requested, and the applicant does not demand a hearing within such time period, the application for renewal of registration shall be denied.

§ 1004.8 Registrations non-transferable.

(a) Registrations issued under this part shall be effective only for the registered organization and shall specify:

1. The name and address of the registered organization;

2. Name of the contact person for the registered organization;

3. The activities the registered organization is permitted to perform under the registration for each approved location; and

4. The real property, buildings and facilities that may be used for the permitted activities of the registered organization.

(b) Registrations are not transferable or assignable, including, without limitation, to another registered organization.

§ 1004.9 Failure to operate.

(a) A registration shall be surrendered to the department upon written notice and demand if the registered organization fails to begin operations, to the satisfaction of the department, of a manufacturing and/or dispensing facility within six months of the date of issuance of the registration.

(b) A registered organization who is required to surrender its registration in accordance with this section shall not be entitled to any refund of fees paid to the department.

§1004.10 Registered organizations; general requirements. – See full section for greater detail

Lists requirements for registered organizations, including making its books and facilities available for monitoring by the department; submitting medical marijuana product samples to the department for quality assurance testing; implementing policies and procedures to investigate complaints and adverse events; as well as closure procedures.

See §1004.5, §1004.6, §1004.7, § 1004.8, § 1004.9, §1004.10 described above as New York State requires manufacturers to be registered organizations. §1004.11 Manufacturing requirements for approved medical marijuana products

(a) Definitions. Wherever used in this part, the following terms shall have the following meanings:

1. “Approved medical marijuana 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 marijuana extraction product that has a homogenous and uniform cannabinoid concentration and product quality, produced according to an approved and stable processing protocol. The specified brand shall have a total THC and total CBD concentration that is within 95 – 105% of that specified in milligrams per dose for that brand and shall have the same composition and concentration of inactive ingredients as that defined for the brand.

3. “Form” of medical marijuana shall be a type of a medical marijuana product approved by the commissioner and shall refer to the final preparation of an approved medical marijuana 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 marijuana 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 marijuana 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 marijuana 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 marijuana 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 marijuana as approved by the department according to the following requirements:

1. Each registered organization may initially produce up to five brands of medical marijuana 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. However, in no case shall marijuana in unprocessed whole flower form be made available to certified patients.

2. Each medical marijuana 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), Cannabigerol (CBG)
   • (viii) Cannabichromene (CBC)
   • (ix) Any other cannabinoid component at > 0.1%

3. The final medical marijuana product shall not contain less than ninety-five percent (95%) or more than one hundred-five percent (105%) of the concentration of total THC or total CBD indicated on the label for this brand. Each brand shall have a maximum of 10mg total THC per dose.

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 marijuana 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. Use only pesticides, fungicides, and herbicides that are approved by the New York State Department of Agriculture and Markets;

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; and

6. Have a separate secure area for temporary storage of any medical marijuana or medical marijuana product that needs to be destroyed.

(f) Production of any approved medical marijuana 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 marijuana and medical marijuana 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 marijuana products shall be limited to the following forms and routes of administration:

1. Liquid or oil preparations for metered oromucosal or sublingual administration or administration per tube;

2. Metered liquid or oil preparations for vaporization;

3. Capsules for oral administration; or

4. Any additional form and route of administration approved by the commissioner. Smoking is not an approved route of administration.

5. Approved medical marijuana products may not be incorporated into edible food products by the registered organization, unless approved by the commissioner.

(h) The registered organization shall package the final form of the approved medical marijuana 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.

• (i) The registered organization shall package the approved medical marijuana product such that it is child-resistant, tamper-proof/tamper-evident, light-resistant, and in a resealable package that minimizes oxygen exposure.
• (ii) The registered organization shall identify each lot of approved medical marijuana product with a lot unique identifier.
• (iii) Each approved medical marijuana product shall be affixed with a product label. Medical marijuana 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 marijuana product form and brand designation;

3. The single dose THC and CBD content for the product set forth in milligrams (mg);

4. The medical marijuana 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 product;

8. The proper storage conditions;

9. Language stating:

   • (i) “Medical marijuana 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 marijuana 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 marijuana product produced, the registered organization shall submit a predetermined number of final medical marijuana 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 marijuana 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 marijuana product lot as passing all contaminant testing and verify that the content is consistent with the brand prior to the medical marijuana 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 the registered organization’s approved operating plan.

2. Any lot not meeting the minimum standards or specifications for brand consistency shall be rejected and destroyed by the registered organization in accordance with the registered organization’s approved operating plan.

3. The registered organization shall keep and maintain records documenting submission of medical marijuana 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 marijuana product produced (each brand in each form) by testing at an approved laboratory in accordance with section 1004.14 of this title:

1. the stability and expiration date of the final distributed medical marijuana product shall be validated and shall be stable for a minimum of 60 days under the specified storage conditions (light, temperature and humidity) when opened;

2. shelf-life of unopened medical marijuana products (e.g., packages or vials) shall be validated by ongoing stability testing according to a schedule determined by the department and an expiration date for unopened products shall be determined through the stability testing;

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 marijuana additives shall be used in the production of any medical marijuana product.

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

See §1004.5, §1004.6, §1004.7, § 1004.8, § 1004.9, §1004.10, §1004.11 described above as New York State requires distributors to be registered organizations. Each registered organization may have up to four dispensaries, geographically dispersed.

See §1004.5, §1004.6, §1004.7, § 1004.8, § 1004.9, §1004.10, §1004.11 described above as New York State requires distributors to be registered organizations.

§1004.16 Medical marijuana marketing and advertising by registered organizations (a) All physical structures owned, leased or otherwise utilized by a registered organization, including any dispensing facility, shall:

1. Restrict external signage to a single sign, with only black and white colors;

2. Not illuminate, at any time, a sign advertising a marijuana product located on any physical structure;

3. Not advertise medical marijuana brand names or utilize graphics related to marijuana or paraphernalia on the exterior of the physical structures; and

4. Not display approved medical marijuana products and paraphernalia so as to be clearly visible from the exterior of a physical structure.

(b) All restrictions listed in subdivision (a) of this section shall apply to any item located on any real property on which a registered organization’s physical structures is located.

(c ) All restrictions listed in subdivision (a) of this section shall apply to all vehicles owned, leased or utilized by a registered organization.

(d) All advertisements, regardless of form, for approved medical marijuana products that make a statement relating to effectiveness, side effects, consequences, and contraindications shall present a true and accurate statement of such information.

(e) An advertisement does not satisfy the requirement that it presents a “true and accurate statement” of information relating to effectiveness, side effects, consequences, and contraindications if it fails to present a fair balance between information relating to effectiveness, side effects, consequences, and contraindications in that the information relating to effectiveness is presented in greater scope, depth, or detail than is the information relating to side effects, consequences and contraindications, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis.

(f) An advertisement is false, lacking in fair balance, or otherwise misleading if it:

1. Contains a representation or suggestion that one marijuana brand or form is better, more effective, useful in a broader range of conditions or patients or safer than other drugs or treatments including other marijuana brands or forms, unless such a claim has been demonstrated by substantial scientific or clinical experience;

2. Contains favorable information or opinions about a marijuana product previously regarded as valid but which have been rendered invalid by contrary and more credible recent information;

3. Uses a quote or paraphrase out of context or without citing conflicting information from the same source, to convey a false or misleading idea;

4. Uses a study on persons without a debilitating medical condition without disclosing that the subjects were not suffering from a debilitating medical condition;

5. Uses data favorable to a marijuana product derived from patients treated with a different product or dosages different from those recommended in New York State;

6. Contains favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions; or

7. Fails to provide adequate emphasis for the fact that two or more facing pages are part of the same advertisement when only one page contains information relating to side effects, consequences and contraindications.

(g) False or misleading information in any part of the advertisement shall not be corrected by the inclusion of a true statement in another distinct part of the advertisement.

(h) An advertisement for any approved medical marijuana product shall not contain:

1. Any statement that is false or misleading;

2. Any statement that falsely disparages a competitor’s products;

3. Any statement, design, or representation, picture or illustration that is obscene or indecent;

4. Any statement, design, representation, picture or illustration that encourages or represents the use of marijuana for a condition other than a serious condition as defined in subdivision seven of section thirty-three hundred sixty of the public health law;

5. Any statement, design, representation, picture or illustration that encourages or represents the recreational use of marijuana;

6. Any statement, design, representation, picture or illustration related to the safety or efficacy of marijuana, unless supported by substantial evidence or substantial clinical data;

7. Any statement, design, representation, picture or illustration portraying anyone under the age of 18, objects suggestive of the presence of anyone under the age of 18, or containing the use of a figure, symbol or language that is customarily associated with anyone under the age of 18;

8. Any offer of a prize, award or inducement to a certified patient, designated caregiver or practitioner related to the purchase of marijuana or a certification for the use of marijuana; or

9. Any statement that indicates or implies that the product or entity in the advertisement has been approved or endorsed by the commissioner, department, New York State or any person or entity associated with New York State provided that this shall not preclude a factual statement that an entity is a registered organization.

• (i) Any advertisement for an approved medical marijuana product shall be submitted to the department at least 30 business days prior to the public dissemination of the advertisement.
• (ii) The submitter of the advertisement shall provide the following information to the department in addition to the advertisement itself:

1. A cover letter that:

   • (i) Provides the following subject line: Medical marijuana advertisement review package for a proposed advertisement
   • (ii) Provides a brief description of the format and expected distribution of the proposed advertisement; and
   • (iii) Provides the submitter’s name, title, address, telephone number, fax number, and email address;

2. An annotated summary of the proposed advertisement showing every claim being made in the advertisement and which references support for each claim;

3. Verification that a person identified in an advertisement as an actual patient or health care practitioner is an actual patient or health care practitioner and not a model or actor;

4. Verification that a spokesperson who is represented as an actual patient is indeed an actual patient;

5. Verification that an official translation of a foreign language advertisement is accurate;

6. Annotated references to support disease or epidemiology information, cross-referenced to the advertisement summary; and

7. A final copy of the advertisement, including a video where applicable, in a format acceptable to the department.

(k) Advertising packages that are missing any of the elements in subdivision (j) of this section, or that fail to follow the specific instructions for submissions, shall be considered incomplete. If the department receives an incomplete package, it shall so notify the submitter.

(l) No advertisement may be disseminated if the submitter of the advertisement has received information that has not been widely publicized in medical literature that the use of any approved medical marijuana product may cause fatalities or serious damage to a patient.

(m) A registered organization, its officers, managers and employees shall not cooperate, directly or indirectly, in any advertising if such advertising has the purpose or effect of steering or influencing patient or caregiver choice with regard to the selection of a practitioner, or approved medical marijuana product.

(n) The department may:

1. Require a specific disclosure be made in the advertisement in a clear and conspicuous manner if the department determines that the advertisement would be false or misleading without such a disclosure; or

2. Require that changes be made to the advertisement that are:

   • (i) Necessary to protect the public health, safety and welfare; or
   • (iii) Consistent with dispensing information for the product under review.

§1004.11 Manufacturing requirements for approved medical marijuana products Marijuana extraction product that has a homogenous and uniform cannabinoid concentration and product quality, produced according to an approved and stable processing protocol. The specified brand shall have a total THC and total CBD concentration that is within 95 – 105% of that specified in milligrams per dose for that brand and shall have the same composition and concentration of inactive ingredients as that defined for the brand.

The final medical marijuana product shall not contain less than ninety-five percent (95%) or more than one hundred-five percent (105%) of the concentration of total THC or total CBD indicated on the label for this brand. Each brand shall have a maximum of 10mg total THC per dose.

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).

The registered organization shall offer and make available at least one brand that has approximately equal amounts of THC and CBD.

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.

§1004.14 Laboratory testing requirements for medical marijuana.

(a) Medical marijuana products produced by a registered organization shall be examined in a laboratory located in New York State that is licensed by the federal Drug Enforcement Administration (DEA) and approved for the analysis of medical marijuana by the department in accordance with article 5 of the public health law and subpart 55-2 of this title.

(b) No board member, officer, manager, owner, partner, principal stakeholder or member of a registered organization shall have an interest or voting rights in the laboratory performing medical marijuana testing.

(c ) The registered organization shall submit to the laboratory, and testing shall only be performed on, the final medical marijuana product equivalent to the sealed medical marijuana product dispensed to the patient (e.g., in a sealed vial or intact capsule).

(d) Testing of the final medical marijuana product is mandatory. However, at the option of the registered organization, testing may be performed on components used for the production of the final medical marijuana product including but not limited to water or growing materials. Testing may also be performed on the final marijuana extract prior to packaging e.g. for cannabinoid profile verification or contaminant testing.

(e) Sampling and testing of each lot of final medical marijuana product shall be conducted with a statistically significant number of samples and with acceptable methodologies such that there is assurance that all lots of each medical marijuana product are adequately assessed for contaminants and the cannabinoid profile is consistent throughout.

(f) Testing of the cannabinoid profile shall include, at a minimum, those analytes specified in section 1004.11(c)(2) of this part.

(g) Testing for contaminants in the final medical marijuana product shall include but shall not be limited to those analytes listed below. The department shall make available a list of required analytes and their acceptable limits as determined by the commissioner.

Analyte:

• E. coli
• Klebsiella
• Pseudomonas (for products to be vaporized)
• Salmonella
• Streptococcus
• Bile tolerant gram negative bacteria
• Aspergillus

Mucor species:

• Penicillium species
• Thermophilic Actinomycetes species
• Aflatoxin
• Ochratoxin
• Antimony
• Arsenic
• Cadmium
• Chromium
• Copper
• Lead
• Nickel
• Zinc
• Mercury
• Any pesticide/herbicide/fungicide used during production of the medical marijuana product.
• Any growth regulator used during production of the medical marijuana product.
• Any other analyte as required by the commissioner.

(h) The laboratory shall track and destroy any quantity of medical marijuana product that is not consumed in samples used for testing.

Only as listed above – must become a registered organization.

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No. However, New York lawmakers decriminalized the possession of small amounts of marijuana when the Senate passed bill 39-23 on June 20, 2019 and the Assembly approved June 21, 2019 39-23 allows individuals to avoid criminal penalties for holding less than two ounces (57 grams). The law calls for a $50 fine for holding less than an ounce, and $200 for one to two ounces. It also provides procedures to expunge records of convictions.

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Pilot Program started in New York in 2015 – “Industrial Hemp Research Pilot Program. ” Section 7606 of the 2014 federal Farm Bill provides that state departments of agriculture and institutions of higher education may undertake hemp research pilot programs to study the growth, cultivation, or marketing of industrial hemp, notwithstanding the fact that hemp is classified by the federal Drug Enforcement Agency as a Class 1 Controlled Substance. Moreover, the federal Omnibus Budget bill of 2016 prohibits the DEA from spending appropriated funds on enforcement actions against institutions of higher education or state departments of agriculture involved in growing industrial hemp and also prohibits the spending of funds on enforcement against the transportation, processing, sale, or use of industrial hemp grown in accordance with an industrial hemp research program as allowed by the 2014 Farm Bill.

(AML) Article 29 §506 – The commissioner may authorize no more than ten sites for the growing or cultivating of industrial hemp as part of agricultural pilot programs conducted by the New York State Department of Agriculture and Markets (the Department) and/or an institution of higher education to study the growth and cultivation, sale, distribution, transportation and processing of such hemp and products derived from such hemp provided that the sites and programs used for growing or cultivating industrial hemp are certified by, and registered with, the Department. Regulatory Requirements: 1 NYCRR Part 159.

In 2017, the State eliminated the cap on the number of sites authorized to grow and research the plant and expanded the program to include farmers and businesses.

Governor Cuomo also introduced and signed new legislation to establish industrial hemp as an agricultural commodity under the State’s Agricultural and Markets Law.

The Governor also announced up to $10 million in grant funding will be available through two initiatives to advance industrial hemp research and economic development opportunities for industrial hemp businesses. The State will make up to $5 million in research grants available to support the research and production of industrial hemp in New York—including nearly $1 million in partnerships with Cornell University and SUNY Morrisville to support industrial hemp research during the 2017 growing season. The State will also make up to $5 million in capital grants available to provide funding to eligible businesses for capital costs related to the processing of industrial hemp, including new construction and the purchase of equipment.

Research of industrial hemp may only be undertaken in this State as part of an agriculture research pilot program, either conducted by the Department or institution of higher education with authorization from the Commissioner. The Program has three authorization types: (1) growing industrial hemp; (2) processing for non-CBD purposes (food, fiber, industrial material and/or other non-cannabinoid uses); and (3) processing for CBD purposes.3 For each of these authorizations, the Department requires, among other things, the description of the proposed research, the identification of the location(s) of the growing or processing operations, and the identification and disclosure of information concerning the individuals involved in the research project. If the project is approved, the Research Partner must sign a Research Partner Agreement which sets forth the approved scope of work and the terms and conditions of the authorization to engage in the specified research.

Institutions of Higher Education: Institutions of higher education may seek authorization to conduct industrial hemp research pilot program as set forth in the Department’s regulations or may apply to the Department to become an industrial hemp research partner (Research Partner”) in the Department’s Industrial Hemp Research Pilot Program (the “Program”). Educational institutions that seek to become a Research Partner must submit an application and a New York State Hemp Research Partner Agreement provided by the Department (the “Research Partner Agreement”), signed by an authorized representative of the university acting in their official capacity. Additionally, university applicants must adhere to all established university protocols during the course of the hemp research project. Institutions of higher education may register with the DEA and procure their own DEA import permit.

Individuals or Business Entities: Those wishing to participate in the Industrial Hemp Research Pilot Program under the auspices of the Department (the “Program”) must apply within the established application period and sign a New York State Hemp Research Partner Agreement.

Sourcing Material

Seed and propagative material can be obtained in two ways:

• Obtaining seed and propagative material from international source: A federal DEA permit to import seed is required. Please note, this is a lengthy process and permits are issued at the discretion of the DEA. Obtaining seed and propagative material from domestic sources: There is uncertainty concerning the legality of transporting domestic industrial hemp seed and propagative materials across state borders from states with Industrial Hemp Research Programs. Therefore, Research Partners who procure domestic industrial hemp seed or other propagative materials do so at their own risk and the Department is not liable for Research Partner’s interstate movement of hemp seed or other hemp plant materials.

Be aware of plant variety protection (PVP) laws and regulations and be certain that the seed procured is in compliance with PVP and all other applicable New York State seed laws and regulations.

Other Considerations

Losses sustained due to compliance actions, weather or any other condition during the course of the research are the responsibility of the participant. Applicants who are unable to bear the potential loss of assets and production costs of participating in the Industrial Hemp Research Pilot Program should not apply to become Research Partners. Research Partners that import domestic or foreign seed may transfer seed only to other Department authorized hemp research pilots within New York State.

There are no pesticides registered nationally or at the state level for industrial hemp. Research Partners are warned that any pesticide applications made to industrial hemp crops are unregistered uses and may be subject to enforcement action from New York State Department of Environmental Conservation.

Annual Reports

All Research Partners are required to file an annual report summarizing the results of their research pilot project and sharing any data collected in the course of that research. Annual reports are due on the anniversary of the project start date. Failure to file annual reports in a timely manner is grounds for revocation of permit. The Department will make research results and annual reports available to the public.

Applications

Those seeking to participate in the Program must submit an application. If the application is approved, the applicant must execute a Research Partner Agreement, which, among other things, describes the authorized scope of work, establishes the standards for the work, and sets forth the respective duties and obligations of the parties.

An application to grow or process industrial hemp shall be made upon a form prescribed by the Commissioner and shall include an application fee of $500. No waivers of the application fee will be granted.

The application is for a three-year authorization to participate in the Program. It is anticipated that with the implementation of the USDA’s hemp licensing program authorized by the 2018 Farm Bill, the Department will terminate the Research Partner Agreements and transition the Research Partners to the licensing/approval structure authorized by the USDA.

Each application and renewal application shall provide the information deemed necessary by the commissioner, including but not limited to:

• A description and map of each location where industrial hemp will be cultivated or possessed, by physical address and by GPS co-ordinates, visually depicting The Department no longer issues authorizations for farmers as “affiliated growers” of a Research Partner. Every farmer growing hemp must have its own grower Research Partner Agreement. the buildings, structures, and improvements on the premises and identifying their use, and describing the relevant activities conducted at the location.
• A detailed research plan and summary of the issues and matters that the applicant intends to study in conjunction with growing, cultivating, or processing industrial hemp.
• A marketing plan.
• A seed/propagule acquisition plan.
• Statement of relevant experience of the individual responsible for the research project.
• $500 application fee.

Disqualifying Factors

An authorization to conduct research in this Department pilot program is not a right. The decision to grant such an authorization is in the sole discretion of the Department based upon, among other things, its needs or interests, the evaluation of the proposed project, and the qualifications and experience of the applicant.

Disqualifying factors may include but are not limited to:

• An incorrect or incomplete application
• Poor research design
• Lack of experience or qualification to undertake the proposed project
• Recent drug-related felony or misdemeanor convictions of researchers
• Proposing to use a growing or processing location already registered by an existing Research Partner
• Inability of the Department to adequately supervise or regulate the proposed project
• The proposed undertaking of medical research
• The proposed use of processed CBD as a food additive or the processing of food in such a way to concentrate CBD content.

Overview of the Application Review Process

Once an applicant submits a completed application to the Department with a $500 application fee, the next steps are as follows:

1. The Department reviews the application and notifies the applicant of the decision.

2. The Department will send approved applicants a Research Partner Agreement to be signed and notarized by the applicant.

3. The applicant will return the signed and notarized Research Partner Agreement to the Department.

4. Upon receipt, the Department will issue and mail to the Research Partner (formerly the applicant) an official Industrial Hemp Research Partner Authorization and the fully executed Research Partner Agreement.

An applicant is not authorized to grow or process industrial hemp until it has received the official Industrial Hemp Research Partner Authorization document from the Department.

Amendments to Applications

Research Partners can submit requests to amend their original application by submitting a Grower Amendment Form. Amendments may include, among other things, adding additional acreage, change of location of grow sites, and changes to the scope of work contained in the research plan set forth in the initial application. All requests to amend are subject to review and approval by the Department. Amendments to an existing Research Partner’s scope of work are not subject to the $500 application fee.

Compliance with prior years’ program reporting requirements, if applicable, is a condition to the granting of an amendment.

Renewal of Applications

It is the responsibility of the Research Partner to submit an application renewal in a timely fashion to ensure that its current authorization to participate in the Program does not lapse. An application renewal should be submitted at least 60 days prior to the expiration date printed on the authorization document. Research Partners interested in renewing must submit the appropriate application document and should check the box labeled Renewal.

Acquisition of Seeds and Plants

• Purchasing Seed: Seed procurement is the responsibility of the Research Partner. Research Partners who plan to obtain seed through an international import should check with the seed supplier to determine what documentation is required for such a transaction.
• Selling Seed: Viable industrial hemp seed shall not be sold to any individual or entity not authorized as a Research Partner.
• Purchasing Hemp Plants: Industrial hemp plants may be procured only by Research Partners and they may be purchased only from an authorized New York State Research Partner or from a license holder from another state that has a pilot program. All interstate shipments of hemp plants must be from a plant grower licensed in the state of origin or be accompanied by a phytosanitary certificate.
• Compliance with seed laws: Be aware of plant variety protection (PVP) laws and regulations and be certain that the seed procured is in compliance with PVP and all other applicable New York State seed laws and regulations.

Inspections

The Research Partner shall inspect the registered locations as often as necessary to ensure compliance with the requirements of the Program.

The registered locations of a Research Partner are subject to inspection by the Commissioner and by his or her authorized agents, employees, or officers, pursuant to Agriculture and Markets Law section 20, as often and to the extent necessary to ensure compliance with the respective Research Partner Agreement and State and Federal laws relating to the possession, sale, or cultivation of industrial hemp. The Commissioner may authorize agents, employees, or officers of the New York State Department of Health and law enforcement to accompany him or her during an inspection of the registered locations of a Research Partner.

See above – the only lawful pathway to grow and manufacture industrial hemp in New York State is through participation in New York’s Industrial Hemp Agricultural Research Pilot Program (the Program), authorized under the provisions of the 2014 Farm Bill and administered by the Department of Agriculture and Markets (the Department). Anyone planning to grow industrial hemp or process industrial hemp for any purpose in New York State must obtain an authorization as a Research Partner before they can undertake their project

See above re: Industrial Hemp Agricultural Research Pilot Program

See above re: Industrial Hemp Agricultural Research Pilot Program

See above re: Industrial Hemp Agricultural Research Pilot Program

Sampling 1. A Harvest Report Form (available at https://agriculture.ny.gov/system/files/documents/2020/04/industrialhempgrowerreportingrequirementsandforms.pdf) must be submitted to the Department at least 20 days prior to the expected harvest date.

2. Once the Department has received the form, a Horticultural Inspector will contact the grower to set up a date, time, and location for inspection.

3. The Horticulture Inspector will arrive on site to take a pre-harvest sample, ideally within 14 days of harvest.

4. The Horticulture Inspector will verify that the locations and descriptions of the industrial hemp fields are consistent with what was reported on the original application and on any addendum to the original application. The Horticulture Inspector will collect samples in labeled paper bags and will send the composite sample to the Department for testing.

Testing for THC Levels

1. A Research Partner shall prepare, maintain, and make available to the Commissioner, upon request, a record that sets forth an accurate inventory of industrial hemp plants and seeds and shall reasonably ensure that the industrial hemp seed and/or plants that are possessed or grown or cultivated meet the definition of industrial hemp.

2. In addition to regulatory testing conducted by the Department, Research Partners are encouraged to submit industrial hemp samples to a third-party laboratory for THC testing of their crop to ensure compliance. The Department does not maintain a list of approved testing labs.

3. The Research Partner shall immediately make available to the Department such records relating to sampled specimens with a concentration above 0.3 percent of delta-9 tetrahydrocannabinol on a dry basis, in a form and at a location satisfactory to the Commissioner.

Destruction of Noncompliant Material - A Research Partner shall promptly dispose of all industrial hemp in its possession reasonably believed, based upon the results of regulatory or other sampling, to have a concentration of more than 0.3 percent of delta-9 tetrahydrocannabinol on a dry weight basis.

N/A – See above re: Industrial Hemp Agricultural Research Pilot Program

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See #5 above regarding “Industrial Hemp Research Pilot Program.” CBD included in this – same requirements

See #5 above regarding “Industrial Hemp Research Pilot Program.” CBD included in this – same requirements

See #5 above regarding “Industrial Hemp Research Pilot Program.” CBD included in this – same requirements

See #5 above regarding “Industrial Hemp Research Pilot Program.” CBD included in this – same requirements

See #5 above regarding “Industrial Hemp Research Pilot Program.” CBD included in this – same requirements

See #5 above regarding “Industrial Hemp Research Pilot Program.” CBD included in this – same requirements

Required Testing of CBD Products Research Partners making any CBD product intended for human or animal consumption or absorption into the body must ensure their CBD products meet the standards set by the New York State Medical Marijuana program (10 NYCRR Part 1004.14) with respect to cannabinoid profile, solvents, pesticides, heavy metals, bacteria and molds.

Research Partners must use an independent laboratory accredited by either the ISO/IEC 17025:2005,2017 standard or the NYS Department of Health Wadsworth Laboratory Environmental Laboratory Approval Program (ELAP).

Process Audits of CBD Processing Facilities

In accordance with the Department’s CBD Processor Research Partner Agreement, any facility manufacturing CBD products intended for human or animal consumption or absorption into the body shall be audited prior to sale or distribution of product to verify compliance with the relevant federal standard (as bulleted below). Such audits must be conducted by a qualified, independent third party. The results of such a third-party audit shall be submitted to the Department prior to sale or distribution of the product. The third-party audit must provide evidence that the CBD processor is complying with the following requirements:

• A CBD product developed and/or produced under a Research Partner Agreement, to the extent it is or will be a component of a dietary supplement,5 shall satisfy the requirements of the Research Partner Agreement if manufactured, tested and labeled in accordance with this agreement and FDA law and regulations concerning dietary supplements, including, without limitation, 21 CFR 111.403(L) and 21 CFR 101.
• In line with Department testing procedures, the sum of both delta-9 tetrahydrocannabinol and THCA is used to define the percent of delta-9 tetrahydrocannabinol on a dry-weight basis. In prior years, the Department based its compliance determinations on THC content only. However, the Department has adopted the 2018 Farm Bill requirement to test the sum of THC and THCA.
• A Dietary Supplement is any product a product intended to supplement the diet, containing a vitamin, mineral, herb, botanical, amino acid, and/or dietary substance used to supplement a person’s diet by increasing the total dietary intake and as further specified in § 201(ff) of the Food Drug and Cosmetic Act
• A CBD or other cannabinoid product developed and/or produced under a Research Partner Agreement, to the extent it introduces cannabinoids into or onto the human body or the body of an animal through topical application or other method for purposes other than as a dietary supplement, the Research Partner shall satisfy the requirements of the Research Partner Agreement if the product is manufactured and labeled in accordance with 21 CFR 111 and 21 CFR 201 and complies with the provisions set forth in the Research Partner Agreement.

To be considered qualified by the Department, a third-party auditor must be accredited by the American National Standards Institute, the ANSI National American Board, or the International Standards Organization (ISO) in the field of dietary supplement manufacturing.

Applicants should be aware that the U.S. Food and Drug Administration has taken the position that CBD products are not dietary supplements. Applicants should understand the different regulatory approaches of the FDA and the State, and they should seek competent professional guidance with respect to the risk of engaging in the processing of CBD and the manufacture of CBD products under all applicable law. All Research Partners must make their own independent determination with respect to the legal obligations and requirements under federal and state law with respect to any product it produces.

See #5 above regarding “Industrial Hemp Research Pilot Program.” CBD included in this – same requirements

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Medical Marijuana – New York State Department of Health Hemp & CBD - State departments of agriculture and institutions of higher education

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New York lawmakers decriminalized the possession of small amounts of marijuana when the Senate passed bill 39-23 on June 20, 2019 and the Assembly approved June 21, 2019. 39-23 allows individuals to avoid criminal penalties for holding less than two ounces (57 grams). The law calls for a $50 fine for holding less than an ounce, and $200 for one to two ounces. It also provides procedures to expunge records of convictions.

The push for legalizing recreational use of marijuana recently failed in the 2019 legislative session.

The expansion of the Research Pilot Program for hemp and cannabis beyond the original ten limited locations to all farmers that apply through the Department of Agriculture and the Decriminalization of the possession of small amounts of marijuana were the top recent developments in New York.

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