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)

[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