PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Amendment of Part 1004 and Subpart 55-2 of Title 10 NYCRR.
Statutory authority:
Public Health Law, art. 33, title V-A, 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):
Pursuant to the authority vested in the Commissioner of Health by Section 3369-a of the Public Health Law (PHL), Part 1004 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York, and pursuant to Section 502 of the PHL, Subpart 55-2 of Title 10, are amended to read as follows, to be effective upon publication of a Notice of Adoption in the New York State Register.
§ 1004.2 Practitioner issuance of certification. Section 1004.2(a) is amended to clarify the department's expectation that practitioners adhere to new section 1004.2(e) which details the statutory requirement to consult the Prescription Monitoring Program Registry. Section 1004.2(a) is further amended to require registered practitioners to indicate on patient certifications whether a patient is temporarily residing in New York State for the purpose of receiving care and treatment from the practitioner.
§ 1004.3 Application for registration as a certified patient. Section 1004.3(b) is amended to clarify that New York State residents must show proof of residency. Section 1004.3(c) is amended to remove the requirement that applicants include a statement in their application if they are temporarily residing in New York State for purposes of receiving care and treatment in in the state, as this requirement will now be documented by the certifying practitioner.
§ 1004.4 Designated caregiver registration. Section 1004.4(b) is amended to indicate that acceptable proof of residence for a caregiver includes a New York State non-driver identification card.
§ 1004.5 Application for initial registration as a registered organization. Section 1004.5(b) is amended to clarify the requirement to submit a prepared financial statement upon initial application for designation as a registered organization.
§ 1004.6 Consideration of registered organization applications. Section 1004.6(e) is amended to clarify that a registered organization's registration may be amended instead of the application for registration.
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§ 1004.10 Registered organizations; general requirements. Section 1004.10(a) is amended to include a process in which the department will provide a statement of findings to a registered organization, and that the registered organization must respond and implement a plan of correction to address any deficiencies identified by the department. Section 1004.10(a) is also amended to allow manufacturing materials to be submitted to the department upon request and to reduce sample retention duration from two years to one year. Further, this section is amended to clarify that registered organizations must notify the department of adverse events and other incidents within 24 hours and must inventory and maintain records of medical marihuana products or by-products which are disposed. Section 1004.10(a) is also amended to account for records that may need to be maintained for a time period other than five (5) years and to require registered organizations to post the registration certificate in a conspicuous location on the premises of each manufacturing and dispensing facility site. Section 1004.10(b) is amended to clarify criminal history requirements for registered organization managers or employees and to include a requirement that registered organizations not steer or influence any individual to a practitioner for the purpose of becoming a certified patient.
§ 1004.11 Manufacturing requirements for approved medical marihuana product(s). Section 1004.11(a) is amended to update the allowable range of THC and CBD concentration per dose and brand for potency testing purposes. Section 1004.11(c) is modified to clarify reporting requirements for other cannabinoid components at >0.2 percent. Section 1004.11(c) is also amended to update the allowable range of THC and CBD concentration per dose and brand for potency testing purposes. Section 1004.11(e) is updated to clarify that the New York State Department of Environmental Conservation is the authority which registers acceptable pesticides. In addition, section 1004.11(e) is modified to add a requirement that registered organizations shall ensure continual environmental monitoring of harvested plant material awaiting additional processing. Section 1004.11(g) is modified to allow registered organizations to produce products in new forms including tablets, film strips, metered dose inhalation, and rectal administration. Section 1004.11(h) is amended to allow registered organizations to break the seal of an approved medical marihuana product for the purpose of internal quality control testing or disposal. Section 1004.11(l) is amended to require registered organizations to report to the department any lot not meeting the minimum standards or specifications for brand consistency, rather than destroying such lots. Section 1004.11(k) is amended to clarify labeling requirements related to stability studies. Section 1004.11(m) is amended to clarify stability testing requirements and to account for initial stability testing limitations. Section 1004.11(n) is amended to make clear that registered organizations may not use any cannabinoid preparation not produced by the registered organization in any of its medical marihuana products.
§ 1004.12 Requirements for dispensing facilities. Section 1004.12(a) is revised to clarify the requirement that dispensing facility pharmacists must complete a four hour course. Section 1004.12(d) is amended to clarify that no food or beverages may be sold on the premises of a dispensing facility without prior approval from the department. Section 1004.12(f) is amended to include a requirement that dispensing facility pharmacists or a designated individual shall consult the Prescription Monitoring Program (PMP) Registry prior to dispensing approved medical marihuana products. Section 1004.12(g) is amended to clarify dispensing facility access restrictions. Section 1004.12(h) is revised to clarify that labels shall include the expiration date of the product once opened on all products. Section 1004.12(m) is modified to include a requirement that dispensing facilities must document returns of approved medical marihuana products and ensure secure storage until disposal.
§ 1004.13 Security requirements for manufacturing and dispensing facilities. Section 1004.13(a) is revised to clarify that production and harvesting is included in the definition of manufacturing and a video surveillance requirement is also added to the disposal process. Section 1004.13(a) is amended to allow registered organizations to use a digital dialer or other acceptable industry standard equivalent. Section 1004.13(j) is amended to clarify that registered organizations must use approved safes, vaults or other storage methods approved by the department for medical marihuana products. Sections 1004.13(n)-(p) are modified to remove the requirement that registered organizations only transport approved medical marihuana products from a manufacturing facility to dispensing facilities. Section 1004.13(u) is added to restrict visitor access to manufacturing facilities.
§ 1004.14 Laboratory testing requirements for medical marihuana. Section 1004.14(b) is amended to add the requirement that no immediate family members of a board member, officer, manager, owner, partner, principal stakeholder or member of a registered organization shall have an interest or voting rights in the lab performing testing on medical marihuana. Section 1004.14(c) is amended to clarify final product testing sample requirements. Section 1004.14(d) is modified to clarify that registered organizations may test final products that have been packaged. Section 1004.14(e) is amended to add the requirement that sampling methodologies must be approved by the department. Section 1004.14(g) is amended to clarify the list of contaminants for which testing must occur and to clarify that pesticides include herbicides and fungicides. Section 1004.14(h) is amended to include a disposal requirement for laboratories. Section 1004.14(i) is added to include stability testing guidance for open and unopened products. Section 1004.14(j) is added to include a requirement for laboratories to return medical marihuana products deemed unsuitable for testing to the registered organization.
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§ 1004.16 Medical Marihuana marketing and advertising by registered organizations. Section 1004.16(a) is modified to remove the requirement that only signs with black and white colors may be allowed on the external structures owned by registered organizations. Sections 1004.16(a), (d), (h) and (i) are further modified to clarify the difference between a brand and an approved medical marihuana product. Section 1004.16(m) is amended to clarify that registered organizations may educate practitioners about medical marihuana brands or devices offered by the registered organization.
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§ 1004.20 Proper disposal of medical marihuana products by patients or designated caregivers. Section 1004.20 is amended to allow patients and caregivers to return approved medical marihuana product(s) to the dispensing facility from which they were purchased or any dispensing facility associated with the registered organization. Section 1004.20(b) is also amended to clarify that the New York State Department of Environmental Conservation provides guidance on proper drug disposal.
§ 1004.21 General prohibitions. Section 1004.21(d) is amended to allow physicians and nurse practitioners employed by registered organizations to counsel certified patients or designated caregivers at a registered organization’s dispensing facility on medical marihuana product use, administration and risks.
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§ 1004.24 Inventory Requirements for registered organizations. Section 1004.24 is added to define inventory requirements for registered organizations.
§ 1004.25 Registered Organizations disposal of medical marihuana. Section 1004.25 is added to provide guidance on acceptable processes for disposing of medical marihuana products and by-products.
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§ 55-2.15 Requirements for laboratories performing testing for medical marihuana. Section 55-2.15(b) is amended to correct the agency name and to include a disposal requirement for laboratories. Section 55-2.15(c) is also amended to include a disposal requirement 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.
Regulatory Impact Statement
Statutory Authority:
The Commissioner is authorized pursuant to Section 3369-a of the Public Health Law (PHL) to promulgate rules and regulations necessary to effectuate the provisions of Title V-A of Article 33 of the Public Health Law. The Commission is authorized pursuant to Section 502 of the PHL to promulgate rules and regulations relating to environmental laboratories.
Legislative Objectives:
The legislative objective of Title V-A is to comprehensively regulate the manufacture, sale and use of medical marihuana, by striking a balance between potentially relieving the pain and suffering of those individuals with serious medical conditions, 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:
These proposed regulations promote the safe and effective use of approved medical marihuana products while safeguarding against diversion and other public safety concerns. Populations that will benefit from the proposed regulations include patients who are suffering from severe debilitating or life-threatening conditions. The regulations will serve the following needs:
1. Practitioner issuance of certifications to patients – The proposed regulations add the practitioner’s statutory requirement to consult the Prescription Monitoring Program Registry. If the practitioner issues a certification to a patient who is a non-resident of New York but is temporarily residing in the State for purposes of receiving care and treatment, the patient certification shall indicate such.
2. Certified patient and designated caregiver registrations – Patients that are New York State Residents will not be required to show proof of temporary residence. Acceptable proof of residence for a caregiver includes a New York State non-driver identification card.
3. Application for initial registration as a registered organization – The requirement for the prepared financial statement upon initial application for a registered organization is clarified to indicate that a registered organization's registration may be amended and not the application for registration.
4. Registered organization requirements for manufacturing and dispensing facilities – Reporting requirements for other cannabinoid components at >0.2% are clarified. The allowable range of THC and CBD concentration per dose and brand for potency testing purposes is amended. Registered organizations shall ensure continual environmental monitoring of harvested plant material awaiting additional processing. Registered organizations may produce products in new forms including tablets, film strips, metered dose inhalers and rectal products. Registered organizations may break the seal of an approved medical marihuana product for the purpose of internal quality control testing or disposal. Labeling requirements related to stability studies are clarified for registered organizations. Stability testing requirements and initial stability testing limitations are further defined. Registered organizations may not use any cannabinoid preparation not produced by the registered organization in any of its medical marihuana products. Dispensing facility pharmacists must complete a department approved four hour course. No food or beverages may be sold on the premises of a dispensing facility without prior approval from the department. Dispensing facility pharmacists or a designated individual shall consult the PMP Registry prior to dispensing approved medical marihuana products. Dispensing facility access restrictions are clarified. Labels on medical marihuana products shall include the expiration date of the product once opened on all products. Dispensing facilities must document returns of approved medical marihuana products and ensure secure storage until disposal.
5. General registered organization requirements – The department may provide a statement of findings to a registered organization and registered organizations must respond to implement a plan of correction to address deficiencies identified by the department. Manufacturing materials may be submitted to the department upon request and sample retention duration is reduced from two years to one year. Registered organizations must notify the department of adverse events and other incidents within 24 hours. Registered organizations must perform inventory and maintain records of medical marihuana products or by-products which are disposed of. Records may need to be maintained for a time period other than five (5) years. Registered organizations must post the registration certificate in a conspicuous location on the premises of each manufacturing and dispensing facility. Criminal history requirements for registered organization managers or employees are clarified. Registered organizations shall not steer or influence any individual to a practitioner to become a certified patient.
6. Laboratory testing requirements – No immediate family members of a board member, officer, manager, owner, partner, principal stakeholder or member of a registered organization shall have an interest or voting rights in the lab performing testing on medical marihuana. Registered organizations may test final products that have been packaged. The list of contaminants for which testing must occur and stability testing guidance for open and unopened products is further defined. A disposal requirement for laboratories and a requirement for laboratories to return medical marihuana products deemed unsuitable for testing to the registered organization has been included.
7. Security requirements for manufacturing and dispensing facilities – A video surveillance requirement was added to the disposal process. Registered organizations must use approved safes, vaults or other storage methods approved by the department for medical marihuana products. Registered organizations may transport approved medical marihuana products between dispensing facilities, to approved laboratories and waste management facilities. Manufacturing facility access restrictions are further clarified.
8. Medical marihuana marketing and advertising by registered organizations – The regulations clarify the terminology related to brand and approved medical marihuana products. Requirements for approved signage and marketing of registered organizations to practitioners is clarified.
9. Proper disposal of medical marihuana products by patients or designated caregivers – A clarification is made that the Department of Environmental Conservation provides guidance on proper drug disposal and patients and caregivers may return approved medical marihuana product(s) to the dispensing facility where they were purchased or any dispensing facility associated with the registered organization.
10. General prohibitions – A physician or a nurse practitioner employed by a registered organization, who has completed the four-hour course, may counsel certified patients or designated caregivers at a registered organization dispensing facility on medical marihuana product use, administration and risks.
11. Inventory requirements for registered organizations – Inventory requirements for registered organizations are defined.
12. Registered Organizations disposal of medical marihuana - Acceptable processes for disposing of medical marihuana products and by-products are defined.
Costs:
Costs to the Regulated Entity:
The proposed streamlined visitor access requirements will result in a simplification of staff responsibilities for registered organizations where emergency personnel and personnel performing regular maintenance will not require prior authorization by the department. The streamlined visitor access policy will still allow the department to review the names of the individuals visiting dispensing facilities and the purpose of their visits.
Registered organizations will also benefit from the easing of the cannabinoid concentration variability requirements, which are amended to be consistent with pharmaceutical industry standards. Increasing the cannabinoid concentration variability will result in reduced staffing costs to registered organizations related to relabeling of final products falling outside of concentration estimates.
Registered organizations will further benefit from decreased costs related to submitting samples for testing which are packaged in a quantity less than what would be provided to the patient but in a sufficient amount for laboratory confirmation of safety and potency. Registered organizations will realize savings by reducing the amount of product needed for testing. In addition, a savings may be experienced by registered organizations due to decreased sample retention requirements.
Registered organizations may have additional costs in staffing related to responding to a statement of findings identified by the department where a written plan of correction is required by the registered organization. These costs are necessary to ensure the program is administered in a manner that protects the public health and safety. Any increase in costs to registered organizations related to the proposed amendments will be offset by additional savings from the proposed amendments.
Costs to Local Government:
The proposed rule does not require the local government to perform any additional tasks; therefore, it is not anticipated to have an adverse fiscal impact.
Costs to the Department of Health:
The Department of Health anticipates the review of additional brands and dosage forms will require the commitment of department staff resources. The department also anticipates an increased administrative cost to support registration of nurse practitioners, ongoing monitoring and compliance of the medical marihuana program, and for laboratory services provided by Wadsworth Center laboratories for testing of medical marihuana products.
Local Government Mandates:
The proposed amendments do not impose any new programs, services, duties or responsibilities on local government.
Paperwork:
Deficiencies identified by the department will result in the issuance of a written statement of findings issued by the department and registered organizations will be required to submit a written plan of correction.
Duplication:
No relevant rules or legal requirements of the Federal and State governments duplicate, overlap or conflict with this rule.
Alternatives:
No alternatives to making the proposed regulatory amendments were considered by the department.
Federal Standards:
Federal requirements do not include provisions for a medical marihuana program.
Compliance Schedule:
There is no compliance schedule imposed by these amendments, which shall be effective upon publication of a notice of adoption.
Regulatory Flexibility Analysis
Effect of Rule:
This proposed rule will amend regulations for registered organizations who manufacture, distribute and sell approved medical marihuana products in New York State, as well as expand access to patients by authorizing nurse practitioners to register with the department. 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 on 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:
No new compliance costs will be required of small business entities and local governments.
Economic and Technological Feasibility:
This proposal is economically and technologically feasible. Statute requires the registered organization to pay an excise tax to the Commissioner of Tax and Finance. This tax will help to provide funds to the counties in New York State where medical marihuana is manufactured and dispensed.
Minimizing Adverse Impact:
To minimize the potential for patient adverse effects associated with the use of medical marihuana, the regulations continue to provide for department authorization of approved brands (cannabinoid profiles) and dosage forms that registered organizations may manufacture. In addition, the regulations continue to 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 also discussed the regulations and received input from various advocacy organizations. 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. The regulatory amendments do not propose any changes that would decrease access to dispensing facilities or practitioners 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 are limited to the registered organizations and practitioners registered with the department.
Costs:
There are no compliance costs to existing establishments in rural areas since no new compliance activities are imposed upon them. Compliance costs are limited to the registered organizations and practitioners registered with the department.
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 is offered online to make the course easily accessible to all practitioners who wish to issue certifications to patients for approved medical marihuana products.
Rural Area Participation:
The Department consulted with other state agencies, including Department of Environmental Conservation. 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
No job impact statement is required pursuant to section 201-a(2)(a) of the State Administrative Procedure Act. It is apparent, from the nature of the proposed amendment, that it will not have an adverse impact on jobs and employment opportunities.
