On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances Act (“CSA”), and much of the political commentary and media attention related to the legislation have focused on this specific provision and its potential impact on the nation’s fentanyl crisis.
However, the HALT Fentanyl Act also contains numerous significant reforms related to research activities with controlled substances, including provisions streamlining the process for conducting research with any Schedule I controlled substance. This Alert summarizes the key takeaways from the HALT Fentanyl Act that drug developers, academic medical centers, research institutions, and others involved in nonclinical or clinical research with controlled substances should consider for their ongoing and future research activities.
Key Research Reforms of the HALT Fentanyl Act
The HALT Fentanyl Act includes five key changes for controlled substance research:
- Establishes an expedited “notice” process to obtain a Drug Enforcement Administration (“DEA”) registration to conduct research with a Schedule I controlled substance;
- Allows related research sites to be covered under a single DEA registration under certain circumstances;
- Permits a researcher who is an agent or employee of the same institution as a DEA-registered researcher to conduct controlled substance research without a separate DEA researcher registration under certain circumstances;
- Clarifies the manufacturing-related activities that are permitted under a DEA researcher registration; and
- Creates a mechanism for continuing research if a substance is classified into Schedule I during the course of a research study.
1. Expedited Notice Process to Conduct Schedule I Research
Schedule I substances—such as heroin, lysergic acid diethylamide (“LSD”), marijuana, and 3,4-methylenedioxymethamphetamine (“ecstasy”) are considered to have no currently accepted medical use and are subject to the highest level of controls under the CSA. The CSA has historically imposed on researchers registration requirements—which have been viewed by some researchers as unduly burdensome—before they can initiate any research involving Schedule I controlled substances. Would-be researchers have been required to submit extensive information to DEA as part of their registration applications, and DEA also had to review and approve each individual protocol for research involving a Schedule I controlled substance, including those protocols separately subject to review by the Food and Drug Administration (“FDA”) as part of an investigational new drug application (“IND”).1 Research activities could not begin until DEA completed its often lengthy review and approved the application.
The HALT Fentanyl Act meaningfully reforms this process. Instead of having to follow the existing Schedule I researcher registration process for every project, researchers starting an eligible research project need only submit a notice to DEA. To be eligible for this new process, the research must be either subject to an active IND from the FDA or conducted or funded by the U.S. Department of Health and Human Services, U.S. Department of Defense, or U.S. Department of Veterans Affairs. The notice sent to DEA must include basic information about the proposed research, including (1) the name of the substance to be studied, (2) the quantity to be used, (3) evidence that the applicant meets the eligibility criteria (in the form of an agency grant number or IND number and IND sponsor name, as applicable), and (4) evidence that the researcher is authorized to conduct research with the substance by the relevant state.
For those researchers who already have an active Schedule I or II research registration, research activities can begin 30 days after submitting the notice to DEA—no approval from DEA is required. Where a researcher does not already possess an active Schedule I or II researcher registration, DEA must treat the notice received as a sufficient application for such registration and, within 45 days, either register the applicant or serve the applicant with an order to show cause that proposes to deny the registration.
2. Related Research Sites under a Single Registration
Historically, DEA has required a separate researcher registration for each “principal place of business or professional practice” involved in research, even if multiple investigators were all collaborating on the same study.2 The HALT Fentanyl Act specifies that controlled substance research may be conducted under a single researcher registration as long as the research sites are all located within the same city or county and under the control of the same institution or organization. Researchers must notify DEA of their intent to use a given site to conduct research or to store or administer controlled substances either in the researcher registration application or otherwise before the site is used for research, storage, or administration.
3. Separate Registrations Not Required for Additional Researchers in Same Institution
The HALT Fentanyl Act permits agents or employees of the same institution as a DEA-registered researcher to conduct research under that researcher’s DEA registration. The DEA-registered researcher must provide notice to DEA that (i) identifies the name, title, and employer of any agent/employee working under the researcher’s registration; (ii) specifically authorizes the agent/employee to perform research under their registration; and (iii) affirms that the registered researcher is responsible for the conduct of the agent/employee with respect to the controlled substance. No separate DEA researcher registration is needed for the agent/employee unless DEA objects within 30 days of receiving the notice.
4. Manufacturing-Related Activities Permitted under Researcher Registration
Existing DEA regulations permit researchers to conduct certain manufacturing activities for research purposes without having to obtain separate manufacturing registrations.3 Researchers were required to detail their proposed manufacturing activities either (a) in the research protocol for Schedule I substances submitted to DEA for approval, or (b) in a manufacturing statement submitted alongside the registration application for substances in Schedules II–V.
The HALT Fentanyl Act modifies these requirements by permitting researchers to manufacture “small” quantities of the controlled substance they are authorized to research, as long as the investigator notifies DEA of the manufacturing activities and the associated quantities. This notification can be submitted to DEA as part of the expedited notice for Schedule I research, in a traditional application for a researcher registration, or via a separate notification to DEA that includes the registrant’s name and an attestation that the research to be conducted with the manufactured substance is consistent with the scope of the researcher’s registration. This provision expressly does not apply to growing marijuana. Unlike existing regulations, which prohibited the manufacture of Schedule II–V substances under a researcher registration for the purposes of dosage form development,4 the HALT Fentanyl Act permits this activity when done for the purpose of preparing an IND for submission to FDA.
5. Continuation of Research Activities in the Event of Schedule I Classification
The HALT Fentanyl Act includes procedures for how research may continue if a drug under study is moved to Schedule I during the pendency of the research. In this situation, a researcher who is already registered to conduct Schedule I research may submit an application for registration to conduct research on the drug under study. Once the application is submitted, study activities—including receipt of the controlled substance from manufacturers and distributors—may continue until either the researcher withdraws their application, or DEA proposes to deny it.
Implementation of the HALT Fentanyl Act
DEA must issue regulations to implement the HALT Fentanyl Act within six months of enactment (i.e., by January 16, 2026). DEA is empowered to issue such regulations as interim final rules, which means they can become effective upon publication without DEA needing to demonstrate good cause. Interested parties will have the opportunity to comment on the interim final rules before they are issued in final form.
Additionally, in a provision entitled “Transparency Regarding Special Procedures,” the HALT Fentanyl Act appears to authorize DEA to determine that researcher registration applications for a particular controlled substance should be evaluated using a different process or criteria from the process and criteria that apply to other substances in the same schedule, so long as DEA publishes notice on the DEA website of the specific process and criteria that will apply. The intended scope of this provision is not clear from its face, so researchers should pay close attention to how it is implemented by DEA, as DEA could, at least theoretically, attempt to use this provision to impose more restrictive registration requirements for research with particular controlled substances.
Conclusion
The HALT Fentanyl Act is a welcome development for many drug developers and researchers that have been eager to conduct more research with controlled substances, especially Schedule I controlled substances (e.g., psychedelics). The new law should serve to lower barriers to initiating research on Schedule I controlled substances while also reducing the volume of researcher registrations necessary for agents and employees of institutions conducting research in all CSA schedules. Drug developers, academic medical centers, research institutions, and others involved in research with controlled substances should carefully assess the immediate impact of the HALT Fentanyl Act on their research practices while also recognizing that the HALT Fentanyl Act does not modify any applicable registration or licensing requirements for research with controlled substances under state law.
