[Federal Register: December 1, 2006 (Volume 71, Number 231)]
[Rules and Regulations]
[Page 69478-69480]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de06-8]
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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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