By Joshua S. Bauchner and Anthony J. D’Artiglio
NEW YORK: On August 10, 2017 the New York State Department of Health announced a bevy of proposed new regulations and changes to existing regulations designed to update New York’s medical marijuana program. These new regulations are part of the State’s continued efforts to expand and modernize its medical marijuana program following the addition of chronic pain as a covered illness earlier this year. This article details the proposed regulations and their impact on the medical marijuana landscape.
Expanded Marijuana Products
Under the current regulations, the dispensable forms of marijuana are severely restricted. However, the proposed amendments to Section 1004.11(g) greatly expand the marijuana products which can be administered by dispensaries, to now include: capsules, chewable and effervescent tablets, lozenges, topical forms, transdermal patches and metered ground plant preparations. Notably, although ground plant preparations are now allowed, the proposed additions to Section 1004.11(g) include a statement that “[s]moking is not an approved route of administration.”
Although not an expansion on the sale of marijuana products, proposed regulation Section 1004.12(b) permits the sale of items which “promote health and well-being” although are not marijuana products.” Although, what constitutes approved health and well-being products is not yet defined within the proposed regulations, the focus is plainly in line with the treatment of cannabis as a medicine to promote healthy living. Additionally, this proposal will allow dispensaries to expand their offerings beyond “marihuana products and related products” lending further legitimacy to the enterprise.
Open Dispensary Facilities
The proposed regulations greatly expand access to dispensary facilities to incorporate prospective patients and practitioners. Specifically, Section 1004.12(f) is to be amended to loosen the restrictions on access to facilities, although Section 1004.12(i) does place the onus on registered organizations to maintain a detailed visitor log of all non-employees accessing the facility. These critical changes will allow prospective patients and practitioners prior access to facilities thereby allowing patients to better assess the potential for marijuana as a treatment option.
The proposed regulations relax the requirements for practitioners who seek to prescribe medical marijuana to qualifying patients, as Section 1004.1(a)(3) would now allow those practitioners to complete a two hour course before issuing certifications. Under the old rules, practitioners were required to complete four hour course, thus placing more onerous restrictions on qualified health care providers seeking to enter the field.
Although registered organizations still face restrictions on advertising, Section 1004.16(m) of the proposed regulations explicitly permits dispensaries to educate “practitioners about the approved medical marihuana products offered by the registered organization.” Furthermore, the proposed regulations loosen the restrictions in Section 1004.16(i), which only require registered organizations to submit advertisements to the Department of Health for approval if the advertisement “makes any claims or statements regarding efficacy.”
Despite relaxing certain regulations to expand the program, there are a number of new, proposed regulations focused on ensuring facility operator compliance. Notably, Section 1004.12(a) has been amended to require that the onsite licensed pharmacist at each facility must also complete “a four-hour course,” thus ensuring that the relaxed two-hour course requirement in the proposed regulations are inapplicable to the onsite pharmacist.
In that same vein, proposed regulation Section 1004.12(d) places an additional burden on dispensaries to “ensure the prescription monitoring program registry is consulted” prior to all marijuana sale transactions.
The new proposed regulations also add a new testing requirement pursuant to Section 1004.14(h) which now provides for stability testing on each brand and form of medical marijuana products.
Furthermore, New York proposes to add regulations addressing the disposal of medical marijuana under new Section 1004.24, which requires, among other things, that all organizations obtain approval from the Department of Health for disposal methods and that all organizations create and maintain detailed records of all marijuana disposals which are subject to Department of Health review.
Although New York is moving towards a less restrictive medical marijuana environment, individuals and businesses which operate within the cannabis sphere must be mindful of the exacting and frequently changing regulations. Experienced legal counsel such as Ansell, Grimm & Aaron, P.C. can assist with ensuring compliance with all government regulations in this ever-changing and rapidly expanding marketplace.
For more information, please visit us at ansellgrimm.com, follow us @THCCounselors, and contact us at (973) 247-9000.
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