[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR8.1]



[Page 54-55]

 

                         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.









                         Subpart A_Accreditation



Sec.

8.1 Scope.

8.2 Definitions.

8.3 Application for approval as an accreditation body.

8.4 Accreditation body responsibilities.

8.5 Periodic evaluation of accreditation bodies.

8.6 Withdrawal of approval of accreditation bodies.



             Subpart B_Certification and Treatment Standards



8.11 Opioid treatment program certification.

8.12 Federal opioid treatment standards.

8.13 Revocation of accreditation and accreditation body approval.

8.14 Suspension or revocation of certification.

8.15 Forms.



Subpart C_Procedures for Review of Suspension or Proposed Revocation of 

    OTP Certification, and of Adverse Action Regarding Withdrawal of 

                    Approval of an Accreditation Body



8.21 Applicability.

8.22 Definitions.

8.23 Limitation on issues subject to review.

8.24 Specifying who represents the parties.

8.25 Informal review and the reviewing official's response.

8.26 Preparation of the review file and written arguments.

8.27 Opportunity for oral presentation.

8.28 Expedited procedures for review of immediate suspension.

8.29 Ex parte communications.

8.30 Transmission of written communications by reviewing official and 

          calculation of deadlines.



[[Page 55]]



8.31 Authority and responsibilities of the reviewing official.

8.32 Administrative record.

8.33 Written decision.

8.34 Court review of final administrative action; exhaustion of 

          administrative remedies.



    Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 300x-

23, 300x-27(a), 300y-11.



    Source: 66 FR 4090, Jan. 17, 2001, unless otherwise note.







    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.