CONTROLS: SCHEDULED DRUGS/DRUG SCHEDULES, U.S.

The Comprehensive Drug Abuse Prevention and Control Act of 1970, commonly known as the Controlled Substance Act (CSA) establishes the procedures that must be followed by drug manufacturers, researchers, physicians, pharmacists, and others involved in the legal manufacturing of, distributing of, prescribing of, and dispensing of controlled drugs. These procedures provide for accountability for a drug from its initial production through distribution to the patient and are intended to reduce widespread diversion of controlled drugs from legitimate medical or scientific use.

CRITERIA FOR CONTROLLING AND SCHEDULING DRUGS

Several factors are considered before a drug is controlled under this act. These factors include the potential for abuse (i.e., history, magnitude, duration, and significance), risk to public health, and potential of physical or psychological dependence. Drugs controlled under this act are divided into five Schedules (I-V) according to their potential for abuse, ability to produce dependence, and medical utility. Drugs in Schedule I have a high potential for abuse and/or dependence with no accepted medical use or they lack demonstrated clinical safety. Those in Schedules II-V may have a high potential for abuse or ability to produce dependence but also have an accepted medical use. (However, some substances which have no accepted medical use but which are precursors to clinically useful substances may also be found in Schedules II-V. For example, thebaine, found naturally in Opium, has no medical use but it is a substance used in the manufacture of Codeine and a series of potent Opioid compounds as well as opioid Antagonists.) The potential for abuse and the ability to produce dependence is considered to be the greatest for Schedule I and II drugs and progressively less for Schedule III, IV, and V (see Table 1).

The amount of controlled drug in a product can also determine the schedule in which it is placed. For example, Amphetamine, Methamphetamine, and codeine, as pure substances, are placed in Schedule II; however, these same drugs in limited quantities and in combination with a noncontrolled drug are placed in Schedules III and V. Drugs in Schedule V generally contain limited quantities of certain narcotic drugs used for cough and antidiarrheal purposes and can only be distributed or dispensed for medical purposes.

LISTS OF SCHEDULED DRUGS

Drugs controlled under the CSA are listed by schedule and drug class in Table 2 (Schedules I and II) and Table 3 (Schedules III, IV, and V). A listing of controlled chemical derivatives, immediate precursors (chemical which precedes the active drug), and chemicals essential for making a controlled drug, along with drugs exempt from control can be found in the most current edition of the Controlled Substances Handbook. Brand names for drugs in Schedules II-V are not included in the Tables but can also be found in the latest edition of the Controlled Substances Handbook.

PRESCRIBING AND DISPENSING OF CONTROLLED DRUGS

Medical practitioners have to follow specific rules for each schedule when prescribing or dispensing controlled drugs. Drugs in Schedule I can only be obtained, prescribed, and dispensed to an individual after special approval is obtained from the Food and Drug Administration (FDA). Drugs in Schedule II cannot be refilled or dispensed without a written prescription from a practitioner, except in an emergency. When they are dispensed in an emergency, a written prescription must be obtained within 72 hours. Drugs in Schedule III and in Schedule IV may not be dispensed without a written or an oral prescription. Prescriptions for these drugs may not be filled or refilled more than six months after their issue date or refilled more than five times unless authorized by a licensed practitioner. Drugs in Schedule V can be refilled, with a practitioner's authorization, without the limitation on number of refills or time. Certain Schedule V drugs may be purchased directly from a pharmacist, in limited quantities, without a prescription. The purchaser must be at least 18 years of age and furnish appropriate identification and the transactions must be recorded by the dispensing pharmacist.

When drugs in Schedule II, III, and IV are dispensed, a warning label stating "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed," must be affixed to the dispensing container. The warning label regarding transfer does not apply to Schedule V drugs.

REGISTRATION, ORDERING, QUOTAS, AND RECORDS OF CONTROLLED DRUGS

Each individual or institution engaged in manufacturing, distributing, or dispensing any controlled drug must be authorized by and register annually with federal and state drug-enforcement agencies, unless specifically exempted. A unique registration number is assigned to each individual or institution registered under the act. A separate registration is required for practitioners who dispense narcotic drugs to individuals for the purpose of addiction treatment (such as Methadone and LAAM [l-Alpha-Acetylmethadol] for opioid detoxification or maintenance).

All orders for Schedule I and II drugs must be made using a special narcotic order form. Proof of registration is required when ordering Schedule III-V drugs.

Annual production quotas are established for drugs in Schedule I and Schedule II. Everyone registered to handle controlled drugs must maintain records, conduct inventories, and file periodic reports specific to their business or professional activity.

SPECIAL ISSUES

The development of designer drugs has raised many concerns about policing drugs of abuse. Underground chemists who develop designer drugs seek to achieve two results: the creation of marketable drugs that mimic the effects of restricted drugs of abuse; and the creation of drugs that are not specifically listed as controlled substances by the Drug Enforcement Administration. The most popular designer drug of the late 1990s was MDMA (methylenedioxymeth-amphetamine), popularly known as Ecstasy. Despite efforts to evade federal drug laws, the designers of these drugs eventually see them added to the CSA. For example, MDMA was placed on Schedule I on an emergency basis in 1985 because of its neurotoxic effects and abuse potential.

State and local laws either parallel the federal regulations as described by the CSA, or impose additional restrictions. Individuals registered to handle controlled drugs must abide by the law (state or federal) that is most stringent in governing their business or professional activity. Examples where state law may be more stringent than federal law include the requirement for Triplicate Prescription forms or the placing of a drug in a higher schedule.

(See also: Addiction: Concepts and Definitions ; Legal Regulation of Drugs and Alcohol )

BIBLIOGRAPHY

Baumgartner, K., & Hoffman, D. (Eds.) (1993). Schedules of controlled substances. In Controlled substances handbook. Arlington, VA: Government Information Services, J. J. Marshall Publisher.

Code of Federal Regulations (21 CFR Parts 1301-1308). (1992). Food and drugs—Drug Enforcement Administration, Department of Justice. Washington, DC: U.S. Government Printing Office.

Simonsmeier, L. M., & Fink, J. L. (1990). The comprehensive drug abuse prevention and control act of 1970. In A. R. Gennaro (Ed.), Remington's pharmaceutical sciences, 18th ed. Easton, PA: Mack Publishing Company.

White House Office of National Drug Control Policy. (2000). National Drug Control Strategy: 2000 Annual Report. Washington, D.C.

Rolley E. Johnson

Anastasia E. Nasis

Revised by Frederick K. Grittner