On September 18, the Drug Enforcement Administration permanently added seven fentanyl-related substances (FRS) to Schedule I of the Controlled Substances Act. They were originally covered by the temporary class-wide FRS ban that became permanent in July, but as the DEA has continued to push the legal boundaries of the scheduling process it’s created some loose ends to tie up.
Fentanyl has been a Schedule II drug since the CSA was enacted in 1970; it has established medical use as a pain reliever. But in 2015 the DEA began targeting previously unscheduled FRS, or fentanyl analogs as they’re sometimes called. Congress and the DEA both have the authority to schedule drugs under the CSA, but because permanent scheduling is such a slow, bureaucratic process with so much back-and-forth between agencies, the DEA also has the authority to temporarily schedule something unilaterally, if it says it’s an emergency and if the substance is not already scheduled or being evaluated for any medical uses.
By February 2018 the DEA had temporarily scheduled 17 FRS. The agency then decided it would be more efficient to ban all FRS at once, enacting its first temporary class-wide ban: All FRS not already scheduled in the CSA would be placed under Schedule I for the next two years. In over a half-century of scheduling actions, all other controlled substances have been scheduled by name.
Traditionally, when temporary scheduling was done one substance at a time, the FDA would then conduct an eight-factor analysis of the medical and scientific merits to determine whether the scheduling should be permanent. But after the DEA implemented the temporary class-wide ban, it never pursued permanency. It just kept extending the temporary order again and again and again.
“[FDA] was not asked for, and did not produce, an ‘eight-factor analysis,’ on fentanyl-related substances as a class,” then-Department of Health and Human Services Assistant Secretary for Health Brett O. Giroir testified in 2020. “Such an evaluation for permanent scheduling of a class of substances, rather than specific substances, would be a significant change from the normal process of scheduling, and might not be feasible for the FDA to develop.”
So permanent scheduling was left to Congress. The DEA kept extending the class-wide ban, which was most recently set to expire September 30. But the agency also continued to schedule specific FRS, a few at a time.
In 2023 the DEA began pursuing permanent scheduling of seven FRS: para-chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl and para-fluoro valeryl fentanyl.
That process triggers eligibility for an extra extension of one year, while the permanency is pending. So in December 2024 the DEA issued those seven FRS a new extension through the end of 2025, “or until the permanent scheduling action for these substances is completed, whichever occurs first”—even though the temporary class-wide ban extension still covered them.
In July, President Donald Trump signed the HALT Fentanyl Act, which made permanent the Schedule I status of FRS that had been under the temporary class-wide ban since 2018.
But the Act specifically defines “FRS” to mean any drugs that meet the criteria for structural relation to fentanyl, unless they’re already scheduled individually. So while the bulk of FRS were designated Schedule I permanently, these seven remained there on a temporary status until a separate process for them was completed. In June, the DEA proposed permanent scheduling for three other FRS once covered by the class-wide ban.
Whether issuing redundant temporary bans was exactly by the book, the DEA appears to have decided that it’s okay because it wasn’t a final ruling, stating in June that the “specific language chosen by Congress indicates an intention for DEA to proceed through the issuance of an order instead of proceeding by rulemaking.”
The DEA has arguably gotten a bit loose with the checks and balances that still exist in the temporary scheduling process. In late 2023, for example, it announced that it “has the final authority to schedule, reschedule or deschedule” any controlled substance even if that meant overriding the FDA’s recommendation, which is a different interpretation of the law than the one found in United States Code.
Top image via Chautauqua County, New York. Inset graphic (cropped) via National Institute of Standards and Technology.