Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Narcotic Treatment Programs Best Practice Guideline

TABLE OF CONTENTS

MESSAGE FROM THE ADMINISTRATOR
PREFACE
ORGANIZATION OF THE GUIDELINES
ACKNOWLEDGMENTS


Message from the Administrator

The Drug Enforcement Administration (DEA) is pleased to provide this guideline to assist in the understanding of the provisions of the Controlled Substances Act of 1970 (CSA) and in the implementation of the regulations as they apply to dosage reconciliation practices in narcotic treatment programs (NTPs). These guidelines should answer many of the questions that treatment programs have and should provide guidance to assist programs in complying with the regulations.

The NTP's role in the proper handling of controlled substances is critical both to the health of patients and to safeguarding against drug abuse and diversion. Programs' adherence to the law and understanding of the law's objectives play a valuable role in the protection of the public health and safety.

This guideline is the result of a collaborative effort of DEA and the American Methadone Treatment Association. It documents these organizations' mutual belief that the benefits of the therapeutic environment are enhanced by maintaining compliance with existing law.

Donnie R. Marshall, Acting Administrator
Donnie R. Marshall
Acting Administrator


Preface

Drug abuse continues to be a significant problem in the United States. Preventing the diversion of legitimate drugs into the illicit market and the abuse of prescription medication, particularly controlled substances, is of great importance to DEA.

There are more than 1,000 NTPs registered with DEA, including methadone maintenance programs, methadone detoxification services, and compounders. The vast majority of these programs voluntarily comply with the Controlled Substances Act of 1970 (CSA) and its implementing regulations. The importance of proper control of the use of all approved narcotic replacement pharmacotherapies by NTP sponsors and staff cannot be overemphasized.

DEA policy and regulations require that all NTPs provide a complete and accurate accounting of all controlled substance medications received and dispensed. Factors that may affect a program's ability to maintain accurate inventory control and correct dispensing procedures include manufacturing standards for bottle fill, use of automatic dispensing pump equipment, effective integration of computer software programs, proper training of dispensing personnel, and accurate recordkeeping in the reconciliation of daily narcotic inventories. The purpose of these guidelines is to help NTPs interpret regulatory requirements and strengthen their ability to maintain accurate dispensing records in compliance with federal law.

It should be noted that some states have more stringent and/or additional requirements than those mandated by federal law. NTPs must comply with these more stringent and/or additional requirements. While the following guidelines include DEA regulatory requirements, NTPs should also consult with their State Methadone Authority, or its equivalent, to ensure compliance with state regulatory statutes.


Organization of the Guidelines

The NTP guidelines that follow represent a joint initiative between DEA and the American Methadone Treatment Association. Their development grew out of the need to provide guidance to NTPs throughout the United States regarding common sense practices for the reconciliation of opioid replacement medications.

The guidelines provide information on a variety of issues related to compliance with DEA regulatory requirements and to the enhancement of NTP operations. Topics addressed range from procedures used when ordering and receiving medications and best practices for using automated dispensing systems, including the use of computer software in the dispensing/ reconciliation process, to recordkeeping and security requirements and procedures.

The guidelines can be used by NTP personnel to access specific information addressing issues or problems that arise during the day to day operation of the NTP. The intent of these guidelines is to ensure greater stability in the treatment process through the use of the same standard throughout the United States. Key management and dispensing personnel are encouraged to study the document as a whole.

In the text to follow, typeface and language are used to differentiate regulatory requirements from recommended practices.

  • Recommended practices are presented in standard typeface and typically include the word "should" (e.g., "The designated staff member who receives a particular shipment should sign for the shipment only after all of the ordered medication has been accounted for.").
  • The word "must" is typically used in presenting regulatory requirements, which are printed in italics and bold. Further, the part and section of Title 21 of the Code of Federal Regulations (CFR) where a specific regulatory requirement is found is presented in brackets after the requirement (e.g., "To order needed medication, a DEA Form-222 must be completed by the NTP. [ 21 CFR 1305.06].").

This document also includes appendices which provide information to support material found in the body of the document. These include a compilation of questions that DEA is frequently asked - about the ordering and delivery of medication, recordkeeping, destruction of medication, security, and other issues - and the answers to these questions (Appendix A). There are also sample DEA forms (Appendix B) and a checklist that NTPs may use when preparing for a DEA investigation (Appendix C).

An appendix listing all local DEA diversion field offices also is included (Appendix D). When an NTP contacts the local DEA office to obtain information from or provide it to DEA personnel, callers should ask to speak with the "Diversion Group" of that office.


Acknowledgements

The Drug Enforcement Administration would like to thank the many individuals who were involved in the development of these guidelines as well as those who reviewed drafts of this document at various stages of its development, including the American Methadone Treatment Association, the Center for Substance Abuse Treatment (CSAT), the Food and Drug Administration, and the State Methadone Authorities from Maryland and Virginia as well as various pharmaceutical companies, software manufacturers, and pump manufacturers.

Special recognition is given to CSAT which provided funding for the services of a professional writer/editor, and to the writer/editor for her efforts in completing this project.

In addition, special recognition is given to American Methadone Treatment Association’s President and Board Members for their insight and expertise which proved to be invaluable to the success of this project.

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