The Controlled Substances Act (CSA), officially known as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the primary U.S. federal law for drug policy that regulates the manufacture, importation, possession, use, and distribution of certain substances. It was enacted on October 27, 1970, and became effective on May 1, 1971. The CSA has three titles, with Title II being of most interest to pharmacists.
Purpose and Scope
The CSA aims to control drug abuse and dependence by regulating controlled substances. It consolidates and expands existing federal drug laws, influences drug law policies, and broadens federal law enforcement related to controlled substances. The CSA serves as the national legislation implementing international drug control treaties.
Key Components
- Drug Scheduling: The CSA establishes five schedules (I-V) for classifying drugs based on their medical use, potential for abuse, and safety or dependence liability.
- Registration: Manufacturers, distributors, and dispensers of controlled substances must register with the Drug Enforcement Administration (DEA).
- Closed System: DEA registration creates a "closed system" for controlled substance distribution, enabling tracking from manufacture to dispensing.
- Controlling Substances: The CSA provides a mechanism for adding, deleting, or changing the schedule of a drug. The DEA, Department of Health and Human Services (HHS), or any interested party can initiate these proceedings.
Drug Schedules
The CSA classifies drugs into five schedules based on their potential for abuse, accepted medical use, and safety/dependence liability.
| Schedule | Potential for Abuse | Accepted Medical Use | Potential for Dependence | Examples |
|---|---|---|---|---|
| I | High | None | Very high; not safe for use, even under medical supervision | Heroin, LSD, marijuana (at the federal level), ecstasy, peyote |
| II | High | Yes, sometimes with severe restrictions | High, if abused | Cocaine, methamphetamine, oxycodone, fentanyl, Adderall, Ritalin |
| III | Medium | Yes | Moderate physical or high psychological dependence, if abused | Tylenol with codeine, ketamine, anabolic steroids, testosterone |
| IV | Low | Yes | Possible moderate mental or physical dependence, if abused | Xanax, Soma, Valium, Ambien, Ativan, Tramadol |
| V | Lowest | Yes | Possible mild dependence, if abused | Robitussin AC, Lomotil, Lyrica |
DEA and Enforcement
The DEA enforces the CSA, investigates drug-related matters, and collaborates with federal, state, local, and foreign entities. They also oversee legally produced controlled substances.
Factors for Scheduling
When determining the appropriate schedule, the DEA and HHS consider these factors:
- Potential for abuse
- Scientific evidence of pharmacological effect
- Current scientific knowledge
- History and current pattern of abuse
- Scope, duration, and significance of abuse
- Risk to public health
- Psychic or physiological dependence liability
- Whether the substance is an immediate precursor of a controlled substance
Amendment of Schedules
The process to add, delete, or change a drug schedule can be initiated by the DEA, HHS, or any interested party. The DEA investigates the drug, and the HHS provides a medical and scientific evaluation. The DEA Administrator then makes the final decision.
Treaty Obligations
The CSA aims to align U.S. drug laws with international treaties, such as the UN Single Convention on Narcotic Drugs. The Secretary of HHS has influence over drug scheduling proposals under the Single Convention, with the power to evaluate proposals and furnish recommendations to the Secretary of State.
Recent & Proposed Changes
- Marijuana Rescheduling: The DEA is currently reviewing a proposal to reschedule marijuana from Schedule I to Schedule III, following a recommendation from HHS. Public comments were being accepted until July 22, 2024, with a decision expected thereafter.
- Tianeptine Regulation: There are increasing calls for Tianeptine, often called "gas station heroin", to be listed as a controlled substance due to its potential for abuse and harmful side effects.
Criticisms and Concerns
- Effectiveness: Critics debate whether CSA classifications effectively prevent drug use or create barriers to legitimate medical access.
- Definition of Abuse: Concerns exist regarding the lack of a concrete definition of "drug abuse" in the CSA, which can affect drug scheduling.
- Racial Disparities: Some suggest the CSA's origins are rooted in racial biases, particularly concerning cannabis and its association with specific ethnic groups.
- State vs. Federal Conflicts: Conflicts arise between state laws legalizing marijuana and its Schedule I status under federal law, impacting banking access and tax deductions for cannabis businesses.
Key Federal Legislation Related to Drug Control
- Pure Food and Drug Act of 1906: Requires labeling of ingredients in medicines.
- Harrison Narcotics Tax Act of 1914: Regulates and taxes the production, importation, and distribution of opiates and coca products.
- Marihuana Tax Act of 1937: Effectively outlawed cannabis at the federal level.
- Controlled Substances Act of 1970: Established the five drug schedules and the DEA.