April 10, 2013

Implementing Chapter 369 of the Acts of 2012 An Act for Humanitarian Medical Use of MarijuanaDraft Presentation of 105 CMR 725.000DPH Medical Marijuana Work Group1 April 10, 2013

Cheryl Bartlett Interim Deputy Commissioner Iyah Romm Special Advisor to the Commissioner Priscilla Fox Deputy General Counsel Alison Mehlman Deputy General Counsel On Behalf of the DPH Medical Marijuana Work Group 1Cheryl Bartlett, Alice Byrd, Dr. Madeleine Biondolillo, Julian Cyr, Dr. Alfred DeMaria, Andy Epstein, Priscilla Fox, Donna Levin, William Luzier, Alison Mehlman, Kara Murray, Jenny Nathans, Lydie Ultimo, Iyah Romm, Dr. Lauren Smith, & Jay Youmans

Agenda • An Act for the Humanitarian Medical Use of Marijuana • Public Engagement and Outreach • Key Policy Decisions • Detailed Review of Regulations – Integrated Q & A • Definitions • Individual Registrations • MMTC Registration • MMTC Operations • General Provisions • Next Steps

Overwhelming passage – “Yes” in 349 communities Lawrence No: 51% Yes: 49% Mendon No: 51% Yes: 49%

An Act for Humanitarian Medical Use of Marijuana Does • Require DPH to promulgate regulations allowing patients with debilitating medical conditions to obtain and consume medical marijuana without state legal penalty; • Require DPH to define key parameters, including “bona-fide physician patient relationship,”“debilitating medical condition,” and “60-day supply;” • Allow home-cultivation under specific hardship parameters; • Include provisions for caregivers to support patients using medical marijuana; • Allow MMTCs (up to 35 in year 1) to grow, process, and dispense marijuana to qualifying patients; • Empower DPH as the authority to oversee all cultivation, dispensing, sales, and consumption of marijuana; and • Gives DPH the authority to make key programmatic and policy decisions. Does Not • Give immunity under federal law or obstruct federal enforcement of federal law; • Supersede MGL prohibiting possession, cultivation, transport, distribution, or sale of marijuana for non-medical purposes; • Allow the operation of a motor vehicle, boat or aircraft while under the influence of marijuana; • Require any health insurer or government entity to reimburse any person for the expenses of the medical use of marijuana; • Require any health care professional to authorize the use of medical marijuana for a patient; • Require any accommodation of the medical use of marijuana in any workplace, school bus or grounds, youth center or correctional facility; or • Require any accommodation of smoking marijuana in any public place.

Listening Sessions, Meetings and Written Comment • Listening Sessions: • 200+ attendees at each and 150+ testimonials in total • Stakeholder Meetings: • More than 65 meetings with patient advocates, industry experts, law enforcement, physicians, elected officials, municipal leaders, and more. • Written Comments: • Hundreds of written comments from diverse array of stakeholders. Key Themes

Summary of Public Response After Regulation Release “The Department of Public Health has done a thoughtful and responsible job with a difficult task in proposing regulations to implement the medical marijuana law. DPH has also narrowed the boundaries of medical conditions and allowed for physician judgment in determining what conditions may qualify for medical marijuana, and has included use of the Prescription Monitoring Program in certifying patients. Today’s regulations suggested by the Department of Public Health show clear evidence that careful consideration was given to what is best for patients, communities, and the Commonwealth.” - Physician Leader “DPH is clearly committed to implementing a model program of strictly medical use…from the patient’s perspective, these draft regulations look mostly positive.” - Patient Advocate “In terms of safety and security, Massachusetts has set the new gold standard with their requirement for oversight from seed to sale, which safely eliminates and prevents diversion and crime… DPH clearly spent time, energy, resources and a tremendous amount of effort into putting together the best regulations I have seen in the industry to date. They make it work for everybody, whether they are a patient, dispensary operator, law enforcement officer or regulator. The regulations proposed will eliminate opportunity for diversion, and therefore should please and allay fears of the public in general, city and town officials and law enforcement” - Industry Expert While voters overwhelmingly approved the framework for Massachusetts' medical marijuana program through the ballot in November, the Department of Public Health was tasked with writing regulations to fill in the details and make the program operational. As a longtime advocate for responsible medical marijuana legislation in the legislature, I am impressed by the due diligence of DPH to get the job done right and the comprehensive regulations that have been put forth as a result. - Legislative Leader

Key Policy Decisions • Stakeholders: • Evaluated each stakeholder comment individually • Examination of Other States: • Reviewed regulations of all other states with active or in-development medical marijuana programs • Specific focus on regional and model states: • CO, CT, NM, NJ, RI, ME, VT,

Advertising Comment(s) Received Prior to Issuance of Regulations • DPH should limit advertising, building signage, and public communication by MMTCs so as to ensure appropriate public messaging. • Recommendations included prohibiting use of colloquial terms in naming MMTCs, as well as a prohibition on direct-to-consumer advertising. Regulation • DPH proposes limiting advertising, building signage, and public communication by MMTCs so as to ensure appropriate public messaging. • Provisions include prohibition of use of colloquial terms in naming MMTCs, as well as prohibiting reference to medical benefits of marijuana without clear supporting evidence.

Continuing Medical Education Comment • No specific comments were received regarding CME, however many stakeholders indicated concerns regarding lack of physician education. • Physicians indicated a lack of comfort with knowledge of medical marijuana – including appropriate use and/or misuse • Patients indicated concern for lack of access that may result from insufficient physicians comfortable certifying patients for medical marijuana use • Substance abuse prevention advocates indicated discomfort with lack of physician education around potential misuse of product by patients, including risk factors and treatment Regulation • Physician must complete a minimum of 2.0 Category 1 continuing professional education credits (CMEs) on the subject of medical marijuana and substance abuse before certifying a debilitating medical condition. • Programs must be planned and implemented by an organization accredited by the Accreditation Council for Continuing Medical Education (ACCME), American Osteopathic Association, American Academy of Family Physicians, or a state medical society recognized by the ACCME. • These CME events may be online to allow greater access and ease of use by physicians. • After January 1, 2014, DPH will require that registering physicians attest to having completed a CME course prior to issuing written certifications of a debilitating medical condition.

Debilitating Medical Condition Comment • Largely recommended leaving the determination of need for medical marijuana to physician discretion. • Some stakeholders encouraged clarification of “debilitating” through a regulatory definition. • Numerous patients who benefited from marijuana have undiagnosed or rare conditions. Further defining debilitating conditions may limit access. Regulation • Minor modifications to statutory definition (in bold) • Debilitating Medical Condition means cancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome (AIDS), hepatitis C, amyotrophic lateral sclerosis (ALS), Crohn’s disease, Parkinson’s disease, and multiple sclerosis when such diseases are debilitating, and other debilitating conditions as determined in writing by a qualifying patient’s physician. • Further defines debilitating to clarify intent: • “Debilitating means causing weakness, cachexia/wasting syndrome,intractable pain, or nausea, or impairing strength or ability, and progressing to such an extent that one or more major life activities are substantially limited. Patients who have had a diagnosis of a debilitating medical condition in the past but do not have active disease and are not undergoing treatment for such condition are not suffering from a debilitating medical condition for which the medical use of marijuana is authorized.”

Defining a Bona-Fide Physician-Patient Relationship Comment • Nearly all stakeholders stated that DPH not overregulate the physician-patient relationship. • Veterans expressed concern that an overly restrictive definition, such as one requiring multiple visits prior to certification, would impose an access burden. • BORiM proposed the following definition: • “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 completed and documented a full assessment of the patient's medical history and current medical condition, including a physical and mental status examination, and has responsibility for the ongoing care and treatment of the patient.” Regulation • “Bona Fide 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.” • BORiM & DPH enforcement authorities

Hardship Cultivation Comment • Many advocated for strict limitation on home cultivation, including through all mechanisms available. • Many commented that home cultivation is more expensive and often presents many more quality assurance challenges than obtaining product from a MMTC. • Most commented that hardship cultivation should be an approach of last resort. • Many suggested that DPH encourage “compassionate use programs” in MMTCs. • Many patients and advocates expressed significant support for home cultivation, and encouraged DPH to minimize barriers to hardship cultivation registrations Regulation • Massachusetts will be the first state to develop hardship cultivation criteria. • DPH intends to minimize hardship cultivation by optimizing access through a variety of approaches, including: 1) mandating the provision of low-income subsidies at all MMTCs, 2) allowing secure home delivery where necessary, and 3) encouraging personal caregivers to pick up product in lieu of cultivation. Therefore the following criteria must be met for a hardship cultivation registration to be obtained: • Physical incapacity to access reasonable transportation • Verified financial hardship • Lack of treatment center within a reasonable distance of the qualifying patient’s residence or lack of access to delivery

Laboratory Testing Comment • Consensus that some defined level of quality assurance testing requirements are required for MMTCs to ensure safe and quality product. • Some recommended in-house testing at MMTCs, while others voiced concern that given the nascent marketplace, regulations should not be so specific as to prohibit integration of technological advances over time within the regulatory framework. • Nearly all recommended testing for mold and other contaminants, such as heavy metals, as a requirement, while a subset recommended strain genotyping and potency testing (i.e. THC levels). Regulation • Describes a required quality assurance and periodic testing plan in the application for approval as a treatment center, with DPH to use responses in evaluating applications. • Further specifies a requirement that the MMTC must test for contaminants as specified by the Department, including at least pests, mold, mildew, heavy metals and the presence of pesticides, while including provisions such that the Department may require additional testing without regulatory change.

Municipal Oversight Comment • Highly varied comment. • Many (especially larger municipalities) seek extensive oversight of industry, while many others favor a model in which state has sole oversight. • Several municipalities indicated interest in collecting fees and acting as designee of state on local level, especially with regard to food inspections. • Landlords and municipal leadership expressed concern for the liabilities and impacts associated with medical marijuana. • Concerns ranged from the use of smoke-able forms of marijuana in non-smoking spaces (both rented residences and public spaces), to the federal liabilities of cultivating or using product in federally subsidized housing or programs (i.e. HUD housing, federally funded programs such as veterans’ homes, hospitals, substance programs, etc.). Regulation • Inclusive, but non-burdensome framework for engaging municipal government. Notably, no other state’s regulations describe a specific role for local health. • DPH has responsibility for the medical marijuana program throughout the state, including registration of individuals and MMTCs, inspection of MMTCs, enforcement, etc. It should be noted that involvement, partnership, or in some cases, the possibility of potential leadership of these efforts will be determined through sub-regulatory guidance and on an individual basis. • DPH will not mandate any local involvement. • Local governments, including boards of health, would be authorized to pass local regulations that do not conflict with state law, such as local zoning regulations, local fees, etc.

Patient Designation of MMTCs Comment • Limited comment was received on patient designation. Regulation • A qualifying patient must designate one MMTC (unless applying for a hardship cultivation registration). • Limiting a patient to one MMTC would give MMTCs the ability plan for and cultivate an appropriate number of marijuana plants for their patients’ needs, cutting down on waste and diversion, while allowing for critical seed-to-sale tracking. • A qualifying patient may designate a MMTC once in a 120-day period with notification to DPH. • No limit on the number of patients who can designate a single center.

Personal Caregivers Comment • Highly varied comment regarding models of MMTC infrastructure and registrations included discussion of personal caregivers as a cottage industry – cultivating in co-ops on behalf of many patients. • Little testimony focused directly on the characteristics of personal caregivers. Regulation • At least twenty-one (21) years old who assists with a qualifying patient’s medical use of marijuana, and is not the qualifying patient’s physician. • Except in the case of a healthcare worker, a caregiver may only serve one patient. • A qualifying patient may have up to two caregivers. • Only one of the two personal caregivers may cultivate marijuana on behalf of the qualifying patient if said patient has obtained a hardship cultivation registration.

Youth Access Comment • Significant concern about direct and indirect impacts of this program on youth. • Pediatric experts commented that those under 18 years of age should be restricted from accessing medical marijuana. • Concerns primarily relate to a lack of evidence of efficacy in minors and evidence of a deleterious effect of marijuana on the developing brains of children and youth. • Others commented that age restrictions were not consistent with the intent of the ballot measure and DPH should pursue the allowance of youth use in one of two models: • 1) only allowing physician certification of youth with life-limiting illness, but prohibiting use for chronic illnesses including pain and ADHD; or • 2) allowing youth use but only with parental consent and certification by two physicians independent from one another. Regulation • Restrictive model for access to those under 18 years of age. No state prohibits youth access. • Two physicians must certify the patient’s debilitating medical condition, at least one of whom must be a board-certified pediatrician. Parental/guardian consent is required prior to youth registration and parent must serve as caregiver. Youth access is restricted to only those youth with a life-limiting illness. • Life-Limiting Illness means a debilitating medical condition that does not respond to curative treatments, where reasonable estimates of prognosis suggest death may occur within six months.

60-Day Supply Comment • Highly varied recommendations were received (as little as 3 to 4 oz. to as much as 24 oz.). • Consistent comment was made that the 60-day supply was intended to be definition for possession. • Many commented that there is no known history of overdose, therefore a margin of safety is believed to exist. • Many commented that severely debilitated patients or those with acute illnesses will consume significantly greater quantities than patients with more intermittent and moderate needs and that patients’ needs will diverge further given the varied methods of consumption • Some stakeholders recommended broad physician discretion while others advocated for a specific, regulated cap. • DPH should allow 30-days dispensing at any given time consistent with narcotics. Regulation • Allows up to 10 ounces of finished product in leaf form (or equivalent) as a 60-day supply for the purposes of defining a maximum amount of medical marijuana that can legally be possessed or dispensed at a given time. • A physician’s certification for a debilitating condition must indicate the time period for which such certification is valid; however, this physician determination may not exceed one year. The amount of medical marijuana that a patient may be dispensed would be in direct proportion to the period of time indicated in the certification. • Physician may over-ride 10 ounce limit for acutely ill patients.

Key Definitions – In Review – 725.004 • Bona Fide Physician-Patient Relationship means a relationship between a certifying 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. • Debilitating Medical Condition means cancer, glaucoma, positive status for human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), hepatitis C, amyotrophic lateral sclerosis (ALS), Crohn’s disease, Parkinson’s disease, and multiple sclerosis (MS), when such diseases are debilitating, and other debilitating conditions as determined in writing by a qualifying patient’s certifying physician. • Debilitating means causing weakness, cachexia, wasting syndrome,intractable pain, or nausea, or impairing strength or ability, and progressing to such an extent that one or more major life activities are substantially limited. • Life Limiting Illness means a debilitating medical condition that does not respond to curative treatments, where reasonable estimates of prognosis suggest death may occur within six months. • Massachusetts Resident means a person whose primary residence is located in Massachusetts. • Medical Marijuana Treatment Center (MMTC) means a not-for-profit entity registered under 105 CMR 725.000, that acquires, cultivates, possesses (including development of related products such as edible MIPs, tinctures, aerosols, oils, or ointments), processes, transfers, transports, sells, distributes, dispenses, or administers marijuana, products containing marijuana, related supplies, or educational materials to registered qualifying patients or their personal caregivers who have designated such entity as the patient’s registered MMTC. Unless otherwise specified, MMTC refers to the site(s) of dispensing, cultivation, and preparation of any marijuana products, including MIPs, if any.

Registration of Certifying Physicians – 725.005 • Physician must hold an active full license, with no prescribing restriction, to practice medicine in Massachusetts and an MCSR. • Physician submits simple documentation to the IT system and is automatically enrolled. • Registration is indefinite unless: • Physician’s license is suspended, revoked, or restricted with regard to prescribing, or the physician has voluntarily agreed not to practice medicine; • MCSR is suspended or revoked; • Physician fraudulently issues a written certification of a debilitating medical condition; • Physician has certified a qualifying patient for a debilitating medical condition on or after January 1, 2014, without appropriate completion of CME • Ongoing responsibility to notify DPH of change in information – lack of notification is grounds for action against registration to certify patients – MCSR not implicated. • BORiM and DPH enforcement authorities

Issuing a Written Certification – 725.010 • After January 1, 2014, physician must have previously completed 2.0 hours of category 1 CME. • Physician must comply with pertinent licensure standards. • Delegation is prohibited and a bona-fide relationship is required. • PMP must be used prior to certifying a patient to review prescription and MMJ history. • Patient without active disease may not be certified. • Initial certifications may not be issued without an office visit (including history, physical exam, risks/benefits, etc). • Certification ranges from 15 days – 1 year. 60 day supply is automatic unless specified. • Allowable amount of substance dispensed tied to length of certification • Physician override • Examination of patients at MMTCs is prohibited as are any financial or otherwise beneficial relationships between MD and MMTC. • Self-certification is prohibited and certification of co-workers/family members must comply with all regulations. • Certifying youth requires two physicians, at least one of whom is a board certified pediatrician. • Required parental/guardian consent and parent must serve as caregiver • Life limiting illness

Registration of Qualifying Patients – 725.015 • Patient submits requisite documentation (including photo ID and designated MMTC) to IT system. • Includes written acknowledgement of the limitations on his or her authorization to cultivate, possess, and use marijuana for medical purposes in the Commonwealth and an attestation that the patient will not engage in diversion. • Registration is valid for 5 years – note distinct from certification period. • Patients using MMJ prior to effective date of regulations must apply to DPH by January 1, 2014. • Ongoing notification requirements to DPH. • Patient may change designated MMTC once in a 120-day period.

Registration of Personal Caregivers – 725.020 • Patient submits requisite documentation (including photo ID) to IT system on behalf of caregiver – even if caregiver is a HCW, requisite attestations and acknowledgement of limitations as for registering patients, and indicates whether caregiver will be cultivating. • Caregivers in place prior to effective date of regulations must apply to DPH by January 1, 2014. • Caregiver may serve only one patient – waiver process for co-located individuals or parents. • No such limit for health care workers. • Each patient may have two caregivers – but only one may cultivate. • Caregiver may not receive payment or other compensation for services rendered as a personal caregiver – HCWs may not be compensated beyond normal wages. • Registration valid for five years. • Ongoing notification requirements.

Responsibilities of Personal Caregivers – 725.025 May Transport a patient to and from a MMTC; Obtain and transport marijuana on behalf of a patient; Cultivate marijuana on behalf of a patient who has obtained a hardship cultivation registration; Prepare marijuana for consumption by a patient; and Administer marijuana to a patient. May Not Consume marijuana that has been dispensed to or cultivated on behalf of a patient; Sell or otherwise divert marijuana; Cultivate marijuana for personal use; or Provide marijuana to anyone other than the patient.

Registration of Dispensary Agents – 725.030 • All individuals associated with an MMTC, including volunteers, must be registered as dispensary agents. • Dispensary agents must be 21yo and not have been convicted of a felony drug offense. • A recent CORI must be submitted for each DA applicant • Registration is tied to an MMTC not the individual and upon severance of that relationship, the dispensary agent registration is void – immediate notification is required. • Annual renewal is required, including annual CORI – may be paid for by individual or the MMTC. • Ongoing notification requirement.

Hardship Cultivation Registration – 725.035 • Individual must have: • Verified financial hardship (<133% FPL, on SSI, or receives MassHealth); or • Physical incapacity to access reasonable transportation, as demonstrated by an inability to use public transportation or drive oneself, lack of a personal caregiver with a reliable source of transportation, and lack of a MMTC that will deliver marijuana to the patient’s or personal caregiver’s primary address; or • Lack of a MMTC within a reasonable distance of the patient’s residence and lack of a MMTC that will deliver marijuana to the patient’s or personal caregiver’s primary address. • Clear demonstration of lack of feasible alternatives. • Written explanation of ability to meet regulatory requirements • Individual may only cultivate at one location, or have one caregiver cultivate at one location. • Hardship cultivation registration must be annually renewed, irrespective of certification or registration status. • Cultivation may only be so much as to support personal use. • Cultivation and storage must be in a secure, enclosed, locked area accessible only to the patient or personal caregiver and cannot be visible from the street or other public areas. • Ongoing notification requirements, and requirement to register by January 1, 2014 if previously cultivating.

Registration of MMTCs (General) – 725.100 • No more than three MMTCs may be owned or controlled directly or indirectly by the same entity, or by any executive, or by any other entity owned or controlled by one or more of such executives. • Each MMTC: • Must incorporate as a non-profit pursuant to MGL c180. • Must make vaporizers available for sale • May cultivate only at one site – either colocated with dispensary or freestanding – not both. • Must have a program to provide reduced cost or free marijuana • All officers, executives, and board members of a MMTC must be registered as dispensary agents. • Prohibition on: • Sales or distribution of product except to registered qualifying patients • Free samples • Internet/mail ordering, • Ongoing required (appropriate) access to DPH, law enforcement, emergency responders, etc. • Comprehensive incident reporting requirements, including 24 hour notification where necessary. • Criminal and regulatory compliance history are important factors of review.

Registration of MMTCs (Phase 1 Application) – 725.100 • Upon DPH publication of Notice of Application Opportunity, entity must submit: • Documentation of non-profit status as incorporated in MA • Documentation of $500,000 in escrow • Documentation that no officer, director, or board member of the entity, and no prospective employee or volunteer of the MMTC, has been convicted of a felony drug offense; • A description of any legal or regulatory enforcement actions in another state against any related entity regarding cultivation, processing, distribution, or sale of medical marijuana; • An attestation signed that the entity is prepared to pay a non-refundable application fee if selected to advance to Phase 2; • Application fee; • A description of the proposed locationfor the MMTC; and • Any other information required by the Department.

Registration of MMTCs (Phase 2 Application) – 725.100 • Comprehensive application, including but not limited to: • Evidence of local support or non-opposition. • Non-refundable fee • Legal details of entity (articles of incorporation, etc) and proposed MMTC location(s), including guarantee that cultivation of, or sale of, marijuana is permissible on the property • Evidence of sufficient interest in the property (ownership, 5 year lease, etc) • Evidence of compliance with ADA and local codes/ordinances/regulations • Evidence that MMTC can begin operations within 120 days (that is, growth can begin within 120 days of receipt of registration) • Detailed policies, procedures, and legal documents such as list of creditors, insurance policies, etc • An analysis of the projected patient population and projected need in the service area of the proposed MMTC • Details of dispensary agent training curricula • Evidence of meeting detailed suitability criteria, including experience running a non-profit organization or other business and history of providing medical marijuana services or other health care services, including provision of services in other states. • Review of Applications will be Merit Based: • Developing Explicit Criteria – e.g. demonstrated expertise, municipal support (or lack thereof) • Application review process to ensure transparency & limit challenges • Clear communication & expectation setting regarding process and timeline

MMTCs Operational Requirements (General) – 725.105 • Policies, Procedures, and Protocols: • Must be maintained on site, including but not limited to security, quality, cultivation, inventory, staffing, emergency response, confidentiality/privacy, and patient education. • Cultivation: • Cultivation, production of MIPs, and dispensing may occur only in one location – each MMTC may have up to two sites. • Cultivation must adhere to USDA Organic Standards. • Lab Testing: • MMTC must test for contaminants and have protocols for responding to issues. • Testing info must be on product labels. • Food Products: • Must be prepared consistent with 105 CMR 500.000: Good Manufacturing Practices for Food, and with the requirements for food handlers specified in 105 CMR 300.000: Reportable Diseases, Surveillance, and Isolation and Quarantine Requirements. • Detailed Sanitary and Storage Requirements • Describes specific requirements for DAs consistent with health care and food preparation. • Storage includes requirements for adequate security, lighting, ventilation, temperature, humidity, space, equipment, and separation of soiled products.

MMTCs Packaging & Labeling Requirements – 725.105 • Labels must include the following information: • Patient and MMTC info • Quantity of usable marijuana (and leaf-form equivalent) • Date of packaging • Key identifiers such as batch and lot numbers • Testing information • THC level • Opaque packaging and storage • Labels must also include this statement: “This product has not been analyzed or approved by the FDA. There is limited information on the side effects of using this product, and there may be associated health risks. Do not drive or operate machinery when under the influence of this product. KEEP THIS PRODUCT AWAY FROM CHILDREN.”

MMTCs Inventory, Record Keeping & Waste – 725.105 • Seed-to-sale tracking/inventory is required at all times, including pre-destruction waste. • Detailed record-keeping requirements are specified, similar to health care facilities, including destruction records and post-closure maintenance. • Liquid waste must be disposed of consistent with DEP requirements. • Solid waste must be disposed of through witnessed incineration. • MMTCs must accept unused, excess, or waste product from any patient or caregiver and dispose of it accordingly.

MMTC Patient Education and Advertising – 725.105 • Detailed patient education requirements are instituted – including on use, abuse, waste disposal, storage, etc. • Appropriate literacy level and language accessibility • Advertising and marketing are significantly limited, including: • Medical symbols, images of marijuana, related paraphernalia, and colloquial references to cannabis and marijuana are prohibited from use in logos • Limits on external signage, including no advertising, price listing, or graphics • Prohibition on visible products from exterior of MMTCs • Prohibition on sales or gifting of novelty items bearing reference to marijuana • Prohibition on encouraging recreational or youth use in advertising.

MMTC Security and Transportation – 725.105 • Extensive security requirements, including: • Established limited access areas • Comprehensive alarm systems (silent/duress/hold-up alarm or automatic voice dialer) • Surveillance cameras • Safes/vaults • Routine inspection (every 30 days) of all security systems • Annual contracted evaluation of security systems by DPH approved vendor • Extensive transportation requirements, including: • Weighing, inventorying, and accounting for all product • Documenting and reporting discrepancies • Shipping manifests • Transportation in secure, locked compartment in secured, unmarked vehicle • Two DAs present at all times (may be contracted vendor with additional security personnel present) • Open lines of communication at all times

Inspection and Enforcement – 725.300-510 • DPH may inspect a MMTC at any time without prior notice. All areas of a MMTC, all dispensary agents and activities, and all records are subject to such inspection. DPH may direct a MMTC to test marijuana or MIPs for contaminants in addition to routine testing. • Unannounced Inspections • Standard DPH protocols for Statements of Deficiency and Plans of Correction are adopted in these regulations. • Detailed grounds are established in these regulations for: • Denial of MMTC initial application • Denial of MMTC renewal application and MMTC registration revocation • Including ability for DPH to restrict sales by an MMTC during a disciplinary process • Denial, void, or revocation of registration cards or hardship cultivation registration • Summary cease and desist and quarantine order • Summary suspension order • Hearing requirements and rights are established consistent with MGL c30A, including due process for appeals.

Municipal Requirements – 725.600 • A MMTC and other registered persons must comply with all local rules, regulations, ordinances, and bylaws. • DPH does not mandate any involvement by municipalities or local boards of health in the regulation of MMTCs, qualifying patients with hardship cultivation registrations, or any other aspects of medical marijuana. • Nothing in these regulations prohibits appropriate, lawful local oversight and regulation, including fee requirements, that does not conflict or interfere with these regulations.

Confidentiality – 725.200 • Information held by the Department about applicants for registration as a qualifying patient, personal caregiver, or dispensary agent, and registered qualifying patients, personal caregivers, and dispensary agents is exempt from public records requests and may only be released by the Department to: • The data subject or the data subject’s authorized representative, pursuant to M.G.L. c. 66A; • Department staff for the purpose of carrying out their official duties with regard to the medical marijuana program; • An individual or entity pursuant to an order from a court of competent jurisdiction; • Law enforcement personnel for the sole purpose of verifying a cardholder’s registration and certification; and • The Board of Registration in Medicine when necessary in connection with referrals to said Board concerning violations of 105 CMR 725.000. • Applications, supporting information, and other information regarding a MMTC are not confidential except relating to patients or caregivers. • Information held by a MMTC about registered qualifying patients and personal caregivers is confidential and shall not be disclosed without the written consent except to the Department.

Waivers – 725.700 • The Commissioner or designee may waive one or more of the requirements imposed by 105 CMR 725.000 upon finding that: • Compliance would cause undue hardship to the registrant; • Non-compliance does not jeopardize the health or safety of any patient or the public; • The registrant has instituted compensating features that are acceptable to the Department; and • The registrant provides to the Commissioner written documentation supporting its request for a waiver. • Given the complexity and magnitude of this regulation, DPH intends to use this waiver provision – consistent with hospital licensure regulations – for unforeseen circumstances, which in repetition, would lead to regulatory changes.

Next Steps • On April 19, 2013 DPH will hold three public hearings in Plymouth, Boston, and Northampton to receive further comment on the proposed regulations. • DPH will accept written comment until 5pm on April 20, 2013. • Mail postmarked by 5pm will be accepted. • Following the comment period, Department staff will return to the Council on May 8, 2013 to provide a review of the testimony, to present any changes proposed in response to the testimony, and to request approval for promulgation of the regulation. • The draft regulations will be released to council prior to the May 8 meeting for review – they will not be released publicly at that time.

Ongoing Information System Development • Core Functions • Register the treatment centers and all of their employees who will have to undergo CORI checks; • Register the thousands of patients and caregivers who will need to supply substantial personally identification information; • Connect and mesh with the PMP system (or equivalent function) so that we can track potential problematic use; • Allow 24/7 access to police and other public safety officials to verify that an individual can possess marijuana under this law; • Allow real time updates of registration information, selection of caregivers, selection of treatment centers; • Track data and perform analytics so we can properly oversee this new industry and allow us to detect any fraud or abuse; • Have appropriate security and access limitations to protect sensitive/confidential information.

Revenue Neutrality – Programmatic Domains and Approaches • Fee Setting – Separate Process Beginning in the Coming Weeks • MMTCs • Multiphasic • Application and annualized registration • Individuals • Patients – at cost of annualized registration workflows • Caregivers – free • Physicians – free • Evaluation

April 10, 2013

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