The STOPP Act would broaden the Controlled Substances Act to regulate not only listed chemicals but also critical components of pill-press equipment. Specifically, it designates certain parts of tableting and encapsulating machines as “critical parts,” creates serialization and registration requirements for those machines and parts, and establishes a National Pill Press Registry to track them. The goal is to curb illicit production of opioids and fentanyl by making the sale, transfer, and possession of pill-press equipment more traceable and tightly controlled. The Attorney General would regulate which machines and parts are subject to these rules, set reporting and recordkeeping standards, and enforce penalties for violations. Some provisions would take effect 120 days after enactment, while others (notably certain penalties) have a later timeline. The bill also adds new offenses and penalties tied to serial-number requirements, and allows for suspension of registrations in cases of imminent danger to public health or safety. It creates a framework for annual registrations, inspections, and orderly disposition of equipment when registrations end, and it provides for an affirmative defense in certain pre-enactment possession situations. Overall, it imposes a comprehensive regulatory regime on the manufacture, sale, and movement of tableting/encapsulating machines and their critical parts.
Key Points
- 1Expanded definitions: The bill adds encapsulating machines and “critical parts” of tableting and encapsulating machines to the Controlled Substances Act, with examples like press punches, die systems, hoppers, and other integral parts.
- 2Serialization requirement (310A): Manufacturers, distributors, importers, and exporters must serialize tableting machines and critical parts, permanently mark them with a serial number, and report transactions to the Attorney General as regulations require.
- 3Central registry (National Pill Press Registry) and recordkeeping (310B): Creates a central national registry of serialized machines and parts, with mandatory reporting and records retention to be set by regulation.
- 4Registration program (310C): Requires annual registration for each principal place of business that manufactures, imports, exports, or deals in these machines or parts; allows waivers; sets termination and reassignment rules; authorizes inspections; and enables regulatory oversight and fees.
- 5Enhanced penalties and enforcement (Section 7): Adds criminal penalties for violating serialization and registration rules, including offenses related to removing or altering serial numbers; provides an affirmative defense for certain pre-enactment possession and describes procedures for suspension or denial of registrations in cases of public danger.