Georgia recently became the first U.S. state to allow pharmacies to sell medical marijuana, with nearly 120 facilities applying to sell cannabis oil as of October. But now the federal Drug Enforcement Administration (DEA) is warning pharmacies that dispensing THC is unlawful because it remains a Schedule I drug.
“All DEA registrants, including DEA-registered pharmacies, are required to abide by all relevant federal laws and regulations,” says a copy of a letter sent to a Georgia pharmacy by Matthew J. Strait, a DEA deputy assistant administrator in the agency’s Diversion Control Division. “A DEA-registered pharmacy may only dispense controlled substances in Schedules II-V of the Controlled Substances Act. Neither marijuana nor THC can lawfully be possessed, handled, or dispensed by any DEA-registered pharmacy.”
The letter, dated November 27, was first posted online by Smart Approaches to Marijuana (SAM), an anti-cannabis advocacy group. DEA did not immediately respond to emails from Marijuana Moment attempting to confirm its authenticity.
One potential complicating factor around DEA’s advisory is a congressional budget rider that prevents the the Department of Justice from spending resources to interfere with the implementation of state medical marijuana laws. The provision was first enacted into law in 2014 and was extended last month to at least February 2024.
It’s not immediately clear how DEA squares its threat against state-authorized pharmacies that provide medical cannabis oil to patients with the agency’s obligation to follow the congressionally enacted federal law.
States that have legalized medical marijuana have typically avoided distribution through traditional pharmacies specifically to avoid conflicts with federal pharmaceutical law and regulations. Similarly, rather than prescribe cannabis—an act that’s illegal under federal law—doctors typically issue recommendations, which are protected on First Amendment grounds in order to preserve open communication between doctors and patients.
In October, however, Georgia’s Board of Pharmacy began accepting applications from independent pharmacies to dispense low-THC cannabis oil, which under state law can contain no more than 5 percent THC. The goal was to improve access to medical marijuana among patients, who are otherwise restricted to just seven dispensaries that have opened in the state since April.
The Atlanta Journal-Constitution reported in early October that nearly 120 pharmacies had applied to the Board of Pharmacy to dispense marijuana products made by Botanical Sciences, one of the state’s two licensed producers. Pharmacies could also distribute medical cannabis from Trulieve, the state’s other licensed producer.
As of late October, at least three pharmacies had begun dispensing Botanical Sciences products, the company said in a press release. According to a map on the company’s website, more than 100 more are slated to open soon.
If sales of medical cannabis products went online in all locations, about 90 percent of Georgians would be within a 30-minute drive of a pharmacy selling marijuana, according to an Associated Press report. The state allowance applies only to independent pharmacies, not larger chains such as CVS and others.
“Pharmacists are a trusted provider, and it’s a way for us to destigmatize this new medicine,” Mindy Leech, a pharmacist and the owner of Lee-King Pharmacy, in Newnan, told AP after the Board of Pharmacy announcement in October. “It will make people more comfortable if they want to come in and ask questions about it.”
For now, it’s unclear how the program will proceed in light of DEA’s recent scrutiny. Georgia’s Board of Pharmacy did not immediately respond to Marijuana Moment’s request for comment about the agency letter. And the state Department of Public Health did not respond to an email Wednesday.
A public relations contact for Botanical Sciences also did not immediately respond to a request for comment.
In comments on social media, SAM President Kevin Sabet, who opposes medical marijuana, touted the DEA guidance as support of “the federal government’s position that marijuana is not medicine.”
That, however, is a misstatement of the federal government’s position. In August, news leaked that the Department of Health and Human Services (HHS) had recommended DEA reschedule marijuana as a Schedule III controlled substance—a clear indication that the agency determined that cannabis does offer medical benefits.
Rather, DEA’s actions instead appear designed to keep federally regulated pharmacies in check as the agency completes its part of the rescheduling review.
It’s been just over three months since HHS sent its rescheduling recommendation to DEA, but since then the agency has been mostly silent on the matter.
While the Congressional Research Service (CRS) recently concluded that it was “likely” that DEA would follow the HHS recommendation based on past precedent, DEA reserves the right to disregard the health agency’s advice because it has final jurisdiction over the Controlled Substances Act (CSA).
On Tuesday, six Democratic governors wrote a letter to the Biden administration urging that rescheduling be completed by the end of the year. As DEA noted in its letter to the Georgia pharmacy, pharmacies would be permitted to dispense marijuana if it’s moved to Schedule III, although pharmaceutical products would first need to be approved by the Food and Drug Administration.
“Rescheduling cannabis aligns with a safe, regulated product that Americans can trust,” says the governors’ letter, which points to a poll that found 88 percent of Americans support legalization for medical or recreational use. “As governors, we might disagree about whether recreational cannabis legalization or even cannabis use is a net positive, but we agree that the cannabis industry is here to stay, the states have created strong regulations, and supporting the state-regulated marketplace is essential for the safety of the American people.”
The government has since released HHS’s rescheduling letter to DEA—in response to a public records request—in highly redacted form. The redacted portions include virtually the entire substance of the message, such as the scheduling recommendation itself, as well as the scientific review portion that was attached to the letter.
The document, sent to DEA Administrator Anne Milgram, says that the HHS recommendation was based on “the eight factors determinative of control of a substance under 21 U.S.C. 81 1 (c).”
The government has since released HHS’s rescheduling letter to DEA—in response to a public records request—in highly redacted form. The redacted portions include virtually the entire substance of the message, such as the scheduling recommendation itself, as well as the scientific review portion that was attached to the letter.
The document, sent to DEA Administrator Anne Milgram, says that the HHS recommendation was based on “the eight factors determinative of control of a substance under 21 U.S.C. 81 1 (c).” (Full Story)