H.R. 27 — HALT Fentanyl Act

This section adds to Schedule I of the Controlled Substances Act a new category (e) for fentanyl-related substances—defined as any material, compound, mixture, or preparation containing any quantity of a substance structurally related to fentanyl by one or more specified modifications (i.e., (1) replacement of the phenyl portion of the phenethyl group by any monocycle; (2) substitution on the phenethyl group with specified groups; (3) substitution on the piperidine ring with specified groups; (4) replacement of the aniline ring with any aromatic monocycle; or (5) replacement of the N-propionyl group with another acyl group)—unless specifically exempted or listed in another schedule. The Attorney General may publish in the Federal Register a list of such substances, but omission from the list does not negate their Schedule I status. (Schedule I substances have high abuse potential, no accepted medical use in the U.S., and lack accepted safety under medical supervision; thus, this provision enables class-wide control of fentanyl analogues without individual scheduling findings required under CSA section 202(b).)

This section amends the Controlled Substances Act to establish expedited registration procedures for practitioners conducting research with schedule I controlled substances (i.e., substances with high potential for abuse and no currently accepted medical use) if the research is subject to an investigational new drug exemption under the Federal Food, Drug, and Cosmetic Act or is conducted or funded by the Department of Health and Human Services, Department of Defense, or Department of Veterans Affairs. Practitioners already registered to research schedule I or II substances may begin such research 30 days after notifying the Attorney General of required details (e.g., chemical name, quantity, proof of qualifying research and state authorization); unregistered practitioners may submit the same notice, which the Attorney General must treat as a registration application and approve or issue a show-cause order within 45 days. The section further requires electronic submission options, limits possession to notified quantities (with supplemental notices allowed), leaves import/export rules unchanged, and directs the Department of Justice Inspector General to report within one year of enactment on qualifying fentanyl research. The section also exempts additional agents or employees of a research institution from needing separate registrations to handle controlled substances if another institutional agent or employee is registered for the same schedule, the registered researcher notifies the Attorney General of the additional person's details and authorizes their research activities, and affirms that the additional person's actions involving controlled substances are attributable to the registered researcher.

This section makes technical corrections to division FF of Public Law 117–328, effective as if included in its enactment, by replacing multiple erroneous cross-references to subsection 303(g) of the Controlled Substances Act (21 U.S.C. 823(g))—which addresses practitioner registration—with references to subsection 303(h) (21 U.S.C. 823(h)) in (1) section 1252(a); (2) section 1262(a) and (b); and (3) section 1263(b).

This section directs the Attorney General to issue rules implementing this Act and its amendments not later than six months after enactment, which may be issued as interim final rules effective immediately without a good cause finding under 5 U.S.C. 553(b)(B) (which generally requires agencies to publish proposed rules in the Federal Register and provide public comment absent such a finding that notice and comment are impracticable, unnecessary, or contrary to the public interest). It further requires an opportunity for public comment and hearing on any interim final rule, followed by issuance of a final rule in accordance with 5 U.S.C. 553.

This section amends penalties under the Controlled Substances Act (CSA) for trafficking offenses involving mixtures or amounts of fentanyl analogues—specifically, in CSA §401(b)(1)(A)(vi) and (B)(vi), which provide for mandatory minimum sentences of 10 years to life (for 1 kg or more mixtures) or 5 to 40 years (for 100 g or more mixtures)—to also apply to fentanyl-related substances. It makes parallel amendments to import and export penalties in 21 U.S.C. §960(b)(1)(F) and (2)(F). The section also adds a definition of "fentanyl-related substance" to CSA §102(60) (21 U.S.C. §802(60)), cross-referencing its meaning in Schedule I §202(c)(e)(2) (i.e., substances structurally similar to fentanyl not otherwise controlled, intended for human consumption).

This section establishes that the amendments made by the Act apply beginning as of the date of enactment, irrespective of when rules required by section 5 are finalized. It includes (1) a rule of construction clarifying that such amendments provide no evidence that a fentanyl-related substance (as defined therein) is not an analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide for conduct prior to enactment under sections 401(b)(1) and 1010(b) of the Controlled Substances Act (21 U.S.C. 841(b)(1), 960(b)); and (2) a sense of Congress agreeing with the interpretation of the Controlled Substances Act (21 U.S.C. 801 et seq.) in United States v. McCray, 346 F. Supp. 3d 363 (S.D.N.Y. 2018).