[Federal Register Volume 69, Number 234 (Tuesday, December 7, 2004)]
[Proposed Rules]
[Pages 70576-70577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26808]



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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 [email protected]. 
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.

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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]
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