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
other · US Department of Health and Human Services · Rule · Published 2012-12-06 · Effective 2013-01-07 · 77 FR 72752
Document
Document number
2012-29417
Federal Register citation
77 FR 72752
CFR reference
42 CFR 8
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
2012-12-06
Effective date
2013-01-07
Abstract
This final rule amends the federal opioid treatment program regulations by modifying the dispensing requirements for 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 would allow opioid treatment programs more flexibility in dispensing take-home supplies of buprenorphine--removing restrictions on the time a patient needs to be in treatment in order to receive take-home supplies--after the assessment and documentation of a patient's responsibility and stability to receive opioid addiction treatment medication. Opioid treatment programs that use these products in the treatment of opioid dependence will continue to adhere to all other federal treatment standards established for methadone.