Overview
Title
To amend the Controlled Substances Act to provide for the regulation of critical parts of tableting machines and encapsulating machines, and for other purposes.
ELI5 AI
H.R. 9790 is like a rulebook to keep an eye on the special parts of machines that make medicine tablets. It wants to make sure everyone who makes or sells these machine parts follows the rules and writes down what they do, so bad people can't use them to make illegal drugs.
Summary AI
H.R. 9790, also known as the "Stop The Opioid Pill Presser and Fentanyl Act" or the "STOPP Act," aims to amend the Controlled Substances Act to regulate critical parts of machines used in making pills and capsules. The bill enhances recordkeeping, reporting, serialization, and registration requirements for manufacturers and distributors of these machines and their parts, and establishes a National Pill Press Registry. It also introduces penalties for failing to comply with these new regulations, intending to prevent the illicit production of controlled substances like opioids.
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AnalysisAI
Summary of the Bill
House Bill H.R. 9790 is titled the "Stop the Opioid Pill Presser and Fentanyl Act," or the "STOPP Act," and it seeks to amend the Controlled Substances Act to regulate critical parts of tableting and encapsulating machines used in the production of drugs. The bill introduces measures requiring these machines and their critical components to have permanent serial numbers for tracking. It mandates registration of these machines and parts with the Attorney General, who will maintain a National Pill Press Registry. The bill also outlines penalties for tampering with serial numbers and establishes a framework for registration and compliance by manufacturers and distributors.
Significant Issues
Several issues emerge from the bill's text, primarily revolving around the lack of clear definitions and potential regulatory burden. Particularly, the term "critical part" is not clearly defined, leading to potential ambiguity in implementation. The bill grants the Attorney General broad regulatory authority without specific oversight or detailed guidelines, raising concerns about possible overreach and inconsistent enforcement. Additionally, the complex legal terminology and cross-references make the bill challenging to comprehend for non-specialists, possibly leading to misinterpretation and unintentional non-compliance.
Impact on the Public
At its core, the bill aims to curb the illegal production of dangerous drugs like opioids by increasing controls and traceability over machines that could be used unlawfully. While this intent aligns with public health interests, the regulatory framework and administrative burdens imposed by the bill could have broader implications. The impact includes potential increases in the cost of legitimate pharmaceutical manufacturing, which could result in higher drug prices for consumers.
Impact on Stakeholders
Manufacturers and Distributors
For manufacturers, distributors, importers, and exporters of tableting and encapsulating machines, the bill's requirements for serialization, registration, and record-keeping could represent substantial administrative and financial burdens. Smaller companies, in particular, may find it challenging to comply with these new regulations due to potentially high costs and complex compliance requirements. This could stifle innovation and competition within the industry if smaller businesses struggle to meet the new standards or are deterred from entering the market altogether.
Law Enforcement and the Attorney General
The bill places significant responsibilities on the Attorney General and related law enforcement agencies, as they are tasked with crafting regulations, overseeing compliance, and maintaining a comprehensive registry. While this centralization of authority can streamline enforcement, it also carries the risk of transparency and accountability issues if not properly regulated.
Consumers
While the bill's primary focus is on regulation and control, consumers might experience indirect effects. A tighter regulatory environment could lead to higher production costs, which may be passed down in the form of increased drug prices. Conversely, if the bill effectively curtails illegal manufacturing, it could positively impact public health by reducing the availability of illicitly produced drugs and promoting safer pharmaceutical practices.
Overall, while the STOPP Act seeks to address critical issues in the fight against opioid abuse, it presents various implementation challenges and could have wide-ranging effects on diverse groups, from industry participants to the broader public.
Issues
The lack of a clear definition for 'critical part' across multiple sections (Sections 2, 3, 4, 5, 6, 310A, 310B, and 310C) could lead to inconsistent interpretations and enforcement, potentially imposing undue burdens on manufacturers and other stakeholders.
The extensive regulatory authority granted to the Attorney General (Sections 2, 3, 4, 5, 6, 310B, 310C) without detailed guidelines or oversight mechanisms raises concerns about potential overreach and inconsistency in application, affecting fairness and transparency.
The requirement for perpetual serialization and reporting (Sections 4 and 310A) may impose significant administrative burdens on manufacturers, distributors, importers, and exporters, potentially deterring business operations and innovation.
The designation of record-keeping and reporting requirements without specific guidance (Sections 3, 4, 5, 6, 310A, 310B, 310C) could lead to confusion and non-compliance, especially for small businesses.
The potential administrative cost of establishing and maintaining a National Pill Press Registry (Section 5, 310B) without clear justification of its necessity could result in government overspending without corresponding benefits.
The ability for the Attorney General to waive registration requirements (Section 6, 310C) without specifying clear criteria or transparency mechanisms raises the risk of favoritism or lack of oversight, potentially impacting equitable application of the law.
The bill entails substantial requirements for registration, serialization, and compliance (Sections 4, 5, 6, 310A, 310B, 310C), which could place a significant financial burden on smaller companies or new market entrants, potentially stifling competition.
The complex legal language and cross-references (throughout the bill and in Section 7) make the bill difficult to understand, potentially leading to misinterpretation and unintentional non-compliance.
The absence of specific penalties or enforcement mechanisms for non-compliance in certain sections (Sections 4, 5, 6, 310A, 310B, 310C) may undermine the bill's efficacy and the deterrence of illegal activities related to tableting and encapsulating machines.
Sections
Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.
1. Short title Read Opens in new tab
Summary AI
The section provides the short title of the Act, which can be referred to as the “Stop The Opioid Pill Presser and Fentanyl Act” or simply the “STOPP Act.”
2. Definitions Read Opens in new tab
Summary AI
This section amends the Controlled Substances Act to expand the definition of equipment involved in drug manufacturing to include critical parts of tableting and encapsulating machines, such as press punches and die systems, and makes technical corrections by renumbering two terms related to serious felonies.
3. Regulated transactions of critical parts Read Opens in new tab
Summary AI
The section amends the Controlled Substances Act to include critical parts of tableting and encapsulating machines in the record-keeping and reporting requirements for regulated transactions. These changes, which become effective 120 days after the law is enacted, aim to improve oversight and control of equipment potentially used to unlawfully produce controlled substances.
4. Serialization of certain machines and parts Read Opens in new tab
Summary AI
The Serialization of Certain Machines and Parts section mandates that manufacturers, distributors, importers, and exporters must label tableting and encapsulating machines, or their critical parts, with a permanent serial number as per regulations. Additionally, transactions involving these serialized machines or parts must be reported to the Attorney General and properly documented.
310A Serialization of certain machines and parts Read Opens in new tab
Summary AI
Manufacturers, distributors, importers, or exporters of tableting and encapsulating machines and their critical parts must assign a permanent serial number to each item as required by the Attorney General's regulations. Additionally, anyone involved in the production or trade of these machines or parts must report each transaction to the Attorney General and keep records in a specified format.
5. Registration of certain machines and parts Read Opens in new tab
Summary AI
The section outlines regulations requiring the registration and reporting of machines used for making pills and their critical parts, with those involved in manufacturing, distributing, or destroying such machines needing to register and report these activities to the Attorney General. It also establishes a national registry for these machines and defines terms like "manufacture," "distribute," and "destroy" related to the machines.
310B. Registration of certain machines and parts Read Opens in new tab
Summary AI
The section requires manufacturers, distributors, importers, or exporters of certain machines and parts used in creating pills to register and report these items to the Attorney General. The Attorney General will maintain a national registry and is responsible for setting rules about which items need to be registered and how they should be reported.
6. Registration of manufacturers, importers, exporters, and dealers of tableting machines, encapsulating machines, and critical parts Read Opens in new tab
Summary AI
The section outlines the requirements for the registration of manufacturers, importers, exporters, and dealers of tableting and encapsulating machines and their critical parts. It explains the necessity for these entities to register annually with the Attorney General, the conditions under which registrations can be denied, revoked, or suspended, and details the responsibilities regarding record-keeping and reports, emphasizing public safety and regulatory compliance.
310C. Registration of manufacturers, importers, exporters, and dealers of tableting machines, encapsulating machines, and critical parts Read Opens in new tab
Summary AI
This section requires manufacturers, importers, exporters, and dealers of tableting and encapsulating machines and their critical parts to register with the Attorney General annually. It outlines the conditions under which the registration can be waived, terminated, or reassigned, and sets forth the factors the Attorney General must consider in granting registration, including public interest and past compliance with laws. It also permits inspections, mandates recordkeeping, and provides for fees and regulations by the Attorney General to ensure the control of these machines, all active 120 days after enactment unless postponed.
7. Offenses; penalties Read Opens in new tab
Summary AI
This section of the bill makes it illegal to tamper with serial numbers on certain machines used in making drugs and mandates registration for dealing with these machines. It also establishes penalties for violating these rules and provides a defense for those who lawfully possessed the machines before the rules take effect.