Becoming a Caregiver, Producer, or Provider in New York
At the time the certified patient applies for a registry ID card, he or she may designate up to two caregivers to assist the patient in obtaining and administering medical marijuana. To become a caregiver, the individual:
- Must be at least 21 years old, unless special permission is obtained from the Department;
- Must be a resident of New York State and have a valid New York State issued driver’s license or a New York State identification card;
- Must be someone other than the patent’s certifying physician.
After the patient’s application is approved, each caregiver must register with the Department to receive a registry ID card that the caregiver can then use to obtain medical marijuana on the patient’s behalf. Caregivers can follow the same registration instructions that are available for patients, which may be found here: http://www.health.ny.gov/regulations/medical_marijuana/patients/
Like the patient, each caregiver must pay the $50 application fee unless he or she can demonstrate financial hardship to waive that fee.
Renewal of the Registry ID Card
The duration of the caregiver’s registry ID card is based on the duration the patient’s certification. Accordingly, a caregiver’s registry card will expire at the same time as the patient’s card. After the patient obtains a new certification from the physician and renews his or her registry card, the caregiver can apply for a renewal of his or her card.
Regulations permit a designated caregiver to obtain payment from the patient for the following two expenses only:
(i) the actual amount charged by the dispensary for the approved medical marihuana product purchased for the patient; and
(ii) reasonable costs incurred in the transportation and delivery of medical marihuana product to the patient.
Each designated caregiver must also comply with the following requirements:
- Must obtain a registry ID card for each certified patient;
- Must provide care to no more than five certified patients;
- Must not possess at any one time a cumulative quantity of medical cannabis that exceeds the amount allowed for each certified patient;
- Must not possess any form of medical cannabis other than those forms recommended specifically for the use of certified patients;
- Must not knowingly share, sell, trade or otherwise deliver medical cannabis to anyone who is not a registered patient;
- Must abide by the same reporting requirements as described above for patients, including the obligation to return registry ID cards issued in connection with those patients who no longer have an eligible condition.
Producer or Provider
Under New York Law, only “registered organizations” may produce, process and dispense medical cannabis to patients or their designated caregivers. Presently, the law allows the Commissioner to register no more than five organizations to manufacture and dispense medical marijuana. Each organization can have up to four dispensaries. There is no limit on the number of certified patients that each registered organization can serve.
On July 31, 2015, the Commissioner approved five registered organizations to produce and dispense medical marijuana from a total of 20 locations across New York State. For locations of those dispensaries, please visit: http://www.health.ny.gov/regulations/medical_marijuana/application/selected_applicants.htm
The Department’s Regulations prescribe a comprehensive regulatory structure that governs every aspect of a producer’s or provider’s operations from applying to become a registered organization to ceasing operations as such. Below is a summary of the key requirements that apply to registered organizations in New York.
The basics requirements for registration are codified in Section 3365 of New York’s Public Health Law; additional application requirements are set forth in Sections 1004.5 and 1004.6 of the Regulations, which are available here.
Generally, each initial registration is valid for only two years.
Applications for registration renewal must be filed with the Department of Health not more than six months nor less than four months prior to the expiration of the existing registration. The Commissioner has discretion to treat late-filed applications for renewal as those for an initial license. Under the law, the Commissioner may decline to renew a registration if he or she determines that:
- the applicant is unlikely to maintain or be able to maintain effective control against diversion of marijuana;
- the applicant is unlikely to comply with all state laws applicable to the activities in which it may engage under the registration;
- it is not in the public interest to renew the registration because the number of registered organizations in an area is excessive to reasonably serve the area; or
- the applicant has either violated or terminated its labor peace agreement with a bona-fide labor organization that is actively engaged in representing or attempting to represent the applicant's employees.
For more detailed description of the registration renewal process, including applicable fees, please consult Section 3365(5) of the Public Health Law and Section 1004.7 of the Regulations.
Termination/Suspension of Registration
The Department may terminate or suspend an existing registration based on any one or more of the relevant factors that provide grounds for denying an application for an initial or renewed registration, including violation or termination of the applicable labor peace agreement.
The law also provides that the governor may immediately terminate all licenses issued to registered organizations, based upon the recommendation of the commissioner and/or the superintendent of state police that there is a risk to the public health or safety.
Conduct which may violate federal law will not be deemed grounds to suspend or terminate a registration so long as said conduct complies with New York law.
Product Testing Requirements
New York law requires each registered organization to contract with an independent laboratory, located in New York, to test its medical marijuana products. To perform such tests, each laboratory must be licensed by the federal Drug Enforcement Administration and also approved by the Department of Health.
According to the MMP webpage, the Department of Health's Wadsworth Laboratories presently conducts all product testing but additional laboratories are expected to be certified by the Department to perform such tests.
For details concerning laboratory testing requirements, please refer to Section 1004.14 of the Regulations.
Manufacturing and Labeling Requirements
All manufacturing of medical marijuana must take place in an indoor, enclosed and secure facility, which may include a greenhouse.
Section 1004.11 of the Regulations sets forth detailed manufacturing specifications and other requirements that must be followed by each registered organization, including specific product labeling that must be implemented at the manufacturing stage.
When dispensing medical marijuana to a patient or caregiver, the registered organization:
- Must ensure that all marijuana dispensed does not exceed the 30-day supply and otherwise conforms to practitioner recommendations and limitations for each individual patient, as set forth in the patient’s certification;
- Must consult the state’s Prescription Monitoring Program to ensure the patient does not receive a new 30-day supply of medical cannabis until they have exhausted all but a one-week supply of their prior refill;
- Must dispense all medical marijuana products in a sealed package, with a “patient-specific” dispensing label containing the information required by Section 3364(12) of the Public Health Law and Section 1004.12(h) of the Regulations;
- Must provide each patient a Department-approved package safety insert that includes various information, as set forth in Section 1004.12(k) of the Regulations;
- Must provide a receipt for all transactions which includes:
- the registered organization’s name, address and ID number;
- the name and ID number of the patient, as well as designated caregiver, if any;
- the date the marijuana was sold;
- any practitioner limitations on the form or quantity sold;
Like manufacturing, all dispensing activities must take place in an indoor, enclosed and secure facility, which may include a greenhouse. Additionally, no dispensing activities may be conducted:
- in the same location where marijuana is grown or manufactured; or
- on the same street or avenue and within one thousand feet of a building occupied exclusively as a school, church, synagogue or other place of worship.
For more information on the requirements governing dispensing facilities, including security requirements, please consult Sections 1004.12 and 1004.13 of the Regulations.
All sales of medical marijuana must be reported electronically to the Department on a daily basis. Section 1004.17 of the Regulations sets forth the various information that must be included in those reports. A zero report must be submitted to the Department when no approved medical marihuana product was dispensed by the dispensing facility.
Additionally, the Regulations require each registered organization to:
- make its books, records and facilities available to the Department for monitoring, on-site inspection and audit;
- maintain records concerning its operations, including cultivation, manufacturing, testing, packaging and labeling of marijuana products, for a period of five (5) years;
- report to the Department any complaints or adverse events relating to the operation of registered organization within 24 hours of the even’s occurrence.
Registered organizations must pay a monthly excise tax of 7% on the gross receipts for all marijuana transactions, which cannot be added as a separate, line item charge to be paid by the customer.
Registered organizations must maintain a record of gross receipts subject to tax for each transaction. All such records must be kept for a minimum of three (3) years from the due date of the return to which those records relate, or the date the return is filed, if later.
Please review Technical Memorandum TSB-M-16(1)M, issued by the New York State Department of Taxation and Finance, for additional information regarding the excise tax on medical marijuana and other tax obligations of registered organizations selling medical marijuana in New York (https://www.tax.ny.gov/pdf/memos/misc/m16_1m.pdf).
New York law prohibits registered organizations from allowing any employee or manager to come into contact with medical marijuana if he or she has a prior conviction for felony sale or possession of any controlled substance that is less than ten years old (not counting time spent in incarceration).