[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
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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.
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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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