[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR8.1]

[Page 55]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 8--CERTIFICATION OF OPIOID TREATMENT PROGRAMS--Table of Contents
 
                        Subpart A--Accreditation
 
Sec. 8.1  Scope.


    The regulations in this part establish the procedures by which the 
Secretary of Health and Human Services (the Secretary) will determine 
whether a practitioner is qualified under section 303(g) of the 
Controlled Substances Act (21 U.S.C. 823(g)) to dispense opioid drugs in 
the treatment of opioid addiction. These regulations also establish the 
Secretary's standards regarding the appropriate quantities of opioid 
drugs that may be provided for unsupervised use by individuals 
undergoing such treatment (21 U.S.C. 823(g)(1)). Under these 
regulations, a practitioner who intends to dispense opioid drugs in the 
treatment of opioid addiction must first obtain from the Secretary or by 
delegation, from the Administrator, Substance Abuse and Mental Health 
Services Administration (SAMHSA), a certification that the practitioner 
is qualified under the Secretary's standards and will comply with such 
standards. Eligibility for certification will depend upon the 
practitioner obtaining accreditation from an accreditation body that has 
been approved by SAMHSA. These regulations establish the procedures 
whereby an entity can apply to become an approved accreditation body. 
This part also establishes requirements and general standards for 
accreditation bodies to ensure that practitioners are consistently 
evaluated for compliance with the Secretary's standards for opiate 
addiction treatment with an opioid agonist treatment medication.