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###### Department of Health and Human Services

###### Substance Abuse and Mental Health Services Administration 

          - 42 CFR Part 9 

# 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                           ( print 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]

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