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. Final rule.

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.