Clarification of Registration
Requirements for Individual Practitioners by the Federal
Drug Enforcement Administration
FR
Doc E6-20334 [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.
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
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 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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