Controlled Substances Security Manual
Application of State and Federal Law
Nothing in this manual shall be construed as authorizing or permitting any person to do any act which is not authorized of permitted under other Federal or state laws. In addition, none of the policy and information in this manual may be construed as authorizing or permitting any person to do any act in violation of Title 21, Chapter II of the Code of Federal Regulations (21 CFR Part 1300 to End). Printed copies of the complete regulations implementing the Controlled Substances Act of 1970 may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. Proposed and finalized amendments to the regulations are published in the Federal Register.
In many cases state law is more stringent than Federal law and must be complied with in addition to Federal law. This manual is an informational outline of Federal law covering specific security situations as set forth in the Federal Regulations.
DEA is the lead Federal law enforcement agency responsible for enforcing the Controlled Substances Act (CSA). Established in 1973, DEA was the product of a merger of the Bureau of Narcotics and Dangerous Drugs, the Office for Drug Abuse Law Enforcement, the Office of National Narcotic intelligence, elements of the Bureau of Customs, and those functions of the Office of Science and Technology which were drug enforcement-related. In carrying out its mission, DEA cooperates with other Federal agencies, state, local, and foreign governments, private industry, professional groups, and other organizations.
Between 1914 and 1970, Congress enacted more than 50 pieces of legislation relating to the control and diversion of drugs. Most of these diverse laws were gathered into one piece of legislation, the CSA, which became effective May 11, 1971. A key element of this law is to improve control over the manufacture, distribution, and dispensing of controlled substances by providing a "closed" system for legitimate handlers of these drugs. Such a closed system deters the diversion of these drugs out of legitimate channels into illicit markets.
The information presented here should acquaint drug handlers with security requirements set up under the CSA, the Diversion Control Amendments of the Comprehensive Crime Control Act 1984, and the Code of Federal Regulations.
The drugs and drug products, i.e. controlled substances, that come under the jurisdiction of the CSA are divided into five schedules. Some examples in each schedule are outlined below. For a complete listing of controlled substances contact any DEA Diversion-Staffed Domestic Field Office.
The CSA places each controlled substance—drug or other substance—into one of five schedules based on the substance’s medical use, potential for abuse, and safety or dependence liability. The Act also allows substance to be added to or removed from a schedule, and to be rescheduled or transferred from one schedule to another. The basis upon which substances are placed into each of the five schedules is explained below, and examples of drugs’ or other substances within the schedules are listed.
Schedule I (CI) Substance
The controlled substances in this schedule are those that have no accepted medical use in the United States (U.S.), are not accepted as safe for use under medical supervision,and have a high abuse potential. Some examples are heroin, marijuana, LSD, peyote, mescaline, psilocybin, MDA, MDMA, ketobemidone, acetylmethadol, fenethylline, tilidine, methaqualone, and certain fentanyl and merperidine analogs.
Schedule II (CII) Substances
The controlled substances in this schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the U.S. CII controlled substances consist of certain narcotic, stimulant, and depressant drugs. Some examples of CII narcotics are: opium, morphine, codeine, hydromorphone (Dilaudid)1, methadone, meperidine (Demerol), cocaine, oxycodone (Percodan), anileridine (Lertine), the immediate precursor phenylacetone (P-2-P), and oxymorphine (Numorphan). Also in CII are the stimulants amphetamine (Dexedrine), methamphetamine (Desoxyn), phenmetrazine (Preludine), and methylphenidate (Ritalin); the depressants amobarbital, pentobarbital, secobarbital; and fentanyl (Sublimaze), etorphine hydrochloride, and phencyclidine (PCP).
Schedule III (CIII) Substances
The controlled substances in this schedule have an abuse potential and dependence liability less than those in CI and CII, and have an accepted medical use in the U.S. They include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.
Schedule IV (CIV) Substances
The controlled substances in this schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the U.S. They include such drugs as: barbital, phenobarbital, methylphenobarbital, chloral hydrate, ethchlorvynol (Placidyl), ethinamate, (Valmid), paraldehyde, methohexital, fenfluramine, diethylproprion, phentermine, chlordiazepoxide (Librium), diazepam (Valium), oxazepam (Serax), clorazepate (Tranxene), flurazepam (Dalmane), lorazepam (Ativan), alprazolam (Xanax), temazepam (Restoril), triazolam (Halcion), mebutamate, dextropropoxyphene (Darvon), and petazocine (Talwin).
Schedule V (CV) Substances
The controlled substances in this schedule have an abuse potential and dependence liability less than those listed in CIV and have an accepted medical use in the U.S. They are often available without prescription, and include preparations containing limited quantities of certain narcotic drugs generally for antitussive and antidiarrheal purposes. Buprenorphine is also a CV drug.
1. Examples of trademark products appear in parentheses. Scheduling applies to all similar drug products of all other pharmaceutical manufactures within each generic drug classification.