Marijuana Moment: Georgians Have High Hopes That Rescheduling Will Make It Easier For Patients To Obtain Medical Marijuana Through Pharmacies

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Medical marijuana businesses and regulators in Georgia are cheering last week’s announcement that the federal Drug Enforcement Administration (DEA) will move cannabis to Schedule III of the Controlled Substances Act (CSA). They say the change could expand patients’ access to marijuana through pharmacies, whereas it is currently available through just nine dispensaries across the state.

Georgia’s medical marijuana law is the first in the nation that, at least in theory, allows registered pharmacies to dispense cannabis. That plan, however, has been on hold following DEA warnings last November that pharmacies licensed with the agency “may only dispense controlled substances in Schedules II-V of the Controlled Substances Act.”

“Neither marijuana nor THC can be lawfully possessed, handled, or dispensed by any DEA-registered pharmacy,” said the DEA warning letters, which were sent to dozens of pharmacies across the state.

As cannabis is poised to move out of Schedule I, however, some are hopeful Georgia pharmacies will be able to move forward with plans to offer marijuana—but it’s not clear how long that change might take.

Botanical Sciences, a dispensary operator and one of only a half dozen companies able to grow medical marijuana in the state, said in an email to reporters last week that the rescheduling move means “pharmacies can provide prescribed medical cannabis directly to patients.”

In an interview with Marijuana Moment, however, Botanical Sciences CEO Jim Long did not provide an on-record answer when asked directly whether he thinks federal rescheduling itself would allow pharmacies in Georgia to dispense marijuana.

“From an on-the-record standpoint, we are very pleased about the fact that rescheduling has a multitude of impacts,” he said. “It creates greater awareness in our state about the issues surrounding medical cannabis. It affords people the opportunity to really better understand the laws in our state, which do allow pharmacies to dispense these products.”

“The availability of medical cannabis through pharmacy is Georgia state law,” he continued. “What was announced earlier this week is just the indication by the DEA that they are now recognizing cannabis has medicinal value. That will go a long way not just with pharmacists, but with physicians who are recommending patients for cards. It also legitimizes the product in the eyes of many patients that may have been sitting on the fence.”

“I think this will help facilitate the industry in our state and around the country, quite honestly,” he said.

Andrew Turnage, executive director of the Georgia Access to Medical Cannabis Commission, said the Schedule III move “really does move in the direction of what Georgia intended for medical cannabis access to look like” insofar as it asserts that marijuana is a medically useful drug that should be regulated much like others.

“We know it’s the first, but we think this model is the best,” the Georgia cannabis official said, referring to the state’s plan to use pharmacies to dispense medical marijuana. “And I think that a lot of other states would say, for a medical program, this is really the way that it should have been from the beginning.”

Turnage said he wasn’t able to speak to how rescheduling would affect Georgia pharmacies, noting that his agency does not license or regulate those businesses.

Dawn Randolph, CEO of the Georgia Pharmacy Association, told the Atlanta Journal–Constitution, meanwhile, that rescheduling “will save patients from the difficulties they’re having in obtaining medical marijuana.”

She cautioned, however, that the change could take some time.

“While this sounds exciting, the path forward is very long and arduous,” Randolph said. “We’re talking about determining proper dosing, monitoring adverse effects and preventing drug-to-drug interactions. There’s just so much involved here.”

According to a memo from the Congressional Research Service (CRS) about the implications of federal rescheduling, the move will make it easier for marijuana pharmaceuticals to be dispensed at pharmacies, but first those drugs need federal approval.

“A key difference between placement in Schedule I and Schedule III is that substances in Schedule III have an accepted medical use and may lawfully be dispensed by prescription, while substances in Schedule I cannot,” the CRS document, issued May 1, says. “However, prescription drugs must be approved by the Food and Drug Administration (FDA).”

It continues: “Although FDA has approved some drugs derived from or related to cannabis, marijuana itself is not an FDA-approved drug.”

In other words, the cannabis products available through state-legal medical marijuana programs like the one in Georgia still won’t be the type of pharmaceuticals DEA-registered pharmacies can dispense.

Moreover, CRS wrote, “Users of medical marijuana would need to obtain valid prescriptions for the substance from medical providers, subject to federal legal requirements that differ from existing state regulatory requirements for medical marijuana.”

A recently published paper by Robert Mikos, a professor at Vanderbilt University Law School who focuses on drug law and federalism, notes that even after rescheduling, marijuana will be “subject to a litany of regulations under the CSA.”

“To begin, the CSA requires every producer and distributor of a Schedule III controlled substance to obtain a registration (e.g., a license) from the DEA before engaging in those activities,” the Tulsa Law Review paper says.

Beyond that, Mikos’s paper notes, the federal Food, Drug and Cosmetics Act (FDCA) requires a finding that marijuana is safe and effective. Though the Department of Health and Human Services (HHS) issued those findings in its rescheduling recommendation to DEA, those findings are separate from those required under FDCA.

Evidence that marijuana “has ‘a currently accepted medical use’ under CSA would also serve to demonstrate the drug is effective under FDCA,” the paper says, but “HHS severed the link between the two statutes in its latest scheduling evaluation.”

“In the past, one might have reasonably expected drug approval to follow on the heels of rescheduling, because the requirements for both were nearly identical,” Mikos wrote. But in light of the changes, “FDA approval of marijuana remains a long way off because the drug approval process remains as demanding as ever.”

“Until FDA approves marijuana,” he continued, “it will be virtually impossible for state-licensed marijuana firms to comply with the FDCA.”

“I suspect that few (if any) of the more than 12,000 firms now licensed by the states to produce and / or sell marijuana will be able and willing to scrupulously comply with all the new regulations CSA will throw at them,” his paper says, concluding: “Because the marijuana industry will continue to struggle to comply with the CSA and FDCA even after rescheduling, firms in that industry will continue to face many of the same vexing challenges they do today.”

At Botanical Sciences, Long said he’s nevertheless “very bullish” on Georgia’s medical marijuana market in light of rescheduling, which he said would help “jumpstart” the industry.

“When we started selling last summer, obviously we had an initial kind of push, and then we started not only opening our own dispensaries, but then this pharmacy channel,” he said. “And everything came to a screeching halt, you know, in the fall” when DEA sent out the threat letters to pharmacies.

“For all the reasons I mentioned previously around the awareness of this, the fact that we can get all of the interested stakeholders back at the table to facilitate so patients, pharmacists, physicians all reengaged into this process without the fear that there’s going to be some federal overhang—that is, you know, an incredible shot in the arm,” Long continued. “And so I think we’re gonna see our business and our industry and our state [system] grow rapidly now.”

Ira Katz, a pharmacist who planned to begin dispensing marijuana to registered patients under the state’s pharmacy program before the DEA warnings, told Atlanta news station WSB-TV that rescheduling would make marijuana suitable for prescription, though likely not in botanical form.

“We’re talking about kids with a seizure disorder, patients with neuropathic pain or pain in general,” Katz said, adding that approved medicines would “probably” initially be in the form of “tinctures, gummies and soft gels.”

Turnage, the head of the state’s Access to Medical Cannabis Commission, predicted that a major change from rescheduling is that it would “open up lawful research of the drug,” especially at institutions that might fear the loss of federal funding.

“We are working very hard in Georgia to get that aspect of our program up and running,” he said, “and while I can’t speak for our colleges and universities, I think all of them would be comfortable saying the concern is because of it being a violation of federal law and the concern of impact on federal funding that research institutions receive. That’s a huge barrier to researching the drug by those most qualified to conduct the research.”

Turnage also said he thinks many in the state are still waiting for more clarity on the implications of rescheduling, as well as when the policy change will be made final.

“We know that it’s an election year. It’s very popular to talk about issues that move lots of people, and that’s really one of my topics of analysis here,” he said: “Are we going to see substantive direction, or are we going to just see a lot of talk? That’s certainly a very Georgia conversation about this.”

State and local officials in support of access to marijuana have generally cheered the rescheduling announcement as an endorsement of legalization, despite remaining questions about how it affects the state–federal conflict in laws.

In Pennsylvania, for example, a spokesperson for Gov. Josh Shapiro (D) said the move could bolster state-level efforts to enact adult-use legalization.

“Governor Shapiro has made clear that we need to catch up—practically every one of our neighbors has legalized marijuana and is benefiting from hundreds of millions of dollars in economic activity and revenue—and this important step by the federal government only adds support to the Governor’s proposal,” Shapiro spokesperson Manuel Bonder told the Pittsburgh Post-Gazette last week.

Former DEA Administrator Asa Hutchinson, meanwhile, said the recent change “reflects the reality” of public support for access to medical cannabis.

“I think it reflects the reality of today’s both culture but also the public sentiment. That’s most significant,” Hutchinson, a Republican who also served as governor of Arkansas, said.

In Congress, meanwhile, Senate Majority Leader Chuck Schumer (D-NY) and colleagues reintroduced legislation last week to federally legalize cannabis and impose certain regulations. Amid staunch partisan divisions, however, the bill’s prospects are doubtful.

Meanwhile, the top Democrat in the U.S. House said last Wednesday that the Biden administration’s move to reschedule marijuana is a “step in the right direction,” but it should be followed up with congressional action such as passing the legalization bill Schumer filed.

On the opposition side, a leading marijuana prohibitionist group has been using the federal rescheduling announcement as a fundraising opportunity and says it may file a legal challenge against the government’s scheduling move.

Florida GOP Formally Opposes Marijuana Legalization Ballot Initiative, Clearing Path For DeSantis To Fund ‘Counter Message’ Campaign

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