Opioid Treatment Programs Can Now Offer Buprenorphine

SAMHSA has announced an interim final rule that will permit opioid treatment programs serving persons addicted to heroin or narcotic pain relievers to offer buprenorphine treatment along with methadone and ORLAAM.

The rule enables opioid treatment programs that are certified by SAMHSA to use newly approved buprenorphine products, Subutex® and Suboxone®, for the maintenance or detoxification treatment of dependence on opioids such as heroin or prescription pain relievers. The rule went into effect May 22, 2003, with a comment period open for 60 days, until July 21.

"The availability and application of buprenorphine marked a new day in the treatment of addiction," said SAMHSA Administrator Charles G. Curie, M.A., A.C.S.W. "With this interim final rule, physicians for opioid treatment programs will be able to improve, expand, and tailor treatment for the individual needs of their patients."

This amendment to the rules for opioid treatment programs will give these 1,200 programs two more medications for their approximately 205,000 patients. As with other medical conditions, some patients will do better with one of the buprenorphine medications while others will require methadone or ORLAAM.

Subutex® is formulated as a sublingual tablet that contains either 2 or 8 milligrams of buprenorphine. Suboxone® is a fixed combination sublingual tablet that contains 2 milligrams of buprenorphine with 0.5 milligrams of naloxone, or 8 milligrams of buprenorphine together with 2 milligrams of naloxone. Naloxone is an opioid antagonist and is present in the Suboxone® formulation to reduce its risk of intravenous abuse.

To offer these buprenorphine medications, opioid treatment programs will need to review their state licensing laws and regulations, and modify their registration with the Drug Enforcement Administration (DEA) to add Schedule III narcotics to their registration certificates. Opioid treatment programs can initiate this process by fax or letter. The letter should include the opioid treatment program's DEA registration number and request that the registration be amended to list Schedule III narcotic drugs. In addition, the letter must be signed by the program sponsor (program director) or medical director.

The completed letter can be either faxed to Ms. Ghana Giles at (202) 353-1125 or mailed to her at DEA, Registration Unit-ODRR, Washington, DC 20537. Following receipt and review, DEA will issue a modified registration certificate to each opioid treatment program. Opioid treatment programs may contact their local DEA office for additional information on the status of their registration modification.

Interested opioid treatment programs may contact DEA by telephone at 1 (800) 882-9539 or online at www.deadiversion.usdoj.gov/drugreg/
change_requests/sched_change.htm.

Once registration is modified, opioid treatment programs can order Subutex® and Suboxone® directly from the product manufacturer by calling 1 (866) 882-2107.

Comments on the interim final rule should be submitted to DPT Federal Register Representative, Division of Pharmacologic Therapy, Center for Substance Abuse Treatment, SAMHSA, Rockwall II, Room 6-18, 5600 Fishers Lane, Rockville, MD 20857. Comments can be faxed to (301) 443-3994 or e-mailed to DPT_Interimrule@samhsa.hhs.gov. Closing date for comments is July 21, 2003.

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