Federal
Register Notices > Rules -
2007 >
Changes to Patient Limitation for Dispensing or Prescribing Approved
Narcotic Controlled Substances for Maintenance or Detoxification Treatment by
Qualified Individual Practitioners
FR Doc E7-18531 [Federal Register: September 20, 2007 (Volume 72, Number
182)] [Proposed Rules] [Page 53734-53736] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr20se07-21]
[[Page 53734]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-275P] RIN 1117-AA99
Changes to Patient Limitation for Dispensing or Prescribing Approved
Narcotic Controlled Substances for Maintenance or Detoxification Treatment by
Qualified Individual Practitioners
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of Proposed Rulemaking.
SUMMARY: The Drug Enforcement Administration (DEA) is proposing to
conform its regulations to recent statutory amendments to the Controlled
Substances Act that changed certain patient limitations for practitioners who
dispense or prescribe certain narcotic drugs for maintenance or detoxification
treatment.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before November 19, 2007.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-275'' on all written and electronic correspondence. Written
comments being sent via regular mail should be sent to the Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement Administration,
Washington, DC 20537, Attention: DEA Federal Register Representative/ODL.
Written comments sent via express mail should be sent to DEA Headquarters,
Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis
Highway, Alexandria, VA 22301. Comments may be sent directly to DEA
electronically by sending an electronic message to dea.diversion.policy@usdoj.gov.
Comments may also be sent electronically through http://www.regulations.gov
using the electronic comment form provided on that site. An electronic copy of
this document is also available at the http://www.regulations.gov Web site.
DEA will accept attachments to electronic comments in Microsoft word,
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any
file formats other than those specifically listed here.
Posting of Public Comments: Please note that all comments received are
considered part of the public record and made available for public inspection
online at http://www.regulations.gov and in the Drug Enforcement
Administration's public docket. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by the
commenter.
If you want to submit personal identifying information (such as your name,
address, etc.) as part of your comment, but do not want it to be posted online
or made available in the public docket, you must include the phrase ``PERSONAL
IDENTIFYING INFORMATION'' in the first paragraph of your comment. You must
also place all the personal identifying information you do not want posted
online or made available in the public docket in the first paragraph of your
comment and identify what information you want redacted.
If you want to submit confidential business information as part of your
comment, but do not want it to be posted online or made available in the
public docket, you must include the phrase ``CONFIDENTIAL BUSINESS
INFORMATION'' in the first paragraph of your comment. You must also
prominently identify confidential business information to be redacted within
the comment. If a comment has so much confidential business information that
it cannot be effectively redacted, all or part of that comment may not be
posted online or made available in the public docket.
Personal identifying information and confidential business information
identified and located as set forth above will be redacted and posted online
and placed in the Drug Enforcement Administration's public docket file. If you
wish to inspect the agency's public docket file in person by appointment,
please see the FOR FURTHER INFORMATION CONTACT paragraph.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement Administration,
Washington, DC 20537, Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Overview
On August 2, 2005, the President signed amendments to the Controlled
Substances Act to increase the patient limitation on prescribing drug
addiction treatments by qualified medical practitioners in group practices
from 30 patients for each group to 30 patients for each qualified practitioner
in a group (Pub. L. 109-56; 119 Stat. 591) (21
U.S.C. 823(g)(2)).
On December 29, 2006, the President signed amendments to the Controlled
Substances Act to permit certain qualifying physicians to dispense and
prescribe Schedule III, IV, and V narcotic controlled substances approved by
the Food and Drug Administration specifically for use in maintenance or
detoxification treatment to up to 100 patients at any one time, after the
practitioner submits to the Secretary of Health and Human Services a
notification of the practitioner's need and intent to treat the increased
number of patients. The amendment was made as part of the Office of National
Drug Control Policy Reauthorization Act of 2006 (ONDCPRA) (Sec. 1102 of Pub.
L. 109-469, 120 Stat. 3502).
This Notice of Proposed Rulemaking (NPRM) would conform DEA regulations to
Pub. L. 109-56 by removing the requirement in 21
CFR 1301.28(b)(iv) that limits to 30 the number of patients that could
receive maintenance or detoxification treatment through a group practice. This
change means that each qualifying practitioner whether working individually or
in a group practice may offer maintenance and detoxification treatment to 30
patients at any one time. This NPRM would also conform DEA regulations to Sec.
1102 of Pub. L. 109-469 by permitting certain qualifying physicians to treat
up to 100 patients. To qualify to treat the additional patients, not sooner
than one year after the practitioner submitted the initial notification, the
practitioner must submit a second notification to the Secretary of Health and
Human Services of the need and intent of the practitioner to treat up to 100
patients. Further, the practitioner must be a ``qualifying physician'' under 21
U.S.C. 823(g)(2)(G) and must have 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 (21 CFR 1301.28(b)(1)(i) and (ii)). These proposed amendments would
not change the requirement that each practitioner must first qualify to
prescribe and dispense these medications for maintenance and detoxification
treatment, or must be prescribing these approved substances using the ``good
faith'' exception, found within current regulations at 21 CFR 1301.28(e).
Background
On October 17, 2000, Congress passed the Drug Addiction Treatment Act of
2000 (DATA), amending the Controlled Substances Act (CSA) (21 U.S.C. Sec. 801
et seq.) to establish ``waiver authority for physicians who dispense or
prescribe certain narcotic drugs for maintenance
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treatment or detoxification treatment'' (Pub. L. 106-310, title XXXV; 114
Stat. 1222, codified at 21 U.S.C. 823(g)(2)). 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 individual registration. The separate NTP registration
authorized the practitioner to dispense or administer, but not prescribe,
narcotic drugs.
With passage of DATA, DEA published a NPRM (68 FR 37429; June 24, 2003)
proposing to amend the regulations affecting maintenance and detoxification
treatment for narcotic treatment by establishing an exemption from the
separate registration requirement. After consideration of the comments
received on the NPRM, DEA published a Final Rule on June 23, 2005 (70 FR
36338). The June 23, 2005, Final Rule permitted the following:
(1) Qualifying physicians to dispense and prescribe Schedule III, IV, and
V narcotic controlled drugs approved by the Food and Drug Administration
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 the Food and Drug Administration specifically
for use in maintenance or detoxification treatment.
(4) Practitioners to offer maintenance and detoxification treatment with
Schedule III, IV, and V narcotic controlled drugs approved by the Food and
Drug Administration specifically for use in maintenance or detoxification
treatment to no more than 30 patients in their private practices without
having a second registration as a NTP.
The exemption and other amendments established by the Final Rule apply to
individual practitioners working in traditional NTPs as well as any other
practice setting. The rule does not affect the existing prohibition against
prescribing any Schedule II narcotic controlled drugs for maintenance or
detoxification treatment.
Under the provisions of DATA implementing regulations as codified in 21 CFR
1301.28(b)(1)(iii) and (iv), the 30-patient limitation applied equally to
individual practices and to group practices (i.e., 30 patients per group),
severely limiting the number of patients that could be treated by physicians
in group practices.
Pursuant to Pub. L. 109-56 effective on August 2, 2005, and Sec. 1102 of
Pub. L. 109-469 effective on December 29, 2006, this NPRM would make
conforming changes to DEA's regulations at 21
CFR 1301.28(b)(1)(iii) and (iv). Specifically, paragraph (b)(1)(iii) is
proposed to be amended to permit the treatment of up to 100 patients by a
qualifying practitioner if the necessary criteria are met and notification is
submitted to the Secretary of Health and Human Services. Further, paragraph
(b)(1)(iii) is proposed to be amended by removing the phrase ``Where the
individual practitioner is not a member of a group practice,'' since there is
no longer a distinction between practitioners in group practices and those
practicing independently. Finally, paragraph (b)(1)(iv) is proposed to be
deleted to remove language regarding members of group practices.
Relevant to the change regarding the treatment of up to 100 patients, the
Director of the Center for Substance Abuse Treatment in the Department of
Health and Human Services issued a letter announcing the statutory change as
follows:
Under ONDCPRA (effective December 29, 2006), physicians who meet the
following criteria may notify the Secretary of Health and Human Services (HHS)
of their need and intent to treat up to 100 patients at any time: (1) The
physician must currently be qualified under DATA 2000; (2) at least one year
must have elapsed since the physician submitted the initial notification for
authorization; (3) the physician must certify their capacity to refer patients
for appropriate counseling and other appropriate ancillary services; and (4)
the physician must certify that the total number of patients at any one time
will not exceed the applicable number.
DEA emphasizes that practitioners must meet these HHS criteria before
prescribing a Schedule III, IV, or V controlled substance for narcotic
maintenance or detoxification treatment to more than 30 patients at any one
time.
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. 601-612) and that it
will not have a significant economic impact on a substantial number of small
entities. This NPRM would relieve a restriction on practitioners desiring to
treat narcotic dependent patients by removing the 30 patient limit for group
practices and by permitting certain qualifying physicians to treat up to 100
patients after certain criteria are met. Thus the changes would provide
greater access to care for patients due to increased patient limits.
Executive Order 12866
The Deputy Assistant Administrator further certifies that this rule has
been drafted in accordance with the principles in Executive Order 12866 Sec.
1(b). It has been determined that this is a significant regulatory action and,
therefore, this action has been reviewed by the Office of Management and
Budget. This rule will not impose additional costs on practitioners as it
simply increases the number of patients that a practitioner may treat for
narcotic dependence. As previously noted, this change would provide greater
access to care for patients due to the increased patient limits.
Executive Order 12988
This rule meets the applicable standards set forth in Sec. Sec. 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform.
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 $120,000,000 or
more (adjusted for inflation) 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.
Congressional Review Act
This rule is not a major rule as defined by Sec. 804 of the Small Business
Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). 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
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based companies in domestic and export markets.
List of Subjects in 21 CFR Part 1301
Administrative practice and procedure, Drug traffic control, Security
measures.
For the reasons set out above, 21 CFR part 1301 is proposed to be amended
as follows:
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS
OF CONTROLLED SUBSTANCES
1. The authority citation for part 1301 continues to read as follows:
Authority: 21 U.S.C. Sec. Sec. 821,
822, 823,
824, 871(b),
875, 877,
886a, 951,
952, 953,
956, 957.
2. Sec.
1301.28 is proposed to be amended by revising paragraph (b)(1)(iii) and
removing paragraph (b)(1)(iv) 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.
* * * * *
(b)(1) * * *
(iii) The total number of patients to whom the individual practitioner will
provide narcotic drugs or combinations of narcotic drugs under this section
will not exceed 30 at any one time unless, not sooner than 1 year after the
date on which the practitioner submitted the initial notification to the
Secretary of Health and Human Services, the practitioner submits a second
notification to the Secretary of the need and intent of the practitioner to
treat up to 100 patients. A second notification under this subparagraph shall
contain the certifications required by subparagraphs (i) and (ii) of this
paragraph. The Secretary of Health and Human Services may promulgate
regulations to change the total number of patients.
* * * * *
Dated: September 13, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E7-18531 Filed 9-19-07; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
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