Emergency Narcotic Addiction Treatment
The Drug Enforcement Administration (DEA) and Center for Substance Abuse Treatment (CSAT) have received numerous inquiries requesting clarification of the three- day (72 hour) exception to the separate registration requirement for maintenance or detoxification treatment. In addition, confusion continues to exist whether practitioners may prescribe Buprenex, a Schedule III Schedule V controlled substance for maintenance and detoxification treatment.
A practitioner who dispenses Schedule II narcotic drugs for maintenance and/or detoxification must obtain separate registration 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, Schedule II 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 drugs approved 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 Health and Human Services.
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 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.
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 Health and Human Services 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 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.
Although the Drug Addiction Treatment Act of 2000 allows the dispensing and prescribing of approved Schedule III, IV and V controlled substances for narcotic addiction treatment, it is important to emphasize at the present time there are no buprenorphine products approved for narcotic addiction treatment. Buprenorphine products are currently under development for use in the treatment of narcotic addiction; however, they have not been approved for marketing. Furthermore, it should be noted that although Buprenex, a Schedule III Schedule V controlled substance, is currently approved for the treatment of pain, it may not be prescribed for use in narcotic addiction treatment.
Hopefully, this letter has clarified the exception to the separate registration requirement in providing narcotic treatment services as well as the status of using Buprenex and other narcotic drugs in the treatment of opioid addiction.
Laura M. Nagel
Deputy Assistant Administrator
Office of Diversion Control