[Federal Register Volume 70, Number 120 (Thursday, June 23, 2005)]
[Rules and Regulations]
[Pages 36338-36344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12440]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1301 and 1306

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


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

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

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SUMMARY: DEA is amending its regulations to allow qualified 
practitioners not otherwise registered as a narcotic treatment program 
to dispense and prescribe to narcotic dependent persons Schedule III, 
IV, and V narcotic controlled drugs approved by the Food and Drug 
Administration specifically for use in maintenance or detoxification 
treatment. This Final Rule is in response to amendments to the 
Controlled Substances Act by the Drug Addiction Treatment Act of 2000 
(DATA) that are designed to expand and

[[Page 36339]]

improve treatment of narcotic addiction. This Final Rule is intended to 
accomplish the goals of DATA while preventing the diversion of Schedule 
III, IV, and V narcotic controlled drugs approved by the Food and Drug 
Administration specifically for maintenance/detoxification treatment.

DATES: Effective Date: July 25, 2005.

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:

Technical Modification Regarding This Final Rule

    In its Notice of Proposed Rulemaking (NPRM) proposing amendment of 
the regulations to implement the Drug Addiction Treatment Act of 2000, 
DEA proposed a new Sec.  1301.27 of Title 21 of the Code of Federal 
regulations. Subsequent to publication of that NPRM, DEA published a 
Final Rule entitled ``Preventing the Accumulation of Surplus Controlled 
Substances at Long Term Care Facilities'' (70 FR 25462, May 13, 2005; 
Docket No. DEA-240, RIN 1117-AA75) which amended Title 21 by adding a 
new Sec.  1301.27. Therefore, amendments regarding the Drug Addiction 
Treatment Act of 2000 which were proposed to be included in new Sec.  
1301.27 are being finalized at Sec.  1301.28.

Background

    On October 17, 2000, Congress passed the Drug Addiction Treatment 
Act of 2000 (DATA), amending the Controlled Substances Act (CSA) to 
establish ``waiver authority for physicians who dispense or prescribe 
certain narcotic drugs for maintenance treatment or detoxification 
treatment'' (Pub. L. 106-310, title XXXV; 114 Stat. 1222). Prior to 
DATA, the Controlled Substances Act and DEA regulations required 
practitioners who wanted to conduct maintenance or detoxification 
treatment using narcotic controlled drugs to be registered as a 
Narcotic Treatment Program (NTP) in addition to the practitioner's 
personal registration. The separate NTP registration authorized the 
practitioner to dispense or administer, but not prescribe, narcotic 
drugs.
    With passage of DATA, DEA published a notice of proposed rulemaking 
(68 FR 37429, June 24, 2003) to amend the regulations affecting 
maintenance and detoxification treatment for narcotic treatment by 
establishing an exemption from the separate registration requirement.
    This Final Rule will permit the following:
    (1) Qualifying physicians to dispense and prescribe Schedule III, 
IV, and V narcotic controlled drugs approved by the Food and Drug 
Administration (FDA) specifically for use in maintenance or 
detoxification treatment.
    (2) Narcotic dependent patients to have one-on-one consultations 
with a practitioner in a private practice setting.
    (3) Pharmacies to fill prescriptions for Schedule III, IV, and V 
narcotic controlled drugs approved by FDA specifically for use in 
maintenance or detoxification treatment.
    (4) Practitioners to offer maintenance and detoxification treatment 
to a limited number of patients in their private practices without 
having a second registration as a NTP.
    The exemption and other amendments established by this Final Rule 
apply to individual practitioners working in traditional NTPs as well 
as any other practice setting. This rule does not affect the existing 
prohibition against prescribing any Schedule II narcotic controlled 
drugs for maintenance or detoxification treatment.

Conditions for Qualifying for an Exemption Under Section 1301.28

    A practitioner who wishes to qualify for the exemption in new Sec.  
1301.28 must submit a notification of intent to dispense or prescribe 
narcotic controlled drugs to opiate-dependent patients to the U.S. 
Department of Health and Human Services (DHHS). In the notification the 
practitioner must certify that all of the 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 DHHS has 
established 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 drugs 
or combinations of narcotic 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 DHHS.
    (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 DHHS.
    The Schedule III, IV or V narcotic drugs or combination of narcotic 
drugs dispensed or prescribed by the practitioner must meet the 
following two conditions:
    (1) The drugs are approved by FDA specifically for use in 
maintenance treatment or detoxification treatment.
    (2) The drugs have not been the subject of an adverse determination 
by DHHS that their use requires additional standards respecting the 
qualifications of practitioners or the quantities of the drugs that may 
be provided for unsupervised use.

Agency Response To Notification and the Issuance of an Identification 
Number

    When DHHS receives a notification of intent to dispense or 
prescribe narcotic controlled drugs for maintenance or detoxification 
treatment it will forward a copy of the notification to DEA. From the 
date DHHS receives the notification it will have up to 45 days to 
review the practitioner's qualifications and make a determination as to 
whether the practitioner meets all of the requirements for the 
exemption. While DHHS 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(f).
    Once DHHS 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(f), 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 DHHS before the conclusion of the 45-day review 
period, or (2) the 45-day review period has concluded and no DHHS 
determination has been received.
    If HHS denies certification to a practitioner or withdraws a 
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 Sec.  1301.28(d) 
the practitioner is required to include the identification number on 
all records when dispensing and on all prescriptions when prescribing 
Schedule III, IV, or V narcotic controlled drugs for use in maintenance 
or detoxification treatment.

[[Page 36340]]

Exception to the 45-Day Review Period

    The practitioner does not have to wait for receipt of an 
identification number from DEA if the practitioner is in compliance 
with Sec.  1301.28(e). The practitioner can 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.  1301.28(b).
    (2) The practitioner reasonably believes that the conditions 
specified in Sec.  1301.28(b) and (c), regarding the practitioner and 
the narcotic drugs, have been met.
    (3) The practitioner reasonably believes that prescribing or 
dispensing the narcotic drugs would facilitate the treatment of an 
individual patient.
    (4) The practitioner has notified both DHHS and DEA of the intent 
to do so.
    (5) DHHS has not notified the registrant that he or she is not a 
qualifying physician.
    (6) The practitioner has the appropriate DEA registration under 21 
CFR 1301.13.
    The practitioner may satisfy the fourth requirement by including 
within the notification required by Sec.  1301.28(b) a statement of his 
or her intent to immediately commence prescribing or dispensing. If 
DHHS refuses to certify a practitioner or withdraws a 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.

Violation of Section 1301.28(b)

    If a practitioner dispenses or prescribes Schedule III, IV, or V 
narcotic drugs in violation of any of the conditions specified in Sec.  
1301.28(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 dependent persons Schedule III, 
IV, and V narcotic controlled drugs approved by the FDA specifically 
for use in maintenance or detoxification treatment.

Practitioners in Traditional NTPs Treated the Same as Practitioners in 
Other Practice Settings

    This Final Rule affects practitioners working in traditional NTPs 
the same as any other practitioners. Prior to this final rule, 
practitioners, whether in a traditional NTP or any other setting, were 
not permitted to prescribe Schedule III, IV, and V narcotic controlled 
drugs for use in maintenance or detoxification treatment. This Final 
Rule applies to any ``qualifying physician,'' working in a NTP or other 
setting, who wants to dispense or prescribe Schedule III, IV, and V 
narcotic controlled drugs approved by FDA specifically for use in 
maintenance or detoxification treatment. However, as discussed further 
below, since narcotic treatment programs are not permitted to prescribe 
controlled substances, if a physician working at a narcotic treatment 
program wishes to prescribe Schedule III, IV, and V narcotic controlled 
drugs approved by the Food and Drug Administration specifically for use 
in maintenance or detoxification treatment, then the physician must 
register separately as an individual practitioner with DEA and obtain a 
waiver pursuant to 21 CFR 1301.28 to conduct such treatment. The 
practitioner would not issue such prescriptions under the narcotic 
treatment program's DEA registration.

Additional Requirements

    Section 1306.05(a) requires the practitioner to include on the 
prescription the identification number (issued under Sec.  1301.28(d)) 
or written notice that the practitioner is acting under the good faith 
exception of Sec.  1301.28(e). These prescriptions will be subject to 
all of the existing requirements of part 1306 that apply to 
prescriptions for controlled substances. 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 as of, 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 existing 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 substances listed in any schedule for maintenance or 
detoxification treatment of an individual.
    For conformity Sec.  1306.04, Purpose of issue of prescription, and 
Sec.  1306.07, Administering or dispensing of narcotic drugs, have been 
amended by this Final Rule. This Final Rule amends Sec.  1306.04(c) to 
permit prescriptions for Schedule III, IV, and V narcotic controlled 
drugs approved by FDA specifically for maintenance or detoxification 
treatment by practitioners who are in compliance with Sec.  1301.28.
    Section 1306.07(a) permits the administering and dispensing (but 
not prescribing) of narcotic drugs for detoxification or maintenance 
treatment only by practitioners who are separately registered as a 
Narcotic Treatment Program. This Final Rule adds paragraph (d) to Sec.  
1306.07 to permit a practitioner to administer or dispense (including 
prescribe) any Schedule III, IV, or V narcotic controlled drug approved 
by FDA specifically for use in maintenance or detoxification treatment 
if the practitioner is in compliance with Sec.  1301.28. This Final 
Rule also revises Sec.  1306.07(a) to improve the clarity of the 
language, as discussed in the Public Comments on the NPRM section 
below.

Refills

    DEA regulations allow practitioners to authorize refills for 
Schedule III, IV, or V controlled substance prescriptions. 
Prescriptions for Schedule III, IV, and V controlled substances 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 
drugs for use in maintenance or detoxification treatment are subject to 
all relevant State and Federal requirements that apply to prescriptions 
for controlled drugs.

Other Relevant Requirements Not Affected by the Final Rule

    Practitioners who administer or dispense (other than by 
prescription) Schedule III, IV, or V narcotic 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 dispensing. 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 
controlled drugs approved by FDA specifically for maintenance or 
detoxification treatment must be stored in a securely locked, 
substantially constructed cabinet.
    Regulations on prescribing allow the use of a written prescription 
signed by a practitioner, or a facsimile of a written prescription 
signed by a practitioner, transmitted by the practitioner, or the 
practitioner's agent, to the pharmacy

[[Page 36341]]

(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)).

Public Comments on the NPRM

    DEA received six comments in response to the proposed rule. 
Commenters included community health centers, hospitals, an industry 
association, and the Center for Substance Abuse Treatment of the 
Department of Health and Human Services (CSAT). While the commenters 
supported the general intent of the rule, they also requested changes 
to certain aspects of the rule. The following discussion summarizes the 
issues raised by commenters and DEA's response to these issues.

Practitioners Other Than Physicians

    Three commenters requested that the rule be modified to permit mid-
level practitioners, including physician assistants, nurse 
practitioners and, where states permit, pharmacists, who meet the 
appropriate training and certification criteria to be deemed 
``qualifying physicians'' and, thus, to be able to prescribe Schedule 
III, IV and V narcotic controlled drugs for maintenance or 
detoxification treatment.
    DEA Response: The final rule has not been modified to allow mid-
level practitioners, such as pharmacists, nurse practitioners, and 
physician assistants to prescribe Schedule III, IV, and V substances 
for substance abuse treatment. In DATA Congress specified that 
physicians may prescribe these substances. This final rule is also 
consistent with the rules and policies of CSAT.

30 Patient Limit

    One commenter expressed concern regarding the 30 patient limit, 
stating that it was difficult to treat all patients served by the 
facility without experiencing problems with this limit.
    DEA Response: The 30 patient limit is specifically referenced in 
the law (21 U.S.C. 823(g)(2)(iii) and (iv)) where it is referred to as 
the ``applicable number''. The law specifically grants the Secretary of 
Health and Human Services the authority to change, by regulation, the 
applicable number. DEA does not have authority regarding the 30 patient 
limit, and, thus, is leaving the regulations unchanged.

Pharmacist Responsibilities

    One commenter was concerned that pharmacists have the necessary 
information to ensure that a physician has made the good faith effort 
to obtain an identification number. The commenter also questioned 
whether the pharmacist is responsible for ensuring that only one 
patient is treated by the physician prior to receipt of the 
identification number. The commenter requested that DEA clarify in the 
final rule that pharmacists are not responsible for ensuring the ``one 
patient'' rule other than patients that the pharmacy serves.
    Further, the same commenter questioned how the pharmacist will know 
if a physician goes over the 30 patient limit, and requested DEA 
clarify whether pharmacists would be responsible for enforcing this 
limit.
    DEA Response: Pharmacists only need to be sure that the 
practitioner either has received an identification number or is 
claiming the good faith exception. Pharmacists are not responsible for 
ensuring that only one patient is treated by the practitioner prior to 
receipt of the identification number. The language in Sec.  
1301.28(e)(3) has been revised in the Final Rule to make this clear.
    Pharmacists are also not covered by the 30-patient rule. 
Pharmacists are not required to investigate the validity of the 
practitioners' good faith claim nor their compliance with the 30-
patient rule.
    DEA wishes to note, however, that if a pharmacy becomes aware of 
circumstances in which it has reason to believe that a qualifying 
physician is violating either the good faith exception or the limit 
regarding the applicable number of patients which a qualifying 
physician is permitted to treat, DEA would expect the pharmacy to 
report this information to DEA as a matter of public interest.
    The individual practitioner (physician) is responsible for 
compliance with the requirements of Sec.  1301.28. The practitioner 
must submit to DHHS a separate notification letter for each patient the 
practitioner plans to treat under Sec.  1301.28(e).

Physicians With Waivers

    CSAT stated that it has received several inquiries from physicians 
with ``waivers'' who intend to treat patients in NTPs as well as other 
settings, including ``drug-free'' treatment programs. CSAT requested 
that the final rule should clarify that physicians with waivers do not 
need to register as NTPs to dispense buprenorphine products under the 
conditions set forth in DATA.
    DEA Response: Individual practitioners with waivers do not need to 
register as NTPs to dispense buprenorphine products under the 
conditions set forth in DATA. These practitioners may treat patients in 
NTPs or other settings just as any other practitioner would in 
accordance with this Final Rule. Practitioners also must comply with 
all state requirements related to buprenorphine products, which may be 
more than DEA requirements.
    DEA wishes to reiterate that narcotic treatment programs may 
administer or dispense directly, but not prescribe, narcotic drugs 
approved by the Food and Drug Administration specifically for use in 
maintenance or detoxification treatment to narcotic dependent persons 
for maintenance or detoxification treatment. Thus, narcotic treatment 
programs may administer or dispense directly Schedule III, IV, and V 
narcotic controlled drugs approved by the Food and Drug Administration 
specifically for use in maintenance or detoxification treatment. 
Narcotic treatment programs are not limited in the number of patients 
to whom they may administer or dispense directly these controlled 
substances. Such controlled substances, however, may not be prescribed. 
If a physician working at a narcotic treatment program wishes to 
prescribe Schedule III, IV, and V narcotic controlled drugs approved by 
the Food and Drug Administration specifically for use in maintenance or 
detoxification treatment, then the physician must register separately 
as an individual practitioner with DEA and obtain a waiver pursuant to 
21 CFR 1301.28 to conduct such treatment. The practitioner would not 
issue such prescriptions under the narcotic treatment program's DEA 
registration.

Records

    CSAT stated that since the CSA defines practitioners to include 
pharmacies, it was unclear from the NPRM (68 FR 37432) whether 
pharmacies are required to maintain records of dispensation.
    DEA Response: In the preamble to the NPRM the use of the word 
practitioners was referring to the individual practitioners 
(physicians) who administer or dispense Schedule III, IV, or V narcotic 
drugs approved by the FDA specifically for maintenance or 
detoxification treatment. In addition, pharmacies are required to 
maintain records of all controlled substance dispensing.

[[Page 36342]]

Written Notification

    CSAT requested that the Final Rule should clarify when a written 
notification is necessary. CSAT recommended allowing all forms of 
notification submission for ``good faith'' waivers.
    DEA Response: The Final Rule has been modified to clarify the 
circumstances in which notification must be provided in writing. The 
requirement for written notification is contained in the law and DEA, 
therefore, has no authority to permit other forms of notification.

Issuance of an Order

    CSAT questioned the requirement in Sec.  1301.28(e)(5), that states 
that DEA will issue a practitioner an identification number if ``the 
Secretary has not issued an order indicating that the registrant is not 
qualified under paragraph (d) of this section.'' CSAT stated that the 
limited review period does not permit sufficient time to issue ``an 
order'' to each physician with incomplete or deficient notifications. 
CSAT believed it should be sufficient to inform physicians of 
deficiencies by phone, fax, or letter. CSAT recommended that the 
language be revised to reflect ``the Secretary has not notified the 
registrant that they are not qualified under paragraph (d) of this 
section.''
    DEA Response: The Final Rule has been modified to remove the 
language specifying that the Secretary must issue an order indicating 
that the registrant is not qualified. The revised language states that 
the Secretary has not notified the registrant that he or she is not 
qualified.

Administering or Dispensing of Narcotic Drugs

    CSAT indicated that the language in Sec.  1306.07(a) should clarify 
that qualifying physicians would only be able to administer or dispense 
directly those schedule III, IV, or V narcotic drugs that meet the 
legislated criteria under DATA. This would not include narcotic drugs 
listed in schedule II.
    DEA Response: DEA agrees with this comment and has clarified the 
language of Sec.  1306.07(a)(2) to remove the reference to Sec.  
1301.28 so that paragraph (a)(2) now states that the practitioner is in 
compliance with DEA regulations regarding treatment qualifications, 
security, records, and unsupervised use of the drugs.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator, Office of Diversion Control, 
has reviewed this 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 rule permits practitioners 
to prescribe Schedule III, IV, and V narcotic 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. Further, the 
ability to prescribe Schedule III, IV and V narcotic controlled 
substances specifically approved by FDA for maintenance/detoxification 
treatment to narcotic dependent persons is not required; physicians 
choosing to conduct this treatment do so voluntarily and choose to 
apply for the waiver.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this rule 
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 rule permits 
practitioners to prescribe Schedule III, IV, and V narcotic 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 rule meets the applicable standards set forth in sections 3(a) 
and 3(b)(2) of Executive Order 12988.

Executive Order 13132

    This rule 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.

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 
$115,000,000 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.


0
For the reasons set out above, 21 CFR Parts 1301 and 1306 are amended 
as follows:

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

0
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, 951, 
952, 953, 956, 957.


0
2. Part 1301 is amended by adding Sec.  1301.28 to read as follows:


Sec.  1301.28  Exemption from separate registration for practitioners 
dispensing or prescribing Schedule III, IV, or V narcotic controlled 
drugs approved by the Food and Drug Administration specifically for use 
in maintenance or detoxification treatment.

    (a) An individual practitioner may dispense or prescribe Schedule 
III, IV, or V narcotic controlled drugs or combinations of narcotic 
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) if all of the following conditions are 
met:
    (1) The individual practitioner meets the conditions specified in 
paragraph (b) of this section.
    (2) The narcotic drugs or combination of narcotic drugs meet the 
conditions specified in paragraph (c) of this section.

[[Page 36343]]

    (3) The individual practitioner is in compliance with either 
paragraph (d) or paragraph (e) of this section.
    (b)(1) The individual practitioner must submit notification to the 
Secretary of Health and Human Services stating the individual 
practitioner's intent to dispense or prescribe narcotic drugs under 
paragraph (a) of this section. The notice must contain all of the 
following certifications:
    (i) The individual practitioner is registered under Sec.  1301.13 
as an individual practitioner 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 individual practitioner has the capacity to refer the 
patients to whom the individual practitioner will provide narcotic 
drugs or combinations of narcotic drugs for appropriate counseling and 
other appropriate ancillary services.
    (iii) Where the individual practitioner is not a member of a group 
practice, the total number of such patients of the individual 
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 individual 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) If an individual practitioner wishes to prescribe or dispense 
narcotic drugs pursuant to paragraph (e) of this section, the 
individual practitioner must provide the Secretary of Health and Human 
Services the following:
    (i) Notification as required under paragraph (b)(1) of this section 
in writing, stating the individual practitioner's name and DEA 
registration number issued under Sec.  1301.13.
    (ii) If the individual practitioner is a member of a group 
practice, the names of the other individual practitioners in the group 
and the DEA registration numbers issued to the other individual 
practitioners under Sec.  1301.13.
    (c) The narcotic drugs or combination of narcotic 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 
``maintenance treatment'' or ``detoxification 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)(1) 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 individual 
practitioner involved meets all requirements for a waiver under section 
303(g)(2)(B) of the Act (21 U.S.C. 823(g)(2)(B)). Health and Human 
Services will notify DEA of its determination regarding the individual 
practitioner. If the individual practitioner has the appropriate 
registration under Sec.  1301.13, then the Administrator will issue the 
practitioner an identification number as soon as one of the following 
conditions occurs:
    (i) The Administrator receives a positive determination from the 
Secretary of Health and Human Services before the conclusion of the 45-
day review period, or
    (ii) The 45-day review period has concluded and no determination by 
the Secretary of Health and Human Services has been made.
    (2) If the Secretary denies certification to an individual 
practitioner or withdraws such certification once it is issued, then 
DEA will not issue the individual practitioner an identification 
number, or will withdraw the identification number if one has been 
issued.
    (3) The individual practitioner must include the identification 
number on all records when dispensing and on all prescriptions when 
prescribing narcotic drugs under this section.
    (e) An individual practitioner may begin to prescribe or dispense 
narcotic drugs to a specific individual patient under this section 
before receiving an identification number from the Administrator if the 
following conditions are met:
    (1) The individual practitioner has submitted a written 
notification under paragraph (b) of this section in good faith to the 
Secretary of Health and Human Services.
    (2) The individual practitioner reasonably believes that the 
conditions specified in paragraphs (b) and (c) of this section have 
been met.
    (3) The individual practitioner reasonably believes that the 
treatment of an individual patient would be facilitated if narcotic 
drugs are prescribed or dispensed under this section before the sooner 
of:
    (i) Receipt of an identification number from the Administrator, or
    (ii) Expiration of the 45-day period.
    (4) The individual 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 drugs before expiration of 
the 45-day period.
    (5) The Secretary has not notified the registrant that he/she is 
not qualified under paragraph (d) of this section.
    (6) The individual practitioner has the appropriate registration 
under Sec.  1301.13.
    (f) If an individual practitioner dispenses or prescribes Schedule 
III, IV, or V narcotic drugs approved by the Food and Drug 
Administration specifically for maintenance or detoxification treatment 
in violation of any of the conditions specified in paragraphs (b), (c) 
or (e) of this section, the Administrator may revoke the individual 
practitioner's registration in accordance with Sec.  1301.36.

PART 1306--PRESCRIPTIONS

0
3. The authority citation for Part 1306 continues to read as follows:

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


0
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 drug approved by the Food and 
Drug Administration specifically for use in maintenance or 
detoxification treatment and the practitioner is in compliance with 
requirements in Sec.  1301.28 of this chapter.

0
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 drug approved by FDA specifically for

[[Page 36344]]

``detoxification treatment'' or ``maintenance treatment'' must include 
the identification number issued by the Administrator under Sec.  
1301.28(d) of this chapter or a written notice stating that the 
practitioner is acting under the good faith exception of Sec.  
1301.28(e). Where a prescription is for gamma-hydroxybutyric acid, the 
practitioner shall note on the face of the prescription the medical 
need of the patient for the prescription. 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, including a pharmacist employed by a central fill 
pharmacy, who fills a prescription not prepared in the form prescribed 
by DEA regulations.
* * * * *

0
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 drugs.

    (a) A practitioner may administer or dispense directly (but not 
prescribe) a narcotic drug listed in any schedule to a narcotic 
dependant person for the purpose of maintenance or detoxification 
treatment 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 in compliance with DEA regulations 
regarding treatment qualifications, security, records, and unsupervised 
use of the drugs pursuant to the Act.
* * * * *
    (d) A practitioner may administer or dispense (including prescribe) 
any Schedule III, IV, or V narcotic drug approved by the Food and Drug 
Administration specifically for use in maintenance or detoxification 
treatment to a narcotic dependent person if the practitioner complies 
with the requirements of Sec.  1301.28 of this chapter.

    Dated: June 16, 2005.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 05-12440 Filed 6-22-05; 8:45 am]
BILLING CODE 4410-09-P