N.Y. Comp. Codes R. & Regs. tit. 10 § 1004.5

Current through Register Vol. 46, No. 45, November 2, 2024

Section 1004.5 - Application for initial registration as a registered organization

(a) No person or entity shall produce, grow or sell medical marihuana 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 marihuana 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 marihuana 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 marihuana 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 marihuana through packaging, sealing and labeling of each lot of medical marihuana 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 marihuana 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 marihuana product returns, complaints and adverse events, and to provide for rapid voluntary or involuntary recalls of any lot of medical marihuana product. Such policies and procedures shall include a plan for any retesting of returned approved medical marihuana products, storage and disposal of marihuana and any manufactured medical marihuana products not passing requirements, and a requirement that adverse events and total recalls are reported to the department within 24 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, recordkeeping, record retention and surveillance systems, relating to all medical marihuana at every stage including cultivating, possessing of marihuana, and manufacturing, delivery, transporting, distributing, sale and dispensing by the proposed registered organization.

(viii) 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 10 years of a 10 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 marihuana, including medical marihuana 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 1 of section 3365 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 $2,000,000; 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 marihuana, 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 marihuana 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 10 percent interest or greater in any firm, association, foundation, trust, partnership, corporation, or other entity or if such entity maintains a 10 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 $500 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 certified financial statement of the applicant, audited by an independent certified public accountant and prepared in accordance with generally accepted accounting principles (GAAP) applied on a consistent basis, 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 marihuana, the manufacturing and/or dispensing of approved medical marihuana products and/or staff with oversight responsibilities for such activities, which shall include:

(i) a senior staff member with a minimum of one 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 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 marihuana who has been convicted of any felony of sale or possession of drugs, narcotics, or controlled substances in accordance with the requirements of section 3364 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.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 1004.5

Adopted, New York State Register April 15, 2015/Volume XXXVII, Issue 15, eff. 4/15/2015

Amended New York State Register December 27, 2017 /Volume XXXIX, Issue 52, eff. 12/27/2017