Researcher's Guide to the HALT Fentanyl Act Provisions

This act was signed into law on July 16, 2025.

The provisions of this Act were originally floated by the Biden Administration several years ago and after many attempts to segregate research registration reform out from fentanyl specific provisions - the bill was pushed forward and signed into law by the current administration.

HALT stands for “Halt All Lethal Trafficking” and permanently places fentanyl-related substances as a class into schedule I of the Controlled Substances Act, essentially making permanent what is already done by the Analogues Act.

Continued criminalization of drugs is not the answer and will likely produce negative outcomes. But, the bill does have a potentially huge impact on researching schedule I substances in the U.S.

Research Impact & Registration Requirements

1. The Research

   To apply for expedited procedures research must be either: part of an IND with FDA, conducted by HHS, DoD, VA; or funded by HHS, DoD, or VA. It is unknown whether or not the grant funding has to specify whether the substance of interest is included or whether the funding is an overall umbrella.

   
   

   This includes research that is funded in any amount by the HHS, DoD and VA. Proof of IND or funding support includes submission within the notice of the IND application or grant number and sponsor record. The submission will then be verified by the corresponding institutions.

   
   

2. Application for those with Schedule I/II Registrations

   Researcher with Schedule I or II registration can send a notice to the Attorney General (AG) and can begin research 30 days after notice is received.

   
   

   The notice to the Attorney General must contain the following: chemical names of substances, quantity of substance to be used in the research, demonstration of funding or IND via application number, sponsor record, approved state authorization. It is unclear whether researchers have to submit full protocols similar to previous schedule I and II registrations.

   
   

    Limitations to amounts are unclear. The bill states that a practitioner may have amounts specified in their notice and can submit supplemental notification if they need additional quantities which includes the additional amount needed and attestation that scope of research is the same as previously described.

   
   

3. Application for those without Schedule I/II Registrations

   Researchers without Schedule I or II registrations can send notice to the AG who decides if sufficient for registration within 45 days. It is unclear how strict this process is or whether the applicants will have to go through the current formal registration process to obtain Schedule I and II registrations.

   
   

   This notice will include all the same information as those with schedule I or II registrations. Within 45 days of receiving the notice, the AG will determine if the notice is sufficient or show cause upon the applicant to further demonstrate eligibility.

   
   

4. Institutional Registrations

   Those within the same institution can register to cover multiple people within the institution by sending notice to AG and can begin 30 days after notice is received.

   
   

   This will make it easier to collaborate within institutions! Any agent or employee of the institution that is conducting research can be covered through this registration notice.

   
   

   The notice must include the names, titles, and employing institution of the agents or employees that are not separately registered; an authorization for those to perform research under the registration and attestation that the registered person on the notice takes responsibility of said persons actions. It is unclear if the substances must remain in the registered laboratory space.

   
   

5. Related Research Sites Registration

   Those conducting research at multiple sites within the same city or county within a state can send notice to AG and start research within 30 days.

   
   

   If practitioners are collaborating across institutions within the same city or county under the same funding or agency they can apply for a multi-site registration. This notice must contain info as outlined for registrants and info on each site where research takes place and where substances will be stored and/or administered. The AG must be notified of the sites in the application at the beginning of the process before research beings and before substance is stored at the site. It is unclear how storage, delivery, security, record maintenance and other matters related to diversion will be handled in this scenario.

   
   

6. Manufacturing

   Person who is registered to perform research may manufacture small quantities without requiring manufacturer registration with notice to the AG.

   
   

   This includes: processing substance to create extracts, tinctures, oils, solutions or derivatives or other forms consistent with notification submitted or research protocol in registration application; dosage form development studies for the purpose of requesting IND. Quantities must be stated in the notice and practitioner must have existing registration. You cannot grow cannabis under this manufacturing clause.

   
   

7. Inspections

   New inspections not required for research with different substances in the same schedule or new schedule with higher designation.

   
   

   If a researcher or practitioner already has a registration and applies for expedited registration or modification of registration to conduct research with a different substance is the same schedule they are approved for or Schedules III-V, new inspection is not required. The AG and DEA will still do inspections they deem necessary to ensure controls against diversion.

   
   

8. Newly Scheduled Drugs

   If someone is already registered they have 90 days to submit a complete application for registration or modification of existing registration to do research on the drug.

   
   

   If you are registered and submit notice or modification of existing registration research can continue until the application is withdrawn or the AG serves a “show cause” order denying application. If denied, a researcher can request a hearing to be held no later than 45 days after request. Regardless of approval, you must send a copy of the application to the manufacturer/distributor as proof of authorization.

   
   

What Next?

The AG will issue rules to implement this act within 6 months after its passing. There will be a public comment and hearing period for ANYONE to submit concerns, questions, comments and recommendations to the interim rules. Following this period, a final rule will be made.

As of right now, there is no formal notice process but practitioners can technically begin taking advantage of these new rules. To send notice, contact the AG office to inquire exactly where to send notice and questions on the process.

The main takeaway?  This will make it easier for scientists to investigate schedule 1 substances and collaborate.

The official language of the bill can be found here.