80 FR 28640 - Karen S. Dunning, N.P.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 96 (May 19, 2015)

[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28640-28643]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12020]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 15-11]


Karen S. Dunning, N.P.; Decision and Order

    On January 9, 2015, I, the Administrator of the Drug Enforcement 
Administration, issued an Order to Show Cause and Immediate Suspension 
of Registration to Karen S. Dunning, N.P. (hereinafter, Respondent) of 
Kouts, Indiana. The Order to Show Cause and Immediate Suspension of 
Registration proposed the revocation of Respondent's DEA Certificate of 
Registration MD2249161, pursuant to which she was authorized to 
dispense controlled substances in schedules II through V as a 
practitioner, and the denial of any application to renew or modify her 
registration, on the ground that she has committed acts which render 
her ``continued registration inconsistent with the public interest.'' 
Show Cause Order, at 1.
    More specifically, the Order alleged that Respondent, who is an 
Advanced Practice Nurse licensed by the Indiana State Board of Nursing, 
is not authorized under state law ``to prescribe controlled substances 
in Schedules III and IV for the purpose of weight reduction or to 
control obesity.'' Show Cause Order, at 1. The Order then alleged that 
``between August 2007 and March 2014,'' Respondent issued 
prescriptions, ``on multiple occasions,'' for phendimetrazine, a 
schedule III controlled substance, and phentermine, a schedule IV 
controlled substance, for ``the purpose of weight loss or to control 
obesity, in violation of state and federal law.'' Id. at 2 (citing Ind. 
Code Sec. Sec.  35-48-3-11; 25-22.5-8-2(a); 21 CFR 1306.03 & 
1306.04(a)). The order then set forth specific allegations regarding 
Respondent's prescribing of the aforesaid controlled substances to nine 
patients. Id. at 2-4.
    The Order also alleged that ``beginning in February 2014 and for 
several months thereafter,'' Respondent had violated federal law by 
issuing controlled substance prescriptions for weight loss medications 
that had been pre-signed by her collaborating physician, as well as 
that between February and August 2014, she issued controlled substance 
prescriptions ``without a collaborative agreement'' having been filed 
with the Indiana Board of Nursing. Id. at 4 (citing 21 CFR 1306.05 and 
1306.03(a)(1); 848 Ind. Admin. Code Sec.  5-1-1(a)(7)). The Order 
further alleged that Respondent had dispensed Bontril (phendimetrazine) 
to

[[Page 28641]]

a patient at an unregistered location. Id. Finally, the Order alleged 
that Respondent had failed to keep various records as required by DEA 
regulations. Id. at 5. Based on the totality of Respondent's 
misconduct, I concluded that her continued registration during the 
pendency of the proceeding ``would constitute an imminent danger to the 
public health and safety'' and therefore ordered that her registration 
be immediately suspended. Id. at 6-7.
    Following service of the Order, Respondent timely requested a 
hearing on the allegations. The matter was placed on the docket of the 
Office of Administrative Law Judges and assigned to Administrative Law 
Judge (ALJ) Christopher B. McNeil, who proceeded to conduct pre-hearing 
procedures.
    However, the next day, the Government moved for summary disposition 
and to stay the proceeding, asserting that the Indiana State Board of 
Nursing had ordered the emergency suspension of Respondent's nursing 
license and advanced practice nurse prescriptive authority, and that 
she was without authority to dispense controlled substances and to 
possess a DEA registration in the State. Mot. For Summ. Disp., at 1-3. 
As support for its Motion, the Government attached a printout from a 
license verification Web page maintained by the State of Indiana. See 
id. at Attachment A. The printout showed that Respondent's Indiana 
Advanced Practice Nurse Prescriptive Authority license was the subject 
of an emergency suspension.\1\ Id.
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    \1\ Subsequently, the Government also filed a copy of the 
Summary Suspension Order issued to Respondent by the Indiana State 
Board of Nursing. See Notice of Filing of Written Suspension Order 
(Exhibit A).
    I take official notice of the registration records of this 
Agency, which establish that Respondent's registration will not 
expire until June 30, 2016. See 21 CFR 1316.59(e). Respondent may 
refute this fact by filing a properly supported motion for 
reconsideration no later than ten (10) business days from the date 
of issuance of this Decision and Order.
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    Upon review of the Government's Motions, the ALJ issued an Order 
for Stay and for Respondent's Response to Allegations Concerning 
Respondent's Lack of State Authority. R.D. at 2. Thereafter, Respondent 
timely filed her Response, in which she did not dispute that her 
license was suspended but asserted that section 824(a)(3) ``authorizes 
suspension or revocation of a DEA registration based on the loss of 
State privileges'' and thus ``gives a choice of remedies and clearly 
contemplates the exercise of administrative discretion.'' Respondent's 
Response, at 1.
    Respondent contends that the Nursing Board has only suspended her 
license and advanced practice nurse prescriptive authority for ninety 
(90) days. Id. at 3. She further argues that the prior cases in which 
the Agency revoked a practitioner's registration based on a state's 
suspension of prescribing authority involved suspensions that ``were of 
indefinite rather than, as here, for a finite, definite, and limited 
time'' and that ``[t]his indefiniteness was the gravamen of the 
decisions holding revocation to be the appropriate remedy.'' Id. 
(citing Anne Lazar Thorn, 62 FR 12847, 12848 (1997)).
    Respondent also argues that the temporary suspension of her license 
``does not render her `no longer authorized by State law' to dispense 
controlled substances. It only temporarily restrains her from 
dispensing controlled substances.'' Id. And she further argues that 
suspending her registration ``mean[s] that she is not holding a DEA 
Registration and would fully satisfy statutory requirements.'' Id. She 
thus contends that revoking her registration would be ``arbitrary, 
capricious, a clear abuse of discretion and not in accordance with the 
law.'' Id. at 4.
    The ALJ correctly rejected these contentions, explaining that the 
CSA defines the term ``practitioner'' to ``mean[] a physician, dentist, 
veterinarian . . . or other person licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which [s]he 
practices to distribute [or] dispense a controlled substance in the 
course of professional practice,'' 21 U.S. C. 802(21), and that under 
section 823(f), only a person who is authorized to dispense controlled 
substances and is therefore a practitioner within the meaning of the 
Act can be registered. R.D., at 3; see also 21 U.S. C. 823(f) (``The 
Attorney General shall register practitioners . . . to dispense . . . 
controlled substances . . . if the applicant is authorized to dispense 
. . . controlled substances under the laws of the States in which he 
practices.'').
    Respondent contends, however, that the decision in Anne Lazar 
Thorn, M.D., 62 FR 12847 (1997), stands for the proposition that the 
Agency's consistent practice of revoking registrations based on a loss 
of state authority ``rests on the indefinite nature of a State 
suspension.'' Respondent's Resp., at 2-3. Respondent quotes the 
following passage from Thorn:

[T]he Acting Deputy Administrator recognizes that he has 
discretionary authority to either revoke or suspend a DEA 
registration. However, given the indefinite nature of the suspension 
of Respondent's state license to practice medicine, the Acting 
Deputy Administrator agrees with [the ALJ] that revocation is 
appropriate in this case.

Id. at 3 (quoting 62 FR at 12848).
    Notwithstanding the implication of the above passage, no decision 
of this Agency has held that a suspension (rather than a revocation) is 
warranted where a State has imposed a suspension of a fixed or certain 
duration. To the contrary, in the case of practitioners, DEA has long 
and consistently interpreted the CSA as mandating the possession of 
authority under state law to handle controlled substances as a 
fundamental condition for obtaining and maintaining a registration. 
See, e.g., Leonard F. Faymore, 48 FR 32886, 32887 (1983) (collecting 
cases). As the Thorn decision further explained:

    DEA has consistently interpreted the Controlled Substances Act 
to preclude a practitioner from holding a DEA registration if the 
practitioner is without authority to handle controlled substances in 
the state in which he/she practices. This prerequisite has been 
consistently upheld.
* * * * *
    The Acting Deputy Administrator finds that the controlling 
question is not whether a practitioner's license to practice 
medicine in the state is suspended or revoked; rather it is whether 
the Respondent is currently authorized to handle controlled 
substances in the state. In the instant case, it is undisputed that 
Respondent is not currently authorized to handle controlled 
substances in the [state in which she practices medicine]. Therefore 
. . . Respondent is not currently entitled to a DEA registration.

62 FR at 128438 (citing and quoting 21 U.S. C. 823(f) and 802(21) and 
collecting cases). Accordingly, in Thorn, the Agency rejected the 
Respondent's contention that her registration should be suspended 
rather than revoked.
    As for Respondent's contention that section 824(a) ``gives a choice 
of remedies and clearly contemplates the exercise of administrative 
discretion,'' it is acknowledged that the opening sentence of section 
824(a) provides that a registration ``may be suspended or revoked by 
the Attorney General'' upon the Attorney General's finding that one of 
the five grounds set forth exists. 21 U.S. C. 824(a). However, this 
general grant of authority in imposing a sanction must be reconciled 
with the CSA's specific provisions which mandate that a practitioner 
hold authority under state law in order to obtain and maintain a DEA 
registration. See Gozlon-Peretz v. United States, 498 U.S. 395, 407 
(1991) (``A specific provision controls over one of more general 
application.''); see also Bloate v.

[[Page 28642]]

United States, 130 S.Ct. 1345, 1354 (2010) (quoting D. Ginsberg & Sons, 
Inc., v. Popkin, 285 U.S. 204, 208 (1932) (``General language of a 
statutory provision, although broad enough to include it, will not be 
held to apply to a matter specifically dealt with in another part of 
the same enactment.'')).
    Indeed, Respondent's argument has previously been tried and 
rejected. See James L. Hooper, 76 FR 71371 (2011), pet. for rev. 
denied, Hooper v. Holder, 481 F. App'x 826 (4th Cir. 2012) 
(unpublished). As the Fourth Circuit explained in Hooper:

    Section 824(a) does state that the DA may ``suspend or revoke'' 
a registration, but the statute provides for this sanction in five 
different circumstances, only one of which is loss of a State 
license. Because Sec.  823(f) and Sec.  802(21) make clear that a 
practitioner's registration is dependent upon the practitioner 
having state authority to dispense controlled substances, the DA's 
decision to construe Sec.  824(a)(3) as mandating revocation upon 
suspension of a state license is not an unreasonable interpretation 
of the CSA.

Id. at 828.
    Moreover, while Respondent points to the fact that the suspension 
imposed by the Board is ``temporary'' and only ``for ninety (90) 
days,'' Respondent's Resp. at 3, the Board's order was non-final. Thus, 
while Respondent may prevail before the Board, the Board may also 
impose an additional period of suspension or revoke her license and 
prescribing authority.
    Accordingly, consistent with the Agency's longstanding precedent, 
revocation remains warranted.\2\ See Gary Alfred Shearer, 78 FR 19009 
(2013) (holding that revocation is warranted even where a state order 
has summarily suspended a practitioner's controlled substances 
authority and the state agency's order remains subject to challenge in 
either administrative or judicial proceedings); Winfield Drugs, Inc., 
52 FR 27070 (1987) (revoking registration based on state emergency 
suspension order notwithstanding state order was under appeal, noting 
that the ``[r]espondent is not currently authorized to handle 
controlled substances in the [s]tate'' and that ``[a]s a matter of law, 
the [DEA] does not have statutory authority . . . to issue or maintain 
a registration for a practitioner if the applicant or registrant lacks 
[s]tate authority to dispense controlled substances'').
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    \2\ As for Respondent's contention that the temporary suspension 
of her license ``does not render her `no longer authorized by State 
law' to dispense controlled substances,'' under Indiana law, ``[a] 
person who . . . practices nursing during the time the person's 
license issued under this chapter . . . is suspended or revoked 
commits a Class B misdemeanor.'' Ind. Code Sec.  25-23-1-27(5). 
Thus, Respondent is not currently authorized to dispense controlled 
substances.
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Order

    Pursuant to the authority vested in me by 21 U.S. C. 824 as well as 
28 CFR 0.100(b), I order that DEA Certificate of Registration MD2249161 
issued to Karen S. Dunning, N.P., be, and it hereby is, revoked. This 
Order is effectively immediately.\3\
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    \3\ Based on the same findings that led me to conclude that 
Respondent's continued registration during the pendency of the 
proceeding constitutes an imminent danger to public health and 
safety, I conclude that the public interest necessitates that this 
Order be effective immediately. 21 CFR 1316.67.

    Dated: May 1, 2015.
Michele M. Leonhart,
Administrator.
Michelle F. Gillice, Esq., Paul A. Dean, Esq., for the Government.
Lakeisha C. Murdaugh, Esq., Scott L. King, Esq., for the Respondent.

ORDER GRANTING THE GOVERNMENT'S MOTION FOR SUMMARY DISPOSITION AND 
FINDINGS OF FACT, CONCLUSIONS OF LAW, AND RECOMMENDED DECISION OF THE 
ADMINISTRATIVE LAW JUDGE

    Administrative Law Judge Christopher B. McNeil. On January 9, 
2015, the Administrator of the Drug Enforcement Administration 
issued an Order to Show Cause and Immediate Suspension of 
Respondent's DEA Certificate of Registration, No. MD2249161. The 
Order affords Respondent the opportunity to show cause why 
Respondent's DEA registration should not be revoked pursuant to 21 
U.S. C. 824(a), on the grounds that Respondent's continued 
registration would be inconsistent with the public interest. The 
Order also seeks to deny any pending applications for registration, 
renewal or modification pursuant to 21 U.S. C. 823(f). In addition, 
the Administrator immediately suspended Respondent's registration 
pursuant to 21 U.S. C. 824(d), upon finding Respondent's continued 
registration constitutes an imminent danger to the public health and 
safety.
    According to the Government's Notice of Service, Respondent was 
personally served with the Order to Show Cause on January 14, 2015. 
On February 18, 2015, the Office of Administrative Law Judges 
received Respondent's Request for Hearing, dated February 13, 2015. 
On February 19, 2015, this Office issued an Order for Prehearing 
Statements and Order Setting the Matter for Hearing.
    On February 20, 2015, this office received Government's Motion 
for Summary Disposition and Motion to Stay Proceedings. The 
Government asserted that the Indiana State Board of Nursing ordered 
an emergency suspension of Respondent's nursing license and her 
advanced practice nurse prescriptive authority, effective 
immediately. Citing this lack of state authority, the Government 
requested that the matter be forwarded to the Administrator for a 
Final Order and that in the interest of efficiency, I grant a Motion 
to Stay the Proceedings and continue the deadlines pending the 
resolution of the Motion for Summary Disposition. In response to the 
Government's filing, I issued an Order for Stay and for Respondent's 
Response to Allegations Concerning Respondent's Lack of State 
Authority. In the Order, I required Respondent to file a response to 
the Government's Motion for Summary Disposition no later than 
February 27, 2015. Additionally, I stayed the matter and held all 
deadlines in abeyance.
    On February 27, 2015, I received Respondent's Response to the 
Government's Motion for Summary Disposition. Respondent first cites 
21 U.S. C. 824(a)(3) to demonstrate that the Administrator has the 
choice of authorizing suspension or revocation of Respondent's 
registration. Respondent then asks that I consider suspending her 
registration based on the premise that the 90 day suspension of her 
advanced practice nurse prescriptive authority is not equivalent to 
the indefinite suspensions in the case law cited by the Government.
    The substantial issue raised by the Government rests on an 
undisputed fact. The Government asserts that Respondent's DEA 
Certificate of Registration must be revoked because Respondent does 
not have a nursing licensed issued by the state in which she 
practices. Under DEA precedent, a practitioner's DEA Certificate of 
Registration for controlled substances must be summarily revoked if 
the applicant is not authorized to handle controlled substances in 
the state in which she maintains her DEA registration.\1\ Pursuant 
to 21 U.S. C. 823(f), only a ``practitioner'' may receive a DEA 
registration. Under 21 U.S. C. 802(21), a ``practitioner'' must be 
``licensed, registered, or otherwise permitted, by the United States 
or the jurisdiction in which he practices or does research, to 
distribute [or] dispense . . . controlled substance[s.]'' Given this 
statutory language, the DEA Administrator does not have the 
authority under the Controlled Substances Act to maintain a 
practitioner's registration if that practitioner is not authorized 
to dispense controlled substances.\2\
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    \1\ See 21 U.S. C. 801(21), 823(f), 824(a)(3); see also House of 
Medicine, 79 FR 4959, 4961 (DEA 2014); Deanwood Pharmacy, 68 FR 
41662-01 (DEA July 14, 2003); Wayne D. Longmore, M.D., 77 FR 67669-
02 (DEA November 13, 2012); Alan H. Olefsky, M.D., 72 FR 42127-01 
(DEA August 1, 2007); Layfe Robert Anthony, M.D., 67 FR 15811 (DEA 
May 20, 2002); George Thomas, PA-C, 64 FR 15811-02 (DEA April 1, 
1999); Shahid Musud Siddiqui, M.D., 61 FR 14818-02 (DEA April 4, 
1996); Michael D. Lawton, M.D., 59 FR 17792-01 (DEA April 14, 1994); 
Abraham A. Chaplan, M.D., 57 FR 55280-03 (DEA November 24, 1992). 
See also Bio Diagnosis Int'l, 78 FR 39327-03, 39331 (DEA July 1, 
2013) (distinguishing distributor applicants from other 
``practitioners'' in the context of summary disposition analysis).
    \2\ See Abraham A. Chaplan, M.D., 57 FR 55280-03, 55280 (DEA 
November 24, 1992), and cases cited therein. In Chaplan, DEA 
Administrator Robert C. Bonner adopts the ALJ's opinion that ``the 
DEA lacks statutory power to register a practitioner unless the 
practitioner holds state authority to handle controlled 
substances.'' Id.

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[[Page 28643]]

    Respondent alternatively asks that I consider suspending her 
registration instead of revoking her registration. This exact issue 
was addressed in James L. Hooper, M.D.; Decision and Order.\3\ Dr. 
Hooper was subject to a one-year suspension of his state license to 
practice medicine after which his license would be automatically 
reinstated.\4\ In comparison to Hooper, Respondent in this case has 
a less persuasive case as there is no guarantee that her advanced 
practice nurse prescriptive authority will be restored after 90 
days. Dr. Hooper sought a suspension of his DEA Registration for the 
same time period his medical license was suspended. DEA 
Administrator Michele M. Leonhart agreed with Chief Administrative 
Law Judge John J. Mulrooney, II who did not find Dr. Hooper's 
argument persuasive. Administrator Leonhart, like Respondent in the 
case at hand, cited to Anne Lazar Thorn, M.D.\5\ Administrator 
Leonhart cites the Acting Deputy Administrator's statement in Thorn 
that ``the controlling question is not whether a practitioner's 
license to practice medicine in the state is suspended or revoked; 
rather, it is whether the Respondent is currently authorized to 
handle controlled substances in the state.'' \6\ In Hooper, 
Administrator Leonhart concludes that ``even where a practitioner's 
state license has been suspended for a period of certain duration, 
the practitioner no longer meets the statutory definition of a 
practitioner.'' \7\ As detailed above, only a ``practitioner'' may 
receive a DEA registration. Therefore, I cannot and will not 
recommend the suspension of Respondent's DEA registration, but will 
instead recommend the registration be revoked.
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    \3\ James L. Hooper, M.D.; Decision and Order, 76 FR 71371-01, 
71371 (DEA Nov. 17, 2011).
    \4\ Id.
    \5\ Anne Lazar Thorn, Revocation of Registration M.D, 62 FR 
12847, 12848 (DEA Mar. 18, 1997).
    \6\ Id. at 12848.
    \7\ Hooper, 76 FR at 71372.
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Order Granting the Government's Motion for Summary Disposition and 
Recommendation

    I find there is no genuine dispute regarding whether Respondent 
is a ``practitioner'' as that term is defined by 21 U.S. C. 802(21), 
and that based on the record the Government has established that 
Respondent is not a practitioner and is not authorized to dispense 
controlled substances in the state in which she seeks to practice 
with a DEA Certificate of Registration. I find no other material 
facts at issue. Accordingly, I GRANT the Government's Motion for 
Summary Disposition.
    Upon this finding, I ORDER that this case be forwarded to the 
Administrator for final disposition and I recommended that 
Respondent's DEA Certificate of Registration should be REVOKED and 
any pending application for the renewal or modification of the same 
should be DENIED.

    Dated: March 9, 2015

Christopher B. McNeil,

Administrative Law Judge

[FR Doc. 2015-12020 Filed 5-18-15; 8:45 am]
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