On May 1, 1971, the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, more commonly known as the Controlled Substances Act, became effective. This federal law contains 3 different titles. Title I deals with the establishment of rehabilitation programs for drug abusers, Title II addresses the registration and distribution of controlled substances, and Title III discusses issues related to the importation and exportation of controlled substances. The main segment of interest to pharmacists is Title II. This RxLegal column is the first of a 4-part series that provides an overview of key components of this important federal law.

The goal of the Controlled Substances Act is to improve the manufacturing, importation and exportation, distribution, and dispensing of controlled substances.¹ To achieve this goal, manufacturers, distributors, and dispensers of controlled substances must be registered with the Drug Enforcement Administration (DEA), the agency charged with enforcement of the Act on the federal level. Registration of these entities with the DEA results in the formation of a “closed system” for controlled substances distribution. This closed system allows for controlled substances to be traced from initial manufacture to final dispensing to the patient.

Controlled substances are generally defined as medications that are considered easily abusable. Under the Controlled Substances Act, these medications are categorized into 5 schedules. Schedule I medications have the highest abuse potential, while medications in Schedule V have a low abuse potential. In addition to the schedules, the Controlled Substances Act contains information on scheduled listed chemical products or SLCPs. These listed chemicals are products that contain ephedrine, pseudoephedrine, or phenylpropanolamine that may be marketed or distributed legally in the United States as nonprescription drugs.

Today, some states have passed laws allowing for the medical or recreational use of marijuana. However, marijuana remains a Schedule I medication under federal law. In addition, medications may be removed or added to a schedule or be switched from one schedule to another.

The US Attorney General has the authority to add, remove, or switch. The Attorney General works with the Secretary of the Department of Health and Human Services to determine a medication’s schedule.