Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Narcotic Treatment Programs Best Practice Guideline

APPENDIX A

ANSWERS TO FREQUENTLY ASKED QUESTIONS

Treatment Outside an NTP


Question: As a practicing physician, I want to open a "medication unit" in my office to dispense methadone to patients enrolled in an NTP. The methadone will not be stored overnight. Must I be registered with DEA?

Answer: Yes. Although FDA does not require a separate registration, you must have a separate DEA registration to conduct maintenance/detoxification treatment even though you do not store methadone overnight. It is the activity (dispensing/administering) that must be registered. [21 CFR 1306.07(a)].


Question: I am a physician with a patient who is addicted to opioids. How can I treat this patient?

Answer: You may administer opioids to a patient for the purpose of relieving acute withdrawal symptoms while arrangements are made to refer your patient for addiction treatment, under the following conditions [21 CFR 1306.07(b)]:

  • Not more than one day’s medication may be administered or given to your patient at one time,
  • This treatment may not be carried out for more than three days, and
  • This three-day period cannot be renewed or extended.

Question: An NTP patient has been admitted to a hospital for treatment of a medical condition other than addiction. Can the hospital supply the treatment medication?

Answer: Yes. A physician, or authorized hospital staff, may administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction. [21 CFR 1306.07(c)].


Question: Can a patient in a Long Term Care Facility (LTCF) receive methadone for maintenance purposes?

Answer: If an LTCF is registered with DEA as a hospital/clinic, it need not be separately registered as an NTP to administer or dispense methadone as an adjunct to medical or surgical treatment of conditions other than addiction. [21 CFR 1306.07(c)]

If an LTCF that is not registered with DEA as a hospital/clinic has a patient who is also currently enrolled in a licensed NTP, the NTP may transfer medication to the LTCF with the approval of the State Methadone Authority.

If an individual not currently enrolled in an NTP is in an LTCF that is not registered with DEA as a hospital/clinic or an NTP, a practitioner may administer narcotic drugs to the individual for relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. No more than one day's medication may be administered to the individual or for the individual's use at one time. Such emergency treatment may be carried out for no more than three days and may not be renewed or extended. [21 CFR 1306.07(b)]


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

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 enrolled.


Question: May an inmate enrolled in an NTP have methadone administered by Department of Corrections medical staff, if the facility does not have a separate registration as an NTP?

Answer: Yes. Medical staff of the Department of Corrections may administer narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made to have methadone supplied by the inmate’s NTP. A separate registration would not be required provided that no more than one day’s medication be administered to the person or for the person’s use at one time. Such treatment is limited to three days and may not be renewed or extended. [21 CFR 1306.07(b)].


Question: May a Department of Corrections medical staff administer methadone to incarcerated, pregnant, opioid dependent women during the course of their pregnancy without a separate registration as an NTP?

Answer: Methadone may be administered in such circumstances when the following conditions are met. A practitioner, or authorized hospital staff, may administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction. Pregnancy is recognized as a medical condition by both DEA and FDA, and, therefore, this would be considered medical treatment of a condition other than addiction.

Such medical treatment is allowed "in a hospital" or institutional setting. However, the Department of Corrections must be licensed by both the state and DEA as a clinic, a hospital, or a hospital/clinic. [21 CFR 1306.07(c)]


Question: Does a nurse have the authority to administer methadone pursuant to a physician’s medication order to an inmate?

Answer: Yes. If, as an agent of the practitioner, the nurse is so authorized by the state, she/he may act on behalf of, or at the direction of, the staff physician, pursuant to the physician’s order for medication, and may administer the methadone to the inmate.


Question: Can I obtain an exception to a separate registration as an NTP to provide methadone maintenance to HIV infected opioid dependent patients who reside in nursing homes?

Answer: An HIV infected opioid dependent patient residing in a nursing home may receive medication only under the following conditions:

  1. If the nursing home is not separately registered with DEA as an NTP, and the patient is currently enrolled in a licensed NTP, the NTP may deliver the patient’s medication to the nursing home.
  2. If the nursing home is registered with DEA as an institutional practitioner (hospital), a practitioner or authorized hospital staff may administer or dispense narcotics to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment. In this example, the primary medical condition is the patient’s HIV infection. Therefore, medication could be dispensed to this patient as an incidental adjunct to his/her treatment.

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