HALT Fentanyl Act
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The HALT Fentanyl Act permanently adds all fentanyl-related substances as a class to Schedule I of the Controlled Substances Act and subjects trafficking offenses to the same mandatory minimum penalties as fentanyl analogues, closing a longstanding gap that let manufacturers evade federal controls by slightly altering fentanyl's chemical structure.
The Act also streamlines DEA registration for Schedule I researchers by creating an expedited notification process for federally funded or IND-linked studies and allowing registered researchers to perform small-quantity manufacturing activities without obtaining a separate manufacturing registration.
What this law does
What it does
The Act permanently adds fentanyl-related substances as a class to Schedule I of the Controlled Substances Act, defining the category by five specified types of structural modifications to fentanyl's chemical formula. It subjects offenses involving these substances to the same quantity thresholds and mandatory minimum penalties as fentanyl analogues — 100 grams or more, for example, triggers a 10-year mandatory minimum prison term — and extends equivalent penalties to import and export offenses under the Controlled Substances Import and Export Act. The Attorney General may publish a list of qualifying substances in the Federal Register, though absence from the list does not negate a substance's Schedule I status if it meets the structural definition.
The Act also reforms DEA registration for Schedule I researchers. It creates an expedited notification-based process for research tied to an IND application or funded by HHS, DoD, or VA; permits a single registration for multi-site research within the same city or county under the same institution; waives new DEA inspections when a researcher expands to a substance in the same or a higher-numbered schedule; and allows registered researchers to perform small-quantity manufacturing activities without a separate manufacturing registration. The Attorney General must issue implementing rules within six months.
Key provisions
- 1Permanently adds all fentanyl-related substances as a class to Schedule I of the Controlled Substances Act, defined by five structural modifications relative to fentanyl.
- 2Subjects trafficking offenses involving fentanyl-related substances to the same quantity thresholds and mandatory minimum penalties as fentanyl analogues; extends the same penalties to import and export offenses.
- 3Creates an expedited notification-based registration process for Schedule I research tied to an IND application or funded by HHS, DoD, or VA, with 30- and 45-day agency response windows.
- 4Permits a single DEA registration for research conducted at multiple sites within the same city or county under the same institution, with prior notification to the Attorney General.
- 5Waives the requirement for a new DEA inspection when a registered researcher applies to add a controlled substance in the same or a higher-numbered schedule.
- 6Allows registered researchers to perform small-quantity manufacturing activities, including extracts and dosage-form development, without obtaining a separate manufacturing registration.
- 7Expresses the sense of Congress agreeing with United States v. McCray (2018), which held a controlled substance can qualify as a fentanyl analogue.
Who is affected
Drug traffickers, manufacturers, and importers of fentanyl-related substances, who now face Schedule I controls and federal mandatory minimum penalties. Academic researchers, federal agency scientists, and research institutions conducting Schedule I controlled-substance studies, who gain streamlined registration options. The DEA and the Attorney General, who must issue rules and administer the new processes.
Why it matters
Permanently scheduling fentanyl-related substances as a class eliminates the need for DEA to schedule each new synthetic opioid variant individually, preventing traffickers from exploiting temporary scheduling gaps. Researchers studying Schedule I substances face significantly reduced administrative burdens, which could accelerate federally supported studies on fentanyl and related opioids. The retroactive rule of construction also preserves prosecutions for pre-enactment conduct.
What changed
Changes to existing law
Amends Controlled Substances Act, 21 U.S.C. 812(c) (Schedule I) (Sec. 2)
Adds fentanyl-related substances as a permanent Schedule I class defined by structural relationship to fentanyl.
Amends Controlled Substances Act, 21 U.S.C. 822 (Sec. 3)
Expands registration exemptions for researchers: single-registration multi-site research, waived inspections, small-quantity manufacturing, and continuation rights when substances are newly scheduled.
Amends Controlled Substances Act, 21 U.S.C. 823 (Sec. 3)
Adds an expedited notification-based registration process for federally funded or IND-related Schedule I research and requires DEA to post special-procedure criteria publicly.
Amends Controlled Substances Act, 21 U.S.C. 841(b)(1) (Sec. 6(a))
Extends mandatory minimum penalty thresholds applicable to fentanyl analogues to fentanyl-related substances.
Amends Controlled Substances Import and Export Act, 21 U.S.C. 960(b) (Sec. 6(b))
Extends import and export penalty provisions applicable to fentanyl analogues to fentanyl-related substances.
Amends Public Law 117-328 (Sec. 4)
Corrects cross-reference numbering errors in controlled-substance dispensing provisions, effective retroactively to enactment of Public Law 117-328.
Agencies directed to act
Effective dates
- All amendments made by the Act
- Attorney General must issue implementing rules
- Inspector General of DOJ must complete study and submit report on fentanyl research
- Technical corrections to controlled-substance dispensing provisions in Public Law 117-328
Funding and costs
Congressional Budget Office estimate
CBO estimates that enacting the HALT Fentanyl Act would increase both revenues and direct spending by $1 million over the 2025–2035 period, with a negligible net effect on the deficit.
CBO estimates that S. 331 would increase revenues and direct spending by $1 million each over the 2025–2035 period, leaving the net effect on the deficit at less than $500,000. The main drivers are a modest increase in criminal fines (recorded as revenues and deposited into the Crime Victims Fund, then spent without further appropriation) from additional convictions, and a small uptick in researcher registration fee collections (which reduce direct spending). Spending subject to appropriation — discretionary funds that Congress would need to approve — would be less than $500,000 over 2025–2030, covering DOJ's costs to write an inspector general report and issue implementing regulations. The bill would impose intergovernmental and private-sector mandates by making permanent the existing Schedule I registration requirement for researchers handling fentanyl-related substances, but CBO estimates the compliance costs would be well below UMRA's annual thresholds ($103 million for intergovernmental and $206 million for private-sector mandates in 2025).
How it works
The Attorney General must issue interim final rules within six months of enactment; those rules take effect immediately without a prior good-cause showing, though public comment and hearing opportunities must follow. The DEA may publish a list of qualifying fentanyl-related substances in the Federal Register and must post on its website any special review processes it applies to particular Schedule I research substances. Researchers use a notice-based system — the AG has 30 days to object for existing registrants and 45 days to register or serve a show-cause order for new applicants. The DOJ Inspector General must submit a report to Congress on fentanyl research within one year.
Legislative status & sources
Latest action
Became Public Law No: 119-26.
Official CRS summary
Show the CRS summaryHide the CRS summary
This act permanently places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act.
Under the act, offenses involving fentanyl-related substances are triggered by the same quantity thresholds and subject to the same penalties as offenses involving fentanyl analogues (e.g., offenses involving 100 grams or more trigger a 10-year mandatory minimum prison term).
Additionally, the act establishes a new, alternative registration process for certain schedule I research.
The act also makes several other changes to registration requirements for conducting research with controlled substances, including
- permitting a single registration for related research sites in certain circumstances,
- waiving the requirement for a new inspection in certain situations, and
- allowing a registered researcher to perform certain manufacturing activities with small quantities of a substance without obtaining a manufacturing registration.
Finally, the act expresses the sense that Congress agrees with the interpretation of the Controlled Substances Act in United States v. McCray, a 2018 case decided by the U.S. District Court for the Western District of New York. In that case, the court held that butyryl fentanyl, a controlled substance, can be considered an analogue of fentanyl even though, under the Controlled Substances Act, the term controlled substance analogue specifically excludes a controlled substance.
Legislative subjects
Administrative law and regulatory procedures; Crime and Law Enforcement; Department of Justice; Drug trafficking and controlled substances; Licensing and registrations; Research administration and funding