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Can an “alcohol treatment center” (ATC) maintain and/or detoxify their patients with methadone from hospital pharmacy stock without a separate registration?

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Can an “alcohol treatment center” (ATC) maintain and/or detoxify their patients with methadone from hospital pharmacy stock without a separate registration?

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NOTE: Prior to admission into the ATC, these patients were enrolled in NTPs, and each patient currently receives a supply of methadone from his/her NTP. Answer: Yes. Medical treatment has been interpreted by both DEA and FDA to include psychological as well as physiological treatment, and, as such, a primary psychiatric diagnosis of alcoholism would be considered medical treatment of a condition other than addiction. Treatment provided at ATCs registered with DEA as hospitals/clinics falls under the regulatory provision related to the administering/dispensing of narcotics for addiction treatment as an incidental adjunct to medical treatment of conditions other than addiction. [21 CFR 1306.07(c)]. An ATC which is not located in a hospital setting and equipped with pharmacy services may not be authorized to administer or dispense narcotics for treatment without separate registration as an NTP. Such an ATC, however, can administer methadone supplied by the NTP in which the patient is enro

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