S. 331 — HALT Fentanyl Act

This section adds fentanyl-related substances to Schedule I of the Controlled Substances Act (CSA). Fentanyl-related substances are defined as any material, compound, mixture, or preparation containing any quantity of a substance structurally related to fentanyl by specified modifications (i.e., replacement or substitution on the phenethyl group, piperidine ring, aniline ring, or N-propionyl group), unless exempted, controlled by the Attorney General under CSA section 201, or listed in another schedule; the Attorney General may publish a non-exhaustive list of such substances in the Federal Register. (Thus, this provision automatically schedules fentanyl analogues in Schedule I—drugs with high abuse potential, no accepted medical use, and lack of safety under medical supervision—without requiring separate scheduling proceedings.)

This section amends section 303 of the Controlled Substances Act (CSA) to (1) redesignate the second subsection (l) as subsection (m) and add subsection (n), which establishes expedited registration procedures—bypassing the general requirements of subsection (g)—for practitioners to conduct research with schedule I controlled substances if the research is subject to an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act or is conducted or funded by the Department of Health and Human Services (HHS), Department of Defense (DoD), or Department of Veterans Affairs (VA); (2) allow practitioners already registered to conduct schedule I or II research to begin such research 30 days after notifying the Attorney General of the substance's chemical name, quantity, qualifying research details (e.g., IND or grant number), and state authorization, with verification available from HHS, DoD, or VA; (3) require the Attorney General to treat notices from unregistered practitioners as registration applications and either register them or issue a show-cause order within 45 days; (4) limit possession to notified quantities (with supplemental notifications permitted); (5) require electronic submission options; and (6) direct the Department of Justice Inspector General to report to Congress within one year of enactment on fentanyl research under these procedures. The section also amends CSA section 302(c) to exempt an agent or employee of a research institution from separate registration to conduct controlled substance research if acting within professional scope, the institution has another registered researcher for the same schedule who notifies the Attorney General of the individual's name, position, and institution, authorizes the research, and affirms compliance. (Thus, these changes expedite federally supported schedule I research, such as for novel therapies, while maintaining oversight.)

This section makes technical corrections, effective as if included in Public Law 117–328, to prior amendments in division FF of that law (sections 1252(a), 1262(a)–(b), and 1263(b); 136 Stat. 5681, 5685) by replacing erroneous cross-references to subsection 303(g) of the Controlled Substances Act with references to subsection 303(h) (i.e., 21 U.S.C. 823(g) to 823(h), including subparagraphs).

This section requires 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 otherwise required by 5 U.S.C. 553(b). It further requires such interim final rules to provide an opportunity for public comment and a hearing, followed by issuance of a final rule in accordance with standard notice-and-comment procedures under 5 U.S.C. 553. (As background, 5 U.S.C. 553 generally requires agencies to publish proposed rules in the Federal Register, solicit public input, and delay effectiveness for 30 days unless good cause justifies otherwise.)

This section expands enhanced penalties for trafficking fentanyl analogues to also include fentanyl-related substances by amending (1) CSA §401(b)(1)(A)(vi) and (B)(vi), which impose mandatory minimum sentences of 20 years (for offenses causing death or serious bodily injury from 28 grams or more) or 5 years (for 4 grams or more), respectively; and (2) import/export penalties under 21 U.S.C. §960(b)(1)(F) and (2)(F) with parallel requirements. This section also adds a definition of "fentanyl-related substance" to CSA §102(60), referencing the meaning in Schedule I(e)(2) of §202(c) (i.e., substances structurally similar to fentanyl with specific chemical modifications).

This section (1) applies amendments made by the Act as of the date of enactment, irrespective of rulemaking under section 5; (2) provides a rule of construction clarifying that such amendments do not affect application of penalty thresholds in 21 U.S.C. 841(b)(1) and 960(b)—which impose mandatory minimum sentences of 10 years to life for specified quantities of controlled substances, including fentanyl analogues—to pre-enactment conduct by deeming fentanyl-related substances analogues of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide; and (3) expresses the sense of Congress agreeing with the interpretation of the Controlled Substances Act in *United States v. McCray*, 346 F. Supp. 3d 363 (W.D.N.Y. 2018).