[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9790 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 9790
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
September 24, 2024
Ms. Stansbury (for herself, Mr. Nickel, Mr. Neguse, Ms. Craig, Mr.
Pappas, Ms. Kuster, Ms. Salinas, Mr. Horsford, Mr. Grijalva, and Ms.
Pettersen) 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.
(a) In General.--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.''.
(b) Technical Corrections.--Section 102 of the Controlled
Substances Act (21 U.S.C. 802), as amended by subsection (a) is further
amended--
(1) by redesignating paragraph (58) (defining the term
``serious violent felony'') as paragraph (59); and
(2) by redesignating the second paragraph (57) (defining
the term ``serious drug felony'') as paragraph (58).
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 3, 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 section 3, 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 regis