HALT Fentanyl Act and FDA-Approved Human Fentanyl Analogs

Background: The HALT Fentanyl Act

The HALT (Halt All Lethal Trafficking) Fentanyl Act permanently places all fentanyl-related substances (FRS) into Schedule I of the Controlled Substances Act. This classification means these substances are considered to have a high potential for abuse, no currently accepted medical use, and are subject to strict regulatory controls and penalties similar to other Schedule I substances12.

Provisions on Fentanyl Analogs

How the Bill Addresses Analogs

• The bill targets all fentanyl-related substances as a class, not individual scheduling.

• Fentanyl analogs are defined broadly to include current and future substances, encompassing a wide variety of structural modifications.

• The bill treats offenses involving fentanyl-related substances under the same quantity thresholds and penalties as fentanyl analogues (e.g., 100 grams or more imposes a 10-year minimum prison sentence)123.

• A key aspect is the permanent, class-wide Schedule I placement for FRS, closing loopholes used by traffickers who have evaded prosecution by modifying fentanyl’s molecular structure45.

Research and Medical Use Exemptions

• The act establishes an alternative registration process for certain Schedule I research, such as waiving site inspections or simplifying registration for qualified researchers12.

• Currently available, FDA-approved fentanyl and certain analogs for medical use remain Schedule II, not Schedule I, and thus are NOT affected by the HALT Fentanyl Act3.

• The broad, class-based scheduling does not cover drugs already FDA-approved and scheduled for medical use such as fentanyl itself and certain analogs.

FDA-Approved Fentanyl Analogs

Several analogs of fentanyl are approved for medical use in humans and remain classified as Schedule II under federal law. Examples include:

• Fentanyl: Used widely for anesthesia and pain management.

• Sufentanil: Utilized in surgical settings for potent analgesia.

• Alfentanil: Used as an intravenous anesthetic adjunct.

• Remifentanil: Employed for its rapid onset and offset during surgery6.

These analogs have undergone thorough FDA evaluation of safety and efficacy for use in humans. The HALT Fentanyl Act does not change the legal status or scheduling of these specific medications. They continue to be regulated as Schedule II drugs, allowing for their medical use under controlled and supervised settings36.

Summary Table

Key Takeaways

• The HALT Fentanyl Act does not target or restrict FDA-approved fentanyl or its medically used analogs. These Schedule II drugs retain their approved medical status.

• All other fentanyl-related substances and potentially harmful analogs—particularly those not FDA approved for human use—are permanently placed in Schedule I.

• The bill aims to combat illicit trafficking and abuse without impeding availability of approved medications for patients in legitimate medical need1236.