DOH Regulations on Medical Marijuana
The Department of Health (DOH) released proposed regulations governing the use of medical marijuana (marihuana) under the recently enacted Compassionate Care Act. The DOH website on medical marijuana is available here, and the full text of the regulations is available here.
As reflected in much of the press coverage around the new law, New York is taking a cautious approach towards legalizing marijuana for medical use, and this is reflected in the strict standards found in the new regulations. According to the DOH website, "DOH is committed to implementing a comprehensive, safe and effective medical marijuana program that meets the needs of New Yorkers. The program will ensure that medical marijuana is available for certified patients with serious conditions and is dispensed and administered in a manner that protects public health and safety."
Under the proposed regulations DOH: (i) establishes strict clinical guidelines for prescribing; (ii) sets criteria for qualified prescribers; (iii) defines clinical criteria for patients to be certified for medical marijuana; and (iv) limits the venues is which marijuana can be manufactured, dispensed and used.
The conditions that would allow a patient to access marijuana as a medical therapy are: cancer, HIV/AIDS, Lou Gehrig's disease (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. The law includes these conditions when there is a clinical association with or complication of the condition resulting in wasting syndrome, severe or chronic pain, severe nausea and seizures, or severe or persistent muscle spasms. The commissioner of health has authority under the regulations to expand this list.
Certified patients and their caregivers would be issued a Registry Identification Card that includes the dosing recommendations. DOH maintains the option of revoking a card for any patient that violates any provision of the law. Patients will receive a maximum of a thirty day supply of medication which must be kept in its original packaging. Re-distributing the medication for any reason would be illegal.
Prescribing practioners would be required to complete a four hour training course and register with DOH. The proposed educational content of such a course includes: the pharmacology of marijuana; contraindications; side effects; adverse reactions; overdose prevention; drug interactions; dosing; routes of administration; risks and benefits; warnings and precautions; abuse and dependence; and such other components as determined by the commissioner.
In order to prescribe medical marijuana, the practitioner must certify that the patient has a serious condition that is likely to be helped by the use of medical marijuana. The practioners must also certify that he or she is qualified to treat the patient’s condition as evidenced by training and/or experience with the designated clinical profile. The goal is to ensure medical marijuana is available only to patients with serious conditions who will benefit from the treatment.
The “form” of medical marijuana is defined as: “a type of a medical marihuana product approved by the commissioner and shall refer to the final preparation of an approved medical marihuana brand; for example, an extract in oil for sublingual administration, an extract for vaporization or an extract in a capsule for ingestion.”
Organizations that wish to manufacture and dispense medical marijuana will have to apply to DOH for registration. If approved, those manufacturers must conform to specific requirements that would include strict security, record-keeping and laboratory testing standards. The law allows for up to five registered organizations, located in New York, to grow, manufacture, distribute and dispense marijuana for medical use. Each registered organization may operate up to four dispensing facilities statewide, for a total of 20 geographically-dispersed dispensing facilities. There is an application fee of $10,000 being proposed, to be accompanied by a check for an additional $200,000, the latter of which will be refunded to applicants not selected as registered. Part of the registration process includes DOH approval of pricing and marketing practices.
There is some question at this time as to how the “vaporization” regulations may correspond and/or conflict with smoking policies in health care facilities and other senior congregate living settings. The proposed regulations states: “approved medical marihuana products shall not be vaporized in a public place. In no event shall approved medical marihuana products be consumed through vaporization in any location in which smoking is prohibited.”
Specifically regarding the “vaporization” of marijuana in nursing homes, the regulations state: “general hospitals and residential health care facilities as defined in article twenty-eight of the public health law, and other health care facilities licensed by the state in which persons reside; provided, however, that the provisions of this subdivision shall not prohibit vaporization by patients in separate enclosed rooms of hospitals, residential health care facilities, and adult care facilities established or certified under title two of article seven of the social services law, community mental health residences established under section 41.44 of the mental hygiene law, or facilities where day treatment programs are provided, which are designated as smoking rooms for patients of such facilities or programs.”
LeadingAge NY is seeking additional clarification from DOH on how the smoking of medical marijuana should be handled in health care and other congregate living situations that currently limit or ban the smoking of tobacco products. We will advise members on this and other issues related to the new law and proposed regulations as we pursue additional information.
As published in the Dec. 31 State Register (starting on page 70), there is currently a 45 day period allowing for public comments regarding the proposed regulations. Comments should be sent to regsqna@health.ny.gov.
Contact: Patrick Cucinelli, pcucinelli@leadingageny.org, 518-867-8827