HALT Fentanyl Act
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Would permanently classify the entire class of fentanyl-related substances — defined by their structural similarity to fentanyl — as Schedule I controlled substances, and impose the same mandatory minimum sentences as fentanyl-analogue offenses, including a 10-year minimum for trafficking 100 grams or more.
The bill would also streamline research registration requirements under the Controlled Substances Act, reducing administrative barriers for scientists studying Schedule I substances while maintaining safeguards against diversion.
What this bill would do
What it would do
The bill would permanently add fentanyl-related substances as a class to Schedule I of the Controlled Substances Act. It defines a "fentanyl-related substance" as any substance structurally related to fentanyl through specific chemical modifications. Trafficking offenses involving these substances would carry the same penalties as fentanyl-analogue offenses — including a 10-year mandatory minimum for 100 grams or more — and the same penalty framework would apply to importation and exportation offenses. The Attorney General could publish a list of qualifying substances, but a substance's absence from the list would not exempt it from control.
The bill would also reform how researchers register to work with Schedule I controlled substances. Researchers already holding a Schedule I or II registration could begin new qualifying research 30 days after notifying the Attorney General, rather than completing a full registration process. Other changes would allow a single registration to cover multiple related sites within the same city or county, waive new facility inspections in certain circumstances, permit researchers to conduct small-scale manufacturing without a separate manufacturing license, and allow ongoing research to continue while a registration application is pending after a substance is newly added to Schedule I.
Key provisions
- 1Would permanently add all fentanyl-related substances — defined by their structural similarity to fentanyl through five categories of chemical modification — as a class to Schedule I of the Controlled Substances Act.
- 2Would subject trafficking offenses involving fentanyl-related substances to the same quantity thresholds and mandatory minimum sentences as fentanyl-analogue offenses, including a 10-year mandatory minimum for 100 grams or more; extends the same penalty framework to importation and exportation offenses.
- 3Would create an expedited alternative registration process allowing researchers with existing Schedule I or II registrations to begin qualifying new research 30 days after notifying the Attorney General, and requiring the AG to register unregistered applicants within 45 days.
- 4Would allow a single DEA registration to cover multiple related research sites within the same city or county and under the same institutional control, upon notification to the Attorney General.
- 5Would allow registered researchers to perform small-scale manufacturing activities — such as creating extracts, solutions, or derivatives — for research purposes without obtaining a separate manufacturing registration.
- 6Would allow researchers already conducting research on a substance to continue that research for up to 90 days after the substance is newly added to Schedule I, while a registration modification application is pending.
- 7Expresses the sense of Congress agreeing with the interpretation of the Controlled Substances Act in United States v. McCray (2018), which held that a controlled substance can be treated as an analogue of fentanyl.
Who would be affected
Drug traffickers and importers dealing in fentanyl-related substances would face mandatory minimum prison sentences previously reserved for fentanyl-analogue offenses. Researchers at universities, hospitals, and federal agencies — particularly those funded or run by HHS, DOD, or VA — studying Schedule I substances would gain streamlined DEA registration options. The Drug Enforcement Administration and Department of Justice would administer both the new classification and the updated registration framework.
Why it matters
Permanent scheduling eliminates the cycle of expiring emergency scheduling orders that has repeatedly left prosecutors and law enforcement in legal uncertainty about whether particular fentanyl variants can be charged under analogue penalties. For the research community, easing registration burdens could accelerate development of treatments for opioid addiction and overdose by reducing the administrative delays that have historically hampered Schedule I research.
What would change
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 similarity to fentanyl through five categories of chemical modification.
Amends Controlled Substances Act, 21 U.S.C. § 841(b)(1) (penalties) (Sec. 6(a))
Extends mandatory minimum trafficking penalties — previously applicable to fentanyl analogues — to fentanyl-related substances, including a 10-year minimum for 100 grams or more.
Amends Controlled Substances Import and Export Act, 21 U.S.C. § 960(b) (Sec. 6(b))
Applies the same penalty framework for fentanyl-analogue importation and exportation offenses to fentanyl-related substances.
Amends Controlled Substances Act, 21 U.S.C. § 823 (Section 303 — registration of manufacturers and distributors) (Sec. 3(a), 3(g))
Creates an expedited alternative registration process for qualifying Schedule I research and adds a DEA transparency requirement for special research-registration procedures.
Amends Controlled Substances Act, 21 U.S.C. § 822 (Section 302 — persons required to register) (Sec. 3(b)–3(f))
Allows single registrations for multi-site research, waives new inspections in certain circumstances, permits research-coincident small-scale manufacturing, and allows continuation of research on newly scheduled substances.
Amends Public Law 117-328 (Sec. 4)
Makes technical corrections to cross-reference numbering in the controlled substances dispensing provisions enacted by that law.
Agencies directed to act
Effective dates
- All amendments made by the Act take effect
- Attorney General must issue implementing rules (may be interim final rules)
- Inspector General of DOJ must complete fentanyl-research study and submit report
- Researchers must submit registration application for substances newly added to Schedule I
How implementation would work
The Attorney General would issue interim final rules within six months of enactment; those rules take effect immediately without a traditional good-cause showing, though interested parties may then comment and request a hearing before a final rule is issued. The DEA would maintain a public list of known fentanyl-related substances, though absence from the list does not exempt a substance from Schedule I control. Researchers with existing Schedule I or II registrations would notify the Attorney General electronically at least 30 days before starting qualifying new research; unregistered researchers would receive a registration decision — or an order to show cause — within 45 days of submitting a complete notice. The Inspector General of the Department of Justice must deliver a report on fentanyl research conducted under the expedited process within one year of enactment.
Legislative status & sources
Latest action
Received in the Senate and Read twice and referred to the Committee on the Judiciary.
Official CRS summary
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This bill 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 bill, 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 bill establishes a new, alternative registration process for certain schedule I research.
The bill 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 bill expresses the sense that Congress agrees with the interpretation of 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