The Nuances of Marijuana’s Potential Rescheduling | ASPL 2024
FDA experts gathered to discuss the DEA’s rescheduling of marijuana and how it will impact the pharmaceutical supply chain.
On August 27, 2024, after a concerted effort to reclassify the federal government’s perspective on marijuana, the DEA announced that it would hold an official hearing to reschedule the substance in regard to the Controlled Substances Act (CSA).1 However, due to a history of states handling marijuana regulation on their own and discrepancies between medical and recreational purposes, the rescheduling of marijuana could have a significant impact on the pharmaceutical industry.2
All drugs within the supply chain, according to the CSA, are assigned to a specific schedule ranging from I to V, with schedule I denoting drugs with the highest potential for abuse and no accepted medical use. However, states have treated marijuana differently, with its recreational use legalized in Colorado since 2014 and its medical use legalized in California since 1996.3 In the meantime, a total of 38 states have legalized marijuana for medical use in some capacity, 24 states have legalized its recreational use, and only 5 states continue to prohibit any use of marijuana.2
“This is [a] confusing dilemma between the federal and state authority here, because any federal rescheduling or descheduling action will require states to automatically schedule, reschedule, or deschedule consistent with that federal action in accordance with state legislation, state constitutions, state regulations. To the extent it is rescheduled, there will be a period of time where this will be in a state of flux,” said Karla Palmer, JD, Director at Hyman Phelps.2
For pharmacists, if marijuana is rescheduled, the way pharmacy operations are conducted could be forever changed. | image credit: Victor Moussa / stock.adobe.com
In accordance with the CSA, in order to reclassify a Schedule I drug, the FDA must complete an 8-factor analysis. This includes almost a total reassessment of the substance’s clinical qualities, giving regulators an idea of the drug’s potential for abuse.
READ MORE: DEA Aims to Reclassify Marijuana as Less Dangerous Drug
The 8-factor analysis includes finding: cannabis’ actual or relative potential for abuse; scientific evidence of the pharmacological effects and general pharmacology of cannabis; the state of current scientific knowledge regarding the drug or other substance; its history and current pattern of abuse; the scope, duration, and significance of abuse; what, if any, risk there is to the public health; its psychic or physiological dependence liability; and whether the substance is an immediate precursor of a substance already controlled.4
“We don't know if, indeed, DEA reschedules marijuana, whether or not the federal government is going to put pressure on states to go into those states and start to enforce federal law. I think this sounds a bit like prohibition to me. I think it's very difficult for the federal government to regulate in an area where at least 38 states have taken a different position on this,” continued Palmer.2 Indeed, with a substance that has been regulated by states for the past 30 years, rescheduling marijuana could create a dilemma for many areas of the country. Palmer’s colleague at Hyman Phelps, Kalie Richardson, JD, further touched on the similarities between marijuana’s legalization and prohibition by comparing the US to Canada.
In Canada, all provinces are tasked with regulating the consumption of cannabis on their own.5 In the province of Nova Scotia, for example, marijuana is fully regulated by the Nova Scotia Liquor Control. In other places, however, alcohol could have nothing to do with marijuana’s regulation as some provinces have differing ages for when individuals are allowed to consume both alcohol and marijuana. “That's certainly an open question, what entities are going to hold marijuana? Is it a separate entity in a pharmacy? Is it in a liquor store?” said Richardson.2
As Palmer and Richardson’s presentation was aimed at establishing the framework of what marijuana’s rescheduling could mean for the US, there was a significant amount of uncertainty being that the future hearing is unprecedented and unlike any DEA or FDA action in recent history. However, one thing they were certain of is the major implications rescheduling could have for multiple businesses and practice types, including growers, processors, dispensaries, distributors, and pharmacies.2
For any entity trying to sell marijuana, they would have to obtain a controlled substance registration, take initial and biannual inventories, maintain transaction records, and many, many more compliant-friendly actions to ensure the safe distribution of the product if rescheduled. But most importantly for pharmacists, if marijuana is rescheduled, dispensing it would require a prescription from a practitioner.
As of right now, the federal government and FDA recognize marijuana as a Schedule I substance with no clinically accepted medical use, but the states continue to treat the drug differently. While the push to reschedule marijuana has been apparent for quite some time, it will come down to the federal government’s 2025 hearing to see whether or not the drug is viewed differently in the US going forward.
“I think that rescheduling marijuana will certainly have significant implications for pharmacy industry and for the medical and recreational marijuana industry. The questions about pharmacy practice related to marijuana, including does it fall within the scope of Pharmacy Practice at all? Are we going to create some other alternative scheme? It's going to take a lot of time to decipher what's going to happen there,” concluded Richardson.2
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