DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION

CENTER FOR SUBSTANCE ABUSE TREATMENT

Form Approved: OMB Number 0930-0206

Expiration Date: 11/30/2024

See OMB Statement on Reverse

Exception Request and Record of Justification

Under 42 CFR § 8.11(h)

DATE OF SUBMISSION: 12/15/2021

Note: This form was created to assist in the interagency review of patient exceptions in opioid treatment programs (OTPs) under 42 CFR § 8.11(h).

Detailed INSTRUCTIONS are provided at http://www.samhsa.gov/medication-assisted-treatment/opioid-treatment-programs/submit-exceptionrequest. PLEASE complete ALL applicable items on this form and submit online* for a prompt reply. Thank you.

Program OTP No:

(e.g., AL-10001-M)

X X – 1 2 3 4 5 – M Patient ID No: A L L S T A B L E P T 

Program Name: ____Example OTP_____________________________________________________________________________________________

Telephone: ___(333) 333-3333__________ E-mail: ___exampleotp@gov.com______

Name & Title of Requestor: ___ John Smith, MD__________________________________________________________________________________ 

Patient’s Admission Date:____N/A________________ 

Patient’s applicable drug(s) and dosage (check all that apply):

___ Methadone ___ Buprenorphine ___ Other 

_30__ mg ___ mg 

Most recent urinalysis result (check all that apply):

__X_ Methadone ___ Buprenorphine 

X positive  negative  positive  negative  positive  negative 

Patient’s program attendance schedule per week

(Place an “X” next to all days that the patient attends*): ___ S ___ M ___ T ___ W ___ T ___ F ___ S 

*If current attendance is less than once per week, please enter the schedule _________________________________________________________

Patient status: ___ Employed ___ Homemaker ___ Student ___ Disabled

___ Other: _______________________________________________________________________________________

Nature of Request:

_X_

_ 

Temporary takehome medication ___Temporary change 

in protocol ___ Detoxification exception ___ Other: __________________________________

Decrease regular attendance to

(Place an “X” next to appropriate days*): ___ S ___ M ___ T ___ W ___ T ___ F ___ S Beginning date: ________________

*If new attendance is less than once per week, please enter the schedule: ___________________________________________________________

Dates of 

Exception: From

__12/23/2021____

_________ to

12/25/2021__________

______ # of doses needed: __1 dose per day for 500 pts________

Justification: __ Family Emergency __ Incarceration __ Funeral __ Vacation __ Transportation Hardship

__ Step/Level Change __ Employment __ Medical __

Long-Term Care 

Facility __

Other Residential 

Treatment

__ Homebound __ Split Dose __ Weather Crisis

__

Other: Christmas Holiday [The Federal holiday is observed on Christmas Eve (12/24) and we are 

seeking blanket exceptions for 12/23 and 12/25].

Regulation Requirements:

1. For take-home medication: Has the patient been informed of the dangers of children ingesting methadone? __X_ Yes ___ No ___ N/A 

2. For take-home medication: Has the program physician considered the 8-point evaluation criteria to determine whether 

the patient is suitable for dispensed methadone or buprenorphine as outlined in 42 CFR § 8.12(i)(2)(i)-(viii)? __X_ Yes ___ No ___ N/A 

3. For multiple detoxification admissions: Did the physician justify more than 2 detoxification episodes per year and 

assess the patient for other forms of treatment (include dates of detoxification episodes) as required by 

42 CFR § 8.12(e)(4)? ___Yes ___ No _X__ N/A 

Comments: __The clinic will be open 12/23 – 12/25 for abbreviated hours for unstable pts (pt# AB3, AB5, AB10, CD40); 500 patients will receive 

unsupervised doses________________________________________________________________________

Submitted by: John Smith, MD

__________________________________

 John Smith, MD ________________________________________

_______12/15/2021___

_ 

Printed Name of Physician Signature of Physician Date

 

FORM SMA-168 (revised 2021) (FRONT)

REQUEST FOR CHANGE REQUIREMENTS BACKGROUND INFORMATION
State response to request: __ Approved __ Denied ___________________________________________ __________________

State Opioid Treatment Authority Date

__Decision not required

Explanation: ________________________________________________________________________________________________________ 

Federal response to request: __ Approved _ Denied ____________________________________________ __________________

Public Health Advisor, 

Center for Substance Abuse Treatment

Date

__ Decision not required

Explanation: ________________________________________________________________________________________________________

*The preferred method for submitting this form to CSAT/DPT is online at the SAMHSA OTP Extranet Web site, http://otp-extranet.samhsa.gov. For instructions 

or technical support, contact the OTP Extranet Information Center at 1-866-348-5741 or OTP-Help@jbsinternational.com. 

This exception is contingent upon approval by your State Opioid Treatment Authority (as applicable) and may not be implemented until you receive such 

approval.

Purpose of Form: This form was created to facilitate the submission and review of patient exceptions under 42 CFR § 

8.11(h). This does not preclude other forms of notification.

Paperwork Reduction Act Statement

Public reporting burden for this collection of information is estimated to average 25 minutes per response, including the time for reviewing 

instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of 

information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing 

this burden to SAMHSA Reports Clearance Officer; Paperwork Reduction Project (0930-0206); 5600 Fishers Lane, Rockville, MD 20857. An agency 

may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control 

number. The OMB control number for this project is 0930-0206. 

FORM SMA-168 (revised 2021) (BACK) APPROVAL