Massachusetts officials have cleared the smoke on the medical marijuana rules and regulations, just six months after voters approved of a ballot initiative to allow the drug to be used by patients with debilitating illnesses.
On Wednesday, the Department of Public Health, the office tasked with compiling an in-depth set of standards for the sale, distribution and use of the drug for medical purposes, brought their draft legislation before the state’s Public Health Council for a vote.
Just hours after reviewing the laws suggested by DPH officials, the council unanimously approved of what was presented, after making a few minor changes to the wording put forth in the pot law package. The final recommendations include allowing a qualifying patient up to 10 ounces of marijuana for a personal 60-day supply, and changing the name of medical marijuana treatment centers to “registered marijuana dispensaries,” while barring advertising that promotes marijuana-infused, edible products that resemble any form of commercially available candy.
“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.”
The regulations address the cultivating process, advertising, and also where and how dispensaries that sell medical marijuana will be able to sprout up, laws that even opponents of the original petition, filed November, are comfortable with.
“I don’t see marijuana as medicine as I define it as a physician. But voters have spoken and it’s very important for the medical society, and physicians in general, to work very hard to try and make sure the law is implemented correctly, and to protect public health and safety,” said Dr. James Broadhurst, family doctor at UMass Memorial Medical Center.
Although the regulations were passed, and will go into effect on May 24, officials said it will still be time before the licensing process for opening marijuana shops begins, which will likely be in the fall of 2013.
Below are the official rules that were voted and accepted by the Public Health Council on Wednesday:
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.
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