Notice2023-24524
Jagjit Kaleka, D.V.M.; Decision and Order
Primary source
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Published
November 7, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 88 Issue 214 (Tuesday, November 7, 2023)</title>
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[Federal Register Volume 88, Number 214 (Tuesday, November 7, 2023)]
[Notices]
[Pages 76856-76858]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24524]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Jagjit Kaleka, D.V.M.; Decision and Order
On February 25, 2022, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Jagjit Kaleka,
D.V.M. (Respondent), of Mauston, Wisconsin. Request for Final Agency
Action (RFAA), Government Exhibit (RFAAX) 13, at 1, 5. The OSC proposed
the revocation of Respondent's DEA Certificate of Registration
(registration), Control No. AK7830640, alleging that Respondent has
``committed such acts as would render [his] registration inconsistent
with the public interest.'' Id. at 1, 2 (citing 21 U.S.C. 824(a)(4),
823(g)(1) \1\).
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\1\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Pub. L. 117-215, 136 Stat. 2257
(2022) (Marijuana Research Amendments or MRA), amended the
Controlled Substances Act (CSA) and other statutes. Relevant to this
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as
21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current
designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA
throughout.
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The Agency makes the following findings of fact based on the
uncontroverted evidence submitted by the Government in its RFAA dated
April 6, 2023.\2\
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\2\ By letter dated March 14, 2022, Respondent requested a
hearing. RFAAX 15, at 1. On May 16, 2022, Respondent withdrew his
hearing request and Chief Administrative Law Judge John J.
Mulrooney, II, issued an Order Terminating Proceedings. RFAAX 16;
RFAAX 17.
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I. Findings of Fact
According to the Declaration of a DEA Diversion Investigator (the
DI), Respondent was the owner of and a veterinarian at Mauston Pet
Hospital (the Pet Hospital). RFAA, Declaration of Diversion
Investigator (Declaration), at 2. From June 21, 2019, through February
22, 2021, the Pet Hospital purchased 500 tablets of 10 mg oxycodone
(Schedule II), 1000 tablets of 2 mg alprazolam (Schedule IV), and 100
tablets of 5 mg zolpidem (Schedule IV). Id.; see also RFAAX 2; RFAAX 9.
On June 8, 2021, the DI served a Notice of Inspection at the Pet
Hospital, and Respondent consented to an inspection of the premises.
Declaration, at 2; see also RFAAX 7. Prior to the inspection, the DI
asked Respondent to take an inventory of all controlled substances at
the Pet Hospital,\3\ and on the day of the inspection, the DI asked
Respondent to produce a biennial inventory, which Respondent was unable
to produce. Declaration, at 2, 4.
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\3\ On June 6, 2021, Respondent emailed the DI a document titled
``Controlled Drug Inventory 5-25-2021.'' Declaration, at 4; see also
RFAAX 6.
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During the inspection, Respondent denied personally ordering the
controlled substances in question, namely, oxycodone, alprazolam, and
zolpidem. Declaration, at 2.\4\ The DI explained that despite the Pet
Hospital's purchases, ``[n]one of these drugs could be located on the
premises and there were no records showing that the drugs had been
dispensed, lost, stolen, or otherwise disposed of.'' Id. at 2, 3.\5\
Further, ``[t]hough Respondent denied knowledge that [G.K., another
practitioner at the Pet Hospital,] had been using the Pet Hospital's
account to purchase and obtain controlled substances for other than a
legitimate medical purpose in the usual course of veterinary practice,
Respondent [admitted that he] was aware of at least one incident during
which [G.K.] purchased and received alprazolam.'' Id.\6\ Notably,
Respondent admitted that
[[Page 76857]]
neither alprazolam nor zolpidem have ever been used at the Pet Hospital
for veterinary purposes. Declaration, at 3.
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\4\ As noted by the DI, the most recent invoice indicated that
Respondent himself purchased 100 tablets of 2 mg alprazolam under
his own DEA registration; all of the other invoices for the
controlled substance purchases in question showed that the
controlled substances were shipped to another practitioner at the
Pet Hospital, G.K. Id. at 2-3; see also RFAAX 2, at 66; RFAAX 8, at
1; RFAAX 9, at 3. Respondent also admitted that his wife paid for
all of the controlled substances ordered for the Pet Hospital.
Declaration, at 3.
\5\ Though unable to produce dispensing records for the
controlled substances in question, Respondent was able to produce
dispensing records for other controlled substances. Id. at 3; see
also RFAAX 4. According to the DI, these other dispensing records
were commingled with records of other practitioners, including G.K.,
and because the records lacked detail, the DI was unable to
determine which controlled substances had been dispensed by
Respondent. Id. Because there were no records showing the
disposition of the oxycodone, alprazolam, or zolpidem in question,
the DI was unable to confirm whether the drugs had been purchased
for a legitimate medical purpose; moreover, there was no evidence
that Respondent had contacted any law enforcement agency to report
the diversion of any oxycodone, alprazolam, or zolpidem.
Declaration, at 3.
\6\ Respondent admitted to DI that he observed G.K. receiving a
shipment of alprazolam in 2019; specifically, Respondent observed
G.K. meet a delivery driver outside the Pet Hospital who gave G.K.
several boxes that G.K. then placed in his personal vehicle. Id.
Respondent stated that he then instructed an employee, S.T., to
retrieve the boxes and bring them inside Pet Hospital where
Respondent confirmed that they contained alprazolam. Id. In
addition, S.T. admitted to filling out a DEA form 222 for the
purchase of oxycodone at G.K.'s request. Id. at 4; see also RFAAX 2,
at 3; RFAAX 3.
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Although Respondent denied that he had any expired controlled
substances, the DI found expired controlled substances in an unsecured
area in the Pet Hospital's basement. Id. at 4; see also RFAAX 12.
Respondent had no records of any disposal of expired or unwanted
controlled substances, but Respondent told the DI that he disposed of
expired or unwanted controlled substances by giving them to the police
or placing them in the garbage, which the DI noted was an unacceptable
method that does not render the controlled substances `` `non-
retrievable' '' pursuant to Federal regulations. Declaration, at 2, 4
(citing 21 CFR 1317.90(a)).<SUP>7 8</SUP>
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\7\ The DI referenced 21 CFR 1317.90(a) once more in noting that
``because Respondent was not the `ultimate user[]' or `[a] person[]
lawfully entitled to dispose of an ultimate user's decedent's
property,'[] he did not dispose of the controlled substances `in
compliance with applicable Federal, State, tribal[], and local laws
and regulations.' '' Id. at 4.
\8\ The DI also described how Respondent had been previously
notified of violations in 2017, with Respondent at that time cited
by DEA for failing to keep a biennial inventory, failing to maintain
separate and readily retrievable records of controlled substances,
failing to keep controlled substances in a securely locked,
substantially constructed cabinet, and accepting controlled
substances from end users without being licensed as a collector. Id.
at 2, 4-5; see also RFAAX 10. Respondent was also subject to
disciplinary action by the State of Wisconsin Veterinary Examining
Board in 2018 following findings that Respondent had failed to store
controlled substances in a securely locked, substantially
constructed cabinet, had failed to keep a biennial inventory, and
had sold a Schedule III controlled substance to an unregistered
individual who had previously surrendered his DEA registration and
was not authorized to possess or purchase controlled substances.
Declaration, at 2, 5; see also RFAAX 11.
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II. Discussion
A. The Five Public Interest Factors
Under the CSA, ``[a] registration . . . to . . . dispense a
controlled substance . . . may be suspended or revoked by the Attorney
General upon a finding that the registrant . . . has committed such
acts as would render his registration under section 823 of this title
inconsistent with the public interest as determined under such
section.'' 21 U.S.C. 824(a). In making the public interest
determination, the CSA requires consideration of the following factors:
(A) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(B) The [registrant]'s experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant]'s conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1).
The DEA considers these public interest factors in the disjunctive.
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Each factor is
weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d
165, 173-74 (D.C. Cir. 2005). Any one factor, or combination of
factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508
(1993).
While the Agency has considered all of the public interest factors
in 21 U.S.C. 823(g)(1),\9\ the Government's evidence in support of its
prima facie case for revocation of Respondent's registration is
confined to Factors B and D. See RFAA, at 6-10.\10\ Moreover, the
Government has the burden of proof in this proceeding. 21 CFR 1301.44.
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\9\ As to Factor A, the Agency considers the recommendation of
the appropriate state licensing board. Here, the state licensing
board has taken disciplinary action against Respondent's veterinary
license arising out of similar misconduct as that which forms the
basis for the OSC in the current matter. See RFAAX 11; RFAAX 14, at
3. Nonetheless, because the Government has not made any
representations as to Factor A in its RFAA, the Agency finds that
Factor A weighs neither for nor against Respondent's continued
registration. As to Factor C, there is no evidence in the record
that Respondent has been convicted of an offense under either
Federal or state law ``relating to the manufacture, distribution, or
dispensing of controlled substances.'' 21 U.S.C. 823(g)(1)(C).
However, as Agency cases have noted, there are a number of reasons
why a person who has engaged in criminal misconduct may never have
been convicted of an offense under this factor. Dewey C. MacKay,
M.D., 75 FR 49956, 49973 (2010). Agency cases have therefore found
that ``the absence of such a conviction is of considerably less
consequence in the public interest inquiry'' and is therefore not
dispositive. Id. Finally, as to Factor E, the Government's evidence
fits squarely within the parameters of Factors B and D and does not
raise ``other conduct which may threaten the public health and
safety.'' 21 U.S.C. 823(g)(1)(E). Accordingly, Factor E does not
weigh for or against Respondent.
\10\ In its RFAA, the Government noted that if the Agency were
to find that Factors B and D did not weigh against Respondent's
continued registration, it would rely on Factor E in the
alternative. Id. at 6.
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Here, the Agency finds that the Government's evidence satisfies its
prima facie burden of showing that Respondent's continued registration
would be ``inconsistent with the public interest.'' 21 U.S.C.
824(a)(4).
B. Factors B and D
Evidence is considered under Public Interest Factors B and D when
it reflects compliance (or non-compliance) with laws related to
controlled substances and experience dispensing controlled substances.
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D.,
87 FR 21156, 21162 (2022). In the current matter, the Government has
alleged that Respondent violated numerous Federal laws regulating
controlled substances. RFAAX 14, at 2-3. Specifically, Federal law
requires that registrants (1) keep a biennial inventory of any
controlled substances on hand; (2) keep controlled substances in a
``securely locked, substantially constructed cabinet''; (3) dispose of
controlled substances properly so as to comply with applicable
regulations and render the controlled substances non-retrievable; (4)
keep records of the disposal of controlled substances; and (5) timely
report any loss of controlled substances. 21 U.S.C. 827(a)-(b); 21 CFR
1301.75(b), 1301.76(b), 1304.11(a), 1304.11(c), 1304.21(e), 1317.90,
and 1317.95.\11\
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\11\ Federal law also prohibits an individual from accepting
controlled substances from end users without being authorized as a
collector. 21 U.S.C. 822(g)(1)(A) (incorrectly cited in the OSC as
21 U.S.C. 821(g)(1)(A), see RFAAX 14, at 3); 21 CFR 1317.30 and
1317.40.
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Here, the record demonstrates that Respondent, among other things,
failed to conduct a biennial inventory of controlled substances, failed
to properly store controlled substances in a securely locked,
substantially constructed cabinet, failed to dispose of controlled
substances properly so as to comply with applicable regulations and
render the controlled substances non-retrievable, failed to keep
records of the disposal of controlled substances, and failed to timely
report the loss of controlled substances. As Respondent's conduct
displays clear violations of the various Federal regulations described
above, the Agency hereby sustains the Government's allegations that
Respondent repeatedly violated Federal law relating to controlled
substances.
Accordingly, the Agency finds that Factors B and D weigh in favor
of revocation of Respondent's registration and thus finds Respondent's
continued registration to be inconsistent with the public interest in
balancing the factors of 21 U.S.C. 823(g)(1). The Agency further finds
that Respondent failed to provide sufficient evidence to rebut the
Government's prima facie case.
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III. Sanction
Where, as here, the Government has established grounds to revoke
Respondent's registration, the burden shifts to the registrant to show
why he can be entrusted with the responsibility carried by a
registration. Garret Howard Smith, M.D., 83 FR 18882, 18910 (2018).
When a registrant has committed acts inconsistent with the public
interest, he must both accept responsibility and demonstrate that he
has undertaken corrective measures. Holiday CVS, L.L.C., dba CVS
Pharmacy Nos 219 and 5195, 77 FR 62316, 62339 (2012) (internal
quotations omitted). Trust is necessarily a fact-dependent
determination based on individual circumstances; therefore, the Agency
looks at factors such as the acceptance of responsibility, the
credibility of that acceptance as it relates to the probability of
repeat violations or behavior, the nature of the misconduct that forms
the basis for sanction, and the Agency's interest in deterring similar
acts. See, e.g., Robert Wayne Locklear, M.D., 86 FR 33738, 33746
(2021).
Here, although Respondent initially requested a hearing, he
withdrew his hearing request and did not otherwise avail himself of the
opportunity to refute the Government's case. As such, Respondent has
made no representations as to his future compliance with the CSA nor
made any demonstration that he can be entrusted with registration. In
fact, despite having already been subject to state action and a Federal
citation in 2017 and thus put on notice of the impropriety of his
actions, Respondent failed to change his ways and continued to commit
much of the same misconduct. Moreover, the evidence presented by the
Government clearly shows that Respondent violated the CSA, further
indicating that Respondent cannot be entrusted. Accordingly, the Agency
will order the revocation of Respondent's registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
AK7830640 issued to Jagjit Kaleka, D.V.M. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Jagjit Kaleka, D.V.M., to renew
or modify this registration, as well as any other pending application
of Jagjit Kaleka, D.V.M., for additional registration in Wisconsin.
This Order is effective December 7, 2023.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 31, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-24524 Filed 11-6-23; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on November 7, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.