Introduction to the Controlled Substance Schedules and the History of Drug Control in the United States
Many Americans understand that certain types of prescription medications are subject to additional controls. Drug control in the United States has transformed over time into the current Controlled Substances Act (CSA). Changes were made to promote public health and safety, including the establishment of a formal consolidated law enforcement framework. The current schedules and examples of drugs are listed below.
- Schedule I: High abuse potential, no accepted medical use (e.g., heroin, LSD, marijuana*, Ecstasy aka MDMA, Peyote). Cannot be prescribed.
- Schedule II: High abuse potential, accepted medical use with restrictions (e.g., morphine, oxycodone, amphetamines, Adderall, Ritalin, fentanyl).
- Schedule III: Moderate abuse potential (e.g., ketamine, anabolic steroids, testosterone, Tylenol w/codeine).
- Schedule IV: Low abuse potential (e.g., benzodiazepines like Xanax and Valium, Ambien, tramadol).
- Schedule V: Lowest abuse potential (e.g., cough preparations with more than 200mg of codeine, Robitussin AC, Lyrica, Lomotil.)
Why is marijuana listed as a Schedule I Drug? I thought it was legal.
Marijuana or cannabis is currently classified as a Schedule I controlled substance under the CSA. The Supremacy Clause of the Constitution holds that Federal law is the “supreme Law of the Land.” However, since 2014, Congress has annually passed an appropriations rider (a.k.a., the Rohrabacher-Farr Amendment) that explicitly prohibits the Department of Justice from spending any funds to interfere with the implementation of state medical cannabis laws. The removal of cannabis for Schedule I of the CSA is currently under consideration. There are proposals to reschedule it to a Schedule III controlled substance, recognizing its medical use and lower potential for abuse. Even though the majority of states have changed their marijuana laws to allow for medical and/or recreational use, the only way to change scheduling at the Federal level is through formal rulemaking. You can read the Notice of Proposed Rulemaking that was published in the Federal Register on May 21, 2024.
DEA-registrants should be wary of handing marijuana if it is not listed or allowed under their registration. This is particularly true for DEA-registered retail pharmacies. Case in point, the State of Georgia approved a medical marijuana program in 2023, which allowed pharmacies to start dispensing marijuana to registered patients in the state. Retail pharmacies are registered to handle Schedule II-V controlled substances, not Schedule I. DEA responded to Georgia’s program with the following: “All DEA registrants, including DEA-registered pharmacies, are required to abide by all relevant federal laws and regulations. A DEA-registered pharmacy may only dispense controlled substances in Schedules II-V of the Controlled Substances Act. Neither marijuana nor THC can lawfully be possessed, handled, or dispensed by any DEA-registered pharmacy.”
Stay tuned for a more detailed blog post on marijuana.
A great online resource for verifying a drug’s schedule is the Orange Book. DEA publishes an updated version every year. Some substances, such as controlled substance analogues, might not be listed. You can contact the DEA’s Drug and Chemical Evaluation Section at DRE@dea.gov.
History of Drug Control in the United States
How did the U.S. get to the current CSA? Below is the timeline of drug control in the U.S. and its participation in various international conventions. Also included is information on the Federal agencies that enforce drug laws.
| Year | Historical Act | What the Act Implemented |
|---|---|---|
| 1820 | Formation of the U.S. Pharmacopeia by a small group of physicians concerned about dangers of poor-quality medicines. | Independent, scientific, non-profit organization focused on building trust in the supply of safe, quality medicines. |
| 1848 | Drug Importation Act | Required the U.S. Customs Service to inspect shipments to stop the entry of adulterated drugs from overseas. |
| 1902 | Brussels Conference | Unification of Pharmaceutical standards, including unified nomenclature and standardized formulation of 49 pharmaceutical preparations. |
| 1906 | Pure Food and Drug Act | Regulates labeling of products containing certain drugs, including cocaine and heroin. |
| 1914 | Harrison Narcotics Tax Act | Regulates opiates and cocaine. |
| 1922 | Narcotic Drugs Import and Export Act | Shifted drug control to the Federal level with the establishment of the Federal Narcotics Control Board. The FNCB oversaw the import and export of opiates and other psychoactive substances for medical purposes. |
| 1925 | Brussels Pharmacopoeia Agreement | Revised the 1902 Agreement, expanded the list of standardized formulations to 77 pharmaceutical preparations; stipulated that the League of Nations would be responsible for producing a unified list. |
| 1930 | The Federal Bureau of Narcotics established | An agency of the U.S. Department of Treasury. Investigated drug trafficking and carried out operations and missions around the world. Pre-cursor to DEA. |
| 1937 | Marihuana Tax Act | Required the taxation of marijuana. |
| 1938 | Food Drug & Cosmetic Act | The FDA was given control over drug safety. Establishes class of drugs available by prescription. |
| 1942 | Opium Poppy Control Act | Regulated the growth of opium poppy and prohibited private cultivation in most states. |
| 1951 | Durham-Humphrey Amendment | Established specific guidelines for prescription drugs: habit forming, safety, and evaluation of new drugs. |
| 1951 | Boggs Amendment to the Harrison Narcotics Tax Act | Established mandatory sentences for narcotics violations. |
| 1956 | Narcotics Control Act | Enacted to amend the tax code and the Narcotic Drugs and Import-Export Act, enhancing control over narcotic drugs and marijuana. |
| 1961 | Single Convention on Narcotic Drugs | U.S. participated in ratifying this international treaty to control marijuana; prompted the creation of the International Narcotics Control Board. |
| 1965 | Drug Abuse Control Amendments (DACA) | Added strict controls over amphetamines, barbiturates, LDC, etc. |
| 1966 | Narcotic Addict Rehabilitation Act (NARA) | Allows treatment as an alternative to jail. |
| 1966 | The Bureau of Drug Abuse Control (BDAC) was established. | This unit was created within the FDA with 100 agents. |
| 1968 | The Bureau of Narcotics and Dangerous Drugs (BNDD) was established. | Consolidated the Federal Bureau of Narcotics and the BDAC into the BNDD. BNDD was reinstated under the Department of Justice. |
| 1970 | Controlled Substances Act | Created a scheduling list for drugs that have a potential for abuse, including drugs that have an accepted medical purpose. |
| 1972 | Drug Abuse Office and Treatment Act | Establishes federally funded programs for prevention and treatment. |
| 1973 | The DEA was established | Remodeled the BNDD into the DEA. |
| 1973 | Methadone Control Act | Regulates Methadone licensing. |
| 1980 | Drug Abuse Prevention, Treatment and Rehabilitation Amendments | Extended prevention, education, and treatment programs. |
| 1984 | Drug Offenders Act | Established special programs for offenders and organized treatment. |
| 1986 | Designer Drug Act | Adds analogues of illegal substances to the CSA. |
| 1988 | Anti-Drug Abuse Act | Established mandatory minimum sentences based on the type and weight of the controlled substance involved. The Office of National Drug Control Policy was created. |
| 1992 | ADAMHA Reorganization | Incorporated ADAMHA programs into the Substance Abuse and Mental Health Services Administration (SAMHSA). |
| 2000 | Drug Addiction Treatment Act (DATA 2000) | Enacted to address the growing opioid crisis. Allowed qualified practitioners (known as DATA-waived practitioners) to treat addiction with CIII-V FDA-approved medications, primarily buprenorphine. |
| 2016 | Comprehensive Addiction and Recovery Act (CARA) | Expanded prevention and education efforts and promoted treatment and recovery. Allowed additional types of practitioners to write prescriptions for buprenorphine. |
| 2018 (reauthorized in 2025) | Substance Use-Disorder Prevention that Promotes Opioid Recovery & Treatment (SUPPORT) for Patients and Communities Act of 2018 | Response to opioid epidemic. Allows pharmacies to deliver implantable and injectable controlled substances used for OUD to the administering or prescribing practitioner. |
The CSA is the modern-day framework for drug control, making certain drugs illegal for any type of use, while placing recordkeeping and security controls on other medically necessary controlled substances. The CSA also provides a framework for handling medications for opioid use disorder (MOUD) alongside recent changes to treatment and recovery efforts.
Most of the scheduled controlled substances will remain as currently scheduled on the controlled substances list. Sometimes a new drug needs to be added, more commonly an analog of a currently scheduled controlled substance. There may be times when a drug needs to be removed from scheduling or changed to a different schedule. Below are the different ways this can happen:
- DEA publishes a Notice of Proposed Rulemaking in the Federal Register inviting public comments; if no hearing is requested, DEA finalizes the decision based on those comments.
- DEA seeks a scientific and medical evaluation from Health and Human Services (HHS), whose findings are binding. The DEA Administrator uses this information to determine whether the drug should be scheduled or removed from control.
- Congress can also schedule substances through legislation, or the Attorney General can schedule substances via an administrative process outlined in the CSA.
- Under the CSA, anyone can ask the DEA to change how a controlled substance is classified. This includes individuals, organizations, and even state governments. Here’s how the process works:
- Submit a request: You provide scientific, medical, and legal reasons for why the drug should be moved to a different category.
- DEA review: The DEA looks at your request and asks the Department of Health and Human Services (HHS) for a detailed scientific review.
- Scientific analysis: HHS conducts an eight-factor analysis, like how likely the drug is to be abused, its risks to public health, and whether it can cause dependence.
- Public input and decision: If the evidence supports rescheduling, the DEA starts a formal process that includes public comments before making a final decision. 21 CFR 1308.43(a).
Need Help with Drug Enforcement Administration Compliance?
If you are concerned about your pharmacy’s DEA compliance, contact Brinks DEA Consulting. We can guide you through corresponding responsibility, DEA recordkeeping, and comprehensive compliance strategies to keep your pharmacy audit-ready and protected.
Brinks DEA Consulting offers expert guidance on controlled substance compliance and regulatory strategy, informed by prior DEA experience but unaffiliated with the agency. We do not provide legal services; for legal advice, please consult a licensed attorney.