HALT Fentanyl Act
Officially: “HALT Fentanyl Act” Read the full text
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1Short title
This section would let the Act be called the Halt All Lethal Trafficking of Fentanyl Act, or the HALT Fentanyl Act.
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1. Short title This Act may be cited as the Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act .
2Class scheduling of fentanyl-related substances
This section would add a new category to schedule I of the Controlled Substances Act, the strictest legal category for controlled drugs. Under the new category, any material, compound, mixture, or preparation that contains any amount of a fentanyl-related substance, including its salts and isomers where those are chemically possible, would be a schedule I substance, unless it is specifically exempted or already listed in a different schedule. A fentanyl-related substance would be defined as any substance that is chemically related to fentanyl through one or more of five kinds of structural changes: replacing the phenyl part of fentanyl's phenethyl group with any single-ring structure, whether or not that ring is further modified; adding certain chemical groups (alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or nitro groups) onto the phenethyl group; adding certain chemical groups (alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups) onto the piperidine ring; replacing the aniline ring with any aromatic single-ring structure, whether or not further modified; or replacing the N-propionyl group with a different acyl group. Even if a substance meets that chemical definition, it would not count as a fentanyl-related substance under this new schedule I category if the Attorney General has separately controlled it under the Act's existing scheduling process in section 201, or if it is already expressly listed in some other schedule. The Attorney General would be allowed, but not required, to publish in the Federal Register a list of substances that meet the fentanyl-related substance definition. If a substance meets the definition but is left off that published list, it would still count as controlled under this new schedule I category.
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2. Class scheduling of fentanyl-related substances Section 202(c) of the Controlled Substances Act ( 21 U.S.C. 812(c) ) is amended by adding at the end of schedule I the following: (e) (1) 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. (2) For purposes of paragraph (1), except as provided in paragraph (3), the term fentanyl-related substance means any substance that is structurally related to fentanyl by 1 or more of the following modifications: (A) By replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle. (B) By substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or nitro groups. (C) By substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups. (D) By replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle. (E) By replacement of the N–propionyl group with another acyl group. (3) A substance that satisfies the definition of the term fentanyl-related substance in paragraph (2) shall nonetheless not be treated as a fentanyl-related substance subject to this schedule if the substance— (A) is controlled by action of the Attorney General under section 201; or (B) is otherwise expressly listed in a schedule other than this schedule. (4) (A) The Attorney General may by order publish in the Federal Register a list of substances that satisfy the definition of the term fentanyl-related substance in paragraph (2). (B) 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 fentanyl-related substance in paragraph (2). .
3Registration requirements related to research
This section would change several registration rules for researchers who work with controlled substances, including fentanyl-related substances added by this Act. It would rename an existing subsection of the Controlled Substances Act dealing with required training for prescribers, moving it from subsection (l) to subsection (m), and would add a new provision letting a practitioner conduct certain schedule I research through an expedited process instead of the normal registration process. This expedited process would be available for research on a drug that is already the subject of an investigational new drug exemption under the Federal Food, Drug, and Cosmetic Act, or for research that either is conducted by the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs, or is funded in whole or in part by a grant, contract, cooperative agreement, or other transaction from one of those three departments. A practitioner who already holds a schedule I or schedule II research registration could start this expedited research 30 days after sending the Attorney General a notice giving the substance's chemical name, the quantity to be used, proof that the research qualifies (through the sponsoring agency and the grant, contract, or project number, or through the application number and sponsor of record for an investigational new drug application), and proof that the researcher is authorized under state law to do the research; the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs, as appropriate, would have to verify that proof if the Attorney General asks. A practitioner who does not already hold a schedule I or II research registration could send the same information as a notice, which the Attorney General would have to treat as a sufficient registration application; within 45 days of receiving a notice with all required information, the Attorney General would have to either register the applicant or serve an order to show cause proposing to deny the application. The Attorney General would have to provide an electronic way to submit these notices. A practitioner researching under this new process could possess only the amounts of the substance listed in the notice, or in a later supplemental notice giving the practitioner's name, the added quantity needed, and a statement that the added amount stays within the scope of the original research. This new process would not change the existing import and export requirements for controlled substances. Within 1 year after enactment, the Department of Justice's Inspector General would have to complete a study and report to Congress on research conducted with fentanyl under this expedited category. This section would also let an agent or employee of a research institution work with a controlled substance without a separate registration, as long as the agent or employee acts within the scope of their professional practice, another agent or employee at the same institution already holds a research registration for a controlled substance in the same schedule, that registered researcher tells the Attorney General the unregistered person's name, position title, and employing institution, authorizes them to do research under the registered researcher's registration, and affirms that any act by that unregistered person involving the controlled substance counts as the registered researcher's own act for purposes of a proceeding to suspend or revoke that registration, and the Attorney General does not, within 30 days of receiving that information, authorization, and affirmation, refuse for one of the reasons listed for denying registrations to allow the arrangement. It would also fix a cross-reference elsewhere in the Act, changing a citation from paragraph (25) to paragraph (27). This section would let a person registered to research a controlled substance operate under a single registration across more than one physical site, if all of the research happens at sites in the same city or county that are all controlled by the same institution, organization, or agency, and the researcher tells the Attorney General about each such site before research starts there or before the substance is stored or administered there. A site would count under the single registration only if the researcher had notified the Attorney General of it, either in the registration application or before research, storage, or administration begins at that site. The Attorney General, in consultation with the Secretary of Health and Human Services, could issue regulations on how substances are delivered to these sites, how they are stored and secured there, how records are kept for them, and other matters needed to guard against diversion at these sites. This section would say that if a person already registered to research a controlled substance applies for a registration, or a change to a registration, to research a second controlled substance in the same schedule as the first one, or in a schedule with a higher numerical designation than the first one, the Attorney General would not have to conduct a new inspection of the registered location. The Attorney General could still conduct an inspection the Attorney General determines is necessary to make sure the registrant is maintaining effective controls against diversion. This section would let a person who is already researching a substance keep researching it after that substance is newly added to schedule I, as long as the person is already registered to research some other schedule I substance. Within 90 days after the new scheduling, the person would have to submit a completed application to register, or to modify an existing registration, to cover the newly scheduled substance, following regulations the Attorney General issues for this purpose. The person could keep doing the research, despite the Act's usual registration rules, until the person withdraws that application or the Attorney General serves an order to show cause proposing to deny it. If the Attorney General serves that order and the person requests a hearing, the hearing would have to be held on an expedited basis, not later than 45 days after the request, unless the person asks for it to be held at a later time. If the person sends a copy of the application to a manufacturer or distributor of the substance, that manufacturer or distributor's receipt of the copy would count as sufficient evidence that the person is authorized to receive the substance. This section would let a person registered to research a controlled substance also carry out manufacturing activities with small quantities of that substance, without needing a separate manufacturing registration, if the activities are done for the research and the activities and quantities involved are stated in a notice filed under the new expedited research provision, in a research protocol filed with a registration application, or in a notice giving the registrant's name and an attestation that the manufacturing stays within the scope of the research. The permitted activities would include processing the substance into extracts, tinctures, oils, solutions, derivatives, or other forms consistent with what was filed, and dosage-form development studies done to request an investigational new drug exemption. This manufacturing allowance would not include authority to grow marihuana. Finally, this section would require the Attorney General, whenever the Attorney General decides that applications to research a particular controlled substance should be handled under a process or criteria different from those used for other controlled substances in the same schedule, to make that fact public, including by posting it on the Drug Enforcement Administration's website. The Attorney General would have to identify which substances this applies to, describe the different process or criteria, and explain how they differ from the standard process or criteria for other substances in the same schedule, and would have to post this information as soon as the determination is made, whether or not any practitioner has yet applied.
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3. Registration requirements related to research (a) Alternative registration process for schedule I research Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended— (1) by redesignating the second subsection (l) (relating to required training for prescribers) as subsection (m); and (2) by adding at the end the following: (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— (A) 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 ( 21 U.S.C. 355(i) ); or (B) 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) In general 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: (I) The chemical name of the substance. (II) The quantity of the substance to be used in the research. (III) Demonstration that the research is in the category described in paragraph (2), which demonstration may be satisfied— (aa) 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 (bb) in the case of an application under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ), by supplying the application number and the sponsor of record on the application. (IV) 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) Verification of information by HHS or VA 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). (B) Researcher without a current schedule I or II research registration (i) In general If a practitioner is not registered to conduct research with a controlled substance in schedule I or II, the practitioner may send a notice to the Attorney General containing the information listed in subparagraph (A)(i), with respect to each substance with which the practitioner will conduct the research. (ii) Attorney General action The Attorney General shall— (I) treat notice received under clause (i) as a sufficient application for a research registration; and (II) not later than 45 days of receiving such a notice that contains all information required under subparagraph (A)(i)— (aa) register the applicant; or (bb) serve an order to show cause upon the applicant in accordance with section 304(c). (4) Electronic submissions The Attorney General shall provide a means to permit a practitioner to submit a notification under paragraph (3) electronically. (5) Limitation on amounts A practitioner conducting research with a schedule I substance under this subsection may only possess the amounts of schedule I substance identified in— (A) the notification to the Attorney General under paragraph (3); or (B) a supplemental notification that the practitioner may send if the practitioner needs additional amounts for the research, which supplemental notification shall include— (i) the name of the practitioner; (ii) the additional quantity needed of the substance; and (iii) an attestation that the research to be conducted with the substance is consistent with the scope of the research that was the subject of the notification under paragraph (3). (6) Importation and exportation requirements not affected Nothing in this subsection alters the requirements of part A of title III, regarding the importation and exportation of controlled substances. (7) Inspector General report Not later than 1 year after the date of enactment of the Halt All Lethal Trafficking of Fentanyl Act , the Inspector General of the Department of Justice shall complete a study, and submit to Congress a report thereon, about research described in paragraph (2) of this subsection with fentanyl. . (b) Separate registrations not required for additional researcher in same institution (1) In general Section 302(c) of the Controlled Substances Act ( 21 U.S.C. 822(c) ) is amended by adding at the end the following: (4) An agent or employee of a research institution that is conducting research with a controlled substance if— (A) the agent or employee is acting within the scope of the professional practice of the agent or employee; (B) another agent or employee of the institution is registered to conduct research with a controlled substance in the same schedule; (C) the researcher who is so registered— (i) informs the Attorney General of the name, position title, and employing institution of the agent or employee who is not separately registered; (ii) authorizes that agent or employee to perform research under the registration of the registered researcher; and (iii) affirms that any act taken by that agent or employee involving a controlled substance shall be attributable to the registered researcher, as if the researcher had directly committed the act, for purposes of any proceeding under section 304(a) to suspend or revoke the registration of the registered researcher; and (D) the Attorney General does not, within 30 days of receiving the information, authorization, and affirmation described in subparagraph (C), refuse, for a reason listed in section 304(a), to allow the agent or employee to possess the substance without a separate registration. . (2) Technical correction Section 302(c)(3) of the Controlled Substances Act ( 21 U.S.C. 822(c)(3) ) is amended by striking (25) and inserting (27) . (c) Single registration for related research sites Section 302(e) of the Controlled Substances Act ( 21 U.S.C. 822(e) ) is amended by adding at the end the following: (4) (A) Notwithstanding paragraph (1), a person registered to conduct research with a controlled substance under section 303(g) may conduct the research under a single registration if— (i) the research occurs exclusively on sites all of which are— (I) within the same city or county; and (II) under the control of the same institution, organization, or agency; and (ii) before commencing the research, the researcher notifies the Attorney General of each site where— (I) the research will be conducted; or (II) the controlled substance will be stored or administered. (B) A site described in subparagraph (A) shall be included in a registration described in that subparagraph only if the researcher has notified the Attorney General of the site— (i) in the application for the registration; or (ii) before the research is conducted, or before the controlled substance is stored or administered, at the site. (C) The Attorney General may, in consultation with the Secretary, issue regulations addressing, with respect to research sites described in subparagraph (A)— (i) the manner in which controlled substances may be delivered to the research sites; (ii) the storage and security of controlled substances at the research sites; (iii) the maintenance of records for the research sites; and (iv) any other matters necessary to ensure effective controls against diversion at the research sites. . (d) New inspection not required in certain situations Section 302(f) of the Controlled Substances Act ( 21 U.S.C. 822(f) ) is amended— (1) by striking (f) The and inserting (f)(1) The ; and (2) by adding at the end the following: (2) (A) If a person is registered to conduct research with a controlled substance and applies for a registration, or for a modification of a registration, to conduct research with a second controlled substance that is in the same schedule as the first controlled substance, or is in a schedule with a higher numerical designation than the schedule of the first controlled substance, a new inspection by the Attorney General of the registered location is not required. (B) Nothing in subparagraph (A) shall prohibit the Attorney General from conducting an inspection that the Attorney General determines necessary to ensure that a registrant maintains effective controls against diversion. . (e) Continuation of research on substances newly added to schedule I Section 302 of the Controlled Substances Act ( 21 U.S.C. 822 ) is amended by adding at the end the following: (h) Continuation of research on substances newly added to schedule I If a person is conducting research on a substance when the substance is added to schedule I, and the person is already registered to conduct research with a controlled substance in schedule I— (1) not later than 90 days after the scheduling of the newly scheduled substance, the person shall submit a completed application for registration or modification of existing registration, to conduct research on the substance, in accordance with regulations issued by the Attorney General for purposes of this paragraph; (2) the person may, notwithstanding subsections (a) and (b), continue to conduct the research on the substance until— (A) the person withdraws the application described in paragraph (1) of this subsection; or (B) the Attorney General serves on the person an order to show cause proposing the denial of the application under section 304(c); (3) if the Attorney General serves an order to show cause as described in paragraph (2)(B) and the person requests a hearing, the hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time if so requested by the person; and (4) if the person sends a copy of the application described in paragraph (1) to a manufacturer or distributor of the substance, receipt of the copy by the manufacturer or distributor shall constitute sufficient evidence that the person is authorized to receive the substance. . (f) Treatment of certain manufacturing activities as coincident to research Section 302 of the Controlled Substances Act ( 21 U.S.C. 822 ), as amended by subsection (e), is amended by adding at the end the following: (i) Treatment of certain manufacturing activities as coincident to research (1) In general Except as provided in paragraph (3), a person who is registered to perform research on a controlled substance may perform manufacturing activities with small quantities of that substance, including activities described in paragraph (2), without being required to obtain a manufacturing registration, if— (A) the activities are performed for the purpose of the research; and (B) the activities and the quantities of the substance involved in the activities are stated in— (i) a notification submitted to the Attorney General under section 303(n); (ii) a research protocol filed with an application for registration approval under section 303(g); or (iii) a notification to the Attorney General that includes— (I) the name of the registrant; and (II) an attestation that the research to be conducted with the small quantities of manufactured substance is consistent with the scope of the research that is the basis for the registration. (2) Activities included Activities permitted under paragraph (1) include— (A) processing the substance to create extracts, tinctures, oils, solutions, derivatives, or other forms of the substance consistent with— (i) the information provided as part of a notification submitted to the Attorney General under section 303(n); or (ii) a research protocol filed with an application for registration approval under section 303(g); and (B) dosage form development studies performed for the purpose of requesting an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ). (3) Exception regarding marihuana The authority under paragraph (1) to manufacture substances does not include the authority to grow marihuana. . (g) Transparency regarding special procedures Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ), as amended by subsection (a), is amended by adding at the end the following: (o) Transparency regarding special procedures (1) In general If the Attorney General determines, with respect to a controlled substance, that an application by a practitioner to conduct research with the substance should be considered under a process, or subject to criteria, different from the process or criteria applicable to applications to conduct research with other controlled substances in the same schedule, the Attorney General shall make public, including by posting on the website of the Drug Enforcement Administration— (A) the identities of all substances for which such determinations have been made; (B) the process and criteria that shall be applied to applications to conduct research with those substances; and (C) how the process and criteria described in subparagraph (B) differ from the process and criteria applicable to applications to conduct research with other controlled substances in the same schedule. (2) Timing of posting The Attorney General shall make information described in paragraph (1) public upon making a determination described in that paragraph, regardless of whether a practitioner has submitted such an application at that time. .
4Technical correction on controlled substances dispensing
This section would make technical corrections, effective as if they had been part of a 2022 law (Public Law 117-328), to fix citations in that law that pointed to section 303(g) of the Controlled Substances Act when they should have pointed to section 303(h). It would correct these citations in section 1252(a) of division FF of that law, in section 1262 of division FF (across several places in both the text being removed and the text being inserted by that section), and in section 1263(b) of division FF, including a related citation to 21 U.S.C. 823(g)(2), which would be corrected to 21 U.S.C. 823(h)(2).
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4. Technical correction on controlled substances dispensing Effective as if included in the enactment of Public Law 117–328 — (1) section 1252(a) of division FF of Public Law 117–328 (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) ; (2) section 1262 of division FF of Public Law 117–328 (136 Stat. 5681) is amended— (A) 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) Practitioners and inserting (h) Practitioners ; and (B) 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 (3) section 1263(b) of division FF of Public Law 117–328 (136 Stat. 5685) is amended— (A) by striking 303(g)(2) and inserting 303(h)(2) ; and (B) by striking ( 21 U.S.C. 823(g)(2) ) and inserting ( 21 U.S.C. 823(h)(2) ) .
5Rulemaking
This section would require the Attorney General to issue rules implementing this Act and its amendments within 6 months after enactment, and would allow the Attorney General to issue those rules as interim final rules. An interim final rule issued this way would take effect immediately, without the Attorney General having to show good cause as would otherwise be required under a specific part of section 553(b) of title 5 of the United States Code, the law governing federal rulemaking. The interim final rule would still have to give interested people a chance to comment and to request a hearing. After that comment and hearing process ends, the Attorney General would have to issue a final rule implementing this Act and its amendments, following the regular rulemaking procedure in section 553 of title 5.
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5. Rulemaking (a) Interim final rules The Attorney General— (1) 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 (2) 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.
6Penalties
This section would add fentanyl-related substances, as newly defined by this Act, into two penalty provisions of the Controlled Substances Act that currently apply to analogues of fentanyl (chemically described in the law as N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide): section 401(b)(1)(A)(vi) and section 401(b)(1)(B)(vi). As a result, fentanyl-related substances would be treated the same as fentanyl analogues under each of those two provisions. It would make the same change to the Controlled Substances Import and Export Act, adding fentanyl-related substances alongside fentanyl analogues in section 1010(b)(1)(F) and section 1010(b)(2)(F), so the same import and export penalty provisions would cover both. It would also add a new definition to section 102 of the Controlled Substances Act stating that fentanyl-related substance has the same meaning given to that term in the new schedule I provision created by section 2 of this Act.
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6. Penalties (a) In general Section 401(b)(1) of the Controlled Substances Act ( 21 U.S.C. 841(b)(1) ) is amended— (1) in subparagraph (A)(vi), by inserting or a fentanyl-related substance after any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide ; and (2) in subparagraph (B)(vi), by inserting or a fentanyl-related substance after any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide . (b) Importation and exportation Section 1010(b) of the Controlled Substances Import and Export Act ( 21 U.S.C. 960(b) ) is amended— (1) in paragraph (1)(F), by inserting or a fentanyl-related substance after any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide ; and (2) in paragraph (2)(F), by inserting or a fentanyl-related substance after any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide . (c) Definition of fentanyl-Related substance Section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ) is amended by adding at the end the following: (60) The term fentanyl-related substance has the meaning given the term in subsection (e)(2) of schedule I of section 202(c). .
7Applicability; other matters
This section would make the amendments in this Act apply starting on the date this Act is enacted, regardless of when the rules required by section 5 are finalized. It would also specify that nothing in this Act's amendments may be used as evidence that, for conduct occurring before this Act's enactment, a fentanyl-related substance as defined by this Act is not an analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide, when applying section 401(b)(1) of the Controlled Substances Act or section 1010(b) of the Controlled Substances Import and Export Act to that earlier conduct. It would also state that Congress agrees with how the Controlled Substances Act was interpreted in the court case United States v. McCray, 346 F. Supp. 3d 363 (W.D.N.Y. 2018).
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7. Applicability; other matters (a) In general Irrespective of the date on which the rules required by section 4 are finalized, the amendments made by this Act apply beginning as of the date of 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 ( 21 U.S.C. 841(b)(1) , 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. (c) Sense of Congress Congress agrees with the interpretation of the Controlled Substances Act ( 21 U.S.C. 801 et seq. ) in United States v. McCray, 346 F. Supp. 3d 363 (W.D.N.Y. 2018). 1. Short title This Act may be cited as the Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act . 2. Class scheduling of fentanyl-related substances Section 202(c) of the Controlled Substances Act ( 21 U.S.C. 812(c) ) is amended by adding at the end of schedule I the following: (e) (1) 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. (2) For purposes of paragraph (1), except as provided in paragraph (3), the term fentanyl-related substance means any substance that is structurally related to fentanyl by 1 or more of the following modifications: (A) By replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle. (B) By substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or nitro groups. (C) By substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups. (D) By replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle. (E) By replacement of the N–propionyl group with another acyl group. (3) A substance that satisfies the definition of the term fentanyl-related substance in paragraph (2) shall nonetheless not be treated as a fentanyl-related substance subject to this schedule if the substance— (A) is controlled by action of the Attorney General under section 201; or (B) is otherwise expressly listed in a schedule other than this schedule. (4) (A) The Attorney General may by order publish in the Federal Register a list of substances that satisfy the definition of the term fentanyl-related substance in paragraph (2). (B) 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 fentanyl-related substance in paragraph (2). . 3. Registration requirements related to research (a) Alternative registration process for schedule I research Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended— (1) by redesignating the second subsection (l) (relating to required training for prescribers) as subsection (m); and (2) by adding at the end the following: (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— (A) 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 ( 21 U.S.C. 355(i) ); or (B) 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) In general 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: (I) The chemical name of the substance. (II) The quantity of the substance to be used in the research. (III) Demonstration that the research is in the category described in paragraph (2), which demonstration may be satisfied— (aa) 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 (bb) in the case of an application under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ), by supplying the application number and the sponsor of record on the application. (IV) 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) Verification of information by HHS or VA 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). (B) Researcher without a current schedule I or II research registration (i) In general If a practitioner is not registered to conduct research with a controlled substance in schedule I or II, the practitioner may send a notice to the Attorney General containing the information listed in subparagraph (A)(i), with respect to each substance with which the practitioner will conduct the research. (ii) Attorney General action The Attorney General shall— (I) treat notice received under clause (i) as a sufficient application for a research registration; and (II) not later than 45 days of receiving such a notice that contains all information required under subparagraph (A)(i)— (aa) register the applicant; or (bb) serve an order to show cause upon the applicant in accordance with section 304(c). (4) Electronic submissions The Attorney General shall provide a means to permit a practitioner to submit a notification under paragraph (3) electronically. (5) Limitation on amounts A practitioner conducting research with a schedule I substance under this subsection may only possess the amounts of schedule I substance identified in— (A) the notification to the Attorney General under paragraph (3); or (B) a supplemental notification that the practitioner may send if the practitioner needs additional amounts for the research, which supplemental notification shall include— (i) the name of the practitioner; (ii) the additional quantity needed of the substance; and (iii) an attestation that the research to be conducted with the substance is consistent with the scope of the research that was the subject of the notification under paragraph (3). (6) Importation and exportation requirements not affected Nothing in this subsection alters the requirements of part A of title III, regarding the importation and exportation of controlled substances. (7) Inspector General report Not later than 1 year after the date of enactment of the Halt All Lethal Trafficking of Fentanyl Act , the Inspector General of the Department of Justice shall complete a study, and submit to Congress a report thereon, about research described in paragraph (2) of this subsection with fentanyl. . (b) Separate registrations not required for additional researcher in same institution (1) In general Section 302(c) of the Controlled Substances Act ( 21 U.S.C. 822(c) ) is amended by adding at the end the following: (4) An agent or employee of a research institution that is conducting research with a controlled substance if— (A) the agent or employee is acting within the scope of the professional practice of the agent or employee; (B) another agent or employee of the institution is registered to conduct research with a controlled substance in the same schedule; (C) the researcher who is so registered— (i) informs the Attorney General of the name, position title, and employing institution of the agent or employee who is not separately registered; (ii) authorizes that agent or employee to perform research under the registration of the registered researcher; and (iii) affirms that any act taken by that agent or employee involving a controlled substance shall be attributable to the registered researcher, as if the researcher had directly committed the act, for purposes of any proceeding under section 304(a) to suspend or revoke the registration of the registered researcher; and (D) the Attorney General does not, within 30 days of receiving the information, authorization, and affirmation described in subparagraph (C), refuse, for a reason listed in section 304(a), to allow the agent or employee to possess the substance without a separate registration. . (2) Technical correction Section 302(c)(3) of the Controlled Substances Act ( 21 U.S.C. 822(c)(3) ) is amended by striking (25) and inserting (27) . (c) Single registration for related research sites Section 302(e) of the Controlled Substances Act ( 21 U.S.C. 822(e) ) is amended by adding at the end the following: (4) (A) Notwithstanding paragraph (1), a person registered to conduct research with a controlled substance under section 303(g) may conduct the research under a single registration if— (i) the research occurs exclusively on sites all of which are— (I) within the same city or county; and (II) under the control of the same institution, organization, or agency; and (ii) before commencing the research, the researcher notifies the Attorney General of each site where— (I) the research will be conducted; or (II) the controlled substance will be stored or administered. (B) A site described in subparagraph (A) shall be included in a registration described in that subparagraph only if the researcher has notified the Attorney General of the site— (i) in the application for the registration; or (ii) before the research is conducted, or before the controlled substance is stored or administered, at the site. (C) The Attorney General may, in consultation with the Secretary, issue regulations addressing, with respect to research sites described in subparagraph (A)— (i) the manner in which controlled substances may be delivered to the research sites; (ii) the storage and security of controlled substances at the research sites; (iii) the maintenance of records for the research sites; and (iv) any other matters necessary to ensure effective controls against diversion at the research sites. . (d) New inspection not required in certain situations Section 302(f) of the Controlled Substances Act ( 21 U.S.C. 822(f) ) is amended— (1) by striking (f) The and inserting (f)(1) The ; and (2) by adding at the end the following: (2) (A) If a person is registered to conduct research with a controlled substance and applies for a registration, or for a modification of a registration, to conduct research with a second controlled substance that is in the same schedule as the first controlled substance, or is in a schedule with a higher numerical designation than the schedule of the first controlled substance, a new inspection by the Attorney General of the registered location is not required. (B) Nothing in subparagraph (A) shall prohibit the Attorney General from conducting an inspection that the Attorney General determines necessary to ensure that a registrant maintains effective controls against diversion. . (e) Continuation of research on substances newly added to schedule I Section 302 of the Controlled Substances Act ( 21 U.S.C. 822 ) is amended by adding at the end the following: (h) Continuation of research on substances newly added to schedule I If a person is conducting research on a substance when the substance is added to schedule I, and the person is already registered to conduct research with a controlled substance in schedule I— (1) not later than 90 days after the scheduling of the newly scheduled substance, the person shall submit a completed application for registration or modification of existing registration, to conduct research on the substance, in accordance with regulations issued by the Attorney General for purposes of this paragraph; (2) the person may, notwithstanding subsections (a) and (b), continue to conduct the research on the substance until— (A) the person withdraws the application described in paragraph (1) of this subsection; or (B) the Attorney General serves on the person an order to show cause proposing the denial of the application under section 304(c); (3) if the Attorney General serves an order to show cause as described in paragraph (2)(B) and the person requests a hearing, the hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time if so requested by the person; and (4) if the person sends a copy of the application described in paragraph (1) to a manufacturer or distributor of the substance, receipt of the copy by the manufacturer or distributor shall constitute sufficient evidence that the person is authorized to receive the substance. . (f) Treatment of certain manufacturing activities as coincident to research Section 302 of the Controlled Substances Act ( 21 U.S.C. 822 ), as amended by subsection (e), is amended by adding at the end the following: (i) Treatment of certain manufacturing activities as coincident to research (1) In general Except as provided in paragraph (3), a person who is registered to perform research on a controlled substance may perform manufacturing activities with small quantities of that substance, including activities described in paragraph (2), without being required to obtain a manufacturing registration, if— (A) the activities are performed for the purpose of the research; and (B) the activities and the quantities of the substance involved in the activities are stated in— (i) a notification submitted to the Attorney General under section 303(n); (ii) a research protocol filed with an application for registration approval under section 303(g); or (iii) a notification to the Attorney General that includes— (I) the name of the registrant; and (II) an attestation that the research to be conducted with the small quantities of manufactured substance is consistent with the scope of the research that is the basis for the registration. (2) Activities included Activities permitted under paragraph (1) include— (A) processing the substance to create extracts, tinctures, oils, solutions, derivatives, or other forms of the substance consistent with— (i) the information provided as part of a notification submitted to the Attorney General under section 303(n); or (ii) a research protocol filed with an application for registration approval under section 303(g); and (B) dosage form development studies performed for the purpose of requesting an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ). (3) Exception regarding marihuana The authority under paragraph (1) to manufacture substances does not include the authority to grow marihuana. . (g) Transparency regarding special procedures Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ), as amended by subsection (a), is amended by adding at the end the following: (o) Transparency regarding special procedures (1) In general If the Attorney General determines, with respect to a controlled substance, that an application by a practitioner to conduct research with the substance should be considered under a process, or subject to criteria, different from the process or criteria applicable to applications to conduct research with other controlled substances in the same schedule, the Attorney General shall make public, including by posting on the website of the Drug Enforcement Administration— (A) the identities of all substances for which such determinations have been made; (B) the process and criteria that shall be applied to applications to conduct research with those substances; and (C) how the process and criteria described in subparagraph (B) differ from the process and criteria applicable to applications to conduct research with other controlled substances in the same schedule. (2) Timing of posting The Attorney General shall make information described in paragraph (1) public upon making a determination described in that paragraph, regardless of whether a practitioner has submitted such an application at that time. . 4. Technical correction on controlled substances dispensing Effective as if included in the enactment of Public Law 117–328 — (1) section 1252(a) of division FF of Public Law 117–328 (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) ; (2) section 1262 of division FF of Public Law 117–328 (136 Stat. 5681) is amended— (A) 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) Practitioners and inserting (h) Practitioners ; and (B) 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 (3) section 1263(b) of division FF of Public Law 117–328 (136 Stat. 5685) is amended— (A) by striking 303(g)(2) and inserting 303(h)(2) ; and (B) by striking ( 21 U.S.C. 823(g)(2) ) and inserting ( 21 U.S.C. 823(h)(2) ) . 5. Rulemaking (a) Interim final rules The Attorney General— (1) 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 (2) 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 the undesignated matter following paragraph (4) 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. 6. Penalties (a) In general Section 401(b)(1) of the Controlled Substances Act ( 21 U.S.C. 841(b)(1) ) is amended— (1) in subparagraph (A)(vi), by inserting or a fentanyl-related substance after any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide ; and (2) in subparagraph (B)(vi), by inserting or a fentanyl-related substance after any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide . (b) Importation and exportation Section 1010(b) of the Controlled Substances Import and Export Act ( 21 U.S.C. 960(b) ) is amended— (1) in paragraph (1)(F), by inserting or a fentanyl-related substance after any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide ; and (2) in paragraph (2)(F), by inserting or a fentanyl-related substance after any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide . (c) Definition of fentanyl-related substance Section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ) is amended by adding at the end the following: (60) The term fentanyl-related substance has the meaning given the term in subsection (e)(2) of schedule I of section 202(c). . 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 date of 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) of the Controlled Substances Act ( 21 U.S.C. 841(b)(1) ) and 1010(b) of the Controlled Substances Import and Export Act ( 21 U.S.C. 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. (c) Sense of Congress Congress agrees with the interpretation of the Controlled Substances Act ( 21 U.S.C. 801 et seq. ) in United States v. McCray, 346 F. Supp. 3d 363 (W.D.N.Y. 2018). March 3, 2025 Reported with an amendment
Where it is
In the Senate.