S 331
HALT Fentanyl Act
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Bill overview
The HALT Fentanyl Act permanently classifies fentanyl-related substances as a Schedule I controlled substance under the Controlled Substances Act. It increases penalties for offenses involving these substances to match those for fentanyl analogues, which typically carry a 10-year mandatory minimum prison sentence. The bill also streamlines research registration processes, allowing for single registrations for related research sites and waiving certain inspection requirements. Furthermore, it clarifies the definition of ‘fentanyl-related substance’ and addresses the continued research on newly scheduled substances.
Key provisions
- Permanently schedules fentanyl-related substances as Schedule I.
- Increases penalties for offenses involving fentanyl-related substances to match those for fentanyl analogues.
- Streamlines research registration processes, allowing for single registrations and waived inspections.
- Clarifies the definition of ‘fentanyl-related substance’ to include various chemical modifications.
- Establishes a process for continued research on substances newly added to Schedule I.
- Permits a single registration for related research sites.
- Waives the requirement for a new inspection in certain research situations.
- Allows a registered researcher to perform certain manufacturing activities with small quantities of a substance.
Who is affected
- Drug traffickers and manufacturers of fentanyl and related substances
- Researchers involved in studying fentanyl and its analogues
Sponsors
Official sponsors from legislative records.
Primary sponsor
Cosponsors
Angus S., Jr. King
Arguments in favor
Reasons to support this legislation.
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119th CONGRESS — 1st Session
S. 331
IN THE SENATE OF THE UNITED STATES
A BILL
To amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes.
This Act may be cited as the Halt All Lethal Trafficking of Fentanyl Act HALT Fentanyl Act
or the
.
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:
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:
By replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle.
By substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or nitro groups.
By substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups.
By replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle.
By replacement of the N–propionyl group with another acyl group.
is controlled by action of the Attorney General under section 201; or
is otherwise expressly listed in a schedule other than this schedule.
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).
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).
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended—
by redesignating the second subsection (l) (relating to required training for prescribers) as subsection (m); and
by adding at the end the following:
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.
Research described in this paragraph is research that—
is with respect to a drug that is the subject of an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)); or
is—
If a practitioner is registered to conduct research with a controlled substance in schedule I or II, the practitioner may conduct research under this subsection on and after the date that is 30 days after the date on which the practitioner sends a notice to the Attorney General containing the following information, with respect to each substance with which the practitioner will conduct the research:
The chemical name of the substance.
The quantity of the substance to be used in the research.
Demonstration that the research is in the category described in paragraph (2), which demonstration may be satisfied—
in the case of a grant, contract, cooperative agreement, or other transaction, or intramural research project, by identifying the sponsoring agency and supplying the number of the grant, contract, cooperative agreement, other transaction, or project; or
in the case of an application under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)), by supplying the application number and the sponsor of record on the application.
Demonstration that the researcher is authorized to conduct research with respect to the substance under the laws of the State in which the research will take place.
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.
The Attorney General shall—
treat notice received under clause (i) as a sufficient application for a research registration; and
not later than 45 days of receiving such a notice that contains all information required under subparagraph (A)(i)—
register the applicant; or
serve an order to show cause upon the applicant in accordance with section 304(c).
The Attorney General shall provide a means to permit a practitioner to submit a notification under paragraph (3) electronically.
A practitioner conducting research with a schedule I substance under this subsection may only possess the amounts of schedule I substance identified in—
the notification to the Attorney General under paragraph (3); or
a supplemental notification that the practitioner may send if the practitioner needs additional amounts for the research, which supplemental notification shall include—
the name of the practitioner;
the additional quantity needed of the substance; and
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).
Nothing in this subsection alters the requirements of part A of title III, regarding the importation and exportation of controlled substances.
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.Section 302(c) of the Controlled Substances Act (21 U.S.C. 822(c)) is amended by adding at the end the following:
An agent or employee of a research institution that is conducting research with a controlled substance if—
the agent or employee is acting within the scope of the professional practice of the agent or employee;
another agent or employee of the institution is registered to conduct research with a controlled substance in the same schedule;
the researcher who is so registered—
informs the Attorney General of the name, position title, and employing institution of the agent or employee who is not separately registered;
authorizes that agent or employee to perform research under the registration of the registered researcher; and
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
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.
(25)and inserting
(27).
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—
the research occurs exclusively on sites all of which are—
within the same city or county; and
under the control of the same institution, organization, or agency; and
before commencing the research, the researcher notifies the Attorney General of each site where—
the research will be conducted; or
the controlled substance will be stored or administered.
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—
in the application for the registration; or
before the research is conducted, or before the controlled substance is stored or administered, at the site.
The Attorney General may, in consultation with the Secretary, issue regulations addressing, with respect to research sites described in subparagraph (A)—
the manner in which controlled substances may be delivered to the research sites;
the storage and security of controlled substances at the research sites;
the maintenance of records for the research sites; and
any other matters necessary to ensure effective controls against diversion at the research sites.
by striking (f) The
and inserting (f)(1) The
; and
by adding at the end the following:
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.
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.
Section 302 of the Controlled Substances Act (21 U.S.C. 822) is amended by adding at the end the following:
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—
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;
the person may, notwithstanding subsections (a) and (b), continue to conduct the research on the substance until—
the person withdraws the application described in paragraph (1) of this subsection; or
the Attorney General serves on the person an order to show cause proposing the denial of the application under section 304(c);
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
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.
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:
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—
the activities are performed for the purpose of the research; and
the activities and the quantities of the substance involved in the activities are stated in—
a notification submitted to the Attorney General under section 303(n);
a research protocol filed with an application for registration approval under section 303(g); or
a notification to the Attorney General that includes—
the name of the registrant; and
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.
Activities permitted under paragraph (1) include—
processing the substance to create extracts, tinctures, oils, solutions, derivatives, or other forms of the substance consistent with—
the information provided as part of a notification submitted to the Attorney General under section 303(n); or
a research protocol filed with an application for registration approval under section 303(g); and
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)).
The authority under paragraph (1) to manufacture substances does not include the authority to grow marihuana.
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:
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—
the identities of all substances for which such determinations have been made;
the process and criteria that shall be applied to applications to conduct research with those substances; and
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.
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.
Effective as if included in the enactment of Public Law 117–328—
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)
;
section 1262 of division FF of Public Law 117–328 (136 Stat. 5681) is amended—
in subsection (a)—
in the matter preceding paragraph (1), by striking 303(g)
and inserting 303(h)
;
in the matter being stricken by subsection (a)(2), by striking (g)(1)
and inserting (h)(1)
; and
in the matter being inserted by subsection (a)(2), by striking (g) Practitioners
and inserting (h) Practitioners
; and
in subsection (b)—
in the matter being stricken by paragraph (1), by striking 303(g)(1)
and inserting 303(h)(1)
;
in the matter being inserted by paragraph (1), by striking 303(g)
and inserting 303(h)
;
in the matter being stricken by paragraph (2)(A), by striking 303(g)(2)
and inserting 303(h)(2)
;
in the matter being stricken by paragraph (3), by striking 303(g)(2)(B)
and inserting 303(h)(2)(B)
;
in the matter being stricken by paragraph (5), by striking 303(g)
and inserting 303(h)
; and
in the matter being stricken by paragraph (6), by striking 303(g)
and inserting 303(h)
; and
section 1263(b) of division FF of Public Law 117–328 (136 Stat. 5685) is amended—
by striking 303(g)(2)
and inserting 303(h)(2)
; and
by striking (21 U.S.C. 823(g)(2))
and inserting (21 U.S.C. 823(h)(2))
.
The Attorney General—
shall, not later than 6 months after the date of enactment of this Act, issue rules to implement this Act and the amendments made by this Act; and
may issue the rules under paragraph (1) as interim final rules.
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.
An interim final rule issued under subsection (a) shall give interested persons the opportunity to comment and to request a hearing.
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.
Section 401(b)(1) of the Controlled Substances Act (21 U.S.C. 841(b)(1)) is amended—
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
in subparagraph (B)(vi), by inserting or a fentanyl-related substance
after any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide
.
Section 1010(b) of the Controlled Substances Import and Export Act (21 U.S.C. 960(b)) is amended—
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
in paragraph (2)(F), by inserting or a fentanyl-related substance
after any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide
.
The term fentanyl-related substance has the meaning given the term in subsection (e)(2) of schedule I of section 202(c).
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).