Summary

Requires new registration, recordkeeping, reporting, serial-numbering, and inspection rules for certain tableting and encapsulating machines and specified "critical parts." Creates a national registry (the National Pill Press Registry), gives the Attorney General authority to define covered machines/parts and to set implementing regulations and fees, and adds new criminal prohibitions and penalties for noncompliance (including removing or possessing machines without required serial numbers). Some provisions take effect within months; others (notably the serial-number ban) are delayed up to two years with narrow compliance/defense windows.

Key Points

• Adds tableting and encapsulating machines and specified 'critical parts' to items subject to federal tracking, reporting, and registration rules.
• Requires permanent serial numbers on covered machines/critical parts and creates a National Pill Press Registry managed by the Attorney General.
• Mandates registration, recordkeeping, and reporting for manufacturers, distributors, importers, exporters, sellers, and others handling covered machines/parts.
• Gives the Attorney General authority to define covered items, set implementing regulations, inspect registrants, assess fees, and suspend or revoke registrations.
• Creates new criminal prohibitions for failing to register/report, removing or possessing machines without required serial numbers, and expands penalties for violations.
• Staggers effective dates: many obligations begin 120 days after enactment (unless delayed), while the serial-number prohibition is delayed up to 2 years.
• Includes a limited affirmative defense and narrow exemptions and provides timelines for compliance actions after registration changes or enforcement.
• Aims to increase traceability of pill-press equipment to deter illicit drug manufacturing while imposing compliance costs on regulated entities.

Categories & Tags