DATA Waived Physicians
Customer Service Plan for Registrants (January 2010)
Questions and Answers
Answer: The Drug Enforcement Administration (DEA) and other federal agencies have received numerous inquiries requesting clarification of the three-day (72-hour) exception to the DEA's separate registration requirement for maintenance or detoxification treatment. In addition, confusion continues to exist whether practitioners may prescribe, dispense, or administer Buprenex, a Schedule III controlled substance, for maintenance and detoxification treatment.
A practitioner who wants to use Schedule II narcotic drugs for maintenance and/or detoxification must obtain separate registration from DEA as a narcotic treatment program pursuant to the Narcotic Addict Treatment Act of 1974. This registration allows a practitioner to administer or dispense, but not prescribe, scheduled narcotic drugs that are approved by the United States Food and Drug Administration (FDA) for the treatment of narcotic addiction. Methadone and levo-alpha-acetyl-methadol (LAAM) are the only scheduled narcotics approved by FDA for use in maintenance and detoxification treatment. If a practitioner plans to use any other narcotic drug for addiction treatment, prior authorization must be obtained from FDA through an Investigational New Drug Application. Registration with DEA is contingent upon proper registration with the State Methadone Authority and the United States Department of Health and Human Services (HHS).
An exception to the registration requirement, known as the "three day rule" (Title 21, Code of Federal Regulations, Part 1306.07(b)), allows a practitioner who is not separately registered as a narcotic treatment program, to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient's referral for treatment, under the following conditions:
Not more than one day's medication may be administered or given to a patient at one time;
This treatment may not be carried out for more than 72 hours and;
This 72-hour period cannot be renewed or extended.
The intent of 21 CFR 1306.07(b) is to provide practitioner flexibility in emergency situations where he or she may be confronted with a patient undergoing withdrawal. In such emergencies, it is impractical to require practitioners to obtain a separate registration. The 72-hour exception offers an opioid dependent individual relief from experiencing acute withdrawal symptoms, while the physician arranges placement in a maintenance/detoxification treatment program. This provision was established to augment, not to circumvent, the separate registration requirement. It should be noted that although Buprenex, a Schedule III controlled substance, is currently approved for the treatment of pain, it may not be prescribed or dispensed for use in narcotic addiction treatment, including the treatment of withdrawal symptoms as provided above under the three-day rule.
New legislation signed into law on October 17, 2000, known as the Children's Health Act of 2000, includes Sections 3501-3502 of the Drug Addiction Treatment Act of 2000 (DATA). DATA amends 823(g) of the Controlled Substances Act by allowing practitioners to dispense or prescribe Schedule III, IV or V controlled substances specifically approved by the FDA for narcotic addiction treatment. These practitioners must notify the Secretary of HHS in writing of their intent to engage in this type of activity and must certify that they are qualified through appropriate measures such as state licensure, certification, training or experience in the area of addiction treatment. The practitioner will then be authorized to dispense and/or prescribe under the authority of his/her DEA practitioner registration. Upon receiving positive determination from HHS that the practitioner meets all the requirements for the exemption, DEA will assign a unique identification number to the practitioner's DEA registration.
On October 8, 2002, the FDA approved two high-dose schedule III formulations of sublingual buprenorphine drug products (Suboxone® and Subutex®) for use in narcotic addiction treatment.
Question: I am a practitioner who has received a waiver to treat opioid dependent patients pursuant to the Drug Addiction Treatment Act of 2000 (DATA). Since receiving my waiver, I have moved my primary practice location. Who do I notify of this address change and how?
Answer: Each DATA Waived Physician (DWP) is responsible for notifying the Department of Health and Human Services' Substance Abuse and Mental Health Services Administration (SAMHSA) and DEA of a change in his/her primary practice address.
A "Change of Address" request to SAMHSA should be made through the Center for Substance Abuse Treatment (CSAT) by:
- Using the Update Physician Contact Module on the Buprenorphine SAMHSA web site,
Additional information regarding HHS policies and regulations concerning the DATA and DWPs may be found on the following SAMHSA/CSAT website at https://www.samhsa.gov/medication-assisted-treatment/buprenorphine-waiver-management
Additionally, a modification of registration is required by DEA when a practitioner moves to a new physical location. Modifications are handled in the same manner as applications and must be approved by DEA. A modification of registration can be requested online at www.DEAdiversion.usdoj.gov or in writing to the local DEA Registration Program Specialist responsible for the area in which the practice is located. If the change of address involves a change in the state, the proper state issued license and, if applicable, state controlled substances registrations must be obtained prior to the approval of modification of the federal registration. If the modification is approved, DEA will issue a new certificate of registration. The registrant should maintain the new certificate with the old certificate until expiration.