Albuquerque Substance Abuse Clinic; Denial of Hearing and Revocation of Approval of a Narcotic Addiction Treatment Program; Final Order

Resumo

The Food and Drug Administration (FDA) is revoking approval of an ``Application for Approval of Use of Methadone in a Treatment Program'' (Form FDA-2632) held by Albuquerque Substance Abuse Clinic, Inc. (ASAC). The sponsor has failed to demonstrate the ability to correct and prevent violations of FDA's methadone regulation. Also, FDA is denying ASAC's request for hearing because they failed to submit information showing that there is a genuine issue of fact to justify a hearing.