H.R. 1100 — STOPP Act

This section establishes the short title as the “Stop the Opioid Pill Presser and Fentanyl Act” or the “STOPP Act.”

This section expands the Controlled Substances Act definitions to cover additional equipment and transactions related to illicit drug manufacturing. It amends 21 U.S.C. § 802 by (1) revising the definition of “machine” in paragraph (38) to include not only an encapsulating machine, but also a critical part of a tableting machine and a critical part of an encapsulating machine; (2) revising paragraph (39)(B) to broaden the definition of “importation” or related conduct to include distribution, receipt, sale, importation, exportation, and international transactions involving shipment of, as well as to include an encapsulating machine, a critical part of a tableting machine, and a critical part of an encapsulating machine; (3) revising paragraphs (42) and (43) to extend the listed-chemical provisions to tableting machines, encapsulating machines, and critical parts of each; and (4) adding a new paragraph (60) defining “critical part” to mean specified integral components of tableting or encapsulating machines, including a press punch, die system, press turret, hopper, compression roller, discharge chute, vacuum system, capsule feeding unit, automatic feeding unit, and any other item identified by regulation by the Attorney General. (Thus, the amendment broadens federal control over equipment used to manufacture controlled substances and related precursor materials.)

This section revises the Controlled Substances Act recordkeeping and reporting requirements for regulated transactions involving tableting machines and encapsulating machines by adding critical parts of those machines to the covered items. It requires regulated persons to keep transaction records in the form and manner prescribed by the Attorney General and to include critical parts of tableting machines and critical parts of encapsulating machines in the required descriptions. It also expands mandatory reports to the Attorney General to cover unusual or excessive loss, disappearance, payment or delivery, and regulated transactions involving critical parts of tableting machines and critical parts of encapsulating machines, in addition to listed chemicals, tableting machines, and encapsulating machines. The amendments apply beginning 120 days after enactment, unless the Attorney General postpones that effective date by order published in the Federal Register for as long as necessary for efficient administration of the Controlled Substances Act.

This section establishes a serialization requirement for tableting machines, encapsulating machines, and critical parts of those machines under the Controlled Substances Act. It requires each manufacturer, distributor, importer, or exporter of such equipment or parts to identify the item by a serial number, when and as required by regulation of the Attorney General, and to engrave, cast, or otherwise permanently affix that number to a non-removable part of the item. It also requires any regulated person who manufactures, distributes, receives, sells, imports, or exports a serialized machine or part to report the transaction to the Attorney General and maintain records of the transaction in the form and manner prescribed by regulation. (Thus, the provision adds traceability requirements for equipment and parts used in tablet and capsule production, which may assist in monitoring diversion of controlled substances.)

This section establishes a registration and reporting regime for tableting machines, encapsulating machines, and their critical parts under the Controlled Substances Act (21 U.S.C. 801 et seq.). It requires each manufacturer, distributor, importer, or exporter of a covered machine or part to register it with the Attorney General when required by regulation, and requires any regulated person who manufactures, distributes, receives, sells, imports, exports, or destroys a covered machine or part to report that activity and maintain records as prescribed by regulation. It directs the Attorney General to issue regulations identifying which machines and parts are subject to these requirements and specifying the information to be reported, including the location of each covered machine or part. It also requires the Attorney General to maintain a central registry of covered machines and parts, to be known as the National Pill Press Registry. The section defines “manufacture,” “distribute,” “deliver,” and “destroy” for purposes of the registry and reporting requirements.

This section establishes a new Controlled Substances Act registration regime for manufacturers, importers, exporters, and dealers of tableting machines, encapsulating machines, and their critical parts under 21 U.S.C. § 310C. It requires annual registration by the Attorney General for any person engaged in manufacturing, importing, exporting, or dealing in those machines or parts, authorizes the Attorney General to waive registration by regulation for certain persons if consistent with public health and safety, and requires separate registrations for each principal place of business. This section terminates a registration when the registrant ceases legal existence, stops engaging in the covered activity, or surrenders the registration, and requires prompt written notice to the Attorney General in those cases. It also limits assignment of a registration to another entity to circumstances approved in writing by the Attorney General and subject to any conditions the Attorney General specifies. This section directs the Attorney General to register an applicant unless registration would be inconsistent with the public interest. In making that determination, the Attorney General must consider five factors: controls against diversion into illegitimate channels, compliance with Federal, State, and local law, prior convictions, past experience in the covered business, and any other relevant public health and safety factors. It further prohibits any person from manufacturing, importing, exporting, or dealing in the covered machines or parts without an active registration, subject to exceptions for agents or employees acting in the usual course of business and for common or contract carriers, warehousemen, and their employees acting in the lawful and usual course of business. This section authorizes the Attorney General to inspect the establishment of a registrant or applicant in accordance with regulations. It also authorizes suspension or revocation of a registration if the registrant materially falsified an application, was convicted of an offense involving the covered machines or parts, or engaged in conduct that would make the registration inconsistent with the public interest. Before denying, suspending, or revoking a registration, the Attorney General must issue an order to show cause stating the basis for the action, citing the laws or regulations allegedly violated, directing the applicant or registrant to appear at a specified time and place, and notifying the person of the opportunity to submit a corrective action plan.

This section expands the prohibited acts under the Controlled Substances Act by adding new offenses related to tableting machines, encapsulating machines, and their critical parts. It adds penalties under 21 U.S.C. § 842(a) for (1) violating section 310A(a), which requires serial numbers on covered machines and parts, (2) refusing or negligently failing to make a report under section 310A(b), (3) violating section 310B(a) or (b), and (4) manufacturing, importing, exporting, or dealing in a tableting machine, encapsulating machine, or covered critical part without the registration required by section 310C, except as otherwise authorized.