HR 27119th CongressIn Committee

HALT Fentanyl Act

Introduced: Jan 3, 2025

Sponsor: Rep. Griffith, H. Morgan [R-VA-9] (R-Virginia)

Standard Summary

Comprehensive overview in 1-2 paragraphs

The HALT Fentanyl Act would place fentanyl-related substances (FRS) under Schedule I of the Controlled Substances Act, meaning they would be treated with the strictest federal controls unless specifically exempted or listed in another schedule. It defines FRS broadly by structural relationships to fentanyl and allows the Attorney General (AG) to publish a list of substances that meet the definition, while clarifying that substances not on the list can still be controlled if they fit the definition. The bill also creates a new, streamlined pathway for approved researchers to work with Schedule I substances (including fentanyl-related ones) through expedited registration procedures, expands cross-site registrations within institutions, relaxes certain inspection requirements in specific research contexts, and provides for manufacturing activities linked to research without separate manufacturing registrations, all under tighter regulatory oversight and with enhanced transparency. The act also sets interim rulemaking to implement the changes, and tightens penalties and import/export controls to cover fentanyl-related substances alongside existing fentanyl analogs.

Key Points

1Scheduling of fentanyl-related substances (FRS)
2- Adds a broad schedule I designation for any material containing a fentanyl-related substance, including salts and isomers, unless exempted or listed elsewhere.
3- Provides a detailed definition of what counts as a fentanyl-related substance, based on specific structural modifications to fentanyl’s core framework.
4- Allows the AG to publish a Federal Register list of FRS, but absence from the list does not remove the substance from control if it meets the definition.
5Research-related registration and procedures
6- Creates an alternative, expedited path for researchers to work with Schedule I substances, including fentanyl-related substances, under specific conditions.
7- Establishes expedited procedures for researchers with or without current Schedule I registrations, including a 30-day notification and a 45-day AG decision window (or faster through other triggers).
8- Requires electronic submission options and sets limits on quantities for research, with mechanisms to modify those quantities as needed.
9Institutional and site-related provisions
10- Allows related researchers within the same institution to operate under a single registration for related sites, with notice to the AG and attribution of actions to the registered researcher.
11- Allows a single registration for research conducted across multiple sites within the same city/county under the same institution, with site-notification requirements and regulatory oversight for delivery, storage, and recordkeeping.
12Compliance, inspections, and transparency
13- Adds specific exceptions to certain inspection requirements in cases where a second substance in the same or higher schedule is being researched under a registered program.
14- Requires the AG to publish, with transparency, determinations about any special procedures for certain substances, including the process, criteria, and how it differs from other substances.
15Manufacturing activities tied to research
16- Permits limited manufacturing activities for small quantities related to research without a separate manufacturing registration, as long as activities are part of the research plan and properly documented.
17- Specifies what manufacturing activities are allowed (e.g., creating extracts, dosage form development) and excludes marihuana from these manufacturing allowances.
18Penalties and regulatory scope
19- Extends penalties under the CSA and related import/export statutes to include fentanyl-related substances as analogs of controlled fentanyl compounds.
20- Defines fentanyl-related substances in a way that aligns penalties with existing analog frameworks.
21Rulemaking and effective date
22- Requires the AG to issue interim final rules within six months of enactment, with a pathway for final rulemaking and public comment.
23- The amendments apply as of enactment, even if final rules are not yet in place.
24Definitions and cross-references
25- Adds a specific cross-reference definition for “fentanyl-related substance” in the general Federal drug terminology, aligning it with the Schedule I definition in the bill.

Impact Areas

Primary group/area affected- Researchers and research institutions working with Schedule I substances, especially fentanyl-related substances, who would gain new, expedited pathways and site-wide registration options for related studies.Secondary group/area affected- Law enforcement, regulatory agencies (e.g., DEA), and compliance professionals who would implement broader scheduling and enhanced control measures for FRS, as well as enhanced import/export oversight.Additional impacts- Pharmaceutical/biotech sectors engaged in fentanyl-related research or drug development could experience changes in their regulatory processes, including potential accelerations for approved research if they meet expedited criteria.- International suppliers and distributors of fentanyl-related substances would face tighter scheduling and import/export controls, affecting cross-border trade and compliance requirements.- Public health and safety outcomes could be influenced by the expanded control regime, potential impact on illicit synthesis and trafficking, and the balance between research needs and drug diversion prevention.While the bill emphasizes tightening controls on fentanyl-related substances, it also introduces new, structured pathways to facilitate essential research under regulated conditions.The act anticipates rapid rulemaking (interim final rules) to implement these changes, with a formal final-rule process to follow.

Generated by gpt-5-nano on Nov 18, 2025