HALT Fentanyl Act

IIB 118TH CONGRESS 1ST SESSION H. R. 467 IN THE SENATE OF THE UNITED STATES MAY 30, 2023 Received; read twice and referred to the Committee on the Judiciary AN ACT To amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 2 HR 467 RFS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Halt All Lethal Traf- 2 ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 3 SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB- 4 STANCES. 5 Section 202(c) of the Controlled Substances Act (21 6 U.S.C. 812(c)) is amended by adding at the end of sched- 7 ule I the following: 8 ‘‘(e)(1) Unless specifically exempted or unless listed 9 in another schedule, any material, compound, mixture, or 10 preparation which contains any quantity of a fentanyl-re- 11 lated substance, or which contains the salts, isomers, and 12 salts of isomers of a fentanyl-related substance whenever 13 the existence of such salts, isomers, and salts of isomers 14 is possible within the specific chemical designation. 15 ‘‘(2) For purposes of paragraph (1), except as pro- 16 vided in paragraph (3), the term ‘fentanyl-related sub- 17 stance’ means any substance that is structurally related 18 to fentanyl by 1 or more of the following modifications: 19 ‘‘(A) By replacement of the phenyl portion of 20 the phenethyl group by any monocycle, whether or 21 not further substituted in or on the monocycle. 22 ‘‘(B) By substitution in or on the phenethyl 23 group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 24 haloalkyl, amino, or nitro groups. 25 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 3 HR 467 RFS ‘‘(C) By substitution in or on the piperidine 1 ring with alkyl, alkenyl, alkoxyl, ester, ether, 2 hydroxyl, halo, haloalkyl, amino, or nitro groups. 3 ‘‘(D) By replacement of the aniline ring with 4 any aromatic monocycle whether or not further sub- 5 stituted in or on the aromatic monocycle. 6 ‘‘(E) By replacement of the N–propionyl group 7 with another acyl group. 8 ‘‘(3) A substance that satisfies the definition of the 9 term ‘fentanyl-related substance’ in paragraph (2) shall 10 nonetheless not be treated as a fentanyl-related substance 11 subject to this schedule if the substance— 12 ‘‘(A) is controlled by action of the Attorney 13 General under section 201; or 14 ‘‘(B) is otherwise expressly listed in a schedule 15 other than this schedule. 16 ‘‘(4)(A) The Attorney General may by order publish 17 in the Federal Register a list of substances that satisfy 18 the definition of the term ‘fentanyl-related substance’ in 19 paragraph (2). 20 ‘‘(B) The absence of a substance from a list published 21 under subparagraph (A) does not negate the control status 22 of the substance under this schedule if the substance satis- 23 fies the definition of the term ‘fentanyl-related substance’ 24 in paragraph (2).’’. 25 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 4 HR 467 RFS SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE- 1 SEARCH. 2 (a) ALTERNATIVE REGISTRATION PROCESS FOR 3 SCHEDULE I RESEARCH.—Section 303 of the Controlled 4 Substances Act (21 U.S.C. 823) is amended— 5 (1) by redesignating the second subsection (l) 6 (relating to required training for prescribers) as sub- 7 section (m); and 8 (2) by adding at the end the following: 9 ‘‘(n) SPECIAL PROVISIONS FOR PRACTITIONERS 10 CONDUCTING CERTAIN RESEARCH WITH SCHEDULE I 11 CONTROLLED SUBSTANCES.— 12 ‘‘(1) IN GENERAL.—Notwithstanding subsection 13 (f), a practitioner may conduct research described in 14 paragraph (2) of this subsection with 1 or more 15 schedule I substances in accordance with subpara- 16 graph (A) or (B) of paragraph (3) of this sub- 17 section. 18 ‘‘(2) RESEARCH SUBJECT TO EXPEDITED PRO- 19 CEDURES.—Research described in this paragraph is 20 research that— 21 ‘‘(A) is with respect to a drug that is the 22 subject of an investigational use exemption 23 under section 505(i) of the Federal Food, Drug, 24 and Cosmetic Act; or 25 ‘‘(B) is— 26 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 5 HR 467 RFS ‘‘(i) conducted by the Department of 1 Health and Human Services, the Depart- 2 ment of Defense, or the Department of 3 Veterans Affairs; or 4 ‘‘(ii) funded partly or entirely by a 5 grant, contract, cooperative agreement, or 6 other transaction from the Department of 7 Health and Human Services, the Depart- 8 ment of Defense, or the Department of 9 Veterans Affairs. 10 ‘‘(3) EXPEDITED PROCEDURES.— 11 ‘‘(A) RESEARCHER WITH A CURRENT 12 SCHEDULE I OR II RESEARCH REGISTRATION.— 13 ‘‘(i) IN GENERAL.—If a practitioner is 14 registered to conduct research with a con- 15 trolled substance in schedule I or II, the 16 practitioner may conduct research under 17 this subsection on and after the date that 18 is 30 days after the date on which the 19 practitioner sends a notice to the Attorney 20 General containing the following informa- 21 tion, with respect to each substance with 22 which the practitioner will conduct the re- 23 search: 24 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 6 HR 467 RFS ‘‘(I) The chemical name of the 1 substance. 2 ‘‘(II) The quantity of the sub- 3 stance to be used in the research. 4 ‘‘(III) Demonstration that the re- 5 search is in the category described in 6 paragraph (2), which demonstration 7 may be satisfied— 8 ‘‘(aa) in the case of a grant, 9 contract, cooperative agreement, 10 or other transaction, or intra- 11 mural research project, by identi- 12 fying the sponsoring agency and 13 supplying the number of the 14 grant, contract, cooperative 15 agreement, other transaction, or 16 project; or 17 ‘‘(bb) in the case of an ap- 18 plication under section 505(i) of 19 the Federal Food, Drug, and 20 Cosmetic Act, by supplying the 21 application number and the spon- 22 sor of record on the application. 23 ‘‘(IV) Demonstration that the re- 24 searcher is authorized to conduct re- 25 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 7 HR 467 RFS search with respect to the substance 1 under the laws of the State in which 2 the research will take place. 3 ‘‘(ii) VERIFICATION OF INFORMATION 4 BY HHS OR VA.—Upon request from the 5 Attorney General, the Secretary of Health 6 and Human Services, the Department of 7 Defense, or the Secretary of Veterans Af- 8 fairs, as appropriate, shall verify informa- 9 tion submitted by an applicant under 10 clause (i)(III). 11 ‘‘(B) RESEARCHER WITHOUT A CURRENT 12 SCHEDULE I OR II RESEARCH REGISTRATION.— 13 ‘‘(i) IN GENERAL.—If a practitioner is 14 not registered to conduct research with a 15 controlled substance in schedule I or II, 16 the practitioner may send a notice to the 17 Attorney General containing the informa- 18 tion listed in subparagraph (A)(i), with re- 19 spect to each substance with which the 20 practitioner will conduct the research. 21 ‘‘(ii) ATTORNEY GENERAL ACTION.— 22 The Attorney General shall— 23 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 8 HR 467 RFS ‘‘(I) treat notice received under 1 clause (i) as a sufficient application 2 for a research registration; and 3 ‘‘(II) not later than 45 days of 4 receiving such a notice that contains 5 all information required under sub- 6 paragraph (A)(i)— 7 ‘‘(aa) register the applicant; 8 or 9 ‘‘(bb) serve an order to show 10 cause upon the applicant in ac- 11 cordance with section 304(c). 12 ‘‘(4) ELECTRONIC SUBMISSIONS.—The Attorney 13 General shall provide a means to permit a practi- 14 tioner to submit a notification under paragraph (3) 15 electronically. 16 ‘‘(5) LIMITATION ON AMOUNTS.—A practitioner 17 conducting research with a schedule I substance 18 under this subsection may only possess the amounts 19 of schedule I substance identified in— 20 ‘‘(A) the notification to the Attorney Gen- 21 eral under paragraph (3); or 22 ‘‘(B) a supplemental notification that the 23 practitioner may send if the practitioner needs 24 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 9 HR 467 RFS additional amounts for the research, which sup- 1 plemental notification shall include— 2 ‘‘(i) the name of the practitioner; 3 ‘‘(ii) the additional quantity needed of 4 the substance; and 5 ‘‘(iii) an attestation that the research 6 to be conducted with the substance is con- 7 sistent with the scope of the research that 8 was the subject of the notification under 9 paragraph (3). 10 ‘‘(6) IMPORTATION AND EXPORTATION RE- 11 QUIREMENTS NOT AFFECTED.—Nothing in this sub- 12 section alters the requirements of part A of title III, 13 regarding the importation and exportation of con- 14 trolled substances. 15 ‘‘(7) INSPECTOR GENERAL REPORT.—Not later 16 than 1 year after the date of enactment of this Act, 17 the Inspector General of the Department of Justice 18 shall complete a study, and submit a report thereon, 19 about research described in paragraph (2) of this 20 subsection with fentanyl.’’. 21 (b) SEPARATE REGISTRATIONS NOT REQUIRED FOR 22 ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sec- 23 tion 302(c) of the Controlled Substances Act (21 U.S.C. 24 822(c)) is amended by adding at the end the following: 25 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 10 HR 467 RFS ‘‘(4) An agent or employee of a research insti- 1 tution that is conducting research with a controlled 2 substance if— 3 ‘‘(A) the agent or employee is acting with- 4 in the scope of the professional practice of the 5 agent or employee; 6 ‘‘(B) another agent or employee of the in- 7 stitution is registered to conduct research with 8 a controlled substance in the same schedule; 9 ‘‘(C) the researcher who is so registered— 10 ‘‘(i) informs the Attorney General of 11 the name, position title, and employing in- 12 stitution of the agent or employee who is 13 not separately registered; 14 ‘‘(ii) authorizes that agent or em- 15 ployee to perform research under the reg- 16 istration of the registered researcher; and 17 ‘‘(iii) affirms that any act taken by 18 that agent or employee involving a con- 19 trolled substance shall be attributable to 20 the registered researcher, as if the re- 21 searcher had directly committed the act, 22 for purposes of any proceeding under sec- 23 tion 304(a) to suspend or revoke the reg- 24 istration of the registered researcher; and 25 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 11 HR 467 RFS ‘‘(D) the Attorney General does not, within 1 30 days of receiving the information, authoriza- 2 tion, and affirmation described in subparagraph 3 (C), refuse, for a reason listed in section 4 304(a), to allow the agent or employee to pos- 5 sess the substance without a separate registra- 6 tion.’’. 7 (c) SINGLE REGISTRATION FOR RELATED RESEARCH 8 SITES.—Section 302(e) of the Controlled Substances Act 9 (21 U.S.C. 822(e)) is amended by adding at the end the 10 following: 11 ‘‘(4)(A) Notwithstanding paragraph (1), a person 12 registered to conduct research with a controlled substance 13 under section 303(f) may conduct the research under a 14 single registration if— 15 ‘‘(i) the research occurs exclusively on sites all 16 of which are— 17 ‘‘(I) within the same city or county; and 18 ‘‘(II) under the control of the same institu- 19 tion, organization, or agency; and 20 ‘‘(ii) before commencing the research, the re- 21 searcher notifies the Attorney General of each site 22 where— 23 ‘‘(I) the research will be conducted; or 24 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 12 HR 467 RFS ‘‘(II) the controlled substance will be 1 stored or administered. 2 ‘‘(B) A site described in subparagraph (A) shall be 3 included in a registration described in that subparagraph 4 only if the researcher has notified the Attorney General 5 of the site— 6 ‘‘(i) in the application for the registration; or 7 ‘‘(ii) before the research is conducted, or before 8 the controlled substance is stored or administered, at 9 the site. 10 ‘‘(C) The Attorney General may, in consultation with 11 the Secretary, issue regulations addressing, with respect 12 to research sites described in subparagraph (A)— 13 ‘‘(i) the manner in which controlled substances 14 may be delivered to the research sites; 15 ‘‘(ii) the storage and security of controlled sub- 16 stances at the research sites; 17 ‘‘(iii) the maintenance of records for the re- 18 search sites; and 19 ‘‘(iv) any other matters necessary to ensure ef- 20 fective controls against diversion at the research 21 sites.’’. 22 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN 23 SITUATIONS.—Section 302(f) of the Controlled Sub- 24 stances Act (21 U.S.C. 822(f)) is amended— 25 VerDate Sep 11 2014 00:30 May 31, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H467.RFS H467 kjohnson on DSK79L0C42PROD with BILLS 13 HR 467 RFS (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 1 The’’; and 2 (2) by adding at the end the following: 3 ‘‘(2)(A) If a person is registered to conduct research 4 with a controlled substance and applies for a registration, 5 or for a modification of a registration, to conduct research 6 with a second controlled substance that is in the same 7 schedule as the first controlled substance, or is in a sched- 8 ule with a higher numerical designation than the schedule 9 of the first controlled substance, a new inspection by the 10 Attorney General of the registered location is not required. 11 ‘‘(B) Nothing in subparagraph (A) shall prohibit the 12 Attorney General from conducting an inspection that the 13 Attorney General determines necessary to ensure that a 14 registrant maintains effective controls against diversion.’’. 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