[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Proposed Rules]
[Pages 55499-55502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25937]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[Docket No. DEA-324a]
RIN 1117-AB21


Registration Requirements for Individual Practitioners Operating 
in a ``Locum Tenens'' Capacity

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

ACTION: Advance notice of proposed rulemaking.

-----------------------------------------------------------------------

    Summary: On December 1, 2006, the Drug Enforcement Administration 
(DEA) published in the Federal Register a Final Rule ``Clarification of 
Registration Requirements for Individual Practitioners'' (71 FR 69478). 
The Final Rule makes 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. The Final Rule also noted that DEA would 
address its policy regarding locum tenens practitioners in a separate 
future document. To adequately address this issue, DEA is publishing 
this Advance Notice of Proposed Rulemaking to seek information useful 
to the agency in promulgating regulations regarding locum tenens 
practitioners.

DATES: Written comments must be postmarked on or before December 28, 
2009, and electronic comments must be sent on or before midnight 
Eastern time December 28, 2009.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-324'' on all written and electronic correspondence. 
Written comments being sent via regular or express mail should be sent 
to the Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. 
Comments may be sent to DEA 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 attachments to electronic comments in Microsoft Word, 
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept 
any file formats other than those specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern Time on the day the comment period 
closes because http://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern Time on the day the 
comment period closes. Commenters in time zones other than Eastern Time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152; 
telephone: (202) 307-7297.

SUPPLEMENTARY INFORMATION: Posting of Public Comments: Please note that 
all comments received are considered part of the public record and made 
available for public inspection online at http://www.regulations.gov 
and in the Drug Enforcement Administration's public docket. Such 
information includes personal identifying information (such as your 
name, address, etc.) voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph

[[Page 55500]]

of your comment. You must also prominently identify confidential 
business information to be redacted within the comment. If a comment 
has so much confidential business information that it cannot be 
effectively redacted, all or part of that comment may not be posted 
online or made available in the public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. Please note 
that the Freedom of Information Act applies to all comments received. 
If you wish to inspect the agency's public docket file in person by 
appointment, please see the ``For Further Information'' paragraph.

DEA's Legal Authority

    DEA implements and enforces the Comprehensive Drug Abuse Prevention 
and Control Act of 1970, often referred to as the Controlled Substances 
Act (CSA) and the Controlled Substances Import and Export Act (CSIEA), 
(21 U.S.C. 801-971), as amended. DEA publishes the implementing 
regulations for these statutes 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 
medical, scientific, and other legitimate purposes and to 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 opioids, 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, dispensed, or otherwise 
disposed of.

Background

    The CSA defines ``dispense'' as meaning ``to deliver a controlled 
substance to an ultimate user or research subject by, or pursuant to 
the lawful order of, a practitioner, including the prescribing and 
administering of a controlled substance * * *'' (21 U.S.C. 802(10)). 
The CSA requires that every person who dispenses controlled substances 
shall obtain from the Attorney General a registration (21 U.S.C. 
822(a)(2)). Authority to issue such registrations has been delegated by 
the Attorney General to the Administrator of the Drug Enforcement 
Administration (28 CFR 0.100). DEA has established, by regulation, that 
the period of registration for persons who dispense controlled 
substances is three years (21 CFR 1301.13(e)(iv)).
    The CSA states that the Attorney General shall register 
practitioners to dispense controlled substances if the applicant for 
registration is authorized to dispense controlled substances under the 
laws of the State in which the applicant practices (21 U.S.C. 823(f)). 
The Attorney General may deny an application for registration if he 
determines that the issuance of registration would be inconsistent with 
the public interest. In determining the public interest, the Attorney 
General is required to consider the following factors:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety. (21 U.S.C. 823(f))

    The CSA further 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 other locations within the same State, are 
not required to register for any other location in that State at which 
they only prescribe controlled substances.
    The exception applies only to additional locations within the same 
State in which the practitioner maintains his DEA 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 
administer, dispense, or prescribe controlled substances and to 
determine what level of authority practitioners have, that is, what 
schedules they may administer, dispense, or prescribe. 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.
    DEA discussed the intrastate exception extensively in a Notice of 
Proposed Rulemaking ``Clarification of Registration Requirements for 
Individual Practitioners'' [Docket No. DEA-244, RIN 1117-AA89] (69 FR 
70576, December 7, 2004) and in a subsequent Final Rule (71 FR 69478, 
December 1, 2006). This rule clarified that the exception discussed 
above related only to intrastate, as opposed to interstate, locations.

Locum Tenens Practitioners

    DEA received three comments to its December 7, 2004, Notice of 
Proposed Rulemaking requesting clarification of the effect of that rule 
on the practice of ``locum tenens'' practitioners. Locum tenens is a 
procedure whereby someone substitutes temporarily for another. Latin 
for ``to hold the place of, to substitute for,'' locum tenens means, in 
layman's terms, a temporary physician or other practitioner. Usually, 
locum tenens practitioners contract with a staffing company to perform 
medical services for a healthcare organization for a specified length 
of time. The practitioner is paid by the staffing firm itself, which is 
then paid by the healthcare facility, i.e., the client.
    Groups supportive of locum tenens indicate that the practice of 
locum tenens benefits both practitioners and healthcare organizations 
because it provides flexibility for both parties. They note that the 
industry offers temporary opportunities for medical professionals 
across the country and worldwide. DEA has found one estimate indicating 
that there are over 100 locum tenens agencies operating in the United 
States and over 30,000 locum tenens practitioners. The practitioners in

[[Page 55501]]

demand are hospital-based specialties including anesthesiology, 
psychiatry, radiology, pediatrics, and surgery.
    The CSA does not specifically reference or acknowledge the practice 
of locum tenens. DEA regulations do make clear that under 21 CFR 
1301.12(a), ``A separate registration is required for each principal 
place of business or professional practice at one general physical 
location where controlled substances are manufactured, distributed, 
imported, or dispensed by a person.'' When a locum tenens practitioner 
substitutes for another practitioner on a temporary or sporadic basis 
at that other practitioner's [DEA registered] place of business, that 
place of business is considered by DEA to be a ``principal place of 
business or professional practice'' for purposes of the locum tenens 
practitioner's DEA registration (21 CFR 1301.12(a)).
    Since DEA individual practitioner registrations are based on State 
authority to practice and prescribe controlled substances, a 
practitioner is not authorized to dispense controlled substances 
outside the State(s) in which he or she is licensed and registered. 
Therefore, any locum tenens practice that is conducted in a State other 
than the State in which the practitioner maintains his DEA registration 
is subject to a separate DEA registration.
    DEA believes that two alternatives presently exist to obtain a 
separate DEA registration in another State to accommodate a locum 
tenens practice. First, if the practitioner is licensed to practice and 
to handle controlled substances in that second state, he may submit an 
address change for his current DEA registration for the temporary 
practice location. There is no cost to change an address, even 
temporarily, and it generally takes one week to process. At the end of 
the locum tenens practice, the practitioner may submit a request to 
change his address to his new primary place of business, within the 
same state.
    Second, if the locum tenens service is with a hospital or other 
institution registered with DEA, if the hospital agrees, and if State 
law allows, the practitioner may use the DEA registration of that 
hospital or other institution to administer, dispense, or prescribe 
controlled substances so long as all requirements are met (21 CFR 
1301.22(c)). Specifically:

    An individual practitioner who is an agent or employee of a 
hospital or other institution may, when acting in the normal course 
of business or employment, administer, dispense, or prescribe 
controlled substances under the registration of the hospital or 
other institution which is registered in lieu of being registered 
himself, provided that:
    (1) Such dispensing, administering or prescribing is done in the 
usual course of his professional practice;
    (2) Such individual practitioner is authorized or permitted to 
do so by the jurisdiction in which he is practicing;
    (3) The hospital or other institution by whom he is employed has 
verified that the individual practitioner is so permitted to 
dispense, administer, or prescribe drugs within the jurisdiction;
    (4) Such individual practitioner is acting only within the scope 
of his employment in the hospital or institution;
    (5) The hospital or other institution authorizes the individual 
practitioner to administer, dispense or prescribe under the hospital 
registration and designates a specific internal code number for each 
individual practitioner so authorized. The code number shall consist 
of numbers, letters, or a combination thereof and shall be a suffix 
to the institution's DEA registration number, preceded by a hyphen 
(e.g., APO123456-10 or APO123456-A12); and
    (6) A current list of internal codes and the corresponding 
individual practitioners is kept by the hospital or other 
institution and is made available at all times to other registrants 
and law enforcement agencies upon request for the purpose of 
verifying the authority of the prescribing individual practitioner. 
(21 CFR 1301.22(c))

    This waiver places the controlled substance registration and 
recordkeeping responsibility with the hospital or other institution; 
therefore, there is no need for individual DEA registration. However, 
the individual practitioner must still maintain State licensure.

State Regulations

    As DEA discussed in its proposed and final rules regarding the 
clarification of registration by individual practitioners (69 FR 70576, 
December 7, 2004; 71 FR 69478, December 1, 2006), 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 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 maintains the registration. These principles are 
discussed extensively in DEA's proposed and final rules referenced 
above.
    While DEA is aware that a few States have legislation or 
regulations regarding the locum tenens industry, DEA does not believe 
that the information it has regarding States' legislation and/or 
regulations is complete. DEA notes that States may address locum tenens 
under general legislative authority and through a variety of State 
regulatory entities, including State boards of medicine and State 
licensing commissions. Therefore, as discussed further below, DEA is 
specifically seeking information from State regulatory authorities 
regarding States' legislative and/or regulatory requirements for locum 
tenens practitioners, agencies, and entities that contract with these 
persons.

Comments Requested

    DEA is soliciting information from the locum tenens industry so 
that DEA may obtain a better understanding of this industry and how it 
functions. DEA seeks to clarify the requirements that apply to locum 
tenens practitioners, especially after considering the December 2006 
final rule that specified that only intrastate locations are subject to 
the exception for registration at separate locations. Commenters are 
encouraged to include the comment number enumerated below in their 
response. Although all comments are welcome, DEA is particularly 
interested in comments regarding the questions listed below. These 
questions are separated into groups by area of interest. The groups 
are:

 Locum tenens practitioners
 Those that employ and place locum tenens practitioners
 Institutions that retain the services of locum tenens 
practitioners
 State regulatory authorities

Locum Tenens Practitioners

    1. In your experience, what types of practitioners participate in 
locum tenens activities (e.g., physicians, dentists, nurse 
practitioners)? Please specify your type of licensure.
    2. How long is the typical locum tenens assignment?
    3. Do locum tenens practitioners seek State/Federal licensure or 
registration prior to accepting a position as a locum tenens 
practitioner?
    4. What is the length of time between hiring for the position and 
reporting to duty?
    5. Do practitioners secure locum tenens positions independently or 
through an agency?

[[Page 55502]]

    6. As locum tenens practitioners, do you administer, dispense and 
prescribe controlled substances? Does your authority to do so vary in 
the States in which you practice?
    7. Can you have more than one locum tenens job at a time?

Those That Employ and Place Locum Tenens Practitioners

    8. What role do you have in the locum tenens process?
    9. Do you assist with State and Federal licensure/registration? If 
so, how?
    10. What types of practitioners do you employ or place (e.g., 
physicians, dentists, nurse practitioners)?
    11. How do you verify the locum tenens practitioner's credentials?
    12. Are criminal background checks performed on locum tenens 
practitioners?
    13. What is the geographical coverage for locum tenens (e.g., 
local, statewide, multi-state, national)?
    14. How much time is there between assignments for one 
practitioner?

Institutions That Retain the Services of Locum Tenens Practitioners

    15. How many locum tenens placement agencies do you contract with?
    16. How frequently do you secure locum tenens services?
    17. What credentialing checks do you perform on the locum tenens 
practitioners working for you? Do you perform fewer checks for 
practitioners supplied by agencies than you do for practitioners you 
contract with individually?
    18. For how long do you secure locum tenens services (i.e., 
duration)?
    19. For what specialties do you use locum tenens practitioners?
    20. What authority do you grant locum tenens practitioners? (For 
example, can they administer, dispense, or prescribe controlled 
substances? Under whose DEA registration would such an activity occur?)
    21. Do you grant locum tenens practitioners the same controlled 
substance authority that other practitioners using the institution's 
DEA registration to dispense controlled substances have? If not, why 
not?

State Regulatory Authorities

    22. What are the State requirements for locum tenens practice for 
practitioners (e.g., physicians, dentists)?
    23. Does the State waive State medical licensure (or automatically 
grant temporary courtesy licensure) for locum tenens practitioners if 
they are properly licensed in another State? If so, what checks are 
performed to confirm State licensure in the other State?
    24. If granted, for how long is the waiver or courtesy licensure?
    25. What are the State requirements for locum tenens practice for 
mid-level practitioners (e.g., physician assistants, nurse 
practitioners)?
    26. Does the State waive State licensure (or automatically grant 
temporary courtesy licensure) for locum tenens practitioners who are 
mid-level practitioners if they are properly licensed in another State? 
If so, what checks are performed to confirm State licensure in the 
other State?
    27. If granted, for how long is the waiver or courtesy licensure?
    28. If the State requires State licensure with the medical or other 
professional board, how long is it good for?
    29. Does the State grant locum tenens practitioners the same 
controlled substance authority that it grants to practitioners that are 
fully licensed by the State professional board? If not, why not?
    30. To dispense controlled substances, must a locum tenens 
practitioner obtain a State controlled substance registration?
    31. Does the State medical or other professional board report board 
actions against locum tenens practitioners to the National Practitioner 
database and to States in which the locum tenens practitioner holds a 
license?

Regulatory Certifications

    This action is an Advance Notice of Proposed Rulemaking (ANPRM). 
Accordingly, the requirement of Executive Order 12866 to assess the 
costs and benefits of this action does not apply. Rather, among the 
purposes DEA has in publishing this ANPRM is to seek information from 
the public regarding locum tenens practitioners. Similarly, the 
requirements of section 603 of the Regulatory Flexibility Act do not 
apply to this action since, at this stage, it is an ANPRM and not a 
``rule'' as defined in section 601 of the Regulatory Flexibility Act. 
Following review of the comments received to this ANPRM, if DEA 
promulgates a Notice or Notices of Proposed Rulemaking regarding this 
issue, DEA will conduct all analyses required by the Regulatory 
Flexibility Act, Executive Order 12866, and any other statutes or 
Executive Orders relevant to those rules and in effect at the time of 
promulgation.

    Dated: October 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E9-25937 Filed 10-27-09; 8:45 am]
BILLING CODE 4410-09-P