S. 331: Halt All Lethal Trafficking of Fentanyl Act

This bill, titled the **Halt All Lethal Trafficking of Fentanyl Act** (or **HALT Fentanyl Act**), aims to address the issue of fentanyl-related substances by making several amendments to the Controlled Substances Act. Here is a summary of its key components:

1. Class Scheduling of Fentanyl-Related Substances

The bill proposes to explicitly include all substances that are related to fentanyl in schedule I of the Controlled Substances Act, unless they are specifically exempted or listed in another schedule. This includes any compound, mixture, or preparation that contains any amount of a fentanyl-related substance.

It defines “fentanyl-related substance” as any substance structurally related to fentanyl, including modifications to its chemical structure like replacing certain groups or altering the base structure.

The Attorney General would also be allowed to publish a list of substances that meet these criteria, which would not negate their controlled status if they are not listed.

2. Research Registration Requirements

The bill proposes changes to the registration process for researchers working with schedule I substances, offering an expedited procedure for those conducting significant research. This would allow practitioners to notify the Attorney General about their research plans, with the expectation of a prompt response.

Moreover, the bill stipulates that researchers may conduct specific types of research without needing a new registration if they already have one for a related substance.

3. Registration Flexibility for Research Institutions

Research institutions would be allowed to register a single practitioner to conduct research without requiring separate registrations for each individual working under that registration, provided that certain conditions are met and the Attorney General is informed.

4. Continuation of Research after Scheduling

If a researcher is already conducting studies on a substance that is newly added to schedule I, that researcher can continue their work for a limited time during which they must apply for appropriate registration to continue this research legally.

5. Manufacturing Activities Linked to Research

The act allows researchers, under certain conditions, to perform small-scale manufacturing of controlled substances solely for their research purposes without requiring a manufacturing registration, as long as they keep detailed records of what they are doing.

6. Transparency and Rulemaking Procedures

The Attorney General is required to implement rules for the act within six months of its enactment, aiming to maintain transparency in how these rules are developed and the processes for different controlled substances.

7. Penalties and Definitions Related to Fentanyl-Related Substances

The bill introduces penalties for the trafficking of fentanyl-related substances, ensuring that any analogue or related substance falls under the same legal implications and penalties applied to fentanyl. The definition of "fentanyl-related substance" will also be established within the Controlled Substances Act.

8. Applicability

All amendments made by the act shall apply from the date of enactment, regardless of when any rules are finalized.

Relevant Companies

• PFE - Pfizer Inc.: As a pharmaceutical company, Pfizer may be engaged in research related to fentanyl or its compounds and could be affected by changes in how fentanyl-related substances are regulated.
• NVS - Novartis AG: Like Pfizer, Novartis is involved in pharmaceuticals and may need to adjust research and development strategies in light of this legislation.