New York State Registered Organization Information

New York State Registered Organization Information 

Registered Organizations
Registered organizations are responsible for manufacturing and dispensing medical marijuana in New York State. Each registered organization is permitted by statute to have up to four dispensing facilities. Click on the link below for a list of registered organizations in New York State.
Registered organizations must manufacture medical marijuana products in an indoor, enclosed, secure facility located in New York State, which may include a greenhouse. Registered organizations may only manufacture medical marijuana products in forms approved by the Commissioner of Health. The following forms are 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;

The Commissioner may approve additional forms and routes of administration. Smoking as a method of administration is prohibited by the Compassionate Care Act. Edible products are also not permitted.
Each registered organization may produce its own brands of medical marijuana products, with prior approval of the Department. The brands must include at least one brand that has a low tetrahydrocannabinol (THC) content and high cannabidiol (CBD) content, and at least one brand with approximately equal amounts of THC and CBD.

Product Quality
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 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.
Dispensing facilities must report dispensing data to the New York State Prescription Monitoring Program Registry and consult the Registry prior to dispensing approved medical marijuana products to certified patients or their designated caregivers.

Medical Marijuana Product Prices
Registered Organizations submitted to the Department their costs to manufacture, market and distribute products, and to certify that the information provided was accurate, complete and current. The Commissioner then determined the reasonableness of the proposed prices and approved them as the maximum price per dose each Registered Organization may charge.