[Federal Register Volume 88, Number 214 (Tuesday, November 7, 2023)]
[Notices]
[Pages 76856-76858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

[[Page 76858]]

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