Revised Protocol Process Overview (posted February 12, 2016)
On January 1, 2013, the Humanitarian Medical Use of Marijuana Act, Chapter 369 of the Acts of 2012 (the “Act”), went into effect allowing qualifying patients with certain defined medical conditions the legal authority to obtain and use marijuana for medicinal use in the Commonwealth of Massachusetts. This law required that DPH promulgate regulations implementing the objective of the Act that qualified patients have timely access to safe marijuana for medical use.
In August, 2014, DPH released the Protocol for Sampling and Analysis of Finished Medical Marijuana Products and Marijuana Infused Products for Massachusetts Registered Medical Marijuana Dispensaries (the “Protocol”). At the time of release, no state or federal guidelines were available to evaluate the potential contaminants in marijuana. As a result, DPH developed guidelines using an approach similar to how the government evaluates contaminated food or water when actual exposure levels or rates of consumption are not known. In this model, initial requirements are set cautiously, designed to overestimate exposure to ensure that vulnerable populations are protected. Once the initial requirements are established, further work may be done to refine them.
Over the course of the past year, officials from DPH have actively worked with representatives from analytical testing laboratories, registered medical dispensaries, and patient advocacy groups (“stakeholders”) to solicit feedback on the Protocol, develop specific assumptions for marijuana for medical use, and refine estimates used in the development of the Protocol. Based on feedback from the stakeholders, as well as a year of operational experience in the regulation of this new industry, DPH developed a new version of the Protocol (“Revised Protocol”).
A significant change to the Revised Protocol is that it describes the adoption of a pharmaceutical industry-type approach, based on a compendium of standards published annually by the United States Pharmacopoeia (USP) Convention. These standards have been developed specifically for drugs sold in the United States and are continuously revised through a public–private collaborative process that involves pharmaceutical scientists from industry, academia, and government, as well as stakeholders from around the world.
A key distinction of the Revised Protocol is that DPH is now adopting established standards (i.e., levels of allowable contaminants) for evaluating marijuana for medical use, rather than developing its own standards. The Revised Protocol is supported by an established framework of guidance documents to support laboratories and manufacturers when developing systems to monitor the purity, safety, and efficacy of medical products. For example, by adopting USP standards for the testing of elemental impurities (e.g., heavy metals), analytical testing laboratories now have access to established methods for meeting the USP standards. The USP approach also has the added advantage of utilizing an established system where all stakeholders have the opportunity for input. USP standards are developed and changed in an open and collaborative process, seeking informed input from independent experts with a wide variety of backgrounds – healthcare, regulatory, industry, academia, and others. By adopting this approach, we are ensuring that the standards within the Revised Protocol have been developed through a rigorous process with a high level of public assurance that they have been developed using a broadly representative body of science.
Following the release of the draft Revised Protocol on November 20, 2015, a Public Comment period ensued and DPH received approximately 185 comments from about 175 different individuals or organizations. Many submissions contained identical or similar comments or questions. In total, there were approximately 42 different comments or questions on approximately 18 different areas. DPH has prepared a response to these items and posted a response here:
In general, the Revised Protocol was very well received. For example, original concerns regarding the laboratory testing of cadmium, arsenic, mercury and lead have been addressed, and DPH received positive comments on developing a consensus approach that was responsive to stakeholder comments. Significant changes to the Revised Protocol that occurred as a result of the public comment period include a clarified flow-chart/process explaining how marijuana products are evaluated, as well as changes to the list of pesticides and cannabinoids that should be included in the testing.
DPH also received comments on the Revised Protocol describing a need for a residual solvent standard for butane. As a standard is not available from USP, DPH developed interim guidance for the use of butane in marijuana extractions that is based on measured levels in prepared food (see DPH Circular Letter DHCQ 15-08-638, available here:
Amendment to the Protocol for Sampling and Analysis of Finished Medical Marijuana Products and Marijuana-Infused Products for Massachusetts Registered Medical Marijuana Dispensaries (Addition of hydrocarbon gases)
DPH is continuing to engage stakeholders on opportunities to refine the interim guidance informed by (a) laboratory reports describing levels of butane in medical marijuana products in Massachusetts; and (b) analyses prepared by consultants that were partially submitted by industry groups describing a proposed standard.
DPH received comments indicating that it should revisit the overall approach for evaluating marijuana for medical use. For example, stakeholders have recommended that DPH revisit our recommended approach to screening for pesticides, sampling marijuana for analyses, and determining the qualifications of laboratories. To address this need, DPH has engaged an independent scientific advisory panel for recommendations on industry best practices, developed a process to provide an evaluation of laboratory capability, and implemented a framework to ensure that a systematic process is in place to consider input from all stakeholders on any proposed changes to the DPH Medical Use of Marijuana Program protocols.
The Revised Protocols went into effect on March 31, 2016.
- Protocol for Sampling and Analysis of Finished Medical Marijuana Products and Marijuana-Infused Products for Massachusetts Registered Medical Marijuana Dispensaries
- Protocol for Sampling and Analysis of Environmental Media for Massachusetts Registered Medical Marijuana Dispensaries