80 FR 28693 - Sharad C. Patel, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

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

Page Range		28693-28695
FR Document		2015-12025
Federal Register, Volume 80 Issue 96 (Tuesday, May 19, 2015)
[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28693-28695]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12025]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 15-13]


Sharad C. Patel, M.D.; Decision and Order

    On March 11, 2015, Administrative Law Judge (ALJ) Christopher B. 
McNeil issued the attached Recommended Decision (cited as R.D.). 
Thereafter, on April 1, Respondent filed a pleading entitled as 
``Objections to Findings of Fact, Conclusions of Law, and Recommended 
Decision of the Administrative Law Judge (hereinafter, Resp. 
Objections). Therein, Respondent objected to the entry of the ALJ's 
Recommended Decision, on the ground that ``he was never properly, or 
sufficiently, served with the [Government's] initial motion'' for 
summary disposition and therefore ``did not respond to the . . . 
[m]otion . . . because he was unaware of any such motion until the 
ALJ's Order granting such motion.'' Objections, at 1.
    Respondent argues that in his request for hearing, his attorneys 
provided both a mailing address and email address for receiving the 
``notices to be sent pursuant to the proceeding.'' 21 CFR 1316.47(a); 
Objections at 1. Respondent did not, however, provide a fax number. Id. 
at 2.
    Thereafter, Respondent received the ALJ's Order for Briefing on 
Allegations Concerning Respondent's Lack of State Authority'' by First 
Class Mail. Id. The ALJ's Order specified the date (Mar. 2, 2015) by 
which the Government was to provide its evidence and arguments (as well 
as its motion for summary disposition) in support of its contention 
that Respondent does not possess ``state authority to handle controlled 
substances,'' as well as the date by which Respondent was to file his 
response (Mar. 9) to any such motion. Id.
    On March 2, the Government filed its Motion for Summary Disposition 
with the Office of Administrative Law Judges. Motion for Summ. Disp., 
at 1. In the Certificate of Service, the Government represented that it 
had served the Motion by facsimile, but not by first class mail or 
email.\1\ Id. at 4. In its Objections, Respondent asserts that he ``did 
not respond to the DEA Motion for Summary Disposition because he was 
unaware of any such motion until the ALJ's Order granting such 
motion.'' Objections, at 1.
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    \1\ Respondent's contention regarding the inadequacy of service 
is not without merit. Of note, Respondent did not consent to the 
service of pleadings by facsimile and the ALJ's Order for Briefing 
on Allegation Concerning Respondent's Lack of State Authority did 
not authorize service of pleadings in this manner. Moreover, while 
the use of electronic means has the advantage of faster service--at 
least where the transmission is successful--a hard copy should still 
be sent by mail, courier, or third party commercial carrier unless 
the serving party contacts the other party and affirmatively 
determines that the entire document was received.
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    As stated above, on March 11, the ALJ issued his Recommended 
Decision. Therein, the ALJ noted that the Government had attached a 
copy of the Emergency Order of Suspension issued by the Kentucky Board 
of Medical Licensure; the Order, which was issued on November 24, 2014, 
suspended Respondent's Kentucky medical license ``effectively 
immediately upon its receipt.'' Mot. For Supp. Disp., Attachment 1, at 
18.
    In his Recommended Decision, the ALJ noted that Respondent had not 
filed a response to the Government's motion. R.D. at 2. However, the 
ALJ also noted that in his hearing request, Respondent had ``admit[ted] 
that his license is temporary [sic] suspended'' but that ``he expects 
to prevail before the medical board at an upcoming hearing on May 18, 
2015.'' Id. at 3. As explained in his decision, the ALJ found that 
there was no dispute that Respondent ``is not authorized to handle 
controlled substances in the State in which he maintains his 
registration'' and is therefore not a practitioner within the meaning 
of the Controlled Substances Act. Id. The ALJ thus recommended that 
Respondent's registration be revoked and that any pending application 
be denied.
    Thereafter, the ALJ forwarded the record to me, noting in his 
letter that Respondent's objections were not timely filed. Letter from 
ALJ to Administrator (Apr. 7, 2015), at 2. The ALJ also provided a copy 
of a Transmission Verification Report showing that the Recommended 
Decision was successfully faxed to Respondent's

[[Page 28694]]

counsel on March 11. Thus, Respondent's Objections (which I have 
treated as his Exceptions) were not received until day twenty-one, one 
day after they were due.\2\ See 21 CFR 1316.66(a). Having offered no 
explanation for why his Objections were late, I agree with the ALJ's 
finding that Respondent's Objections were out of time.
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    \2\ It is further noted that Respondent did not mail his 
Objections until March 31, 2015. Objections, at 4. DEA's regulation 
provides that ``[d]ocuments shall be dated and deemed filed upon 
receipt by the Hearing Clerk.'' 21 CFR 1316.45. This case does not 
raise any issue of delay being attributable to the physical address 
of the Office of Administrative Law Judges being different from the 
mailing address of that Office.
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    In any event, in his Objections, Respondent does not dispute that 
he remains without authority to handle controlled substances in State 
of Kentucky. Objections, at 3. Rather, he seeks a delay in responding 
to the Government's Motion until July 1, 2015 on the ground that the 
State's ``suspension is temporary [and] was not issued after a full and 
fair hearing on the issues,'' and that ``[t]he sole support for the 
Government's Motion . . . is the temporary action taken by the state 
medical board.'' Id. He further contends that he ``is vigorously 
defending himself from the unwarranted suspension of his Kentucky 
medical license and believes he will ultimately prevail'' and have his 
medical license and state controlled substance authority restored. Id.
    However, the Agency has long held that ``a practitioner can neither 
obtain nor maintain a DEA registration unless the practitioner 
currently has authority under state law to handle controlled 
substances.'' James L. Hooper, 76 FR 71371 (2011), pet. for rev. 
denied, Hooper v. Holder, 481 F. App'x 826 (4th Cir. 2012). This 
holding is derived from the plain meaning of two provisions of the 
Controlled Substances Act.
    The first is section 102(21), which defines the term 
``practitioner'' to ``mean[ ] a physician . . . licensed, registered, 
or otherwise permitted, by . . . the jurisdiction in which he practices 
. . . to distribute, dispense, [or] administer . . . a controlled 
substance in the course of professional practice.'' 21 U.S.C. 802(21). 
The second is section 303(f), which sets forth the criteria for 
obtaining a practitioner's registration and which explicitly provides 
that ``[t]he Attorney General shall register practitioners . . . to 
dispense . . . controlled substances . . . if the applicant is 
authorized to dispense . . . controlled substances under the laws of 
the State in which he practices.'' Id. Sec.  823(f) (emphasis added). 
Based on these provisions, the Agency has long held 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. See Gary Alfred Shearer, 78 FR 19009 (2013); see also 
Newcare Home Health Services, 72 FR 42126, 42127 n.2 (2007) (collecting 
cases and holding that ``ALJ properly rejected . . . request for stay'' 
and that ``[i]t is not DEA's policy to stay proceedings under section 
304 while registrant litigate in other forums'').
    According to the allegations of the Show Cause Order, Respondent's 
registration was not due to expire until March 31, 2015. Thus, at the 
time the ALJ issued his decision, Respondent still held a DEA 
registration. However, at the time the case was forwarded to my Office, 
the record contained no evidence as to whether Respondent had filed a 
timely renewal (or even an untimely renewal) application and whether 
his registration remained in effect.\3\
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    \3\ Even in summary disposition proceedings which are based on a 
lack of state authority, the ALJ is obligated to make a finding 
establishing that the Agency has jurisdiction. Moreover, where it is 
unclear whether a respondent may have allowed his registration to 
expire during the course of the proceeding, the ALJ is obligated to 
determine whether the respondent has filed a renewal application 
before forwarding the record to the Administrator.
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    In his request for hearing, Respondent contended that ``he is 
prohibited from applying for his DEA certificate until the Kentucky 
medical board acts upon his suspension.'' R.D. at 3. The ALJ rejected 
Respondent's contention, stating that under 21 CFR 1301.36(i), ``the 
existing registration of an applicant for reregistration will be 
automatically extended until the Administrator issues her order if the 
applicant applies for reregistration.'' Id.
    According to the registration records of the Agency--of which I 
have taken official notice \4\--Respondent filed a renewal application 
on March 23, eight days before the expiration date of his registration. 
However, contrary to the ALJ's explanation of 21 CFR 1301.36(i), where 
a registrant-applicant has been issued an order to show cause, the 
regulation actually provides:
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    \4\ See 21 CFR 1316.59(e). Respondent may refute my finding by 
filing a properly supported motion for reconsideration no later than 
fifteen (15) calendar days from the date of issuance of this 
Decision and Order.

[i]n the event an applicant for reregistration (who is doing 
business under a registration previously granted and not revoked or 
suspended) has applied for reregistration at least 45 days before 
the date on which the existing registration is due to expire, and 
the Administrator has issued no order on the application on the date 
on which the existing registration is due to expire, the existing of 
the applicant shall automatically be extended and continue in effect 
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until the date on which the Administrator so issues his/her order.

21 CFR 1301.36(i) (emphasis added).
    To be sure, the regulation also provides that a registration may be 
extended ``under the circumstances contemplated in this section even 
through the registrant failed to apply for reregistration at least 45 
days before expiration of the existing registration, with or without 
request by the registrant, if the Administrator finds that such 
extension is not inconsistent with the public health and safety.'' 21 
CFR 1301.36(i). However, based on the Kentucky Board's Emergency 
Suspension order and the extensive findings (which include allegations 
related to his prescribing of controlled substances) made therein, I 
find that the extension of Respondent's registration would be 
``inconsistent with the public health and safety.'' See Paul H. 
Volkman, 73 FR 30630, 30641 (2008) (declining to extend registration of 
practitioner subject to order to show cause who did not file his 
renewal application until nineteen days before expiration of the 
registration but finding that the application remained pending before 
the Agency).
    Accordingly, I hold that Respondent's registration has expired but 
that his application remains pending before the Agency. However, 
because Respondent is not currently authorized to dispense controlled 
substances under the laws of the State of Kentucky, the State in which 
he seeks registration, he is not entitled to be registered. See 21 
U.S.C. 823(f) & 802(21).
    I therefore adopt the ALJ's finding that Respondent is not 
currently authorized to dispense controlled substances in Kentucky, the 
State in which he seeks registration, and is therefore not a 
practitioner within the meaning of the CSA. I further adopt the ALJ's 
order granting the Government's Motion for Summary Disposition. 
However, I adopt the ALJ's Recommendation only with respect to the 
denial of Respondent's pending application to renew his registration.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 
CFR 0.100(b), I order that the application of Sharad C. Patel, M.D., 
for a DEA Certificate of Registration as a practitioner, be, and it

[[Page 28695]]

hereby is, denied. This Order is effectively immediately.

    Dated: May 1, 2015.
Michele M. Leonhart,
Administrator.

Brian Bayly, Esq., for the Government.
Marc S. Murphy, Esq., and Michael Denbow, 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 29, 
2015, the Deputy Assistant Administrator of the Drug Enforcement 
Administration issued an Order to Show Cause as to why the DEA 
should not revoke DEA Certificate of Registration Number FP2719245 
issued to Sharad C. Patel, M.D., the Respondent in this matter. The 
Order seeks to revoke Respondent's registration pursuant to 21 
U.S.C. 824(a)(3) and 823(f), and to deny any pending applications 
for renewal or modification of such registration, and deny any 
applications for any new DEA registrations pursuant to 21 U.S.C. 
823(f). As grounds for denial, the Government alleges that 
Respondent is ``without authority to handle controlled substances in 
Kentucky, the state in which [Respondent is] registered with the 
DEA.''
    On February 20, 2015, the DEA's Office of Administrative Law 
Judges received Respondent's written request for a hearing, which is 
dated February 19, 2015. Respondent states that his medical license 
is ``temporarily suspended'' by the state's medical board and that 
he plans to challenge the suspension in an upcoming state 
administrative hearing scheduled for May 18, 2015.
    On February 23, 2015 this Office issued an Order for Briefing on 
Allegations Concerning Respondent's Lack of State Authority. In the 
Order, I mandated that the Government provide evidence to support 
the allegation that Respondent lacks state authority to handle 
controlled substances and if appropriate file a motion for summary 
disposition no later than 2:00 p.m. Eastern Standard Time (EST) on 
March 2, 2015. On March 2, 2015, the Government timely submitted a 
brief in support of the allegation regarding state authority and 
filed a Motion for Summary Disposition. According to the 
Government's brief, the Board of Medical Licensure of the 
Commonwealth of Kentucky issued an Emergency Order of Suspension 
suspending Respondent's license to practice medicine, effective 
November 24, 2014. The Government attached the emergency order 
pertaining to Respondent to the Motion for Summary Disposition. 
Based on this suspension, the Government moved for a summary 
disposition of these proceedings.
    In my Order for Briefing on Allegations Concerning Respondent's 
Lack of State Authority, I also provided Respondent the opportunity 
to respond to the Government's allegations with a brief due not 
later than 2:00 p.m. EST on March 9, 2015. As of today, no brief was 
received and therefore the Government's Motion for Summary 
Disposition will stand unopposed. In Respondent's Request for 
Hearing, Respondent admits that his license is temporary suspended. 
Respondent further states that he expects to prevail before the 
medical board at an upcoming hearing on May 18, 2015. Finally he 
notes that his DEA Certificate of Registration will expire by its 
own terms on March 31, 2015, and alleges that he is prohibited from 
applying for his DEA certificate until the Kentucky medical board 
acts upon his suspension.
    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 medical license issued by the state in which he practices 
-- a fact which Respondent does not deny. 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 he 
maintains his 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\ 
As noted by the Government in its Motion for Summary Disposition, 
Respondent's concern regarding the impending expiration of his DEA 
registration is unfounded. Under 21 CFR 1301.36(i), incorrectly 
cited by the Government as 21 CFR 1306.36(i), the existing 
registration of an applicant for reregistration will be 
automatically extended until the Administrator issues her order if 
the applicant applies for reregistration.\3\
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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 Jan. 30, 2014); Deanwood Pharmacy, 
68 FR 41662-01 (DEA July 14, 2003); Wayne D. Longmore, M.D., 77 FR 
67669-02 (DEA Nov. 13, 2012); Alan H. Olefsky, M.D., 72 FR 42127-01 
(DEA Aug. 1, 2007); Layfe Robert Anthony, M.D., 67 FR 15811 (DEA May 
20, 2002); George Thomas, PA-C, 64 FR 15811-02 (DEA Apr. 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 Apr. 14, 1994); Abraham 
A. Chaplan, M.D., 57 FR 55280-03 (DEA Nov. 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 
Nov. 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.
    \3\ See also Ronald J. Riegel, D.V.M., 63 FR 67132-01, 67132 
(DEA Dec. 4, 1998).
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    As detailed above, only a ``practitioner'' may receive a DEA 
registration. Therefore, I will recommend the revocation of 
Respondent's DEA registration.

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 he 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 11, 2015.
Christopher B. McNeil,
Administrative Law Judge.
[FR Doc. 2015-12025 Filed 5-18-15; 8:45 am]
 BILLING CODE 4410-09-P
Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices 28693

establishing grounds to deny an Accordingly, I GRANT the On March 2, the Government filed its
application for registration upon Government’s Motion for Summary Motion for Summary Disposition with
sufficient proof establishing the Disposition. the Office of Administrative Law Judges.
applicant does not possess a state Upon this finding, I ORDER that this Motion for Summ. Disp., at 1. In the
controlled substance registration. That case be forwarded to the Administrator Certificate of Service, the Government
proof is in the record before me, and it for final disposition and I represented that it had served the
warrants the summary revocation of RECOMMEND the Administrator DENY Motion by facsimile, but not by first
Respondent’s DEA Certificate of Respondent’s application for a DEA class mail or email.1 Id. at 4. In its
Registration. Certificate of Registration. Objections, Respondent asserts that he
I am mindful of the arguments raised ‘‘did not respond to the DEA Motion for
Dated: October 23, 2014.
by Respondent in her Reply to the Summary Disposition because he was
Government’s Motion for Summary Christopher B. McNeil,
unaware of any such motion until the
Judgment, including the fact that Administrative Law Judge.
ALJ’s Order granting such motion.’’
Respondent is currently appealing the [FR Doc. 2015–12023 Filed 5–18–15; 8:45 am] Objections, at 1.
revocation of her state controlled BILLING CODE 4410–09–P As stated above, on March 11, the ALJ
substance registration.49 These issued his Recommended Decision.
difficulties do not, however, change the Therein, the ALJ noted that the
fact that without a state controlled DEPARTMENT OF JUSTICE Government had attached a copy of the
substance registration, Respondent is Emergency Order of Suspension issued
not a ‘‘practitioner’’ and cannot be Drug Enforcement Administration
by the Kentucky Board of Medical
granted a Certificate of Registration. Licensure; the Order, which was issued
Some care should be taken to assure [Docket No. 15–13] on November 24, 2014, suspended
the parties that the actions taken in this Respondent’s Kentucky medical license
administrative proceeding conform to Sharad C. Patel, M.D.; Decision and ‘‘effectively immediately upon its
constitutional requirements. I have Order receipt.’’ Mot. For Supp. Disp.,
examined the parties’ contentions with Attachment 1, at 18.
On March 11, 2015, Administrative
an eye towards ensuring all tenets of In his Recommended Decision, the
Law Judge (ALJ) Christopher B. McNeil
due process have been adhered to. ALJ noted that Respondent had not filed
issued the attached Recommended
There is, however, no authority for me a response to the Government’s motion.
Decision (cited as R.D.). Thereafter, on
to evaluate the facts that underlie R.D. at 2. However, the ALJ also noted
April 1, Respondent filed a pleading
Respondent’s contentions. In the that in his hearing request, Respondent
entitled as ‘‘Objections to Findings of
proceedings now before me, the only had ‘‘admit[ted] that his license is
Fact, Conclusions of Law, and
material question was answered by temporary [sic] suspended’’ but that ‘‘he
Recommended Decision of the
Respondent in her Request for Hearing. expects to prevail before the medical
Administrative Law Judge (hereinafter,
Further, while the Order to Show Cause board at an upcoming hearing on May
Resp. Objections). Therein, Respondent
sets forth a non-exhaustive summary of 18, 2015.’’ Id. at 3. As explained in his
objected to the entry of the ALJ’s
facts and law relevant to a decision, the ALJ found that there was
Recommended Decision, on the ground
determination that granting this no dispute that Respondent ‘‘is not
that ‘‘he was never properly, or
application would be inconsistent with authorized to handle controlled
sufficiently, served with the
the public interest under 21 U.S.C. substances in the State in which he
[Government’s] initial motion’’ for
823(f), the conclusion, order and maintains his registration’’ and is
summary disposition and therefore ‘‘did
recommendation that follow are based therefore not a practitioner within the
not respond to the . . . [m]otion . . .
solely on a finding that Respondent is meaning of the Controlled Substances
because he was unaware of any such
not a ‘‘practitioner’’ as that term is Act. Id. The ALJ thus recommended that
motion until the ALJ’s Order granting
defined by 21 U.S.C. 802(21), and I Respondent’s registration be revoked
such motion.’’ Objections, at 1.
make no finding regarding whether and that any pending application be
Respondent argues that in his request
granting this application would or denied.
for hearing, his attorneys provided both
would not be inconsistent with the Thereafter, the ALJ forwarded the
a mailing address and email address for
public interest. record to me, noting in his letter that
receiving the ‘‘notices to be sent
Order Granting the Government’s pursuant to the proceeding.’’ 21 CFR Respondent’s objections were not timely
Motion for Summary Disposition and 1316.47(a); Objections at 1. Respondent filed. Letter from ALJ to Administrator
Recommendation did not, however, provide a fax number. (Apr. 7, 2015), at 2. The ALJ also
Id. at 2. provided a copy of a Transmission
I find there is no genuine dispute Verification Report showing that the
regarding whether Respondent is a Thereafter, Respondent received the
ALJ’s Order for Briefing on Allegations Recommended Decision was
‘‘practitioner’’ as that term is defined by successfully faxed to Respondent’s
21 U.S.C. 802(21), and that based on the Concerning Respondent’s Lack of State
record the Government has established Authority’’ by First Class Mail. Id. The 1 Respondent’s contention regarding the
that Respondent is not a practitioner ALJ’s Order specified the date (Mar. 2, inadequacy of service is not without merit. Of note,
and is not authorized to dispense 2015) by which the Government was to Respondent did not consent to the service of
controlled substances in the state in provide its evidence and arguments (as pleadings by facsimile and the ALJ’s Order for
well as its motion for summary Briefing on Allegation Concerning Respondent’s
which she seeks to operate under a DEA Lack of State Authority did not authorize service of
tkelley on DSK3SPTVN1PROD with NOTICES

Certificate of Registration. I find no disposition) in support of its contention pleadings in this manner. Moreover, while the use
other material facts at issue, for the that Respondent does not possess ‘‘state of electronic means has the advantage of faster
reasons set forth in the Government’s authority to handle controlled service—at least where the transmission is
substances,’’ as well as the date by successful—a hard copy should still be sent by
Motion for Summary Disposition. mail, courier, or third party commercial carrier
which Respondent was to file his unless the serving party contacts the other party
49 Reply to the Government’s Motion for response (Mar. 9) to any such motion. and affirmatively determines that the entire
Summary Judgment at 2–3. Id. document was received.

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hereby is, denied. This Order is Respondent’s Request for Hearing, Order Granting the Government’s Motion for
effectively immediately. Respondent admits that his license is Summary Disposition and Recommendation
temporary suspended. Respondent further I find there is no genuine dispute regarding
Dated: May 1, 2015. states that he expects to prevail before the whether Respondent is a ‘‘practitioner’’ as
Michele M. Leonhart, medical board at an upcoming hearing on that term is defined by 21 U.S.C. 802(21), and
Administrator. May 18, 2015. Finally he notes that his DEA that based on the record the Government has
Certificate of Registration will expire by its established that Respondent is not a
Brian Bayly, Esq., for the Government. own terms on March 31, 2015, and alleges
Marc S. Murphy, Esq., and Michael Denbow, practitioner and is not authorized to dispense
that he is prohibited from applying for his controlled substances in the state in which
Esq., for the Respondent. DEA certificate until the Kentucky medical he seeks to practice with a DEA Certificate
Order Granting the Government’s Motion for board acts upon his suspension. of Registration. I find no other material facts
Summary Disposition and Findings of Fact, The substantial issue raised by the at issue. Accordingly, I GRANT the
Conclusions of Law, and Recommended Government rests on an undisputed fact. The Government’s Motion for Summary
Decision of the Administrative Law Judge Government asserts that Respondent’s DEA Disposition.
Certificate of Registration must be revoked Upon this finding, I ORDER that this case
Administrative Law Judge Christopher B.
because Respondent does not have a medical be forwarded to the Administrator for final
McNeil. On January 29, 2015, the Deputy
license issued by the state in which he disposition and I recommended that
Assistant Administrator of the Drug
practices — a fact which Respondent does Respondent’s DEA Certificate of Registration
Enforcement Administration issued an Order
to Show Cause as to why the DEA should not not deny. Under DEA precedent, a should be REVOKED and any pending
revoke DEA Certificate of Registration practitioner’s DEA Certificate of Registration application for the renewal or modification of
Number FP2719245 issued to Sharad C. for controlled substances must be summarily the same should be DENIED.
Patel, M.D., the Respondent in this matter. revoked if the applicant is not authorized to
handle controlled substances in the state in Dated: March 11, 2015.
The Order seeks to revoke Respondent’s
registration pursuant to 21 U.S.C. 824(a)(3) which he maintains his DEA registration.1 Christopher B. McNeil,
and 823(f), and to deny any pending Pursuant to 21 U.S.C. 823(f), only a Administrative Law Judge.
applications for renewal or modification of ‘‘practitioner’’ may receive a DEA [FR Doc. 2015–12025 Filed 5–18–15; 8:45 am]
such registration, and deny any applications registration. Under 21 U.S.C. 802(21), a
BILLING CODE 4410–09–P
for any new DEA registrations pursuant to 21 ‘‘practitioner’’ must be ‘‘licensed, registered,
U.S.C. 823(f). As grounds for denial, the or otherwise permitted, by the United States
Government alleges that Respondent is or the jurisdiction in which he practices or
‘‘without authority to handle controlled does research, to distribute [or] dispense . . . DEPARTMENT OF JUSTICE
substances in Kentucky, the state in which controlled substance[s.]’’ Given this statutory
[Respondent is] registered with the DEA.’’ language, the DEA Administrator does not Drug Enforcement Administration
On February 20, 2015, the DEA’s Office of have the authority under the Controlled [Docket No. 13–34]
Administrative Law Judges received Substances Act to maintain a practitioner’s
Respondent’s written request for a hearing, registration if that practitioner is not Annicol Marrocco, M.D.; Decision and
which is dated February 19, 2015. authorized to dispense controlled
substances.2 As noted by the Government in
Order
Respondent states that his medical license is
‘‘temporarily suspended’’ by the state’s its Motion for Summary Disposition, On May 17, 2013, the Deputy
medical board and that he plans to challenge Respondent’s concern regarding the Assistant Administrator, Office of
the suspension in an upcoming state impending expiration of his DEA registration Diversion Control, Drug Enforcement
administrative hearing scheduled for May 18, is unfounded. Under 21 CFR 1301.36(i),
incorrectly cited by the Government as 21
Administration, issued an Order to
2015.
On February 23, 2015 this Office issued an CFR 1306.36(i), the existing registration of an Show Cause to Annicol Marrocco, M.D.,
Order for Briefing on Allegations Concerning applicant for reregistration will be (hereinafter, Respondent), of Mahwah,
Respondent’s Lack of State Authority. In the automatically extended until the New Jersey. ALJ Ex. 1. The Show Cause
Order, I mandated that the Government Administrator issues her order if the Order proposed the revocation of
provide evidence to support the allegation applicant applies for reregistration.3 Respondent’s DEA Certificate of
that Respondent lacks state authority to As detailed above, only a ‘‘practitioner’’ Registration BM8059102, which
handle controlled substances and if may receive a DEA registration. Therefore, I authorized her to dispense controlled
appropriate file a motion for summary will recommend the revocation of substances in schedules II through V, at
disposition no later than 2:00 p.m. Eastern Respondent’s DEA registration.
Standard Time (EST) on March 2, 2015. On
the registered address of Olean General
March 2, 2015, the Government timely 1 See 21 U.S.C. 801(21), 823(f), 824(a)(3); see also
Hospital, 515 Main Street, Olean, New
submitted a brief in support of the allegation House of Medicine, 79 FR 4959, 4961 (DEA Jan. 30, York 14760, on the ground that her
regarding state authority and filed a Motion 2014); Deanwood Pharmacy, 68 FR 41662–01 (DEA ‘‘continued registration is inconsistent
for Summary Disposition. According to the July 14, 2003); Wayne D. Longmore, M.D., 77 FR with the public interest.’’ Id. (citing 21
Government’s brief, the Board of Medical 67669–02 (DEA Nov. 13, 2012); Alan H. Olefsky, U.S.C. 823(f) and 824(a)(4)).
Licensure of the Commonwealth of Kentucky M.D., 72 FR 42127–01 (DEA Aug. 1, 2007); Layfe
Robert Anthony, M.D., 67 FR 15811 (DEA May 20,
The Show Cause Order specifically
issued an Emergency Order of Suspension alleged that between January 2008 and
2002); George Thomas, PA–C, 64 FR 15811–02
suspending Respondent’s license to practice (DEA Apr. 1, 1999); Shahid Musud Siddiqui, M.D., August 2009, Respondent issued
medicine, effective November 24, 2014. The 61 FR 14818–02 (DEA April 4, 1996); Michael D.
Government attached the emergency order
approximately twenty-one prescriptions
Lawton, M.D., 59 FR 17792–01 (DEA Apr. 14, 1994);
pertaining to Respondent to the Motion for Abraham A. Chaplan, M.D., 57 FR 55280–03 (DEA
to S.C. for oxycodone, a schedule II
Summary Disposition. Based on this Nov. 24, 1992). See also Bio Diagnosis Int’l, 78 FR controlled substance, ‘‘outside the usual
suspension, the Government moved for a 39327–03, 39331 (DEA July 1, 2013) (distinguishing course of professional practice and for
summary disposition of these proceedings. distributor applicants from other ‘‘practitioners’’ in other than a legitimate medical
In my Order for Briefing on Allegations the context of summary disposition analysis).
2 See Abraham A. Chaplan, M.D., 57 FR 55280–
purpose.’’ Id. (citing 21 U.S.C. 841(a)
Concerning Respondent’s Lack of State
tkelley on DSK3SPTVN1PROD with NOTICES

03, 55280 (DEA Nov. 24, 1992), and cases cited and 21 CFR 1306.04(a)). The Show
Authority, I also provided Respondent the Cause Order further alleged that
therein. In Chaplan, DEA Administrator Robert C.
opportunity to respond to the Government’s
allegations with a brief due not later than
Bonner adopts the ALJ’s opinion that ‘‘the DEA Respondent failed to maintain medical
lacks statutory power to register a practitioner records supporting the prescriptions, in
2:00 p.m. EST on March 9, 2015. As of today, unless the practitioner holds state authority to
no brief was received and therefore the handle controlled substances.’’ Id. violation of Florida law; that she was in
Government’s Motion for Summary 3 See also Ronald J. Riegel, D.V.M., 63 FR 67132– a personal relationship with S.C.; and
Disposition will stand unopposed. In 01, 67132 (DEA Dec. 4, 1998). that she ‘‘did not examine S.C. except to

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 28693
80 FR 28693 - Sharad C. Patel, M.D.; Decision and Order

DEPARTMENT OF JUSTICEDrug Enforcement Administration

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

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
