HALT Fentanyl Act

I 118TH CONGRESS 1ST SESSION H. R. 171 To amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JANUARY 9, 2023 Mr. GRIFFITH (for himself and Mr. LATTA) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subse- quently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 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 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 171 IH SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB- 1 STANCES. 2 Section 202(c) of the Controlled Substances Act (21 3 U.S.C. 812(c)) is amended by adding at the end of sched- 4 ule I the following: 5 ‘‘(e)(1) Unless specifically exempted or unless listed 6 in another schedule, any material, compound, mixture, or 7 preparation which contains any quantity of a fentanyl-re- 8 lated substance, or which contains the salts, isomers, and 9 salts of isomers of a fentanyl-related substance whenever 10 the existence of such salts, isomers, and salts of isomers 11 is possible within the specific chemical designation. 12 ‘‘(2) For purposes of paragraph (1), except as pro- 13 vided in paragraph (3), the term ‘fentanyl-related sub- 14 stance’ means any substance that is structurally related 15 to fentanyl by 1 or more of the following modifications: 16 ‘‘(A) By replacement of the phenyl portion of 17 the phenethyl group by any monocycle, whether or 18 not further substituted in or on the monocycle. 19 ‘‘(B) By substitution in or on the phenethyl 20 group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 21 haloalkyl, amino, or nitro groups. 22 ‘‘(C) By substitution in or on the piperidine 23 ring with alkyl, alkenyl, alkoxyl, ester, ether, 24 hydroxyl, halo, haloalkyl, amino, or nitro groups. 25 VerDate Sep 11 2014 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 171 IH ‘‘(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 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 171 IH SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE- 1 SEARCH. 2 (a) ALTERNATIVE REGISTRATION PROCESS FOR 3 SCHEDULE I RESEARCH.—Section 303 of the Controlled 4 Substances Act (21 U.S.C. 823) is amended by adding at 5 the end the following: 6 ‘‘(m) SPECIAL PROVISIONS FOR PRACTITIONERS 7 CONDUCTING CERTAIN RESEARCH WITH SCHEDULE I 8 CONTROLLED SUBSTANCES.— 9 ‘‘(1) IN GENERAL.—Notwithstanding subsection 10 (f), a practitioner may conduct research described in 11 paragraph (2) of this subsection with 1 or more 12 schedule I substances in accordance with subpara- 13 graph (A) or (B) of paragraph (3) of this sub- 14 section. 15 ‘‘(2) RESEARCH SUBJECT TO EXPEDITED PRO- 16 CEDURES.—Research described in this paragraph is 17 research that— 18 ‘‘(A) is with respect to a drug that is the 19 subject of an investigational use exemption 20 under section 505(i) of the Federal Food, Drug, 21 and Cosmetic Act; or 22 ‘‘(B) is— 23 ‘‘(i) conducted by the Department of 24 Health and Human Services or the De- 25 partment of Veterans Affairs; or 26 VerDate Sep 11 2014 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 171 IH ‘‘(ii) funded partly or entirely by a 1 grant, contract, cooperative agreement, or 2 other transaction from the Department of 3 Health and Human Services or the De- 4 partment of Veterans Affairs. 5 ‘‘(3) EXPEDITED PROCEDURES.— 6 ‘‘(A) RESEARCHER WITH A CURRENT 7 SCHEDULE I OR II RESEARCH REGISTRATION.— 8 ‘‘(i) IN GENERAL.—If a practitioner is 9 registered to conduct research with a con- 10 trolled substance in schedule I or II, the 11 practitioner may conduct research under 12 this subsection on and after the date that 13 is 30 days after the date on which the 14 practitioner sends a notice to the Attorney 15 General containing the following informa- 16 tion, with respect to each substance with 17 which the practitioner will conduct the re- 18 search: 19 ‘‘(I) The chemical name of the 20 substance. 21 ‘‘(II) The quantity of the sub- 22 stance to be used in the research. 23 ‘‘(III) Demonstration that the re- 24 search is in the category described in 25 VerDate Sep 11 2014 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •HR 171 IH paragraph (2), which demonstration 1 may be satisfied— 2 ‘‘(aa) in the case of a grant, 3 contract, cooperative agreement, 4 or other transaction, or intra- 5 mural research project, by identi- 6 fying the sponsoring agency and 7 supplying the number of the 8 grant, contract, cooperative 9 agreement, other transaction, or 10 project; or 11 ‘‘(bb) in the case of an ap- 12 plication under section 505(i) of 13 the Federal Food, Drug, and 14 Cosmetic Act, by supplying the 15 application number and the spon- 16 sor of record on the application. 17 ‘‘(IV) Demonstration that the re- 18 searcher is authorized to conduct re- 19 search with respect to the substance 20 under the laws of the State in which 21 the research will take place. 22 ‘‘(ii) VERIFICATION OF INFORMATION 23 BY HHS OR VA.—Upon request from the 24 Attorney General, the Secretary of Health 25 VerDate Sep 11 2014 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •HR 171 IH and Human Services or the Secretary of 1 Veterans Affairs, as appropriate, shall 2 verify information submitted by an appli- 3 cant under clause (i)(III). 4 ‘‘(B) RESEARCHER WITHOUT A CURRENT 5 SCHEDULE I OR II RESEARCH REGISTRATION.— 6 ‘‘(i) IN GENERAL.—If a practitioner is 7 not registered to conduct research with a 8 controlled substance in schedule I or II, 9 the practitioner may send a notice to the 10 Attorney General containing the informa- 11 tion listed in subparagraph (A)(i), with re- 12 spect to each substance with which the 13 practitioner will conduct the research. 14 ‘‘(ii) ATTORNEY GENERAL ACTION.— 15 The Attorney General shall— 16 ‘‘(I) treat notice received under 17 clause (i) as a sufficient application 18 for a research registration; and 19 ‘‘(II) not later than 45 days of 20 receiving such a notice that contains 21 all information required under sub- 22 paragraph (A)(i)— 23 ‘‘(aa) register the applicant; 24 or 25 VerDate Sep 11 2014 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •HR 171 IH ‘‘(bb) serve an order to show 1 cause upon the applicant in ac- 2 cordance with section 304(c). 3 ‘‘(4) ELECTRONIC SUBMISSIONS.—The Attorney 4 General shall provide a means to permit a practi- 5 tioner to submit a notification under paragraph (3) 6 electronically. 7 ‘‘(5) LIMITATION ON AMOUNTS.—A practitioner 8 conducting research with a schedule I substance 9 under this subsection may only possess the amounts 10 of schedule I substance identified in— 11 ‘‘(A) the notification to the Attorney Gen- 12 eral under paragraph (3); or 13 ‘‘(B) a supplemental notification that the 14 practitioner may send if the practitioner needs 15 additional amounts for the research, which sup- 16 plemental notification shall include— 17 ‘‘(i) the name of the practitioner; 18 ‘‘(ii) the additional quantity needed of 19 the substance; and 20 ‘‘(iii) an attestation that the research 21 to be conducted with the substance is con- 22 sistent with the scope of the research that 23 was the subject of the notification under 24 paragraph (3). 25 VerDate Sep 11 2014 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •HR 171 IH ‘‘(6) IMPORTATION AND EXPORTATION RE- 1 QUIREMENTS NOT AFFECTED.—Nothing in this sub- 2 section alters the requirements of part A of title III, 3 regarding the importation and exportation of con- 4 trolled substances.’’. 5 (b) SEPARATE REGISTRATIONS NOT REQUIRED FOR 6 ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sec- 7 tion 302(c) of the Controlled Substances Act (21 U.S.C. 8 822(c)) is amended by adding at the end the following: 9 ‘‘(4) An agent or employee of a research insti- 10 tution that is conducting research with a controlled 11 substance if— 12 ‘‘(A) the agent or employee is acting with- 13 in the scope of the professional practice of the 14 agent or employee; 15 ‘‘(B) another agent or employee of the in- 16 stitution is registered to conduct research with 17 a controlled substance in the same schedule; 18 ‘‘(C) the researcher who is so registered— 19 ‘‘(i) informs the Attorney General of 20 the name, position title, and employing in- 21 stitution of the agent or employee who is 22 not separately registered; 23 VerDate Sep 11 2014 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •HR 171 IH ‘‘(ii) authorizes that agent or em- 1 ployee to perform research under the reg- 2 istration of the registered researcher; and 3 ‘‘(iii) affirms that any act taken by 4 that agent or employee involving a con- 5 trolled substance shall be attributable to 6 the registered researcher, as if the re- 7 searcher had directly committed the act, 8 for purposes of any proceeding under sec- 9 tion 304(a) to suspend or revoke the reg- 10 istration of the registered researcher; and 11 ‘‘(D) the Attorney General does not, within 12 30 days of receiving the information, authoriza- 13 tion, and affirmation described in subparagraph 14 (C), refuse, for a reason listed in section 15 304(a), to allow the agent or employee to pos- 16 sess the substance without a separate registra- 17 tion.’’. 18 (c) SINGLE REGISTRATION FOR RELATED RESEARCH 19 SITES.—Section 302(e) of the Controlled Substances Act 20 (21 U.S.C. 822(e)) is amended by adding at the end the 21 following: 22 ‘‘(3)(A) Notwithstanding paragraph (1), a person 23 registered to conduct research with a controlled substance 24 VerDate Sep 11 2014 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •HR 171 IH under section 303(f) may conduct the research under a 1 single registration if— 2 ‘‘(i) the research occurs exclusively on sites all 3 of which are— 4 ‘‘(I) within the same city or county; and 5 ‘‘(II) under the control of the same institu- 6 tion, organization, or agency; and 7 ‘‘(ii) before commencing the research, the re- 8 searcher notifies the Attorney General of each site 9 where— 10 ‘‘(I) the research will be conducted; or 11 ‘‘(II) the controlled substance will be 12 stored or administered. 13 ‘‘(B) A site described in subparagraph (A) shall be 14 included in a registration described in that subparagraph 15 only if the researcher has notified the Attorney General 16 of the site— 17 ‘‘(i) in the application for the registration; or 18 ‘‘(ii) before the research is conducted, or before 19 the controlled substance is stored or administered, at 20 the site. 21 ‘‘(C) The Attorney General may, in consultation with 22 the Secretary, issue regulations addressing, with respect 23 to research sites described in subparagraph (A)— 24 VerDate Sep 11 2014 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 12 •HR 171 IH ‘‘(i) the manner in which controlled substances 1 may be delivered to the research sites; 2 ‘‘(ii) the storage and security of controlled sub- 3 stances at the research sites; 4 ‘‘(iii) the maintenance of records for the re- 5 search sites; and 6 ‘‘(iv) any other matters necessary to ensure ef- 7 fective controls against diversion at the research 8 sites.’’. 9 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN 10 SITUATIONS.—Section 302(f) of the Controlled Sub- 11 stances Act (21 U.S.C. 822(f)) is amended— 12 (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 13 The’’; and 14 (2) by adding at the end the following: 15 ‘‘(2)(A) If a person is registered to conduct research 16 with a controlled substance and applies for a registration, 17 or for a modification of a registration, to conduct research 18 with a second controlled substance that is in the same 19 schedule as the first controlled substance, or is in a sched- 20 ule with a higher numerical designation than the schedule 21 of the first controlled substance, a new inspection by the 22 Attorney General of the registered location is not required. 23 ‘‘(B) Nothing in subparagraph (A) shall prohibit the 24 Attorney General from conducting an inspection that the 25 VerDate Sep 11 2014 23:19 Jan 18, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H171.IH H171 pbinns on DSKJLVW7X2PROD with $$_JOB 13 •HR 171 IH Attorney General determines necessary to ensure that a 1 registrant maintains effective controls against diversion.’’. 2 (e) CONTINUATION OF RESEARCH ON SUBSTANCES 3 NEWLY ADDED TO SCHEDULE I.—Section 302 of the 4 Controlled Substances Act (21 U.S.C. 822 [Text truncated for display. 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