The Drug Enforcement Administration (DEA) has released new quotas for the production of Schedule I and Schedule II controlled substances for research purposes—calling for an increase in the manufacturing of the psychedelics ibogaine, psilocybin and psilocyn, while continuing to maintain stable quotas for other substances such as marijuana, THC and MDMA.
As DEA prepares to hold an administrative hearing in December to gain additional input on the Biden administration’s proposal to move cannabis to Schedule III of the Controlled Substances Act (CSA), the agency has posted a pair of notices, set to be published in the Federal Register on Wednesday, that outline its Aggregate Production Quotas (APQs) for a variety of drugs that could be used in approved studies.
Over recent years, DEA has generally ramped up production goals for marijuana and certain psychedelics as interest in their therapeutic potential has grown within the public and scientific community. But the revised 2024 and new 2025 proposed numbers seem to signal that, for most substances, those quotas are leveling out, at least for now.
That’s especially true of cannabis, as the DEA hasn’t sought to increase its marijuana APQ from 6,675,000 grams since 2023. The 2025 quotas also remained the same compared to the current year’s for DMT (11,000 grams), MDMA (12,000 grams), LSD (1,200 grams) and mescaline (1,200 gram), for example.
However, the agency is calling for greater production of psilocybin and psilocyn in its revised 2024 quotas—raising the levels from 20,000 gram to 30,000 gram and 24,000 grams to 36,000 grams, respectively. Those higher levels are set to continue into 2025 as well.
“These proposed increases are to support research and clinical trials by DEA-registered schedule I researchers,” the notice about the new 2024 revisions says “These proposed increases demonstrate DEA’s support for research with schedule I controlled substances. The proposed increases reflect research and development needs as part of the process for seeking the FDA approval of new drug products.”
DEA also called for an increase in the production of ibogaine for 2025 from 150 grams to 210 grams in the separate new notice.
This comes as recent studies and anecdotal evidence—including from a sitting member of Congress, Rep. Morgan Luttrell (R-TX)—indicate the powerful psychedelic holds significant potential in the treatment of serious mental health conditions.
“DEA is proposing a higher APQ for ibogaine than DEA granted for 2024 to support manufacturing activities related to the increased level of research and clinical trials with this schedule I controlled substance,” the 2025 notice says.
The CSA requires the attorney general to set APQs for Schedule I and Schedule II drugs each year. In theory that means that if marijuana is ultimately placed in Schedule III, DEA would cease to include it in these annual quotas because researchers would go through a different process to request access for study purposes.
That said, the Congressional Research Service (CRS) said in a report this month that while Schedule III drugs are generally subject to fewer research barriers, “medical researchers and drug sponsors of marijuana or CBD containing drugs would not benefit from these looser restrictions associated with rescheduling without congressional action.” In part, that’s because President Joe Biden signed a bill into law in late 2022 that was specifically meant to streamline cannabis-specific studies.
Meanwhile, a DEA administrative law judge (ALJ) recently scheduled a 10-day hearing on the agency’s proposal to ban two psychedelic compounds amid pushback from researchers and advocates.
The scheduling of the hearing comes about two months after a federal court dismissed a case challenging the constitutionality of DEA’s process for adjudicating scheduling actions as the agency seeks to ban the two psychedelic compounds.
Prior to that ruling, DEA had formally cancelled the planned administrative hearing, which came in response to an agency administrative law judge staying the proceeding in light of the now-dismissed lawsuit.
Separately, last month an advisory board of the Food and Drug Administration (FDA) declined to approve a new drug application for MDMA-assisted therapy, a setback for advocates and researchers that’s generated pushback from bipartisan lawmakers.
Image element courtesy of Kristie Gianopulos.
The Drug Enforcement Administration (DEA) has released new quotas for the production of Schedule I and Schedule II controlled substances for research purposes—calling for an increase in the manufacturing of the psychedelics ibogaine, psilocybin and psilocyn, while continuing to maintain stable quotas for other substances such as marijuana, THC and MDMA. As DEA prepares to Read More