Methadone Federal Drug Laws

[drhemi70]

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All,
I am looking for a law reference such as "title 21 chapter 1306 paragraph 1 subsection b of the federal code of regulations," That describes the law which states that pharmacists may not dispense methadone with an indication of detoxification or maintenance of opiate addiction. It should also state that a MD may not prescribe methadone for the maintenance of addiction unless they are part of an opiate addiction treatment program. I am getting ready to write hospital protocol on how methadone clinic patients will be handled at our hospital.
I have looked numerous places including Abood's law book, section 5 of title 1 comprehensive drug abuse prevention and control act of 1970, section 3 of the narcotic addict treatment act of 1974 and the drug addiction treatment act (DATA 106-310).
I have failed to find the law to specifically quote. Our basic premise will be ambulatory care type of patients (ED admits) will not be able to receive methadone or a prescription for it to maintain detoxification. If the patient is admitted then they will be able to receive a continuation of their therapy once their specific methadone clinic has been contacted and confirms that they are indeed a methadone clinic patient.
If any of you have specific methadone policies in your hospital and would like to share please let me know.
Thanks for the help,
DR

 

[MountainPharmD]

You are writing the protocol and you cannot find this info?

From the Pharmacists Manual on the DEA's website;

Opioid (Narcotic) Addiction Treatment Programs
The Narcotic Addiction Treatment Act of 1974 and the Drug Addiction Treatment Act (DATA) of 2000 amended the CSA with respect to the use of controlled substances in the medical treatment of opioid addiction. These laws established the procedures for approving and licensing practitioners involved in the treatment of opioid addiction as well as improving the quality and delivery of that treatment to the segment of society in need.

Practitioners wishing to prescribe and dispense FDA approved schedule II controlled substances (i.e., methadone) for maintenance and detoxification treatment must obtain a separate DEA registration as a Narcotic Treatment Program via a DEA Form 363 which may be completed online at www.DEAdiversion.usdoj.gov. In addition to obtaining this separate DEA registration, this type of activity also requires the approval and certification by the Center for Substance Abuse Treatment (CSAT) within the Substance Abuse and Mental Health Services Administration (SAMHSA) of the U.S. Department of Health and Human Services as well as the applicable state methadone authority.

If a practitioner wishes to prescribe or dispense schedules III, IV, or V controlled substances approved by the FDA for addiction treatment (i.e., Suboxone® or Subutex® drug products), the practitioner must request a waiver from CSAT which will then notify DEA of all waiver requests. These practitioners are referred to as DATA waived practitioners.

DATA waived practitioners may treat 30 or 100 patients at any one time, dependent on individual authorization from CSAT. Upon authorization by CSAT, DEA will issue a new DEA certificate of registration bearing (1) the DEA registration number, (2) a unique identification number, and (3) the corresponding business activity to identify whether the physician is authorized to treat 30 or 100 patients. Pursuant to 21 C.F.R. §1301.28(d), the practitioner is required to include the identification number on all records when dispensing and on all prescriptions when prescribing Schedules III, IV, or V narcotic controlled drugs for use in maintenance or detoxification treatment. The listing of the identification number on a prescription is in addition to all other information required on a valid prescription to include the practitioner's DEA registration number (see Section IX, Valid Prescription Requirements).

This covers the federal part. If you are looking for something specific on what a Pharmacist can dispense then you need to check your State Board of Pharmacy website.

 

[drhemi70]

Mountain,
Thanks for the reply, I had seen the both the NATA and the DATA amendments to the CSA, and had referenced them in my original question. I wanted to know if federal law addressed exactly what indications the pharmacist could dispense methadone under. Thanks for pointing me towards state law for this.
Thanks,
DR