FR 2021-04242

Overview

Title

Schedules of Controlled Substances: Temporary Placement of Brorphine in Schedule I

Agencies

ELI5 AI

The government made a rule to keep a very dangerous drug called brorphine away because it can hurt people. This drug is like a super strong painkiller that can make people very sick, so they put strict rules on it to keep everyone safe.

Summary AI

The Drug Enforcement Administration (DEA) temporarily placed a substance called brorphine in Schedule I of the Controlled Substances Act due to its high potential for abuse, lack of accepted medical use, and potential danger to public safety. This action means strict regulatory controls are now in place regarding the manufacturing, distribution, and possession of brorphine. The DEA found brorphine on the illicit market in several countries and associated it with several fatalities in the U.S. Brorphine is a synthetic opioid with effects similar to fentanyl, which poses significant health risks and has been linked to the ongoing opioid epidemic. This temporary scheduling will last for two years and can be extended for an additional year.

Abstract

The Acting Administrator of the Drug Enforcement Administration is issuing this temporary order to schedule 1-(1-(1-(4- bromophenyl)ethyl)piperidin-4-yl)-1,3-dihydro-2H-benzo[d]imidazol-2-one (commonly known as brorphine), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act . This action is based on a finding by the Acting Administrator that the placement of brorphine in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle brorphine.

Type: Rule
Citation: 86 FR 11862
Document #: 2021-04242
Date:
Volume: 86
Pages: 11862-11867

AnalysisAI

The document under review is a rule from the Drug Enforcement Administration (DEA), temporarily placing the substance known as brorphine into Schedule I of the Controlled Substances Act. This decision was influenced by findings of brorphine's high potential for abuse, lack of medical use, and immediate public safety concerns. The placement in Schedule I imposes strict controls on the handling of this substance.

General Summary

The primary purpose of this DEA rule is to control the distribution and use of brorphine, a synthetic opioid that has emerged on the illicit drug market. This action is driven by the potential hazards that brorphine presents, as it has effects similar to fentanyl, a potent opioid often linked to the ongoing opioid epidemic. The scheduling of brorphine in Schedule I will last for two years and may extend for another year, restricting its possession, sale, and manufacture in the United States.

Significant Issues or Concerns

Several issues arise from this document:

  1. Complex Chemical Language: The document uses technical chemical nomenclature, such as 1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-yl)-1,3-dihydro-2H-benzo[d]imidazol-2-one, which might not be accessible to general readers.

  2. Medical Use Criteria: The criterion for a drug to have a "currently accepted medical use" is briefly mentioned but not fully explained, leaving gaps that might confuse readers unfamiliar with regulatory requirements.

  3. Varied Data Sources: The DEA relies on multiple reports and studies for its decision. Differences in methodologies across these sources might result in inconsistencies, lacking reconciliation in the document.

  4. Legal and Procedural Jargon: The document is heavily laden with legal jargon related to U.S. law, specifically the Controlled Substances Act, which can be daunting for readers without prior legal background.

  5. Implied Knowledge: It assumes the reader has an existing understanding of how scheduling decisions are made, which may not be the case for everyone.

Impact on the Public

Broad Impact

The scheduling of brorphine as a Schedule I substance means that the general public will face tight restrictions on any potential use or exposure to this drug. It helps mitigate health risks associated with widespread opioid abuse, thereby contributing to public safety. However, it also eliminates any potential exploration of therapeutic uses of brorphine, should such possibilities exist.

Impact on Specific Stakeholders

  • Law Enforcement and Regulators: Law enforcement agencies will have clear directives to control the manufacture and distribution of brorphine, aiding in the broader fight against drug abuse.

  • Healthcare Professionals and Researchers: Medical and scientific communities may find the temporary scheduling restrictive if they are exploring any potential legitimate uses for brorphine, as further approval is required for legal use in research or medical settings.

  • Communities Affected by Drug Abuse: Communities plagued by opioid abuse could benefit as access to another potentially dangerous opioid is curtailed. However, individuals with substance use disorders may find the emergence of brorphine on the illicit market complicating their recovery efforts due to its harmful effects.

In conclusion, the DEA's temporary scheduling of brorphine as a Schedule I substance is a significant action reflecting ongoing efforts to curb the opioid crisis. While it poses challenges for certain sectors, it aligns with public health objectives in minimizing the potential negative impact of synthetic opioids.

Financial Assessment

The document addresses the temporary scheduling of a synthetic opioid, brorphine, into Schedule I of the Controlled Substances Act by the Drug Enforcement Administration (DEA). While primarily focused on legal and regulatory aspects, there is an implicit financial dimension related to potential regulatory impacts on various sectors.

One critical point is the discussion regarding E.O. 12866, which outlines what constitutes a "significant regulatory action." For a regulation to be classified as significant, it should potentially "have an annual effect on the economy of $100 million or more; adversely affect the economy, productivity, competition, jobs, environment, public health or safety; or influence state, local, or tribal governments and communities." However, the document explicitly states that the temporary scheduling action on brorphine does not meet this threshold. This statement indicates that, from the DEA's perspective, the financial impact of this temporary scheduling is not substantial enough to disrupt the economy or particular sectors critically.

In connection to the identified issues, the use of complex chemical nomenclature and potential inconsistencies in data sources do not directly relate to these financial thresholds. However, one might consider how the public health and safety concerns addressed by legal actions like these could indirectly affect financial areas previously mentioned, such as public health costs, legal enforcement expenditures, and economic productivity. By placing brorphine temporarily in Schedule I, the DEA aims to mitigate potential public health crises which, if not addressed, could lead to significant economic burdens, particularly in healthcare systems through increased emergency treatment demands and drug rehabilitation needs.

The discussion on the temporary nature of this scheduling action also highlights the aspect of fiscal responsibility. It underscores the attempt to balance regulatory actions without causing immediate large-scale economic consequences. By preventing uncontrolled distribution and minimizing public health risks through this measure, potential future financial strains, such as those associated with widespread drug abuse and related social services demands, may be alleviated.

The document does not involve direct spending, appropriations, or detailed financial allocations but makes clear the regulatory action's economic rationale is rooted in prevention rather than immediate fiscal intervention or support. Understanding these regulatory measures within the broader economic context helps highlight the nuanced approaches government agencies take concerning potentially hazardous substances while being mindful of broader financial implications.

Issues

  • • The document uses complex chemical nomenclature (1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-yl)-1,3-dihydro-2H-benzo[d]imidazol-2-one) which may not be easily understood by general readers.

  • • The text mentions the necessity of a five-part test for a drug to have a currently accepted medical use, which could benefit from more detailed explanation.

  • • The reliance on multiple sources and reports may lead to potential inconsistencies if those data sources have different standards or methodologies that aren't reconciled here.

  • • The legal and procedural language regarding the CSA and DEA procedures can be difficult to follow without specific prior knowledge of U.S. law.

  • • The document assumes some implicit knowledge about the Controlled Substances Act and how scheduling decisions are typically made, which might not be clear to all readers.

Statistics

Size

Pages: 6
Words: 6,116
Sentences: 215
Entities: 524

Language

Nouns: 1,880
Verbs: 451
Adjectives: 501
Adverbs: 95
Numbers: 361

Complexity

Average Token Length:
5.02
Average Sentence Length:
28.45
Token Entropy:
5.86
Readability (ARI):
20.25

Reading Time

about 23 minutes