[Federal Register: June 24, 2003 (Volume 68, Number 121)]
[Proposed Rules]
[Page 37429-37434]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn03-20]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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