Chapter 17 - Legal Authority, Medical Basis and Public Policy for Controlling and Scheduling Controlled Substances

Abstract

The protocols for controlling drugs and estimates of United States medical requirements for scheduling drugs arose from the Controlled Substance Act (CSA). The responsibility for controlling and scheduling drugs and other substances is jointly shared by the Drug Enforcement Agency (DEA) expressed through the United States attorney general, and the Food and Drug Administration (FDA) within the Department of Health and Human Services. The FDA assesses the abuse potential through a risk assessment and labeling of abuse/dependence risks, and the DEA issues licenses for controlled substances and manufacturers, sets quotas, and licenses prescribers, and provides law enforcement. The states have the authority to regulate further the use and distribution of substances controlled by the CSA in medical practice, based on their broad police power to protect the public morals, and health and safety afforded by the United States Constitution. The medical basis for scheduling medications is a complex process that focuses on balancing the therapeutic value against the abuse potential of the medications as indicated by the numbered class (CI–V) assigned to the drugs and other substances. Evaluation of data is based on characteristics of the drug, which include chemistry, pharmacology (animal and human), pharmacokinetics and pharmacodynamics, and adverse events reported in clinical trials. The current drug control policy balances the availability for medical use against the prohibition to reduce actual and potential abuse from scheduled medications. The primary methods of reducing the misuse of controlled substances include increased monitoring and restrictions on availability of obtaining controlled substances through illicit and fraudulent means.