In brief
- On September 23, 2026, the U.S. Government Accountability Office (GAO) released a report on how controlled substances were scheduled between 2020 and 2025.
- Of 208 substances subject to DEA action, 95 required consultation with the HHS; in all 84 cases with a final rule, the decision aligned with the HHS recommendation.
- Nevertheless, neither the DEA nor the FDA has comprehensive written procedures, and the memorandum of understanding between the FDA and the NIH is outdated. Both agencies accepted the three recommendations.
The GAO, the congressional watchdog, has examined how the Drug Enforcement Administration (DEA) decides which schedule to assign to each substance. Its conclusion has two sides: in practice, the DEA has followed the guidance of the Department of Health and Human Services (HHS), but almost none of this process is codified in writing.
What the report measured
The study covers six calendar years, from 2020 to 2025. During that period, the DEA took scheduling actions on 208 substances. In only 95 cases did the law require the agency to request and consider a scientific and medical evaluation from the HHS, prepared by the FDA. The DEA considered these in all 95 instances. Of those, in the 84 cases that had a final rule as of December 31, 2025, the decision matched the HHS recommendation. The remaining 11 were still under extended temporary orders.
The rest of the 208 substances were classified through pathways that do not require such an evaluation, such as legislation passed by Congress or temporary scheduling in Schedule I, which the DEA can mandate by order for up to two years—with a one-year extension if an administrative procedure is underway—without first seeking the opinion of the HHS.
Identified gaps
According to the report, the DEA lacks policies or procedures regarding how its staff should evaluate or classify a substance. The FDA also lacks them for conducting evaluations or drafting recommendations, which follow the so-called eight-factor analysis of the Controlled Substances Act. Furthermore, the memorandum of understanding between the FDA and the National Institutes of Health (NIH), which is over 40 years old, is obsolete because it does not reflect current entities or procedures.
The GAO recommends that the DEA and FDA develop these procedures and that the FDA and NIH update the memorandum. The Department of Justice (for the DEA) and the HHS (for the FDA and NIH) agreed with all three recommendations.
Immediate effect on cannabis
In April 2026, cannabis products approved by the FDA and state-licensed medical cannabis were rescheduled, while a broader rescheduling remains pending. According to the Psychedelics Today newsletter, three parties opposing that rescheduling requested that the GAO report be admitted into evidence and that the case be suspended. On September 29, the DEA’s chief administrative law judge, Derek Julius, stayed the proceeding indefinitely, and the government’s response is due by October 13. We have not been able to read the original order, as access is blocked to us; we are reporting this via that newsletter.
What it implies
This is a procedural report, not a decision on any specific substance, and it says nothing about the merits of psilocybin, MDMA, or cannabis. What it does document is that, for the 84 substances with a final rule, the DEA followed the HHS recommendation, and that the three GAO recommendations remain open. This is the same circuit (FDA evaluation, HHS recommendation, and DEA decision) that any psychedelic medication will have to pass through to be approved in the United States.
For more context, see our articles on the appeals court’s refusal to stay the cannabis order and on the DEA’s proposal for five psychedelic tryptamines. In our cannabis and cannabinoids pillar, you can find the general framework.
Source
- U.S. Government Accountability Office. Drug Scheduling: While DEA Decisions Have Aligned with Recent HHS Recommendations, Both Need Comprehensive Policies (GAO-26-108623). Report to Congressional Requesters, September 23, 2026.
- Psychedelics Today. Weekly Psychedelic Policy Briefing (suspension of DEA proceedings), October 5, 2026.
Educational content written from a harm reduction perspective and with respect for individual freedom. It is not a substitute for advice from a healthcare professional and is not intended to encourage or condemn any drug use.
