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HHS/SAMHSA RIN: 0930-AA39 Publication ID: Fall 2021 
Title: ●Treatment of Opioid use Disorder With Extended Take Home Doses of Methadone 

SAMHSA will revise 42 CFR part 8 to make permanent some regulatory flexibilities for opioid treatment programs to provide extended take home doses of methadone. To facilitate this new treatment paradigm, sections of 42 CFR part 8 will require updating to reflect current treatment practice. SAMHSA’s changes will impact roughly 1800 opioid treatment programs and state opioid treatment authorities.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 42 CFR 8   
Legal Authority: 21 U.S.C. sec. 823(g)(1)   
Legal Deadline:  None

Statement of Need:

This change will help ensure continuity of access to Medications for Opioid Use Disorder (MOUD) in SAMHSA-regulated opioid treatment programs ( program ). Research and stakeholder feedback details that the take home flexibilities have been well received by treatment programs and patients. There are very few reports of diversion or overdose, and the provision of extended take home doses facilitates patient engagement in activities, such as employment, that support recovery. Moreover, those with limited access to transportation benefit from extended take home doses since they are not required to attend the OTP almost each day of the week to receive Methadone. In this way, making permanent the methadone extended take home flexibility will facilitate treatment engagement.

Summary of the Legal Basis:

The current OTP exemption at issue allows OTPs to operate in a manner that is otherwise inconsistent with existing OTP regulations, and therefore, a permanent extension of such exemptions would necessitate revisions of the OTP regulations.


In the absence of congressional action, rulemaking is required.

Anticipated Costs and Benefits:

This change will help facilitate and ensure continuity of access to medication treatment for opioid use disorder in SAMHSA-regulated opioid treatment programs. Programs have already incorporated this flexibility into practice and have systems in place that support its delivery in a cost effective and patient centered manner. This proposed rule is not expected to impart a cost to patients. In fact, the proposed rule allows patients to engage in employment and necessary daily activities. This supports income generation and also recovery. The increased number of take homes allowed may affect OTP clinic visit and thereby reduce revenue derived from clinical encounters and medication visits. Conversely patients may experience more convenient engagement with OTPs as the visits to clinic would be decreased.


Patients seeking this care should still be required to have an in-person visit at the OTP in between provision of take- home doses, as directed by their treating physician’s plan of care. Without this provision, there is risk of patients receiving a lower standard of care and increased risk of diversion of the prescribed medications.

Action Date FR Cite
NPRM  09/00/2022 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
Agency Contact:
Dr. Neeraj Gandotra
Chief Medical Officer
Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane, 18E67,
Rockville, MD 20857
Phone:202 823-1816