[Federal Register Volume 73, Number 100 (Thursday, May 22, 2008)]
[Rules and Regulations]
[Pages 29685-29688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11471]


=======================================================================
-----------------------------------------------------------------------

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.

0
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

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, 886a, 
951, 952, 953, 956, 957.


0
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]
BILLING CODE 4410-09-P