[Federal Register Volume 71, Number 231 (Friday, December 1, 2006)]
[Rules and Regulations]
[Pages 69478-69480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20334]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[Docket No. DEA-244F]
RIN 1117-AA89


Clarification of Registration Requirements for Individual 
Practitioners

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is amending its 
registration regulations to make it clear that when an individual 
practitioner practices in more than one State, he or she must obtain a 
separate DEA registration for each State. This amendment will make it 
easier for practitioners to understand the requirements of the 
Controlled Substances Act and its implementing regulations.

DATES: The rule is effective January 2, 2007.

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: 

DEA's Legal Authority

    DEA enforces the Controlled Substances Act (21 U.S.C. 801-971) 
(CSA), as amended. DEA publishes the implementing regulations for this 
statute in Title 21 of the Code of Federal Regulations (CFR), Parts 
1300 to end. These regulations are designed to ensure that there is a 
sufficient supply of controlled substances for legitimate medical and 
scientific purposes and deter the diversion of controlled substances to 
illegal purposes. Controlled substances are drugs that have a potential 
for abuse and psychological and physical dependence; these include 
substances classified as opiates, stimulants, depressants, 
hallucinogens, anabolic steroids, and drugs that are immediate 
precursors of these classes of substances. DEA lists controlled 
substances in 21 CFR Part 1308. The substances are divided into five 
schedules: Schedule I substances have a high potential for abuse and 
have no accepted medical use in treatment in the United States. These 
substances may only be used for research, chemical analysis, or 
manufacture of other drugs. Schedule II-V substances have an accepted 
medical use and also have a potential for abuse and psychological and 
physical dependence.
    The CSA mandates that DEA establish a closed system of control for 
manufacturing, distribution, and dispensing of controlled substances. 
Any person who manufactures, distributes, dispenses, imports, exports, 
or conducts research or chemical analysis with controlled substances 
must register with DEA (unless exempt), keep track of all stocks of 
controlled substances, and maintain records to account for all 
controlled substances received, distributed, or otherwise disposed of.

Background

    The CSA requires that a separate registration be obtained for each 
principal place of business or professional practice where controlled 
substances are manufactured, distributed, or dispensed (21 U.S.C. 
822(e)). DEA has provided a limited exception to this requirement (21 
CFR 1301.12(b)(3)): practitioners who register at one location, but 
practice at others within the same State, are not required to register 
for any other location in that State at which they only prescribe 
controlled substances. If they maintain supplies of controlled 
substances, administer, or directly dispense controlled substances at a 
location, they must register for that location (21 U.S.C. 823(f)).
    The exception applies only to secondary locations within the same 
State in which the practitioner maintains his/her DEA registration. 
However, because the language in Sec.  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. DEA 
individual practitioner registrations are based on a State license to 
practice medicine and prescribe controlled substances. DEA relies on 
State licensing boards to determine that practitioners are qualified to 
dispense, prescribe or administer controlled substances and to 
determine what level of authority practitioners have, that is, what 
schedules they may dispense, prescribe, or administer. State authority 
to conduct the above-referenced activities only confers rights and 
privileges within the issuing State; consequently, the DEA registration 
based on a State license cannot authorize controlled substance 
dispensing outside the State.
    To clarify the regulation, DEA issued a Notice of Proposed 
Rulemaking (NPRM) on December 7, 2004 (69 FR 70576), proposing to 
revise Sec.  1301.12(b)(3) to make explicit that the exception from 
registration requirements is limited to other locations in the same 
State or jurisdiction of the United States, and seeking comments on the 
proposed revision.

Discussion of Comments

    Nine commenters submitted comments on the proposed rule; all of the 
commenters were practitioners or represented practitioners.
    General Objections. One physician stated that he had licenses in 
three States and asserted that because the licensed entity was the 
physician, it was contradictory to impose different Federal licenses on 
the same individual. Another commenter noted that practitioners are 
required to comply with State laws whether DEA issues a State-specific 
or a national registration.
    Other commenters stated that requiring multiple registrations would 
result in physicians writing the wrong DEA number on prescriptions and 
in patients receiving unwarranted law enforcement scrutiny because they 
receive a prescription in one State and fill it in another. One 
pharmacist stated that multiple DEA registration numbers for 
practitioners would increase the burden on pharmacies. Two commenters 
stated that separate DEA registrations would make it difficult to mine 
data on pharmacy claims for Medicare, whose regions include more than 
one State; there would be no way to determine whether practitioners 
with the same name prescribing in multiple States are the same person. 
The commenters stated that holding multiple DEA registrations would 
hinder attempts to identify excessive prescribing of controlled 
substances. One commenter suggested registering each practice site, 
collecting fees for each State, but using a single DEA number. Another 
commenter stated the

[[Page 69479]]

system is contrary to efforts to move toward a uniform and centralized 
health care information system. The commenter stated that the proposed 
Department of Health and Human Services National Health Information 
Network would include prescription information, including the 
registration number under which the prescription was issued; requiring 
the system to recognize multiple registrations for a practitioner would 
introduce unnecessary complexity into the system.
    Two commenters believed that requiring registrations for separate 
States would increase their costs. One commenter stated that he could 
not recoup the cost of registering more than one location through 
reimbursement fees or other charges passed on to patients.
    DEA Response: As mandated in the CSA, DEA issues registrations 
based on the State license to practice medicine and dispense controlled 
substances. Section 823(f) of Title 21, U.S. Code, states that DEA 
shall register a practitioner to dispense controlled substances if the 
applicant is authorized to dispense controlled substances under the 
laws of the State in which the applicant practices. Just as a license 
to practice medicine in one State does not authorize a practitioner to 
practice in any other State, a DEA registration based on a particular 
State license cannot authorize dispensing controlled substances in 
another State. As DEA pointed out in the NPRM, different States may 
provide a practitioner with different prescribing authority; State 
medical licenses may be suspended or revoked in one State, but not 
another. A single DEA registration would, in effect, divorce the DEA 
registration from State authorizations. Although, as one commenter 
noted, practitioners have separate legal obligations under State laws, 
separate DEA registrations provide a means of taking action against 
those practitioners who ignore their State authorizations and whose 
licenses are suspended or revoked in a single State. In addition, 
linking the DEA registration to State authority allows pharmacies to 
rely on the DEA registration to determine whether the prescriber is 
authorized to issue a controlled substance prescription in the State. 
If the DEA registration was not based on authority from a specific 
State, the burden on pharmacies to verify the eligibility of 
practitioners to authorize prescriptions would increase significantly.
    DEA recognizes that the requirement to have separate DEA 
registrations for each State imposes a burden on practitioners who 
practice in multiple States. However, DEA notes that it received only 
nine comments from practitioners or their representatives; currently, 
DEA has almost 1.1 million practitioner registrants. This may indicate 
that most practitioners operating in multiple States already hold 
appropriate DEA registrations.
    DEA also recognizes that multiple registrations make it difficult 
to use prescription records to identify practitioners who may be 
overprescribing. That problem, however, is not unique to those 
operating in multiple States. Under the CSA, practitioners who 
administer or directly dispense controlled substances must maintain a 
separate DEA registration at each location where they handle controlled 
substances. Consequently, many practitioners already hold multiple DEA 
registrations even when they practice within a single State. DEA 
currently has almost 1.1 million practitioner registrants; based on the 
number of practitioners in the United States, it is likely that at 
least 200,000 registrants have multiple DEA registrations. Although 
this may create problems for databases and other healthcare information 
systems, the CSA requires this approach to maintain control over the 
dispensing of controlled substances.
    The CSA requires persons handling controlled substances in more 
than one State to be registered with the DEA in each State in which 
they practice. The CSA also requires DEA to recover the full costs of 
the Diversion Control Program through registration and reregistration 
application fees. Thus, DEA must abide by its statutory mandates by 
collecting registration fees for each registered location.
    Locum Tenens: Three commenters raised the issue of multiple 
registrations for practitioners who serve as locum tenens practitioners 
in multiple States. They stated that adding separate DEA registrations 
for each of the States would be confusing and costly.
    DEA Response: The revision of the regulation will not affect DEA's 
approach on locum tenens practitioners. DEA will be addressing policies 
regarding locum tenens practitioners in other documents to be published 
in the Federal Register.
    Other Issues: Several commenters noted that they practice close to 
State borders and see patients who live in other States. One commenter 
asked if a practitioner would need a separate registration if the 
patients were from another State. Two commenters asked if a 
practitioner's prescription could legally be filled in another State. 
One commenter asked if he needed multiple registrations in a single 
State if he administers controlled substances in two locations.
    DEA Response: A practitioner must have a DEA registration for any 
State in which he or she is dispensing (including prescribing) 
controlled substances. A practitioner must have a separate registration 
for each location at which he or she stores, administers, or directly 
dispenses controlled substances.

Summary

    The CSA requires that a separate registration be obtained for each 
principal place of business or professional practice where controlled 
substances are manufactured, distributed, or dispensed (21 U.S.C. 
822(e)). DEA has historically provided an exception that a practitioner 
who is registered at one location, but also practices at other 
locations, is not required to register separately for any other 
location at which controlled substances are only prescribed (21 CFR 
1301.12(b)(3)). If the practitioner maintains supplies of controlled 
substances, administers, or directly dispenses controlled substances at 
the separate location the practitioner must register for that location. 
The exception applies only to a secondary location within the same 
State in which the practitioner maintains his/her registration. DEA 
individual practitioner registrations are based on State authority to 
practice medicine and prescribe controlled substances. Since a DEA 
registration is based on a State license, it cannot authorize 
controlled substance dispensing outside that State. Hence, the separate 
registration exception applies only to locations within the same State 
in which practitioners have their DEA registrations.

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 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

[[Page 69480]]

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 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 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 in a State to 
register with DEA, 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 register as a 
result of publication of this clarification should have been previously 
registered with DEA, 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 
$118,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions are 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 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 forth 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, 951, 
952, 953, 956, 957.


0
2. Section 1301.12 is amended by revising paragraph (b)(3) 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: October 21, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
 [FR Doc. E6-20334 Filed 11-30-06; 8:45 am]
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