The Drug Supply Chain Security Act was enacted in 2013 to put protocols into place for the serialization and traceability of pharmaceuticals that move through the drug supply chain – from manufacturer through to the distributors until they reach the hands of the patient. The goal being to ensure the safety and purity of each medication.
With medical marijuana being legalized in more states, this brings up the important question of if and how medical use marijuana should be handled under the guidelines of the DSCSA. Currently, the only states where medical marijuana is prohibited for all uses are Nebraska, Idaho and South Dakota. For the rest of the country, there are circumstances in which marijuana can be legally dispensed and consumed with a doctor’s prescription. Obviously, there’s the need for strict regulations, but the process for putting these regulations into place remains a little cloudy.
How Is Marijuana Regulated Differently from Pharmaceuticals
Requirements are fragmented and depends from state-to-state. The regulation of the marijuana supply chain is more complex than most people realize. Before the passage of the Farm Bill in 2018, the cannabis supply chain included both marijuana and hemp. After the passage of the bill, we can’t really look at them as the same anymore because hemp is legal from a production and commerce standpoint in every state, whereas marijuana is still federally illegal – regardless of individual state laws. Considering that marijuana is regulated on a local level, this presents unique challenges when considering the possibility of traceability within the drug supply chain.
On state or local basis, where marijuana is legal, strict standards and regulations are in place to track every stage medical marijuana production – from the earliest stages of planting, to the manufacture of marijuana-based product, continuing on to distribution.
For the marijuana industry, it is common for the regulatory government agencies to inform you of the track & trace software that they are using and the needed reports and data uploads you must send to them. You are free to use whatever track & trace system, but it must be able to communicate with their system. This centralized system is different compared to the requirements of tracing prescription medicine under the DSCSA. With the DSCSA, every salable unit must be serialized and have their respective movements tracked. No data is required to be uploaded to a government repository.
Because of the separation between state and federal government, the federal regulations of the DSCSA doesn’t currently apply to the medical use marijuana – however this could all change if in some point in the future, the federal government legalizes its uses, even if only for medicinal purposes. Remember how prior to the DSCSA, each state had their local track & trace law under the ePedigree requirements until Congress intervened and passed the DSCSA law in 2013 taking the law nationwide.
Barriers to the Drug Supply Chain Regulation of Marijuana
Last year, the FDA approved Epidiolex, the first prescription drug made from marijuana. Epidiolex, which is used to treat rare forms of epilepsy, is made from a purified chemical from the cannabis plant. Cannabidiol, the purified cannabis chemical found in Epidiolex, doesn’t produce the any of the “high” that’s experienced by marijuana, but it does open up an important discussion about marijuana products in the drug supply chain.
Obviously, like all pharmaceuticals, Epidiolex is regulated and any trading partner within the drug supply chain who handles the medication will be required to be DSCSA compliant. However, as more research is put into the use of Cannabidiol in prescription strength medications, the lines between medical marijuana and marijuana chemicals that are used in medications legally under federal law become more blurred.
When we tear the issue down to the most basic level, the fact remains that marijuana is considered a schedule one controlled substance under federal law. Drugs that are classified as schedule one controlled substances are labeled as having no accepted medical use. Therefore, marijuana – even though medicinally legal in many states – can’t technically qualify as a pharmaceutical, and thus doesn’t fit into the scope of the DSCSA.
State Regulation and Federal Interference
Although the legal use of medical marijuana isn’t federally recognized, any marijuana product must still pass through strict regulations at the state level. Most states that have legalized medical marijuana follow a very similar tracking and traceability protocol. This involves identifying information about the strain of the plant, potency, dosage, and all pertinent information about the business, including license numbers.
State level protocols for tracking and traceability are important for obvious reasons, and at this time, the federal government is taking a wait and see approach regarding their degree of involvement in regulating the medical marijuana supply chain. The general assumption here is that as long as states continue to show diligence in their own tracking and tracing protocols, it’s unlikely that the federal government will step in and intervene.
One of the main goals of the DSCSA is to prevent counterfeit, contaminated, or otherwise inferior products from entering or making their way through the drug supply chain. These issues are still concerns for the medicinal marijuana supply chain, and it puts those who work in medicinal marijuana pharmacies and dispensaries in difficult position. They’re ethically obligated to put only what they know to be the purest substances in their patient’s hands, but the risk of contaminated or inferior product is arguably greater than it is with legal pharmaceuticals.
For instance, when medicinal marijuana products are contaminated, it’s often the result of mold or pesticides -which is entirely different from the contamination concerns with prescription medications. There’s also a greater risk for these products to be targeted for theft or diversion into the black market. This is of special concern in states where medical use marijuana is legal, but recreational use isn’t.
Illicit products have found their way in the supply chain and are not being tested for purity and potency. There were deaths associated with due to black market vape cartridges. The problem lies in the current state of the marijuana track & trace systems that are reportedly complex, deficient and integration issues.
Looking Forward to the Future of Medicinal Marijuana and the Drug Supply Chain
The medical marijuana industry is still in its infancy stages, and this means that we can expect plenty of learning experiences, growing pains and changes in our current approach as the industry matures. The medical marijuana industry faces its own unique set of challenges with tracking and regulatory procedures. It’s quite likely that the regulatory framework surrounding the medical marijuana industry will continue to evolve, and that in the future, we’ll see tighter regulations that protect patients put into place.
About the Author: Christian Souza is the Co-Founder of TrackTraceRx