[Federal Register: December 7, 2004 (Volume 69, Number 234)]
[Proposed Rules]
[Page 70576-70577]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07de04-22]
[[Page 70576]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-244P]
RIN 1117-AA89
Clarification of Registration Requirements for Individual
Practitioners
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration (DEA) proposes to amend
its registration regulations to make it clear that when an individual
practitioner who practices and is registered in one state seeks to
practice and prescribe controlled substances in another state, he/she
must obtain a separate DEA registration for the subsequent state. The
current regulation was intended to apply to intrastate offices only,
but has been misunderstood by some practitioners to apply to interstate
offices. To avoid any further misinterpretation, DEA is proposing to
modify its current regulation to indicate that it applies only to
separate locations maintained within one state for which the
practitioner possesses state licensure and DEA registration.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before February 7, 2005.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-244'' 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/CCD. Written comments sent via express
mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/CCD, 2401 Jefferson-Davis Highway, Alexandria,
VA 22301. Comments may be directly sent 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 electronic
comments containing MS word, WordPerfect, Adobe PDF, or Excel file
formats only. DEA will not accept any file format other than those
specifically listed here.
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:
Purpose of This Proposed Rule
There is confusion regarding whether a practitioner who practices
and is registered in one state and wishes to practice and prescribe in
another state must register with DEA in the second state. DEA proposes
to amend its regulations to make it clear that when an individual
practitioner who practices and is registered in one state seeks to
practice and prescribe controlled substances in another state, he/she
must obtain a separate DEA registration for the subsequent state.
Background
The Controlled Substances Act (CSA) requires that a separate
registration be obtained for each location at which controlled
substances are manufactured, distributed, or dispensed (21 U.S.C.
822(e)). Under this requirement, an individual practitioner must have a
separate DEA registration, predicated on a separate state license, if
he/she practices in offices that are located in different states and
administers, dispenses directly, or prescribes controlled substances
from both offices. However, DEA has provided in the regulations (21 CFR
1301.12(b)(3)) that ``an office used by a practitioner (who is
registered at another location) where controlled substances are
prescribed but neither administered nor otherwise dispensed as a
regular part of the professional practice of the practitioner at such
office, and where no supplies of controlled substances are
maintained,'' is not a location for which a registration must be
obtained. This regulation is intended to apply only to secondary
locations within the same state in which the practitioner maintains
his/her DEA registration. However, because the language in Section
1301.12(b)(3) does not specify that it pertains to intrastate locations
only, individual practitioners have been applying the regulation to
interstate situations, which is contrary to the intent of the
regulation, the CSA, and the underlying principles that apply to
individual practitioner registration.
State Licensure
The issuance by DEA of an individual practitioner registration is
predicated, in part, on the practitioner being authorized (e.g.
licensed) to dispense controlled substances by the state in which he/
she practices (21 U.S.C. 823(f)). Valid state authority to dispense
controlled substances is a necessary, but not sufficient, condition for
obtaining a DEA registration. DEA will not register a practitioner at a
particular location within a state if the practitioner lacks valid
state authority to dispense controlled substances in that state. DEA
registration serves, in part, to reflect that the individual
practitioner has been granted some level of controlled substances
authority by the state. In light of the above, a DEA registration is
considered to be related directly and exclusively to the license issued
to the practitioner by the state in which he/she maintains the
registration.
Explanation of DEA Registration Predicated on State Authority
There are problems associated with use of a single DEA registration
in different states. For instance, if a practitioner licensed in the
State of North Carolina and possessing a DEA registration predicated on
that state license subsequently opened an office in Virginia, then any
controlled substance prescriptions he/she wrote in Virginia would be
invalid for the following reason.
To be valid in a particular jurisdiction, a controlled substance
prescription must be written by a practitioner who possesses valid
state authority in that jurisdiction and, equally important, the
practitioner must possess a DEA registration predicated upon valid
state authority in that jurisdiction (or be exempted from the
registration requirement) (21 CFR 1306.03(a)). In the example cited
above, the practitioner possesses valid state authority in North
Carolina and a DEA registration based upon that state authority.
Therefore, the practitioner's controlled substance prescriptions would
be valid in North Carolina. Because the practitioner lacks a DEA
registration based on valid state authority in Virginia, the
practitioner's controlled substance prescriptions in Virginia would be
invalid.
Similarly, if an optometrist licensed in the State of Virginia and
possessing a DEA registration predicated on said license subsequently
opened an office in North Carolina prescribing oxycodone with
acetaminophen (a Schedule II controlled substance) the prescription
would be invalid. This is due to the fact that the DEA registration was
issued pursuant to Virginia authority while the prescription was
written based on North Carolina state licensure and authority.
[[Page 70577]]
North Carolina and Virginia authorize different levels of prescribing
authority to optometrists. In Virginia, optometrists are only permitted
to prescribe analgesics in Schedules III and IIIN, while in North
Carolina optometrists are authorized to prescribe Schedules II through
V controlled substances. Therefore, the prescription for oxycodone with
acetaminophen would also be invalid due to the fact that Virginia
authority is more restrictive than North Carolina's and does not allow
the prescribing of Schedule II controlled substances by optometrists.
Title 21 U.S.C. 823(f) states that the Attorney General (as
delegated to DEA) shall register practitioners to dispense controlled
substances if the applicant is authorized to dispense the controlled
substances under the laws of the state in which the applicant
practices. Title 21 U.S.C. 841(a) prohibits any person from knowingly
or intentionally dispensing a controlled substance except as permitted
by the CSA. As previously stated, controlled substances may not be
dispensed without state authorization to do so.
Reason for Modification of Existing Regulation
To avoid any further misinterpretation, DEA is proposing to modify
its current regulation found in 21 CFR 1301.12(b)(3) by adding the
words ``in the same state or jurisdiction of the United States'' to the
parenthetical statement. This would make clear that the regulation
applies only to separate locations maintained within one state for
which the practitioner possesses state licensure and DEA registration.
The practitioner must maintain separate state licensure and DEA
registration for separate locations in a different state.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator hereby certifies that this
rulemaking has been drafted in accordance with the Regulatory
Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and by
approving it certifies that this regulation will not have a significant
economic impact on a substantial number of small entities. This
proposed rule merely clarifies existing regulations regarding the
registration by individual practitioners conducting business in more
than one state.
Executive Order 12866
The Deputy Assistant Administrator further certifies that this
rulemaking has been drafted in accordance with the principles in
Executive Order 12866 Section 1(b). This rule has been determined to be
a significant regulatory action. Therefore, this action has been
reviewed by the Office of Management and Budget. This proposed rule
merely clarifies existing regulations regarding the registration by
individual practitioners conducting business in more than one state.
Executive Order 12988
This regulation 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 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.
Paperwork Reduction Act
This Notice of Proposed Rulemaking merely clarifies that DEA
registration must be obtained by practitioners for each state in which
a practitioner conducts business, except under certain specific
circumstances. While it is possible that the amendment of the
regulations could cause certain persons who were not previously
registered to register with the Administration, it is not possible for
DEA to determine how many persons might be affected by this
circumstance. It is important to note that this rule serves merely as a
clarification; the Controlled Substances Act, which establishes the
requirement of registration, has not been changed, and the requirement
of registration addressed by this rulemaking remains consistent.
Therefore, persons who would register as a result of publication of
this clarification should have been previously registered with the
Administration but were not registered due to confusion regarding
registration requirements. Thus, at this time, as DEA is not able to
determine the impact of this rulemaking on the registrant population,
DEA will make any necessary revisions to the affected information
collection at the time of renewal of the collection.
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 in 21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
For the reasons set forth above, 21 CFR 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. 821, 822, 823, 824, 871(b), 875, 877, 951,
952, 953, 956, 957.
2. Section 1301.12(b)(3) is proposed to be revised to read as
follows:
Sec. 1301.12 Separate registrations for separate locations.
* * * * *
(b) * * *
(3) An office used by a practitioner (who is registered at another
location in the same state or jurisdiction of the United States) where
controlled substances are prescribed but neither administered nor
otherwise dispensed as a regular part of the professional practice of
the practitioner at such office, and where no supplies of controlled
substances are maintained.
* * * * *
Dated: November 30, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 04-26808 Filed 12-6-04; 8:45 am]
BILLING CODE 4410-09-P