[Federal Register: June 23, 2005 (Volume 70, Number 120)]
[Rules and Regulations]
[Page 36338-36344]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn05-10]
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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