According to a press release, the State of Delaware has chosen BioTrackTHC as their partner in seed-to-sale tracking software. Delaware’s Department of Health and Social Services (DHSS) signed a contract with BioTrackTHC for the tracking and patient registry software.
In 2016, Delaware issued a request for proposals for “the Delaware Enterprise Consolidated Cannabis Control System,” which encompasses the statewide patient registry and seed-to-sale traceability systems. “Our sincerest thanks to DHSS for choosing Team BioTrack,” says Patrick Vo, CEO of BioTrackTHC. “DHSS has been wonderful to work with throughout the contracting process, and we look forward to partnering with them to provide the tools and data they need to continue overseeing the industry and protecting their patients.” BioTrack’s software was selected as the winner of a number of government contracts in other states previously for the same role.
Their software is currently used in government traceability systems in Washington, New Mexico, Illinois, Hawaii, New York and the city of Arcata, California. The press release states regulators will have the ability to view the retail data “including plant counts and usable inventory, lab results, transportation, and point-of-sale data—to perform periodic audits and ensure compliance.” The patient registry will also provide better patient accessibility through the new software with a faster turn around time and automated application processing.
BioTrackTHC provides technology solutions for businesses and governments to tracking products throughout the supply chain to the point of sale. The software systems help businesses remain compliant with regulations and monitor data for things like inventory management.
BioTrackTHC, partnering with the Hawaii Department of Health, is deploying the first live seed-to-sale traceability system for cannabis in a FedRAMP-authorized environment, according to a press release. The Federal Risk and Authorization Management Program (FedRAMP) is a government-wide risk management platform that provides standards for security assessment, authorization and continuous monitoring for cloud products and services. “BioTrackTHC, utilizing Amazon Web Service’s Government Cloud (AWS GovCloud), has met all necessary requirements to host its live government cannabis seed-to-sale Traceability Systems in one of the most secure cloud platforms in the world,” states the press release.
“The BioTrackTHC team invested an incredible amount of time and effort into this high priority project, and we are excited to see it transform from last year’s concept to clean execution,” says Patrick Vo, president and chief executive officer of BioTrackTHC. “We are grateful for the Hawaii Department of Health’s trust in us to get it right the first time.” Hawaii working with BioTrackTHC and AWS GovCloud essentially affords them an ultra-high level of data security in their state traceability program.
“We’re pleased to know that our state’s seed-to-sale Traceability System is now housed in the most secure cloud server available,” says Keith Ridley, chief of the Hawaii DOH Office of Health Care Assurance. “This ensures safety and comfort for our licensees, business operators, and our patients, who can all be confident in knowing their business data and protected patient information is being stored in the most secure traceability system in the world.” The FedRAMP decision-making body is comprised of the Chief Information Officers (CIOs) from the Department of Defense, Department of Homeland Security, and the General Services Administration, with additional collaboration from the National Institute of Standards and Technology, National Security Agency, Office of Management and Budget, and the Federal CIO Council.
The FedRAMP standards include “400 security measures and allows government agencies to use these and only these cloud environments for high-impact data where the loss of data confidentiality, integrity, or availability could be expected to have a severe or catastrophic effect on organizational operations, assets, or individuals,” according to the press release. Essentially this means that they meet the highest security requirements of the program.
In a New York Times article published yesterday, news broke of Microsoft’s entry into the cannabis marketplace, teaming up with KIND Financial to launch its Microsoft Health and Human Services Pod for Managed Service Providers, which is essentially a seed-to-sale tracking technology. Their goal is to provide local and state governments with software solutions for traceability in the burgeoning cannabis industry.
In a press release yesterday, Kimberly Nelson, executive director of state and local government solutions from Microsoft said, “KIND’s strategic industry positioning, experienced team and top-notch-technology running in the Microsoft Azure Government cloud, made for an easy decision to align efforts.” According to KIND Financial founder and chief executive officer, David Dinenberg, the cannabis marketplace will continue to have strict oversight and government regulations. “I am delighted that Microsoft supports KIND’s mission to build the backbone for cannabis compliance,” says Dinenberg.
This move could represent an opening of the floodgates for corporate interest in the space. According to Matt Karnes, founder of GreenWave Advisors, a cannabis financial data analysis firm, this could potentially result in an increase in capital flow into the cannabis industry. “This signals a wider acceptance of cannabis and perhaps that changes to national policies are more likely now that we see a large corporation stepping in,” says Karnes. “This could certainly mean an inflow of capital from larger, mainstream enterprises that were previously unwilling to take the risk.” Microsoft also made news recently for the acquisition of LinkedIn for $26.2 billion. The move to get into the cannabis space could represent a diminishing stigma associated with the market and a wider mainstream acceptance in business.
According to Nic Easley, chief executive officer at Comprehensive Cannabis Consulting (3C), this is another legitimizing factor for the cannabis industry. “It shows that cannabis is here to stay, and the fact that Microsoft is now spending resources on software, further validates that,” says Easley. “Many of the first mover seed-to-sale companies, entered the industry too early, had problems with their technology and lacked quality customer service, which created opportunities for new companies to emerge to dominate and capitalize upon the first ‘Netscapes’ of the cannabis industry’s failures.” Additionally, this could rationalize the market for other quality software companies such as Compliant Cannabis, according to Easley.
While Microsoft publicly announced their entrance into the cannabis marketplace, one can speculate that other large companies are planning their entrance as well. “We are fielding inquiries from Fortune 500 companies, Wall Street investors and even major foreign investors on a weekly basis,” says Easley. “In the past week alone, we received calls from three different Fortune 500 companies asking us how they can get into the industry.” It appears that because Microsoft is in the cloud business and they are offering this ancillary service that not only does this further legitimize the industry, but it could be quelling the dated stigma associated with cannabis.
We have two key software platforms at our laboratory that help us stay compliant with our standard operating procedures. Saif Al-Dujaili, quality manager at Eurofins-Experchem, oversees quality assurance in our laboratory. As we like to say, you are safe with Saif.
A Customized Sample Tracking System
Sample-tracking software consists of four main modules:
Tracking samples in our facility: When a sample is booked by our tracking system, a unique identification number is generated by the system and printed on a sticker, which is placed on the sample. When a sample is booked, department heads then have the ability to assign work orders to the analysts through the tracking system.
When testing is complete, results are entered by the analyst into the tracking system and reviewed by the quality assurance (QA) department. QA reviewers are responsible for approving results entered in the system before they are sent to the client. A certificate of analysis is then generated and e-mailed to the client for their review.
Controlling stability studies conducted in our facility: Stability studies are scheduled and controlled on different samples pulled for analysis. Within our facility’s sample-tracking system we have different chamber names with different conditions where products can be placed. Which chamber we place samples in depends on protocols and requests from our client. The software used also generates a unique study number for each stability study that occurs. The stability schedule that includes each study is reviewed every week by the stability coordinator to schedule what samples need to be pulled for testing.
Controlling methods used for tests: Methods are entered into the tracking system after department heads have reviewed them and it is approved by QA. The tracking system generates a unique ID number for each method as well as each sample. The method can now be tracked in our laboratory’s system. Within the software you can enter the name of the method, client name and effective date and any revisions applied to the method.
Controlling inventory of columns and electrodes: Sample tracking also helps us with our purchasing patterns to make sure we have supplies for our client’s testing needs. Every time that columns and electrodes are received, they are entered into our tracking system for inventory purposes.
REES Environmental Monitoring Software
REES is used to monitor the environmental conditions of our testing facility. Key inputs measured include temperature, humidity, differential pressure and elimination or intensity of light. REES is linked to the QA department’s computers. An audible alarm is sounded as well as e-mails sent to QA personnel to notify them if anything is out of specification. REES also phones related personnel’s cell phones to notify them of any alarms. No alarms are missed, even if they occur after working hours. Having a 24-hour environmental monitoring system in place helps Eurofins-Experchem ensure integrity in operations of stability, microbiological and other environmental conditions essential for accuracy in testing results.
With the news of Pennsylvania’s medical cannabis legalization measure passing, lawmakers are clamoring for strict regulatory oversight in the form of traceability to prevent diversion and misuse. State Senator Daylin Leach (D- Montgomery/Delaware) introduced the bill and believes it 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 Steve Hoenstine, spokesperson for State Senator Leach. “The seed-to-sale tracking system and the bill’s other protections do just that.”
At the recent Cannabis Labs Conference, Cody Stiffler, vice president of government affairs at BioTrackTHC, discussed why traceability is so important. Stiffler previously served as the chief executive officer of the American Medical Management Association, where he fought the Florida prescription drug abuse epidemic. “We originally started tracking prescription medications and methamphetamine precursors to combat the prescription drug abuse and meth epidemic in Florida,” says Stiffler. He focused on providing accountability and traceability, making sure every prescription was legitimate and keeping drugs off the black market. Implementing tracking protocols allowed for the accountability of pharmacists, physicians and patients.
The primary goals of a traceability system, according to Stiffler, are to prevent diversion and promote public safety. “We want to advance the cannabis industry with respect to traceability and regulatory compliance by integrating laboratory testing with traceability,” says Stiffler. “Our software helps get safe products to patients and consumers in a responsible manner.”
Stiffler’s role at BioTrackTHC is to provide industry insights to states looking to legalize cannabis and support them with identifying the best practices that meet requirements in their state. Traceability is commonly defined as the ability to verify history, location and application of a product from source to distribution. BioTrackTHC’s tracking software covers everything from seed to sale, involving regulatory bodies in oversight. In the beginning of cultivation, each plant is assigned a bar code or sixteen-digit identifier. According to Stiffler, Colorado’s system uses radio-frequency identification (RFID) tags while Washington’s system gives the business a choice because the software can work with any type of identifier, whether it is a barcode, QR code or RFID tag. “Our system generates those numbers and prevents diversion with a closed loop system,” says Stiffler.
Washington, Illinois, New York, New Mexico and Hawaii are the five states that use BioTrackTHC’s software. “If the state wants to see the chain-of-custody, they can go back in the system and see every touch point and the full life cycle of the product in real time,” says Stiffler. “Our system also incorporates lab testing to ensure no product reaches shelves unless test values are associated with it.”
For many states, problems lie not in diversion, but inversion, where black market growers bring their products into the legal market. “A lot of people growing black market product are inverting it into the regulated market,” notes Stiffler. This kind of black market activity can flood the legal market with un-tested cannabis.
Product recalls are examples of when traceability software can be very useful. Pesticides, microbiological contaminants, heavy metals and other contaminants are at issue. Stiffler invokes an example from a company in Washington making THC-infused drinks. “Because of an issue in the manufacturing process, the bottles were exploding in refrigerators and on shelves,” says Stiffler. “Because the product’s lineage was completely tracked, we could isolate all of the products in that specific batch from that specific manufacturer and then forward trace to every retailer that had it in inventory,” he adds. “Whenever someone who did not get the recall notice would attempt to scan that barcode at point of sale, a message appeared noting its recall status and that it is not for sale.” The software’s financial data analytics can provide real time visibility for profit margins or losses resulting from recalls.
According to Stiffler, these kinds of protections in place give law enforcement and government agencies piece of mind that they are helping to prevent diversion and promote public safety. Traceability software is one of the very important safeguards protecting food safety and product safety.
HARRISBURG, PA– On Wednesday, the Pennsylvania Legislature approved a bill to legalize medical cannabis. Pennsylvania will be the 24th 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.”
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.
Stephen Spinosa, vice president of retail operations at Good Chemistry, has over seven years of experience working in the cannabis industry in the operation and management of licensed dispensaries.
He was previously an inventory manager in a 7,000-square-foot medical marijuana cultivation in Colorado. Spinosa is currently part of the team at Good Chemistry dispensaries, which has locations in Aurora and Denver, Colorado. He oversees staff training, state and local regulatory compliance and seed-to-sale inventory tracking.
Spinosa recently delivered a keynote presentation at the Dispensary Next Conference in Portland, Oregon titled “From Waiting Room to High-End Retail Experience: How Dispensary Culture Has Changed from 2009 to Now.” He discussed the rise of high-end experience and gave tools for dispensaries to improve retail operations.
In the presentation, he covered supplier quality, security, tiered pricing, inventory tracking and safety issues. Much of what he discussed revolved around the consumer experience and how important the culture at a dispensary is for the buying experience. After his keynote presentation, I sat down with Spinosa to discuss the customer experience, consumer education and safety and sales trends.
Cannabis Industry Journal: What are some of the key areas where dispensaries can improve the quality of customer experience?
Stephen Spinosa: Ultimately, the dispensary experience is like any retail experience. Good Chemistry’s staff is always friendly, smiling, welcoming and helpful to all customers that walk through our doors. Having employees who are experts at providing advice to any user level, and who are extremely knowledgeable on each strain and edible effect is extremely important to us. It is all about making the customer feel comfortable in their experience, especially for novice users who may feel timid when entering a dispensary for the first time.
Good Chemistry’s high-end retail experience includes our up-to-date LED menu screens that present our daily flower menu. That may seem like common sense, however, you would be surprised how many dispensaries do not have a flower menu for their customers to peruse. It helps the customer navigate through all the strains that we offer, and adds to the overall retail experience. We offer twenty or more strains every day.
Additionally we do not have an armed guard hovering at the entrance, making our guests feel uncomfortable. We have highly sophisticated security, like every dispensary, but we’ve left out this intimidating and unnecessary aspect.
CIJ: Can you discuss what you and your employees do for consumer education and safety?
Spinosa: When introducing cannabis to consumers, it is our mission to educate our customers on the correct dosage based on experience level. Our bud tenders are trained to ask a lot of questions before recommending anything. If a customer is a first timer, the bud tenders will have certain recommendations based on their experience level, such as high-CBD [cannabidiol] flower, a low THC percentage vaporizer pen, or a 1-5mg edible serving.
That said, strains of cannabis often cannot be neatly compartmentalized into sativa vs. indica, so our bud tenders also educate customers about the entourage effect, the interaction of the various compounds in marijuana to produce each strain’s unique feeling.
We have developed a pioneering category system to help our customers, whether novice or connoisseur. The system is broken down into four main categories to help consumers decide what sensation they would like to experience: stimulation, relaxation, sleep or relief. We use the four categories to guide our customers through our daily flower menu by labeling each strain with a category.
If a customer is purchasing edibles, we provide an Edibles Education brochure from the Cannabis Business Alliance that stresses the Start Low, Go Slow motto. We also educate consumers on the difference between edibles made with butter vs. oil. Additionally, all of our third party vendor edible products for adult-use are packaged safely in 100% child resistant packaging.
It is important that our customers have a great experience, which is always possible with good guidance. A happy customer is a repeat customer. We are also well aware of the importance of educated employees. Our employees go through a formal training program, and we have monthly meetings where vendors come in and educate the employees on how to sell and dose various products.
CIJ: Can you tell me about your inventory and some consumer trends you are noticing?
Spinosa: Flower is the biggest seller, and for good reason: we have award-winning strains that are $30 an eighth, every strain, every day. Not many dispensaries offer such incredible pricing. Right now, the purchasing trend tends to lean toward the strains that have the highest THC percentage.
This may not accurately depict the best strains, because there have been findings that the entourage effect means different strains can have unique lifts, but it is definitely what the industry is seeing as far as sales trends. As far as edibles, gummies are the biggest sellers followed by hard candies, chocolate and baked goods. Lastly, concentrates such as live resin, shatter and wax have increased in popularity. Good Chemistry produces a new product called solvent-less rosin, concentrated THC oil that is produced using just heat and pressure. Rosin is currently picking up a good amount of traction, although not many dispensaries currently offer it.
According to Phil Bergman, senior communications consultant at BioTrackTHC, just yesterday the company announced it had surpassed 1,500 locations that its software systems are used in. BioTrackTHC has a traceability software solution that provides “real-time visibility into the seed-to-sale tracking data of licensed medical marijuana dispensaries, including plant and inventory quantities, production activity, laboratory testing results, transportation activity, and dispensing activity.”
The Hawaii Department of Health’s Office of Health Care Assurance selecting BioTrackTHC for the contract marks five state contracts that the company has won. Currently, the software is used by Washington, New Mexico and Illinois and soon to come are New York and now Hawaii.
The software essentially allows private businesses and regulators access to data on cannabis plants in real-time, tracking them through every step in the production process including growing, harvesting, quality and safety testing, transportation and sale. These state-mandated systems have the ability to prevent issues like diversion, theft and contamination, helping with transparency in regulatory compliance.
The software is used in both “medical and recreational cannabis facilities in 23 states, Washington D.C., Canada, Jamaica and South America. “The development of a healthy and successful medical cannabis program is a top priority for Hawaii, and we are extremely proud to have been chosen to be a critical part of it,” said Patrick Vo, chief executive officer of BioTrackTHC.
“We demonstrated significant interest in the state of Hawaii early on, including sponsoring the first ever Cannabis Business Expo there last year,” says Vo. “The Hawaiian people have their own special values and way of life, which is important to understand when working in Hawaii.” Winning the contract means their software will be used to track the production, transportation and sale of all medical marijuana in the state of Hawaii.
A lot has changed since last year’s article, “Marijuana Edibles: A Regulatory Nightmare.” Marijuana has since catapulted into mainstream thinking via activism, state decriminalization, and medical reforms while investors and banks are beginning to trust the market more, further legitimizing the nascent industry. According to an article from the Washington Post, Colorado’s legal marijuana industry reached $700 million in 2014 and is expected to grow to $1 billion by 2016.
Innovators are beginning to analyze trends on a national level, looking toward federal rescheduling of the drug as a catalyst for more state reforms and wider legalization measures. Federal legalization is in the back of many minds, as the introduction of pivotal state and federal legislative reforms promises more access to banking services, medical research, and more state independence.
While a black market mentality remains prevalent, widespread state reforms, increased venture capital investment, and further legitimization of an industry with less barriers of entry have fostered a perceived reduction in risk. States like Oregon, Washington, and Colorado that have already legalized marijuana for recreational and medical sales are beginning to implement strict packaging rules, requirements for traceability, QA programs, testing and laboratory monitoring requirements, and other regulations that would suggest FDA oversight down the road.
State regulatory bodies such as the Colorado Marijuana Enforcement Division (MED) have matured and expanded their oversight to include certifications and requirements for lab testing and analysis. Marijuana testing facilities can now be certified by the MED to test for residual solvents, poisons or toxins, harmful chemicals, dangerous molds, mildew or filth, harmful microbials such as E. coli or Salmonella, pesticides, and THC levels and Cannabinoid potency.
According to an article from theCannabist.com, edible marijuana took 45% of the market share in 2014 and continues to grow, proving that food manufacturers and processors will gain a bigger share of the market.
BioTrackTHC develops a seed-to-sale traceability system that is the state-mandated reporting system used by any business that touches the plant in compliance with Washington’s i502 regulations (The company also won the contract bid for New Mexico’s and New York’s state-run traceability systems). “From day one, all retail products under i502, including infused edibles, must have laboratory-submitted passing test results and data in the traceability system before it can be unlocked for shipment to retailers,” says Patrick Vo, CEO of BioTrackTHC.
Regulations, especially those addressing traceability, are crucial for advancing the industry and fighting the black market, performing recalls, and improving product quality and safety. Vo adds, “As more states adopt a centralized traceability system, food safety will improve as we see the industry grow.”
“Most of the marijuana edibles producers we advise are working comfortably within their state health department regulations versus a year ago when they were struggling to implement routine compliance,” says Stephen Goldner, CEO of Regulatory Affairs Associates. “But there is a long way to go to make this new marketplace meet the standards routinely met by US food producers in other markets such as nutritional supplements and medical foods.”
Many edible producers are sadly mistaken to ignore FDA labeling and production regulations just because the producer only ships within their own state, according to Goldner. “Whenever FDA has found label or food safety violations of products, whether they are food, drugs or any other product, it has always acted quickly to seize the product, inspect the producer and insist that violative labeling or production practices be remedied,” he says, adding that it won’t be surprising to see FDA start to “seize marijuana-infused food products that make drug claims, especially from the leading current producers” as a way for the agency to insert itself into the inspection and compliance process. “These companies need to have FDA food GMP’s solidly in place and properly documented,” says Goldner.
“Those who have experienced the most consistent and long term success in this industry are those who play above board, those who take the extra effort and make the investment in effort, time, and money to treat their business as if it was already federally legal and had to adhere to standards that other industries must follow,” says Vo. He agrees with the view held by many that long term planning is vital in this industry. “Those who have implemented best practices, QA programs, and traceability software will succeed in the long run, and the bad actors will eventually, by their own poor practices, be filtered out by regulatory and market forces.”
In the near future, the industry will look to other states in regulatory experiments on opposite sides of the spectrum. “New York, which legalized medical marijuana in 2014, is handing out 5 licenses to operate 4 dispensaries each, and allowing licensees to have a grow facility to supply their respective dispensaries. The Commissioner of the New York State Department of Health will have authority on licensing, testing, and medical requirements for patients seeking treatment with medical marijuana,” says R. David Marquez, who operates a Long Island law firm focusing on the cannabis industry.
New York is implementing very strict rules regarding cultivating and processing the plant. California, on the other side of the spectrum, already operates a somewhat loosely regulated medical marijuana market and has been doing so since 1996. The bill to legalize marijuana recreationally in the state is widely expected to pass vote and be implemented in 2016. This would open up an enormous market potential and contribute to the growth of the industry on a national level.
Because marijuana edibles are theoretically both a food and a drug, it is only appropriate that the FDA should look to regulate the industry in the future. In the meantime “Those who have invested the time and money in staying compliant now will be far ahead of the game tomorrow,” says Patrick Vo, who is looking toward federal legalization.
It seems that manufacturers and processors at the forefront of quality and safety testing will succeed in the long run.
Footnote: This is a regulatory update on the cannabis industry with an emphasis on edible marijuana. CannabisIndustryJournal.com, the newest publication, will be launched in September of this year. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!
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