Federal Regulations & Documents


Code of Federal Regulations

42 CFR Part 8.
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction.
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42 CFR Part 2.
Confidentiality of Alcohol and Drug Abuse Patient Records.
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Federal Register 17 January 2001, Vol. 66, No. 11, pages 4076-4102.(PDF Format)
Publication of Final Rule 42 CFR Part 2. Comments and DHHS Response.

New Take Home Regulations
Page 4098 from Federal Register describing new take home regulations.

Single State Agencies
List of Single State Agencies (SSA) on the internet.

State Opioid Treatment Authorities

U.S. Government Printing Office - Federal Digital System (FDsys)

Regulations and Accreditation Resources

CSAT Accreditation Page
The OTP Accreditation Program, CSAT Accreditation Guidelines and updates.

OTP Accrereditation Guidelines
2007.(PDF Format)
Publication of Fin240al Rule. Comments and DHHS Response.

CSAT's OTP Certification Page
Information about the new certification process, deadlines, applications and directories.

CSAT Patient Exceptions Page
SMA-168-Exception Request and Record of Justification under 42 CFR § 8.12 and how to submit an Exception Request.

Patient Exceptions FORM SMA-168 Instructions for SMA-168
Download the Exception Form Request and Instructions.

Opioid Treatment Program Accreditation Bodies
List of current approved accreditation bodies with basic information.

CSAT Regulations index

State Methadone Authorities
List of SMA's, State Director, Methadone Contact Person, Website, Regulation Page and other information.

Press Releases and Notices

Orlaam (levomethadyl acetate hydrochloride). FDA Medwatch Sept 9, 2003.


Announcement of OTP Accrediting Organizations. CSAT Letter December 4, 2001.

FDA Announces Labeling Changes Following Cardiac Adverse Events With Addiction Drug. FDA Talk Paper April 20, 2001.

FDA Warns About Orlaam. FDA Alert April 20, 2001.

New Federal Regulations Issued to Improve Methadone Treatment. SAMHSA Press Release January 17, 2001.

Improving Quality and Oversight of Methadone Treatment.  CSAT Fact Sheet January 16, 2001.

Frequently Asked Questions About the Proposed New Methadone Regulations.  SAMHSA FAQ July 22, 1999.

New Federal Rules Proposed to Improve Quality and Oversight of Methadone Treatment.  CSAT Press Release July 22, 1999.

Federal Agencies

Center for Substance Abuse Treatment CSAT CSAT OTP Hotline 1-866-INFO-OTP

Substance Abuse and Mental Health Services Administration SAMHSA

National Institute on Drug Abuse NIDA

Accrediting Agencies

CARF - Accreditation

Joint Commission on Accreditation of Healthcare Organizations JCAHO

Council on Accreditation for Children and Family Services COA

Washington Department of Social and Health Services Division of Alcohol and Substance Abuse

State of Missouri Department of Mental Health Division of Alcohol and Drug Abuse

Important Agencies & Links

Federal Register FR

American Association for the Treatment of Opiate Dependence AATOD

National Association of State Alcohol and Drug Abuse Directors NASADAD

Federal Regulation of Methadone Treatment  Richard A. Rettig and Adam Yarmolinsky. National Academy Press, 1995 (Complete, browsable text of this book).

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Last Modified: August 26, 2011
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