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
To amend the Controlled Substances Act to provide for the regulation of critical parts of tableting machines and encapsulating machines, and for other purposes.
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:
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:
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:
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 safetymeans 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.