By Greg Tucker
Last month, the Maryland Medical Cannabis Commission voted to adopt what is expected to be the final draft of regulations that will cover the state’s MMJ industry.
Entrepreneurs interested in applying for grower, processor, dispensary or independent testing laboratory licenses are likely satisfied with the rules, which have undergone several revisions over the last year.
Recently, there has been a trend among states to legalize medical cannabis begrudgingly, with several only allowing low-THC/high-CBD or non-smokeable products. But Maryland has approached its program with a genuine desire to care for its patients and learn how medical cannabis will help them.
Applicants hoping to win a license will therefore need to focus on how they are prioritizing patient care over other aspects of running a cannabis business.
Here are four patient-centric aspects of the regulations that entrepreneurs seeking licenses should focus on to create a more compelling application.
Certifying Physicians and Patient Cards
The list of qualifying conditions ultimately helps determine the size of the market – and how entrepreneurs should structure their businesses.
Fortunately, Maryland’s proposed regulations are quite lenient in this regard.
Physicians will have a lot of leeway in determining if a patient is a good candidate for medical cannabis. Essentially, patients will qualify if other treatments have been ineffective and the physician has a reasonable expectation that medical cannabis will help.
The actual list of qualifying conditions is comprised mostly of symptoms (seven) for which medical cannabis may be prescribed – including chronic pain and nausea, the most common ailments for which patients traditionally seek medical cannabis.
This means patient cards won’t be restricted by the actual condition or disease a patient is suffering from, but the symptoms they wish to treat. In fact, glaucoma and post-traumatic stress disorder are the only specific conditions listed.
Additionally, the commission has removed most of the barriers from earlier drafts for physicians that want to become “registered” to prescribe medical cannabis. It also wants to exempt qualifying patients in hospice care from the formality of obtaining a patient card, and it wants to give patients visiting Maryland for medical care the ability to obtain an MMJ card for the duration of their treatment in the state.
From these regulations, applicants can learn which symptoms they should design their products for – and how they should justify the strains they are proposing to grow. Additionally, these rules reveal two unique markets that applicants can target in their marketing plans: hospice care and non-resident patients.
The Dispensary Clinical Director
Under the regulations, dispensaries can hire a “clinical director” to ensure that the operation has well-trained employees to dispense medical cannabis like pharmacists and inform patients of the uses, risks, benefits and side effects of using medical cannabis.
The commission defines a clinical director as a Maryland-licensed physician, nurse practitioner or pharmacist.
Although the position will be optional (vs. mandatory in a previous version of the rules), the commission will likely give preference to applicants that plan to hire a clinical director. But it is important to look at earlier drafts of the regulations to learn more about the clinical director’s responsibilities, as the final rules have removed nearly every passage mentioning the position.
From this part of the regulations, dispensary applicants learn the commission prefers for each dispensary to have a pharmacist, nurse practitioner or pharmacist licensed in Maryland on staff to train employees and educate patients.
Quality Control and Product Safety
Each business type will be responsible for complying with a facet of Maryland’s quality control and product safety regulations.
Growers and processors will need to follow stability testing and retention sampling rules. That will involve providing a sample from each released batch to an independent laboratory so that stability testing can be performed at 6-month intervals to ensure product potency, purity and accurate expiration dating.
Growers and processors will also be required to retain samples for one year past the expiration date for each released batch for follow-up testing.
The commission also expects each business to prepare to receive complaints, respond to adverse event reports and participate in a product recall if necessary.
From these regulations, applicants learn they need comprehensive quality control, inventory control, record-keeping and production procedures.
It’s apparent from the regulations that the commission is looking for applicants that have relevant experience and are prepared to train their employees.
However, the commission does not seem particularly interested in applicants with direct cannabis-related experience.
For starters, any individual who wishes to work for a medical cannabis business in Maryland will need to pass a drug test that includes cannabis. Additionally, each applicant must have alcohol- and drug-free workplace policies and a plan to enforce them.
Essentially, the commission wants dispensaries operated like pharmacies; processing facilities operated like laboratories and mainstream product production facilities; and grower facilities operated like commercial horticultural businesses.
From these regulations, applicants learn that:
- Dispensary applicants will be graded on their knowledge in the science and use of medical cannabis, including the pharmacology of cannabis, its active components, dosage forms, its pharmacodynamic impact, potential drug interactions and consumer safety issues.
- Processing applicants will be graded on their knowledge of commercial laboratory practices, pharmaceutical manufacturing procedures, consumer products production and chemical plant management.
- Grower applicants will be graded on their knowledge of commercial horticulture and agriculture.
In a nutshell, the commission prioritizes transferable knowledge from other industries over direct experience operating a medical cannabis business.
Because the commission is comprised of several individuals from Maryland’s healthcare industry, the regulations contain many themes and rules inspired by their backgrounds.
Consequently, to create a high-scoring application in Maryland, applicants must focus on these topics. It’s also a good idea to review previous drafts of the regulations to learn which rules were removed as a result of public comment but may still help applicants earn more points.
Maryland will likely accept applications at the end of this summer or the beginning of fall. Good luck to everyone who’s applying.
Greg Tucker founded Potent Proposals, a company that helps marijuana entrepreneurs apply for and win cannabis business licenses.