Oklahoma: New OMMA Emergency Rules Now In Effect

OKLAHOMA: New emergency rules for all Oklahoma Medical Marijuana Agency businesses and patients have gone into effect Oct. 15, 2020. The rules have been signed by the Governor.

The new emergency rules contain changes for reporting, testing standards and the contents of the laboratory Certificates of Analysis. The rules and a summary are available on the OMMA website. The rules reflect our latest efforts to help build a safer industry for businesses and patients in our state

The new rules are effective immediately and can be found at https://omma.ok.gov/rules-regulations.

Ohio Board Of Pharmacy Awards Dispensary Certificate Of Operation In Canton

OHIO: The State of Ohio Board of Pharmacy today awarded a Dispensary Certificate of Operation to ZenLEAF Canton, located at 1851 Steinway Blvd. SE, Canton.

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The interactive map of Dispensaries with Certificates of Operation will be updated within the next 48 hours.

Murphy Administration Seeking Up To Six New Dispensaries To Expand Access To Medicinal Marijuana

NEW JERSEY: The Murphy Administration today announced it is seeking up to six new applicants to operate medicinal marijuana dispensaries — two each in the northern, central and southern regions of New Jersey.

“We look forward to the opening of six new dispensaries so we can ensure that all qualifying patients who want access to medicinal marijuana can have it,’’ said Governor Phil Murphy. “Due to the steps that Commissioner Elnahal and I have taken since January, we have seen the addition of 10,000 new patients. Accordingly, we have to expand the number of businesses who are growing product and serving patients.”

Screenshot 2018-07-16 09.45.16Currently, more than 26,000 patients, 1,000 caregivers and 700 physicians are participating in the program.

“As we strive to make the program more responsive to the needs of patients, caregivers and Alternative Treatment Centers (ATCs), we recognize the need to grow the industry and create more options for patients,” said Health Commissioner Shereef Elnahal, M.D.

A Request for Applications (RFA), which was noticed in today’s New Jersey Register and published on the Department’s website, notes that applicants would have to operate a dispensary and facilities that do cultivating and manufacturing and provide evidence of site control and verification of the approval of the governing body in the municipality where they intend to locate. The business can be either nonprofit or for profit and is also required to submit a business plan including a budget detailing revenues and expenses over a five-year period. The RFA is available here.

Applicants can submit applications for more than one region of the state but must submit a separate application for each region. The fee for applying is $20,000, although $18,000 of that fee will be returned to unsuccessful applicants.

A mandatory pre-application conference is scheduled for Thursday, Aug. 9 at the Department of Health headquarters in Trenton. The purpose of the conference is to give potential applicants a chance to have questions answered about the process. The Department will electronically accept questions until 4 p.m. on Tuesday, Aug. 7 from all potential applicants via email at mmpquestions@doh.nj.gov. Applications are due Friday, Aug. 31, 2018. Applicants chosen to proceed in the permitting process will be announced Nov. 1, 2018.

The six currently operating ATCs are not eligible to participate in this application process. Existing ATCs already have the opportunity to add additional sites for cultivating, manufacturing and dispensing. Additional opportunities to apply to build cultivating, manufacturing and dispensing sites will be available in the future.

The Commissioner is also working to expand physician participation in the program. Last week, he conducted two grand rounds lectures with 300 physicians at teaching hospitals to dispel myths and reduce stigma in the medical community. Although more than 100 new doctors have signed up since the expansion began, only 700 of the 28,000 licensed physicians in New Jersey are currently registered to participate in the Department of Health’s Medicinal Marijuana program.

Tilray Exports Medical Cannabis To South Africa

First-ever export of plant-derived cannabinoid product to the continent of Africa

CANADA: Tilray, a global pioneer in cannabis cultivation, processing and distribution, today announced that it has successfully exported medical cannabis products to South Africa for nationwide distribution to qualified patients through pharmacies. Tilray’s product is the first cannabinoid-based product derived from the cannabis plant that has ever been legally exported to and made available for medical purposes in the country of South Africa and on the continent of Africa.

“With this announcement, Tilray products are now available in nine countries on five continents. This export is another strategic milestone as we aim to build the world’s leading medical cannabis brand,” said Brendan Kennedy, Tilray CEO. “We are encouraged by the evolving regulations pertaining to cannabis in South Africa and around the world and are pleased to make our pharmaceutical-grade products available to qualified patients in need in throughout the country.”

Tilray’s medical cannabis product in South Africa is a GMP-manufactured, full-spectrum oral solution featuring a balanced ratio of tetrahydrocannabinol (THC) and cannabidiol (CBD). The product is available to qualified patients under South Africa’s named patient program. Through that program, authorized practitioners can apply for permission to access and prescribe unregistered medicines, including the Tilray product, when intending to treat individual patients for specific conditions where certain registered medicines have failed. The product will then be distributed to patients through authorized distribution channels.

 

New York’s Proposed Expansion Of Medical Marijuana Regulations

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.

Practitioner Rules

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.

Advertising

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.”

Miscellaneous Regulations 

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.

Update on Pennsylvania’s Medical Marijuana Program Implementation Process

PENNSYLVANIA: In a continued commitment to transparency throughout the development and implementation of Pennsylvania’s Medical Marijuana Program, Secretary of Health Dr. Karen Murphy today provided an update on accomplishments, gave a preview of pending activities, and highlighted the need for physician participation.

“The department is being very thoughtful and thorough in our approach to developing and implementing a medically-focused program that will benefit patients with serious medical conditions,” said Secretary Murphy. “We have started working closely with physician groups to disseminate important information, and have formed a physician workgroup to ensure continued communication and feedback on the program and its implementation. Physicians and their medical expertise are crucial to the success of Pennsylvania’s medical marijuana program, and we will continue to engage them throughout the process to ensure their medical expertise is heard on behalf of patients.”

The first Medical Marijuana Physician Workgroup will be convened within the next few weeks. Participants will include:

  • Allegheny Health Network
  • Geisinger Health System
  • Penn State Health
  • Port Allegany Health Center
  • Temple University Health Systems
  • The Lehigh Valley Health Network
  • Thomas Jefferson University Hospitals
  • University of Pennsylvania – Perelman Center for Advanced Medicine
  • University of Pittsburgh Medical Center
  • The Commonwealth Medical College
  • Pennsylvania Academy of Family Physicians
  • Pennsylvania Chapter – American Academy of Pediatrics
  • Pennsylvania Medical Society

The department will also soon release a survey asking for feedback to help in the development of temporary regulations pertaining physicians. The public and physicians will be alerted when this survey is available on the department’s website.

The medical marijuana program was signed into law by Governor Tom Wolf on April 17, 2016. Since that time, the Department of Health has:

The department expects to have the temporary regulations for growers and processors completed and published by the end of August. The remainder of the temporary regulations will be released sequentially for dispensaries/laboratories, physicians, patients, and caregivers. The temporary regulations will be in place for two years from the date they are published.

The program is expected to be implemented by early 2018 and, when completed, will offer medical marijuana to patients who are residents of Pennsylvania and under a physician’s care for the treatment of a serious medical condition as defined by Act 16.

Questions about the medical marijuana program can be emailed to RA-DHMedMarijuana@pa.gov. Information is also available on the Department of Health website at www.health.pa.gov.

First Marijuana Dispensary In Las Vegas Area Opens

NEVADA:  It was a moment more than two years in the making — or 17 years, depending on how you look at it.

The first legal medical marijuana dispensary in Clark County opened Monday morning and made its first sales to invited customers.

Euphoria Wellness, a shop in the southwest Las Vegas Valley, is one of 40 dispensaries approved for Clark County last year by state health officials.

 

Want To Sell Medical Marijuana In New York? It Could Cost You $30 Million

NEW YORK: In business, you have to spend money to make money. In the New York medical marijuana industry, you may just be spending money.

Medical marijuana was legalized in New York in July 2014; however, the licenses to sell were just announced July 31 of this year. Applicants had to pay a refundable registration fee of $200,000 along with a non-refundable $10,000 fee. For a comparison, in Oregon, the application fee is $4,000 and in Massachusetts, there is a Stage One application fee of $1,500 and a Stage Two application fee of $30,000.

Of the 43 businesses that applied, five companies — Bloomfield Industries, Columbia Care NY, Empire State Health Solutions, Etain and PharmaCann — were awarded licenses. Of the states that have legalized marijuana, some — like Florida and Minnesota — also restrict the number of license holders, while others, such as Colorado and California, grant much greater access to licensees.