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/.
