State of the States Scoring Rubric

How States Are Evaluated For Our State of the States Report

The grade for each state’s medical cannabis program is based on how well it meets the needs of patients in five categories, worth 100 points each, that are described in detail below.

Each state was scored based on how well its current law and regulations accommodate patient needs, as broken down into five general categories:

  1. Patient Rights and Civil Protection from Discrimination
  2. Access to Medicine
  3. Ease of Navigation 
  4. Functionality
  5. Consumer Safety and Provider Requirements

ASA developed these criteria based on a series of over 100 public meetings across the U.S. as well as surveys of our 100,000+ members and they reflect the current realities of state medical cannabis laws. Definitions for each item can be found below. States that partially met the definition for certain criteria, either directly or indirectly, were eligible for partial points when appropriate.

 

1. Patient Rights and Civil Protections from Discrimination

 

Arrest Protection — 40 pts

DOES THE LAW SUFFICIENTLY PROTECT PATIENTS FROM ARREST?

Arrest protection refers to explicit legislative language that instructs law enforcement to refrain from arresting individuals who are in compliance with state law.

 

Affirmative Defense — 15 pts

DOES THE LAW OFFER A CLEAR AFFIRMATIVE DEFENSE IN STATE COURT?

An affirmative defense refers to a criminal defendant’s right to argue medical necessity or compliance with state law as a defense in state court. With an affirmative defense, the burden is on the defendant to prove that they were not in violation of the law. Ideally, a state will afford a necessity defense for medical cannabis conduct that does not conform to the strict limits of the state law: for example, possessing amounts above the statutory limit in order to have a consistent supply of medicine. Some states have an implied affirmative defense within their arrest protection. 

 

Parental Rights Protections — 10 pts

ARE PARENTS AT RISK OF LOSING THEIR CHILDREN IN A CHILD CUSTODY, DIVORCE AND SEPARATION PROCEEDINGS BASED ON THEIR PATIENT STATUS?

Most states list marijuana possession and cultivation as an indication of child abuse and/or neglect. Explicit protections against such assumptions can, and should, instruct state agencies and family courts to recognize that a parent’s status as a medical cannabis patient should not be a determining factor in any CPS or court intervention, or other family court proceedings like divorce including or others that altering parental rights. States that set an “unreasonable danger” standard or have similar provisions should include clear guidance that a patient acting in accordance with the state law is not creating an unreasonable danger.

 

DUI Protections — 5 pts

DOES THE LAW RECOGNIZE THAT PATIENTS MAY HAVE RESIDUAL THC METABOLITES IN THEIR BLOODSTREAM WITHOUT BEING IMPAIRED?

Many states allow their Driving Under the Influence (DUI) or Driving Under the Influence of Drugs (DUID) statutes to be used as a means of penalizing drivers who are medical cannabis patients, even without evidence of impairment while driving. An individual’s participation in a state medical cannabis program should not constitute probable cause for a sobriety test, nor should the presence of cannabis metabolites in the body - which can be detected days or weeks after last use - indicate actual impairment. By treating cannabis like any other medication under a state’s DUI or DUID laws, patients will still be prohibited from driving while impaired or using cannabis while driving, but patients will not be unnecessarily subjected to arrest and prosecution solely for being a medical cannabis patient or having metabolites in their bodies.

 

Employment Protections — 5 pts

CAN AN EMPLOYEE BE FIRED MERELY FOR BEING A PATIENT OR FOR HAVING CANNABIS IN THEIR SYSTEM, IF IT DOES NOT AFFECT THEIR JOB PERFORMANCE?

An individual’s status as a medical cannabis patient, or a positive test for cannabis metabolites, should not be an employer’s sole basis for either refusal to hire or dismissal of that person. Because of their regular cannabis use, most patients will test positive without being impaired. Medical cannabis use should be treated like any other prescription medication under state law. While some states have explicit protections, many laws are inadequate in providing necessary safeguards against employment discrimination. Despite concerns to the contrary, it is possible to provide workplace protections for patients while adhering to the federal drug-free workplace requirements that certain employers must meet, as many states have successfully done so.

 

Explicit Privacy Protections — 7 pts

ARE PATIENTS’ MEDICAL RECORDS KEPT PRIVATE FROM ACCESS BY LAW ENFORCEMENT AND RISK FROM EXPOSURE TO THIRD PARTIES?

Medical cannabis patients deserve the same healthcare privacy rights as all other patients in the U.S., but these rights are often abridged. Information about patients, caregivers, or healthcare providers contained in a registry should be kept confidential in perpetuity and unneeded data should be destroyed. Some states explicitly protect patient information and some have even criminalized privacy violations. The unsanctioned release of registry information should carry substantial administrative penalties.

 

Housing Protections — 5 pts

CAN LANDLORDS EVICT PATIENTS FROM THEIR HOMES BASED ON THEIR MEDICAL STATUS?

Patients who use medical cannabis should not have to live in fear of losing their housing. Patients have routinely been evicted from public and private housing in medical cannabis states that have not created explicit protections against such discrimination. While some states do protect patients from housing discrimination, the federal government has left decisions to the discretion of local housing authorities, and has issued guidance to evict tenats who are found to be medical cannabis patients.

 

Does Not Create New Criminal Penalties for Patients — 5 pts

DOES THE MEDICAL ACCESS LAW SUBJECT PATIENTS TO NEW CRIMINAL MISDEMEANORS OR FINES?

Some states create new criminal penalties related to their medical cannabis programs, including fraudulent use of the medical cannabis program (i.e. diversion), violation of privacy provisions, and falsely identifying oneself as a participant in the medical cannabis program. As states allow for the non-medical use of cannabis states should not punish existing patients for failure to comply with the provisions of the new law.

 

Organ Transplants — 5 pts

ARE PATIENTS EXPLICITLY PROTECTED FROM BEING DISCRIMINATED AGAINST REGARDING ORGAN TRANSPLANTS?

Several hospitals in the U.S. have removed medical cannabis patients from their organ transplant lists after the patients tested positive for cannabis metabolites. This exclusionary practice is based on outdated policies with no scientific basis, that assume cannabis use automatically indicates substance abuse and therefore poses a danger that the transplanted organ will be rejected. Transplant candidates should not be forced off the treatment a doctor has recommended while they wait for life-extending measures.

 

Reciprocity — 3 pts

ARE PATIENTS WHO ARE LEGALLY RECOGNIZED IN THEIR HOME JURISDICTION PROTECTED WHEN VISITING OUTSIDE THE STATE?

Reciprocity refers to laws providing some measure of legal protection for non-resident medical cannabis patients. These laws generally require that patients carry documentation of their status in their home state's program. Reciprocity is important for traveling patients, patients who are seeking specialty treatments, and those who need to stay in the care of friends or family out of state, as many state medical cannabis programs require residency for participation or legal protections.

 

2. Access to Medicine

  

Allows Distribution Programs — 40 pts total 

ARE THERE LOCATIONS WHERE PATIENTS CAN LEGALLY PURCHASE MEDICINE?

While most states regulate the production and distribution of medical cannabis, some states have failed to do so. ASA has found that a majority of patients rely on local dispensaries and that access to medical cannabis in states without licensed dispensaries is severely limited. Many patients do not have the time, skills, or resources to cultivate their own medicine, and cultivation is not a solution for a patient who needs medicine sooner rather than later. It is imperative that states provide for regulated distribution if they wish to have a functional, effective medical cannabis program. States that have taken measures for the implementation of dispensary programs were awarded partial points.

Allows Access to Dried Flowers — 15 pts

DOES THE STATE PROHIBIT ACCESS TO THE MOST COMMONLY USED FORM OF CANNABIS?

A majority of medical cannabis states have allowed patients access to the dried flowers of whole-plant cannabis either for direct inhalation or to process their own medicated edibles or concentrates. However, a few states have limited access to dried flowers in favor of non-inhaled cannabis preparations. This is the most obvious flaw in some states, but it is also part of many of the “CBD-only” laws that restrict patients to a manufactured product only. ASA’s experience shows that restricting patients from whole-plant cannabis use can prevent patients from accessing the most effective medicine for their particular condition and can make proper dosing more difficult to achieve.

 

Allows Delivery — 5 pts 

DOES THE STATE LAW ALLOW FOR THE DELIVERY OF MEDICAL CANNABIS TO LEGAL PATIENTS?

Many legal medical cannabis patients cannot travel to access points to receive medical cannabis due to physical, economic, or time constraints. This is especially problematic for legal patients who are in the hospital, are bedridden, or live far from an access point. Allowing for delivery of medicine is a compassionate and common-sense solution for these patients. Common-sense protocols can be used to ensure safety and discretion. There is no evidence to show that delivering medicine leads to crime or diversion of medical cannabis for non-medical use. States should be clear that provisions allowing for “delivery” refer to home delivery rather than the criminal law context of delivery of a controlled substance.

 

No Sales Tax or Reasonable Sales Tax — 5 pts 

IS MEDICAL CANNABIS EXEMPT FROM SALES TAX OR IS THE TAX RATE REASONABLE?

Medical cannabis is real medicine that millions of Americans use to treat serious medical conditions such as cancer, HIV/AIDS, chronic pain, and more. Unfortunately, medical cannabis is generally more expensive than other medication and not currently covered by any public or private insurance policies. Ideally, this medicine would be exempt from sales tax to ease the financial burden on legal patients. Taxation of medicine should be avoided, but when necessary, it should be reasonable. ASA recommends taxation that is comparable to similar products – herbal medicine, over-the-counter remedies, etc. Excessive sales tax is a financial hardship and may compel some patients to buy medical cannabis in the unregulated illicit market.

 

Allows for a Reasonable Number of Dispensaries — 5 pts

DOES THE STATE BURDEN PATIENTS BY PLACING SIGNIFICANT LIMITS ON THE NUMBER OF LOCATIONS WHERE THEY MAY OBTAIN THEIR MEDICINE?

Safe, affordable access is directly related to the number of dispensaries in any given geographical area. When there are insufficient dispensaries, the cost of medical cannabis goes up while the quality of care goes down. Limitations or arbitrary caps on the number of dispensaries should be avoided. When limits are imposed, they must account for patients who live outside urban areas and those with mobility issues or who are confined to their homes.

 

Does Not Require Vertical Integration — 2 pts

DOES THE STATE REQUIRE THAT DISPENSARIES MUST GROW THEIR OWN MEDICINE?

Vertical integration refers to the requirement that distribution centers also cultivate and manufacture all or most of their products. While vertical integration allows producers to maximize cost effectiveness, it can also lead to supply problems and increased costs for consumers. ASA’s experience has shown that vertical integration is a decision best left to each individual provider. 

 

Ownership/Employment Restrictions — 2 pts

ARE PEOPLE WITH PRIOR CANNABIS OFFENSES, OTHER MISDEMEANORS OR FELONIES PROHIBITED FROM BEING MEDICAL CANNABIS PROVIDERS?

Ownership and employment restrictions related to cannabis businesses are commonly included in legislation. Most restrictions on ownership of medical cannabis businesses stem from background check procedures. These types of restrictions disproportionately impact people of color and have a discriminatory effect. Marijuana-related convictions should not automatically exclude a person from ownership of, or employment by, a cannabis business; instead, each individual should be considered on a case-by-case basis.

 

Provisions for Labor Standards — 2 pts

ARE EMPLOYEES OF MEDICAL CANNABIS BUSINESSES AFFORDED PROTECTIONS? 

Workplace safety and employment standards should be part of the development and implementation of medical cannabis laws, including consideration of such issues as living wages, sick pay, and a standard 40-hour work week as well as health care coverage and other benefit packages. These provisions should also cover a neutrality, recognition, or existing collective bargaining agreement with a certified labor union.

 

Environmental Impact Regulations — 2 pts

DOES THE STATE HAVE SPECIFIC REQUIREMENTS FOR MEDICAL CANNABIS PROVIDERS IN TERMS OF THEIR IMPACT ON THE ENVIRONMENT?

ASA places a premium on policies that encourage sustainable practices, including but not limited to implementation of best management practices that promote environmentally sound production and processing methods that reduce the potential for high-carbon footprints by allowing open air, row cover, and greenhouse methods of cultivation. States should avoid restricting the ability for cultivators to utilize natural sunlight and creating overly burdensome plastic packaging requirements.

 

Choice of Dispensary Without Restrictions — 2 pts

ARE PATIENTS REQUIRED TO DESIGNATE A SINGLE DISPENSARY WHERE THEY MAY ACQUIRE MEDICINE?

Some states require that patients designate a single dispensary from which they may acquire their medicine. While such an approach may be easier to regulate, it can result in patients bearing artificially high costs, reduced choice in available cultivars and products, and extra expense and bureaucracy.

  

Noncommercial Cultivation — 20 pts total 

Personal Cultivation — 15 pts

ARE PATIENTS ALLOWED TO GROW THEIR OWN MEDICINE?

Unfortunately, states have been moving to limit personal cultivation by patients and their caregivers, restricting and, in some cases, completely obstructing access to medical cannabis. In states that have relied exclusively on regulated production and distribution programs, patients have frequently been left without any options if those programs fail to meet the basic needs of proximity, affordability, safety, or privacy.

Collective Gardening — 5 pts

CAN SEVERAL PATIENTS FORM A GROUP TO MUTUALLY GROW THEIR MEDICINE IN ORDER TO OFFSET COSTS AND BEST UTILIZE SHARED EXPERTISE?

Allowing experienced caregivers to cultivate for a limited number of patients can ensure adequate access to a reliable supply of safe, affordable medicine. Collective gardens intended strictly for private consumption among a small group of patients should not be subject to regulatory authority, provided the activity remains non-commercial. Collective gardening is not associated with dispensaries or other commercial businesses that engage in sales, advertising, or trade. States without explicit collective gardening rights that do allow individual caregivers to grow for more than one patient were eligible for partial points in this category. 

 

Explicit Right to Edibles/Concentrates/Other Forms — 10 pts

ARE PATIENTS EXPLICITLY ALLOWED TO OBTAIN FORMS OF CANNABIS OTHER THAN DRIED FLOWERS?

Some states explicitly provide for the manufacture and use of edible products or concentrated forms of medical cannabis. Some states do not explicitly allow these forms of medicine, but may tolerate the sale and production of such items. Edibles are important, as this form of administration is ideal or preferred for certain ailments and can offer ease of use for certain patients. States without this explicit right, but that allow for availability of these products in practice, were eligible for partial points. While tolerance is better than denying access to alternative forms, clear guidance is optimal, and ASA encourages states to protect and regulate the manufacturing, use, and distribution of edible and concentrated medical cannabis products.

 

Does Not Impose Limits or Bans on THC — 10 pts

DOES THE STATE HAVE A MAXIMUM LEVEL OF THC ALLOWED IN CULTIVARS OR INFUSED PRODUCTS?

THC is a proven therapeutic component of the cannabis plant that the FDA has recognized for medical use and has been demonstrated to work in synergy with other important therapeutic cannabinoids such as CBD.  States that have passed so-called "CBD-only" legislation, which in some cases are better described as “low-THC” programs, have imposed arbitrary limits on the amount of THC permitted in the medical preparation or enacted outright bans. THC has far more proven medical applications than CBD alone, and CBD has been shown to work more effectively in tandem with other plant components like THC.

 

Does Not Impose Limits or Bans on CBD — 10 pts

DOES THE STATE REQUIRE THAT ALL FORMS OF MEDICAL CANNABIS MUST HAVE A MINIMUM CBD LEVEL?

Some states have passed "CBD-enriched" or "CBD-only" legislation. The legislative intent behind this has been to eliminate the intoxicating properties of cannabis, namely THC, however these preparations only benefit a small portion of a state’s patient population because CBD has been shown to work more effectively in tandem with other plant components. Even among the minority of patients who can benefit from low-THC preparations, minimum CBD requirements restrict access to the ratios of CBD to THC that may work best for them.  For example, while some pediatric patients with seizure disorders benefit greatly from 30:1 ratios, other children will respond better to 1:1 ratios (and anything in between or beyond). Imposing arbitrary cannabinoid level minimum requirements that are not rooted in science provide no benefit to the public health of a state.

 

Local Bans/Zoning — 10 pts

DOES THE STATE LAW ALLOW LOCAL JURISDICTIONS TO BAN MEDICAL CANNABIS BUSINESSES OR TO USE ZONING LAWS TO EXCLUDE THEM?

Cities and counties have a legitimate role in regulating land use within their borders. In some states, however, local governments can ban medical cannabis activity that is allowed under state law. In other cases, cities and counties have used local zoning regulations to effectively exclude medical cannabis businesses. Local bans and onerous zoning regulations are harmful to patients because they cut off legitimate access to medicine for legal patients. Research conducted by ASA, and our experience with local regulations over the last 17 years, has shown that sensible regulations preserve legal access for legitimate patients while reducing crime and complaints in communities. An ideal state law would limit or eliminate the right of local jurisdictions to ban medical cannabis activity while preserving the city or county's authority to adopt reasonable local zoning rules. 

 

3. Ease of Navigation

 

Comprehensive Qualifying Conditions — 50 pts

DOES THE STATE ALLOW DOCTORS OR POLITICIANS TO DETERMINE WHICH PATIENTS HAVE ACCESS TO MEDICAL CANNABIS?

Every state that has enacted protections for medical cannabis patients has mentioned conditions that may be effectively treated by cannabis (see Chart 1). Some states recognize the Constitutional right of physicians to recommend cannabis to any patients who could benefit from it, while other states limit the ability of physicians to certify patients for participation in their medical cannabis program with restrictive qualifying conditions lists. Many states provide for a rigorous process to expand their "approved ailment" list through the state department of health. ASA's position is that there should be access to medical cannabis for every patient who needs it, and that the decision to use cannabis as a treatment should be left to the patients and their physicians, not the state. A state will receive 50 points automatically if it allows cannabis to be used for any qualifying condition. 

  

Adding New Conditions — 10 pts

DOES THE STATE ALLOW FOR NEW QUALIFYING CONDITIONS TO BE ADDED THROUGH RULEMAKING WITHOUT THE NEED FOR LEGISLATIVE APPROVAL?

In most states that have a restrictive list of qualifying conditions, a procedure exists for the addition of new conditions to the list of approved ailments that may be effectively treated by cannabis. New studies are being published regularly, and treatments that are not contemplated by the law should be available to physicians, much like "off-label" use is available in the realm of prescription medication. It is ASA's position that if these restrictions are imposed, then the procedure to add new conditions should be uncomplicated and timely. While many states have created such a process, the hurdles to add new conditions are impossible to meet. The scoring for this section includes 5 points for having a process in place to add new conditions, and 5 points if that system is working as intended. States that allow healthcare practitioners to recommend cannabis for any condition automatically receive full points in this category. 

 

Reasonable Access for Minors — 10 pts

ARE YOUTH UNREASONABLY RESTRICTED FROM LEGAL PROTECTIONS FOR MEDICAL CANNABIS USE?

Though some states limit the age of a patient, many of these restrictions may be overcome through parents or guardians consenting to the treatment and agreeing to be in control of the minor patient’s acquisition and administration of medical cannabis. States that require pediatric patients to have a recommendation from multiple doctors fail to realize that the added time and expense is a great challenge to meet, especially for families raising a special needs child. More research has begun around using medical cannabis to treat youth, and it is important to allow parents, along with their children’s physicians, to determine the best, most effective medication for their children.

 

Reasonable Caregiver Background Checks — 4 pts

DOES THE STATE PROHIBIT THOSE WITH CANNABIS OFFENSES FROM BEING CAREGIVERS?

A caregiver is a person who assists the patient with procuring and administering his or her medication. Some states prohibit patients from having caregivers with criminal histories related to drugs. It is ASA's position that this type of restriction serves no purpose, as they do not protect patients from criminals; rather, they punish the patient for having a family member or trusted confidant who may have had a criminal past. These provisions disproportionately impact people of color.

 

Number of Caregivers — 2 pts

DOES THE STATE RECOGNIZE THAT A SINGLE CAREGIVER PER PATIENT MAY NOT BE SUFFICIENT TO PRACTICALLY ASSIST A PATIENT WHO REQUIRES A CAREGIVER IN ORDER TO OBTAIN OR ADMINISTER THEIR MEDICINE?

The number of caregivers allowed for a qualified patient varies from state to state, as does the number of patients a caregiver may serve. Some states are very restrictive and allow only one caregiver per patient, thus putting patients who have mobility problems in a situation where they must rely on a single person to assist with their access to and use of cannabis. Although ASA is mindful about diversion to the illicit market, we support patients being able to designate caregivers as determined by their unique situations so that they always have access to cannabis when needed. For example, an elderly patient may need to have multiple family members serve as caregivers because no individual in a family has the availability to consistently assist the patient. 

 

Patient/Practitioner-Focused Task Force or Advisory Board — 2 pts

DOES THE LAW CREATE AN OVERSIGHT BODY, AND DOES THAT BODY HAVE SUFFICIENT REPRESENTATION BY PATIENTS, CAREGIVERS, AND RELEVANT MEDICAL PROFESSIONALS?

Regulatory agencies for medical cannabis programs vary by state. ASA has found that keeping the medical cannabis program within the Department of Public Health, or its equivalent, provides the most effective assistance to patients and their providers. States that have developed a regulated program should create task forces or advisory boards to help guide the administration of the medical cannabis program and provide assistance in developing regulations. These task forces and advisory boards can be a boon to the program by providing a voice for those most knowledgeable about its effectiveness: patients and healthcare professionals. The makeup of such task forces or boards should only include a minimal presence from law enforcement, if any, as the priorities of police and prosecutors may be at odds with the needs of patients. ASA supports the development of these programs and encourages the inclusion of patients and healthcare providers in them.

 

Reasonable Fees for Patients & Caregivers — 10 pts

ARE PATIENTS ASSESSED A FEE BY THE STATE SIMPLY TO HAVE LEGAL PROTECTION AND ACCESS TO MEDICINE?

Fees for patient registration should be set to meet reasonable administrative costs of the registry program. Patient fees should not cover costs of medical marijuana business oversight, nor should they be looked at as a source of revenue for any other purposes. Reasonable fees are particularly important due to the lack of health insurance coverage for medical cannabis expenses. Because of the financial challenges of many chronically ill patients, ASA recommends a sliding scale fee tied to state or federal benefits for which a patient qualifies. 

 

Allows Multiple-Year Registrations — 2 pts

DO PATIENTS FILL OUT RENEWAL FORMS AND PAY A RENEWAL FEE ON AN ANNUAL BASIS?

It makes little sense to make patients with chronic, long-lasting conditions go through an annual renewal process when their condition is almost certainly going to be with them for years to come. ASA recommends that multi-year registrations be available to these patients based on the condition listed on their application.

 

Reasonable Physician Requirements — 5 pts

DOES THE LAW CONTAIN PROVISIONS THAT WOULD PREVENT PHYSICIANS FROM UTILIZING MEDICAL CANNABIS AS PART OF THEIR PRACTICE?

Some states require patients to have an ongoing relationship with their doctor, often referred to as a "bona fide" relationship. Generally, states define the relationship to include a complete examination and medical history, along with an ongoing expectation of care provided by the physician. Some require that physicians register with the state, or impose education requirements on physicians, which may be beneficial to patients but could be onerous to physicians and are not a requirement for writing prescriptions for more dangerous pharmaceutical medications. ASA's position is that physicians should only treat ailments and recommend treatments that they are familiar with and feel comfortable discussing. Within the medical field, there are many specialties; prohibiting patients from choosing a doctor who specializes in medical cannabis is antithetical to the practice of medicine. 

Any physician in good standing with the state should be allowed to recommend the use of medical cannabis to his or her patients. Physicians who use medical cannabis themselves should not be restricted from recommending it. Because patients with chronic illnesses often seek health care services from a variety of sources, ASA prefers that nurse practitioners, physician assistants, dentists, naturopathic doctors, chiropractors and other healthcare professionals be allowed to recommend medical cannabis, if it is not prohibited by legislation. Health care professionals who are allowed to recommend medical cannabis should not be allowed to have direct or indirect financial interest in a dispensary, manufacturer, laboratory or cultivation operations, or financially benefit from any business that might benefit from a patient’s or caregiver’s use, acquisition, or purchase of medical cannabis.

 

Does Not Classify Cannabis as a Medicine of Last Resort — 5 pts

DOES THE STATE LAW CLASSIFY MEDICAL CANNABIS AS A MEDICINE OF LAST RESORT?

Some state laws only allow medical cannabis as a last resort, after all other treatments have failed. This approach is harmful and interferes with the doctor-patient relationship. Doctors should be able to recommend or approve medical cannabis use at any point in a patient’s treatment. Requiring patients to try less desirable treatments first is an unnecessary burden and may cause needless suffering. Emerging science and the experience of healthcare practitioners and patients all over the country indicate that cannabis is a safe, legitimate medicine with real benefits for patients. State law should respect the welfare of the patients, the doctor’s discretion, and the science of cannabis. 

 

 4. Functionality

 
Patients Able to Access Medicine at Dispensaries or Via Cultivation — 50 pts

ARE THERE A SUFFICIENT NUMBER OF EASILY ACCESSIBLE RETAIL DISTRIBUTION POINTS FOR PATIENTS TO OBTAIN THEIR MEDICINE BY PURCHASING IT, AND/OR ARE PATIENTS OR THEIR DESIGNATED CAREGIVERS ALLOWED TO GROW THE MEDICINE NEEDED TO TREAT THE PATIENT’S CONDITION? 

Ideally a patient or caregiver would be able to gain access to their medicine through multiple means, including dispensaries, cooperative gardens, and personal cultivation. Personal cultivation is an important option if a state fails to expeditiously license sufficient dispensaries, if there is a change in ownership, or if there are supply issues in the commercial program. States implementing access programs were eligible for partial points.

 

No Significant Administrative or Supply Problems — 15 pts

DOES THE PROGRAM WORK AS INTENDED AND PROVIDE A SUFFICIENT SUPPLY OF CANNABIS TO MEET PATIENT NEEDS? 

While ASA supports the creation of a statewide regulatory framework for medical cannabis, administrative oversight has become a hindrance to safe access in some states. Some states have programs that inadvertently caused shortages (and therefore disruptions) in the supply and variety of available medical cannabis. Restrictions on commercial cultivation plant numbers, the number of cultivation or access points, or over-regulation of certain areas of production and distribution can have an adverse effect on the patient population. States should consider third-party certification as a way to ease administrative burdens. ASA discourages the development of policies that unnecessarily restrict or otherwise hamper the supply of medical cannabis. 

 

Patients Can Receive Legal Protections Within a Reasonable Time After Receiving Recommendation — 10 pts

DOES MEDICAL NEED AS DETERMINED BY A MEDICAL PROFESSIONAL ESTABLISH IMMEDIATE LEGAL PROTECTIONS? 

Ideally, protection from arrest and prosecution should begin the moment a patient leaves the doctor's office with a recommendation. In cases where patients must register with the state to obtain arrest protection, an affirmative defense should be granted to defendants with a valid authorization so as not to leave patients vulnerable while their documentation is processed.

 

Reasonable Possession Limit — 5 pts

DO LIMITS ACCOMMODATE ROUTE OF ADMINISTRATION AND HARVEST AMOUNTS? 

While it might make sense to have possession thresholds that give law enforcement guidance on personal medical use, it does not make sense for the state to determine the quantity any patient might need for his or her particular illness. The type and severity of symptoms, the cultivar of cannabis, factors specific to each patient (e.g., age, body composition, metabolism), and the route of administration each greatly impact the amount that a specific patient may need at any point in time. The decision as to how much cannabis is sufficient to treat a patient's illness should ultimately correspond to the amount that allows the patient an uninterrupted supply rather than arbitrary caps that can needlessly burden seriously ill patients. In order to create safe access to a consistent supply of medical cannabis and related products that work best for them, patients should be able to possess and maintain a 90-day supply of medicine. 

 

Reasonable Purchase Limits — 5 pts

DO LIMITS ALLOW FOR AN ADEQUATE SUPPLY OF MEDICINE?  

When a state is considering imposing purchase limits on patients that will restrict the amount they can obtain from a dispensary, it should take into account the distance a patient must travel, the severity of an individual’s medical condition, and any patient mobility issues. Certain cultivars or products may have limited availability, and patients who need those products should not be denied access in favor of concerns with regulatory expediency. The best policy does not restrict patients’ ability to purchase medicine to certain windows of time, as such limits may disrupt patients’ ability to maintain a consistent supply of medical cannabis.

 

Allows Patients to Medicate Where They Choose — 5 pts

ARE PATIENTS ALLOWED TO USE THEIR MEDICINE FREELY WITH RESPECT TO LOCATION, JUST AS PATIENTS OF PRESCRIPTION MEDICATION?

Some states restrict the locations where patients can use medical cannabis. While it may make sense to limit the right to use inhaled cannabis to places where other smoking is allowed, it is abhorrent to otherwise limit locations where a sick person can use his or her medicine. Cannabis should be treated like any other medication in this regard.

 

Covered by Insurance or State Health Programs — 3 pts

IS MEDICAL CANNABIS COVERED BY INSURANCE OR STATE HEALTH PROGRAMS?

Until federal laws regarding medical cannabis are reformed, patients will not be able to use federal medical benefits and health insurance providers will be reluctant to include coverage for medical cannabis. However, there is no reason why state law should prevent private insurance carriers from covering medical cannabis. An ideal law would require that insurance carriers and state health programs treat medical cannabis like any other legal medication.

 

Financial Hardship (Fee Waivers/Discount Medicine) — 7 pts

DOES THE STATE OFFER DISCOUNTED REGISTRATION FEES OR REQUIRE DISPENSARIES TO OFFER DISCOUNTED MEDICINE FOR LOW-INCOME PATIENTS?

With medical cannabis not currently covered by health insurance, many patients are unable to afford treatment without experiencing undue hardship. To ease the financial burden, ASA encourages the adoption of sliding-scale fees and donation programs that cover all or part of the cost of doctor's visits, registration fees, and medicine for patients in need.

 

5. Consumer Safety and Provider Requirements

States were evaluated for consumer safety and provider requirements in four areas: (1) dispensaries, (2) cultivation, (3) manufacturing, and (4) laboratory testing.

Dispensaries

Staff Training — 5 pts

ARE DISPENSARY WORKERS REQUIRED TO BE TRAINED IN BOTH MEDICAL CANNABIS AND RELEVANT LAWS?

Many state governments have training requirements for the staff of dispensaries. It is ASA's position that dispensary staff, as health care professionals, must be adequately trained in order to best understand the medication and products they sell and be able to provide patients with up-to-date information. New medical cannabis patients are often unfamiliar with the cultivars and routes of administration available to them. A well-educated staff can, and should, provide answers to common questions. ASA maintains that proper training of employees is essential to deliver safe, quality cannabis products to patients and caregivers. Training should include information about state and federal regulations, law enforcement interaction, and regulatory inspection preparedness.

 

Standard Operating Procedures and Protocols — 5 pts

ARE DISPENSARY FACILITIES REQUIRED TO DEVELOP AND MAINTAIN STANDARD OPERATING PROCEDURES AND PROTOCOLS?

Early medical cannabis laws only provided protection from criminal prosecution. As the field of medical cannabis has developed, new laws are incorporating requirements to ensure patient and product safety. State laws should require medical cannabis businesses to develop and follow standard operating procedures and protocols to ensure product safety and industry legitimacy.  Such standard operating procedures and protocols should include, at a minimum, the following considerations: 

 

Facility Sanitary Conditions 

IS THE FACILITY CLEAN AND SAFE?

State laws should require that medical cannabis dispensing facility operations be conducted in sanitary conditions. ASA recommends using existing sanitation standards for food packaging, storage, and distribution, as well as herbal medicine handling and storage standards, as models for sensible regulations to protect patients from contaminants. The American Herbal Products Association’s Recommendations for Regulators is a good place to start this process.

  

Reasonable Security Protocols

ARE THE SECURITY PROTOCOLS FOR MEDICAL CANNABIS REASONABLE AND EFFECTIVE?

State laws or regulations should require legal medical cannabis businesses to develop and implement a reasonable and effective security plan. The plan should address physical security, loss prevention, training, etc. However, state laws should not place arbitrary or onerous restrictions on legal medical cannabis businesses where they are unwarranted.

 

Storage Protocols 

ARE THE STORAGE PROTOCOLS ADEQUATE TO PROTECT THE QUALITY OF THE MEDICINE AND PREVENT LOSS?

State laws should require medical cannabis businesses at every stage of the production and distribution chain to store medicine in a manner that is sanitary, preserves the integrity of the cannabis or derived product, and is secure. This is important to protect patients from mold, mildew, and other contaminants that may be harmful. Furthermore, state laws should require adequate loss control procedures to prevent theft or robbery.

 

Inventory Control

DOES THE STATE LAW REQUIRE INVENTORY CONTROL MECHANISMS?

State law should require reasonable inventory control protocols to ensure the integrity of the supply chain and prevent diversion of medical cannabis for non-medical use. The inventory tracking system should include a continuous chain of custody for cannabis and cannabis products, periodic inventory counts, and a procedure for dealing with lost or stolen medicine.

 

Recall Protocol and Adverse Event Reporting — 5 pts

IS THE MEDICAL CANNABIS FACILITY REQUIRED TO DEVELOP AND IMPLEMENT A PRODUCT RECALL STRATEGY? 

As with other products produced for human consumption, spoilage, human error, and the unexpected all pose the risk of contamination. As a result, ASA encourages the development of product recall and adverse-event reporting programs. Product recall strategies should include transportation guidelines that allow the patient to return recalled products to the dispensary from which the product came and a mechanism for the dispensary to return the recalled products to the original manufacturer and/or cultivator. Additionally, the rules and regulations should require that all recall programs include the recording of consumer-reported adverse events.

 

Product Labeling — 5 pts 

Some state government regulatory models allow or require dispensaries to obtain medical cannabis that is repackaged at the dispensary.  If the dispensary can engage in such activities, then it should be required to meet these minimum standards for labeling:  

Product Contents, Including Source Material Identification 

Cannabis regulations often dictate the type of packaging for raw plant material and derived products. In some cases, the packaging requirements may prevent the consumer from seeing the contents or render the cannabis as part of a compound making the form of plant material (e.g., leaves, stems, seeds, flowers) unrecognizable. When this occurs, dispensaries should be required to label the product’s contents, including identifying the source plant material used or contained within. Nutritional information should also be included for edible products. 

Allergens

When labeling derived products that have been mixed with foodstuffs or known common allergens, or that have been packaged or produced in a facility that uses known common allergens, consumers should be notified. All products labeled by dispensing facilities that might contain known common allergens should be required to provide a list on the product's label.

Potency/Compound Identification 

Medical cannabis patients often rely on product labels to gauge the strength of the various compounds present in the medicine they consume. Labeling requirements for cannabis and cannabis-derived products should include a listing of the product’s active compounds and the potency of each. 

 

Required Testing — 5 pts

ARE MEDICAL CANNABIS AND MEDICAL CANNABIS PRODUCTS REQUIRED TO BE TESTED BEFORE BEING DISTRIBUTED TO A PATIENT? 

State government regulations are increasingly requiring laboratory testing to verify product safety and help patients understand the potency of products’ active compounds. Laboratory testing regulations should ensure that the analytical records of cannabis and derived products are made available at all levels of the supply chain, including to the dispensary (should they be engaged in the processing, packaging, and labeling of medical cannabis or derived products) and consumers. Such laboratory testing results should include the analytical results necessary to provide the information required to produce, or verify the accuracy of, a product's label.

 

Active Compound Identification and Potency

Cannabis and cannabis-derived products vary greatly based on the cultivar of cannabis as well as the technique or method used to create the cannabis products. In order to ensure that cannabis and derived products are accurately labeled, laboratory testing facilities should be required to provide analytical services that can accurately determine the presence of active compounds and the potency of all compounds determined to be in the raw cannabis and cannabis-derived products. 

 

Contaminants

Laboratory testing facilities should be required to utilize validated methodologies and provide analysis that accurately tests raw cannabis and cannabis-derived finished products for the presence of contaminants, to include microbiological, residual solvent, pesticide, heavy metals, mycotoxin, and foreign matter contaminants

 

Cultivation

Staff Training — 5 pts

ARE CULTIVATION STAFF REQUIRED TO BE TRAINED IN BOTH MEDICAL CANNABIS KNOWLEDGE AND THE STATE LAW?

Many state governments have training requirements for the staff of cultivation facilities. It is ASA's position that cultivation facility staff should be required to successfully complete a training curriculum that includes an overview of medical cannabis knowledge as well as applicable state and local laws and regulations. Such training is essential to maintaining workplace safety, regulatory compliance, and product safety. 

 

Standard Operating Procedures and Protocols — 5 pts

ARE CULTIVATION FACILITIES REQUIRED TO DEVELOP AND MAINTAIN STANDARD OPERATING PROCEDURES AND PROTOCOLS?

As product safety guidelines have been added to many state government regulatory programs, the requirement for businesses to create and implement standard operating procedures and protocols has become common. Standard operating procedures and protocols serve to ensure that a facility’s operations are conducted in a manner that is safe for all staff working in the facility as well as the surrounding environment, and that proper records are kept to ensure product safety. Written standard operating procedures and protocols also serve as internal training and resource guides for the staff and should include, at a minimum, the following key components designed to address workplace, environmental, and product safety issues:

 

Facility and Equipment Sanitary Conditions 

ARE THE FACILITY AND THE EQUIPMENT USED CLEAN AND SAFE?

Contamination can occur at any stage during the cultivation and processing of cannabis. State laws should require that medical cannabis cultivation and processing, manufacturing, distribution, and laboratory testing be conducted in sanitary conditions. ASA recommends using existing sanitation standards for farming, food packaging, and herbal medicine processing as models for sensible regulations to protect patients from contaminants. The American Herbal Products Association Recommendations for Regulators is a good place to start this process.

 

Workforce Safety Protocols 

Cannabis, like other crops produced for human consumption, requires the use of various types of equipment, mediums, amendments, and plant treatments during the course of its production. The proper use and storage of these items, coupled with the use of appropriate personal protective equipment by employees who are operating equipment and working with cultivation mediums, amendments, and plant treatments, helps to ensure that the workplace is safe and accident-free. Standard operating procedures and protocols addressing workplace safety are a key component to ensuring that the equipment is used appropriately and that workers understand the proper use of mediums, amendments, and plant treatments.

 

Storage Protocols (Short-Term and Long-Term Storage) 

State laws should require that medical cannabis businesses store medicine in a manner that is sanitary and appropriate for the products on hand at every stage of the production and distribution chain. Cannabis is a perishable product, and different types of storage containers may be needed to prevent contamination and preserve freshness at different stages of the production process. In order to reduce the risk of spoilage and contamination, state law should allow for both short-term and long-term storage options as opposed to requiring that all cultivated cannabis be immediately sealed once processing is completed.

 

Batch and Lot Tracking

As product safety has become more of a consideration in state government regulations and recall and adverse event reporting programs are increasingly required of cannabis facilities, lot and batch tracking has become a necessary component to ensuring product safety throughout the supply chain. The need for lot and batch tracking touches all aspects of the supply chain and must be implemented during propagation and cultivation of cannabis in order to effectively track the cannabis forward and backward through the supply chain. Successful lot and batch tracking systems allow the consumer, dispensary, manufacturer, and processor to obtain information regarding the production facility, including details pertaining to the treatment and laboratory testing of the plant material or product.

 

Reasonable Security Protocols 

State laws or regulations should require legal medical cannabis businesses to develop and implement a reasonable and effective security plan. The plan should address physical security, loss prevention, theft or robbery prevention, and training. However, state laws should not place arbitrary or onerous restrictions on legal medical cannabis business where they are unwarranted.

 

Disposal/Waste

To protect the safety and purity of cannabis and cannabis products, states should require that cannabis cultivation and processing facilities create and implement waste disposal procedures and protocols that are designed to ensure that no discarded cannabis can contaminate or be confused with cannabis destined for distribution to patients or manufacturing facilities. Such protocols include segregating material that is to be discarded from other material and rendering material to be discarded as clearly unusable.

 

Water Management

To address environmental concerns surrounding the cultivation of cannabis, several state governments have developed regulatory programs to address water use and the agricultural discharges sometimes associated with cannabis cultivation. Cultivation facilities should be required to develop and implement a water management plan that acts to ensure that water is used appropriately and not wasted, that the water used is safe for the cultivation of the crop, and that all wastewater leaving the cultivation site is safe for the surrounding environment.

 

Pesticide Guidance and Protocols (Pesticide Guidance and Disclosure/Labeling) — 5 pts

WHAT TYPE OF PESTICIDES ARE USED DURING THE CULTIVATION PROCESS AND HOW DOES THE CONSUMER KNOW?

The use of pesticides during the cultivation of cannabis can lead to irreversible contamination. The U.S. Environmental Protection Agency has not established tolerance thresholds for pesticide products used during the cultivation of cannabis, resulting in a lack of clear guidance on the federal level regarding the appropriate usage of pesticide products. In order to protect consumers from encountering pesticide-adulterated products, ASA encourages state governments to limit allowable pesticides to “minimum risk pesticides” as identified in 40 CFR 152.25(f) or produce a specific list of state-government-approved pesticide products.  

Cultivation facilities should be required to track and record pesticide use and fully disclose which pesticide products were used during the cultivation of each lot and batch of cannabis produced. State governments should require that cultivation facilities disclose pesticide use in their labeling requirements. 

 

Required Testing — 5 pts 

ARE CULTIVATORS REQUIRED TO TEST ALL MEDICAL CANNABIS PRODUCED AND BE PREPARED TO DISCLOSE THOSE RESULTS?

In order to ensure patient safety and accurate labeling of medical cannabis and medical cannabis products, state governments should require that representative samples of each batch and lot of medical cannabis produced by a cultivation facility be analyzed by an independent, third-party laboratory testing facility to determine their purity, chemical profile, potency, and quality, screen for potential contaminants, and verify that the product safety practices at the cultivation facility are adequate and effective. Laboratory facilities should be required, or at least allowed, to retain portions of representative samples for analysis at a later date should there be an adverse event or other product safety concern.

 

Recall Protocol and Adverse Event Reporting — 5 pts

IS THE MEDICAL CANNABIS FACILITY REQUIRED TO DEVELOP AND IMPLEMENT A PRODUCT RECALL STRATEGY? 

Product recall strategies are an integral step to ensuring the safety of medical cannabis consumers. State regulations should require cultivation facilities to implement a product recall program that includes transportation guidelines that allow the consumer, a manufacturing facility, and/or a dispensary to return adulterated and recalled products to the facility from which the products originated. Additionally, the rules and regulations should require that all recall programs include the recording of consumer-reported adverse events. Labs or third-party vendors should also be required to collect the representative samples to ensure no adulteration has taken place.

 

Manufacturing

Staff Training — 5 pts

ARE MANUFACTURING FACILITY STAFF REQUIRED TO BE TRAINED IN MEDICAL CANNABIS KNOWLEDGE AND THE STATE LAW?

Many state governments have training requirements for the staff of manufacturing facilities. It is ASA's position that manufacturing facility staff should be required to successfully complete a training curriculum that includes an overview of medical cannabis knowledge as well as applicable state and local laws and regulations and good manufacturing practices. Such training is essential to maintaining workplace safety, regulatory compliance, and product safety.  

 

Standard Operating Procedures and Protocols — 5 pts

ARE MANUFACTURING FACILITIES REQUIRED TO DEVELOP AND MAINTAIN STANDARD OPERATING PROCEDURES AND PROTOCOLS?

As product safety guidelines have been added to many state government regulatory programs, the development and implementation of standard operating procedures and protocols has become a common requirement. Standard operating procedures and protocols serve to ensure that a facility’s operations are conducted in a manner that is safe for all staff working in the facility as well as the surrounding environment and that proper records are kept to ensure product safety. Written standard operating procedures and protocols also serve as internal training and resource guides for the staff and should include, at a minimum, the following key components designed to protect workers as well as product safety, purity, and consistency:

 

Facility and Equipment Sanitary Conditions 

ARE THE FACILITY AND THE EQUIPMENT USED CLEAN AND SAFE?

Contamination can occur at any time during the manufacturing of cannabis-derived products. State laws should require that medical cannabis cultivation, processing, manufacturing, distribution, and laboratory testing be conducted in sanitary conditions. ASA recommends using existing sanitation standards for farming, food packaging, and herbal medicine processing as models for sensible regulations to protect patients from contaminants. The American Herbal Products Association Recommendations for Regulators is a good place to start this process.

 

Workforce Safety Protocols 

Cannabis products, like other herbal products produced for human consumption, come into contact with various types of equipment and materials designed to assist with the extraction, mixing, development, and packaging of cannabis and cannabis-derived products. Observing appropriate safety procedures regarding the use and storage of equipment and materials used during the manufacturing process helps to ensure that the workplace is safe and accident-free. Standard operating procedures and protocols addressing workplace safety are key to ensuring that workers understand the proper use, handling, and storage of equipment and materials used during the manufacturing process.

 

Storage Protocols 

As cannabis is a perishable product, state laws should require medical cannabis businesses to store medicine in a manner that is sanitary and appropriate for the product on hand at every stage of the production and distribution chain. Upon its arrival at a manufacturing facility, cannabis should be stored in a separate incoming holding area until the raw plant material or derived product can be inspected, verified for quality, logged into inventory, and moved into a storage area designated for materials ready to be used in the manufacturing process. In order to reduce the risk of spoilage and contamination, storage procedures and protocols should include separate and distinct storage areas for products that are considered to be in-holding, in-process, awaiting labels, and ready for distribution.

 

Reasonable Security Protocols 

State laws or regulations should require legal medical cannabis businesses to develop and implement a reasonable and effective security plan. The plan should address physical security, loss prevention, theft or robbery prevention, and training. However, state laws should not place arbitrary or onerous restrictions on legal medical cannabis business where they are unwarranted.

 

Batch and Lot Tracking

As product safety has become more of a consideration in state government regulations, and recall and adverse event reporting programs are increasingly required of cannabis facilities, lot and batch tracking has become a necessary component to ensuring product safety throughout the supply chain. The need for lot and batch tracking touches all aspects of the supply chain and must be implemented during propagation and cultivation of cannabis in order to effectively track the cannabis forward and backward through the supply chain. Successful lot and batch tracking systems allow the consumer, dispensary, manufacturer, and processor to obtain information regarding the production facility, including details pertaining to the treatment and laboratory testing of the plant material or product. 

 

Disposal/Waste

To protect the safety and purity of cannabis and cannabis products, states should require that cannabis manufacturing facilities create and implement waste disposal procedures and protocols that are designed to ensure that no discarded cannabis or cannabis-derived products can contaminate or be confused with cannabis-derived products destined for distribution to patients. Such protocols include segregating material that is to be discarded from other material and rendering material to be discarded as clearly unusable.

 

Product Labeling — 5 pts

WHAT INFORMATION SHOULD BE REQUIRED ON MEDICAL CANNABIS PRODUCT LABELS?

Consumers often have a range of medical cannabis products available to them, some of which contain a broad variety of ingredients. Consumers should be able to expect clear and accurate labeling that includes the following product information: 

 

Product Contents, Including Source Material Identification 

State government regulations should require manufacturing facilities to label each product in a manner that clearly discloses a list of all ingredients, including the portion of the cannabis plant used or the source of cannabis if not raw plant material.  Nutritional panels should be included for edible products. 

 

Allergens 

Allergen warnings should be required on the labels of edible cannabis products that contain, or were produced, manufactured, or packaged in a facility that uses known common allergens.

 

Potency and Compound Identification 

Medical cannabis patients often rely on product labels to determine which medicinal compounds are present and at what strength. Labeling requirements for cannabis and cannabis-derived products should include a listing of the products’ active compounds and the potency of each, and not be limited to only CBD and THC, if other cannabinoids are present.

 

Required Testing – 5 pts

ARE MANUFACTURING FACILITIES REQUIRED TO TEST ALL MEDICAL CANNABIS PRODUCTS IN ORDER TO ENSURE THE ACCURACY OF LABELING AND VERIFY THE QUALITY, PURITY, AND CONSISTENCY OF THE PRODUCTS PRODUCED?

In order to ensure patient safety and accurate labeling of medical cannabis and medical cannabis products, state governments should require that representative samples of each batch and lot of all cannabis-derived products be analyzed by an independent, third-party laboratory testing facility to determine their purity, chemical profile, potency, and shelf-life, screen for potential contaminants, and verify that the product is of the quality and consistency it purports to be. Laboratory facilities should be required, or at least allowed, to retain portions of representative samples for analysis at a later date should there be an adverse event or other product safety concern. Labs or third-party samplers should be required to collect the representative samples.

 

Recall Protocol and Adverse Event Reporting — 5 pts

Product recall strategies are an integral step to ensuring the safety of medical cannabis consumers. State governmental regulations should require all manufacturing facilities to implement a product recall program that includes transportation guidelines that allow the consumer and/or dispensary to return adulterated and recalled products to the facility from which they originated. Additionally, the rules and regulations should require that all recall programs include the recording of consumer-reported adverse events.

 

Laboratory Operations

Staff Training — 5 pts

ARE MANUFACTURING FACILITY STAFF REQUIRED TO BE TRAINED IN MEDICAL CANNABIS KNOWLEDGE AND THE STATE LAW?

Many state governments have training requirements for the staff of laboratory testing facilities. It is ASA's position that laboratory staff should be required to successfully complete a training curriculum that includes an overview of medical cannabis knowledge as well as applicable state and local laws and regulations and good laboratory practices. Such training is essential to maintaining workplace safety, regulatory compliance, and product safety.  

 

Method Validation in Accordance with AHP Guidelines — 5 pts

HAS THE MEDICAL CANNABIS OR MEDICAL CANNABIS PRODUCT BEEN TESTED USING A STANDARDIZED METHOD?

In December 2013, the American Herbal Pharmacopoeia (AHP) released a cannabis monograph that outlines the quality control criteria for identifying the quality, purity, and potency of the cannabis plant. It also provides analytical standards to guide cannabis laboratory operations, with a baseline for contaminant testing and standardized methodologies for cannabis analysis. Multiple state governments have adopted the standards for laboratory analysis provided by AHP in the cannabis monograph.

 

Result Reporting — 5 pts

IS THE LABORATORY REQUIRED TO DISCLOSE THE TYPE OF METHOD USED TO DETERMINE THE REPORTED TEST RESULTS?

Laboratory testing facilities should be required to disclose the type of method and instrumentation (where applicable) used to generate the provided test result. For example, was the presence of bacteria ruled out due to visual inspection with a microscope or was the product cultured?  

 

Independent or Third-Party — 5 pts

CAN CULTIVATORS AND MANUFACTURERS TEST THEIR OWN PRODUCTS IN-HOUSE TO VERIFY LABELING AND PRODUCT SAFETY?

In order for a laboratory to maintain integrity while serving as a body that can verify the quality, purity, and composition of a product, it must maintain its independence. As such, the verification of medical cannabis and medical cannabis products should be performed by independent third-party entities. 

 

Standard Operating Procedures and Protocols — 5 pts

ARE LABORATORY TESTING FACILITIES REQUIRED TO DEVELOP AND MAINTAIN STANDARD OPERATING PROCEDURES AND PROTOCOLS?

ASA recognizes that the accuracy and consistency of laboratory analysis is dependent on a facility's ability to implement standard operating procedures and protocols that address and standardize testing activities. State governments should require that laboratory testing facilities develop and implement standard operating procedures and protocols to ensure regulatory compliance and worker safety while protecting the quality, purity, and consistency of the products with which the laboratory works. Standard operating procedures and protocols should include the following topics:

 

Equipment and Instrument Calibration 

Regular calibration of all equipment and instruments used in the laboratory testing facility should be required to help ensure the ongoing accuracy of analytical results.

 

Facility and Equipment Sanitary Conditions 

The testing facility and all equipment used therein should be subject to regular sanitation protocols designed to ensure that new samples that come into contact with equipment and instruments cannot become contaminated with residuals from previous test samples.

 

Sample Tracking 

State governments should require that samples be subject to a detailed tracking protocol.

 

Disposal/Waste Protocols 

The laboratory testing facility should be required to have clear disposal protocols in place that regularly track the amount of waste produced by the operation, as well as include provisions for the safe disposal of chemicals, standards, and reagents generated during testing activities. Most states fail to appreciate that labs have different waste streams that need to be accounted for. The same waste disposal practices that apply to cultivation and manufacturing operations are not always sufficient, i.e. the unrecognizable and unusable clauses that are always present. Labs will generate controlled substance hazardous waste that must be disposed of through licensed environmental (for chemical test sample extracts) or biohazard (for micro test sample extracts) providers.

 

Storage Protocols 

Laboratory facilities should be required to store test and reserve samples under appropriate environmental conditions that protect the integrity of the sample while ensuring their security prior to analysis. Post-analysis samples and extracts should be stored appropriately while awaiting test results, and disposed of promptly thereafter. Reserve samples should be stored for a specified period of time for no greater than two months.

 

Workforce Safety Protocols 

Laboratory testing facilities should be required to develop and implement standard operating procedures and protocols that ensure workplace safety. Such protocols should address the proper use and storage of any solvents or chemicals on site as well as the proper use of all equipment and instruments utilized in the facility.