[Federal Register Volume 68, Number 121 (Tuesday, June 24, 2003)]
[Proposed Rules]
[Pages 37429-37434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15787]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1301, 1306

[Docket No. DEA-202P]
RIN 1117-AA68


Authority for Practitioners To Dispense or Prescribe Approved 
Narcotic (Opioid) Controlled Substances for Maintenance or 
Detoxification Treatment

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: DEA proposes to amend its regulations to allow qualified 
practitioners to dispense and prescribe to narcotic (opioid) dependent 
persons Schedule III, IV, and V narcotic (opioid) controlled drugs 
approved by the Food and Drug Administration specifically for use in 
maintenance or detoxification treatment. These practitioners would not 
need to obtain a separate DEA registration as a narcotic treatment 
program to legally dispense or prescribe these drugs. Such 
practitioners, however, must be deemed ``qualifying physicians'' by the 
Secretary, Department of Health and Human Services. This notice of 
proposed rulemaking is in response to the recent amendments to the 
Controlled Substances Act by the Drug Addiction Treatment Act of 2000 
(DATA), title XXXV of the Children's Health Act of 2000 (Pub. L. 106-
310), that are designed to expand and improve treatment of opioid 
addiction. The proposed regulations are intended to accomplish the 
goals of DATA while preventing the diversion of Schedule III, IV, and V 
narcotic (opioid) controlled drugs approved by the Food and Drug 
Administration specifically for maintenance/detoxification treatment.

DATES: Written comments must be postmarked on or before September 22, 
2003.

ADDRESSES: Comments should be submitted to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Attention: DEA Federal Register 
Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:

What Change in the Current Regulations Is This Notice Proposing?

    With passage of the Drug Addiction Treatment Act of 2000 (DATA), 
title XXXV of the Children's Health Act of 2000 (Pub. L. 106-310; 116 
Stat. 1222), this notice of proposed rulemaking proposes to amend the 
regulations affecting maintenance and detoxification treatment for 
narcotic (opioid) addiction. The Controlled Substances Act (CSA) and 
current regulations require that practitioners who want to conduct 
maintenance or detoxification treatment using narcotic (opioid) 
controlled drugs be registered with DEA as narcotic treatment programs 
(NTPs) in addition to the practitioners' personal registrations. The 
separate NTP registrations authorize the practitioners to dispense or 
administer, but not prescribe, narcotic (opioid) controlled drugs.
    Proposed Sec.  1301.27 would establish an exemption from the 
separate registration requirement for qualified

[[Page 37430]]

practitioners dispensing or prescribing Schedule III, IV, and V 
narcotic (opioid) controlled drugs approved by the Food and Drug 
Administration (FDA) specifically for use in maintenance or 
detoxification treatment (see also proposed amendments to Sec. Sec.  
1306.04(c) and 1306.07). This NPRM would allow ``qualifying 
physicians,'' whether they are already registered as NTPs or not, to 
dispense and prescribe Schedule III, IV, and V narcotic (opioid) 
controlled drugs or combinations of controlled drugs approved by FDA 
specifically for use in maintenance or detoxification treatment. (On 
October 8, 2002, FDA approved two products containing buprenorphine, 
subutex and suboxone, Schedule III controlled drugs, for use in 
maintenance and detoxification treatment.) Under this proposed rule, 
practitioners permitted to dispense and prescribe Schedule III, IV, and 
V narcotic (opioid) controlled drugs approved by FDA specifically for 
use in maintenance or detoxification treatment would not be required to 
have separate DEA registrations as NTPs. DEA is taking this proposed 
action in conjunction with the Department of Health and Human Services' 
(HHS) adoption of the concept of Office-Based Opioid Treatment. 
Proponents believe that the changes proposed here would provide greater 
access to narcotic (opioid) addiction treatment, and permit expanded 
treatment services. This action also responds to the recent amendment 
to the Controlled Substances Act by the Drug Addiction Treatment Act of 
2000. This proposed rule would not affect the existing prohibition 
against prescribing any Schedule II narcotic (opioid) controlled drugs 
for maintenance or detoxification treatment.
    The proposed rule would:
    (1) Permit qualifying physicians to dispense and prescribe Schedule 
III, IV, and V narcotic (opioid) controlled drugs approved by FDA 
specifically for use in maintenance or detoxification treatment;
    (2) Permit opioid dependent patients to have one-on-one 
consultations with a practitioner in a private practice setting;
    (3) Permit pharmacies to fill prescriptions for Schedule III, IV, 
and V narcotic (opioid) controlled drugs approved by FDA specifically 
for use in maintenance or detoxification treatment; and
    (4) Permit practitioners to offer maintenance and detoxification 
treatment in their private practices without having a second 
registration as a NTP.
    This proposed rule would apply to individual practitioners working 
in traditional NTPs or any other practice setting.

What Is the Legal Basis for Providing Maintenance or Detoxification 
Treatment?

    Congress passed the Harrison Narcotic Act of 1914 to fulfill U.S. 
obligations to uphold the international Opium Convention signed at the 
Hague in 1912. The Act was the first comprehensive federal legislation 
to place controls on licit pharmaceuticals and allowed practitioners to 
prescribe narcotics (opioids) only for legitimate medical purposes in 
the course of their professional practice. It did not permit the 
prescribing of narcotics (opioids) simply to support or maintain an 
addiction.
    During the late 1960s and the early 1970s, drug substitution 
therapy for addiction treatment using methadone was introduced as a 
medical modality and was considered ``research,'' that is, still 
outside the scope of ``medical treatment.'' At that time, medical and 
legal standards governing the use of methadone in addiction treatment 
programs did not exist. In effect, there were no clear means for 
differentiating legitimate treatment efforts using the drug as part of 
a comprehensive program of treatment services from bogus clinics or 
unethical practitioners distributing methadone to addicts under the 
guise of treatment. As a result the diversion of methadone was 
occurring on a large-scale basis.
    In 1970, Congress passed the Comprehensive Drug Abuse Prevention 
and Control Act (Pub. L. 91-513), which consolidated existing Federal 
drug control statutes, and created new laws regarding activities 
pertaining to controlled drugs. Title II of this legislation, also 
known as the Controlled Substances Act, regulates the manufacture and 
distribution of controlled drugs. However, the issues of maintenance 
treatment and detoxification treatment were not addressed.
    In the mid-1970s, methadone maintenance treatment became the 
subject of intense policy debate, and Congress passed the Narcotic 
Addict Treatment Act of 1974. This amendment to the Controlled 
Substances Act required practitioners who wished to conduct 
maintenance/detoxification treatment to obtain separate registration as 
NTPs. To be registered as NTPs, practitioners must comply with DEA 
requirements for secure drug storage and record keeping; must be 
qualified under the treatment standards established by the Department 
of Health and Human Services (HHS); and must comply with standards 
established by HHS (after consultation with DEA) regarding quantities 
of narcotic (opioid) drugs for unsupervised take-home use by persons 
undergoing addiction treatment (21 U.S.C. 823(g)). Since the mid-1970s, 
products containing methadone and, by the 1990's products containing 
levo-alpha-acetyl-methadol (LAAM), which are Schedule II controlled 
substances, have been approved by FDA specifically for use in 
maintenance or detoxification treatment. (On October 8, 2002, FDA 
approved buprenorphine products, Schedule III controlled drugs, for use 
in maintenance and detoxification treatment.)
    The Narcotic Addict Treatment Act allows practitioners to dispense 
narcotic (opioid) drugs for maintenance or detoxification treatment. 
Under this legislation the term dispense means to deliver a controlled 
drug to an ultimate user under a lawful order of a practitioner, 
including the prescribing and administering of a controlled drug. 
However, as drug replacement therapy was considered research at that 
time, and to ensure public health and safety, practitioners were 
restricted to administering and dispensing (other than by prescription) 
controlled drugs for maintenance or detoxification treatment. After 
passage of the Narcotic Addict Treatment Act, such drug replacement 
therapy was no longer considered research.
    Today treatment experts view addiction as a medical condition, 
which should be treated as a chronic disease, and believe that drug 
replacement therapy is a viable form of medical treatment for opioid 
dependent individuals. On October 17, 2000, Congress passed DATA, 
amending the Controlled Substances Act to establish ``waiver authority 
for physicians who dispense or prescribe certain narcotic (opioid) 
drugs for maintenance treatment or detoxification treatment'' (Pub. L. 
106-310, title XXXV; 116 Stat. 1222). When the DATA bill was introduced 
in the United States Senate, it was described as follows:

    The goal of the DATA provisions is simple but it is important: 
The DATA bill attempts to make drug treatment more available and 
more effective to those who need it. This legislation focuses on 
increasing the availability and effectiveness of drug treatment. The 
purpose of the Drug Addiction Treatment Act is to allow qualified 
physicians, as determined by the Department of Health and Human 
Services, to prescribe schedule III, IV and V anti-addiction 
medications in physicians' offices without an additional Drug 
Enforcement Administration, DEA, registration if certain conditions 
are met.


[[Page 37431]]


146 Cong. Rec. S9262 (daily ed. Sept. 26, 2000).

What Are the Conditions for Qualifying for the Proposed Sec.  1301.27 
Exemption From Separate Registration for Practitioners Dispensing or 
Prescribing Schedule III, IV, and V Narcotic Drugs Approved by FDA 
Specifically for Use in Maintenance or Detoxification Treatment?

    There are two main sets of conditions involved in the proposed 
exemption: Conditions with respect to the practitioner and conditions 
with respect to the Schedule III, IV, or V narcotic (opioid) drugs 
approved by FDA specifically for use in maintenance or detoxification 
treatment. To qualify for the proposed exemption, a practitioner would 
have to submit notification to HHS stating his or her intent to 
dispense or prescribe narcotic (opioid) controlled drugs to opiate-
dependent patients and certifying that all of following are true:
    (1) The practitioner is a ``qualifying physician.'' A practitioner 
is a ``qualifying physician'' if he or she is licensed under State law 
and has specific medical certification, training or experience in 
maintenance or detoxification treatment. The Secretary of HHS will 
establish criteria to be used for determining whether a practitioner is 
a ``qualifying physician.''
    (2) The practitioner has the capacity to refer the patients, to 
whom the practitioner will provide specifically approved narcotic 
(opioid) drugs or combinations of narcotic (opioid) drugs, for 
appropriate counseling and other appropriate ancillary services.
    (3) The total number of patients treated for opiate dependence by 
the practitioner who is not a member of a group practice will not 
exceed 30 at any one time, unless modified by regulation by the 
Secretary of HHS.
    (4) If the practitioner is a member of a group practice, the total 
number of patients treated for opiate dependence by the group practice 
of which the practitioner is a member will not exceed 30 at any one 
time, unless modified by regulation by the Secretary of HHS.
    Schedule III, IV and V narcotic (opioid) drugs to be dispensed or 
prescribed must meet the following two conditions:
    (1) They must have been approved by FDA specifically for use in 
maintenance treatment or detoxification treatment.
    (2) They cannot have been the subject of an adverse determination 
by HHS that their use requires additional standards respecting the 
qualifications of practitioners or the quantities of the drugs that may 
be provided for unsupervised use.

What Will Happen After the Practitioner Submits to HHS the Notification 
Under Proposed Sec.  1301.27 of Intent To Dispense or Prescribe 
Narcotic Drugs?

    When HHS receives a notification of intent to dispense or prescribe 
narcotic (opioid) controlled drugs for maintenance or detoxification 
treatment it will forward a copy of the notification to DEA. From the 
date HHS receives the notification it will have up to 45 days to review 
the practitioner's qualifications and make a determination whether the 
practitioner meets all of the requirements for the exemption. While HHS 
is conducting its determination, DEA will conduct its own review to 
determine if the practitioner has the appropriate DEA registration in 
accordance with 21 U.S.C. 823(a) and if there are any adverse 
determinations.
    Once HHS has made its determination, it will send the findings to 
DEA. If DEA determines that the practitioner has the appropriate DEA 
registration in accordance with 21 U.S.C. 823(a) and if there are no 
adverse determinations, then DEA will issue the practitioner an 
identification number as soon as either of the following conditions 
occurs: (1) DEA receives the positive determination from HHS before the 
conclusion of the 45 day review period, or (2) the 45 day review period 
has concluded and no determination by HHS has been received. If HHS 
refuses to certify a practitioner or withdraws such certification once 
it is issued, then DEA will not issue the practitioner an 
identification number, or will withdraw the identification number if 
one has been issued. Under proposed Sec.  1301.27(d) the practitioner 
would be required to include the identification number on all records 
when dispensing and on all prescriptions when prescribing Schedule III, 
IV or V narcotic (opioid) controlled drugs for use in maintenance or 
detoxification treatment.

Would Practitioners Have To Wait Until They Receive an Identification 
Number From DEA Before They Could Dispense or Prescribe Schedule III, 
IV or V Narcotic (Opioid) Drugs Approved by FDA Specifically for Use in 
Maintenance Treatment or Detoxification Treatment?

    The practitioner would not have to wait if the practitioner was in 
compliance with proposed Sec.  1301.27(e). As proposed, the 
practitioner could begin dispensing or prescribing during the 45-day 
review period if all of the following requirements are met:
    (1) The practitioner has submitted, in good faith, a written 
notification under Sec.  1301.27(b).
    (2) The practitioner reasonably believes that the conditions 
specified in Sec. Sec.  1301.27(b) and (c), regarding the practitioner 
and the narcotic (opioid) drugs, have been met.
    (3) Prescribing or dispensing the narcotic (opioid) drugs would 
facilitate the treatment of an individual patient.
    (4) The practitioner has notified both the Secretary of HHS and DEA 
of the intent to do so.
    (5) The Secretary has not issued an order indicating that the 
registrant is not a qualified physician.
    (6) The practitioner has the appropriate DEA registration under 21 
CFR 1301.13.
    The practitioner would be able to satisfy the fourth requirement by 
including within the notification required by proposed Sec.  1301.27(b) 
a statement of his or her intent to immediately commence prescribing or 
dispensing. If HHS refuses to certify a practitioner or withdraws such 
certification once it is issued, then DEA will not issue the 
practitioner an identification number, or will withdraw the 
identification number if one has been issued.

What Happens if a Practitioner Dispenses or Prescribes Schedule III, 
IV, or V Narcotic (Opioid) Drugs in Violation of One of the Conditions 
in Proposed Sec.  1301.27(b)?

    If a practitioner dispenses or prescribes Schedule III, IV, or V 
narcotic (opioid) drugs in violation of any of the conditions specified 
in proposed Sec.  1301.27(b), then DEA may revoke the practitioner's 
DEA registration in accordance with Sec.  1301.36.
    Due to the potential for diversion and in an effort to verify 
compliance with these regulations, DEA intends to conduct at least two 
regulatory investigations per field office per year of practitioners 
dispensing and prescribing to narcotic (opioid) dependent persons 
Schedule III, IV, and V narcotic (opioid) controlled drugs approved by 
the Food and Drug Administration (FDA) specifically for use in 
maintenance or detoxification treatment.

Would the Proposed Requirements Be Applied Differently to Practitioners 
Working in Traditional NTPs as Opposed to Practitioners in Other 
Practice Settings?

    The proposed regulation would affect practitioners working in 
traditional NTPs the same as any other practitioners. If a ``qualifying 
physician'' working in a NTP wants to dispense or

[[Page 37432]]

prescribe Schedule III, IV, and V narcotic (opioid) controlled drugs 
approved by FDA specifically for use in maintenance or detoxification 
treatment, then he or she would have to comply with the proposed 
regulations.

What Additional Requirements Would Apply When a ``Qualifying 
Physician'' Writes a Prescription for Schedule III, IV, and V Narcotic 
(Opioid) Drugs Approved by FDA Specifically for Maintenance or 
Detoxification Treatment?

    Proposed changes to Sec.  1306.05(a) require the practitioner to 
include on the prescription the identification number (issued under 
proposed Sec.  1301.27(d)) or written notice that the practitioner is 
acting under the good faith exception of proposed Sec.  1301.27(e). 
These prescriptions would be subject to all of the existing 
requirements of Part 1306 that apply to prescriptions for controlled 
drugs. To be valid, a prescription must be written for a legitimate 
medical purpose by a practitioner acting in the usual course of his or 
her professional practice (Sec.  1306.04(a)). The prescription must be 
dated and signed on the day issued, must contain the full name and 
address of the patient, the drug name, strength, dosage form, quantity 
prescribed, directions for use, and the name, address, and registration 
number of the practitioner (Sec.  1306.05(a)).
    Under current law practitioners are not normally required to keep 
records of prescriptions issued. However, DEA regulations (Sec.  
1304.03(c)) do require records to be kept by practitioners prescribing 
controlled drugs listed in any schedule for maintenance or 
detoxification treatment of an individual.
    For conformity Sec. Sec.  1306.04, Purpose of issue of 
prescription, and 1306.07, Administering or dispensing of narcotic 
(opioid) controlled drugs, would also be amended by this NPRM. Section 
1306.04(c) currently prohibits the issuance of prescriptions for 
narcotic (opioid) drugs listed in any schedule for ``detoxification 
treatment'' or ``maintenance treatment.'' Under this NPRM, the 
prohibition against prescriptions in Sec.  1306.04(c) would be amended 
to permit prescriptions for Schedule III, IV, and V narcotic (opioid) 
controlled drugs approved by FDA specifically for maintenance or 
detoxification treatment by practitioners who are in compliance with 
proposed Sec.  1301.27.
    Section 1306.07(a) currently permits the administering and 
dispensing (but not prescribing) of narcotic (opioid) drugs for 
detoxification or maintenance treatment only by practitioners who are 
separately registered as a Narcotic Treatment Program. This proposed 
rule would add paragraph (d) to Sec.  1306.07 to permit a practitioner 
to administer or dispense (including prescribe) any Schedule III, IV, 
or V narcotic (opioid) controlled drug approved by FDA specifically for 
use in maintenance or detoxification treatment if the practitioner is 
in compliance with proposed Sec.  1301.27. This NPRM would also revise 
Sec.  1306.07(a) to improve the clarity of the language, but not to 
change the drug of the paragraph.

Could a Practitioner Authorize Refills of Prescriptions for Schedule 
III, IV, or V Narcotic (Opioid) Drugs Approved by FDA Specifically for 
Use in Maintenance or Detoxification Treatment?

    DEA regulations allow practitioners to authorize refills for 
Schedule III, IV, or V controlled drug prescriptions. Prescriptions for 
Schedule III, IV and V controlled drugs are subject to the requirements 
in Sec. Sec.  1306.22 and 1306.23, regarding the refilling and partial 
filling of prescriptions. In addition, practitioners prescribing 
Schedule III, IV, or V narcotic (opioid) drugs for use in maintenance 
or detoxification treatment would be subject to all relevant state and 
federal requirements that apply to prescriptions for controlled drugs.

Under Current Regulations, What Other Requirements Would Apply When a 
Practitioner Administers or Dispenses Schedule III, IV, or V Narcotic 
(Opioid) Drugs Approved by FDA Specifically for Maintenance or 
Detoxification Treatment?

    Practitioners who administer or dispense (other than by 
prescription) Schedule III, IV, or V narcotic (opioid) drugs approved 
by FDA specifically for maintenance or detoxification treatment must 
maintain records and provide security for the controlled drugs in their 
possession. Records required to be maintained include inventories, 
records of receipt, reports of theft or loss, destruction of controlled 
drugs, and records of dispensation. These records must be maintained 
for two years.
    The regulations also require practitioners to safeguard controlled 
drugs (Sec.  1301.75(b)). The Schedule III, IV, or V narcotic (opioid) 
controlled drugs approved by FDA specifically for maintenance or 
detoxification treatment must be stored in a securely locked, 
substantially constructed cabinet.
    Current regulations on prescribing permit the use of a written 
prescription signed by a practitioner. Current regulations also permit 
a practitioner, or the practitioner's agent, to transmit a facsimile of 
a written signed prescription to a pharmacy (Sec.  1306.21). In 
addition, a practitioner may telephone the pharmacy with an oral 
prescription. The pharmacist must immediately reduce the oral 
prescription to writing, including all information required in Sec.  
1306.05, except for the signature of the practitioner (Sec.  
1306.21(a)).

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator, Office of Diversion Control, 
has reviewed this proposed regulation and hereby certifies that it has 
been drafted in accordance with the Regulatory Flexibility Act (5 
U.S.C. 605(b)) and that it will not have a significant economic impact 
on a substantial number of small entities. This proposed rulemaking 
would permit practitioners to prescribe Schedule III, IV and V narcotic 
(opioid) controlled drugs approved by FDA specifically for use in 
maintenance or detoxification treatment without being separately 
registered with DEA as a NTP. Although virtually all entities affected 
would be small, the cost of determining eligibility and applying for a 
waiver is negligible.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this 
proposed rulemaking has been drafted in accordance with the principles 
in Executive Order 12866 Section 1(b). DEA has determined that this is 
not a significant rulemaking action. Therefore, this action has not 
been reviewed by the Office of Management and Budget. As noted above, 
this proposed rulemaking would permit practitioners to prescribe 
Schedule III, IV and V narcotic (opioid) controlled drugs approved by 
FDA specifically for use in maintenance or detoxification treatment 
without being separately registered with DEA as a NTP.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of state 
law; nor does it impose enforcement responsibilities on any state; nor 
does it diminish the power of any state to enforce its own laws. 
Accordingly, this rulemaking does not have Federalism implications 
warranting the application of Executive Order 13132.

[[Page 37433]]

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This rule 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

List of Subjects

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures.

21 CFR Part 1306

    Drug traffic control, Prescription drugs.

    For the reasons set out above, 21 CFR Parts 1301 and 1306 are 
proposed to be amended as follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES--[AMENDED]

    1. The authority citation for part 1301 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 956.

    2. Part 1301 is proposed to be amended by adding Sec. 1301.27 to 
read as follows:


Sec.  1301.27  Exemption from separate registration for practitioners 
dispensing or prescribing Schedule III, IV, or V narcotic (opioid) 
controlled drugs approved by FDA specifically for use in maintenance or 
detoxification treatment.

    (a) A practitioner may dispense or prescribe Schedule III, IV, or V 
narcotic (opioid) controlled drugs or combinations of narcotic (opioid) 
controlled drugs which have been approved by the Food and Drug 
Administration (FDA) specifically for use in maintenance or 
detoxification treatment without obtaining the separate registration 
required by Sec.  1301.13(e) so long as all of the following conditions 
are met:
    (1) The practitioner meets the conditions specified in paragraph 
(b) of this section.
    (2) The narcotic (opioid) drugs or combination of narcotic (opioid) 
drugs meet the conditions specified in paragraph (c) of this section.
    (3) The practitioner is in compliance with either paragraph (d) or 
paragraph (e) of this section.
    (b)(1) The practitioner must submit notification to the Secretary 
of Health and Human Services stating the practitioner's intent to 
dispense or prescribe narcotic (opioid) drugs under paragraph (a) of 
this section. The notice must contain all of the following 
certifications:
    (i) The practitioner is registered under Sec.  1301.13 and is a 
``qualifying physician'' as defined in section 303(g)(2)(G) of the Act 
(21 U.S.C. 823(g)(2)(G)).
    (ii) The practitioner has the capacity to refer the patients to 
whom the practitioner will provide narcotic (opioid) drugs or 
combinations of narcotic (opioid) drugs for appropriate counseling and 
other appropriate ancillary services.
    (iii) Where the practitioner is not a member of a group practice, 
the total number of such patients of the practitioner will not exceed 
30 at any one time, unless regulations promulgated by the Secretary of 
Health and Human Services are modified.
    (iv) Where the practitioner is a member of a group practice, the 
total number of such patients of the group practice will not exceed 30 
at any one time, unless regulations promulgated by the Secretary of 
Health and Human Services are modified.
    (2) In addition, if a practitioner wishes to prescribe or dispense 
narcotic (opioid) drugs pursuant to paragraph (e) of this section, the 
practitioner must provide the following:
    (i) Notification as required under subparagraph (1) of this 
paragraph must be provided in writing, and must state the name of the 
practitioner and the registration number of the practitioner issued 
under Sec.  1301.13.
    (ii) If the practitioner is a member of a group practice, the names 
of the other practitioners in the group and the registration numbers 
issued to the other practitioners under Sec.  1301.13 shall be 
provided.
    (c) The narcotic (opioid) drugs or combination of narcotic (opioid) 
drugs to be dispensed or prescribed under this section must meet all of 
the following conditions:
    (1) The drugs or combination of drugs have been approved for use in 
``detoxification treatment'' or ``maintenance treatment'' under the 
Federal Food, Drug, and Cosmetic Act or section 351 of the Public 
Health Service Act.
    (2) The drugs or combination of drugs have not been the subject of 
an adverse determination by the Secretary of Health and Human Services, 
after consultation with the Attorney General, that the use of the drugs 
or combination of drugs requires additional standards respecting the 
qualifications of practitioners or the quantities of the drugs that may 
be provided for unsupervised use.
    (d) After receiving the notification submitted under paragraph (b) 
of this section, the Secretary of Health and Human Services will 
forward a copy of the notification to the Administrator. The Secretary 
of Health and Human Services will have 45 days from the date of receipt 
of the notification to make a determination of whether the practitioner 
involved meets all requirements for a waiver under Sec.  823(g)(2)(B) 
of the Act (21 U.S.C. 823(g)(2)(B)). HHS will notify DEA of its 
determination regarding the practitioner. If the practitioner has the 
appropriate registration under Sec.  1301.13 of this chapter, then the 
Administrator will issue the practitioner an identification number as 
soon as one of the following conditions occurs:
    (1) The Administrator receives a positive determination from the 
Secretary of Health and Human Services before the conclusion of the 45-
day review period, or
    (2) The 45-day review period has concluded and no determination by 
the Secretary of Health and Human Services has been made. If HHS 
refuses to certify a practitioner or withdraws such certification once 
it is issued, then DEA will not issue the practitioner an 
identification number, or will withdraw the identification number if 
one has been issued. The practitioner must include the identification 
number on all records when dispensing and on all prescriptions when 
prescribing narcotic (opioid) drugs under this section.
    (e) A practitioner may begin to prescribe or dispense narcotic 
(opioid) drugs under this section before receiving an identification 
number from the Administrator so long as the following conditions are 
met:
    (1) The practitioner has submitted a notification under paragraph 
(b) of this section in good faith to the Secretary of Health and Human 
Services.

[[Page 37434]]

    (2) The practitioner reasonably believes that the conditions 
specified in paragraphs (b) and (c) of this section have been met.
    (3) The practitioner reasonably believes that prescribing or 
dispensing narcotic (opioid) drugs under this section before the sooner 
of:
    (i) Receipt of an identification number from the Administrator, or
    (ii) Expiration of the 45-day period would facilitate the treatment 
of an individual patient.
    (4) The practitioner has notified both the Secretary of Health and 
Human Services and the Administrator of his or her intent to begin 
prescribing or dispensing the narcotic (opioid) drugs before expiration 
of the 45-day period.
    (5) The Secretary has not issued an order indicating that the 
registrant is not qualified under paragraph (d) of this section.
    (6) The practitioner has the appropriate registration under Sec.  
1301.13 of this chapter. If HHS refuses to certify a practitioner or 
withdraws such certification once it is issued, then DEA will not issue 
the practitioner an identification number, or will withdraw the 
identification number if one has been issued.
    (f) If a practitioner dispenses or prescribes Schedule III, IV, or 
V narcotic (opioid) drugs approved by FDA specifically for maintenance 
or detoxification treatment in violation of any of the conditions 
specified in Sec.  1301.27(b) or (c), the Administrator may revoke the 
practitioner's registration in accordance with Sec.  1301.36.

PART 1306--PRESCRIPTIONS--[AMENDED]

    3. The authority citation for Part 1306 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted.

    4. Section 1306.04 is amended by revising paragraph (c) to read as 
follows:


Sec.  1306.04  Purpose of issue of prescription.

* * * * *
    (c) A prescription may not be issued for ``detoxification 
treatment'' or ``maintenance treatment,'' unless the prescription is 
for a Schedule III, IV, or V narcotic (opioid) drug approved by FDA 
specifically for use in maintenance or detoxification treatment and the 
practitioner is in compliance with requirements in Sec.  1301.27 of 
this chapter.
    5. Section 1306.05 is amended by revising paragraph (a) to read as 
follows:


Sec.  1306.05  Manner of issuance of prescriptions.

    (a) All prescriptions for controlled substances shall be dated as 
of, and signed on, the day when issued and shall bear the full name and 
address of the patient, the drug name, strength, dosage form, quantity 
prescribed, directions for use and the name, address and registration 
number of the practitioner. In addition, a prescription for a Schedule 
III, IV, or V narcotic (opioid) drug approved by FDA specifically for 
``detoxification treatment'' or ``maintenance treatment'' must include 
the identification number issued by the Administration under Sec.  
1301.27(d) of this chapter or a written notice stating that the 
practitioner is acting under the good faith exception of Sec.  
1301.27(e). A practitioner may sign a prescription in the same manner 
as he would sign a check or legal document (e.g., J.H. Smith or John H. 
Smith). Where an oral order is not permitted, prescriptions shall be 
written with ink or indelible pencil or typewriter and shall be 
manually signed by the practitioner. The prescriptions may be prepared 
by the secretary or agent for the signature of a practitioner, but the 
prescribing practitioner is responsible in case the prescription does 
not conform in all essential respects to the law and regulations. A 
corresponding liability rests upon the pharmacist who fills a 
prescription not prepared in the form prescribed by these regulations.
* * * * *
    6. Section 1306.07 is amended by revising the section heading and 
paragraph (a) and adding paragraph (d) to read as follows:


Sec.  1306.07  Administering or dispensing of narcotic (opioid) drugs.

    (a) A practitioner may administer or dispense directly (but not 
prescribe) a narcotic (opioid) drug listed in Schedule II if the 
practitioner meets both of the following conditions:
    (1) The practitioner is separately registered with DEA as a 
narcotic treatment program.
    (2) The practitioner is a qualifying physician under Sec. 1301.27 
of this chapter and in compliance with DEA regulations regarding 
security, and records.
* * * * *
    (d) A practitioner may administer or dispense (including prescribe) 
any Schedule III, IV or V narcotic (opioid) drug specifically approved 
by the Food and Drug Administration for use in maintenance or 
detoxification treatment to a narcotic (opioid) dependent person if the 
practitioner complies with the requirements of Sec.  1301.27 of this 
chapter.

    Dated: June 17, 2003.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 03-15787 Filed 6-23-03; 8:45 am]
BILLING CODE 4410-09-P