Federal
Register Notices > Rules - 200 8
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Changes to Patient Limitation for Dispensing or Prescribing
Approved Narcotic Controlled Substances for Maintenance or
Detoxification Treatment by Qualified Individual Practitioners
FR Doc E8-11471[Federal Register: May 22, 2008 (Volume 73,
Number 100)] [Rules and Regulations] [Page 29685-29688] From the
Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my08-2]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-275F] 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: Final rule.
SUMMARY: On September 20, 2007, the Drug Enforcement
Administration (DEA) published a Notice of Proposed Rulemaking (NPRM)
in the Federal Register (72 FR 53734) 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. DEA received one
comment in support of this rulemaking. DEA is finalizing the
rule as proposed.
DATES: Effective Date: This rule is effective June 23,
2008.
[[Page 29686]]
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 (FDA) 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 (HHS) 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) (Section
1102 of Pub. L. 109-469, 120 Stat. 3502).
Notice of Proposed Rulemaking
On September 20, 2007 (72 FR 53734), DEA published a Notice
of Proposed Rulemaking (NPRM) proposing to conform DEA
regulations to Public Law 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. That NPRM also proposed to conform DEA
regulations to Section 1102 of Public Law 109-469 by permitting
certain qualifying physicians to treat up to 100 patients. As
discussed in 21 U.S.C. 823(g)(2)(B) and (D) (and not modified by
this rule), to be a "qualifying physician'' the
practitioner must submit to the Secretary of HHS notification of
the practitioner's intent to begin dispensing the drugs approved
by FDA specifically for maintenance or detoxification treatment.
The notification must contain the following certifications:
- The practitioner is registered with DEA as an individual
practitioner.
- The practitioner is a "qualifying physician.'' A
practitioner is a "qualifying physician'' if he is
licensed under State law and has specific medical
certification, training, or experience in maintenance or
detoxification treatment as specified in the CSA.
- With respect to patients to whom the practitioner will
provide such drugs or combinations of drugs, the
practitioner has the capacity to refer the patients for
appropriate counseling and other appropriate ancillary
services.
- The total number of such patients of the practitioner at
any one time will not exceed the applicable number. The
applicable number is 30, unless, not sooner than one year
after the date on which the practitioner submitted the
initial notification, the practitioner submits a second
notification to the Secretary of HHS of the need and intent
of the practitioner to treat up to 100 patients.
- The notification to the Secretary of HHS must be in
writing and must state the name and DEA registration number
of the practitioner.
- If the practitioner is a member of a group practice, the
notification states the names of the other practitioners in
the practice and identifies the registrations issued for the
other practitioners.
As noted, certain qualifying physicians may treat up to 100
patients, instead of the thirty permitted for all qualifying
physicians. 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 HHS 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) as discussed above (21 CFR 1301.28(b)(1)(i)
and (ii)). These amendments do 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).
The "good faith'' exception was established by the Drug
Addiction Treatment Act of 2000, and is not affected by this
Final Rule. The Controlled Substances Act (CSA) (21
U.S.C. 823(g)(2)(D)) states that not later than 45 days
after the Secretary of HHS receives a notification discussed
above, the Secretary shall make a determination of whether the
practitioner meets all requirements for a waiver of the
requirement of separate registration. Upon the expiration of the
45-day time period, a practitioner who in good faith submits a
notification discussed above and reasonably believes that the
conditions specified in 21 U.S.C. 823(g)(2)(B) through (D) have
been met shall, in dispensing narcotic drugs in schedule III,
IV, or V or combinations of such drugs for maintenance treatment
or detoxification treatment, be considered to have a waiver
until notified otherwise by the Secretary of HHS. The
practitioner may commence to prescribe or dispense such narcotic
drugs for maintenance or detoxification treatment prior to the
expiration of the 45-day period if it facilitates the treatment
of an individual patient and both the Secretary and the Attorney
General are notified by the practitioner of the intent to
commence prescribing or dispensing such narcotic drugs.
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. 801 et seq.) 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, 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
[[Page 29687]]
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 Public Law 109-56 effective on August 2, 2005,
and Section 1102 of Public Law 109-469 effective on December 29,
2006, this Final Rule makes conforming changes to DEA's
regulations at 21
CFR 1301.28(b)(1)(iii) and (iv). Specifically, paragraph
(b)(1)(iii) is amended to permit the treatment of up to 100
patients by a qualifying practitioner if the necessary criteria
are met (i.e., the practitioner previously was granted authority
to dispense or prescribe Schedule III, IV, or V narcotic
controlled drugs or combinations of narcotic controlled drugs
approved by the Food and Drug Administration specifically for
use in maintenance or detoxification treatment without being
separately registered as a narcotic treatment program, and, not
sooner than one year after the submission of the initial
notification, the practitioner submits a second notification to
the Secretary of HHS of the need and intent of the practitioner
to treat up to 100 patients) and notification is submitted to
the Secretary of Health and Human Services. Further, paragraph
(b)(1)(iii) is 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 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.
Comments Received
DEA received one comment to its NPRM published September 20,
2007 at 72 FR 53734 from an association representing physicians.
The commenter supported the rulemaking as proposed. The
commenter strongly supported the proposed change to conform DEA
regulations to the statutory changes made by Public Law 109-56,
believing that the previous requirement limiting the number of
patients who could receive treatment through a group practice to
30 was a barrier to treatment access. Further, the commenter
supported the proposed change to conform DEA regulations to
Section 1102 of Public Law 109-469, believing that the
requirement for physicians to submit a supplemental notification
to the Secretary of HHS of their need and intent to treat up to
100 patients, not sooner than one year after the practitioner
submitted the initial notification, is "a reasonable
compromise at this time.'' Therefore, DEA is finalizing this
rulemaking as proposed.
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 rule relieves 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 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 Section 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 provides greater access to care for patients due to the
increased patient limits.
Executive Order 12988
This rule meets the applicable standards set forth in
Sections 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.
[[Page 29688]]
Congressional Review Act
This rule is not a major rule as defined by Section 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-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 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. 821, 822, 823, 824, 871(b), 875, 877, 886a, 951, 952,
953, 956, 957.
- 2. Section 1301.28 is 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: May 13, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion
Control.
[FR Doc. E8-11471 Filed 5-21-08; 8:45 am]
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