Michael E. Smith, D.V.M.; Decision and Order, 4944-4954 [2022-01840]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4944-4954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01840]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 21-11]


Michael E. Smith, D.V.M.; Decision and Order

    On December 3, 2020, a former Assistant Administrator, Diversion 
Control Division, of the Drug Enforcement Administration (hereinafter, 
DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to 
Michael E. Smith, D.V.M. (hereinafter, Respondent) of Zanesville, Ohio. 
Administrative Law Judge Exhibit (hereinafter, ALJX) 1 (OSC), at 1 and 
5. The OSC proposed the denial of Respondent's application for DEA 
Certificate of Registration No. W20010614C (hereinafter, COR or 
registration) and the denial of any applications for any other DEA 
registrations pursuant to 21 U.S.C. 824(a)(2) and 824(a)(4) because 
Respondent was convicted of a felony related to controlled substances 
and because ``[Respondent's] registration would be inconsistent with 
the public interest, as that term is defined in 21 U.S.C. 823(f).'' Id. 
at 1.
    On January 1, 2021, the Respondent timely requested a hearing, 
which commenced (and ended) on April 19, 2021, at the DEA Hearing 
Facility in Arlington, Virginia with the parties, counsel, and 
witnesses participating via video teleconference (VTC). On June 30, 
2021, Administrative Law Judge Paul E. Soeffing (hereinafter, the ALJ) 
issued his Recommended Rulings, Findings of Fact, Conclusions of Law, 
and Decision of the Administrative Law Judge (hereinafter, Recommended 
Decision or RD).
    By letter dated August 5, 2021, the ALJ certified and transmitted 
the record to me for final Agency action. In the letter, the ALJ 
advised that the Respondent filed untimely exceptions to the Recommend 
Decision on July 26, 2021. The ALJ stated that the Respondent had 
received an extension of time to file his exceptions by 2:00 p.m. ET on 
July 26, but did not file them until 2:58 p.m. ET. The ALJ also advised 
that the Government filed its Response to the Respondent's Exceptions 
on August 5, 2021.
    Having reviewed the entire record, I find Respondent's Exceptions 
without merit and I adopt the ALJ's rulings, findings of fact as 
modified, conclusions of law and recommended sanction with minor 
modifications, where noted herein.*\A\ Although Respondent's Exceptions 
were untimely, in this case, I decided to nonetheless consider and 
address each of Respondent's Exceptions, and issue my final Order in 
this case following the Recommended Decision.
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    *\A\ I have made minor, nonsubstantive, grammatical changes to 
the RD and nonsubstantive conforming edits. Where I have made 
substantive changes, omitted language for brevity or relevance, or 
where I have added to or modified the Chief ALJ's opinion, I have 
noted the edits in brackets, and I have included specific 
descriptions of the modifications in brackets or in footnotes marked 
with an asterisk and a letter. Within those brackets and footnotes, 
the use of the personal pronoun ``I'' refers to myself--the 
Administrator.
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Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge

Paul E. Soeffing

U.S. Administrative Law Judge

June 30, 2021
    *\B\ The issue in this case is whether the record as a whole 
establishes by a preponderance of the evidence that the Respondent's 
application for a DEA COR, Control No. W20010614C, should be denied, 
and any other pending applications for additional registrations should 
be denied, pursuant to 21 U.S.C. 824(a)(2) and (a)(4), because the 
Respondent has been convicted of a felony relating to controlled 
substances, and because his registration would be inconsistent with the 
public interest, as that term is defined in 21 U.S.C. 823(f).
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    *\B\I have omitted the RD's discussion of the procedural history 
to avoid repetition with my introduction.
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    After carefully considering the testimony elicited at the hearing, 
the admitted exhibits, the arguments of counsel, and the record as a 
whole, I have set forth my recommended findings of fact and conclusions 
of law below.

I. Findings of Fact

A. Allegations

    The Government alleges that the Respondent's application for a DEA 
COR, Control No. W20010614C, should be denied and any applications by 
the Respondent for any other DEA registrations should be denied, 
pursuant to 21 U.S.C. 824, because (1) Respondent has been convicted of 
a felony relating to controlled substances; and (2) that registration 
would be inconsistent with the public interest, as that term is defined 
in 21 U.S.C. 823(f).

B. Stipulations

    The Government and the Respondent agreed to fourteen stipulations, 
which I recommend be accepted as fact in these proceedings:

    1. Respondent was previously registered with the DEA to handle 
controlled substances in Schedules II through V under DEA COR No. 
FS1126146 at 100 Sally Road, Zanesville, Ohio 43701.
    2. Respondent surrendered DEA COR No. FS1126146 for cause on or 
about July 20, 2015, pursuant to his plea agreement in Case CR2015-
0052, State of Ohio v. Michael E. Smith.
    3. Respondent submitted an electronic application for a new DEA 
COR on or about February 3, 2020.
    4. Government Exhibit No. 1 is a true and correct copy of 
Respondent's February 3, 2020 application for a DEA COR.
    5. Government Exhibit No. 2 is a true and correct copy of the 
Certification of Registration History showing Respondent's answers 
to the liability questions from his February 3, 2020 application for 
a DEA COR.
    6. Government Exhibit No. 3 is a true and correct copy of the 
docket sheet in Case CR2015-0052, State of Ohio v. Michael E. Smith.
    7. Government Exhibit No. 4 is a true and correct copy of 
Respondent's signed plea agreement, dated July 20, 2015, in Case 
CR2015-0052, State of Ohio v. Michael E. Smith.
    8. Government Exhibit No. 5 is a true and correct copy of the 
court's entry of Respondent's plea agreement, dated July 23,

[[Page 4945]]

2015, in Case CR2015-0052, State of Ohio v. Michael E. Smith.
    9. Government Exhibit No. 6 is a true and correct copy of the 
court's entry of Respondent's sentence, dated October 7, 2015, in 
Case CR2015-0052, State of Ohio v. Michael E. Smith.
    10. Government Exhibit No. 7 is a true and correct copy of the 
transcript of Respondent's plea hearing, dated July 20, 2015, in 
Case CR2015-0052, State of Ohio v. Michael E. Smith.
    11. Government Exhibit No. 8 is a true and correct copy of the 
transcript of Respondent's sentencing hearing, dated October 5, 
2015, in Case CR2015-0052, State of Ohio v. Michael E. Smith.
    12. DEA lists Dilaudid (hydromorphone) as a Schedule II 
controlled substance under 21 CFR 1308.12(b)(1)(vii).
    13. DEA lists oxycodone as a Schedule II controlled substance 
under 21 CFR 1308.12(b)(1)(xiii).
    14. Dr. Smith currently holds an unrestricted license to 
practice veterinary medicine and surgery in the State of Ohio.

C. Government's Case-in-Chief

    The Government presented its case in chief through the testimony of 
a single witness, Diversion Investigator (DI) K.P.
    K.P. has worked for the DEA as a DI in Columbus, Ohio since May 
2019. Tr. 14. She has been a DI since January 2019. Tr. 14-15. Her 
mission is to prevent, detect, and investigate diversion of controlled 
substances. Tr. 15. She conducts inspections, schedules investigations, 
and ensures registrants are in compliance with applicable laws. Tr. 15. 
If an applicant answers ``yes'' to a liability question \1\ on the 
application, it will get flagged and assigned to a DI. Tr. 15-16. Once 
K.P. is assigned a new application for review, she will first read 
through the application and will then run a criminal history check. Tr. 
16-17.
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    \1\ This includes whether an applicant had prior issues with 
controlled substances, convictions, or any disciplinary action on a 
state or federal controlled substance license. Tr. 16.
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    K.P. was assigned the Respondent's case because Respondent answered 
``yes'' to three of the liability questions on the DEA Form 224, 
Application for Registration (``application'').\2\ Tr. 17-19; Gov't Ex. 
1 at 1. To the best of K.P.'s knowledge, the Respondent answered these 
questions correctly on his application. Tr. 38. After being assigned 
the case, K.P. called the Respondent. Tr. 17. She then reviewed the 
Ohio Veterinary Medical Licensing Board (``the Board'') action on his 
previous state license and realized he had a new Ohio state license. 
Tr. 18. She then ran his criminal history and submitted a request to 
Muskingum County for documents relating to the Respondent's criminal 
history. Tr. 18, 25-37; See Gov't Exs. 3-8. Throughout the 
investigation, K.P. spoke to the Respondent two or three times on the 
phone. Tr. 39. Otherwise, she was in contact with his counsel, Mr. I. 
Tr. 39. K.P. never met with the Respondent in person. Tr. 39.
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    \2\ The Respondent submitted this application in February 2020. 
Stip. 3; Tr. 19; Gov't Exs. 1, 2.
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    In his answer to the first liability question, the Respondent 
stated that he pled guilty to ten counts of Illegal Processing of Drug 
Documents, had surrendered his vet license and his DEA registration, 
and served seventeen months of incarceration. Tr. 24; Gov't Ex. 2.\3\ 
K.P. was concerned because the Respondent indicated he was addicted to 
opiates and had written prescriptions under his COR for dogs, but took 
them for his own personal use. Tr. 23-24; Gov't Ex. 2. K.P. asserted 
that the DEA's concern with granting the Respondent's application for 
registration is that the Respondent would not be able to responsibly 
handle a DEA registration because he has a proven history of misusing 
it. Tr. 40. The Respondent's guilty plea to ten counts of Illegal 
Processing of Drug Documents was significant to her because she 
believed it showed that the Respondent was not responsible with his 
registration. Tr. 24, 40.
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    \3\ The Government presented evidence indicating that the 
Respondent pled guilty in State of Ohio v. Michael E. Smith, No. 
CR2015-0052 to ten counts of ``Illegal Processing of Drug 
Documents,'' in violation of Ohio Revised Code (``ORC'') Sec.  
2925.23(B)(1), which is a fourth-degree felony. Gov't Ex. 4. The 
Respondent also pled guilty to ``Having a Weapon While Under 
Disability'' in violation of ORC Sec.  2923.13(A)(3), a third-degree 
felony. Id.
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    K.P. did not believe that the Respondent had provided her with 
proof that he had been working on his addiction. Tr. 40. Although he 
provided her with certificates of the programs he completed, none were 
more recent than 2017. Tr. 40-41. She did not have an opinion on how 
often the Respondent should be attending a rehabilitation program or 
attending meetings. Tr. 41-42.
    K.P.'s testimony was primarily focused on the non-controversial 
introduction of documentary evidence and her contact with this case.\4\ 
Her testimony was generally consistent and genuine and there was no 
indication she harbors any animosity towards the Respondent. As a 
public servant, K.P. has no personal stake in the DEA's action on the 
Respondent's application for registration. I therefore find her 
testimony to be entirely credible and it will be afforded considerable 
weight.
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    \4\ Although the Government called K.P. as a rebuttal witness to 
introduce into evidence additional documentary evidence, the 
tribunal sustained the Respondent's objection to proposed Government 
Exhibit 9 being admitted into evidence. Tr. 163-67.
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D. Respondent's Case

    The Respondent presented his case in chief through the testimony of 
four witnesses: himself and three character witnesses A.B., R.W., and 
G.G.
Respondent
    The Respondent graduated from Ohio State University and obtained 
his degree in 1994. Tr. 44-45; Gov't Ex. 1 at 1.\5\ He worked with his 
father in a private practice, where they saw over 10,000 clients, 
including over thirty-seven species of animals from seven counties. Tr. 
45. He is prepared to handle situations in internal medicine, emergency 
medicine, preventive care, and surgical procedures. Tr. 46. The 
Respondent currently has a veterinary practice, Smith Veterinary 
Services, in Muskingum County, Zanesville, Ohio, which is mainly a 
rural area. Tr. 44-46.
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    \5\ Although not specified in the testimony, this appears to be 
when the Respondent graduated from Veterinary school. See Gov't Ex. 
1 at 1.
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    Within a few years of graduating, the Respondent's veterinary 
license was disciplined for the first time. Tr. 46-47. One night, 
sometime in the 1990's, a client offered him cocaine, he took it, and 
ultimately became addicted to cocaine.\6\ Tr. 47, 122. He was arrested 
with a possession charge and reprimanded by the Board with a two-year 
suspension of his license. Tr. 48, 110. When he was first arrested, he 
was put on probation, but he violated that probation and served a 
sentence. Tr. 128. He was incarcerated for eight months total for this 
drug conviction.\7\ Tr. 129. The Board set conditions on the 
reinstatement of his license in a settlement agreement in 2000, 
including the requirement that he complete a rehabilitation program and 
demonstrate that he was capable of operating in a proper manner.\8\ Tr. 
48-49; 131-33.

[[Page 4946]]

When his license was reinstated, he went back to working with his 
father. Tr. 49. His father died in 2010, but he continued to work in 
the office with his half-sister, who was also a veterinarian. Tr. 50. 
They ultimately ``parted ways'' in the fall of 2011. Tr. 50-51. At this 
point, the Respondent had been sober for approximately thirteen years. 
Tr. 120.
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    \6\ When questioned by the tribunal as to the year he first 
started abusing drugs, the Respondent stated that he ``may have had 
casual use throughout my youth'' which would presumably predate this 
cocaine use after he became a licensed veterinarian and was ``well 
into [his] 30's.'' Tr. 119-20.
    \7\ Respondent's first drug conviction, for cocaine, was in 
1997. Tr. 129; Gov't Ex. 7 at 14:21-22. In the sentencing transcript 
for the Respondent's 2015 conviction, his defense attorney indicates 
the Respondent served a six-month sentence for the 1997 conviction. 
Gov't Ex. 8 at 6:4-5.
    \8\ During the testimony, there was some confusion as the 
Respondent's Prehearing Statement indicated there was a settlement 
agreement with the Board in 2005. ALJ Ex. 8 at 2. The Respondent's 
counsel also referenced a 2005 settlement agreement with the Board, 
but the Respondent clarified that the settlement agreement was in 
2000. Tr. 48. According to the Respondent and his counsel, the 2005 
date listed in the Respondent's Prehearing Statement is a 
typographical error and the year should actually be 2000. Tr. 130-
32.
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    In October of 2011, he learned that he had avascular necrosis of 
both of his hips, which he found to be quite painful. Tr. 51. He was 
prescribed opiates by the emergency room doctor, likely Percocet, after 
this diagnosis, and continued receiving opiate prescriptions after 
having hernias repaired in November 2011. Tr. 51, 52, 120. He had hip 
replacement surgery in January 2012. Tr. 52. He continued to receive 
opiate prescriptions from various doctors until a doctor indicated that 
he would no longer prescribe him opiates. Tr. 52-53. He then reached 
out to a surgeon who prescribed him opiates after the Respondent ``used 
an argument of professional courtesy,'' but this doctor ultimately 
stopped prescribing opiates to him. Tr. 53. The Respondent then started 
doing illegal activities \9\ to acquire his own drugs for about three 
or four months. Tr. 53 (``went on for maybe three months''); Tr. 83 
(``over a four-month period''). A pharmacist friend called and asked 
about one of the prescriptions the Respondent wrote and he lied and 
told the pharmacist that the prescription was ``okay.'' \10\ Tr. 53. 
This incident prompted him to seek help. He started going to meetings 
and took part in a faith-based rehabilitative program, Alcohol Chemical 
Tobacco Symposium (``ACTS'') prior to his incarceration.\11\ Tr. 53-55, 
62; Resp't Ex. C.
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    \9\ This appears to be a reference to the Respondent's criminal 
activity of writing prescriptions in the names of dogs that he or 
others would then fill so that the Respondent could use the drugs to 
satisfy his addiction.
    \10\ The Respondent later testified that this was a turning 
point for him where he realized that ``[n]ot only was I destroying 
myself, now I put him in a position of where he shouldn't have been 
and I came to the realization that what I was doing to myself, I may 
have been contributing this to happening to others as well.'' Tr. 
97.
    \11\ The Respondent later testified that he took part in the 
program post-incarceration. Tr. 62. Furthermore, the certificate of 
completion for this ACTS program is dated August 16, 2017. Resp't 
Ex. C.
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    The Respondent was ultimately served with a warrant in September 
2012. Tr. 56. After receiving the warrant, he went to church, attended 
Alcoholics Anonymous (``AA'') and Narcotics Anonymous (``NA'') 
meetings, and continued to practice as a vet.\12\ Tr. 57. Criminal 
charges were filed against him in 2015, and he was arrested. Tr. 58. 
The Respondent pleaded guilty to ten counts of Illegal Processing of 
Drug Documents. Tr. 58-59. The Respondent admitted that he pleaded 
guilty to ten counts of Illegal Processing of Drug Documents based on a 
scheme whereby he would write false prescriptions for dogs that he did 
not examine, and would either fill those prescriptions and take the 
pills for his own use or would sell the prescriptions to others.\13\ 
Tr. 101-02. He also admitted that by issuing those prescriptions, in 
most cases, he did so without a legitimate medical purpose and outside 
the usual course of professional practice. Tr. 103.
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    \12\ The Respondent did not provide documentation of his 
attendance when he went to these meetings since he ``went on [his] 
own accord'' and ``the only time [he] signed was when [he] was 
incarcerated'' or ``back in the 90s when [the Courts] wanted [him] 
to have a paper signed.'' Tr. 57.
    \13\ The Respondent qualified his answer by saying ``[a] few of 
the prescriptions were actually for dogs that were damaged 
horribly.'' Tr. 102.
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    He denied using marijuana or smoking crack in 2011 or 2012. Tr. 
122. But see Gov't Ex. 8 at 21:1-11, 22:7-14 (During the 2015 
sentencing hearing, the Respondent testified that prior to his arrest 
he was smoking marijuana almost daily and started smoking crack again 
in 2011). He testified that he did not recall making the statement to 
the trial judge in 2015 that he was smoking crack, although he may have 
used powdered cocaine in early 2012. Tr. 124. He also did not recall 
making the statement in 2015 to the trial judge that he was smoking 
marijuana, and he did not recall smoking marijuana in 2011 or 2012. Tr. 
125. However, he later testified he probably last smoked marijuana 
during his opiate addiction in 2011 or 2012. Tr. 125-26. He also did 
not recall a period when he was smoking marijuana almost daily. Tr. 
126-27. He stated that he did not ``recall all that was going on'' 
during the time of his opiate addiction and his ``mind was horribly 
confused . . . and everything is a daze.'' Tr. 126.
    The Respondent was also given a twenty-four-month sentence for a 
gun violation.\14\ Tr. 127; Gov't Ex. 6 at 2; Gov't Ex. 8 at 19-20. He 
served a seventeen-month prison sentence for his drug-related crimes 
from late 2015 until spring 2017, and received about thirty days off 
his sentence for good behavior. Tr. 59, 64. But see Tr. 127 (The 
Respondent testified that he served a concurrent twenty-four-month 
sentence for his gun-related crime with about thirty days off his 
sentence for good behavior.). While incarcerated, he surrendered his 
veterinary license to the Board. Tr. 63.
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    \14\ The Respondent was a convicted felon in possession of a 
firearm, which he had used after his felony conviction. Gov't Ex. 8 
at 19-20. At the hearing for the instant case, the Respondent 
admitted to having ``a deer shotgun and a .22 rifle here for 
protection for [his] office and family.'' Tr. 127.
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    While he was incarcerated, he applied to the Seeking a New 
Direction (``SAND'') program, which had limited seating, attended NA 
and AA meetings weekly to bi-weekly, and chaired some NA meetings. Tr. 
59-61, 103; Resp't Ex. B.\15\ Also while incarcerated, he applied to 
and was accepted into the Kairos Inside Weekend Program, which is a 
faith-based organization where a group of men take part in ``a complete 
weekend of spirituality,'' learning to love themselves and forgive 
others. Tr. 60, 103; Resp't Ex. D.
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    \15\ The Respondent testified that the Certificate of Completion 
for the Intensive Outpatient Program of Hocking County that was 
admitted into evidence as Respondent's Exhibit B is the same program 
as the SAND program. Tr. 60-61, 103.
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    After being released from jail, he thanked God, took care of his 
wife, found employment, and took part in the ACTS program. Tr. 62, 64; 
Resp't Ex. C. This program focused him on maintaining his sobriety. Tr. 
96. He also got a job at Winland's Complete Landscaping as a laborer, 
then advanced to head mower and trained others. Tr. 64, 66-67. Despite 
pain from his hip, he never used opiates or other illegal substances 
while employed there, and ``will never touch another one.'' Tr. 65. 
Instead, he took over-the-counter Ibuprofen and Tylenol and was 
prescribed Meloxicam and Flexeril, a muscle relaxant. Tr. 65, 99.
    Post-release, he attended AA and NA meetings. Tr. 65. He ``used to 
go a lot,'' but he has ``pulled back some'' and now goes when he feels 
``a little stressed'' to hear other addicts, including ``ones that are 
newly trying to recover,'' so he can ``recall the pain, the discomfort, 
the dysfunction.'' Tr. 66.
    When the Respondent applied for his veterinary license to be 
reinstated in Ohio, the Board initially denied his application. Tr. 68. 
The Board then held a hearing and decided ``the same day'' to reinstate 
his license. Tr. 69; Resp't Ex. A. His veterinary license was 
reactivated in January 2020. Tr. 67, 70, 87. Despite the fact that the 
Board's decision stated that it was issuing him a license ``with a 
reprimand letter,'' the Respondent asserts that he did not receive such 
a letter. Tr. 107, 109; Resp't Ex. A at 3. The Respondent further 
testified that there are no restrictions on his veterinary license and 
there was no discipline or reprimand. Tr. 69. The Board did not require 
any particular

[[Page 4947]]

rehabilitation or monitoring by the Board for his current license. Tr. 
110-11. In its Finding and Order, the Board did suggest that the 
Respondent ``operate his practice under direct supervision by a 
licensed veterinarian.'' Tr. 107-08, 135-36; Gov't Ex. A at 3. The 
Respondent is not doing that. Tr. 107-08, 135. The Board's Finding and 
Order also suggested that he attend Ohio Physicians' Health Plan 
counseling for five years. Tr. 108, 134-35; Gov't Ex. A at 3. 
Respondent is also not doing this because when he previously looked 
into it--back in the 1990's--it was quite expensive and he would have 
to commute to Columbus, Ohio.\16\ Tr. 108, 134-35. The Board has not 
checked in on the Respondent since reinstating his license. Tr. 69-70.
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    \16\ Upon further questioning by the tribunal, the Respondent 
admitted that he did not know if the Ohio Physicians' Health Plan 
counseling is currently an in-person program, nor did he know if 
financial assistance or a lower fee arrangement might be available 
to him. Tr. 134-35. The Respondent further admitted that ``I don't 
know what the program actually consists of or how they run it, at 
this time.'' Tr. 134. It therefore appears that the Respondent 
rejected out of hand any consideration of participating in the 
program based on his understanding of the program as it existed over 
twenty years ago, without making any inquiry as to how he might take 
part in or benefit from the program as it exists today. There did 
not seem to be any inquiry or investigation by the Respondent since 
the 1990's to justify his testimony that ``[i]t's very expensive'' 
and ``something [he] could not afford.'' Tr. 108.
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    The Respondent built up his practice and set up an office in his 
house as a sole practitioner with his wife as his secretary and 
assistant. Tr. 70, 93-94, 106. He has seen approximately 1,000 patients 
since his license was reinstated. Tr. 70. The Respondent is 
specifically seeking the use of Schedule III, IV, and V drugs including 
Ketamine, which he would use as an anesthetic. Tr. 71-72, 90. He is 
also requesting Diazepam and Phenobarbital, which are used on animals 
having seizures. Tr. 73, 90. He is also seeking the use of testosterone 
and estrogen, which can be used on dogs with prostatitis. Tr. 74, 90. 
He is also seeking use of Nandrolene, an anabolic steroid, and Telazol, 
a short-acting narcotic. Tr. 75-76, 90. The Respondent would only 
administer these controlled substances, except for Phenobarbital, which 
he would prescribe to epileptic dogs. Tr. 91, 92. The Respondent is 
aware that Ketamine and Diazepam are controlled substances that are 
diverted. Tr. 94-95.
    Every day, he prays, and he has learned many concepts and tools 
through NA and his rehabilitation programs. Tr. 79, 137-38. He has 
learned that addiction is ``a lifelong condition and it needs proper 
maintenance'' and that sobriety ``takes work, it takes maintenance.'' 
Tr. 80, 111. He would describe himself as ``a grateful recovered 
addict.'' Tr. 112. He also believes that addiction is ``part of [his] 
personality.'' Tr. 121. He testified that he appreciates that the Board 
reinstated his license and ``can guarantee [he] would never, ever, ever 
abuse that authority again.'' Tr. 81.\17\
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    \17\ At the conclusion of his direct examination, the Respondent 
read a prepared statement to the tribunal. Tr. 81-86. He explained 
that he does not ``make light of the abuse of the trust given to my 
profession.'' Tr. 83. He admitted that he was convicted of the 
Illegal Processing of Drug Documents and has not lied or denied any 
of that. Tr. 83. He stated that he realized his actions harmed 
himself and potentially others and he regrets that. Tr. 83-84. He 
has also reviewed the standards for record-keeping for controlled 
substances, purchased key locks and a key lockbox, and will comply 
with all necessary regulations. Tr. 85, 116.
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    Since his incarceration, the Respondent has not taken any classes 
or continuing education regarding his responsibilities and duties as 
someone with the authority to prescribe and administer controlled 
substances, but he did review regulations for the storage of controlled 
substances and record-keeping. Tr. 85, 116. The Respondent testified 
that he was ``not aware of any classes'' regarding responsibilities and 
duties of those with the authority to prescribe and administer 
controlled substances. Tr. 116. The last time the Respondent used an 
illegal controlled substance or any properly prescribed controlled 
substance was in 2012. Tr. 56, 96-98. He has been drug tested ``[m]any 
times'' since 2012 and has never had a positive result.\18\ Tr. 56.
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    \18\ The Respondent did not offer into evidence any 
documentation of any drug test results he may have had over the 
years. Nor did the Respondent testify regarding what drugs he was 
tested for or when he last submitted to a drug test.
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    The Respondent stated that what is currently different as it 
relates to his prescribing or administering of controlled substances is 
the fact that he is no longer addicted to opiates. Tr. 111-12. He also 
does not continue to associate with any of the people he provided false 
prescriptions to in 2012. Tr. 112. The Respondent asserts that he did 
not provide drugs to his son (or any other relatives), either by 
prescribing or diverting them. Tr. 113, 115-16, 117-18. But see Gov't 
Ex. 8 at 16:17-18 (The Respondent stated that he ``became addicted 
[himself] and [his] son as well . . . .''); Gov't Ex. 8 at 18:15-19 (At 
the sentencing hearing, the trial judge stated ``you probably don't 
even know who all the victims are that got those drugs, do you?'' to 
which the Respondent replied ``One was my son, one was myself, I know 
that.'').
    The Respondent believes a DEA COR would allow him to ``practice at 
a higher level'' and would provide for a ``better outcome or safety.'' 
Tr. 71, 76-77. The State of Ohio has never taken an action against his 
veterinary license due to the care he provided or failed to provide to 
an animal.\19\ Tr. 77. The Respondent stated that he does not plan on 
writing prescriptions and trading them for drugs and he takes 
responsibility for his actions. Tr. 77, 137.
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    \19\ Although the Board may not have ever taken action against 
his license, this certainly does not mean that the Respondent has at 
all times provided proper care. The Respondent testified that one of 
the illegal prescriptions he wrote drew the attention of the filling 
pharmacist who questioned the legitimacy of the prescription. Tr. 
53, 97. Though this prescription was diverted for illegal human use, 
the medical records of the animal patient would presumably falsely 
reflect that the animal had been prescribed the drug.
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    Regarding the Respondent's credibility, I note several areas of his 
testimony where there were inconsistencies or where his testimony was 
in direct opposition to previous testimony or established facts. First, 
the Respondent's testimony in this hearing that he never provided drugs 
to his son is in direct conflict with testimony he provided in his 2015 
criminal proceedings as reflected in the sentencing transcript. Second, 
the Respondent's testimony in this hearing that he was not abusing 
other drugs, specifically crack and marijuana, at the time that he 
developed his addiction to opiates conflicts with testimony he 
provided, as reflected in the transcript, to the court during his 2015 
sentencing. Third, the Respondent first testified that the Ohio 
Physicians' Health Plan counseling was too expensive for him to afford 
and also too far away for him to attend the in-person sessions. 
However, upon further examination by the tribunal, Respondent admitted 
he did not make any inquiries into the program after receiving the 
Board's Finding and Order and that his testimony was based on an 
inquiry he made back in the 1990's. Based on these inconsistencies in 
the Respondent's statements, and Respondent's uninformed (to be 
charitable) initial testimony regarding the Ohio Physicians' Health 
Plan counseling, I cannot fully credit the Respondent's testimony.
A.B.
    A.B. has known the Respondent since 1995 and has taken her pets to 
him as her veterinarian since that time, except when he was not able to 
practice. Tr. 142-43. She is not a veterinarian and has never 
prescribed or administered controlled substances. Tr. 147-48. She knows 
that the Respondent was unable

[[Page 4948]]

to practice because he lost his license due to ``some mistakes with 
drugs.'' Tr. 143. She has chronically ill animals--puppy mill 
survivors--that she takes to the Respondent for care because their 
severe illnesses require someone who will take the time to ``keep these 
dogs going.'' Tr. 143-45. The Respondent has always taken time to sit 
down and order lab tests. Tr. 144. She has never seen the Respondent 
appear to be under the influence of drugs or alcohol during any of her 
visits. Tr. 146-47. She trusts the Respondent. Tr. 147.
    A.B. was called as a character witness,\20\ and although the depth 
of her knowledge of the Respondent's suitability to act as a 
responsible DEA registrant is extremely limited, she presented 
testimony that was sufficiently cogent, detailed, plausible, and 
internally consistent to be considered generally creditable. Although 
A.B. has known the Respondent for over twenty-five years, her 
interactions with him have been limited to the times over the years 
when she has brought her animals to him for care. Nevertheless, I 
credit her testimony that the Respondent has rendered compassionate 
care to her animals and has never appeared to be under the influence of 
alcohol or drugs.
---------------------------------------------------------------------------

    \20\ Tr. 140.
---------------------------------------------------------------------------

R.W.
    The Respondent was employed by R.W.'s landscaping \21\ company 
about three and a half years ago. Tr. 150. R.W. is not a veterinarian 
and has never prescribed or administered controlled substances. Tr. 
153. Although the Respondent had felony convictions, R.W. needed 
employees and the Respondent was ``up front and honest'' with him about 
his situation, so R.W. gave him a chance. Tr. 150. The Respondent 
passed the initial drug test and never appeared to be under the 
influence of drugs or alcohol while he worked for R.W. Tr. 150-51. He 
was a hard worker and R.W. trusts him. Tr. 151. R.W. takes all of his 
pets to the Respondent for veterinary care. Tr. 151-52. The Respondent 
has never appeared to be under the influence of drugs or alcohol when 
R.W. brought his animals to the clinic. Tr. 152.
---------------------------------------------------------------------------

    \21\ Although R.W. did not testify as to the type of business he 
operates, he did describe the Respondent's responsibilities as 
``mowing'' and being ``in charge of the mowing crew.'' Tr. 151. The 
Respondent also previously testified that he worked for W.'s 
Complete Landscaping, a landscaping service. Tr. 64.
---------------------------------------------------------------------------

    R.W. was called as a character witness \22\ and, like the first 
character witness, although the depth of his knowledge of the 
Respondent's suitability to act as a responsible DEA registrant is 
extremely limited, he presented testimony that was sufficiently cogent, 
detailed, plausible, and internally consistent to be considered 
generally creditable. As a past employer, R.W. had more opportunities 
to observe the Respondent's condition on a day-to-day basis and he also 
had a stake in the Respondent remaining sober while employed. I 
therefore credit his testimony that the Respondent passed an initial 
drug test and maintained sobriety during the course of his employment.
---------------------------------------------------------------------------

    \22\ Tr. 140.
---------------------------------------------------------------------------

G.G.
    The Respondent and the Respondent's father had taken care of G.G.'s 
cats in 1990.\23\ Tr. 156. G.G. ran an animal shelter, which he took 
over in 1992, until he retired in 2005. Tr. 156-57. G.G. does not keep 
in contact with anybody from the shelter. Tr. 159. The Respondent's 
father and the Respondent worked with this shelter, taking care of 
animals. Tr. 156. G.G. is not a veterinarian and he does not have a DEA 
COR. Tr. 160-61. G.G. believed that the Respondent was very 
knowledgeable in pet care and would explain to his clients how to care 
for their pets. Tr. 158. G.G. currently takes his dog to the 
Respondent. Tr. 158. Despite the fact that the Respondent is a 
convicted felon, it has never come up in conversation because he 
believes the Respondent's concern is what he can do for the pets. Tr. 
158-59. G.G. has never seen the Respondent appear to be under the 
influence of drugs or alcohol. Tr. 159. While G.G. worked at the 
shelter, he never heard any complaints about the Respondent's care. Tr. 
159-60.
---------------------------------------------------------------------------

    \23\ The Respondent testified he did not graduate from 
veterinary school until 1994 and he then went into private practice 
with his father. Tr. 44-45. While G.G. may have been mistaken as to 
whether the Respondent had personally cared for his cats as early as 
1990, the Respondent also testified that he had ``managed dogs and 
horses and cats'' since he was six, (Tr. 68), so it is plausible 
that the Respondent was assisting in his father's practice in 1990 
in some capacity.
---------------------------------------------------------------------------

    G.G. was called as a character witness \24\ and, like the other two 
character witnesses, although the depth of his knowledge of the 
Respondent's suitability to act as a responsible DEA registrant is 
extremely limited, he presented testimony that was sufficiently cogent, 
detailed, plausible, and internally consistent to be considered 
generally creditable. Because G.G. retired from the animal shelter in 
2005, well before the Respondent's most recent drug violations, and 
because he has not kept in touch with people at the animal shelter, I 
find that the substance of his testimony is more relevant as a client 
who takes his dog to the Respondent for care. I therefore credit his 
testimony that the Respondent has rendered compassionate care to his 
dog and has never appeared to be under the influence of alcohol or 
drugs.
---------------------------------------------------------------------------

    \24\ Tr. 140.
---------------------------------------------------------------------------

    Other facts necessary for a disposition of this case are set forth 
in the balance of this Recommended Decision.

II. Discussion

    The burden of proof at this administrative hearing is a 
preponderance-of-the-evidence standard. Steadman v. SEC, 450 U.S. 91, 
100-01 (1981). The Administrator's factual findings will be sustained 
on review to the extent they are supported by ``substantial evidence.'' 
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). The Supreme Court has 
defined ``substantial evidence'' as such ``relevant evidence as a 
reasonable mind might accept as adequate to support a conclusion.'' 
Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). While ``the 
possibility of drawing two inconsistent conclusions from the evidence'' 
does not limit the Administrator's ability to find facts on either side 
of the contested issues in the case, Shatz v. U.S. Dep't of Justice, 
873 F.2d 1089, 1092 (8th Cir. 1989), all ``important aspect[s] of the 
problem,'' such as a respondent's defense or explanation that runs 
counter to the Government's evidence must be considered. Wedgewood 
Vill. Pharmacy v. DEA, 509 F.3d 541, 549 (D.C. Cir. 2007). The ultimate 
disposition of the case must ``be in accordance with the weight of the 
evidence, not simply supported by enough evidence to justify, if the 
trial were to a jury, a refusal to direct a verdict when the conclusion 
sought to be drawn from it is one of fact for the jury.'' Steadman, 450 
U.S. at 99 (internal quotation marks omitted).
    Regarding the exercise of discretionary authority, the courts have 
recognized that gross deviations from past agency precedent must be 
adequately supported, Morall v. DEA, 412 F.3d 165, 183 (D.C. Cir. 
2005), but ``mere unevenness'' in application does not, standing alone, 
render a particular discretionary action unwarranted. Chein v. DEA, 533 
F.3d 828, 835 (D.C. Cir. 2008) (citing Butz v. Glover Livestock Comm'n 
Co., 411 U.S. 182, 188 (1973)). It is well-settled that because the 
Administrative Law Judge has had the opportunity to observe the 
demeanor and conduct of hearing witnesses, the factual findings set 
forth in this

[[Page 4949]]

Recommended Decision are entitled to significant deference, Universal 
Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951), and that this 
Recommended Decision constitutes an important part of the record that 
must be considered in the Administrator's decision. Morall, 412 F.3d at 
179. However, any recommendations set forth herein regarding the 
exercise of discretion are by no means binding on the Administrator and 
do not limit the exercise of that discretion. 5 U.S.C. 557(b); River 
Forest Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); 
Attorney General's Manual on the Administrative Procedure Act Sec.  8 
(1947).
    In the adjudication of a denial of a DEA registration, the DEA has 
the burden of proving that the requirements for such registration are 
not satisfied. 21 CFR 1301.44(d). Where the Government has sustained 
its burden and made its prima facie case, a respondent must both accept 
responsibly for his actions and demonstrate that he will not engage in 
future misconduct. Patrick W. Stodola, M.D., 74 FR 20,727, 20,734 
(2009). Acceptance of responsibility and remedial measures are assessed 
in the context of the ``egregiousness of the violations and the [DEA's] 
interest in deterring similar misconduct by [the] Respondent in the 
future as well as on the part of others.'' David A. Ruben, M.D., 78 FR 
38,363, 38,364 (2013).

A. 21 U.S.C. 824(a)(2): Felony Related to Controlled Substances

    The Government alleges that the Respondent's COR application should 
be denied because he has been convicted of a felony related to 
controlled substances, pursuant to 21 U.S.C. 824(a)(2). Under this 
provision, the Attorney General may deny,*\C\ revoke, or suspend a 
registration issued under 21 U.S.C. 823 ``upon a finding that the 
registrant . . . has been convicted of a felony under this subchapter 
or subchapter II of this chapter or any other law of the United States, 
or of any State, relating to any substance defined in this subchapter 
as a controlled substance or a list I chemical.'' 21 U.S.C. 
824(a)(2)(emphasis added). Under 21 U.S.C. 824(a)(2), a felony 
conviction related to controlled substances is a lawful basis to revoke 
a COR, but the question of whether the registration is revoked is a 
matter of discretion. Alexander Drug Co., Inc., 66 FR 18,299, 18,302 
(2001).
---------------------------------------------------------------------------

    *\C\ A provision of section 824 may be the basis for the denial 
of a practitioner registration application and allegations related 
to section 823 remain relevant to the adjudication of a practitioner 
registration application when a provision of section 824 is 
involved. See Robert Wayne Locklear, M.D., 86 FR 33,738, 33,744-45.
---------------------------------------------------------------------------

    The Government alleges that on July 20, 2015, the Respondent 
pleaded guilty to ten counts of Illegal Processing of Drug Documents in 
violation of Ohio Rev. Code. Ann. Sec.  2925.23(B)(1),\25\ and that the 
Respondent was sentenced to seventeen months of imprisonment to be 
served concurrently with a twenty-four-month prison sentence for a 
weapons charge.*\D\ ALJ Ex. 1 at 2 ] 7. The Government further alleges 
that these ten convictions were based on a scheme in which the 
Respondent prepared false prescriptions for opioid medications, 
including hydromorphone and oxycodone/acetaminophen, for canines that 
did not exist or that the Respondent did not examine, and that the 
Respondent would either fill these prescriptions for his personal use 
or sell the prescriptions to others in exchange for cash or other 
controlled substances. ALJ Ex. 1 at 2-3 ] 8.
---------------------------------------------------------------------------

    \25\ Ohio Rev. Code. Ann. Sec.  2925.23(B)(1) states that ``[n]o 
person shall intentionally make, utter, or sell, or knowingly 
possess any of the following that is false or forged: (1) 
Prescription.''
    *\D\ Although discussed herein as background, I am not 
considering the weapons charge under 21 U.S.C. 824(a)(2).
---------------------------------------------------------------------------

    The Government provided a copy of the Respondent's signed guilty 
plea in which the Respondent pleaded guilty to ten counts of Illegal 
Processing of Drug Documents and one count of Having a Weapon While 
Under Disability.\26\ Gov't Ex. 4. The Respondent also admitted that he 
pleaded guilty to ten counts of Illegal Processing of Drug Documents in 
his Application for Registration, Form DEA 224 (``application''). Gov't 
Ex. 2 at 1-2. Specifically, in response to background question one on 
the application, which asks whether the applicant has ``ever been 
convicted of a crime in connection with controlled substance(s) under 
state or federal law,'' the Respondent responded ``Yes'' and indicated 
the following:
---------------------------------------------------------------------------

    \26\ The Government provided a copy of the signed plea agreement 
from the Muskingum County Court of Common Pleas. Gov't Ex. 4. The 
parties stipulated that this document is a true and correct copy of 
Respondent's signed plea agreement, dated July 20, 2015, in Case 
CR2015-0052, State of Ohio v. Michael E. Smith. Stip. 7.

    Incident Date: 10/05/2015 Incident Location: MUSKINGUM COUNTY 
OHIO Incident Nature: IN 2012 I BECAME ADDICTED TO OPIATES AFTER 5 
STRAIGHT MONS OF DR. PRESCRIBED OPIATES FOR 2 MAJOR SURGERIES. WHEN 
THE DRS. FINALLY STOPPED THEM I WROTE OPIATE PRESCRIPTIONS FOR DOGS 
AND TOOK SOME FOR MY OWN USE. I DID THIS OVER A THREE MONTH PERIOD 
UNTIL I CAME TO MY SENSES AND SOUGHT HELP FOR MY ADDICTION. Incident 
Result: IN 2015 AFTER BEING CHARGED I PLEAD GUILTY TO 10 COUNTS OF 
ILLEGAL PROCESSING OF DRUG DOCUMENTS AND SURRENDERED MY VET. LICENSE 
AND MY DEA REGISTRATION. I SERVED 17 MONS. INCARCERATED AND 
---------------------------------------------------------------------------
COMPLETED 2 REHABILITATION/RECOVERY PROGRAMS . . . .

    Gov't Ex. 1 at 1-2 (emphasis in original).
    The Respondent also testified at the April 19, 2021 hearing that he 
had pleaded guilty to ``10 counts . . . of illegal processing of drug 
documents'' and that he received a seventeen-month sentence for these 
charges and served all seventeen months, except ``possibly 30 days off 
the sentence for good behavior.'' Tr. 58-59, 101.
    During cross-examination, the Government referenced ALJ Exhibit 1, 
the Order to Show Cause for the instant case. Tr. 100.\27\ The 
Government read through Paragraphs 7 and 8, and the Respondent agreed 
he pleaded guilty to these ten counts of Illegal Processing of Drug 
Documents. Tr. 101. The Government also asked the Respondent whether 
these false prescriptions were based on a scheme whereby he would write 
false prescriptions for dogs the Respondent did not examine and would 
then fill those prescriptions for his own use or would sell the 
prescriptions to others. Tr. 102; ALJ Ex. 1 at 3 ] 11. The Respondent 
indicated that although a ``few of the prescriptions were actually for 
dogs that were damaged horribly,'' he ``did write prescriptions that 
should not have been written so [he] could acquire these drugs to feed 
[his] addiction. [He] fully admit[s] . . . freely admit[s] that.'' Tr. 
102. The Respondent also testified that he knew ``some people did 
acquire'' these false prescriptions. Tr. 102. Although the Respondent 
did not testify at the April 19, 2021 hearing that the specific 
controlled substances included hydromorphone and oxycodone, the 
transcript from his guilty plea, which was stipulated to by the 
parties, indicates that this scheme indeed included prescriptions for 
hydromorphone/Dilaudid, and oxycodone/APAP, which are both Schedule II 
controlled substances. Gov't Ex. 7 at 14; See Stip. 10, 12, 13.
---------------------------------------------------------------------------

    \27\ The Government ``shared'' this document on the screen so 
the Respondent, who was attending the hearing from a different 
physical location from his counsel, (Tr. 6), and did not have copies 
of the ALJ exhibits, was able to follow along with this line of 
questioning. Tr. 100.
---------------------------------------------------------------------------

    Therefore, through the Respondent's testimony, the exhibits, and 
the stipulations, there is no controversy that the Respondent has 
pleaded guilty to ten counts of Illegal Processing of Drug Documents in 
violation of Ohio Rev.

[[Page 4950]]

Code Ann. Sec.  2925.23(B)(1), was sentenced to seventeen months 
imprisonment to be served concurrently with a twenty-four month prison 
sentence for a weapons charge, and that these counts were based on a 
scheme by which the Respondent prepared false prescriptions for canines 
that did not exist or that he did not examine, and that he either 
filled the prescriptions for his own use or sold the false 
prescriptions to others in exchange for cash or other controlled 
substances.
    Therefore, the allegations set forth in the OSC Allegations 7 and 8 
are Sustained.

B. 21 U.S.C. 823(f): Public Interest Determination

    Pursuant to 21 U.S.C. 823(f), the Administrator may deny an 
application for a registration if persuaded that maintaining such 
registration would be inconsistent with the public interest. The 
following factors shall be considered in determining the public 
interest:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.
    21 U.S.C. 823(f).

    ``These factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Any one or a combination 
of factors may be relied upon, and when exercising authority as an 
impartial adjudicator, the Agency may properly give each factor 
whatever weight it deems appropriate in determining whether a 
registrant's registration should be revoked. Id.; David H. Gillis, 
M.D., 58 FR 37,507, 37,508 (1993); see also Morall, 412 F.3d at 173-74 
(D.C. Cir. 2005); Henry J. Schwarz, Jr., M.D., 54 FR 16,422, 16,424 
(1989).
    Moreover, the Agency is ``not required to make findings as to all 
of the factors,'' Hoxie, 419 F.3d at 482; see also Morall, 412 F.3d at 
173, and is not required to discuss consideration of each factor in 
equal detail, or even every factor in any detail. Trawick v. DEA, 861 
F.2d 72, 76 (4th Cir. 1988) (holding that the Administrator's 
obligation to explain the decision rationale may be satisfied even if 
only minimal consideration is given to the relevant factors, and that 
remand is required only when it is unclear whether the relevant factors 
were considered at all). The balancing of the public interest factors 
``is not a contest in which score is kept; the Agency is not required 
to mechanically count up the factors and determine how many favor the 
Government and how many favor the registrant. Rather, it is an inquiry 
which focuses on protecting the public interest . . . .'' Jayam 
Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
Factors Two, Three, and Four
    The Government contends that granting the Respondent's application 
for registration would be inconsistent with the public interest based 
on Factors Two, Three, and Four.\28\ ALJ Ex. 1 at 3 ] 10. Under Factor 
Two, the DEA analyzes a registrant's ``experience in dispensing . . . 
controlled substances.'' 21 U.S.C. 823(f)(2). This analysis focuses on 
the registrant's acts that are inconsistent with the public interest, 
rather than on a registrant's neutral or positive acts and experience. 
Kansky J. Delisma, M.D., 85 FR 23,845, 23,852 (2020) (citing Randall L. 
Wolff, M.D., 77 FR 5106, 5121 n.25 (2012)). Likewise, under Factor 
Four, the DEA analyzes an applicant's compliance with Federal and state 
laws, with the analysis focusing on violations of state and Federal 
laws and regulations concerning controlled substances. 21 U.S.C. 
823(f)(4); Kansky J. Delisma, M.D., 85 FR 23,852 (citing Volkman v. 
DEA, 567 F.3d 215, 223-24 (6th Cir. 2009). Under Factor Three, the 
tribunal may consider a registrant's ``conviction record under Federal 
or State laws relating to the manufacture, distribution, or dispensing 
of controlled substances.'' 21 U.S.C. 823(f)(3). A guilty plea may be 
considered under the third factor of the public interest standard. Mark 
P. Koch, D.O., 79 FR 18,714, 18,734 n.121 (2014).
---------------------------------------------------------------------------

    \28\ The record contains no recommendation from any state 
licensing board or professional disciplinary authority (Factor One), 
but, aside from cases establishing a complete lack of state 
authority, the presence or absence of such a recommendation has not 
historically been a case-dispositive issue under the Agency's 
precedent. Stodola, M.D., 74 FR 20,730 n.16; Krishna-Iyer, 74 FR 
461. Two different forms of recommendations have appeared in Agency 
decisions: (1) An explicit recommendation regarding the DEA's 
decision to issue or sanction a COR; and (2) the action of the 
relevant state authority regarding state licensure under its 
jurisdiction on the same matter that is the basis for the OSC. Mark 
A. Wimbley, 86 FR 20,713, 20,725 (2021); see also, Jennifer L. St. 
Croix, M.D., 86 FR 19,010, 19,022 (2021) (Agency affords minimal 
weight to a state board reprimand due to differences in evidence 
considered by the state in issuing its order.); Jeanne E. Germeil, 
M.D., 85 FR 73,786, 73,799 (2020) (Agency recognizes that its prior 
final orders have considered this dichotomy of sources for Factor 
One consideration). In the instant case, the Board did reinstate the 
Respondent's veterinary license in a Finding and Order dated 
November 14, 2019, after he surrendered it in 2015. See Resp't Ex. 
A; ALJ Ex. 20 at 10 (``There is approval from the Ohio Veterinary 
Medical Board. They granted Dr. Smith an unrestricted veterinary 
license, knowing his history of drug use and addiction.''). The 
Respondent currently has an Ohio veterinary license. Therefore, 
although not determinative in this proceeding, Factor One tends to 
lean in favor of the Respondent. As the Government's allegations and 
evidence fit squarely within the parameters of Factors Two, Three, 
and Four and do not raise ``other conduct which may threaten the 
public health and safety,'' 21 U.S.C. 823(f)(5), Factor Five 
militates neither for nor against the sanction sought by the 
Government in this case.
---------------------------------------------------------------------------

    Regarding Factor Two, the Respondent has approximately seven years 
of experience \29\ with dispensing controlled substances as a 
veterinarian. Gov't Ex. 2 at 1. In 2015, after pleading guilty to ten 
counts of Illegal Processing of Drug Documents, the Respondent 
surrendered his registration. As discussed supra, the Respondent 
admitted that he wrote false prescriptions ``that should not have been 
written so [he] could acquire these drugs to feed [his] addiction.'' 
Tr. 102. He also admitted that ``some people did acquire'' some of 
these false prescriptions. Tr. 102, 112. These prescriptions included 
hydromorphone/Dilaudid, a Schedule II controlled substance, and 
oxycodone/APAP, also a Schedule II controlled substance. Gov't Ex. 7 at 
14; Stips. 12, 13.
---------------------------------------------------------------------------

    \29\ The Respondent's first and only DEA registration, COR No. 
FS1126146, was assigned to the Respondent on October 22, 2008, and 
was surrendered for cause on July 27, 2015. Gov't Ex. 2 at 1.
---------------------------------------------------------------------------

    As it relates to Factor Four, the record establishes multiple 
instances in which the Respondent failed to comply with applicable 
Federal and State laws. The Government alleges that the Respondent 
violated 21 U.S.C. 841(a), 842(a), and Ohio Admin. Code 4729:5-30.\30\ 
ALJ Ex. 1 at 3 ] 11. The Controlled Substances Act's (``CSA'') general 
criminal provision is contained in 21 U.S.C. 841(a), and in relevant 
part states: ``[e]xcept as authorized by this subchapter, it shall be 
unlawful for any person knowingly or intentionally . . . to 
manufacture, distribute, or dispense, or possess with intent to 
manufacture, distribute, or dispense, a controlled

[[Page 4951]]

substance.'' 21 U.S.C. 841(a)(1). ``Congress devised a closed 
regulatory system making it unlawful to manufacture, distribute, 
dispense, or possess any controlled substance except in a manner 
authorized by the CSA'' to prevent abuse and diversion of controlled 
substances. Gonzales v. Raich, 545 U.S. 1, 13 (2005). DEA regulations 
require that for a prescription for a controlled substance to be 
effective it must be issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of professional 
practice. 21 CFR 1306.04(a).
---------------------------------------------------------------------------

    \30\ While OSC Allegation 11 charges the Respondent with 
violating Ohio Admin. Code 4729:5-30, the Government did not present 
any evidence on this issue during the hearing and did not address 
the issue in its post-hearing brief. Therefore, the Government has 
apparently abandoned this particular portion of OSC Allegation 11. 
See George Pursley, M.D., 85 FR 80,162, 80,181-82, 80,185 (2020) 
(finding the Government abandoned allegation by not addressing it 
within its post-hearing brief). I also take official notice that 
this particular administrative code section was rescinded, effective 
March 15, 2021. Ohio Admin. Code 4729:5-30 (LexisNexis 2021).
---------------------------------------------------------------------------

    Under the CSA, a veterinarian falls within the definition of a 
practitioner, and upon obtaining a registration, a veterinarian has 
legal authority to prescribe, administer or distribute a controlled 
substance to an ``ultimate user,'' who is a person who has lawfully 
obtained a controlled substance ``for an animal owned by him or a 
member of his household.'' Daniel Koller, D.V.M., 71 FR 66,975, 66,981 
(2006) (citing 21 U.S.C. 802(21), (27)).
    As discussed supra, the Government referenced ALJ Exhibit 1 and 
read through OSC Allegations 10 and 11. Tr. 101-03. The Respondent 
indicated that he understood the allegations and that he was guilty of 
the alleged conduct. Tr. 101-03.
    Regarding Factor Three, as discussed at length throughout this 
Recommended Decision, the Respondent's guilty plea, which may be 
considered under the third factor of the public interest standard,\31\ 
included ten counts of Illegal Processing of Drug Documents, which 
related to a scheme by which the Respondent would write fraudulent 
prescriptions which he would either fill himself, taking the pills for 
his own use, or would sell to others. Tr. 101-02. The Respondent began 
doing these ``illegal activities'' to acquire drugs for himself after 
he was unable to obtain further valid opioid prescriptions from other 
practitioners. Tr. 53, 83.
---------------------------------------------------------------------------

    \31\ Koch, 79 FR 18,734 n.121.
---------------------------------------------------------------------------

    Therefore, OSC Allegation 10 is Sustained and OSC Allegation 11 is 
Sustained in Part to the extent that the Respondent unlawfully issued 
prescriptions for controlled substances in violation of 21 U.S.C. 
841(a) and 842(a), specifically, by issuing fraudulent prescriptions 
and then converting those prescriptions to his own use or selling them, 
and that the Respondent issued prescriptions for controlled substances 
outside the usual course of professional practice and not for a 
legitimate medical purpose, (21 CFR 1306.04(a)). OSC Allegation 11 is 
Not Sustained in Part to the extent that the Respondent violated Ohio 
Admin. Code 4729:5-30.
    As it relates to the Respondent's experience in dispensing 
controlled substances, the Respondent's compliance with applicable 
State and Federal laws relating to controlled substances, and the 
Respondent's conviction record under Federal or State laws relating to 
the manufacture, distribution, or dispensing of controlled substances, 
Factors Two, Three, and Four militate strongly in favor of the 
Government's position that granting the Respondent a DEA registration 
is inconsistent with the public interest.
    Based upon my review of the allegations by the Government, it is 
necessary to determine if it has met its prima facie burden of proving 
the requirements for a sanction pursuant to 21 U.S.C. 824(a).
    It is clear from the stipulations, the Government's evidence, and 
the Respondent's position in this matter that there is no controversy 
between the parties that the Respondent was convicted of the underlying 
criminal charges. The Government's evidence clearly demonstrates the 
necessary elements of proof under 21 U.S.C. 824 and I find that the 
Government has established a prima facie case for denial of the 
Respondent's application for registration.

III. Sanction

A. Acceptance of Responsibility and Rehabilitative Measures

    With the Government's prima facie burden having been met, an 
unequivocal acceptance of responsibility stands as a condition 
precedent for the Respondent to prevail. Jones Total Health Care 
Pharmacy, L.L.C. & SND Health Care, L.L.C., 81 FR 79,188, 79,201 
(2016). This feature of the Agency's interpretation of its statutory 
mandate on the exercise of its discretionary function under the CSA has 
been sustained on review. MacKay v. DEA, 664 F.3d 808, 819-20 (10th 
Cir. 2011). Accordingly, the Respondent must ``present[ ] sufficient 
mitigating evidence to assure the Administrator that [he] can be 
entrusted with the responsibility carried by such a registration.'' 
Medicine Shoppe-Jonesborough, 73 FR 363, 387 (2008) (quoting Samuel S. 
Jackson, 72 FR 23,848, 23,853 (2007)). As past performance is the best 
predictor of future performance, the DEA has repeatedly held that where 
an applicant has committed acts inconsistent with the public interest, 
the applicant must accept responsibility for its actions and 
demonstrate that it will not engage in future misconduct. ALRA Labs, 
Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995).
    Although the Respondent ``freely admit[s] [he] did wrong,'' his 
language was conditional, and as opposed to taking unequivocal 
responsibility, the record is replete with examples of the Respondent 
placing the blame of his addiction on others, including a former client 
and his doctors. Tr. 112. For example, when he discussed using cocaine 
a few years after graduating from veterinary school, he prefaced this 
by explaining that a lot his previous friends from high school ``were 
using illicit drugs including cocaine'' and that he did not ``know much 
about'' cocaine until he ``had a client one night offer'' him some. Tr. 
47. When the Respondent was prescribed opiates in October 2011 and 
ultimately became addicted to them, he blamed a string of doctors who 
treated him for various ailments. He testified that he was ``not aware 
of the force of opiate addiction'' (Tr. 121) and that he ``had no idea 
what it was like until I found out myself.'' Tr. 84. He explained that 
he ``trusted the doctors to help'' him, (Tr. 121), and ``maybe [he] 
should have told the doctors, please don't give me these opiates.'' Tr. 
122. With this detached approach, the Respondent appears to have 
abdicated his responsibility to participate in the proper management of 
his pain by accounting for his history of drug addiction. Even in his 
application, which is the subject of these proceedings, he stated that 
he ``BECAME ADDICTED TO OPIATES AFTER 5 STRAIGHT MONS OF DR. PRESCRIBED 
OPIATES FOR 2 MAJOR SURGERIES. WHEN THE DRS. FINALLY STOPPED THEM I 
WROTE OPIATE PRESCRIPTIONS FOR DOGS AND TOOK SOME FOR MY OWN USE.'' 
Gov't Ex. 2 at 1 (emphasis in original). Essentially, the Respondent, 
despite his status as a medical professional and onetime DEA 
registrant, claimed ignorance of the potential for addiction of cocaine 
and opiates and instead blamed others for his addiction.
    When the Respondent was cross-examined by Government counsel 
regarding the ten prescriptions he wrote for which he was convicted of 
Illegal Processing of Drug Documents, the Respondent expressed 
ambivalence stating that a ``few of the prescriptions were actually for 
dogs that were damaged horribly.'' Tr. 102. During this same line of 
questioning regarding the ten prescriptions for which he was convicted, 
when asked if he issued the prescriptions ``without a legitimate 
medical purpose and outside the usual

[[Page 4952]]

course of professional practice,'' the Respondent would only allow that 
``[i]n most cases that is exactly correct.'' Tr. 103 (emphasis added). 
The Respondent's answers to these pointed questions about the ten 
distinct prescriptions for which he was convicted do not exhibit an 
unequivocal acceptance of responsibility.
    He also appears to have regret mostly for what his actions caused 
to his own life and it is evident the Respondent does not fully 
comprehend the repercussions of his actions and the effects it had on 
the community at large. During his testimony, he stated that his 
``actions had harmed [himself] and potentially others.'' \32\ Tr. 83-
84; 102 (emphasis added). He also discussed the fact that he went 
through bankruptcy proceedings and ``lost everything that [he] ever 
worked for.'' Tr. 108. When questioned regarding the other people who 
obtained false prescriptions through him, the Respondent was only able 
to ``mainly recall two people [whose] prescriptions were improper,'' 
one of which he ``found out later . . . was a very big drug dealer in 
this area.'' Tr. 112-13. The Respondent's failure to fully grasp how 
his diversion adversely impacted his community is a failure to accept 
full responsibility for his actions.
---------------------------------------------------------------------------

    \32\ It is startling that the Respondent couched his diversion 
of Schedule II controlled substances as ``potentially'' harming 
others when he also testified that he was diverting to a ``very big 
drug dealer,'' thereby implicitly acknowledging the widespread 
effect of his diversion. Tr. 112-13. Additionally, when testifying 
that, were he to obtain a new DEA registration, he would not divert 
drugs from his practice to his son, he also testified that he was 
``almost thankful'' his son is ``in jail right now so I don't read 
in the morning paper that he's dead.'' Tr. 118. Thus, while the 
Respondent is intimately familiar with his own struggles with drug 
addiction and that of his son, the fact that he couches his own 
diversion as having ``potentially'' harmed others leads this 
tribunal to conclude that he has not yet come to terms with his own 
role in this country's opioid crisis.
---------------------------------------------------------------------------

    Therefore, I do not find that the Respondent has demonstrated an 
``unequivocal acceptance of responsibility'' for his actions. Jones 
Total Health Care Pharmacy, L.L.C., 81 FR 79,201-02. Due to the fact 
that this is the Respondent's second episode of addiction and the fact 
that he used his DEA registration to divert controlled substances for a 
period spanning several months, I do not have confidence in the 
Respondent's statement that he ``can guarantee [he] would never, ever, 
ever abuse that authority again.'' Tr. 81.\33\
---------------------------------------------------------------------------

    \33\ Where a registrant has not accepted responsibility, it is 
not necessary to consider evidence of the registrant's remedial 
measures. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019) (citing 
Jones Total Health Care Pharmacy, L.L.C. & SND Health Care, L.L.C., 
81 FR 79,202-03 (2016)). [In this case, even if Respondent had 
accepted responsibility, his remedial measures were inadequate.] 
Although the Respondent stated he believes he is fully 
rehabilitated, the tribunal is not entirely convinced the Respondent 
is taking the necessary measures to maintain his sobriety long term. 
He attended a few programs while incarcerated and on an outpatient 
basis after his release from jail. Although he stated that he 
attends NA meetings, by his own admission, he only does so when he 
``feel[s] maybe a little stressed.'' Tr. 66. Furthermore, although 
he has ``reviewed the standards for record keeping,'' ``purchased 
keyed locks, key lockbox,'' and ``will acquire controlled substance 
logbooks and keep meticulous records,'' he has not taken any classes 
that relate to prescribing controlled substances. Tr. 85, 94. 
Finally, the Respondent does not appear to have seriously considered 
the Board's suggestions, when he was relicensed, that he attend 
counseling and practice under the supervision of another 
veterinarian. See supra at 9 n.19. Although the Respondent asserts 
that he ``learned through education about addiction that it is a 
lifelong condition,'' he does not appear to have in place an 
adequate support system (such as participating in the Ohio 
Physicians' Health Plan counseling) or an oversight structure (such 
as operating his practice under direct supervision by a licensed 
veterinarian) such that the tribunal has confidence he can be 
entrusted with a registration. Tr. 80.
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B. Egregiousness, Deterrence, and Lack of Candor

    While a registrant must accept responsibility and demonstrate that 
he will not engage in future misconduct in order to establish that his 
continued registration is consistent with the public interest, DEA has 
repeatedly held these are not the only factors that are relevant in 
determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 FR 
10,083, 10,094 (2009); Southwood Pharm., Inc., 72 FR 36,487, 36,502-04 
(2007). The egregiousness and extent of a registrant's misconduct are 
significant factors in determining the appropriate sanction. See Jacobo 
Dreszer, 76 FR 19,386, 19,387-88 (2011) (explaining that a respondent 
can ``argue that even though the Government has made out a prima facie 
case, his conduct was not so egregious as to warrant revocation''); 
Paul H. Volkman, 73 FR 30,630, 30,644 n.45 (2008).
    Further, in determining whether and to what extent imposing a 
sanction is appropriate, besides the egregiousness of the offenses 
established by the Government's evidence, consideration must also be 
given to the Agency's interest in both specific and general deterrence. 
Ruben, M.D., 78 FR 38,385. Here, the egregiousness of the offense 
favors denial of the application. The Respondent was convicted of ten 
counts of Illegal Processing of Drug Documents. These ten illegal 
prescriptions were for Schedule II controlled substances: Eight were 
for hydromorphone/Dilaudid and two were for oxycodone/APAP. Gov't Ex. 7 
at 14. The Respondent admitted that he diverted to numerous people, a 
few of whom he could recall and two of whom he specifically identified 
at the hearing. Tr. 112-13. The Respondent described one of these 
individuals as someone that he ``found out later . . . was a very big 
drug dealer.'' Tr. 112-13.
    Considerations of specific and general deterrence in this case 
militate in favor of denial of the application.\34\ As to specific 
deterrence, this is not the Respondent's first bout with drug 
addiction, having suffered from cocaine addiction in the 1990's and 
having served a term of incarceration for possession of that drug.\35\ 
Thus, the Respondent has acknowledged his past history of drug 
addiction, even going so far as to state he believes his ability to 
become ``highly addicted'' is ``part of [his] personality.'' Tr. 121. 
Thus, the interests of specific deterrence, even standing alone, 
motivate powerfully in favor of the denial of the Respondent's 
application.
---------------------------------------------------------------------------

    \34\ I note that the Respondent did not include his 1997 
conviction related to cocaine possession or his two-year veterinary 
license suspension in the late 1990's in his liability question 
responses. Gov't Ex. 2 at 1-2. However, because the Government did 
not make any allegations regarding a material falsification of the 
Respondent's application and also did not specifically rely on these 
events for denial of the instant application, I have not considered 
the previous conviction and license discipline except as historical 
information to put the Respondent's 2015 conviction and loss of his 
veterinary license into the proper context given his past 
experience. Presumably, the Agency was aware of these incidents when 
it granted the Respondent's previous application for registration in 
2008--which the Respondent surrendered for cause in 2015. Gov't Ex. 
2 at 1.
    \35\ In the Respondent's mind, his cocaine addiction in the 
1990's and his opiate addiction years later are unconnected and he 
implies he could not have foreseen his later addiction to opiates 
because he was ``never addicted to opiates'' and ``didn't go looking 
for a new addiction.'' Tr. 121. The Respondent also took issue with 
the tribunal's characterization of his opiate addiction as ``a 
relapse.'' Tr. 122. The Respondent made similar statements to the 
judge at his criminal sentencing in 2015 when the judge stated he 
was concerned because the Respondent had a drug addiction earlier in 
life and the Respondent replied ``I never had a (sic) opiate 
problem.'' Gov't Ex. 8 at 16-17. The judge in the criminal 
proceeding did not appear to accept this rationale, stating ``[y]ou 
had an addictive problem'' and ``[y]ou know how addictive opiates 
are. And you're an addict. Were and are.'' Gov't Ex. 8 at 17.
---------------------------------------------------------------------------

    The interests of general deterrence compel a like result. As the 
regulator in this field, the Agency bears the responsibility to deter 
similar misconduct on the part of others for the protection of the 
public at large. Ruben, 78 FR 38,385. Where the record demonstrates 
that the Government has borne its burden and established that the 
Respondent was convicted of a felony related to controlled substances 
and abused his prescriptive privileges to actively divert controlled 
substances to himself and others by writing prescriptions in the names 
of purported

[[Page 4953]]

animal patients, the unmistakable message to the regulated community 
would be that such conduct can be overlooked after a period of non-
registration. Although the Respondent surrendered for cause his 
previous DEA registration in 2015,\36\ he was not eligible to reapply 
for a new registration until January 2020, when he reacquired his state 
veterinary license. The following month, he submitted his application 
for a new DEA registration.\37\ At this time, the Respondent has been 
without a DEA registration for nearly six years. I find that this is 
not an insignificant period of time. However, based on the 
egregiousness of the Respondent's behavior discussed above, I find that 
the interests of general deterrence support the denial sought by the 
Government.
---------------------------------------------------------------------------

    \36\ Gov't Ex. 2 at 1.
    \37\ The Respondent's COR application was submitted on February 
3, 2020. Gov't Ex. 2 at 1.
---------------------------------------------------------------------------

    Another factor that weighs significantly in favor of the denial 
sanction sought by the Government is lack of candor. In making the 
public interest determination, ``this Agency places great weight on [a 
respondent's] candor, both during an investigation and in [a] 
subsequent proceeding.'' Fred Samimi, M.D., 79 FR 18,698, 18,713 (2014) 
(quoting Robert F. Hunt, D.O., 75 FR 49,995, 50,004 (2010)).
    Although the Agency did not make any allegations regarding a lack 
of candor by the Respondent during the investigation, in making my 
credibility determination, as discussed above, I found discrepancies 
between the Respondent's prior testimony to the court at his sentencing 
hearing and statements made by the Respondent in this proceeding. 
During the instant proceeding, the Respondent downplayed the scope and 
extent of his drug use, contradicting statements he made at his 
sentencing hearing that he was doing crack around the same time he 
became addicted to opiates and disavowing his previously acknowledged 
``almost daily'' use of marijuana by stating he was not using marijuana 
because he ``was after something for [his] pain, not marijuana.'' Tr. 
126. Other statements at the hearing that his son was not the recipient 
of any of his diverted drugs again conflict with testimony he gave at 
his sentencing hearing that his son received drugs that he diverted 
from his false prescribing. Finally, I find that the Respondent's 
initial testimony that he was not participating in the Ohio Physicians' 
Health Plan counseling, due to its cost, exhibits a lack of candor 
where the basis for his statement regarding cost was from when he 
previously considered the program in the 1990's relating to his cocaine 
addiction. I find that the Respondent's statement that the program was 
too expensive for him to participate in demonstrated a lack of candor, 
inasmuch as he later admitted he had no idea how the program is run 
today and that he had not explored options regarding financial 
assistance or other accommodations regarding cost. Hence, the 
Respondent's lack of candor undermines the confidence that the Agency 
can have in the Respondent's ability to be a responsible DEA 
registrant.
    For the above reasons, I find that the Respondent's misconduct is 
egregious and that deterrence considerations and the Respondent's lack 
of candor weigh in favor of revocation.
    Considering the entire record before me, the conduct of the 
hearing, and observation of the testimony of the witnesses presented, I 
find that the Government has met its burden of proof and has 
established a prima facie case for denial of the Respondent's 
application for registration. Furthermore, I find that the Respondent 
has failed to meet his burden to overcome the Government's case. While 
the Respondent is to be commended for rebuilding his veterinary 
practice and while the testimony of his three character witnesses leads 
me to conclude that the Respondent is a caring and capable 
veterinarian, *\E\ I cannot overlook the egregiousness of his offenses, 
his failure to unequivocally accept responsibility, and the need for 
specific and general deterrence in this case, each of which, even 
standing alone, provides a compelling reason for denial of the 
application.
---------------------------------------------------------------------------

    *\E\ See Raymond A. Carlson, 53 FR 7425 (1988) (finding that 
none of the character ``witnesses was in a position to make an 
adequate assessment of [r]espondent's ability to properly handle 
controlled substances.'').
---------------------------------------------------------------------------

    Therefore, I recommend that the Respondent's application for a DEA 
registration, Control No. W20010614C, be Denied and any pending 
applications for other DEA registrations likewise be Denied.
[GRAPHIC] [TIFF OMITTED] TN31JA22.000

Respondent's Exceptions
    On July 26, 2021, Respondent filed his Exceptions to the 
Recommended Decision. DEA regulations require that Exceptions ``include 
a statement of supporting reasons for such exceptions, together with 
evidence of record (including specific and complete citations of the 
pages of the transcript and exhibits) and citations of the authorities 
relied upon.'' 21 CFR 1316.66. For the most part, Respondent's 
Exceptions not only fail to comply with this regulatory requirement, 
but also lack evidentiary support in the Administrative Record. 
Additionally, some of Respondent's Exceptions repeat arguments that 
were already raised throughout the proceedings and were adequately 
addressed in the adopted Recommended Decision. Therefore, I reject 
Respondent's Exceptions and adopt the Recommended Decision of the ALJ 
as amended above.
Exception 1
    In his first Exception, Respondent argues that the ALJ failed to 
properly consider Factor One in the public interest analysis under 21 
U.S.C. 823(f)(1). Respondent's Exceptions, at 1. Respondent argues that 
``by granting [Respondent] a license to practice medicine and surgery 
in the State of Ohio after he surrendered it due to the criminal 
matter, the Ohio Veterinary Medical Licensing Board has given their 
stamp of approval for [Respondent] to

[[Page 4954]]

use [sic] controlled substances in Ohio'' and that ``the Tribunal 
should have taken this into consideration.'' Id.
    In determining the public interest under Factor One, the 
``recommendation of the appropriate State licensing board or 
professional disciplinary authority . . . shall be considered.'' 21 
U.S.C. 823(f)(1). ``Two forms of recommendations appear in Agency 
decisions: (1) A recommendation to DEA directly from a state licensing 
board or professional disciplinary authority (hereinafter, appropriate 
state entity), which explicitly addresses the granting or retention of 
a DEA COR; and (2) the appropriate state entity's action regarding the 
licensure under its jurisdiction on the same matter that is the basis 
for the DEA OSC.'' John O. Dimowo, M.D., 85 FR 15,800, 15,809 (2020); 
see also Vincent J. Scolaro, D.O., 67 FR 42,060, 42,065 (2002) (``While 
the State Board did not affirmatively state that the Respondent could 
apply for a DEA registration, [the ALJ] found that the State Board by 
implication acquiesced to the Respondent's application because the 
State Board has given state authority to the Respondent to prescribe 
controlled substances.''). It is the Administrator who makes a 
determination of whether granting a registration is in the public 
interest as defined by the CSA, and the Administrator's purview is 
focused on entrusting Respondent with a controlled substances 
registration. See Ajay S. Ahuja, M.D., 84 FR 5479, 5490 (2019).
    In Respondent's case, contrary to Respondent's Exception, the ALJ 
did consider in his Factor One analysis that the Board was aware of 
Respondent's history of drug use and addiction and nonetheless 
reinstated Respondent's Ohio veterinary license without restriction. 
RD, at 19 n.31. As such, the ALJ found that Factor One leaned in favor 
of Respondent. Id.
    Ultimately, the ALJ found, and I agree, that Factors Two, Three, 
and Four militate strongly in favor of the Government's position that 
granting the Respondent a DEA registration is inconsistent with the 
public interest. Accordingly, I find Respondent's assertion that the 
ALJ did not take the unrestricted reinstatement of Respondent's 
veterinary license into consideration in the Factor One analysis to 
lack merit.
Exception 2
    In his second Exception, Respondent argues that the ALJ improperly 
interpreted Respondent's nervous demeanor as a lack of remorse or a 
``conditional remorse,'' citing the ALJ's analysis of Respondent's 
acceptance of responsibility. Respondent's Exceptions, at 1-2; see RD, 
at 23-25. However, in his analysis regarding Respondent's acceptance of 
responsibility, the ALJ made no reference whatsoever to Respondent's 
demeanor or nervousness. RD, at 23-25. Instead, the ALJ found that 
Respondent had not demonstrated an unequivocal acceptance of 
responsibility because Respondent's testimony itself demonstrated that 
he was ambivalent regarding the extent of his wrongdoing, consistently 
placed the blame of his addiction on others, and was primarily 
regretful for how his misconduct had affected his own life rather than 
the community at large. Id. Accordingly, I find Respondent's argument 
that the ALJ improperly interpreted Respondent's demeanor in the 
analysis of Respondent's acceptance of responsibility to lack merit. I 
credit Respondent's honest acknowledgment of his nerves during the 
proceeding. Tr. 81.
    In spite of Respondent's commendable sobriety thus far, I have 
reason to doubt his claim that he would always be a compliant 
registrant. See George R. Smith, M.D., 78 FR 44,972, 44,980 (2013). 
Particularly, I remain concerned that if he relapsed, which the record 
has demonstrated previously occurred, while entrusted with a controlled 
substances registration, he could harm himself and others too quickly 
for detection by this Agency or his monitoring. See Robert Wayne 
Locklear, M.D., 86 FR 33,745. Ensuring that a registrant is trustworthy 
to comply with all relevant aspects of the CSA without constant 
oversight is crucial to the Agency's ability to complete its mission of 
preventing diversion within such a large regulated population. Jeffrey 
Stein, M.D., 84 FR 46,974.
Exception 3
    In his third Exception, Respondent argues that ``[t]he Tribunal 
gave too much weight to the DI [K.P.]'s opinions about [Respondent's] 
work on his addiction.'' Respondent's Exceptions, at 2. Respondent also 
argues that ``[t]here was no reason to include this as part of the 
Government's case'' and that ``there was no reason for the Tribunal to 
challenge [Respondent] about the Ohio Physicians' Health Plan.'' Id. 
However, where the Government has met its prima facie burden of showing 
that a ground for revocation exists, the burden shifts to the 
Respondent to show why he can be entrusted with a registration. See 
Jeffrey Stein, M.D., 84 FR 46,968, 46,972 (2019). As such, because the 
Respondent presented evidence of his remedial measures in order to meet 
this burden, it was entirely relevant to the adjudication of this 
matter and appropriate for the Government to present its own evidence 
pertaining to Respondent's remedial measures, as well as for the ALJ to 
question Respondent regarding these remedial measures.
    Moreover, in his third Exception, Respondent again argues the 
significance of the Board reinstating his license without restriction. 
Respondent's Exceptions, at 2. As already discussed supra, the ALJ 
adequately addressed this point in his public interest Factor One 
analysis. Accordingly, I find the claims made in Respondent's third 
Exception to lack merit.
Exception 4
    In his fourth Exception, Respondent argues that rather than an 
unrestricted DEA registration, he should instead be granted a limited 
DEA registration ``to utilize a limited number of [S]chedule III or 
lower substances.'' Respondent's Exceptions, at 2. However, Respondent 
does not provide adequate substantiation as to why I should accept this 
proposal, nor is there sufficient evidence in the Administrative Record 
to support it. Moreover, Respondent has not adequately demonstrated 
that he can be entrusted with a controlled substance registration at 
any schedule. See Larry C. Daniels, M.D., 86 FR 61,630, 61,664 n.30 
(2021). Accordingly, I find Respondent's argument that he should be 
granted a limited DEA registration to lack merit.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a) and 21 U.S.C. 823(f), I hereby deny the pending 
application for a Certificate of Registration, Control Number 
W20010614C, submitted by Michael E. Smith, D.V.M., as well as any other 
pending application of Michael E. Smith, D.V.M., for additional 
registration in Ohio. This Order is effective March 2, 2022.

Anne Milgram,
Administrator.
[FR Doc. 2022-01840 Filed 1-28-22; 8:45 am]
BILLING CODE 4410-09-P