SECTION I - INTRODUCTION

This practitioner’s manual is intended to summarize and explain the basic requirements for prescribing, administering, and dispensing controlled substances under the Controlled Substances Act (CSA), 21 USC 801-890, and the DEA regulations, Title 21, Code of Federal Regulations (CFR), Parts 1300 to 1316. Pertinent citations to the law and regulations are included in this manual.

Printed copies of the CFR and the complete regulations implementing the CSA may be obtained from:

Superintendent of Documents
U.S. Government Printing Office
Washington, D.C. 20402

Both the CFR and the Federal Register (which includes proposed and final regulations implementing the CSA) are available on the Internet through the U.S. Government Printing Office (GPO) website. This website, which provides information by section, citation and keywords, can be accessed at:

www.gpoaccess.gov/cfr/index.html

Unofficial copies of pertinent CFR citations may be found at:

www.DEAdiversion.usdoj.gov

This practitioner’s manual may also be found on the Internet at DEA’s Web Site (under "publications"):

www.DEAdiversion.usdoj.gov

Should any pertinent provisions of the law or regulations be modified in the future, DEA will issue a revised electronic version of this document, which will be published on the DEA Diversion Website.

If you encounter errors in this document, please notify:

Editor, DEA Practitioner’s Manual
c/o DEA, Office of Diversion Control
Liaison and Policy Section
Washington, D.C. 20537

Inquiries regarding topics within this document may be addressed to your local DEA field office (listed in Appendix E) or the address above.

All material in this publication is in the public domain and may be reproduced without the express permission of the Drug Enforcement Administration.

Message from the Administrator

The Drug Enforcement Administration is pleased to provide this updated edition of the 1990 Practitioner’s Manual to assist you in understanding your responsibilities under the Controlled Substances Act (CSA) and its implementing regulations. This manual will help answer questions that you may encounter in your practice and provide guidance in complying with federal requirements.

DEA remains committed to the 2001 Balanced Policy of promoting pain relief and preventing abuse of pain medications. In enforcing the CSA, it is DEA’s responsibility to ensure drugs are not diverted for illicit purposes. Unfortunately, this country is now experiencing an alarming prescription drug abuse problem:

• Today, more than 6 million Americans are abusing prescription drugs—that is more than the number of Americans abusing cocaine, heroin, hallucinogens, and inhalants, combined.
• Researchers from the Centers for Disease Control and Prevention report that opioid prescription painkillers now cause more drug overdose deaths than cocaine and heroin combined.
• Today more new drug users have begun abusing pain relievers (2.4 million) than marijuana (2.1 million) or cocaine (1.0 million).

It is more important now than ever to be vigilant in preventing the diversion and abuse of controlled substances. This manual will help you do that by listing some safeguards you can take to prevent such diversion. It also explains registration, recordkeeping, and valid prescription requirements.

As a practitioner, your role in the proper prescribing, administering, and dispensing of controlled substances is critical to patients’ health and to safeguarding society against the diversion of controlled substances. DEA is committed to working jointly with the medical community to ensure that those in need are cared for and that legitimate controlled substances are not being diverted for illegal use.

Karen P. Tandy
Administrator
September 2006

Preface

The Drug Enforcement Administration (DEA) was established in 1973 to serve as the primary federal agency responsible for the enforcement of the Controlled Substances Act (CSA). The CSA sets forth the federal law regarding both illicit and licit (pharmaceutical) controlled substances. With respect to pharmaceutical controlled substances, DEA’s statutory responsibility is twofold: to prevent diversion and abuse of these drugs while ensuring an adequate and uninterrupted supply is available to meet the country’s legitimate medical, scientific, and research needs. In carrying out this mission, DEA works in close cooperation with state and local authorities and other federal agencies.

Under the framework of the CSA, the DEA is responsible for ensuring that all controlled substance transactions take place within the "closed system" of distribution established by Congress. Under this "closed system," all legitimate handlers of controlled substances – manufacturers, distributors, physicians, pharmacies, and researchers – must be registered with DEA and maintain strict accounting for all distributions.

To carry out DEA’s mission effectively, this 2006 Practitioner’s Manual seeks to aid DEA registrants in complying with the CSA and its implementing regulations. The DEA understands that it can best serve the public interest by working with practitioners to prevent diversion of legal pharmaceutical controlled substances into the illicit market.

The federal controlled substances laws are designed to work in tandem with state controlled substance laws. Toward this same goal, DEA works in close cooperation with state professional licensing boards and state and local law enforcement officials to ensure that pharmaceutical controlled substances are prescribed, administered, and dispensed for legitimate medical purposes in accordance with federal and state laws. Within this cooperative framework, the majority of investigations into possible violations of the controlled substances laws are carried out by state authorities. However, DEA also conducts investigations into possible violations of federal law as circumstances warrant.

In the event a state board revokes the license of a practitioner, the DEA will take action and request a voluntary surrender of the practitioner’s DEA registration. If the practitioner refuses to voluntarily surrender the registration, the DEA will pursue administrative action to revoke the DEA registration. The DEA may also pursue judicial action if there is sufficient evidence of illegal distribution or significant recordkeeping violations. All such actions are intended to deny the practitioner the means to continue to divert or abuse controlled substances as well as to protect the health and safety of the public and the practitioner.

The DEA is authorized under federal law to pursue legal action in order to prevent the diversion of controlled substances and protect the public safety. A lack of compliance may result in a need for corrective action, such as administrative action (that is, Letter of Admonition, an informal hearing or "order to show cause"), or in extreme cases, civil, or criminal action.

Table of Contents | Section II

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