[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28640-28643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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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