HALT Fentanyl Act

II 118TH CONGRESS 1ST SESSION S. 1141 To amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes. IN THE SENATE OF THE UNITED STATES MARCH 30, 2023 Mr. CASSIDY (for himself, Mr. MARSHALL, and Mr. YOUNG) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL 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 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Halt All Lethal Traf- 4 ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 5 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1141 IS SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB- 1 STANCES. 2 Section 202(c) of the Controlled Substances Act (21 3 U.S.C. 812(c)) is amended by adding at the end of sched- 4 ule I the following: 5 ‘‘(e)(1) Unless specifically exempted or unless listed 6 in another schedule, any material, compound, mixture, or 7 preparation which contains any quantity of a fentanyl-re- 8 lated substance, or which contains the salts, isomers, and 9 salts of isomers of a fentanyl-related substance whenever 10 the existence of such salts, isomers, and salts of isomers 11 is possible within the specific chemical designation. 12 ‘‘(2) For purposes of paragraph (1), except as pro- 13 vided in paragraph (3), the term ‘fentanyl-related sub- 14 stance’ means any substance that is structurally related 15 to fentanyl by 1 or more of the following modifications: 16 ‘‘(A) By replacement of the phenyl portion of 17 the phenethyl group by any monocycle, whether or 18 not further substituted in or on the monocycle. 19 ‘‘(B) By substitution in or on the phenethyl 20 group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 21 haloalkyl, amino, or nitro groups. 22 ‘‘(C) By substitution in or on the piperidine 23 ring with alkyl, alkenyl, alkoxyl, ester, ether, 24 hydroxyl, halo, haloalkyl, amino, or nitro groups. 25 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1141 IS ‘‘(D) By replacement of the aniline ring with 1 any aromatic monocycle whether or not further sub- 2 stituted in or on the aromatic monocycle. 3 ‘‘(E) By replacement of the N–propionyl group 4 with another acyl group. 5 ‘‘(3) A substance that satisfies the definition of the 6 term ‘fentanyl-related substance’ in paragraph (2) shall 7 nonetheless not be treated as a fentanyl-related substance 8 subject to this schedule if the substance— 9 ‘‘(A) is controlled by action of the Attorney 10 General under section 201; or 11 ‘‘(B) is otherwise expressly listed in a schedule 12 other than this schedule. 13 ‘‘(4)(A) The Attorney General may by order publish 14 in the Federal Register a list of substances that satisfy 15 the definition of the term ‘fentanyl-related substance’ in 16 paragraph (2). 17 ‘‘(B) The absence of a substance from a list published 18 under subparagraph (A) does not negate the control status 19 of the substance under this schedule if the substance satis- 20 fies the definition of the term ‘fentanyl-related substance’ 21 in paragraph (2).’’. 22 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1141 IS 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 (21 U.S.C. 355(i)); or 25 ‘‘(B) is— 26 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1141 IS ‘‘(i) conducted by the Department of 1 Health and Human Services or the De- 2 partment of Veterans Affairs; or 3 ‘‘(ii) funded partly or entirely by a 4 grant, contract, cooperative agreement, or 5 other transaction from the Department of 6 Health and Human Services or the De- 7 partment of Veterans Affairs. 8 ‘‘(3) EXPEDITED PROCEDURES.— 9 ‘‘(A) RESEARCHER WITH A CURRENT 10 SCHEDULE I OR II RESEARCH REGISTRATION.— 11 ‘‘(i) IN GENERAL.—If a practitioner is 12 registered to conduct research with a con- 13 trolled substance in schedule I or II, the 14 practitioner may conduct research under 15 this subsection on and after the date that 16 is 30 days after the date on which the 17 practitioner sends a notice to the Attorney 18 General containing the following informa- 19 tion, with respect to each substance with 20 which the practitioner will conduct the re- 21 search: 22 ‘‘(I) The chemical name of the 23 substance. 24 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1141 IS ‘‘(II) The quantity of the sub- 1 stance to be used in the research. 2 ‘‘(III) Demonstration that the re- 3 search is in the category described in 4 paragraph (2), which demonstration 5 may be satisfied— 6 ‘‘(aa) in the case of a grant, 7 contract, cooperative agreement, 8 or other transaction, or intra- 9 mural research project, by identi- 10 fying the sponsoring agency and 11 supplying the number of the 12 grant, contract, cooperative 13 agreement, other transaction, or 14 project; or 15 ‘‘(bb) in the case of an ap- 16 plication under section 505(i) of 17 the Federal Food, Drug, and 18 Cosmetic Act (21 U.S.C. 355(i)), 19 by supplying the application 20 number and the sponsor of 21 record on the application. 22 ‘‘(IV) Demonstration that the re- 23 searcher is authorized to conduct re- 24 search with respect to the substance 25 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 7 •S 1141 IS under the laws of the State in which 1 the research will take place. 2 ‘‘(ii) VERIFICATION OF INFORMATION 3 BY HHS OR VA.—Upon request from the 4 Attorney General, the Secretary of Health 5 and Human Services or the Secretary of 6 Veterans Affairs, as appropriate, shall 7 verify information submitted by an appli- 8 cant under clause (i)(III). 9 ‘‘(B) RESEARCHER WITHOUT A CURRENT 10 SCHEDULE I OR II RESEARCH REGISTRATION.— 11 ‘‘(i) IN GENERAL.—If a practitioner is 12 not registered to conduct research with a 13 controlled substance in schedule I or II, 14 the practitioner may send a notice to the 15 Attorney General containing the informa- 16 tion listed in subparagraph (A)(i), with re- 17 spect to each substance with which the 18 practitioner will conduct the research. 19 ‘‘(ii) ATTORNEY GENERAL ACTION.— 20 The Attorney General shall— 21 ‘‘(I) treat notice received under 22 clause (i) as a sufficient application 23 for a research registration; and 24 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 8 •S 1141 IS ‘‘(II) not later than 45 days of 1 receiving such a notice that contains 2 all information required under sub- 3 paragraph (A)(i)— 4 ‘‘(aa) register the applicant; 5 or 6 ‘‘(bb) serve an order to show 7 cause upon the applicant in ac- 8 cordance with section 304(c). 9 ‘‘(4) ELECTRONIC SUBMISSIONS.—The Attorney 10 General shall provide a means to permit a practi- 11 tioner to submit a notification under paragraph (3) 12 electronically. 13 ‘‘(5) LIMITATION ON AMOUNTS.—A practitioner 14 conducting research with a schedule I substance 15 under this subsection may only possess the amounts 16 of schedule I substance identified in— 17 ‘‘(A) the notification to the Attorney Gen- 18 eral under paragraph (3); or 19 ‘‘(B) a supplemental notification that the 20 practitioner may send if the practitioner needs 21 additional amounts for the research, which sup- 22 plemental notification shall include— 23 ‘‘(i) the name of the practitioner; 24 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 9 •S 1141 IS ‘‘(ii) the additional quantity needed of 1 the substance; and 2 ‘‘(iii) an attestation that the research 3 to be conducted with the substance is con- 4 sistent with the scope of the research that 5 was the subject of the notification under 6 paragraph (3). 7 ‘‘(6) IMPORTATION AND EXPORTATION RE- 8 QUIREMENTS NOT AFFECTED.—Nothing in this sub- 9 section alters the requirements of part A of title III, 10 regarding the importation and exportation of con- 11 trolled substances.’’. 12 (b) SEPARATE REGISTRATIONS NOT REQUIRED FOR 13 ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sec- 14 tion 302(c) of the Controlled Substances Act (21 U.S.C. 15 822(c)) is amended by adding at the end the following: 16 ‘‘(4) An agent or employee of a research insti- 17 tution that is conducting research with a controlled 18 substance if— 19 ‘‘(A) the agent or employee is acting with- 20 in the scope of the professional practice of the 21 agent or employee; 22 ‘‘(B) another agent or employee of the in- 23 stitution is registered to conduct research with 24 a controlled substance in the same schedule; 25 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 10 •S 1141 IS ‘‘(C) the researcher who is so registered— 1 ‘‘(i) informs the Attorney General of 2 the name, position title, and employing in- 3 stitution of the agent or employee who is 4 not separately registered; 5 ‘‘(ii) authorizes that agent or em- 6 ployee to perform research under the reg- 7 istration of the registered researcher; and 8 ‘‘(iii) affirms that any act taken by 9 that agent or employee involving a con- 10 trolled substance shall be attributable to 11 the registered researcher, as if the re- 12 searcher had directly committed the act, 13 for purposes of any proceeding under sec- 14 tion 304(a) to suspend or revoke the reg- 15 istration of the registered researcher; and 16 ‘‘(D) the Attorney General does not, within 17 30 days of receiving the information, authoriza- 18 tion, and affirmation described in subparagraph 19 (C), refuse, for a reason listed in section 20 304(a), to allow the agent or employee to pos- 21 sess the substance without a separate registra- 22 tion.’’. 23 (c) SINGLE REGISTRATION FOR RELATED RESEARCH 24 SITES.—Section 302(e) of the Controlled Substances Act 25 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 11 •S 1141 IS (21 U.S.C. 822(e)) is amended by adding at the end the 1 following: 2 ‘‘(3)(A) Notwithstanding paragraph (1), a person 3 registered to conduct research with a controlled substance 4 under section 303(f) may conduct the research under a 5 single registration if— 6 ‘‘(i) the research occurs exclusively on sites all 7 of which are— 8 ‘‘(I) within the same city or county; and 9 ‘‘(II) under the control of the same institu- 10 tion, organization, or agency; and 11 ‘‘(ii) before commencing the research, the re- 12 searcher notifies the Attorney General of each site 13 where— 14 ‘‘(I) the research will be conducted; or 15 ‘‘(II) the controlled substance will be 16 stored or administered. 17 ‘‘(B) A site described in subparagraph (A) shall be 18 included in a registration described in that subparagraph 19 only if the researcher has notified the Attorney General 20 of the site— 21 ‘‘(i) in the application for the registration; or 22 ‘‘(ii) before the research is conducted, or before 23 the controlled substance is stored or administered, at 24 the site. 25 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 12 •S 1141 IS ‘‘(C) The Attorney General may, in consultation with 1 the Secretary, issue regulations addressing, with respect 2 to research sites described in subparagraph (A)— 3 ‘‘(i) the manner in which controlled substances 4 may be delivered to the research sites; 5 ‘‘(ii) the storage and security of controlled sub- 6 stances at the research sites; 7 ‘‘(iii) the maintenance of records for the re- 8 search sites; and 9 ‘‘(iv) any other matters necessary to ensure ef- 10 fective controls against diversion at the research 11 sites.’’. 12 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN 13 SITUATIONS.—Section 302(f) of the Controlled Sub- 14 stances Act (21 U.S.C. 822(f)) is amended— 15 (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 16 The’’; and 17 (2) by adding at the end the following: 18 ‘‘(2)(A) If a person is registered to conduct research 19 with a controlled substance and applies for a registration, 20 or for a modification of a registration, to conduct research 21 with a second controlled substance that is in the same 22 schedule as the first controlled substance, or is in a sched- 23 ule with a higher numerical designation than the schedule 24 VerDate Sep 11 2014 00:45 Apr 13, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1141.IS S1141 kjohnson on DSK79L0C42PROD with BILLS 13 •S 1141 IS of the first controlled substance, a new inspection by the 1 Attorney General of the registered location is not required. 2 ‘‘(B) Nothing in subparagraph (A) shall prohibit the 3 Attorney General from conducting an inspection that the 4 Attorney General determines necessary to ensure that a 5 registrant maintains effective controls against diversion.’’. 6 (e) CONTINUATION OF RESEARCH ON SUBSTANCES 7 NEWLY ADDED TO SCHEDULE I.—Section 302 of the 8 Controlled Substances Act ( [Text truncated for display. 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