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Medical Marijuana Regulations for New York are Here!
The Department of Health (DOH) issued a notice of adoption of regulations for the implementation of medical marijuana (or “marihuana”) cultivation and dispensing in New York State. The regulations include provision of the following: (Read more)
This article is not offered as, and should not be relied on as, legal advice. You should consult an attorney for advice in specific situations.
- Practitioner registration. Establishes a process for practitioners who have completed an educational course approved by the Commissioner of the Department of Health (the “Department” or “DOH”) on the use of medical marihuana to register with the Department to issue patient certification.
- Practitioner issuance of certification. Establishes a process for registered practitioners to issue a certification to patients with certain severe debilitating or life-threatening conditions, with certain clinically associated conditions or complications that are likely to receive therapeutic or palliative benefit from the treatment of medical marihuana to be able to receive approved medical marihuana products from a registered organization.
- Application for registration as a certified patient. Provides the criteria by which a person may obtain a registration as a certified patient and receive a registry identification card.
- Designated caregiver registration. Caregivers designated to handle approved medical marihuana products on behalf of certified patients are required to register with the Department according to the procedures detailed in the regulation and to obtain a registry identification card.
- Application for initial registration as a registered organization. Establishes the application process for registered organizations interested in manufacturing and dispensing approved medical marihuana products. No person or entity may manufacture or dispense medical marihuana without such registration.
- Consideration of registered organization applications. Requires potential registered organizations to submit an application including enumerated factors. Requires that the applicant allow for reasonable access to its facilities for inspection by the Department. Provides that registrations shall be valid for two years, except that initial registrations may be extended up to eleven months by the commissioner.
- Application for renewal of registered organization registrations. Establishes the process by which registered organizations renew their registration. Requires an application fee of $10,000, accompanied by a check for an additional $200,000, the latter of which will be refunded to applicants not granted renewal registration. Provides an opportunity to submit additional information or to demand a hearing for applicants not granted renewal registration.
- Registrations non-transferable. Prohibits the transfer or assignment of registrations.
- Failure to operate. Provides that a registration shall be surrendered to the Department if a registered organization fails to begin operations to the satisfaction of the Department within six months of the issuance of a registration.
- Registered organizations; general requirements. Contains requirements for registered organizations, including making its books and facilities available for monitoring by the Department; submitting medical marihuana product samples to the Department for quality assurance testing; implementing policies and procedures to investigate complaints and adverse events; as well as closure procedures.
- Manufacturing requirements for approved medical marihuana product(s). Contains requirements for the manufacturing of medical marihuana products. Provides the brands, forms and routes of administration of medical marihuana products authorized for manufacturing, as well as product labeling requirements. Provides that no synthetic marihuana additives shall be used in the production of any medical marihuana product.
- Requirements for dispensing facilities. Details the requirements for the operation of dispensing facilities as well as the required patient specific label required to be affixed to each medical marihuana product dispensed. Provides that no medical marihuana product shall be consumed or vaporized on the premises of such facilities.
- Security requirements for manufacturing and dispensing facilities. Details the minimum security requirements for manufacturing and dispensing facilities and for the transportation of medical marihuana products.
- Laboratory testing requirements for medical marihuana. Details the minimum laboratory testing requirements for medical marihuana products. Testing shall be performed by a Department approved laboratory located within New York State.
- Pricing. Requires registered organizations to submit proposed prices for medical marihuana products to the Department for approval. The Department may approve the proposed price, refuse approval of a proposed price, or modify or reduce the proposed price.
- Medical marihuana marketing and advertising by registered organizations. Restricts the marketing and advertising of medical marihuana.
- Reporting dispensed medical marihuana products. Details reporting requirements for dispensed medical marihuana products.
- Prohibition of the use of medical marihuana in certain places. Restricts the vaporization of medical marihuana in certain places.
- Reporting requirements for practitioners, patients and designated caregivers. Details reporting requirements for practitioners related to changes in circumstances affecting the patient’s certification. Defines reporting requirements for patients and designated caregivers for scenarios where certain information contained on the patient certification changes or if the certified patient or designated caregiver loses his or her registry identification card.
- Proper disposal of medical marihuana products by patients or designated caregivers. Details the required disposal procedures for medical marihuana products.
- Prohibitions. Contains general prohibitions, practitioner prohibitions and prohibitions on designated caregivers.
All practitioners and organizations should consult qualified legal counsel experienced with Department of Health (DOH) Certificate of Need (CON) applications and the regulation of professional practice.