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

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

Rockwall II, 5600 Fishers Lane
Rockville, MD 20857

Table of Contents

Foreword

Executive Summary

Introduction

Part I: History of Federal and State Involvement in Narcotic Treatment

Part II: The Approval and Monitoring Process

Appendices
Appendix A: FDA Forms and Information
Appendix B: DEA Forms and Information
Appendix C: FDA Regulations
Appendix D: DEA Regulations
Appendix E: Confidentiality Regulations
Appendix F: Standard Definitions Used During Application and Monitoring
Appendix G: State Authorities
Appendix H: Some Additional Resources
Investigational New Drug Application Regulations

Acronyms

Bibliography

Exhibits:
A. Major Federal Legislation and the Advent of Federal Regulation of Narcotic Treatment
B. Roles of Federal and State Agencies
C. Federal Initiatives
D. Application Process Flow Chart [Not available in electronic format]
E. Questions Often Asked About FDA Regulations
F. Questions Often Asked About DEA Regulations
G. What Should I Ask My SA Contact?
H. Most Common Reasons Programs Are Denied DEA Registration
I. Preparing for an Inspection
J. Typical Problems That Can Lead to Adverse Action by FDA
K. Typical Problems That Can Lead to Loss of DEA Registration

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