105 CMR 725.000 - PHC 2.0 FINAL [Read-Only] Blog

105 CMR 725.000

Implementation of an Act for the Humanitarian Medical Use of Marijuana Final Regulatory Amendment Presentation

Eric J. Sheehan, JD Director of the Bureau of Health Care Safety and Quality

Bryan Harter, MBA, LICSW Director, Medical Use of Marijuana Program

Beth D. McLaughlin, Esq. Senior Deputy General Counsel

Marc Nascarella, MS, PhD, CPH Director, Environmental Toxicology Program

Public Health Council November 8, 2017

Slide 1

Background

? The purpose of this presentation is to request final promulgation by the Public Health Council of the proposed revisions to 105 CMR 725.000, Implementation of an Act for the Humanitarian Medical use of Marijuana.

? These amendments are proposed as part of the regulatory review process, mandated by Executive Order 562.

? This regulation sets forth standards for the medical use of marijuana, the registration of patients, physicians, caregivers and registered marijuana dispensaries (RMDs), and the operation of the RMDs.

? This regulation ensures a high quality of care, industry standardization, and strong consumer protection for individuals in need of medical marijuana.

? First, we would like to give you a brief overview of the Program's

accomplishments to date.

Slide 2

Program Accomplishments

Streamlined the Registered Marijuana Dispensary (RMD) application process to be more efficient and transparent

? Process more effectively provides access to patients in all areas ? Applications are accepted on a rolling basis ? Applicants have the opportunity to provide clarifications and updates to DPH

throughout the application review process ? Municipal permitting may take place at any time throughout the process ? All RMD application materials and the status of each RMD application are posted online

Application of Intent (AI) $1,500 fee

?Non-profit or Domestic Business incorporation

?Proof of initial capital

?Character and Competency forms submitted

Management & Operations Profile (MOP)

$30,000 fee

?Non-profit compliance, if applicable

?Operations policies and procedures

? Background check authorization forms submitted

?Must submit a MOP within 45 days of the invitation to do so

Siting Profile (SP)

?Evidence of interest in site

?Letter of municipal support or non-opposition

?Compliance with municipal requirements

?Must receive an invitation to submit a SP within one year of the date of submission of the MOP

Provisional Certificate of Registration (PCR)

$50,000 fee

?Ongoing inspections by DPH begin

?Build-out of facility begins

?Must receive a PCR within one year of the date of the invitation letter to submit a SP

Final Certificate of Registration (FCR)

?RMD begins MMJ cultivation and prepares for sales ?Upon final DPH inspection and successful testing of product, sales begin

Slide 3

Program Accomplishments

Expanded patient access

? 15 RMDs are currently open for sales ? Five RMDs are approved by the Department to deliver medical marijuana

statewide to registered patients ? Every county in the Commonwealth has at least one Provisionally Certified RMD

Improved patient safety

? Established laboratory testing protocols to ensure consistency in the testing of marijuana for medical use so that patients have reliable access to safe medical marijuana products across the Commonwealth

? Developed product quality reports based upon marijuana product testing results to better understand what medical marijuana product looks like in Massachusetts

Built collaborative stakeholder relationships

? Work with patient advocates, RMDs, and testing laboratories to understand the issues that affect both patients and the industry in order to make informed improvements to the program

Slide 4

Current Program Snapshot

Active Patients Active Caregivers Registered Physicians

RMDs with a PCR RMDs open for sales RMDs with an FCR, but not yet open for sales

March 2015 6,587 193 64

March 2015 14 0 1

September 2017 41,077 4,201 208

September 2017 123 15 6

Slide 5

Registered Marijuana Dispensaries (RMDs)

Slide 6

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