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NY issues regulations for statewide medical marijuana program expected to start in 2016

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ALBANY, New York — Cancer, AIDS, Lou Gehrig's disease, Parkinson's disease and multiple sclerosis are among the conditions for which New Yorkers can apply for the statewide medical marijuana program expected to start next year.

Also included in the final regulations posted by the New York Health Department are certain spinal cord injuries, epilepsy, inflammatory bowel disease, neuropathies and Huntington's Disease and symptoms including severe or chronic pain, seizures, severe nausea, persistent muscle spasms and wasting syndrome.

Under the law signed last July, patients with those diseases will be able to obtain non-smokeable versions of the drug, which can be ingested or vaporized. The regulations posted Tuesday night authorize the health commissioner to add other conditions, symptoms or complications.

Approved products will be limited to liquids, oils or capsules, according to the regulations set to take effect when published April 15 in the State Register.

"Approved medical marijuana products may not be incorporated into edible food products by the registered organization, unless approved by the commissioner," the regulations said. "Smoking is not an approved route of administration."

The rules call for licensing five businesses or nonprofits in New York to grow, process and distribute the drug. Any who fail to get an operation or distribution facility properly operating within six months can lose their registrations.

Applicants have to pay a $10,000 fee for review. Those selected would pay an additional $200,000 registration fee and meet security guidelines. The licenses would be for two years.

The Drug Policy Alliance said Wednesday that the department made no substantive changes from the proposed regulations issued in December, despite receiving thousands of comments from patients, families and others urging revisions. Another 22 states have passed medical marijuana laws, while some have passed laws taxing and regulating marijuana for adult use, and the federal government has indicated it won't interfere with properly administered state programs, the group said.

Two concerns are patient access, with plans for only 20 dispensaries statewide and no specific provisions for locations or shipping, and prices that will be set by the department instead of the market, with no specific provision for low-income patients, said Gabriel Sayegh, alliance managing director of policy and campaigns. "The cost is not going to be covered by any insurance," he said. "You don't want a situation where the cost is prohibitive."

In comments posted online, the department said the law requires the commissioner to set the price per dose, to take into account fixed and variable costs, and doesn't allow for price differences based on patient income. While the regulations prohibit free samples, they allow authorizing a registered organization to implement a charity program. The department can waive the $50 fee for patients' identification cards due to financial hardship.

The department also said that the law authorizes registering no more than five organizations with four dispensing facilities each, though coverage will be a consideration in the initial selection process and the health commissioner can consider more. It noted that its prior approval is required for use of a delivery service, and that patient needs will be monitored.


http://www.health.ny.gov/regulations/medical_marijuana/regulations.htm

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