DEA, Manufacturers Limit Supply of 40mg Methadone Tablets

The U.S. Drug Enforcement Administration's Office of Diversion Control says manufacturers of 40mg (dispersible) methadone hydrochloride tablets have voluntarily agreed to restrict distribution of them to hospitals and facilities authorized for detoxification and maintenance treatment of opioid addiction as of Jan. 1, 2008. The manufacturers will instruct their wholesale distributors not to supply the tablets to any facility not meeting those criteria.

SAMHSA, the Substance Abuse and Mental Health Services Administration (www.sahmsa.gov), published the ODC Advisory (www.deadiversion.usdoj.gov/pubs/pressrel/methadone_advisory.htm) on its Web site last month.

The 5mg and 10mg formulations used for pain relief will continue to be available to all authorized registrants, including pharmacies, but the 40mg tablets are not FDA-approved for pain management. Dated Dec. 10, the Advisory said DEA and the pharmaceutical industry agreed that the reported increase in methadone-related adverse incidents merits action and agreed on a united effort to ensure methadone is properly distributed.

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