us-doj-guidance-DEA-DC-024•COVID-19 Q&A Mail Methadone
Question: Can a narcotic treatment program (NTP) mail methadone to enrolled patients at their home using the U.S Postal Service? Answer: No – The Controlled Substances Act (CSA) generally permits the dispensing and delivery of controlled substances by mail from a DEA-registered pharmacy to a legitimate ultimate user pursuant to a valid prescription. However, the CSA and DEA regulations include additional controls for narcotic drugs used for maintenance or detoxification treatment. See 21 U.S.C. 823(g); 21 CFR 1301.28, 1301.74(i)-(l), 1306.07. Due to the high risk of diversion posed by maintenance or detoxification treatment using the schedule II narcotic methadone, DEA regulations provide that an NTP may not prescribe methadone for maintenance or detoxification treatment, and may only administer or dispense it directly to a narcotic dependent person for the purpose of maintenance or detoxification treatment. 21 CFR 1301.74(i), 1306.07. Recently, in light of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020, DEA has waived some of the limitations regarding methadone dispensing for maintenance and detoxification treatment to ensure continued access during the COVID-19 (Coronavirus) emergency. At this time, DEA has authorized employees of the NTP to personally deliver methadone to patients who otherwise cannot travel to the NTP (DEA NTP Delivery Guidance). In addition, DEA has issued a waiver to permit law enforcement and National Guard personnel to deliver methadone directly to patients of NTPs (DEA NTP Delivery Guidance). However, it remains the assessment of the DEA Diversion Control Division that the potential for diversion and abuse of methadone for maintenance and detoxification treatment of narcotic dependent persons is too high to extend the waiver further to permit dispensing via the U.S. Postal Service or other common carriers. Thus, DEA’s regulations prohibiting such delivery have not been waived and remain in effect. Guidance documents, like this document, are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance document that is not accessible through the Department’s guidance portal, or similar guidance portals for other Executive Branch departments and agencies, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department’s complete discretion, consistent with applicable laws. DEA070 - March 24, 2020
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