[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1100 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1100
To amend the Controlled Substances Act to provide for the regulation of
critical parts of tableting machines and encapsulating machines, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 6, 2025
Ms. Stansbury (for herself, Mr. Grijalva, Ms. Pettersen, Ms. Salinas,
and Mr. Horsford) 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 subsequently 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 to provide for the regulation of
critical parts of tableting machines and encapsulating machines, and
for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Stop the Opioid Pill Presser and
Fentanyl Act'' or the ``STOPP Act''.
SEC. 2. DEFINITIONS.
Section 102 of the Controlled Substances Act (21 U.S.C. 802) is
amended--
(1) in paragraph (38), by striking ``or an encapsulating
machine'' and inserting ``an encapsulating machine, a critical
part of a tableting machine, or a critical part of an
encapsulating machine'';
(2) in paragraph (39)(B)--
(A) by striking ``distribution, importation, or
exportation of'' and inserting ``distribution, receipt,
sale, importation, or exportation of, or an
international transaction involving shipment of''; and
(B) by striking ``or encapsulating machine'' and
inserting ``, encapsulating machine, critical part of a
tableting machine, or critical part of an encapsulating
machine'';
(3) in paragraph (42), by striking ``a listed chemical''
and inserting ``a listed chemical, a tableting machine, an
encapsulating machine, a critical part of a tableting machine,
or a critical part of an encapsulating machine'';
(4) in paragraph (43), by striking ``a listed chemical''
and inserting ``a listed chemical, a tableting machine, an
encapsulating machine, a critical part of a tableting machine,
or a critical part of an encapsulating machine''; and
(5) by adding at the end the following:
``(60) The term `critical part', when used in reference to a
tableting machine or encapsulating machine, means any of the following
integral parts when designed primarily for use in a tableting or
encapsulating machine:
``(A) Press punch.
``(B) Die system.
``(C) Press turret.
``(D) Hopper.
``(E) Compression roller.
``(F) Discharge chute.
``(G) Vacuum system.
``(H) Capsule feeding unit.
``(I) Automatic feeding unit.
``(J) Any other item identified in a regulation published
by the Attorney General used in the operating of tableting or
encapsulating machines.''.
SEC. 3. REGULATED TRANSACTIONS OF CRITICAL PARTS.
(a) Record of Regulated Transactions.--Section 310 of the
Controlled Substances Act (21 U.S.C. 830) is amended--
(1) in subsection (a)(1)--
(A) by striking ``or an encapsulating machine'' and
inserting ``an encapsulating machine, a critical part
of a tableting machine, or a critical part of an
encapsulating machine''; and
(B) by inserting ``, in such form and manner as the
Attorney General shall prescribe by regulation,'' after
``record of the transaction''; and
(2) in paragraph (a)(2), by striking ``or encapsulating
machine'' and inserting ``, encapsulating machine, critical
part of a tableting machine, or critical part of an
encapsulating machine''.
(b) Reports to Attorney General and Recordkeeping.--Section
310(b)(1) of the Controlled Substances Act (21 U.S.C. 830) is amended--
(1) in subparagraph (A)--
(A) by striking ``payment or delivery'' and
inserting ``payment or delivery of a listed chemical,
tableting machine, encapsulating machine, a critical
part of a tableting machine, or a critical part of an
encapsulating machine''; and
(B) by striking ``any other circumstance that the
regulated person believes may indicate that the listed
chemical'' and inserting ``any other circumstance that
the regulated person believes may indicate that the
listed chemical, tableting machine, encapsulating
machine, critical part of a tableting machine, or
critical part of an encapsulating machine'';
(2) in subparagraph (C), by striking ``listed chemical''
and inserting ``listed chemical, tableting machine,
encapsulating machine, critical part of a tableting machine, or
critical part of an encapsulating machine''; and
(3) in subparagraph (D), by striking ``or an encapsulating
machine'' and inserting ``, an encapsulating machine, critical
part of a tableting machine, or critical part of an
encapsulating machine''.
(c) Effective Date.--The amendments made by this section shall
apply beginning on the date that is 120 days after the date of
enactment of this Act, except that the Attorney General may, by order
published in the Federal Register, postpone such date of application
for such period as the Attorney General may determine to be necessary
for the efficient administration of the Controlled Substances Act (21
U.S.C. 801 et seq.).
SEC. 4. SERIALIZATION OF CERTAIN MACHINES AND PARTS.
The Controlled Substances Act (21 U.S.C. 801 et seq.) is amended by
inserting after section 310 (21 U.S.C. 830) the following:
``SEC. 310A SERIALIZATION OF CERTAIN MACHINES AND PARTS.
``(a) Serial Number.--Each manufacturer, distributor, importer, or
exporter of a tableting machine, encapsulating machine, a critical part
of a tableting machine, or a critical part of an encapsulating machine
shall, when and as required by regulation of the Attorney General,
identify the tableting machine, encapsulating machine, critical part of
a tableting machine, or critical part of an encapsulating machine by a
serial number which shall be engraved, cast, or otherwise permanently
affixed to a non-removable part of the tableting machine, encapsulating
machine, critical part of a tableting machine, or critical part of an
encapsulating machine in accordance with such regulations.
``(b) Reporting.--Any regulated person who manufactures,
distributes, receives, sells, imports, or exports a tableting machine,
encapsulating machine, critical part of a tableting machine, or
critical part of an encapsulating machine that is subject to the
serialization requirement set forth in subsection (a), shall report the
transaction to the Attorney General and maintain records of such
transaction, in such form and manner as the Attorney General shall
prescribe by regulation.''.
SEC. 5. REGISTRATION OF CERTAIN MACHINES AND PARTS.
The Controlled Substances Act (21 U.S.C. 801 et seq.), as amended
by section 4, is further amended by inserting after section 310A the
following:
``SEC. 310B. REGISTRATION OF CERTAIN MACHINES AND PARTS.
``(a) Registration of Certain Machines and Parts.--Each
manufacturer, distributor, importer, or exporter of a tableting
machine, encapsulating machine, critical part of a tableting machine,
or critical part of an encapsulating machine shall, when and as
required by regulation of the Attorney General, register the tableting
machine, encapsulating machine, critical part of a tableting machine,
or critical part of an encapsulating machine with the Attorney General
in accordance with such regulation.
``(b) Reporting.--Any regulated person who manufactures,
distributes, receives, sells, imports, exports, or destroys a tableting
machine, encapsulating machine, critical part of a tableting machine,
or critical part of an encapsulating machine that is required to be
registered pursuant to subsection (a), shall report that act to the
Attorney General and maintain records of such act as required in
section 310, in such form and manner as the Attorney General shall
prescribe by regulation.
``(c) Regulations.--The Attorney General is authorized to
promulgate rules and regulations relating to tableting machines and
encapsulating machines. The Attorney General shall by regulation
establish which tableting machines, encapsulating machines, critical
parts of tableting machines, and critical parts of encapsulating
machines are subject to the registration and reporting requirements of
subsections (a) and (b) and the information to be provided pursuant to
subsections (a) and (b), which shall include the location of the
tableting machine, encapsulating machine, critical part of a tableting
machine, or critical part of an encapsulating machine.
``(d) National Pill Press Registry.--The Attorney General shall
maintain a central registry of all tableting machines, encapsulating
machines, critical parts of a tableting machine, or critical parts of
an encapsulating machine that are subject to the registration
requirement set forth in subsection (a), which shall be known and
referred to as the National Pill Press Registry.
``(e) Definitions.--For the purposes of this section:
``(1) Manufacture.--The term `manufacture' means the
production or assembly of a tableting machine, encapsulating
machine, critical part of a tableting machine, or critical part
of an encapsulating machine.
``(2) Distribute.--The term `distribute' means to deliver a
tableting machine, encapsulating machine, critical part of a
tableting machine, or critical part of an encapsulating
machine.
``(3) Deliver.--The term `deliver' means the actual,
constructive, or attempted transfer of a tableting machine,
encapsulating machine, critical part of a tableting machine, or
critical part of an encapsulating machine, whether or not there
exists an agency relationship.
``(4) Destroy.--The term `destroy' means to cause such
serious damage to a tableting machine, encapsulating machine,
critical part of a tableting machine, or critical part of an
encapsulating machine so that it can no longer be used for its
intended purpose.''.
SEC. 6. REGISTRATION OF MANUFACTURERS, IMPORTERS, EXPORTERS, AND
DEALERS OF TABLETING MACHINES, ENCAPSULATING MACHINES,
AND CRITICAL PARTS.
The Controlled Substances Act (21 U.S.C. 801 et seq.), as amended
by sections 4 and 5, is further amended by inserting after section 310B
the following:
``SEC. 310C. REGISTRATION OF MANUFACTURERS, IMPORTERS, EXPORTERS, AND
DEALERS OF TABLETING MACHINES, ENCAPSULATING MACHINES,
AND CRITICAL PARTS.
``(a) Registration.--
``(1) In general.--Every person who manufactures, imports,
exports, or deals, or proposes to engage in the manufacture,
importation, exportation, or dealing of any tableting machine,
encapsulating machine, critical part of a tableting machine, or
critical part of an encapsulating machine, shall obtain, on an
annual basis, a registration issued by the Attorney General.
``(2) Waiver.--The Attorney General may, by regulation,
waive the requirement for registration of certain
manufacturers, importers, exporters, and distributors of any
tableting machine, encapsulating machine, critical part of a
tableting machine, or critical part of an encapsulating machine
if the Attorney General finds that issuing such a waiver would
be consistent with public health and safety.
``(3) Separate registrations required.--A separate
registration shall be required for each principal place of
business where the applicant manufactures, imports, exports, or
deals a tableting machine, encapsulating machine, critical part
of a tableting machine, or critical part of an encapsulating
machine.
``(4) Termination.--
``(A) In general.--A registration to manufacture,
import, export, or deal a tableting machine,
encapsulating machine, critical part of a tableting
machine, or critical part of an encapsulating machine
terminates if and when such registrant--
``(i) ceases legal existence;
``(ii) ceases to engage in the manufacture,
importation, exportation, or dealing of such a
machine or critical part thereof; or
``(iii) surrenders such registration.
``(B) Notification.--In the case of such a
registrant who ceases legal existence or ceases to
engage in the manufacture, importation, exportation, or
dealing, such registrant, or agent or successor in
interest of such registrant, shall promptly notify the
Attorney General in writing of such fact.
``(5) Re-assignment.--A registration to manufacture,
import, export, or deal a tableting machine, encapsulating
machine, critical part of a tableting machine, or critical part
of an encapsulating machine may only be assigned to another
entity with the written consent of, and upon such conditions
as, the Attorney General may specify.
``(b) Registration Considerations.--The Attorney General shall
register an applicant to manufacture, import, export, or deal a
tableting machine, encapsulating machine, critical part of a tableting
machine, or critical part of an encapsulating machine, unless the
Attorney General determines that registration of the applicant is
inconsistent with the public interest.
``(c) Considerations.--In determining the public interest for the
purposes of subsection (b), the Attorney General shall consider--
``(1) development and maintenance of effective controls
against diversion of tableting machines, encapsulating
machines, and critical parts thereof into other than legitimate
channels;
``(2) compliance with applicable Federal, State, and local
law;
``(3) prior conviction record of the applicant;
``(4) past experience in the manufacture, import, export,
and dealing of tableting machines, encapsulating machines, or
critical parts thereof; and
``(5) such other factors as may be relevant to and
consistent with the public health and safety.
``(d) Authorized Activities.--No person may manufacture, import,
export, or deal any tableting machine, encapsulating machine, critical
part of a tableting machine, or critical part of an encapsulating
machine unless such person has an active registration to do so issued
by the Attorney General, unless--
``(1) such person is an agent or employee of any registrant
acting in the usual course of his business or employment; or
``(2) a common or contract carrier or warehouseman, or an
employee thereof, whose possession of the tableting machine,
encapsulating machine, or critical part thereof is in the
lawful and usual course of his business or employment.
``(e) Inspection.--The Attorney General is authorized to inspect
the establishment of a registrant or applicant for registration in
accordance with the rules and regulations promulgated by the Attorney
General.
``(f) Denial, Revocation, or Suspension of Registration.--
``(1) Suspension or revocation.--A registration pursuant to
subsection (b) of this section to manufacture, import, export,
or deal a tableting machine, encapsulating machine, critical
part of a tableting machine, or critical part of an
encapsulating machine may be suspended or revoked by the
Attorney General upon a finding that the registrant--
``(A) has materially falsified any application
filed pursuant to or required by this subchapter or
subchapter II;
``(B) has been convicted in any court of an offense
involving a tableting machine, encapsulating machine, a
critical part of a tableting machine, or a critical
part of an encapsulating machine; or
``(C) has committed such acts as would render his
registration inconsistent with the public interest.
``(2) Order.--
``(A) In general.--Before suspending or revoking a
registration to manufacture, import, export, or deal
tableting machines, encapsulating machines, critical
parts of tableting machines, or critical parts of
encapsulating machines, or pursuant to a denial of
registration, the Attorney General shall serve upon the
applicant or registrant an order to show cause why
registration should not be denied, revoked, or
suspended.
``(B) Contents.--An order to show cause shall
contain a statement of the basis for the denial,
revocation, or suspension, including specific citations
to any laws or regulations alleged to be violated by
the applicant or registrant, direct the applicant or
registrant to appear before the Attorney General at a
time and place stated in the order, and notify the
applicant or registrant of the opportunity to submit a
corrective action plan on or before the date of
appearance.
``(C) Corrective action plan review.--Upon review
of any corrective action plan submitted by an applicant
or registrant pursuant to subparagraph (B), the
Attorney General shall determine whether denial,
revocation, or suspension proceedings should be
discontinued, or deferred for the purposes of
modification, amendment, or clarification to such plan.
``(D) Applicable law.--Proceedings to deny, revoke,
or suspend shall be conducted in accordance with
subchapter II of chapter 5 of title 5. Such proceedings
shall be independent of, and not in lieu of, criminal
prosecutions or other proceedings under this subchapter
or any other law of the United States.
``(E) Relationship to immediate suspension order.--
The requirements of this subsection shall not apply to
the issuance of an immediate suspension order under
paragraph (3).
``(3) Suspension of registration in cases of imminent
danger.--
``(A) In general.--The Attorney General may, in the
discretion of the Attorney General, suspend any
registration simultaneously with the institution of
proceedings under this section, in cases where he finds
that there is an imminent danger to the public health
or safety. A suspension under this subsection shall
continue in effect until the conclusion of such
proceedings, including judicial review thereof, unless
sooner withdrawn by the Attorney General or dissolved
by a court of competent jurisdiction.
``(B) Imminent danger to the public safety
defined.--In this subsection, the phrase `imminent
danger to the public health or safety' means that, due
to the failure of the registrant to maintain effective
controls against diversion or otherwise comply with the
obligations of a registrant under this Act, there is a
substantial likelihood that a tableting machine,
encapsulating machine, critical part of a tableting
machine, or critical part of an encapsulating machine
will be used in the illicit manufacture of controlled
substances and cause death, serious bodily harm, or
abuse of a controlled substance in the absence of an
immediate suspension of the registration.
``(g) Disposition of Tableting Machines, Encapsulating Machines,
and Critical Part.--
``(1) In general.--Upon termination, suspension, or
revocation of registration of a registrant, the former
registrant may, within 30 days or such additional period
designated by the Attorney General for good cause, liquidate
any remaining tableting machines, encapsulating machines,
critical parts of tableting machines, or critical parts of
encapsulating machines by lawfully selling, transferring, or
otherwise disposing of the tableting machines, encapsulating
machines, critical parts of a tableting machines, or critical
parts of encapsulating machines to a registered manufacturer,
importer, exporter, or dealer of tableting machines,
encapsulating machines, critical parts of tableting machines,
or critical parts of encapsulating machines.
``(2) Exception.--Except for the liquidation of remaining
inventory to a registrant within 30 days (or approved period)
in accordance with paragraph (1), a former registrant may no
longer deal tableting machines, encapsulating machines,
critical parts of tableting machines, or critical parts of
encapsulating machines.
``(h) Records and Reports.--
``(1) Every registrant shall maintain, on a current basis,
a complete and accurate record of each tableting machine,
encapsulating machine, critical part of a tableting machine, or
critical part of an encapsulating machine possessed,
manufactured, received, imported, exported, sold, distributed,
delivered, or destroyed, with such information, and in such
form and manner as the Attorney General may by regulations
require.
``(2) Every registrant shall, at such time or times, with
such information, and in such form and manner as the Attorney
General may by regulations require, make periodic reports to
the Attorney General.
``(3) Every record required under this section shall be
kept and be readily retrievable, for at least 10 years, for
inspection and copying by officers or employees of the United
States authorized by the Attorney General.
``(i) Regulations and Fees.--The Attorney General is authorized to
promulgate rules and regulations and charge reasonable fees relating to
the registration and control of the manufacture, importation,
exportation, and dealing of tableting machines, encapsulating machines,
critical parts of tableting machines, and critical parts of
encapsulating machines. The Attorney General shall by regulation
establish which tableting machines, encapsulating machines, critical
parts of tableting machines, and critical parts of encapsulating
machines are subject to the registration, recordkeeping, and reporting
requirements under this section, and the form, manner, and information
to be maintained and furnished under such requirements.
``(j) Definitions.--For the purposes of this section:
``(1) Deal.--The term `deal' means to engage in the
business of selling or distributing tableting machines,
encapsulating machines, critical parts of tableting machines,
or critical parts of encapsulating machines at wholesale or
retail.
``(2) Delivery, distribute, destroy, manufacture.--The
terms `deliver', `distribute', `destroy', and `manufacture'
have the meanings given such terms in section 310B.
``(3) Engaged in the business.--The term `engaged in the
business' means devoting time, attention, and labor to dealing
tableting machines, encapsulating machines, critical parts of
tableting machines, or critical parts of an encapsulating
machine as a regular trade or business to predominantly earn a
profit through the repetitive purchase and resale.
``(k) Effective Date.--This section shall apply beginning 120 days
after the date of enactment of this section, except that the Attorney
General may by order published in the Federal Register postpone the
effective date of this section for such period as the Attorney General
may determine to be necessary for the efficient administration of this
Act.''.
SEC. 7. OFFENSES; PENALTIES.
(a) Serial Numbers.--
(1) Prohibited acts b--penalties.--Section 402(a) of the
Controlled Substances Act (21 U.S.C. 842(a)) is amended--
(A) in paragraph (16), by striking ``or'' at the
end;
(B) in paragraph (17), by striking the period at
the end and inserting a semicolon; and
(C) by inserting after paragraph (17) the
following:
``(18) to violate subsection (a) of section 310A;
``(19) to refuse or negligently fail to make a report under
subsection (b) of section 310A;''.
(2) Prohibited acts c--penalties.--Section 403 of the
Controlled Substances Act (21 U.S.C. 843) is amended--
(A) in subsection (a), in each of paragraphs (6)
and (7), by inserting ``critical part of a tableting
machine, critical part of an encapsulating machine,''
after ``encapsulating machine,''; and
(B) by adding at the end the following:
``(g) It shall be unlawful to--
``(1) intentionally remove, alter, or obliterate any serial
number affixed to any tableting machine, encapsulating machine,
critical part of a tableting machine, or critical part of an
encapsulating machine that is required to have a serial number
pursuant to subsection (a) of section 310A, if the person
removing, altering, or obliterating such serial number knows or
has reasonable cause to believe the serial number is so
required;
``(2) transport, ship, receive, or possess any tableting
machine, encapsulating machine, critical part of a tableting
machine, or critical part of an encapsulating machine that is
required to have a serial number pursuant to subsection (a) of
section 310A, if the person transporting, shipping, receiving,
or possessing such a machine or critical part thereof knows
that the serial number has been removed, obliterated, or
altered, and has reasonable cause to believe the serial number
is required pursuant to subsection (a) of section 310A; or
``(3) possess a tableting machine or an encapsulating
machine that is required to have a serial number pursuant to
subsection (a) of section 310A, if the person in possession of
such machine knows that the machine does not have a serial
number, and has reasonable cause to believe the serial number
is required pursuant to subsection (a) of section 310A.
``(h) In a prosecution for an offense under subsection (g)(3), it
is an affirmative defense, as to which the defendant has the burden of
proof by a preponderance of the evidence, that the person possessed the
tableting machine or encapsulating machine on the day before the
effective date of this subsection and, not later than 180 days after
that date, or for such additional period designated by the Attorney
General for good cause, the person--
``(1) sold or otherwise transferred the tableting machine
or encapsulating machine to a manufacturer, importer, exporter,
or dealer of tableting machines or encapsulating machines that
is registered under section 310C(a);
``(2) had a serial number engraved, cast, or otherwise
affixed to a non-removable part of the tableting machine or
encapsulating machine by a manufacturer, importer, exporter, or
dealer of tableting machines or encapsulating machines that is
registered under section 310C(a); or
``(3) destroyed the tableting machine or encapsulating
machine.
``(i) For purposes of this subsection, the term `destroy' has the
meaning given such term in section 310B.
``(j) Subsection (g) does not apply to a manufacturer, importer,
exporter, or dealer of tableting machines or encapsulating machines
that is registered under section 310C(a)(1) or exempt from registration
pursuant to section 310C(a)(2). Subsection (g) shall become effective 2
years after the date of enactment, except that the Attorney General may
by order published in the Federal Register postpone the effective date
of subsection (g) for such period as he may determine to be necessary
for the efficient administration of this Act.''.
(b) Registration of Certain Machines and Parts.--Section 402(a) of
the Controlled Substances Act (21 U.S.C. 842(a)), as amended by
subsection (a), is further amended by inserting after paragraph (19)
the following:
``(20) to violate subsection (a) or (b) of section 310B;
or''.
(c) Registration of Manufacturers, Importers, Exporters, and
Dealers.--Section 402(a) of the Controlled Substances Act (21 U.S.C.
842(a)), as amended by subsections (a) and (b), is further amended by
inserting after paragraph (20) the following:
``(21) to manufacture, import, export, or deal a tableting
machine, encapsulating machine, critical part of a tableting
machine, or critical part of an encapsulating machine without a
registration required by section 310C, except as specified in
subsection (g)(1) of such section.''.
<all>