New York Issues Final Regulations for Medical Marijuana Program

April 3, 2015

The New York State Department of Health (“DOH”) has released the final regulations for the state’s medical marijuana program. The regulations have been released on the DOH’s website, available here, and will be made official when published in the April 15 State Register. Applications from interested entities, as well as physician education and patient certifications, are expected to soon follow.

Many stakeholders had lobbied for changes to the regulations that some saw as overly restrictive, but the final regulations remain almost entirely unchanged from their proposed form (discussed in a previous alert available here). DOH states in its commentary that it was careful to craft the regulations in a manner that would not invite enforcement actions or legal challenges from the federal government, accounting for the minimal change.

For patients, the list of illnesses for which medical marijuana may be provided has not changed, despite many comments requesting its expansion. However, the commentary does state that the Commissioner of DOH will consider the comments in exercising his authority to expand the list of illnesses in the future. The commentary also clarifies a point of confusion for many, stating that in order to be eligible for medical marijuana, a patient must both have a listed illness and suffer from one of the listed symptoms, and not just one or the other. Otherwise, the medical marijuana program will not be significantly different from a patient’s point of view than it was in the proposed regulations.

The final regulations do not alter a physician’s requirements, though they do paint a clearer picture of how a physician may be approved to certify a patient’s use of marijuana. The DOH also reaffirmed its intention to certify practitioners to provide medical marijuana certifications in time for the first availability of medical marijuana in early 2016.

In another area of significant comment relating to patient care, the roll of “caregivers,” individuals not entitled to use medical marijuana, but to possess and transport it on behalf of someone who is, has not been expanded. Those limitations, coupled with the relative scarcity of dispensaries in the State, have caused some stakeholders to be concerned that patients in residential treatment facilities and rural areas will have difficulty accessing medical marijuana. Some commenters had suggested, for example, exceptions that would allow nurses in residential treatment facilities to serve as “caregivers” to more than five patients in the facility. DOH rejected these comments, and patients in residential treatment facilities will have to rely on individuals who can only serve up to five patients to obtain, deliver, and assist in administering the medical marijuana.

On the applicant’s side of the regulations, stakeholders submitted comments on the required “labor peace agreement” with a labor union, however DOH made no changes to that requirement, pointing out that it did not have the authority to substantively change the statutory requirement for such an agreement. The commentary issued by DOH accompanying the final regulations did provide some additional clarity for Registered Organizations. DOH clarified that a Registered Organization will not be required to have a one-year supply on-site, as some read the proposed regulations to mean, but that the Registered Organization is capable of ensuring the ongoing availability of at least a one year supply. DOH also seems to suggest in their commentary that an interpretation of the regulations that would require each patient’s dosing be separately packaged and labelled in manufacturing is incorrect, and that such packaging and labelling may be done at the dispensary. Notably, the commentary also appears to foreclose the possibility of a Registered Organization contracting out any activity relating to the Registered Organization’s operations to another individual or entity, even going so far as to suggest an independent contractor relationship would be impermissible with an individual involved with the operations of the Registered Organization.

DOH also promised additional future guidance in certain areas of particular concern. The requirement that a Registered Organization be fully operational within six months of licensure remains, for example, though DOH states it will issue further guidance in the future about the precise level of operation it wishes to see within six months. Further guidance will also be forthcoming on the approval requirements necessary to modify a Registered Organization’s facilities, appropriate vaults for storage, security requirements in the case of power outages, and stability and shelf-life testing for lots of medical marijuana products.

The regulations will officially be “final” on April 15th, though DOH acknowledged that future rulemaking in the medical marijuana program will be likely. With the publishing on the regulations on April 15th, much of the logistical work to implement New York’s medical marijuana program will begin.

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  • Benjamin P. Malerba





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