Form SMA-162 Application for Certification to Use Opioid Drugs in a T

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: 09/30/2006
See OMB Statement on Reverse

Application for Certification to Use Opioid Drugs
in a Treatment Program Under 42 CFR § 8.11

Note:

DATE OF SUBMISSION

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)

c. DEA Registration Number

b. Opioid Treatment Program Number (OTP Number):
(same as FDA ID)
2. ADDRESS OF PRIMARY DISPENSING LOCATION (Include Zip
Code)

3. TELEPHONE NUMBER (Include Area Code)
4. FAX NUMBER (Include Area Code)
5. E-MAIL ADDRESS

6. NAME AND ADDRESS OF PROGRAM SPONSOR (Include Zip Code)

7. TELEPHONE NUMBER (Include Area Code)
8. FAX NUMBER (Include Area Code)
9. E-MAIL ADDRESS

10. NAME OF MEDICAL DIRECTOR (AND ADDRESS–(If different than
Dispensing Location, above)

11. TELEPHONE NUMBER (Include Area Code)
12. FAX NUMBER (Include Area Code)
13. E-MAIL ADDRESS

14. PURPOSE OF APPLICATION
Provisional Certification G

New Sponsor

G

New Medical Director

G

Relocation G

Medication Unit G

Renewal/Re-certification

G
15. NUMBER OF PATIENTS IN TREATMENT ON DATE OF SUBMISSION:
_______METHADONE

_________ LEVO-ALPHA-ACETYL-METHADOL (LAAM) _________ SUBUTEX/SUBOXONE (BUPRENORPHINE)

_______ OTHER (Specify)
16a. PROGRAM STATUS

G For-profit

G Nonprofit

G Public/Government

G Other (Specify)

b. PROGRAM FUNDING SOURCES (Check each appropriate agency and attach the address of each, if applicable.)

G SAMHSA (Block Grant)
G Patient Payment
G Indian Health Service

G Private Charities
G State Government
G Private Health Insurance

G Department Of Veterans Affairs
G City & County Government
G Other (Specify)

17. Application
Substance Abuse and Mental Health Services Administration
Division of Pharmacologic Therapies
Attention: OTP Certification Program
Rockwall II Building, Suite 740
5600 Fishers Lane
Rockville, MD 20857
Dear Sir/Madam:
As the person responsible for the program (OTP), I submit this
application in triplicate for approval to use approved opioid drugs in a
program for detoxification and/or maintenance treatment for 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).

FORM SMA-162 (revised 2003) (FRONT)

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.
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.
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.

(Submit in triplicate)

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.

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.

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 of such
an arrangement will be documented and submitted to SAMHSA. Within
three weeks of any replacement of the medical director, I shall notify
SAMHSA.

J. I agree to comply with the conditions of certification set forth under
42 CFR §8.11(f). In addition, I shall allow, in accordance with Federal
controlled substance laws and Federal confidentiality laws, inspections
and surveys by duly authorized employees of SAMHSA, by
accreditation bodies, the DEA, and by authorized employees of any
relevant State or Federal governmental authority. I agree that OTPs
must operate in accordance with Federal opioid treatment standards
and accreditation elements.

F. Attached is the address of each medication unit or other facility under
control of the OTP. Any new dispensing site for this program, including
medication units shall be approved by SAMHSA and the State authority
prior to its use. SAMHSA and the State authority shall be notified within
three weeks of the deletion of any facility used to dispense opioid
treatment drugs.
G. A patient records system will be established and maintained to
document and monitor patient care in this program. It shall be maintained
so as to comply with the 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 to specific patients. This drug dispensing record
must be retained for a period of three years from the date of dispensing.

K. I agree to adhere to all rules, directives, and procedures 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 shall inform other individuals who work in this treatment
program of the provisions of this regulation, and monitor their
activities to assure compliance with the provisions.
L. I understand that failure to abide by the rules directives, and
procedures described above may cause a suspension 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.

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 to maintain the confidentiality of alcohol and drug abuse
treatment patient records. I agree to protect the identity of all patients in
accordance with the regulations.
PROGRAM SPONSOR (Signature)

DATE

Please send three copies of this form and all attachments to:
Substance Abuse and Mental Health Services Administration
Attention: OTP Certification Program
Center for Substance Abuse Treatment
Division of Pharmacologic Therapies
Rockwall II Building, Suite 618
5600 Fishers Lane
Rockville, MD 20857
and two copies to the appropriate State authority.
If submitting this form electronically, please submit electronic copies of all attachments by e-mail to [email protected] or submit
three copies of all attachments to the mailing address above.
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 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); Room 16-105, Parklawn Building; 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-162 (revised 2003) (BACK)