On July 31, 2015 the Department selected five applicants to become registered organizations. Click on the links below for more information.
Registered organizations in New York State will be manufacturing medical marijuana products that will be available in the following dosage forms, approved in regulation:
- liquid or oil preparations for metered oromucosal or sublingual administration or administration per tube;
- metered liquid or oil preparations for vaporization;
- capsules for oral administration;
- any additional form and route of administration approved by the commissioner.
Smoking as a method of administration is prohibited by the Compassionate Care Act. Edible products are also not permitted.
To protect the public's health and safety, registered organizations must meet high product quality standards in New York State. Final products must be tested for their cannabinoid profile, as well as for various contaminants and pesticides.
Until such time as independent laboratories are certified in New York State to test medical marijuana products, the Department of Health's Wadsworth Laboratories is conducting the final product testing. The regulations require that the testing of each lot of final medical marijuana product be conducted with a statistically significant number of samples using acceptable methodologies to ensure that all lots manufactured of each medical marijuana product are adequately assessed for contaminants and the cannabinoid profile is consistent throughout.
Labeling and Safety Information
New York State's Medical Marijuana Program includes detailed product and dispensing label requirements, which can be found in the regulations at 10 NYCRR § 1004.11(k) and 10 NYCRR § 1004.12(h). Registered organizations are also required to provide a department-approved package safety insert to patients when dispensing medical marijuana. Listed below are examples of the types of information that must be included in the package safety insert:
- a list of any excipients used;
- a warning if there is any potential for allergens in the medical marijuana product;
- contraindications (specific situations where medical marijuana should not be used because it may be harmful to the patient);
- a warning of adverse effects and/or any potential dangers stemming from the use of medical marijuana;
- instructions to report adverse events;
- information on tolerance, dependence and withdrawal and substance abuse;
Please refer to 10 NYCRR § 1004.12(k) to view all information required as part of the package safety insert.
Prices of Medical Marijuana Products
The Compassionate Care Act requires that the Department set the price of medical marijuana products. The Commissioner must set the price per dose of each form of medical marijuana sold by the registered organizations, and must take into account the fixed and variable costs of producing the form of marijuana in approving such price. The Department is actively working on the pricing process. The Department will review proposed prices submitted by the registered organizations and may approve, deny or modify proposed prices per 10 NYCRR § 1004.15(c)(4).