Tag Archives: regulatory

September 6, 2016

The Devil is in the Detail – Changes to Canada’s Cannabis Regs to Encourage Patient Independence and Business Competition

By Tegan Adams, Elfi Daniel-Ivad MSc

Canada’s new ACMPR was launched late last month on August 24^th. The key change that most notice is that Canadians may now again grow their own cannabis at home for medical purposes. In addition, more strict guidelines for product testing and labeling requirements for Licensed Producers (LPs) were released.

Short term pain for long term gain. While the combination of allowing patients to grow at home and more strict regulations for LPs may at first seem like a business disadvantage; overtime LPs will be thankful for the combination switch. Health Canada’s new requirements encourage a leveling of the playing field globally between LPs and large scale product manufacturers of pharmaceuticals, therapeutics and natural health products. The steps Health Canada is taking to regulate our producers, is exactly what they need to get ready for mass production that will be necessary for recreational markets, scheduled for release in Spring 2017.

Picture rows of Tylenol bottles on the shelf at your favorite pharmacy. Now picture rows of cannabis bottles on the shelf beside them. This is what medical cannabis will look like in Canada perhaps as early as 2018, if not sooner. With just under forty LPs on the map and a projected sales volume of modest billions, Canada’s LPs’ eyes are widening with dollar signs as they lube up their oil production and more to see what shelves in Canada will hold.

Curious to know more? Our regulatory department manager Elfi Daniel-Ivad is an expert in regulatory change. She has worked on close to 150 submissions for cannabis licensees in Canada and beyond. Here are a few key changes from her department’s overview to better understand.

MMPR	ACMPR (Updated)
No personal production or designated production available to patients (aside from that grandfathered in by MMAR).	Personal production and designated production available. Patients may grow 5 indoor plants OR 2 outdoor plants at any given time per gram prescribed to them.
Licensed Producers were not required to label THC or CBD amounts in dried cannabis, though most producers did for sales and educational purposes. Oils had to be labeled with THC and CBD amounts.	Licensed Producers must label their percent THC and CBD for dried and fresh cannabis products.
For the labelling of oils, the total quantity of THC, CBD and oil in a container had to be shown. Restrictions on THC allowed no more than 10mg/mL THC per capsule and no more than 30mg/mL THC per mL oil to be distributed.	In addition, oil labels must now include information on “carrier” oil and allergen information. Containers must be labelled with number of capsules, the net weight and volume of each capsule. .
No reference to validation of analytical testing methods.	Analytical testing must be completed using validated testing methods; confirming reliability and consistency in results for contaminants, disintegration, residues and THC, THC-A, CBD and CBD-A
Accredited labs can only test products as received from Licensed Producers.	In addition to Licensed Producers, patients growing their own or having a designated grower growing for them may also test their products at an accredited lab.

In addition to these changes, it is important to note that if an individual or company has an MMPR proposal already submitted they can now revise it to include oil production (previously, it was first dried bud only). If a company submits a new ACMPR proposal, they can include oil production on their application right away. Interested in submitting your own application? Or need help with one in the USA? Our regulatory department would be happy to answer any questions you might have about the process.

June 29, 2016

Q&A with Dan Anglin: Cannabis Safety is an American Duty

By Aaron G. Biros

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Dan Anglin, a Marine Corps veteran and chairman of the Colorado Cannabis Chamber of Commerce, is the founder and chief executive officer of Americanna, an infused products business in Colorado with a heavy focus on regulatory compliance, consistent dosing and product safety. The company was the very first to implement the THC stamp, a requirement for all infused products in Colorado this coming October 1^st.

As a veteran of Operation Desert Storm, Anglin began his career as a legislative analyst in Arizona, and then moved to Colorado where he worked for the Colorado Legislative Council. Soon after, he became a lobbyist for the Colorado Association of Commerce and Industry. With a focus on health policy, he became the primary lobbyist for anything related to healthcare at the state level.

After running his own lobbying firm, he was hired by EdiPure, which was at the time the largest infused product manufacturer, to lobby against an amendment in the state legislature that would have all but shut down the infused products industry. Within six months, he was made a partner and co-owner of EdiPure for almost three years where he focused on regulatory compliance and legislative matters. In April of 2015, Anglin left EdiPure to buy Boulder Pharma with Frank Falconer, rebranding the company as Americanna making primarily edible products.

According to him, over the past few years, public opinion has grown in favor of differentiating cannabis products from other food products beyond just the packaging. Anglin said he saw this coming and embraced it as a core concept of his business model. Americanna produces gummies in the shape of a cannabis leaf with the THC stamp on each individual gummy. “This is a matter of public safety that you can clearly tell it is a cannabis product by its shape and symbol,” says Anglin. “We should be proud of cannabis products as an expression of American liberty, it is our duty not to hide it in an unrecognizable food product, but celebrate it with a clear shape and stamp, providing for consumer safety.” In this Q&A, we sit down with Dan Anglin to learn about his quality and safety controls, manufacturing processes and why his business embodies American freedom.

CannabisIndustryJournal: How do you see what you are doing as exercising your American liberties?

Dan Anglin: I served my country and protected the rights of Americans overseas. Because the people of Colorado have chosen this [adult use cannabis legalization] to be a right expressed in the state constitution, I feel that every day our 38 employees come to work and make cannabis products, we are exercising our rights as citizens of Colorado and of the United States.

The adult use side of the cannabis industry is a true expression of liberty in choice. This is what freedom is all about! In the past five years, the United States has given more and more groups of people more freedoms and liberties; this is another group of people that believe they deserve rights, in this case the liberty to consume cannabis freely.

This is an issue of states’ rights too. The people of Colorado voted to make the adult use of cannabis a right in their state constitution. We are abiding by the Cole Memo by doing everything we can to protect public safety. There is still a long way to go, but the fact that my employees and I are paying taxes and selling this in a regulated environment is absolutely an expression of our American liberty.

CIJ: Walk us through some of your quality controls in manufacturing infused products.

Dan: We have a contract manufacturer with a white label agreement, so our food products are of the same quality as any food product you would find in major retailers. Quality controls begin as soon as we unpack the food product, making sure it has been stored at the right temperature with all of the right conditions. We toss any products that do not meet our quality standards. Post-infusion, we go into packaging and separate them into flavors. As packagers are putting them into the child resistant packaging as required by law, they are doing QC checks on every single gummy.

The most important part of our quality control system is the testing for potency, homogeneity and microbial contamination. Post-harvest, the cannabis is tested and after it is extracted, the product is tested again but this time also for residual solvents. Once we infuse the product, we test it again. This is so important because making any type of food product requires doing everything you can to prevent bacterial contamination.

CIJ: How do you view cannabis safety as your responsibility?

Dan: Frank and I developed the business based on compliance and consistency. We already comply with rules expected to be enforced six months from now. We want consumers to be able to count on the consistency of the dosing in our products. Our semi-automated process of infusion can precisely dose every single product to ten milligrams. It is an infusion that soaks through the product, not a spray, and is one of the most homogenous products available.

Because we are creating food products, we have the same responsibility as any other food producer. When you make something that people ingest, it is your responsibility to follow health codes that provide guidelines for food handling. Every one of my employees is ServSafe certified. We are treating cannabis as an ingredient in a food product. Food safety is paramount and should be at the top of every infused product manufacturer’s mind.

June 15, 2016

Documentation & Compliance: A Q&A with Michael Shea, ConformanceWare

By Aaron G. Biros

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Cannabis safety throughout the supply chain requires active documentation tools for business owners to keep up with standards and regulations on the local and state level. Michael Shea, founder and president of AccessQMS and chief executive officer of Upshot’s ConformanceWare, provides consulting support across multiple industries with independent referral services to compliance professionals. With quality, safety and efficiency at top of mind, ConformanceWare’s design team developed the Medical Cannabis Series (MC Series™) to help cannabis business owners make the task of compliance easier. The documentation tools in the program are individually tailored to address needs in cultivation, processing, analyzing and dispensing.

The MC Series-Analyze Edition is currently in use at Canalysis Laboratories and NV Cann Labs, both operating in Nevada. According to Tara Lynn, chief executive officer at NV Cann Labs, the product helps them meet all of their documentation needs. “I appreciate all of the development using the MC Series- Analyze Edition and look forward to developing even more of a relationship through the years to come,” says Lynn. We sit down with Michael Shea to learn more about his product and how cannabis business owners can stay on top of regulatory compliance.

CannabisIndustryJournal: How will the MC Series help cannabis laboratories, cultivators, processors and dispensaries navigate regulatory compliance?

Michael Shea: To open a sustainable business involving cannabis goes beyond submitting applications, paying fees and focusing on profit alone. As laws adjust and tighter controls are put in place, more and more business owners are realizing what preserves and sustains their business is, in fact, compliance.

True sustainability is driven by forward thinking that values documenting and following best practices to ensure quality, safety and efficiency. Ambiguity concerning where to turn or how to correctly produce this documentation not only poses a difficult dilemma, it can put one’s investment at risk as well.

Finding a remedy for the situation begins with an expansion of perspective. Businesses will benefit most by actively working toward compliance from the onset. This approach eliminates having to face non-compliance and the enforcement that goes along with it.

MC Series™ is designed for this purpose and will greatly help businesses precisely document how their method of operation demonstrates full compliance with applicable laws and standards. Each MC Series™ edition is developed using Microsoft Word and Excel, which is then customized to mirror each organization’s processes, procedures and instructions.

Being user friendly, we have built in numerous hyperlinks for navigating and managing files and documents so that the documentation behaves like a website. This enables each user to access, edit, save and retrieve information instantly.

CIJ: How does your product utilize CMC’s, FDA, ISO, FOCUS, AHPA and EPA standards to help business owners?

Michael: Businesses handling cannabis are subject to strict regulations and are expected to show full compliance with regulatory protocols. Setting up your business correctly means playing by the rules and operating with the proper documentation and structural foundation.

By applying established best practices from the start, business owners will be able to minimize risk for investors, tighten efficiencies and quickly adapt to regulatory changes with minor adjustments. This serves two primary functions: Business owners will now have the protection they need and the means to promote their brand as a world-class operation.

Because laws surrounding cannabis are in such a state of flux and revision, what is most valuable to know is what technical documents lawmakers select for the purpose of writing regulations. Putting this knowledge to work, the MC series uses a variety of guidance documents designated by regulatory and standards bodies for best establishing compliance.

Developed with regulations in mind, each series edition accurately defines the scope of applicability required for your business model. Whether you’re a grower, processor, cannabis testing service or dispensary the MC series has a solution. It significantly helps business owners to achieve compliance by providing the required documentation with an operations framework.

MC series merges regulatory best practices with internationally accepted standards to deliver a complete solution with a very quick turnaround time. Designed to ensure public safety and protect human health, the MC series provides a much-needed tool that bridges the gap between compliance and profitability.

CIJ: How might you be ahead of the curve in looking toward a rescheduling or a schedule 2 cannabis framework?

Michael: Being ahead of the curve simply translates to knowing the regulatory landscape and what’s involved moving forward. When the goal is to legalize cannabis for its great many uses and benefits, public health and safety must come first. Now is the time for business owners to get serious and effectively address the process of legitimizing it.

As with anything available for consumption, standardization is the method and regulators have a long established process for putting controls in place to ensure the health and safety of consumers. We have a lot of experience in this area, and our MC Series™ is an exceptionally useful tool for people who don’t. It is our way of contributing to assisting and accelerating the process.

Essentially, we are saying to business owners, operate your business as if cannabis is already legal. Managing your operations in compliance to existing regulatory best practices will speak volumes to lawmakers. You will be effectively demonstrating to Federal and State governments that you understand the importance of regulations to ensure public health and safety and are making compliance top priority.

This will make your business fluid in relation to regulatory changes and prepare you for Schedule II and beyond.

CIJ: Why should business owners be proactive in navigating regulatory compliance with a documentation management system?

Michael: With so many regulations targeting the cannabis industry, it is hard to keep track of and adjust accordingly. Many business owners are getting excited about being involved and making a difference. Amidst all this enthusiasm, the importance of best practices is often times overlooked and prioritized for when business is good and finances improve.

At this point, business owners can no longer afford to position best practices for future use.

For businesses handling cannabis, taking a future stance will always increase risk.. This leaves you legally exposed to unforeseen costs and complications. More importantly, it will exponentially increase the potential for watching your investment, hard work and business be out paced by the competition, or even worse, closed down permanently.

Alternatively, being proactive will yield different results. Great benefits will come by adopting and following best practices to operate your business. In doing so, you now have an effective method to ensure quality, health and safety, environmental stewardship and sustainability. As a rapidly growing industry, these areas of discipline are absolutely critical for cannabis to reach its full potential and be fully accepted.

In many industries, legitimate and successful companies see best practices as simply part of doing business. Many see it as a tool that provides a useful roadmap for continually improving their operations and strengthening their position in the market.

When the legal obligations have been taken care of, success becomes a matter of setting realistic goals, planning well and delivering with impeccable timing. Operational performance can now be measured and improved for unhindered growth. Everyone involved or tied to your business is now on the same page and in areas of supervision, micromanagement is replaced with a documented system. Documentation should clearly define everyone’s roles and responsibilities, so that when errors occur, there are corrective action procedures available to fix them.

Editor’s note: For more information you may reach out directly to Michael Shea at 313-303-6763 or info@conformanceware.com

June 14, 2016

Biros' Blog

NCIA Guest Post: Waiver Program Could Clear Path for State Legalization

By Aaron G. Biros

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In last week’s guest post on the National Cannabis Industry Association (NCIA) blog, I discussed The State Marihuana [sic] And Regulatory Tolerance (SMART) Enforcement Act, bill H.R. 3746, and its potential to alleviate a number of problems in the cannabis industry.

The bill would exempt states from the federal prohibition of cannabis via a waiver program. The Attorney General could grant those waivers to states that operate a robust regulatory framework and oversight of the cannabis marketplace. It also has measures in place to help prevent diversion of cannabis into the black market, protecting consumer safety and public health, eliminating criminal enterprise involvement and more.

Cody Stiffler, vice president of Government Affairs at BioTrackTHC, believes this bill could be a panacea for many ailments facing the cannabis market. “They [Congress] plan to give the U.S. Attorney General powers to offer waivers to state governments, exempting that state from federal law regarding cannabis, allowing banks and other institutions to take part in the industry without fear of federal backlash under the Controlled Substances Act,” says Stiffler. Perhaps the most significant effect this bill could have on the cannabis industry is knocking down the burden of the 280E tax code on cannabis businesses primarily because it would exempt states from The Controlled Substances Act. Click here to read the full guest post on the NCIA blog.

April 14, 2016

Pennsylvania to Legalize Medical Cannabis

By Aaron G. Biros

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HARRISBURG, PA– On Wednesday, the Pennsylvania Legislature approved a bill to legalize medical cannabis. Pennsylvania will be the 24^th state to legalize cannabis in the United States. The House voted 149-46, passing bill SB3 and sending it to Governor Tom Wolf, who signed the bill into law on Sunday.

The bill, with a list of seventeen qualifying conditions, will allow for certifying physicians by the Pennsylvania Department of Health and licensing growers and dispensaries. The bill also requires standards for traceability in regulatory oversight, establishing criminal penalties for diversion or falsification of identification cards issued to caregivers and patients.

House Majority Leader, Rep. Dave Reed (R-Indiana), believes the bill allows for robust regulatory oversight. “[…] I am confident Senate Bill 3 provides all the necessary protections to prevent the abuse of medical cannabis, including its unavailability in leaf form,” says Reed. “This new health care program will be closely monitored and if there are found to be weaknesses in the law down the road, we can certainly make any necessary revisions.”

The measure’s prohibiting the distribution of cannabis in dry flower form follows New York’s policy of only allowing patients to use it in forms other than smoking, such as vaporizing or consuming orally in capsules.

Tom Santanna, director of government relations at the Pennsylvania Medical Cannabis Society, is confident the PA Department of Health is the right organization to regulate medical cannabis. “An important part of the regulatory process includes providing for the safety of cannabis via laboratory testing, and it is our feeling that the PA Department of Health is the correct agency for that task,” says Santanna. “The legislation gives the Department of Health the authority to create standards for safety and it is our goal as an organization to work with them to make sure the proper safeguards are in place.”

State Senator Daylin Leach introduced the bill.

The passing of this legislation will undoubtedly encourage more doctors to consider recommending cannabis as a treatment option in Pennsylvania. Dr. David Casarett, professor of medicine at the Perelman School of Medicine, University of Pennsylvania, believes this could help a number of his patients. “When it becomes legal in Pennsylvania, I will certainly discuss it as an option for some of my patients,” says Casarett. “If it is legal, then at least I will know my patients are getting it from a safe and reliable source, without supporting the illegal drug trade and organized crime.”

State Senator Daylin Leach (D- Montgomery/Delaware) introduced the bill and has introduced medical cannabis legislation in every session since 2009. Steve Hoenstine, spokesperson for State Senator Leach, believes the measure will have the most intensive protections for safety in the country. “Our goal was to create a system that helps as many patients as possible, as soon as possible and as safely as possible,” says Hoenstine. “The seed-to-sale tracking system and the bill’s other protections do just that.” State Senator Leach will deliver the keynote speech at the Innovation in the Cannabis Industry; Technology, Medical & Investment Conference in Philadelphia on April 30.

It is expected to take up to two years to begin the implementation of regulations and allow retailers to open their doors to patients.

April 12, 2016

Soapbox

Bridging the Gap: Doctors, Education and Compliance

By Aaron G. Biros

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Doctors are still very hesitant to recommend cannabis in medical treatment of their patients. A key aspect missing from the medical cannabis industry is participation from physicians and the medical community. Cannabis’ Schedule I drug status blocks medical research and leaves a stigma in the medical community. Doctors are concerned with the implications of recommending cannabis, the possibility of losing their license to practice and most lack any formal education in prescribing cannabis. The DEA’s recent announcement to consider rescheduling cannabis this year could dramatically impact doctor’s willingness to work with the drug.

The DEA’s plan to release a decision on the matter represents a major shift in attitude toward treating patients with medical cannabis. This could very possibly culminate in the rescheduling of cannabis, which would allow for more medical research, including clinical trials. Dr. Scott Gottlieb, board-certified anesthesiologist and pain management specialist from Pearl River, New York, believes the bigger obstacles for doctors prescribing cannabis include the stigma associated with it, legal concerns and physicians’ lack of education. Dr. Gottlieb has practices in both New York and New Jersey where he recommends patients cannabis. He believes there should be some type of recourse to help physicians circumvent legal issues. “Some of the bigger legal concerns regarding cannabis surround complying with state regulations,” says Gottlieb. “That sort of compliance includes confirming the diagnosis of the patient with thorough documentation, making sure it is an approved condition to treat with cannabis, documenting continued treatment of the illness and clearing the patient of any contraindications.”

Dr. Gottlieb believes it should be a collaborative effort on behalf of states, dispensaries and patients working to help educate doctors on the legal concerns surrounding the recommendation of cannabis. “Physicians are not taught anything in medical school about dosing or the medical effects of cannabis,” says Gottlieb. “With more education we can get rid of the stigma and get physicians aware of the potential benefits for their patients and the ability to control dosage in medication.”

Currently, there is very little communication between doctors and dispensaries in New York. A collaborative effort to educate all stakeholders involved could help get more doctors involved and streamline the entire process. “Doctors want patients to feel comfortable and know what to expect in receiving treatment with cannabis,” continues Gottlieb. “Which will come with a more transparent system, involving patients, doctors and dispensaries in a conversation about education.”

Pointing to the success of doctors actively recommending cannabis could also facilitate doctor participation. “The number one reason why I recommend cannabis is that I have a number of patients that use it to successfully treat their conditions and completely eliminate their opioid regiment,” says Gottlieb. That kind of success in a treatment should grab the attention of physicians as what could possibly be best for their patients. With more education and research, doctors will gradually feel more comfortable recommending cannabis to their patients.

April 12, 2016

DEA To Consider Rescheduling Cannabis, Could Mean Policy Shift

By Aaron G. Biros

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In a letter sent to lawmakers last week, the Drug Enforcement Agency (DEA) announced plans to make a decision on rescheduling cannabis by mid-2016. The announcement could represent the culmination of a shift in the federal government’s attitude toward cannabis legalization.

Currently, cannabis is a Schedule I narcotic, meaning the government views it as lacking medical benefits and have a high potential for abuse. The rescheduling of cannabis has the potential to open the floodgates for research, including much needed clinical trials.

Derek Peterson, chief executive officer at Terra Tech, a cannabis-focused agriculture company, believes this bodes well for the growth potential of the cannabis industry. “From the perspective of quality and safety standards, I find it unlikely that rescheduling it would negatively impact the degree to which cannabis is examined,” says Peterson. “It’s unnecessarily high position on the DEA drug schedule does nothing but limit the industry’s potential for growth, stall any meaningful pharmaceutical testing and increase law enforcement’s ability to prosecute non-violent drug offenders,” adds Peterson.

The rescheduling could also potentially allow for the prescribing of cannabis for patients. Stephen Goldner, founder of Pinnacle Labs and president of Regulatory Affairs Associates, is hopeful this will lead to a greater shift in public attitude towards cannabis. “The DEA’s announcement is a clear message to all States and possibly even to United Nations policy makers: even the DEA is willing to reconsider cannabis,” says Goldner. “Since the DEA is reconsidering cannabis, state politicians and local police departments can also be flexible and move away from prohibition, towards the regulation of cannabis.”

The rescheduling of cannabis could have a tremendous impact on the growth of the cannabis industry, including more clinical trials, medical research and physician participation. It could also open the door for more federal agency involvement, as the Schedule I status inhibits any EPA research on cannabis pesticide use or FDA guidance on food and drug good manufacturing practices. When reached for comment, the FDA’s press office said they could not speculate on any involvement in the matter.

March 22, 2016

Supreme Court Denies Challenge to Colorado’s Cannabis Laws: Industry Outlooks

By Aaron G. Biros

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The Supreme Court shut down a lawsuit on Monday brought by two states against Colorado for its recreational cannabis laws. Nebraska and Oklahoma brought the case to the Supreme Court, claiming that the recreational cannabis industry in Colorado is responsible for the illegal exportation of cannabis outside of Colorado. “Colorado has facilitated purchase of marijuana by residents of neighboring states by issuing licenses to an unusually high number of marijuana retailers perched on Colorado’s borders,” the two states told the court in a supplemental brief.

In that brief, the two states argue that Colorado’s cannabis industry led to more cannabis illegally crossing state lines. They argue because of that influx of cannabis, they spend more on law enforcement and state resources, which is a detriment to their citizens. The Supreme Court did not provide an explanation for why they refused to hear the case.

Many view this as a big win for the legal cannabis industry. “The Supreme Court has protected the will of the people today and I believe the court has demonstrated that it understands legal cannabis is a fundamental right,” says Andy Williams, president of Medicine Man, the largest cannabis dispensary in Denver.

Still others see this simply as business as usual. “While I’m pleased to see the Court reject the challenge to Colorado’s cannabis law, this decision isn’t really a win for cannabis advocates- it only maintains the status quo,” says Aaron Herzberg, partner and general counsel at CalCann Holdings, a medical cannabis holding company specializing in real estate and licensing. “We are struggling with diversion in California, so hopefully states will continue to be on track to create a more regulated and taxed environment where cannabis can be manufactured and sold through channels where it is safe and tested,” continues Herzberg.

Adam Koh, chief cultivation officer at Comprehensive Cannabis Consulting (3C), warns that the Court’s denial to hear the case is not necessarily an affirmation of state’s cannabis programs. “It is evident that some diversion is taking place, which of course is against the provisions of the Cole Memorandum,” says Koh. “In order to avoid being implicated in such activities, legally licensed cannabis businesses in Colorado should not take the SCOTUS decision as a signal to relax, but should instead work to make sure that inventory control and record-keeping protocols are in place and even exceed the standards required in state regulations.”

The fact alone that Nebraska and Oklahoma even brought the case to the Supreme Court means that diversion is a major issue facing the cannabis industry. “Only by going above and beyond in terms of compliance will this controversial industry make itself credible in the eyes of its detractors,” says Koh. Some cannabis industry leaders take it upon themselves to help guide rule makers in crafting standards.

Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (F OCUS), believes the Cole Memo is currently the best guidance for states and business owners to follow by the federal government in regards to cannabis. “Gaping holes in cannabis regulations are glaringly identified via the pesticide issues and recalls recently,” says Engelking. “These issues showcase each state being in violation of the Cole Memo’s expectation that they will implement strong and effective regulatory and enforcement systems that address the threat to public safety, public health, and other law enforcement interests.”

The Supreme Court’s denial of the two states’ challenge to Colorado’s cannabis legislation suggests the federal government’s intentional avoidance of involvement in current state cannabis issues. The government’s inaction does not, however, indicate their support.

March 8, 2016

Soapbox

Health Care Industry Cannot Ignore Cannabis Any Longer

By Robert T. Hoban, Esq.

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Twenty-four U.S. states now have some form of medical marijuana legalization on the books. These states allow patients with a variety of qualifying conditions to possess and cultivate cannabis lawfully as a treatment for such medical conditions. The number of states allowing medical cannabis is set to increase dramatically, as various additional state legislatures have bills or ballot measures pending on this topic. You can read more about this topic here.

The federal government surprisingly already has their hands in medical marijuana. The federal government sends free, pre-rolled cannabis cigarettes to a special, albeit dwindling, group of patients on a regular basis and they have been doing so since 1976. This is a product of the 1976 federal Investigational New Drug Program (Compassionate Access I.N.D.), which still operates, but was closed in 1992 to any new patients.

The U.S. Government holds a federal patent for therapeutic cannabinoid use (US6630507 B1). The patent, “Cannabinoids as antioxidants and neuroprotectants,” (LINK) covers a method of treating diseases by applying a therapeutically effective amount of cannabinoids derived from marijuana. In addition, the White House website provides links to government-funded research projects involving medical marijuana. Presently, the links show 219 completed projects and 95 projects in progress.

On June 23, 2015, the American Medical Association adopted the formal position that marijuana is a form of medicine. Reliable scientific studies address the medical efficacy of the use of medical cannabis for an increasing number of conditions. Medical cannabis is here to stay and the health care industry needs to pay close attention.

Simply put, the health care industry has been resistant to beginning the study of medical marijuana. This does not bode well for health care systems that will see more patients utilizing various forms of medical cannabis. Moreover, this is not a sustainable health care business model. With an increased focus on alternative forms of medicine and treatment both by practitioners and health care insurance providers, it is imperative that the health care industry studies the facts.

The New Mexico Workers’ Compensation Administration began requiring employers and insurers to reimburse injured workers for medical marijuana when the state’s health care provider fee schedule took effect January 1, 2016. Workers compensation claimants can be reimbursed up to $12.02 per gram of marijuana for up to 226.8 grams of marijuana per year, according to the fee schedule. Such reimbursements were ordered after the New Mexico Court of Appeals had ruled three times since May, 2014 that medical marijuana should be classified as reasonable and necessary medical care for injured workers.

The same momentum is impacting Latin America. Brazil’s governmental health care agency, ANVISA, recently removed a component of cannabis, cannabidiol (CBD), from the list of banned substances, meaning the marijuana molecule can now be prescribed by physicians for treating seizures, multiple sclerosis, schizophrenia and other ailments. As such, ANVISA has approved the importation of CBD from the United States.

More and more research studies are published every year. In the National Center for Biotechnology Information database of biomedical literature, 4,516 medical abstracts reference both cannabis and cannabinoids. Still the vast majority of medical schools do not educate students about the human endocannabinoid system.

Denis Petro, a neurologist and pharmacologist, researches cannabis as a treatment for multiple sclerosis. He founded Patients Out of Time, a non-profit organization dedicated to research and education on the endocannabinoid system. “At present, conventional treatments for spasticity are unsatisfactory,” Dr. Petro wrote, in an article, Indications for Therapeutic Use of Cannabis. “Based on scientific evidence, cannabis is a safe and effective alternative when compared to conventional treatments.”

Physicians in Colorado can recommend marijuana and the Colorado Constitution legally protects them (Article XVII, Section 14). The Colorado Constitution gives physicians immunity for advising a patient about the risks and benefits of medical marijuana for a debilitating medical condition, and for recommending medical marijuana to a patient.

Moreover, physicians have a duty to care for their patients, and that includes considering medical marijuana if it would help that patient. Consequently, by understanding the health benefits and the particularized sources of liability, physicians can lend clarity to the medical marijuana industry.

While medical marijuana policy changes may lead to uncertainty, most questions about the marijuana industry, including the risks and its related legality, have answers. The problem is that health care providers and insurance companies do not know where to turn for this information.

I delivered a number of presentations concerning this topic to various provider and insurance-related entities across the country serving our health care system. It is evident that many of these health care related entities can move forward with a better understanding of the risk implications and devise better informed strategies to incorporate medical cannabis into their operational plans, whether for now or in the near future.

An understanding of the researched health benefits of medical marijuana is increasingly necessary for physicians and other members of our health care system. A conservative approach is certainly advisable, but it is more than just a good thing to learn about; it is a necessity in this day and age to remain relevant and informed. This needs to happen now. And the providers that take appropriate steps soon will be better positioned to deal with these issues as they become increasingly prevalent.

February 17, 2016

Amanda Rigdon to Offer Guidance on Method Validation at Cannabis Labs Conference

By Aaron G. Biros

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With multiple states now requiring third-party certification as part of licensing cannabis laboratories, there is a large role for laboratory accreditation in the cannabis industry. Using method validation can prove that your data is reproducible and that you have robust methods for sample preparation and calibration. All of these tools are instrumental in getting a laboratory accredited.

Amanda Rigdon, associate marketing manager for GC columns at Restek, Inc. — Amanda Rigdon, associate marketing manager for GC columns at Restek

Amanda Rigdon, associate marketing manager for gas chromatography columns at Restek, Inc., will deliver a presentation, Opportunities and Challenges for Method Validation in the Evolving Cannabis Industry, at the first annual Cannabis Labs Conference taking place this March 9^th in Atlanta, Georgia. The Cannabis Labs Conference will be co-located with the third annual Food Labs Conference and the Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy (Pittcon) at the Georgia World Congress Center.

In her presentation, Rigdon will discuss established validation guidelines from a variety of regulatory bodies. “Method validation is absolutely critical to the cannabis industry,” she says. “Accurate test results not only help to protect consumers, but because of the high dollar value of cannabis products, accurate results can also protect producers from false positives, and laboratories in backing up their results.” She will also be sharing actual validation data from a number of cannabis analytical methods.

Scott Radcliffe, technical support scientist at Romer Labs, Inc., will share his validation methods of immunoassays for the detection of pathogens and mycotoxins in cannabis. He will include a discussion of specific rapid pathogen detection methods for Salmonella and E. coli O157 species. This will cover their small-scale validation studies with partner labs in Michigan and Washington for immunoassays.

stevegoldner — Stephen Goldner, Esq, founder of Pinnacle Laboratory and Regulatory Affairs Associates

Stephen Goldner, Esq, founder of Pinnacle Laboratories, will discuss how cannabis labs can apply FDA lab practices with recommendations for short and long term management implementation. Goldner’s presentation will include a discussion of preparation for FDA involvement in sate regulatory systems.

Beyond validation methods in laboratories, the Cannabis Labs Conference will feature several presentations on ISO/IEC 17025:2005 compliance, the need for standardization, seed-to-sale traceability, FDA best lab practices and cannabis quality. Nic Easley, chief executive officer of Comprehensive Cannabis Consulting (3C), will deliver the keynote presentation on the role of quality assurance in the cannabis industry.