Abuse deterrent formulations and the Controlled Substances Act (CSA)

Area of Science:

• Pharmacology and Toxicology
• Drug Policy and Regulation
• Public Health

Background:

• The Controlled Substances Act (CSA) has historically curbed drug diversion at manufacturing and distribution levels.
• Recent trends indicate a significant increase in controlled substance diversion occurring at the retail level.
• Drug diversion and abuse patterns often correlate with medical availability, influenced by product formulation and risk management.

Purpose of the Study:

• To explore the potential of abuse-deterrent formulations (ADFs) in mitigating controlled substance diversion and abuse at the retail level.
• To analyze factors influencing the development and implementation of ADFs, including industry incentives and regulatory considerations.
• To examine the feasibility and challenges of differential scheduling of controlled substances under the CSA based on product formulation.

Main Methods:

• Review of existing literature on controlled substance diversion, abuse patterns, and the efficacy of abuse-deterrent formulations.
• Analysis of the Controlled Substances Act (CSA) provisions related to scheduling and risk management strategies.
• Examination of factors influencing the development and adoption of abuse-deterrent formulations by the pharmaceutical industry.

Main Results:

• Abuse-deterrent formulations can reduce abuse and associated adverse health outcomes, irrespective of product diversion.
• Development of ADFs requires careful consideration of diverse abuse methods, including manipulation of dosage, route, and combination with other substances.
• Industry incentives for developing ADFs include enhanced corporate image and potential for less stringent regulatory controls.

Conclusions:

• Abuse-deterrent formulations represent a promising strategy to combat the rising tide of retail-level controlled substance diversion and abuse.
• Differential scheduling under the CSA, based on product formulation, presents legal, scientific, and regulatory challenges that require thorough investigation.
• Addressing issues such as legal authority, standard scheduling criteria, predictive data, and international obligations is crucial before implementing differential scheduling.