Public Health Council Approves Medical Marijuana Regulations
Regulations balance patient access with community safety; competitive application process for registered marijuana dispensaries to take place this summer and fall
BOSTON — The Massachusetts Department of Public Health (DPH) today presented the Public Health Council with a final regulation implementing An Act Regarding Humanitarian Medical Use of Marijuana. The Public Health Council unanimously approved the regulation, commending the Department for its thoughtful development of the regulation.
In November 2012, 63 percent of Massachusetts voters approved Ballot Question 3, with majority support from 349 out of 351 communities across the Commonwealth. The Act became law on January 1, 2013, allowing qualifying patients with certain defined debilitating medical conditions to obtain and use marijuana for medicinal purposes as approved by their physicians. Under the law, DPH was charged with drafting regulations for medical marijuana in Massachusetts.
The regulations approved today reflect unprecedented public input from hundreds of stakeholders across the Commonwealth including legislators, patient advocates, nationally recognized dispensaries, prevention advocates, leading clinician and physician groups, municipal leadership and law enforcement. DPH also took into account best practices from 17 other states as well as public input from several listening sessions and formal public hearings.
“DPH has carefully considered hundreds of opinions and concerns from across the Commonwealth to create a medical marijuana system that is right for Massachusetts,” said DPH Interim Commissioner Dr. Lauren Smith. “The final regulations reflect a balanced approach that will provide appropriate access to patients, while maintaining a secure system that keeps our communities safe.”
Through the ballot initiative, DPH was charged with creating regulations for cultivation and dispensing of medical marijuana and guidelines for personal caregivers, among other issues. DPH’s final regulation includes the following provisions:
- Registered Marijuana Dispensaries: DPH requires each non-profit organization, now known as a Registered Marijuana Dispensary (RMD), previously known as medical marijuana treatment centers, to operate their own cultivation and dispensing facilities. This allows for uniform seed-to-sale control and maximized security. Limited wholesale distribution of marijuana is allowed between dispensaries to maximize appropriate access to patients with legitimate needs. The change in nomenclature, proposed and adopted by the Public Health Council, stems from a recognition that the activity of these entities is limited to cultivation, preparation, and dispensing of products, and that they do not provide treatment to patients.
- Promoting Patient Access: Recognizing the challenges presented by having access to only one RMD, DPH has responded to public comment by adopting a regulation in which patients may choose which RMD to purchase products from, similar to a pharmacy, instead of being required to designate only one RMD. This inclusive framework will promote appropriate access for patients in need, while strict requirements on RMDs will ensure security.
- Hardship Cultivation: DPH minimizes home cultivation by optimizing access through a variety of approaches, including: 1) Mandating the industry provides and finances discounted rates for low-income residents at all RMDs. 2) allowing secure home delivery where necessary, and 3) encouraging personal caregivers to pick up product in lieu of cultivation.
- Personal Caregivers: A family member or friend who is at least twenty-one (21) years old may care for a patient using marijuana for medical purposes. DPH’s final regulation requires that except in the case of certain health care workers providing care to a qualifying patient, or immediate family members, a caregiver may only serve one patient. A qualifying patient may have up to two caregivers.
- Debilitating Medical Condition: DPH does not further define which medical conditions qualify patients for medicinal use of marijuana, instead leaving that important decision to physicians and their patients. DPH does, however, define the word ‘debilitating,’ clarifying that medical marijuana is intended for use in patients with serious conditions.
- Defining a 60-Day Supply: Balancing the potential for diversion with legitimate patient needs, the final regulation allows up to 10 ounces for a personal 60-day supply. Physicians retain the autonomy and authority to increase the amount of a 60-day supply in limited circumstances as they see fit in their professional judgment.
- Defining a Bona-Fide Physician-Patient Relationship: Means a relationship between a physician, acting in the usual course of his or her professional practice, and a patient in which the physician has conducted a clinical visit, completed and documented a full assessment of the patient’s medical history and current medical condition, has explained the potential benefits and risks of marijuana use, and has a role in the ongoing care and treatment of the patient.
- Limiting Pediatric Access: The regulation restricts access to those less than 18 years of age, requiring parent or guardian approval and certification by two physicians, one of whom must be a pediatrician or pediatric specialist. The regulation allows youth access for a life-limiting illness, likely to result in death within two years. Recognizing the need of a small population of youth with debilitating conditions that may not lead rapidly to death, two physicians may override the life-limiting restriction if they determine the benefits of medical use of marijuana outweigh the risks.
- Laboratory Testing: The regulations require a quality assurance and periodic testing plan for contaminants, such as pests, mold, mildew, heavy metals and pesticides. The testing is to be done by an accredited, independent laboratory and paid for by the RMD.
- Municipal Oversight: DPH has responsibility for the medical marijuana program throughout the state, including registration of individuals and RMDs, inspection of RMDs, and enforcement. DPH has developed an inclusive framework for engaging municipal government. DPH does not preclude municipalities from assessing fees or passing certain local regulations, including zoning or siting. The regulation takes local support into account in the consideration of applications. The regulation also requires that applicants notify communities early in the application process, and grants certain rights to local authorities in the inspection of RMDs.
- Advertising: Recognizing the concerns of the substance abuse prevention community and municipalities, while also taking into account the need for qualifying patients to have access to information about RMDs, DPH has limited certain advertising materials, including, for example, prohibiting ads that depict or encourage the recreational use of marijuana, or portray youth, or show smoking or smokable products.
- Deceptive Packaging: The regulations prohibit marijuana-infused, edible products from resembling any form of commercially available candy.
The regulation approved today goes into effect on May 24, 2013. For qualifying patients who have already received a written recommendation from a physician, no further action is needed at this time. The law allows such a qualifying patient to cultivate a supply of marijuana for personal medicinal use in the absence of a formalized medical marijuana program. Until DPH implements this program and provides public notification of the need to register with the Department, this provision remains in effect.
This spring, DPH will also be engaging in a process to determine fees for medical marijuana registrants. By law, this program must be self-sustaining through these fees. No taxpayer dollars will be used to subsidize marijuana for medical use.
DPH will then engage in a competitive application process for medical marijuana treatment centers in the summer and fall of 2013.
For further information, frequently asked questions are available on the DPH medical marijuana website,www.mass.gov/medicalmarijuana, along with a memo to the Public Health Council summarizing key issues, and the full regulations.
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