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Online SMA-162 Form
*denotes a required field
DEPARTMENT OF HEALTH AND HUMAN
Form Approved: OMB Number 0930-0206
Expiration Date: 01/31/2010
SERVICES
SUBSTANCE ABUSE AND MENTAL HEALTH OMB Statement
SERVICES ADMINISTRATION
CENTER FOR SUBSTANCE ABUSE TREATMENT
Application for Certification to Use Opioid
Drugs in a Treatment Program Under 42 Date of Submission: 3/3/2010
CFR § 8.11
Note: This form is required by 42 CFR 8.11 pursuant to Sec. 303, Controlled Substances Act (21 USC § 823
and the Drug Abuse Prevention and Control Act of 1970 (42 USC § 275(a)). Failure to report may result in a
recommendation for the suspension or revocation of the opioid treatment program registration.

* 1a. Name of Program (Name of primary
dispensing location):

*

b. Doing Business As:

*

c. Program Setting:

*

d. DEA Registration Number:

 Outpatient





 Hospital-based





2. Address of Primary Dispensing Location 3. Program Telephone Number ( e.g. 999-999-999

* Address
1:

4. Program Fax Number (e.g. 999-999-9999)

* Address
2:

* City:

5. Program E-Mail Address

* State:
* Zip:

http://dpt2.samhsa.gov/sma162/sma162.aspx

7 Program Sponsor Telephone Number (e g
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6. Name and Address of Program Sponsor

* 7. Program Sponsor Telephone Number (e.g.
999-999-9999)

* First
Name:

* 8. Program Sponsor Fax Number (e.g. 999-999

* Last
Name:

(Must be the name of an individual, not a
company or organization)

9999)

* 9. Program Sponsor E-Mail Address

Degree:

 Same address as primary dispensing location





* Address
1:

* Address

A confirmation email will be sent to this address. Th
Program Sponsor must respond to that email to
electronically sign this SMA-162 and complete the
submission process.

2:

* City:
* State:
* Zip:
10. Name of Medical Director (and
Address-If different than Dispensing Location,
above)
 Check if Medical Director pending





* First
Name:

(Enter "Pending" if not available)

* Last
Name:

11. Medical Director Telephone Number (e.g. 999
999-9999)

12. Medical Director Fax Number (e.g. 999-9999999)

13. Medical Director DEA Number

Degree:
 Same address as primary dispensing location





14. Medical Director E-Mail Address

*
Address 1:

*
Address
2:

* City:
http://dpt2.samhsa.gov/sma162/sma162.aspx

The Medical Director’s email address must be
one to which only the Medical Director has
access. It must not be the same as the program’s
email address or that of any other program
personnel.
Why?
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* State:
* Zip:
*15. Purpose of Application
 Provisional





Certification 
Renewal/Re--certification 
 Renewal/Re



 New Sponsor 



 New Medical Director



 Relocation 




 Medication Unit




* 16. Number of Patients in Treatment on Date of Submission:
Methadone

Subutex/Suboxone (Buprenorphine)

Levo-Alpha-Acetyl-Methadol (LAAM)

Other (Medication Name):

* 17a. Program Status:

ProgramStatus: --Select one--

* b. Program Funding Sources (Check each appropriate agency and attach the address of each, if
applicable.)
 SAMHSA Grant




 Patient Payment




 Indian Health Service





 Private Charities




 State Government




 Private





Health Insurance

 Department





Of Veterans Affair
 County Government




 Other (Specify):





18. Comments

19. Application
Substance Abuse and Mental Health Services
Administration
Division of Pharmacologic Therapies
Attention: OTP Certification Program
1 Choke Cherry Road
Suite 2-1073
Rockville, MD 20857
Fax: 240-276-2710

E. A medical director will be designated to assume
responsibility for administering all medical services
performed by the program. If a medical director is
responsible for more than one program, the feasibility o
such an arrangement will be documented and submitte
to SAMHSA. Within three weeks of any replacement of
medical director, I shall notify SAMHSA.

F. Attached is the address of each medication unit or ot
facility under control of the OTP. Any new dispensing s
for this program, including medication units shall be
approved by SAMHSA and the State authority prior to i
Dear Sir/Madam:
use. SAMHSA and the State authority shall be notified
As the person responsible for the program (OTP), I within three weeks of the deletion of any facility used to
dispense opioid treatment drugs.
submit this application for approval to use
approved opioid drugs in a program for
detoxification and/or maintenance treatment for G. A patient records system will be established and
http://dpt2.samhsa.gov/sma162/sma162.aspx

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narcotic addicts in accordance with 42 CFR Part 8,
Certification of Opioid Treatment Programs. A
copy of this application has been sent to the State
Authority within which State the program is
located. I understand that SAMHSA and State
approvals are necessary to obtain a registration
from the Drug Enforcement Administration
(DEA).

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maintained to document and monitor patient care in th
program. It shall be maintained so as to comply with th
Federal and State reporting requirements relevant to
narcotic treatment. A drug dispensing record will be
maintained to show dates, quantity, and batch or code
marks of the drug administered or dispensed, traceable
specific patients. This drug dispensing record must be
retained for a period of three years from the date of
dispensing.

A. I have a copy of, or access to 42 CFR Part 8,
Certification of Opioid Treatment Programs,
including 42 CFR §8.12, the Federal Opioid
Treatment Standards. I have read, understand and
will comply with these standards which govern the
treatment of narcotic addiction with approved
opioid drugs.

H. I have a copy of, or access to 42 CFR Part 2,
Confidentiality of Alcohol and Drug Abuse Patient
Records. I have read and understand the requirements
maintain the confidentiality of alcohol and drug abuse
treatment patient records. I agree to protect the identity
all patients in accordance with the regulations.

B. Attached is a description of the current
accreditation status of the OTP. This description
includes the name and address of the accreditation
body and the date of the last accreditation action.

I. I shall comply with the security standards for the
distribution of controlled substances, as required by 21
CFR §1301, Registration of Manufacturers, Distributors
and Dispensers of Controlled Substances.

C. Attached is a description of the organizational
structure of the OTP which includes the name and
complete address of any central administration or
larger organizational structure to which this
program is responsible. The description shall
specify how the program will provide adequate
medical, counseling, vocational, educational, and
assessment services, at the primary facility, unless
the program sponsor has entered into a formal
documented agreement with another entity to
provide these services to patients enrolled in the
OTP. In addition, the attachment includes the
names of the persons responsible for the OTP.

J. I agree to comply with the conditions of certification
forth under 42 CFR §8.11(f). In addition, I shall allow, i
accordance with Federal controlled substance laws and
Federal confidentiality laws, inspections and surveys by
duly authorized employees of SAMHSA, by accreditatio
bodies, the DEA, and by authorized employees of any
relevant State or Federal governmental authority. I agre
that OTPs must operate in accordance with Federal opi
treatment standards and accreditation elements.
K. I agree to adhere to all rules, directives, and procedu
set forth in 42 CFR Part 8, and any regulation regarding
the use of an opioid drug for the treatment of narcotic
addiction which may be promulgated in the future. I sh
inform other individuals who work in this treatment
program of the provisions of this regulation, and monit
their activities to assure compliance with the provisions

D. Attached are the names, addresses, and a
description of each hospital, institution, clinical
laboratory, or other facility used by this program
to provide the necessary medical and rehabilitative
services.
L. I understand that failure to abide by the rules directiv
and procedures described above may cause a suspensio
or revocation of approval of my registration by the Drug
Enforcement Administration.
M. I, as program sponsor, certify that the information
submitted in this application is truthful and accurate.
I certify that the information being submitted is true and correct to the best of my knowledge. I certify that
will notify SAMHSA at the address below if any of the information submitted changes. Note: Any false,
fictitious, or fraudulent statements or information presented in this submission or misrepresentations relat
thereto may violate Federal laws and could subject you to prosecution, and/or monetary penalties, and or
denial, revocation or suspension of DEA registration (see 18 U.S.C. Section 1001; 31 U.S.C. Sections 38013812; 21 U.S.C. Section 824.)
http://dpt2.samhsa.gov/sma162/sma162.aspx

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Paperwork Reduction Act Statement

Public reporting burden for this collection of information is estimated to average between 6 minutes and 1
hour 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 comme
regarding this burden estimate or any other aspect of this collection of information, including suggestions f
reducing this burden to SAMHSA Reports Clearance Officer; Paperwork Reduction Project (0930-0206); 1
Choke Cherry Road, Room 2-1075, Rockville, MD 20857. An agency may not conduct or sponsor, and a per
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.
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FORM SMA-162 (revised 2007)
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Department of Health and Human Services
Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment
Division of Pharmacologic Therapies
1 Choke Cherry Road • Room 2-1075 • Rockville, MD 20857 • 240-276-2700 • [email protected]

http://dpt2.samhsa.gov/sma162/sma162.aspx

3/3/2010