HALT Fentanyl Act · Engrossed in House (2025-02-06)

SEC. 2. Class scheduling of fentanyl-related substances

Section 202(c) of the Controlled Substances Act () is amended by adding at the end of schedule I the following: 21 U.S.C. 812(c)

(e)
- Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of a fentanyl-related substance, or which contains the salts, isomers, and salts of isomers of a fentanyl-related substance whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.
- For purposes of paragraph (1), except as provided in paragraph (3), the term means any substance that is structurally related to fentanyl by 1 or more of the following modifications: fentanyl-related substance
  - By replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle.
  - By substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or nitro groups.
  - By substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups.
  - By replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle.
  - By replacement of the N–propionyl group with another acyl group.
- A substance that satisfies the definition of the term in paragraph (2) shall nonetheless not be treated as a fentanyl-related substance subject to this schedule if the substance—
  - is controlled by action of the Attorney General under section 201; or
  - is otherwise expressly listed in a schedule other than this schedule.
- (4)
  - The Attorney General may by order publish in the Federal Register a list of substances that satisfy the definition of the term in paragraph (2). fentanyl-related substance
  - The absence of a substance from a list published under subparagraph (A) does not negate the control status of the substance under this schedule if the substance satisfies the definition of the term in paragraph (2). fentanyl-related substance

SEC. 3. Registration requirements related to research

(a) Alternative registration process for schedule I research

Section 303 of the Controlled Substances Act () is amended— 21 U.S.C. 823
- by redesignating the second subsection (l) (relating to required training for prescribers) as subsection (m); and
  - (n) Special provisions for practitioners conducting certain research with schedule i controlled substances
    - (1) In general
      - Notwithstanding subsection (g), a practitioner may conduct research described in paragraph (2) of this subsection with 1 or more schedule I substances in accordance with subparagraph (A) or (B) of paragraph (3) of this subsection.
    - (2) Research subject to expedited procedures
      - Research described in this paragraph is research that—
        
        is with respect to a drug that is the subject of an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act; or
        
        is—
        
        (i) conducted by the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs; or
        
        (ii) funded partly or entirely by a grant, contract, cooperative agreement, or other transaction from the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs.
    - (3) Expedited procedures
      - (A) Researcher with a current schedule i or ii research registration
        
        (i) If a practitioner is registered to conduct research with a controlled substance in schedule I or II, the practitioner may conduct research under this subsection on and after the date that is 30 days after the date on which the practitioner sends a notice to the Attorney General containing the following information, with respect to each substance with which the practitioner will conduct the research:
        
        The chemical name of the substance.
        
        The quantity of the substance to be used in the research.
        
        Demonstration that the research is in the category described in paragraph (2), which demonstration may be satisfied—
        
        in the case of a grant, contract, cooperative agreement, or other transaction, or intramural research project, by identifying the sponsoring agency and supplying the number of the grant, contract, cooperative agreement, other transaction, or project; or
        
        in the case of an application under section 505(i) of the Federal Food, Drug, and Cosmetic Act, by supplying the application number and the sponsor of record on the application.
        
        Demonstration that the researcher is authorized to conduct research with respect to the substance under the laws of the State in which the research will take place.
        
        (ii) Upon request from the Attorney General, the Secretary of Health and Human Services, the Department of Defense, or the Secretary of Veterans Affairs, as appropriate, shall verify information submitted by an applicant under clause (i)(III).

SEC. 4. Technical correction on controlled substances dispensing

Effective as if included in the enactment of — Public Law 117–328

section 1252(a) of division FF of (136 Stat. 5681) is amended, in the matter being inserted into section 302(e) of the Controlled Substances Act, by striking 303(g)and inserting 303(h); Public Law 117–328
section 1262 of division FF of (136 Stat. 5681) is amended— Public Law 117–328
- in subsection (a)—
  - (i) in the matter preceding paragraph (1), by striking 303(g)and inserting 303(h);
  - (ii) in the matter being stricken by subsection (a)(2), by striking (g)(1)and inserting (h)(1); and
  - (iii) in the matter being inserted by subsection (a)(2), by striking (g) Practitionersand inserting (h) Practitioners; and
- in subsection (b)—
  - (i) in the matter being stricken by paragraph (1), by striking 303(g)(1)and inserting 303(h)(1);
  - (ii) in the matter being inserted by paragraph (1), by striking 303(g)and inserting 303(h);
  - (iii) in the matter being stricken by paragraph (2)(A), by striking 303(g)(2)and inserting 303(h)(2);
  - (iv) in the matter being stricken by paragraph (3), by striking 303(g)(2)(B)and inserting 303(h)(2)(B);
  - (v) in the matter being stricken by paragraph (5), by striking 303(g)and inserting 303(h); and
  - (vi) in the matter being stricken by paragraph (6), by striking 303(g)and inserting 303(h); and
section 1263(b) of division FF of (136 Stat. 5685) is amended— Public Law 117–328
- by striking 303(g)(2)and inserting 303(h)(2); and
- by striking and inserting .

SEC. 5. Rulemaking

(a) Interim final rules

The Attorney General—
- shall, not later than 6 months after the date of enactment of this Act, issue rules to implement this Act and the amendments made by this Act; and
- may issue the rules under paragraph (1) as interim final rules.

(b) Procedure for final rule

(1) Effectiveness of interim final rules
- A rule issued by the Attorney General as an interim final rule under subsection (a) shall become immediately effective as an interim final rule without requiring the Attorney General to demonstrate good cause therefor, notwithstanding subparagraph (B) of section 553(b) of title 5, United States Code.
(2) Opportunity for comment and hearing
- An interim final rule issued under subsection (a) shall give interested persons the opportunity to comment and to request a hearing.
(3) Final rule
- After the conclusion of such proceedings, the Attorney General shall issue a final rule to implement this Act and the amendments made by this Act in accordance with section 553 of title 5, United States Code.

SEC. 6. Penalties

(a) In general

Section 401(b)(1) of the Controlled Substances Act () is amended— 21 U.S.C. 841(b)(1)
- in subparagraph (A)(vi), by inserting after ; and
- in subparagraph (B)(vi), by inserting after .

(b) Importation and exportation

Section 1010(b) of the Controlled Substances Import and Export Act () is amended— 21 U.S.C. 960(b)
- in paragraph (1)(F), by inserting after ; and
- in paragraph (2)(F), by inserting after .

Section 102 of the Controlled Substances Act () is amended by adding at the end the following: 21 U.S.C. 802
- The term ‘fentanyl-related substance’ has the meaning given the term in subsection (e)(2) of schedule I of section 202(c).

SEC. 7. Applicability; other matters

(a) In general

Irrespective of the date on which the rules required by section 5 are finalized, the amendments made by this Act apply beginning as of the enactment of this Act.

(b) Rule of construction

Nothing in the amendments made by this Act may be construed as evidence that, in applying sections 401(b)(1) and 1010(b) of the Controlled Substances Act ( and 960(b)) with respect to conduct occurring before the date of the enactment of this Act, a fentanyl-related substance (as defined by such amendments) is not an analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide. 21 U.S.C. 841(b)(1)

The Congress agrees with the interpretation of the Controlled Substances Act () in United States v. McCray, 346 F. Supp. 3d 363 (2018). 21 U.S.C. 801 et seq.

H.R. 27

Table of contents

SEC. 1. Short title

SEC. 4. Technical correction on controlled substances dispensing

SEC. 5. Rulemaking

SEC. 6. Penalties

SEC. 7. Applicability; other matters