[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR8.11]



[Page 62-65]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 8_CERTIFICATION OF OPIOID TREATMENT PROGRAMS--Table of Contents

 

             Subpart B_Certification and Treatment Standards

 

Sec. 8.11  Opioid treatment program certification.





    (a) General. (1) An OTP must be the subject of a current, valid 

certification from SAMHSA to be considered qualified by the Secretary 

under section 303(g)(1) of the Controlled Substances Act (21 U.S.C. 

823(g)(1)) to dispense opioid drugs in the treatment of opioid 

addiction. An OTP must be determined to be qualified under section 

303(g)(1) of the Controlled Substances Act, and must be determined to be 

qualified by the Attorney General under section 303(g)(1), to be 

registered by the Attorney General to dispense opioid agonist treatment 

medications to individuals for treatment of opioid addiction.

    (2) To obtain certification from SAMHSA, an OTP must meet the 

Federal opioid treatment standards in Sec. 8.12, must be the subject of 

a current, valid accreditation by an accreditation body or other entity 

designated by SAMHSA, and must comply with any other conditions for 

certification established by SAMHSA.

    (3) Certification shall be granted for a term not to exceed 3 years, 

except that certification may be extended during the third year if an 

application for accreditation is pending.

    (b) Application for certification. Three copies of an application 

for certification must be submitted by the OTP to the address identified 

in Sec. 8.3(b). SAMHSA will consider and accept the electronic 

submission of these materials when electronic submission systems are 

developed and available. The application for certification shall 

include:

    (1) A description of the current accreditation status of the OTP;

    (2) A description of the organizational structure of the OTP;

    (3) The names of the persons responsible for the OTP;

    (4) The addresses of the OTP and of each medication unit or other 

facility under the control of the OTP;

    (5) The sources of funding for the OTP and the name and address of 

each governmental entity that provides such funding; and

    (6) A statement that the OTP will comply with the conditions of 

certification set forth in paragraph (f) of this section.

    (7) The application shall be signed by the program sponsor who shall 

certify that the information submitted in the application is truthful 

and accurate.

    (c) Action on application. (1) Following SAMHSA's receipt of an 

application for certification of an OTP, and after consultation with the 

appropriate State authority regarding the qualifications of the 

applicant, SAMHSA may grant the application for certification, or renew 

an existing certification, if SAMHSA determines that the OTP has 

satisfied the requirements for certification or renewal of 

certification.

    (2) SAMHSA may deny the application if SAMHSA determines that:

    (i) The application for certification is deficient in any respect;

    (ii) The OTP will not be operated in accordance with the Federal 

opioid treatment standards established under Sec. 8.12;

    (iii) The OTP will not permit an inspection or a survey to proceed, 

or will not permit in a timely manner access to relevant records or 

information; or



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    (iv) The OTP has made misrepresentations in obtaining accreditation 

or in applying for certification.

    (3) Within 5 days after it reaches a final determination that an OTP 

meets the requirements for certification, SAMHSA will notify the Drug 

Enforcement Administration (DEA) that the OTP has been determined to be 

qualified to provide opioid treatment under section 303(g)(1) of the 

Controlled Substances Act.

    (d) Transitional certification. OTPs that before May 18, 2001 were 

the subject of a current, valid approval by FDA under 21 CFR, part 291 

(contained in the 21 CFR parts 200 to 299 edition, revised as of July 1, 

2000), are deemed to be the subject of a current valid certification for 

purposes of paragraph (a)(11) of this section. Such ``transitional 

certification'' will expire on August 17, 2001 unless the OTP submits 

the information required by paragraph (b) of this section to SAMHSA on 

or before August 17, 2001. In addition to this application, OTPs must 

certify with a written statement signed by the program sponsor, that 

they will apply for accreditation within 90 days of the date SAMHSA 

approves the second accreditation body. Transitional certification, in 

that case, will expire on May 19, 2003. SAMHSA may extend the 

transitional certification of an OTP for up to one additional year 

provided the OTP demonstrates that it has applied for accreditation, 

that an accreditation survey has taken place or is scheduled to take 

place, and that an accreditation decision is expected within a 

reasonable period of time (e.g., within 90 days from the date of 

survey). Transitional certification under this section may be suspended 

or revoked in accordance with Sec. 8.14.

    (e) Provisional certification. (1) OTPs that have no current 

certification from SAMHSA, but have applied for accreditation with an 

accreditation body, are eligible to receive a provisional certification 

for up to 1 year. To receive a provisional certification, an OTP shall 

submit the information required by paragraph (b) of this section to 

SAMHSA along with a statement identifying the accreditation body to 

which the OTP has applied for accreditation, the date on which the OTP 

applied for accreditation, the dates of any accreditation surveys that 

have taken place or are expected to take place, and the expected 

schedule for completing the accreditation process. A provisional 

certification for up to 1 year will be granted, following receipt of the 

information described in this paragraph, unless SAMHSA determines that 

patient health would be adversely affected by the granting of 

provisional certification.

    (2) An extension of provisional certification may be granted in 

extraordinary circumstances or otherwise to protect public health. To 

apply for a 90-day extension of provisional certification, an OTP shall 

submit to SAMHSA a statement explaining its efforts to obtain 

accreditation and a schedule for obtaining accreditation as 

expeditiously as possible.

    (f) Conditions for certification. (1) OTPs shall comply with all 

pertinent State laws and regulations. Nothing in this part is intended 

to limit the authority of State and, as appropriate, local governmental 

entities to regulate the use of opioid drugs in the treatment of opioid 

addiction. The provisions of this section requiring compliance with 

requirements imposed by State law, or the submission of applications or 

reports required by the State authority, do not apply to OTPs operated 

directly by the Department of Veterans Affairs, the Indian Health 

Service, or any other department or agency of the United States. Federal 

agencies operating OTPs have agreed to cooperate voluntarily with State 

agencies by granting permission on an informal basis for designated 

State representatives to visit Federal OTPs and by furnishing a copy of 

Federal reports to the State authority, including the reports required 

under this section.

    (2) OTPs shall allow, in accordance with Federal controlled 

substances laws and Federal confidentiality laws, inspections and 

surveys by duly authorized employees of SAMHSA, by accreditation bodies, 

by the DEA, and by authorized employees of any relevant State or Federal 

governmental authority.

    (3) Disclosure of patient records maintained by an OTP is governed 

by the provisions of 42 CFR part 2, and



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every program must comply with that part. Records on the receipt, 

storage, and distribution of opioid agonist treatment medications are 

also subject to inspection under Federal controlled substances laws and 

under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). 

Federally-sponsored treatment programs are subject to applicable Federal 

confidentiality statutes.

    (4) A treatment program or medication unit or any part thereof, 

including any facility or any individual, shall permit a duly authorized 

employee of SAMHSA to have access to and to copy all records on the use 

of opioid drugs in accordance with the provisions of 42 CFR part 2.

    (5) OTPs shall notify SAMHSA within 3 weeks of any replacement or 

other change in the status of the program sponsor or medical director.

    (6) OTPs shall comply with all regulations enforced by the DEA under 

21 CFR chapter II, and must be registered by the DEA before 

administering or dispensing opioid agonist treatment medications.

    (7) OTPs must operate in accordance with Federal opioid treatment 

standards and approved accreditation elements.

    (g) Conditions for interim maintenance treatment program approval. 

(1) Before a public or nonprofit private OTP may provide interim 

maintenance treatment, the program must receive the approval of both 

SAMHSA and the chief public health officer of the State in which the OTP 

operates.

    (2) Before SAMHSA may grant such approval, the OTP must provide 

SAMHSA with documentation from the chief public health officer of the 

State in which the OTP operates demonstrating that:

    (i) Such officer does not object to the providing of interim 

maintenance treatment in the State;

    (ii) The OTP seeking to provide such treatment is unable to place 

patients in a public or nonprofit private comprehensive treatment 

program within a reasonable geographic area within 14 days of the time 

patients seek admission to such programs;

    (iii) The authorization of the OTP to provide interim maintenance 

treatment will not otherwise reduce the capacity of comprehensive 

maintenance treatment programs in the State to admit individuals 

(relative to the date on which such officer so certifies); and

    (iv) The State certifies that each individual enrolled in interim 

maintenance treatment will be transferred to a comprehensive maintenance 

treatment program no later than 120 days from the date on which each 

individual first requested treatment, as provided in section 1923 of the 

Public Health Service Act (21 U.S.C. 300x-23).

    (3) SAMHSA will provide notice to the OTP denying or approving the 

request to provide interim maintenance treatment. The OTP shall not 

provide such treatment until it has received such notice from SAMHSA.

    (h) Exemptions. An OTP may, at the time of application for 

certification or any time thereafter, request from SAMHSA exemption from 

the regulatory requirements set forth under this section and Sec. 8.12. 

An example of a case in which an exemption might be granted would be for 

a private practitioner who wishes to treat a limited number of patients 

in a non-metropolitan area with few physicians and no rehabilitative 

services geographically accessible and requests exemption from some of 

the staffing and service standards. The OTP shall support the rationale 

for the exemption with thorough documentation, to be supplied in an 

appendix to the initial application for certification or in a separate 

submission. SAMHSA will approve or deny such exemptions at the time of 

application, or any time thereafter, if appropriate. SAMHSA shall 

consult with the appropriate State authority prior to taking action on 

an exemption request.

    (i) Medication units, long-term care facilities and hospitals. (1) 

Certified OTPs may establish medication units that are authorized to 

dispense opioid agonist treatment medications for observed ingestion. 

Before establishing a medication unit, a certified OTP must notify 

SAMHSA by submitting form SMA-162. The OTP must also comply with the 

provisions of 21 CFR part 1300 before establishing a medication unit. 

Medication units shall comply with all pertinent state laws and 

regulations.



[[Page 65]]



    (2) Certification as an OTP under this part will not be required for 

the maintenance or detoxification treatment of a patient who is admitted 

to a hospital or long-term care facility for the treatment of medical 

conditions other than opiate addiction and who requires maintenance or 

detoxification treatment during the period of his or her stay in that 

hospital or long-term care facility. The terms ``hospital'' and ``long-

term care facility'' as used in this section are to have the meaning 

that is assigned under the law of the State in which the treatment is 

being provided. Nothing in this section is intended to relieve hospitals 

and long-term care facilities from the obligation to obtain registration 

from the Attorney General, as appropriate, under section 303(g) of the 

Controlled Substances Act.



[66 FR 4090, Jan. 17, 2001, as amended at 66 FR 15347, Mar. 19, 2001]