[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Rules and Regulations]
[Pages 34837-34838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14421]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 8

[Docket No. 2012-29417]
RIN 0930-AA14


Opioid Drugs in Maintenance and Detoxification Treatment of 
Opiate Addiction; Proposed Modification of Dispensing Restrictions for 
Buprenorphine and Buprenorphine Combination as Used in Approved Opioid 
Treatment Medications; Correction

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Health and Human Services Department (HHS) is correcting a 
final rule that appeared in the Federal Register of December 6, 2012. 
The document modified the dispensing requirements buprenorphine and 
buprenorphine combination products approved by the Food and Drug 
Administration (FDA) for opioid dependence and used in federally 
certified and registered opioid treatment programs. In particular, this 
rule allows opioid treatment programs more flexibility in dispensing 
take-home supplies of buprenorphine after the assessment and 
documentation of a patient's responsibility and stability to receive 
opioid addiction treatment medication. However, an inadvertent removal 
of paragraphs was made. This correction reinstates the missing 
paragraphs.

DATES: Effective June 18, 2015.

FOR FURTHER INFORMATION CONTACT: Jinhee Lee, Division of Pharmacologic 
Therapies, Center for Substance Abuse Treatment, SAMHSA, 1 Choke Cherry 
Road, Room 7-1028, Rockville, MD 20857, (240) 276-2700, email: 
[email protected].

SUPPLEMENTARY INFORMATION: On December 6, 2012 (77 FR 72752), HHS 
published a final rule in the Federal Register modifying the dispensing 
requirements in 42 CFR 8.12 for buprenorphine and buprenorphine 
combination products approved by FDA for opioid dependence and used in 
federally certified and registered opioid treatment programs. An 
inadvertent error was made whereby Sec.  8.12(i)(3)(i) through (vi) was 
deleted. The original intention was only to revise Sec.  8.12(i)(3) 
introductory text, however, this was not made clear and thus the entire 
section following the introductory text was removed. This correction 
properly modifies the dispensing requirements in 42 CFR 8.12 as 
published in the Federal Register on December 6, 2012, without removing 
Sec.  8.12(i)(3)(i) through (vi).

[[Page 34838]]

List of Subjects in 42 CFR Part 8

    Health professions, Levo-AlphaAcetyl-Methadol (LAAM), Methadone, 
Reporting and recordkeeping requirements.

PART 8--CERTIFICATION OF OPIOID TREATMENT PROGRAMS

0
1. The authority citation for part 8 continues to read as follows:

    Authority: 21 U.S.C. 823; 42 U.S.C. 290bb-2a, 290aa(d), 290dd-2, 
300x-23, 300x-27(a), 300y-11.

0
2. In Sec.  8.12, paragraph (i)(3) is revised to read as follows:


Sec.  8.12  Federal opioid treatment standards.

* * * * *
    (i) * * *
    (3) Such determinations and the basis for such determinations 
consistent with the criteria outlined in paragraph (i)(2) of this 
section shall be documented in the patient's medical record. If it is 
determined that a patient is responsible in handling opioid drugs, the 
dispensing restrictions set forth in paragraphs (i)(3)(i) through (vi) 
of this section apply. The dispensing restrictions set forth in 
paragraphs (i)(3)(i) through (vi) of this section do not apply to 
buprenorphine and buprenorphine products listed under paragraph 
(h)(2)(iii) of this section.
    (i) During the first 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) is limited to a 
single dose each week and the patient shall ingest all other doses 
under appropriate supervision as provided for under the regulations in 
this subpart.
    (ii) In the second 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) are two doses per 
week.
    (iii) In the third 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) are three doses per 
week.
    (iv) In the remaining months of the first year, a patient may be 
given a maximum 6-day supply of take-home medication.
    (v) After 1 year of continuous treatment, a patient may be given a 
maximum 2-week supply of take-home medication.
    (vi) After 2 years of continuous treatment, a patient may be given 
a maximum one-month supply of take-home medication, but must make 
monthly visits.
* * * * *

    Dated: June 4, 2015.
Oliver Potts,
Deputy Executive Secretary, U.S. Department of Health and Human 
Services.
[FR Doc. 2015-14421 Filed 6-17-15; 8:45 am]
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