Overview of Drug Control: A Regulatory Primer on Scheduling and Controlled Substance Regulations

Identifying the abuse potential of drug products in the premarketing and postmarketing environment has been a critical component in the implementation of drug abuse control laws worldwide. In the US, the Controlled Substances Act of 1970 (CSA) is a comprehensive federal law enacted to prevent the abuse or diversion of substances with abuse liability or addiction potential (for present purposes, these terms are used interchangeably). Under the jurisdiction of the Drug Enforcement Administration, the law applies to the manufacture and distribution of narcotics and other drug substances with potential of abuse. The CSA classifies substances with abuse potential into schedules I-V based on the substance's risk of diversion or abuse, and thus provides a legal framework for the assessment of abuse liability of New Molecular Entities. When the Food and Drug Administration reviews the safety and efficacy of a New Drug Application it also determines whether the drug has potential for abuse, and if so, will begin the process to schedule the drug under the CSA. As the assessment of abuse potential is a critical component of a marketing application, pharmaceutical companies (sponsors) bear the responsibility of generating a comprehensive preclinical and clinical data package for regulators to review and make decisions on labeling and the corresponding postmarketing surveillance. Recent regulatory guidelines adopted in the European Union (EU) (2006), Canada (2007), and USA (2010) provide recommendations to sponsors on preclinical and clinical methodologies for the assessment of abuse potential. This paper reviews the legal framework of the assessment of abuse liability and scheduling of controlled substances in the USA and describes the current global regulatory environment and the challenges that sponsors and regulators face when assessing abuse liability of New Molecular Entities, from the early stages of development through the late stages, review, and approval.

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A Critical Appraisal on Controlled Drugs: Classification, Global Regulatory Provisions, and Distribution

Ranjan,

Gaurav,

Sandeep Patil

et al. 2023

CIS

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Controlled drugs, characterized by their potential for abuse and addiction, require stringent regulation to ensure their safe and appropriate use. This critical appraisal provides a scientifically sound examination of the classification of controlled drugs, global regulatory provisions governing their use, and the challenges associated with their distribution. Due to poor regulation, it is anticipated that 80% of the world’s population will have insufficient access to these painkillers. India needs a more robust enforcement mechanism, with the main goal of ensuring that medications are accessible to patients in need while preventing abuse and trafficking. As a result, studying the topic of “A Regulatory Need of Controlled Drugs” is important, serious, and indispensable. As a result, the authors of the present review discussed numerous regulatory authorities, drug enforcement agencies, and the storage and distribution of banned substances in India. In light of the findings, this review suggests future directions and recommendations. Strengthening international collaboration and information sharing can facilitate the development of more effective regulatory measures. Improved tracking and monitoring systems, incorporating technological advancements, hold promise for enhancing control over the distribution of controlled drugs.

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Overview of Drug Control: A Regulatory Primer on Scheduling and Controlled Substance Regulations

Cited by 3 publications

References 4 publications

Physicians’ knowledge and attitudes toward scheduling

Physicians’ knowledge and attitudes toward scheduling

Principles of assessment of abuse liability

A Critical Appraisal on Controlled Drugs: Classification, Global Regulatory Provisions, and Distribution

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