PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Amendment of Subpart 55-2; and addition of Subpart 80-1 to Title 10 NYCRR.
Statutory authority:
Public Health Law, section 3369-a
Subject:
Medical Use of Marihuana.
Purpose:
To comprehensively regulate the manufacture, sale and use of medical marihuana.
Substance of proposed rule (Full text is posted at the following State website:www.health.ny.gov):
As required by section 3369-a of the Public Health Law (“PHL”), Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York is amended, to be effective upon publication of a Notice of Adoption in the New York State Register. A new subpart 80-1 is added to read as follows:
§ 80-1.1 Practitioner registration. Establishes a process for practitioners who have completed an educational course approved by the Commissioner on the use of medical marihuana under Title V-A of the Public Health Law to register with the department to issue patient certification.
§ 80-1.2 Practitioner issuance of certification. Establishes a process for registered practitioners to issue a certification to patients with certain severe debilitating or life-threatening conditions, with certain clinically associated conditions or complications, that are likely to receive therapeutic or palliative benefit from the treatment of medical marihuana to be able to receive approved medical marihuana products from a registered organization.
§ 80-1.3 Application for registration as a certified patient. Provides the criteria by which a person may obtain a registration as a certified patient and receive a registry identification card.
§ 80-1.4 Designated caregiver registration. Caregivers designated to handle approved medical marihuana products on behalf of certified patients are required to register with the department according to the procedures detailed in this section and to obtain a registry identification card.
§ 80-1.5 Application for initial registration as a registered organization. Establishes the application process for registered organizations interested in manufacturing and dispensing approved medical marihuana products. Provides that no person or entity shall manufacture or dispense medical marihuana without such registration.
§ 80-1.6 Consideration of registered organization applications. Requires potential registered organizations to submit an application fee of $10,000, accompanied by a check for an additional $200,000, the latter of which will be refunded to applicants not selected as registered organizations. Provides that the department shall initially register up to five applicants as registered organizations according to enumerated factors. Requires that the applicant allow for reasonable access to its facilities for inspection by the department. Provides that registrations shall be valid for two years, except that initial registrations may be extended up to eleven months by the commissioner.
§ 80-1.7 Application for renewal of registered organization registrations. Establishes the process by which registered organizations renew their registration. Requires an application fee of $10,000, accompanied by a check for an additional $200,000, the latter of which will be refunded to applicants not granted renewal registration. Provides an opportunity to submit additional information or to demand a hearing for applicants not granted renewal registration.
§ 80-1.8 Registrations non-transferable. Prohibits the transfer or assignment of registrations issued under this subpart.
§ 80-1.9 Failure to operate. Provides that a registration shall be surrendered to the department if a registered organization fails to begin operations to the satisfaction of the department within six months of the issuance of a registration.
§ 80-1.10 Registered organizations; general requirements. Lists requirements for registered organizations, including making its books and facilities available for monitoring by the department; submitting medical marihuana product samples to the department for quality assurance testing; implementing policies and procedures to investigate complaints and adverse events; as well as closure procedures.
§ 80-1.11 Manufacturing requirements for approved medical marihuana product(s). Contains requirements for the manufacturing of medical marihuana products. Provides the brands, forms and routes of administration of medical marihuana products authorized for manufacturing, as well as product labeling requirements. Provides that no synthetic marihuana additives shall be used in the production of any medical marihuana product.
§ 80-1.12 Requirements for dispensing facilities. Details the requirements for the operation of dispensing facilities as well as the required patient specific label required to be affixed to each medical marihuana product dispensed. Provides that no medical marihuana product shall be consumed or vaporized on the premises of such facilities.
§ 80-1.13 Security requirements for manufacturing and dispensing facilities. Details the minimum security requirements for manufacturing and dispensing facilities and for the transportation of medical marihuana products.
§ 80-1.14 Laboratory testing requirements for medical marihuana. Details the minimum laboratory testing requirements for medical marihuana products. Testing shall be performed by a DOH approved laboratory located within NYS.
§ 80-1.15 Pricing. Requires registered organizations submit proposed prices for medical marihuana products to the department for approval. The department may approve the proposed price, refuse approval of a proposed price, or modify or reduce the proposed price.
§ 80-1.16 Medical marihuana marketing and advertising by registered organizations. Restricts the marketing and advertising of medical marihuana.
§ 80-1.17 Reporting dispensed medical marihuana products. Details reporting requirements for dispensed medical marihuana products.
§ 80-1.18 Prohibition of the use of medical marihuana in certain places. Restricts the vaporization of medical marihuana in certain places.
§ 80-1.19 Reporting requirements for practitioners, patients and designated caregivers. Details reporting requirements for practitioners related to changes in circumstances affecting the patient’s certification. Defines reporting requirements for patients and designated caregivers for scenarios where certain information contained on the patient certification changes or if the certified patient or designated caregiver loses his or her registry identification card.
§ 80-1.20 Proper disposal of medical marihuana products by patients or designated caregivers. Details the required disposal procedures for medical marihuana products.
§ 80-1.21 General prohibitions. Contains general prohibitions.
§ 80-1.22 Practitioner prohibitions. Lists prohibitions on practitioners.
§ 80-1.23 Designated caregiver prohibitions. Lists prohibitions on designated caregivers.
* * *
Subpart 55-2 is amended as follows:
§ 55-2.2 Certificates of approval. Paragraph 5 is renumbered paragraph 6 and a new paragraph 5 is added to provide for certification of laboratories to test medical marihuana.
§ 55-2.15 Requirements for laboratories performing testing for medical marihuana. Adds requirements for laboratories.
Text of proposed rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Summary of Regulatory Impact Statement
Statutory Authority:
Chapter 90 of the Laws of 2014 amended Article 33 of the Public Health Law to add a new Title V-A. Title V-A of the Public Health Law sets forth the requirements for manufacturing, dispensing and making available to certified patients, medical marihuana. The Commissioner is authorized pursuant to Section 3369-a of the Public Health Law to promulgate rules and regulations necessary to effectuate the provisions of Title V-A of Article 33 of the Public Health Law.
Legislative Objectives:
In enacting Title V-A, the legislative objective was to establish a comprehensive program for the manufacture, sale and use of medical marihuana by striking a balance between potentially relieving the pain and suffering of those individuals suffering from a serious medical condition as defined in Section 3360(7) of the Public Health Law and protecting the public against risks to its health and safety.
Needs and Benefits:
The proposed regulations implement the medical marihuana program established in Title V-A of Article 33 of the Public Health Law. They promote the safe and effective use of approved medical marihuana products while safeguarding against diversion and other public safety concerns.
Compliance Costs:
Costs for the Implementation of, and Continuing Compliance with the Regulation to the Regulated Entity:
There will be costs associated with the application for registration as a registered organization. In order to apply for registration, an applicant must submit a $10,000 non-refundable application fee along with an additional $200,000 refundable registration fee. The $10,000 non-refundable application fee will cover the cost to the department in reviewing the application. The additional $200,000 registration fee will be refunded to those applicants not selected as registered organizations. For those applicants selected as registered organizations, the $200,000 registration fee will cover all of the registered organization’s manufacturing and dispensing facilities for a period of two-years.
Applicants selected as registered organizations will have ongoing costs related to reporting and response to issues regarding oversight. In addition, registered organizations will have costs associated with requirements for testing of medical marihuana products by approved independent laboratories. These costs are necessary to ensure that the approved medical marihuana product made available to certified patients is safe and reliable.
The proposed regulations set forth manufacturing and dispensing requirements for the registered organizations. There will be costs associated with the manufacture, laboratory testing, packaging, labeling and distribution of the product to dispensing facilities. Costs will also be associated with the reporting requirements of the registered organization, security of the facilities, and labor.
Certified Patients and designated caregivers will incur costs in the form of a fifty dollar fee for a registry identification card, which may be reduced or waived in the case of financial hardship, and the cost of purchasing the dispensed approved medical marihuana product.
Costs to State and Local Government:
The proposed rules do not require the state or local government to perform any additional tasks.
Costs to the Department of Health:
The review of practitioner registration, patient certification, registration identification card and registered organization applications will require the commitment of department staff resources. The Department of Health also anticipates an increased administrative cost to support the ongoing monitoring and compliance of the medical marihuana program, and for laboratory services provided by the Wadsworth Center for quality assurance testing of medical marihuana products and for any ongoing testing required to investigate serious adverse events.
Local Government Mandates:
The proposed rule does not impose any new programs, services, duties or responsibilities on local government.
Paperwork:
The paperwork associated with processing applications for entities who wish to become registered organizations in New York State will include, but are not limited to, detailed architectural plans, standard operating procedures, and security procedures. The process to certify patients and provide registry identification cards will require minimal paperwork as the process will be automated to the fullest extent possible.
Duplication:
The proposed regulations do not duplicate any existing State or federal requirements.
Alternatives:
There are no alternatives to the adoption of regulations to be considered during the regulatory process since regulations are required by Title V-A of Article 33 of the Public Health Law.
Federal Standards:
Federal requirements do not include provisions for a medical marihuana program.
Compliance Schedule:
The proposed regulations will take effect upon publication of a Notice of Adoption in the New York State Register.
Regulatory Flexibility Analysis
Effect of Rule:
This proposed rule will allow registered organizations to manufacture, distribute and sell approved medical marihuana products in New York State. Each registered organization may have up to four dispensaries, geographically dispersed. There are no costs to existing small business establishments or government entities in New York State.
Compliance Requirements:
There are no new compliance requirements imposed to existing small business establishments as a result of these amendments.
Professional Services:
No new professional services will be required of small business entities and local governments.
Compliance Costs:
Since there are no small business entities which currently provide for the manufacture, distribution and dispensing of medical marihuana, the proposed regulations do not impose an economic impact on any existing small business entity. Entities who wish to become licensed as a registered organization will incur costs associated with the building and operation of facilities to manufacture, distribute and dispense the approved medical marihuana product. Laboratory testing of the final product, which will also incur a cost to the registered organization, will be required. The manufacture of the plant into approved dosage forms and product testing are required to minimize the risk of adverse events to patients from mislabeled products or products containing contaminants.
Economic and Technological Feasibility:
This proposal is economically and technologically feasible. Statute requires the registered organization to pay a 7% excise tax to the Commissioner of Tax and Finance. This tax will provide for a return of 22.5% to the counties in New York State where medical marihuana is manufactured, 22.5% to the counties in New York State in which the medical marihuana is dispensed, 5% to the Division of Criminal Justice Services and 5% to the Office of Alcoholism and Substance Abuse Services.
Minimizing Adverse Impact:
These regulations will allow for the manufacture, distribution and sale of medical marihuana to patients suffering from a severe debilitating or life-threatening condition. To minimize the potential for patient adverse effects associated with the use of medical marihuana, the regulations provide for a limited number of approved brands (cannabinoid profiles) and dosage forms that registered organizations may manufacture. In addition, the regulations require laboratory testing of the final manufactured product by a laboratory certified by New York State and located in New York State. These requirements do not create an adverse impact to small business and local governments.
Small Business and Local Government Participation:
The Department consulted with other state agencies, including the Department of Environmental Conservation, the Department of Agriculture and Markets, the Division of New York State Police, the Division of Criminal Justice Services, the Empire State Development Corporation, the Department of Taxation and Finance and the Office for Alcoholism and Substance Abuse Services. The Department also discussed the statute and received input from various advocacy organizations. These organizations and advocates spoke on behalf of patients and their families, physicians, addiction treatment specialists, and potential employees of registered organizations. The Department also solicited feedback from interested parties through a web form on the Medical Marihuana Program website. There will be a 45-day public comment period with the regulations that will allow for additional comments to be considered.
Rural Area Flexibility Analysis
Types and Estimated Numbers of Rural Areas:
Outside of major cities and metropolitan population centers, the majority of counties in New York State contain rural areas. Entities who wish to become a registered organization may have up to four dispensaries, geographically dispersed. The selection of the five registered organizations will take into account geographic distribution to ensure the needs of patients in rural areas are met. Due to the limited number of dispensing facilities that will operate in New York State, the ability for a patient to designate a caregiver was included in the regulations to increase accessibility to patients in rural areas.
Reporting, Recordkeeping and Other Compliance Requirements; and Professional Services:
There are no new reporting, recordkeeping or other compliance requirements imposed on rural areas as a result of these amendments. No new professional services will be required of rural areas. Compliance requirements will be limited to the entities who become licensed as a registered organization.
Costs:
There are no compliance costs to existing establishments in rural areas since no new compliance activities are imposed upon them. Compliance costs will be limited to the entities who become licensed as a registered organization.
Minimizing Adverse Impact:
The proposed rule will apply to practitioners who wish to complete the educational requirement in order to issue certifications to patients for medical marihuana. Practitioners in rural areas of the state may complete this course, which will be offered online to make the course easily accessible to all practitioners who wish to issue certifications to patients for approved medical marihuana products. Due to the limited number of dispensing facilities that will operate in New York State, designated caregivers are authorized to obtain approved medical marihuana products from dispensing facilities to increase accessibility to patients in rural areas.
Rural Area Participation:
The Department consulted with other state agencies, including Department of Environmental Conservation, Department of Agriculture and Markets, Division of New York State Police, Division of Criminal Justice Services, Empire State Development Corporation, Department of Taxation and Finance, and the Office of Alcoholism and Substance Abuse Services. The Department also solicited feedback from interested parties through a web form on the Medical Marihuana Program website. There will be a 45-day public comment period with the regulations that will allow for additional comments to be considered regarding rural areas.
Job Impact Statement
A Job Impact Statement is not included because the Department has concluded that the proposed regulatory amendments will not have a substantial adverse effect on jobs and employment opportunities. The proposed amendments will allow for the opposite effect on jobs as new jobs will be created to support the activities of registered organizations.
