[Federal Register Volume 65, Number 87 (Thursday, May 4, 2000)]
[Proposed Rules]
[Pages 25894-25895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10969]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

42 CFR Part 9


Opioid Drugs in Maintenance and Detoxification Treatment of 
Opiate Addiction; Conditions for the Use of Partial Agonists Treatment 
Medications in the Office-Based Treatment of Opiate Addiction

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice of intent to issue regulations.

-----------------------------------------------------------------------

SUMMARY: The Secretary, Department of Health and Human Services, is 
announcing its intent to develop and issue regulations to address the 
use of approved partial agonist treatment medications in the ``office-
based'' treatment of opiate addiction.

FOR FURTHER INFORMATION CONTACT:  Nicholas Reuter, Center for Substance 
Abuse Treatment (CSAT), SAMHSA, 5600 Fishers Lane, Rockville, MD 20857, 
301-443-0457.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 4 of the Comprehensive Drug Abuse Prevention and Control 
Act of 1970 (Pub. L. 91-513) requires the Secretary of Health and Human 
Services (the Secretary) to determine the appropriate methods of 
professional practice for the medical treatment of narcotic addiction. 
In addition, the Narcotic Addict Treatment Act of 1974 (Pub. L. 93-281) 
amended the Controlled Substances Act (21 U.S.C. 823) to require that 
practitioners who wish to dispense narcotic drugs to individuals for 
the maintenance treatment or detoxification treatment of narcotic 
addiction must be registered annually with the Department of Justice, 
Drug Enforcement Administration (DEA). Registration depends, in part, 
upon a determination by the Secretary that the applicant is qualified, 
under treatment standards established by the Secretary, to provide such 
treatment. In addition, the applicant must comply with standards 
established by the Secretary (after consultation with DEA) respecting 
the quantities of narcotic drugs that may be provided for unsupervised 
use by individuals in such treatment. Finally, the applicant must 
comply with standards established by DEA respecting security of stocks 
of narcotic drugs used

[[Page 25895]]

for such treatment and maintenance of records on such drugs.
    These statutory mandates have been reflected in treatment 
regulations that have been enforced by the Food and Drug Administration 
(FDA) since 1972. EDA has approved over 900 ``narcotic treatment 
programs'' under these regulations. Up until 1993, methadone was the 
only narcotic treatment medication approved for use under these 
regulations. In 1993, the regulations were revised to add regulatory 
standards for the use of levo-alpha-acetyl-methadol (LAAM), following 
review and approval of a New Drug Application (NDA) for this use by 
FDA.
    FDA has received and is reviewing NDAs for two new narcotic 
treatment medications, buprenorphine and buprenorphine/naloxone 
(buprenorphine/nx). If approved, both products must be the subject of 
treatment standards.
    The Secretary recognizes that partial or mixed agonist medications, 
are different than full agonists, such as methadone and LAAM. The 
Secretary has, therefore, determined that these differences warrant a 
different treatment standard model:

    The Secretary notes that there are new medications under 
development for the treatment of opioid addiction. While still under 
investigation and review, it is conceivable that these new 
medications will present safety and effectiveness profiles that 
differ from the existing approved treatment medications, methadone 
and LAAM. A new medication, for example, could rely on weak or 
partial agonist properties or on mixed agonist-antagonist 
properties, with pharmacokinetic and pharmacodynamic properties that 
would minimize the risk of deliberate abuse through injection and, 
in turn, would minimize the overall risk of diversion. As such, it 
may be appropriate to tailor the Federal opioid treatment standards 
to the specific characteristics of these future medications. (See 
Federal Register, July 22, 1999, 64 FR 39810.)

    Because of their special characteristics, partial agonist 
medications should be the subject of specific treatment standards. 
Indeed, partial agonist medications' pharmacological properties and 
safety profiles warrant a new paradigm in narcotic addiction treatment, 
office-based treatment. Therefore, the Department of Health and Human 
Services is announcing its intent to develop and issue a proposed rule 
that will address the use of partial agonist treatment medications in 
the office-based treatment of narcotic addiction.

II. Office-Based Treatment of Narcotic Addiction

    The Department is preparing a proposed rule for publication in the 
near future that will address the use of approved narcotic partial 
agonist treatment drugs controlled in Schedules III-V, in office-based 
settings. The proposed rule will include standards and procedures for 
determining the training and experience necessary to safely and 
effectively treat opiate addicts with partial agonist treatment 
medications in an office-based setting. This may include limits on the 
number of patients that may be treated by any one office-based 
physician. In addition, the proposal will include standards that relate 
to medical and psychosocial services, including counseling, that should 
be available to patients that are determined to need them. The proposed 
rule will include standards respecting the quantities of medications 
that may be prescribed, dispensed or administered to patients for 
unsupervised use.
    In anticipation of the availability of partial agonist treatment 
medications, a Subcommittee on Buprenorphine was formed as part of 
SAMHSA's Center for Substance Abuse Treatment (CSAT) National Advisory 
Council. The Subcommittee considered the available research base on 
buprenorphine, office-based settings, and Federal oversight during two 
public meetings. The full CSAT National Advisory Council, after 
deliberation, adopted the Subcommittee's findings and recommendations 
which were subsequently conveyed to CSAT by the Council on June 11, 
1999, in the form of a comprehensive report. The report may be obtained 
by notifying the CSAT contact listed above. The report is also 
available at the SAMHSA website (www.samhsa.gov).
    SAMHSA believes that a key feature of office-based treatment will 
be the ability of the office-based physician to prescribe partial 
agonist treatment medications to patients in treatment. Without the 
ability to prescribe, office-based physicians would have to store and 
dispense medications directly to patients. These practices could be 
expensive and impractical for the patient and office-based physician. 
Current regulations enforced by the Drug Enforcement Administration (21 
CFR 1306.07(a)) prohibit prescriptions for narcotics drugs used in the 
treatment of narcotic addiction. However, DEA is preparing a separate 
proposed rule to rescind this prohibition as it pertains to narcotic 
treatment drugs controlled in Schedules III-V.

III. References

    1. Using Buprenorphine for Office-Based Treatment of Opiate 
Addiction, Recommendations to the Center for Substance Abuse Treatment.

    Dated: December 29, 1999.
Nelba Chavez,
Administrator, Substance Abuse and Mental Health Services 
Administration.

    Dated: March 30, 1999.
Donna E. Shalala,
Secretary, Health and Human Services.
[FR Doc. 00-10969 Filed 5-3-00; 8:45 am]
BILLING CODE 4162-20-M