Recommendations for creating effective state medical marijuana programs

The success of new state medical marijuana programs at meeting the needs of qualified patients, while also alleviating the concerns of the broader community, depends largely on the appropriateness of the rules that govern them.

Over the past five years, the 4Front team has had many opportunities to weigh in on medical marijuana programs while they’re still under development. Generally, we provide our expert guidance on strengthening these programs to ensure the rules encourage the safety and wellness of patients and their communities, while limiting diversion, but also supporting compliance and appropriate enforcement.

We’re sharing some of these recommendations in hopes they inform conversations surrounding draft legislation and rules for emerging programs. We do not intend for this to be an exhaustive list, but rather a perspective on some of the most important considerations.

Vertical Integration—In an optimum model, dispensary operators should have the option to produce their own medicine — also known as vertical integration — but this approach should not be mandatory. Dispensary operators should have the opportunity to produce medicine because they best understand the needs of their patients. Since the cost of production is typically lower than wholesale prices, vertical integration means that retailers can afford to get medicine to patients at lower retail prices, as well. In addition to dispensary licenses, states should also have separate licenses for cultivators and producers. This will ensure that retailers have access to products and strains that may be beneficial to their patients, but which they may not have the capacity or expertise to produce themselves. It also ensures competition on the wholesale market, which leads to more cost savings for patients.

Qualifying Conditions — To help transition patients from the illicit market to the state-legal market, we encourage a diverse range of qualifying conditions, including language similar to what’s currently found in Massachusetts:

Qualifying conditions include 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.

The intent is to empower those with medical conditions or medical issues that may benefit from marijuana to have access without significant friction. Because there is still a strong need for research and development to support specific treatment protocols, we believe erring on the side of patient choice and access is appropriate.

Limits—Patients should have access to appropriate quantities of medicine, based on their qualifying conditions, but there should also be limits to the amount of medicine they can purchase, which are important to preventing diversion. The average limit imposed by state regulators is typically 2.5 ounces every 14 days. Most states also include provisions in their regulations allowing physicians to recommend amounts exceeding the patient’s limit in order to ensure they have access to an adequate supply of medicine to address their conditions. States should include a physician-waiver feature in their rules as a patient’s consumption of medicine can vary greatly depending on his or her medical condition.

Products—A broad range of products should be available to patients, as they have different consumption requirements and preferences, again erring on the side of choice and access. These products include flowers, buds, salves, tinctures, edibles, and paraphernalia. In regards to paraphernalia, we strongly encourage states to include provisions for vapor-based medical delivery devices.

Packaging—Opaque, childproof packaging that does not resemble commercially available candies or products, should be required in order to discourage misuse of products by children and non-patients. Additionally, any edible product received from registered cultivation centers should be packaged in an airtight, tamper-evident, opaque, food-grade plastic pouch. Packaging for liquid products should be in sealed bottles based on grams and milligrams; solid concentrates should also be weighed and packaged by gram.

Labeling—While each program requires varying degrees of information be included on packaging labels, the following should be standard for all product labels:

• The name of the cultivation center where the medical marijuana was produced.
• The name of the dispensary where the medical marijuana was dispensed.
• The quantity of medical marijuana contained within the package.
• The cannabinoid profile of medical marijuana contained within, including THC and CBD levels.
• Any ingredients other than marijuana contained within, listed from the most abundant to least abundant. If the product is ingestible, potential food allergens (milk, eggs, fish, shellfish, nuts, wheat and soybeans) should also be identified.
• A statement that the product is for medical use and not for resale or transfer to another person.
• A list of all chemical additives, including but not limited to inorganic and organic pesticides, herbicides and fertilizers used in cultivation/production.
• The dispensing date that the medical marijuana was transferred to the qualified patient or caregiver.

Product labeling for marijuana infused products should include the same information as listed above, with the addition of two (2) new categories:

• Dosage: Since edible products cannot be titrated like raw flowerbuds or solid concentrates, and patients may experience adverse effects from using too large a dose, proper dosage labeling is essential.
• Expiration Date: Any edible or potable product has a shelf life that must be placed on the label to inform the customer of a “best-if-used-by date.”

Inventory and Verification Systems—Dispensaries should be required to implement an integrated inventory management and point-of-sale system to continuously monitor inventory and allow for reconciliation of inventory against patient purchases. Additionally, a state-managed patient verification system should be created in order to ensure only registered patients are able to purchase medicine from state-approved dispensaries and do not exceed purchasing limits. Ideally, state patient verification systems should be populated directly from industry-specific point of sale systems like MJ Freeway, BioTrack THC, and Agrisoft, in order to eliminate discrepancies arising from maintaining the same information in two separate systems.

Education—Patient and staff education is critical to successful medicine distribution and use. We recommend the requirement of at least annual staff training on topics like safe consumption, legal requirements, substance abuse prevention, security and diversion, and compliant retail practices. Educational resources should be made available for patients regarding their legal rights and responsibilities, safe consumption, and consumption options.

Security—Security policies should ensure the absolute safety of patients, staff, and community members, and also maintain a welcoming aesthetic that conveys a wellness philosophy. For these reasons, we generally discourage the use of armed guards within facilities, the appearance of bulletproof glass in patient services areas, as well as elements like barred-windows and barbed wire as external features. A well-trained security staff, a strong security system, and robust chain-of-custody protocols can be just as effective as, or even better than, more aggressive and explicit security features.

Transportation—Well-trained facility staff can successfully and safely transport medicine, rather than requiring the use of armed courier services. Using cars for transportation that have live GPS capabilities, are unmarked, have concealed secure storage containers, and that use randomized routes and delivery schedules can ensure that medicine is transported without incident.

Facility Design—Effective facilities embrace a wellness aesthetic that is welcoming to patients and guests. It is important that the facility is large enough to serve the population and features designated patient-care spaces (e.g., reception, waiting area, patient counseling, sales floor) and limited/restricted access areas that allow for appropriate levels of surveillance and a smooth flow of patients.

Additionally, appropriate exterior signage is critical to ensuring that these facilities are welcomed by community members and local officials. We recommend that exterior designs and signage mimic those employed by medical offices and pharmacies and should avoid negatively perceived features such as images of marijuana plants, neon signs, or distasteful advertisements and/or window displays.

Real Estate Zoning—The Cole Memo released by the Justice Department serves to guide federal prosecutors on enforcement priorities for medical marijuana facilities. As a means of preventing access to marijuana by children, the department established guidance on appropriate sensitive use setbacks. Specifically, medical marijuana facilities must be at least 1,000 feet from schools, playgrounds, or public housing in order to avoid federal intervention and possible prosecution. Even though state and local jurisdictions may decrease this setback requirement (for example, Massachusetts requires a 500-foot setback), we highly recommend compliance with the federal guidelines.

Audit & Compliance Function—In order to ensure compliance with state requirements and to maintain transparent operations, we recommend implementing regular inventory audits. Inventory audits should be conducted on a monthly basis, in compliance with generally accepted accounting principles. In addition, an annual audit of the organization’s financial records should take place to ensure accurate representation of the company’s financial statements. All documentation for internal and/or external audits should be maintained for at least five years and made available to the regulating agency upon their request.

As medical marijuana programs have spread across the country, we have seen some successful elements from early programs carry over into newer programs. We are hopeful our recommendations will be integrated into more programs in the future.