Wholesaling of Medical Marijuana Products

NYSDOH Announces Ability for Wholesaling of Medical Marijuana Products and Removes Cap On Number of Products Available to Patients

Regulations Filed Defining Chronic Pain As Qualifying Condition

ALBANY, N.Y. (December 8, 2016) - The New York State Department of Health today announced several enhancements to the state's Medical Marijuana Program that will improve access for patients, streamline production, increase choice and help lead to reduced costs. They include allowing wholesaling of medical marijuana products, removing the cap on the number of products available to patients, defining chronic pain as a qualifying condition and making it easier for hospitals to allow certified patients to self-administer medical marijuana.

"These are major steps forward for New York's Medical Marijuana Program and the thousands of patients who are benefiting from it every day," said Health Commissioner Dr. Howard A. Zucker. "These enhancements will continue to strengthen the program and improve patient access by making medical marijuana available to patients suffering from chronic pain and making more products available at dispensing facilities across the state."

WHOLESALING AND LIFTING OF BRAND RESTRICTION

The Department is providing guidance to registered organizations licensed to manufacture and dispense medical marijuana in New York on wholesaling their products to other registered organizations. This will make more varieties of products available at dispensaries across the state.

Effective immediately, registered organizations may submit proposals to sell and distribute approved medical marijuana products and/or marijuana that has been extracted pursuant to the regulations ("extracts") to other registered organizations.

As part of the Department's efforts to make more medical marijuana products available to patients across the state, registered organizations will be allowed to manufacture and dispense additional brands beyond the initial five required by regulation.

Allowing the wholesaling of extracts and removing the cap on brands will help ensure the continuous availability of medical marijuana products even if a crop fails, and allow registered organizations to obtain critical extracts to keep making their products without having to wait for their own new crops to be ready.

Registered organizations that wish to sell and distribute their extracts and/or approved medical marijuana products to other registered organizations within New York State must first submit a proposed operating plan for wholesaling to the Department and receive the Department's prior written approval. Registered organizations interested in manufacturing additional brands must submit brand information to the Department and receive prior written approval as well.

DEFINITION OF CHRONIC PAIN

On Tuesday, the Department filed a proposed regulatory amendment to add chronic pain as a qualifying condition. It defines chronic pain as"any severe debilitating pain that the practitioner determines degrades health and functional capability; where the patient has contraindications, has experienced intolerable side effects, or has experienced failure of one or more previously tried therapeutic options; and where there is documented medical evidence of such pain having lasted three months or more beyond onset, or the practitioner reasonably anticipates such pain to last three months or more beyond onset."

The amendment will be published in the New York State Register onDecember 21, 2016. It will then be subject to a 45-day comment period before it can be adopted.

OTHER ENHANCEMENTS

In addition to Tuesday's filing, on Friday, the Department proposed amendments to its regulations that, among other things, will explicitly allow hospitals to create policies and procedures that permit patients to self-administer certain medications, including medical marijuana, or have their caregivers administer the medication in the hospital. Hospitals that wish to permit self-administration of such medications must develop and follow policies and procedures to ensure the safe administration and security of the medication. These regulations will also be published in the New York State Register on December 21, 2016 for a 45-day comment period.

Last week,the Department authorized nurse practitioners to certify patients for medical marijuana. Also, a proposed rulemaking was published to enable physician assistants to register with the Department to certify patients for medical marijuana, as long as their supervising physicians are also registered to certify patients. This amendment will not take effect until it is filed for adoption after the public comment period.

The Department continues to implement other recommendations from the two-year report on the Medical Marijuana Program, including increasing the number of laboratories in New York State that are certified to test medical marijuana products. Last week, Wadsworth Center posted a solicitation of interest on the Environmental Laboratory Approval Program webpage (http://www.wadsworth.org/regulatory/elap/medical-marijuana).

For more information on the two-year report for the Medical Use of Marijuana under the Compassionate Care Act, visit: https://www.health.ny.gov/regulations/medical_marijuana/.

NYSDOH Announces Chronic Pain to Be Added As Qualifying Condition for Medical Marijuana

Chronic Pain Will Join List of Ten Current Qualifying Conditions

ALBANY, N.Y. (December 1, 2016) - The New York State Department of Health today announced that chronic pain will be added as a qualifying condition for medical marijuana.

"After conducting a thorough review of the scientific literature, it became clear that there may be certain benefits in the use of medical marijuana by patients suffering from chronic pain," said Health Commissioner Dr. Howard A. Zucker. "Medical marijuana is already helping thousands of patients across New York State, and adding chronic pain as a qualifying condition will help more patients and further strengthen the program."

The Department will develop a proposed regulatory amendment, which will include language specifying the chronic pain conditions that would qualify for medical marijuana. The proposed regulatory amendment will be published for public comment shortly.

The other ten qualifying conditions are cancer, HIV infection or AIDS, amyotrophic lateral sclerosis (ALS), Parkinson's disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, epilepsy, inflammatory bowel disease, neuropathies, and Huntington's disease.

Regulatory amendments filed by the Department to authorize nurse practitioners to certify patients for medical marijuana took effect on Wednesday, when the notice of adoption was published in the New York State Register. In order to register with the Department, nurse practitioners must take the Department-approved Medical Use of Marijuana course online and submit their certificate of course completions to the Department using the instructions provided on the Department's Medical Marijuana Program Practitioner Information page: www.health.ny.gov/regulations/medical_marijuana/practitioner/.

In addition, a proposed rulemaking was published Wednesday that would enable physician assistants to register with the Department to certify patients for medical marijuana, as long as their supervising physician is also registered to certify patients. This proposed rulemaking will be subject to a 45-day public comment period and would not take effect until it is filed for adoption after the public comment period.

The Department continues to implement other recommendations from the two-year report on the Medical Marijuana Program. For more information on the two-year report for the Medical Use of Marijuana under the Compassionate Care Act, visit: https://www.health.ny.gov/regulations/medical_marijuana/.

NYSDOH Announces Expansion of Medical Marijuana Program

Nurse Practitioners Empowered to Certify Patients for Medical Marijuana Through New Regulations

New Proposed Regulation Would Authorize Physician Assistants to Certify Patients for Medical Marijuana

ALBANY, N.Y. (November 22, 2016) - The New York State Department of Health today announced that it has officially filed amendments to the Medical Use of Marijuana regulations that will authorize nurse practitioners to register with the Department to certify patients for medical marijuana as of the end of November. These regulatory amendments will take effect on November 30, 2016, when the notice of adoption will be published in the New York State Register.

In order to register with the Department, nurse practitioners will need to take the Department-approved Medical Use of Marijuana course online and submit their course completions to the Department using the instructions provided on the Department's Medical Marijuana Program Practitioner Information page: www.health.ny.gov/regulations/medical_marijuana/practitioner/.

In the interest of further improving patient access, the Department has also filed proposed rulemaking that would enable physician assistants to register with the Department to certify patients for medical marijuana, as long as their supervising physician is also registered to certify patients. The proposed rulemaking will be published on November 30, 2016, and will be subject to a 45-day public comment period. This amendment would not take effect until it is filed for adoption after the public comment period.

"The first year of New York's Medical Marijuana Program has been a success. Over 10,500 patients have been certified by more than 740 registered physicians to date," said Health Commissioner Dr. Howard A. Zucker. "Authorizing nurse practitioners and physician assistants to certify patients will only help to further strengthen the program and improve patient access."

Nearly 19,000 nurse practitioners and more than 11,000 physician assistants are licensed to practice in New York State, where they are already authorized to prescribe controlled substances (including opioids). Empowering them to issue medical marijuana certifications will help patients suffering from severe, debilitating or life-threating conditions, particularly in many rural counties where far fewer physicians are available.

In addition to expanding the certification options for patients, the Department is continuing its review of evidence for the use of medical marijuana for patients suffering from chronic pain. It is anticipated that a decision will be made by the end of the month.

The Department has also provided guidance to registered organizations regarding home delivery, and has been reviewing home delivery proposals from registered organizations consistent with its guidance.

The Department continues to implement other recommendations from the two-year report on the Medical Marijuana Program, including:

  • Making the registration process more user friendly;
  • Increasing the number of laboratories in New York State that are certified to test medical marijuana products;
  • Continuing federal outreach;
  • Making it easier for patients to locate practitioners;
  • Completing an assessment of possible regulatory amendments to make it easier for healthcare facilities and schools to possess, secure, and administer patients' medical marijuana products under limited circumstances necessary to safeguard the health of those patients;
  • Reviewing additional brands beyond the initial five required by regulation; and
  • Registering five additional organizations over the next two years to expand patient access to medical marijuana throughout New York State.

For more information on the two-year report for the Medical Use of Marijuana under the Compassionate Care Act, visit:https://www.health.ny.gov/regulations/medical_marijuana/.