Lynne C. McArthur, M.A., A.M.L.S.
Yvonne Goldsberry, M.P.H., M.S.U.P.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Treatment

Rockwall II, 5600 Fisher Lane
Rockville, MD 20857

Foreword of TAP 12: Approval and Monitoring of Narcotic Treatment Programs: A Guide on the Roles of Federal and State Agencies

This publication is part of the Substance Abuse Prevention and Treatment Block Grant technical assistance program. All material appearing in this volume except quoted passages from copyrighted sources is in the public domain and may be reproduced or copied without permission from the Center for Substance Abuse Treatment (CSAT) or the authors. Citation of the source is appreciated.

This publication was prepared under contract no. 270-91-004 from the Substance Abuse and Mental Health Services Administration (SAMHSA). Robert Lubran, M.S., M.P.A., served as the Government project officer.

The opinions expressed herein are the views of the authors and do not necessarily reflect the official position of CSAT or any other part of the U.S. Department of Health and Human Services (DHHS).

DHHS Publication No.
(SMA) 94-2082
Printed 1994

The following individuals reviewed this document and participated in its development:

Center for Substance Abuse Treatment
Jerome Jaffe, M.D.
Associate Director

Robert Lubran
Acting Chief
Quality Assurance and Evaluation Branch
Division of State Programs

Drug Enforcement Administration
G. Thomas Gitchel
Chief
Liaison and Policy Section
Office of Diversion Control

William Reinig
Unit Chief
Liaison and Policy Section
Office of Diversion Control

Denise Curry
Staff Coordinator
Liaison and Policy Section
Office of Diversion Control

Food and Drug Administration
Betty L. Jones
Chief
Regulatory Management Branch
Division of Scientific Investigations

(Food and Drug Administration, continued)
Nicholas Reuter
Consumer Safety Officer
Health Assessment Policy Branch
Associate Commissioner for Health Affairs and Research

National Institute on Drug Abuse
Dorynne Czechowicz, M.D.
Associate Director for Medical and Professional Affairs
Medical Affairs Branch
Division of Clinical Research

Stephen Molinari, J.D.
Regulatory Counsel
Medical Affairs Branch
Division of Clinical Research

Erwin Bloom
Program Analyst
Legislative, Government, and Constituent Relations Branch
Office of Science Policy, Education, and Legislation

Patricia Rosenman, Ph.D.
Program Analyst
Legislative, Government, and Constituent Relations Branch
Office of Science Policy, Education, and Legislation

National Association of State Alcohol and Drug Abuse Directors Linda Lewis
Director of Public Policy

Foreword

The Center for Substance Abuse Treatment (CSAT) of the Substance Abuse and Mental Health Services Administration (SAMHSA) is pleased to present this document Approval and Monitoring of Narcotic Treatment Programs: A Guide on the Roles of Federal and State Agencies. Narcotic treatment programs are the most heavily regulated substance abuse services. Treatment program staff and management, as well as State agency officials, sometimes find Federal regulatory procedures complex and confusing. This guide was developed to address some of the questions asked by State agency officials, program administrators, and sponsors as they begin working with Federal agencies.

The guide is one of several products recently developed by the CSAT Methadone Treatment Improvement Project (MTIP) to provide basic information to prospective direct care providers. It presents information about State and Federal application requirements for program approval and compliance with ongoing regulatory standards. It may also serve as a reference for Federal agencies and State authorities involved in program oversight, management, and technical assistance.

Information contained herein was prepared in collaboration with staff from the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), National Institute on Drug Abuse (NIDA), and the National Association of State Alcohol and Drug Abuse Directors (NASADAD). We wish to thank these agencies and their staff for collaborating in this effort.

Nothing in this guide should be construed as authorizing or permitting any person to perform an act that is not permitted under the regulations governing narcotic treatment programs as cited throughout the guide, or by any other Federal and State laws.

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