[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR291.501]

[Page 157]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 291--DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS--Table of Contents
 
Sec. 291.501  Narcotic drugs in the maintenance treatment of narcotic addicts.

    (a) The Food and Drug Administration, the National Institute on Drug 
Abuse, and the Drug Enforcement Administration, Department of Justice, 
recognize that the use of narcotic drugs in the prolonged maintenance of 
narcotic dependence has been shown to be an effective part of a total 
treatment effort in the management and rehabilitation of selected 
narcotic addicts. It is also recognized that a number of dangers and 
possible abuses may arise from such efforts if professional services and 
controls are inadequately applied.
    (b) Therefore, the Commissioner of Food and Drugs, the Director of 
the National Institute on Drug Abuse, and the Administrator of the Drug 
Enforcement Administration, Department of Justice, agree that interested 
professionals, municipalities, and organizations should be allowed to 
use narcotic drugs in the medical treatment of narcotic addiction within 
a framework of adequate controls designed to protect the individual 
patients and the community. Narcotic drugs that are to be used as part 
of the treatment of narcotic addiction must have an approved new drug 
application for such use. To facilitate this purpose, the Food and Drug 
Administration, the National Institute on Drug Abuse, and the Drug 
Enforcement Administration, Department of Justice, have jointly agreed 
upon acceptable conditions for the use of narcotic drugs in a treatment 
program, which are set forth in Sec. 291.505. In addition, such other 
provisions of the Federal narcotic laws and regulations as are 
applicable must also be observed.

[58 FR 38709, July 20, 1993]