Federal Register, Volume 86 Issue 241 (Monday, December 20, 2021)

[Federal Register Volume 86, Number 241 (Monday, December 20, 2021)]
[Notices]
[Pages 72030-72065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27416]

[[Page 72029]]

Vol. 86

Monday,

No. 241

December 20, 2021

Part II

Department of Justice

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Drug Enforcement Administration

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Medical Pharmacy Decision and Order; Notice

Federal Register / Vol. 86 , No. 241 / Monday, December 20, 2021 /
Notices

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-04]

Medical Pharmacy Decision and Order

On November 18, 2019, a former Acting Administrator of the Drug
Enforcement Administration (hereinafter, DEA or Government), issued an
Order to Show Cause and Immediate Suspension of Registration
(hereinafter, OSC/ISO) to Medical Pharmacy (hereinafter, Respondent).
Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at 1.
The OSC informed Respondent of the immediate suspension of its DEA
Certificate of Registration Number AL3398117 (hereinafter, registration
or COR) and proposed its revocation, the denial of any pending
applications for renewal or modification of such registration, and the
denial of any pending applications for additional DEA registrations
pursuant to 21 U.S.C. 824(a)(4) and 823(f), because Respondent's
``continued registration is inconsistent with the public interest.''
Id. (citing 21 U.S.C. 824(a)(4) and 823(f)).
In response to the OSC, Respondent timely requested a hearing
before an Administrative Law Judge. ALJ Ex. 2. The hearing in this
matter was conducted from May 4-7, 2020, at the DEA Hearing Facility in
Arlington, Virginia, with the parties and their witnesses participating
through video teleconference (VTC). On July 2, 2020, Chief
Administrative Law Judge John J. Mulrooney, II, (hereinafter, Chief
ALJ) issued his Recommended Rulings, Findings of Fact, Conclusions of
Law and Decision (hereinafter, Recommended Decision or RD). On July 22,
2020, the Respondent filed Exceptions to the Recommended Decision
(hereinafter, Resp Exceptions), to which the Government responded on
August 7, 2020. Having reviewed the entire record, I find Respondent's
Exceptions without merit and I adopt the Chief ALJ's Recommended
Decision with minor modifications, as noted herein.*\A\ I have
addressed the majority of Respondent's Exceptions in footnotes added to
the corresponding parts of the RD, and the remaining exceptions are
addressed in ``The Respondent's Exceptions'' section following the RD.
While I have made some modifications to the RD based on the exceptions,
none of those changes and none of Respondent's arguments persuaded me
to reach a different conclusion than the Chief ALJ in this matter.
Therefore, I 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 *^B
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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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The issue ultimately to be adjudicated by the Administrator, with
the assistance of this recommended decision, is whether the record as a
whole establishes by substantial evidence that the Respondent's COR
should be revoked on the grounds alleged by the Government.\1\ 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.
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\1\ The immediate suspension aspect of the Government's case was
final as of the date the OSC/ISO was issued by the Administrator,
and is not the subject of these proceedings. 21 U.S.C. 824(d)(1)
(``A[n immediate] suspension . . . shall continue in effect until
the conclusion of [administrative enforcement] proceedings,
including judicial review thereof, unless sooner withdrawn by the
Attorney General or dissolved by a court of competent
jurisdiction.''); 21 CFR 1301.36(h) (``Any suspension shall continue
in effect until the conclusion of all proceedings upon the
revocation or suspension, including any judicial review thereof,
unless sooner withdrawn by the Administrator or dissolved by a court
of competent jurisdiction.'').
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The Allegations

The Government alleges that the Respondent's COR should be revoked
because on numerous occasions between October 2016 and September 2019,
it repeatedly filled prescriptions without addressing or resolving
factual indicia (i.e., ``red flags'') of potential drug diversion. ALJ
Ex. 1 at 2. According to the Government, this constituted unlawfully
reckless and negligent dispensing. ALJ Ex. 1 at 2.

The Evidence

Stipulations

The parties entered into factual stipulations prior to and during
the litigation of this matter which were accepted by the tribunal. The
following factual matters are deemed conclusively established in this
case.
1. The Respondent pharmacy is registered with the DEA to handle
controlled substances in Schedules II through V under DEA COR number
AL3398117. The Respondent pharmacy's registered address is 6400 Main
St., P.O. Box 475, Zachary, LA 70791.
2. The Respondent pharmacy's DEA COR expires by its own terms on
January 31, 2021.
3. The Respondent pharmacy filled the following prescriptions for
Patient C.H.:

a. 9/12/17: Carisoprodol 350 mg, 120 tablets
b. 9/12/17: Alprazolam 1 mg, 90 tablets
c. 9/12/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
d. 9/12/17: Oxycodone-Acetaminophen 10 mg/325 mg, 30 tablets

4. The Respondent pharmacy filled the following prescriptions for
Patient J.M.B.:

a. 6/05/17: Hydromorphone 8 mg, 120 tablets
b. 6/05/17: Alprazolam 1 mg, 60 tablets
c. 6/05/17: Carisoprodol 350 mg, 120 tablets
d. 6/05/17: Morphine SO4 ER 30 mg, 90 tablets
e. 7/05/17: Alprazolam 1 mg, 60 tablets
f. 7/05/17: Morphine SO4 ER 30 mg, 90 tablets
g. 7/05/17: Carisoprodol 350 mg, 120 tablets
h. 7/05/17: Hydromorphone 8 mg, 120 tablets
i. 9/14/17: Alprazolam 1 mg, 60 tablets
j. 9/27/17: Morphine SO4 ER 15 mg, 30 tablets
k. 9/27/17: Morphine SO4 ER 30 mg, 60 tablets
l. 9/27/17: Carisoprodol 350 mg, 120 tablets
m. 9/27/17: Hydromorphone 8 mg, 120 tablets
n. 10/27/17: Carisoprodol 350 mg, 120 tablets
o. 10/27/17: Hydromorphone 8 mg, 120 tablets
p. 12/20/17: Carisoprodol 350 mg, 120 tablets
q. 12/20/17: Alprazolam 1 mg, 50 tablets
r. 12/20/17: Hydromorphone 8 mg, 120 tablets
s. 12/21/17: Morphine SO4 ER 30 mg, 60 tablets
t. 8/16/18: Alprazolam 1 mg, 60 tablets
u. 8/30/18: Hydromorphone 8 mg, 120 tablets
v. 8/30/18: Carisoprodol 350 mg, 120 tablets
w. 9/10/18: Morphine SO4 ER 30 mg, 60 tablets
x. 9/21/18: Alprazolam 1 mg, 60 tablets
y. 9/27/18: Carisoprodol 350 mg, 120 tablets

[[Page 72031]]

z. 9/27/18: Hydromorphone 8 mg, 120 tablets
aa. 10/15/18: Morphine SO4 ER 30 mg, 60 tablets
bb. 10/24/18: Carisoprodol 350 mg, 120 tablets
cc. 10/24/18: Hydromorphone 8 mg, 120 tablets
dd. 11/13/18: Morphine SO4 ER 30 mg, 60 tablets
ee. 11/27/18: Hydromorphone 8 mg, 120 tablets
ff. 11/27/18: Carisoprodol 350 mg, 120 tablets
gg. 11/29/18: Alprazolam 1 mg, 60 tablets
hh. 12/24/18: Carisoprodol 350 mg, 120 tablets
ii. 12/24/18: Hydromorphone 8 mg, 120 tablets
jj. 12/28/18: Alprazolam 1 mg, 60 tablets
kk. 1/08/19: Morphine SO4 ER 30 mg, 60 tablets
ll. 1/22/19: Hydromorphone 8 mg, 120 tablets
mm. 1/22/19: Carisoprodol 350 mg, 120 tablets
nn. 2/08/19: Alprazolam 1 mg, 60 tablets
oo. 2/08/19: Morphine SO4 ER 30 mg, 60 tablets
pp. 2/19/19: Carisoprodol 350 mg, 120 tablets
qq. 2/19/19: Hydromorphone 8 mg, 120 tablets
rr. 7/01/19: Morphine SO4 ER 30 mg, 60 tablets
ss. 7/08/19: Carisoprodol 350 mg, 120 tablets
tt. 7/08/19: Hydromorphone 8 mg, 120 tablets
uu. 8/05/19: Hydromorphone 8 mg, 120 tablets
vv. 8/05/19: Carisoprodol 350 mg, 120 tablets
ww. 8/20/19: Alprazolam 1 mg, 60 tablets
xx. 8/27/19: Hydromorphone 8 mg, 120 tablets
yy. 8/27/19: Carisoprodol 350 mg, 120 tablets

5. The Respondent pharmacy filled the following prescriptions for
Patient T.D.:

a. 7/13/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 180 tablets
b. 8/08/17: Clonazepam 0.5 mg, 60 tablets
c. 8/08/17: Carisoprodol 350 mg, 60 tablets
d. 8/12/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 180 tablets
e. 7/11/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 180 tablets
f. 7/18/18: Clonazepam 0.5 mg, 60 tablets
g. 7/18/18: Carisoprodol 350 mg, 60 tablets

6. The Respondent pharmacy filled the following prescriptions for
Patient D.G.:

a. 2/10/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
b. 2/10/17: Carisoprodol 350 mg, 30 tablets
c. 2/21/17: Diazepam 10 mg, 60 tablets
d. 3/09/17: Carisoprodol 350 mg, 30 tablets
e. 3/09/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
f. 3/21/17: Diazepam 10 mg, 60 tablets
g. 4/06/17: Carisoprodol 350 mg, 30 tablets
h. 4/06/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
i. 4/26/17: Diazepam 10 mg, 60 tablets
j. 5/04/17: Carisoprodol 350 mg, 30 tablets
k. 5/04/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
l. 5/30/17: Diazepam 10 mg, 60 tablets
m. 6/01/17: Carisoprodol 350 mg, 30 tablets
n. 6/01/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
o. 6/29/17: Diazepam 10 mg, 60 tablets
p. 6/29/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
q. 6/29/17: Carisoprodol 350 mg, 30 tablets
r. 7/27/17: Carisoprodol 350 mg, 30 tablets
s. 7/27/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
t. 7/28/17: Diazepam 10 mg, 60 tablets
u. 8/23/17: Diazepam 10 mg, 60 tablets
v. 8/24/17: Carisoprodol 350 mg, 30 tablets
w. 8/27/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
x. 9/21/17: Carisoprodol 350 mg, 30 tablets
y. 9/21/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
z. 9/25/17: Diazepam 10 mg, 60 tablets
aa. 11/16/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
bb. 11/16/17: Carisoprodol 350 mg, 30 tablets
cc. 11/20/17: Diazepam 10 mg, 60 tablets
dd. 12/14/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
ee. 12/14/17: Carisoprodol 350 mg, 30 tablets
ff. 12/14/17: Diazepam 10 mg, 60 tablets
gg. 1/12/18: Carisoprodol 350 mg, 30 tablets
hh. 1/12/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
ii. 1/24/18: Diazepam 10 mg, 60 tablets
jj. 2/09/18: Carisoprodol 350 mg, 30 tablets
kk. 2/09/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
ll. 2/21/18: Diazepam 10 mg, 60 tablets
mm. 3/09/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
nn. 3/09/18: Carisoprodol 350 mg, 30 tablets
oo. 3/26/18: Diazepam 10 mg, 60 tablets
pp. 6/06/18: Carisoprodol 350 mg, 30 tablets
qq. 6/06/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
rr. 6/14/18: Diazepam 10 mg, 60 tablets
ss. 7/05/18: Carisoprodol 350 mg, 30 tablets
tt. 7/05/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
uu. 7/16/18: Diazepam 10 mg, 60 tablets
vv. 8/02/18: Carisoprodol 350 mg, 30 tablets
ww. 8/02/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
xx. 8/13/18: Diazepam 10 mg, 60 tablets
yy. 8/30/18: Carisoprodol 350 mg, 30 tablets
zz. 8/30/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
aaa. 9/08/18: Diazepam 10 mg, 60 tablets
bbb. 10/26/18: Carisoprodol 350 mg, 30 tablets
ccc. 10/26/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
ddd. 11/06/18: Diazepam 10 mg, 60 tablets

7. The Respondent pharmacy filled the following prescriptions for
Patient J.H.:

a. 2/07/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 45 tablets
b. 2/07/17: Diazepam 10 mg, 18 tablets
c. 2/07/17: Zolpidem Tartrate 10 mg, 30 tablets
d. 2/09/17: Carisoprodol 350 mg, 90 tablets
e. 7/13/17: Diazepam 10 mg, 90 tablets
f. 7/13/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 40 tablets

[[Page 72032]]

g. 7/13/17: Carisoprodol 350 mg, 120 tablets
h. 7/31/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 40 tablets
i. 8/11/17: Diazepam 10 mg, 90 tablets
j. 8/11/17: Carisoprodol 350 mg, 120 tablets
k. 9/29/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 90 tablets
l. 10/10/17: Carisoprodol 350 mg, 120 tablets
m. 10/11/17: Diazepam 10 mg, 90 tablets
n. 10/26/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
o. 4/26/18: Carisoprodol 350 mg, 120 tablets
p. 4/26/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 90 tablets
q. 4/26/18: Diazepam 10 mg, 35 tablets
r. 5/24/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 90 tablets
s. 5/24/18: Carisoprodol 350 mg, 120 tablets
t. 5/24/18: Diazepam 10 mg, 35 tablets
u. 9/20/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 90 tablets
v. 9/20/18: Carisoprodol 350 mg, 120 tablets
w. 9/20/18: Diazepam 10 mg, 35 tablets
x. 10/18/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
y. 10/18/18: Carisoprodol 350 mg, 120 tablets
z. 10/18/18: Diazepam 10 mg, 35 tablets

8. The Respondent pharmacy filled the following prescriptions for
Patient R.I.:

a. 8/17/17: Alprazolam 1 mg, 120 tablets
b. 8/25/17: Zolpidem Tartrate 10 mg, 30 tablets
c. 8/25/17: Carisoprodol 350 mg, 30 tablets
d. 8/25/17: Oxycodone-Acetaminophen 10 mg/325 mg, 30 tablets
e. 9/11/17: Alprazolam 1 mg, 120 tablets
f. 9/25/17: Carisoprodol 350 mg, 30 tablets
g. 9/25/17: Oxycodone-Acetaminophen 10 mg/325 mg, 30 tablets
h. 10/12/17: Alprazolam 1 mg, 120 tablets
i. 10/25/17: Carisoprodol 350 mg, 30 tablets
j. 10/25/17: Oxycodone-Acetaminophen 10 mg/325 mg, 30 tablets
k. 11/13/17: Zolpidem Tartrate 10 mg, 30 tablets
l. 11/13/17: Alprazolam 1 mg, 120 tablets
m. 11/24/17: Carisoprodol 350 mg, tablets 30
n. 11/24/17: Oxycodone-Acetaminophen 10 mg/325 mg, 30 tablets
o. 12/09/17: Zolpidem Tartrate 10 mg, 30 tablets
p. 12/13/17: Alprazolam 1 mg, 120 tablets
q. 12/23/17: Oxycodone-Acetaminophen 10 mg/325 mg, 30 tablets
r. 12/27/17: Carisoprodol 350 mg, 30 tablets
s. 08/15/18: Alprazolam 1 mg, 90 tablets
t. 08/24/18: Carisoprodol 350 mg, 30 tablets
u. 08/24/18: Oxycodone-Acetaminophen 10 mg/325 mg, 30 tablets
v. 11/08/18: Alprazolam 1 mg, 90 tablets
w. 11/23/18: Zolpidem Tartrate 10 mg, 30 tablets
x. 11/24/18: Carisoprodol 350 mg, 30 tablets
y. 11/24/18: Oxycodone-Acetaminophen 10 mg/325 mg, 30 tablets
z. 12/06/18: Alprazolam 1 mg, 90 tablets
aa. 12/24/18: Oxycodone-Acetaminophen 10 mg/325 mg, 30 tablets
bb. 12/24/18: Hydrocodone-Acetaminophen 5 mg/325 mg, 10 tablets
cc. 12/24/18: Carisoprodol 350 mg, 30 tablets
dd. 01/04/19: Alprazolam 1 mg, 90 tablets

9. The Respondent pharmacy filled the following prescriptions for
Patient J.B.:

a. 7/02/19: Dextroamphetamine-Amphetamine 20 mg, 90 tablets
b. 7/02/19: Alprazolam 0.5 mg, 60 tablets
c. 7/02/19: Hydrocodone-Acetaminophen 10 mg/325 mg, 60 tablets

10. The Respondent pharmacy filled the following prescriptions for
Patient P.W.:

a. 4/04/19: Alprazolam 0.5 mg, 60 tablets
b. 4/04/19: Hydrocodone-Acetaminophen 10 mg/325 mg, 30 tablets
c. 8/01/19: Alprazolam 0.5 mg, 60 tablets
d. 8/01/19: Hydrocodone-Acetaminophen 10 mg/325 mg, 30 tablets
e. 8/29/19: Alprazolam 0.5 mg, 60 tablets
f. 8/29/19: Hydrocodone-Acetaminophen 10 mg/325 mg, 30 tablets

11. The Respondent pharmacy filled the following prescriptions for
Patient L.H.:

a. 6/14/17: Alprazolam 1 mg, 360 tablets
b. 6/22/17: Dextroamphetamine-Amphetamine 30 mg, 30 tablets
c. 6/22/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 20 tablets

12. The Respondent pharmacy filled the following prescriptions for
Patient A.P.:

a. 8/02/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 25 tablets
b. 8/02/17: Zolpidem Tartrate 10 mg, 30 tablets

13. The Respondent pharmacy filled the following prescriptions for
Patient M.A.:

a. 10/12/17: Alprazolam 1 mg, 30 tablets
b. 10/12/17: Dextroamphetamine-Amphetamine 30 mg, 60 tablets
c. 10/12/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets

14. The Respondent pharmacy filled the following prescriptions for
Patient B.B.:

a. 10/19/17: Alprazolam 1 mg, 90 tablets
b. 10/19/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 60 tablets
c. 1/11/17: Alprazolam 0.5 mg, 2 tablets
d. 1/11/17: Diazepam 10 mg, 2 tablets
e. 1/12/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 60 tablets
f. 2/08/17: Alprazolam 0.5 mg, 2 tablets
g. 2/08/17: Diazepam 10 mg, 2 tablets
h. 2/10/17: Alprazolam 0.5 mg, 60 tablets
i. 2/10/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 60 tablets
j. 3/09/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 60 tablets
k. 3/09/17: Alprazolam 0.5 mg, 60 tablets
l. 5/04/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 60 tablets

15. The Respondent pharmacy filled the following prescriptions for
Patient T.D.:

a. 3/07/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 180 tablets
b. 3/07/18: Clonazepam 0.5 mg, 60 tablets

16. The Respondent pharmacy filled the following prescriptions for
Patient L.D.:

a. 8/19/19: Oxycodone-Acetaminophen 10 mg/325 mg, 90 tablets
b. 8/19/19: Lorazepam 0.5 mg, 60 tablets
c. 8/19/19: Morphine SO4 ER 30 mg, 60 tablets
17. The Respondent pharmacy filled the following prescriptions for
Patient R.W.:

[[Page 72033]]

a. 8/12/19: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
b. 8/12/19: Diazepam 5 mg, 30 tablets
c. 9/09/19: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
d. 9/09/19: Diazepam 5 mg, 30 tablets

18. The Respondent pharmacy filled the following prescriptions for
Patient L.C.:

a. 3/21/19: Oxycodone-Acetaminophen 7.5 mg/325 mg, 14 tablets
b. 3/21/19: Oxycodone-Acetaminophen 7.5 mg/325 mg, 16 tablets

19. The Respondent pharmacy filled the following prescriptions for
Patient K.W.:

a. 4/16/19: Alprazolam 0.25 mg, 60 tablets
b. 4/16/19: Dextroamphetamine-Amphetamine 20 mg, 90 tablets

20. The Respondent pharmacy filled the following prescriptions for
Patient D.M.:

a. 6/08/17: Alprazolam 1 mg, 60 tablets
b. 6/08/17: Dextroamphetamine-Amphetamine 30 mg, 60 tablets

21. The Respondent pharmacy filled the following prescriptions for
Patient K.S.:

a. 6/26/17: Dextroamphetamine-Amphetamine 30 mg, 60 tablets
b. 6/26/17: Oxycodone-Acetaminophen 10 mg/325 mg, 60 tablets

22. The Respondent pharmacy filled the following prescription for
Patient P.B.:

a. 6/26/19: Methadone 10 mg, 60 tablets
b. 6/29/19: Oxycodone-Acetaminophen 10 mg/325 mg, 90 tablets

23. The Respondent pharmacy filled the following prescriptions for
Patient C.S.:

a. 6/11/19: Oxycodone 30 mg, 90 tablets
b. 7/09/19: Oxycodone 30 mg, 90 tablets

24. The Respondent pharmacy filled the following prescriptions for
Patient S.N.:

a. 6/05/19: Hydrocodone-Acetaminophen 7.5 mg/325 mg, 30 tablets
b. 6/19/19: Hydrocodone-Acetaminophen 7.5 mg/325 mg, 60 tablets

25. The Respondent pharmacy filled the following prescriptions for
Patient P.R.:

a. 10/24/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 112 tablets
b. 6/13/19: Hydrocodone-Acetaminophen 10 mg/325 mg, 112 tablets

26. The Respondent pharmacy filled the following prescriptions for
Patient D.F.:

a. 6/04/19: Alprazolam 0.5 mg, 120 tablets
b. 6/04/19: Dextroamphetamine-Amphetamine 30 mg, 60 tablets
c. 6/04/19: Butalbital-Acetaminophen-Caffeine 50 mg/325 mg/40 mg, 60
tablets

27. The Respondent pharmacy filled the following prescriptions for
Patient D.L.:

a. 8/09/17: Diazepam 10 mg, 90 tablets
b. 8/09/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 60 tablets

28. The Respondent pharmacy filled the following prescriptions for
Patient M.L.:

a. 8/02/17: Diazepam 10 mg, 45 tablets

29. The Respondent pharmacy filled the following prescriptions for
Patient K.C.:

a. 10/09/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 75 tablets
b. 10/09/17: Alprazolam 1 mg, 60 tablets

30. The Respondent pharmacy filled the following prescriptions for
Patient G.C.:

a. 10/10/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
b. 10/10/17: Alprazolam 1 mg, 90 tablets

31. The Respondent pharmacy filled the following prescriptions for
Patient V.M.:

a. 10/20/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
b. 10/20/17: Alprazolam 1 mg, 60 tablets

32. The Respondent pharmacy filled the following prescriptions for
Patient A.G.:

a. 9/06/16: Oxycodone 15 mg, 90 tablets
b. 6/27/19: Oxycodone 15 mg, 120 tablets
c. 7/24/19: Oxycodone 15 mg, 120 tablets
d. 8/22/19: Oxycodone 15 mg, 120 tablets

33. The Respondent pharmacy filled the following prescriptions for
Patient T.B.:

a. 5/22/17: Oxycodone 15 mg, 90 tablets
b. 6/25/18: Oxycodone 15 mg, 60 tablets
c. 7/09/18: Oxycodone 15 mg, 60 tablets
d. 7/23/18: Oxycodone 15 mg, 60 tablets

34. The Respondent pharmacy filled the following prescriptions for
Patient K.R.:

a. 4/09/18: Oxycodone-Acetaminophen 10 mg/325 mg, 90 tablets
b. 8/04/18: Oxycodone-Acetaminophen 10 mg/325 mg, 90 tablets

35. The Respondent pharmacy filled the following prescriptions for
Patient L.W.:

a. 7/27/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
b. 7/27/17: Alprazolam 1 mg, 90 tablets
c. 7/27/17: Dextroamphetamine-Amphetamine 20 mg, 60 tablets
d. 7/27/17: Phentermine 37.5 mg, 30

36. The Respondent pharmacy filled the following prescriptions for
Patient K.J.:

a. 5/21/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
b. 7/21/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets
c. 11/19/18: Hydrocodone-Acetaminophen 10 mg/325 mg, 120 tablets

37. The Respondent pharmacy filled the following prescription for
Patient V.E.: 5/22/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120
tablets.
38. The Respondent pharmacy filled the following prescription for
Patient T.P.: 5/22/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120
tablets.
39. The Respondent pharmacy filled the following prescription for
Patient I.J.: 5/23/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 90
tablets.
40. The Respondent pharmacy filled the following prescription for
Patient R.S.: 5/26/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120
tablets.
41. The Respondent pharmacy filled the following prescription for
Patient R.W.: 6/01/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 120
tablets.
42. The Respondent pharmacy filled the following prescription for
Patient J.W.: 5/12/17: Oxycodone-Acetaminophen 10 mg/325 mg, 60
tablets.
43. The Respondent pharmacy filled the following prescription for
Patient M.S.: 5/12/17: Oxycodone-Acetaminophen 10 mg/325 mg, 60
tablets.
44. The Respondent pharmacy filled the following prescription for
Patient P.F.: 5/22/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 90
tablets.
45. The Respondent pharmacy filled the following prescription for
Patient D.W.: 5/22/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 90
tablets.
46. The Respondent pharmacy filled the following prescription for
Patient K.D.: 5/04/17: Hydrocodone-Acetaminophen 10 mg/325 mg, 60
tablets.

[[Page 72034]]

47. Alprazolam, a type of benzodiazepine, is a Schedule IV
Controlled Substance. See 21 CFR 1308.14(C)(2).
48. Carisoprodol, a type of muscle relaxer, is a Schedule IV
Controlled Substance. See 21 CFR 1308.14(c)(6).
49. Clonazepam, a type of benzodiazepine, is a Schedule IV
Controlled Substance. See 21 CFR 1308.14(c)(11).
50. Diazepam, a type of benzodiazepine, is a Schedule IV Controlled
Substance. See 21 CFR 1308.14(c)(16).
51. Lorazepam, a type of benzodiazepine, is a Schedule IV
Controlled Substance. See 21 CFR 1308.14(c)(30).
52. Methadone is a Schedule II Controlled Substance. See 21 CFR
1308.12(c)(15).
53. Oxycodone is a Schedule II Controlled Substance. See 21 CFR
1308.12(b)(1)(xiii).
54. Phentermine is a Schedule IV Controlled Substance. See 21 CFR
1308.14(f)(9).
55. Zolipidem, a type of sedative, is a Schedule IV Controlled
Substance. See 21 CFR 1308.14(c)(54).
56. Hydrocodone is a Schedule II Controlled Substance. See 21 CFR
1308.12(b)(1)(vi).
57. Dextroamphetamine-Amphetamine, a type of stimulant, is a
Schedule II Controlled Substance. See 21 CFR 1308.12.(d)(1).
58. Centreville, MS is 33.2 \2\ miles from Zachary, LA.
---------------------------------------------------------------------------

\2\ The original stipulation reflected the distance between the
Respondent pharmacy and Centreville, Louisiana. At the Respondent's
unopposed request (which was supported by good cause), the
stipulation was modified during the hearing. Tr. 149.
---------------------------------------------------------------------------

59. Gloster, MS is 41.2 miles from Zachary, LA.
60. Hornbeck, LA is 174.2 miles from Zachary, LA.
61. Independence, LA is 53 miles from Zachary, LA.
62. Liberty, MS is 45.8 miles from Zachary, LA.
63. Vidalia, LA is 80.3 miles from Zachary, LA.

The Government's Case

In addition to the foregoing ponderous number of stipulations, the
Government's case consisted of the testimony of a Diversion
Investigator and an expert witness.

Diversion Investigator

The first witness to testify was a DEA Diversion Investigator (DI).
DI testified that she is currently assigned to the New Orleans Field
Division, a position she has held for about two years. Tr. 19. She
described her training and responsibilities as a DI, regulating
registrants and enforcing Controlled Substances Act (CSA). Tr. 20. In
her testimony, DI provided background information about the Louisiana
prescription monitoring program (PMP), a database used for the
statewide tracking of controlled substance prescriptions. Id. DI
explained that under Louisiana law, pharmacies doing business in the
state are required to enter dispensing data into the PMP for every
controlled substance prescription that they dispense. Id.
The investigation that culminated in the present administrative
charges was initiated by DI2, DI's predecessor. Tr. 21-22. Upon DI2's
transfer to DEA Headquarters DI assumed responsibility as the lead DEA
investigator on the case and inherited the open and closed evidence
requests, as well as the balance of the investigative case file. Tr.
22. According to DI, the Respondent pharmacy became the focus of DEA's
attention based on data acquired during a larger investigation
concerning Morris & Dickson, Co., L.L.C (M&D), a major pharmaceutical
distributor in Louisiana. Tr. 23. As part of the M&D investigation, it
came to DEA's attention that the Respondent pharmacy was one of the top
purchasers of oxycodone and hydrocodone in the state. Id. DI noted that
this was significant because the Respondent was purchasing
substantially more oxycodone and hydrocodone than other pharmacies in
the area. Id. She characterized the Respondent's dispensing as
``approximately six or seven times the national average.'' Tr. 25.
DI testified that during the course of her investigation she
reviewed reports from DEA's Automation of Reports and Consolidated
Ordering System (ARCOS) database. Tr. 25-26. She explained that DEA
registrants are required to input transactions involving controlled
substances in Schedules I and II, as well as Schedule III narcotics
into ARCOS. Id. The information entered by registrants is routinely
mined an analyzed by the DEA ARCOS Targeting and Analysis Unit (ARCOS
Unit) at DEA Headquarters, which can (as was the case here) generate
investigative leads. Tr. 26. DI testified that she reviewed the data
forwarded to her by the ARCOS Unit. Tr. 27-28. Through DI, the
Government introduced ARCOS data which established some discernible
trends regarding the Respondent's purchasing and dispensing of
controlled substances. Tr. 33; Gov't. Ex. 71. According to the ARCOS
data, in 2015 the Respondent was the sixth highest purchaser of
hydrocodone in the state of Louisiana at 677,878 dosage units that
year. Tr. 33; Gov't. Ex. 71 at 1-2. In 2016, the Respondent was the
second highest purchaser,\3\ at 677,583 dosage units of hydrocodone.
Tr. 33; Gov't. Ex. 71 at 2. This trend of high volume purchasing
continued into 2017 where the Respondent was the third highest
purchaser at 615,924 dosage units. Tr. 35; Gov't. Ex. 71 at 6.
---------------------------------------------------------------------------

\3\ Throughout her testimony, DI clarified that the data in the
ARCOS report refers to the number of dosage units that the
Respondent purchased. Tr. 43.
---------------------------------------------------------------------------

A similar trend was present with respect to the Respondent's
purchasing of oxycodone. Tr. 34. In 2015, the Respondent was the fifth
highest purchaser of oxycodone, having purchased 519,219 dosage units.
Tr. 44; Gov't. Ex. 71 at 7. The Respondent was the seventh highest
purchaser in 2016 at 494,730 dosage units. Tr. 34; Gov't. Ex. 71 at 9.
In 2017, the Respondent was again the fifth highest purchaser at
482,770 dosage units of oxycodone. Tr. 34-35; Gov't. Ex. 71 at 11-12.
According to the averages for 2015 aggregated in the ARCOS report, the
pharmacies in the same zip code as the Respondent purchased an average
of 174,695 dosage units of oxycodone. Tr. 35; Gov't. Ex. 71 at 15. The
state average in 2015 for Louisiana was 102,698 dosage units while the
national average was 87,261 dosage units. Tr. 35; Gov't, Ex. 71 at 15.
Within its (70791) zip code in 2015, the Respondent pharmacy was
the highest purchaser of hydrocodone. Tr. 36; Gov't. Ex. 71 at 14. The
second highest purchaser, a Walgreens, purchased only 191,668 dosage
units compared to the Respondent's 677,872. Tr. 36; Gov't. Ex. 71 at 4.
The average for its zip code was 202,161 while the state average for
Louisiana was 112,588, and the national average was 95,866. Tr. 37;
Gov't. Ex. 71 at 16. In 2017, the average purchasing of hydrocodone for
pharmacies in the Respondent's zip code was 214,518. Tr. 38; Gov't. Ex.
71 at 19. The state average was 93,636 while the national average was
60,488. Tr. 38; Gov't. Ex. 71 at 19. In 2017, the Respondent was again
the highest purchaser of hydrocodone in its zip code. Tr. 39; Gov't.
Ex. 71 at 20-21. Medical Pharmacy West (MP West),\4\ a pharmacy owned
by the same corporate entity as the Respondent, was the second highest
purchaser at 182,058

[[Page 72035]]

dosage units. Tr. 39; Gov't. Ex. 71 at 21, 40.
---------------------------------------------------------------------------

\4\ DI testified that MP West and the Respondent pharmacy are
``sister pharmacies,'' sharing common ownership, but she made it
clear that only the conduct of the Respondent pharmacy (Medical
Pharmacy), was the subject of the present enforcement case. Tr. 40.
---------------------------------------------------------------------------

In 2015, the average oxycodone purchasing within the Respondent's
zip code was 120,274, whereas the Respondent purchased 519,219 dosage
units. Tr. 39; Gov't. Ex. 71 at 22. The state average was 55,179 while
the national average was 72,729. Tr. 39; Gov't Ex. 71 at 22. Similarly,
in 2017, the average purchasing within the Respondent's zip code was
116,706 while the Respondent purchased 482,770 dosage units. Tr. 42;
Gov't. Ex. 71 at 28. The state average that year was 53,219 and the
national average was 49,415. Tr. 42; Gov't. Ex. 71 at 28.
One peculiar aspect of the Government's table comparisons is the
inclusion of a United States Post Office zip code (70072) that did not
correspond to the Respondent's registered address or any other location
in the universe that bore any logical relationship to the present
case.\5\ DI had no idea why data regarding 70072 was included, and DI2,
who apparently requested the data, was not produced by the Government
as a witness. Tr. 153, 172-73. This zip code was used for comparisons
on pages 13, 16, 19, 22, 25, and 28 of the ARCOS data report. Tr. 154;
Gov't. Ex. 71. In an even stranger development, DI attempted to explain
the inclusion of the errant zip code data by inexplicably describing it
as an ``exemplar'' zip code for the state of Louisiana. Tr. 169-70. No
one at the hearing seemed to have the foggiest notion as to why
information relative to this zip code bore any relation to any relevant
fact. In any event, the data pertaining to zip code 70072 was not
relevant and was not considered in this recommended decision.
---------------------------------------------------------------------------

\5\ Official notice (upon the concurrence of the parties) was
taken that zip code 70072 corresponds to Marrero, Louisiana. Tr.
153-56.
---------------------------------------------------------------------------

DI stated that purchasing data of this sort indicated that from an
investigative standpoint, high purchasing numbers raise the specter
that ``maybe there's something awry'' because a pharmacy purchasing
that many dosage units is likely dispensing at a high volume which is
an indicator of possible diversion. Tr. 44. She clarified her
understanding that it is not against the law to be a high volume
purchaser or dispenser, but offered that the data informed their
investigation and led the investigators to probe further.*\C\ Tr. 44-
45. The Louisiana PMP data confirmed that the high volume purchasing
was indeed consistent with a concomitantly high volume dispensing by
the Respondent pharmacy.\6\ Tr. 45. After reviewing the PMP data and
seeing that it corroborated the ARCOS data, DEA acquired the services
of an expert, Dr. Diane Ginsburg, to review the data. Tr. 46-47, 72.
Prior to requesting the expert report, an administrative subpoena was
issued to the Respondent on May 28, 2019. Tr. 47-48; Gov't Ex. 64. This
subpoena requested the prescriptions and dispensing data for 30
patients. Tr. 49; Gov't. Ex. 64. Initially not all of the data was
provided, but was later supplied in response to an additional subpoena.
Tr. 53-54; Gov't. Ex. 66. Another subpoena was issued on September 18,
2019, requesting copies of the prescription fill screens following the
dispensing of controlled substances, including pharmacist notations and
comments, from January 1, 2017, to March 28, 2019. Tr. 57-58; Gov't.
Ex. 66.
---------------------------------------------------------------------------

*\C\ The information in the DI's testimony related to the volume
of controlled substances purchased by Respondent is relevant only to
the rationale and foundation for the beginning of DEA's
investigation and is considered herein for that purpose alone.
\6\ DI stated that she was given access to the Louisiana PMP, in
the form of a username and password, as part of her onboarding
process as a diversion investigator. Tr. 178. The witness credibly
testified that the application was made through, and granted by,
Louisiana state officials, and that Louisiana furnished password-
protected access to the data to DI as a DEA investigator. Tr. 177-
80. The Respondent initially declined to object to the Government's
PMP evidence, but subsequently attempted to interpose an objection
after the evidence was accepted in the record. Tr. 130-34. The
evidence had been timely supplied by the Government far in advance
of the hearing, the Respondent's objection to it was clearly waived,
and the evidence was correctly admitted and considered. Tr. 136.
However, even in the absence of waiver, the DI's testimony regarding
the level of state-controlled access deliberately granted to the DEA
investigators by the State of Louisiana sufficiently distinguishes
this case from Grider Drug #1 and Grider Drug #2, 77 FR 44069, 44071
n.8 (2012), that the evidence is properly considered in these
proceedings. Testimony from DI regarding the manner in which her PMP
access was granted by the State of Louisiana, coupled with
information supplied via email from JF, R.Ph, Assistant Executive
Director of the Louisiana Pharmacy Board (Gov't Ex. 76) (no relation
to the Respondent pharmacy PIC, Tr. 1064), provides more than a
sufficient foundation to admit the PMP evidence as legally procured
pursuant to an authorized administrative request under Louisiana
law. La. R.S. 40:1007(F)(3).
---------------------------------------------------------------------------

Upon review of the responsive material to the first subpoena, the
investigators observed that there were no patient profiles or
pharmacist comments that corresponded to some of the patients described
in the DEA's subpoena. Tr. 53-54. The Respondent was informed that this
data was missing and a second administrative subpoena issued. Tr. 53.
Additional material was provided in response to the second subpoena.\7\
Tr. 53-54. On the issue of compliance with the subpoena, Respondent
pharmacy technician TM advised the investigators that where patient
profiles and pharmacists' comments were not provided it was because
those items do not exist. Tr. 54-56.
---------------------------------------------------------------------------

\7\ All of the requested data was received in response to a
total for four subpoenas. Tr. 63-64. DI also clarified that the
Government's Exhibits 3-63 did not contain all of the copious volume
of documents that the Respondent supplied to the DEA in response to
the subpoenas, merely a subset of them. Tr. 66-67.
---------------------------------------------------------------------------

According to DI, upon review of the documents received from the
Respondent the investigators concluded that what they saw demonstrated
potential evidence of combination prescribing, to include many
prescriptions for the ``trinity'' (an opioid, a benzodiazepine, and
carisoprodol) drug cocktail as well as other opioid and benzodiazepine
combinations. Tr. 71. Additionally, the materials she reviewed
reflected patients who traveled long distances from their home
addresses to the Respondent pharmacy, and that many patients received
the highest available quantity and strength of various opioids. Id.
Based on its evaluation of the data it retrieved from ARCOS, PMP,
and the Respondent pharmacy, DEA issued an OSC/ISO. ALJ Ex. 1. DI
acknowledged that although under the CSA, an OSC/ISO authorizes the
seizure and storage under seal of controlled substances in the
possession of the registrant upon whom it is executed,\8\ the cognizant
DEA officials on the scene declined to seize the drugs and authorized
the transfer of the controlled medications to MP West, the Respondent's
sister pharmacy. Tr. 162-64. DI allowed that, at least in her view, the
decision to allow the transfer of the medications to MP West should not
be read as an indication that DEA did not consider the potential
charges to be serious. Tr. 164.
---------------------------------------------------------------------------

\8\ 21 U.S.C. 824(f).
---------------------------------------------------------------------------

DI also conceded that in May of 2016, a period for which ARCOS and
PMP data was used to support the issuance of the OSC/ISO, a cyclical
investigation \9\ of the Respondent was conducted by DEA investigators,
and yielded no violations or charges, but she allowed that it was
possible that the regulators conducting the cyclical may not have
consulted the ARCOS database. Tr. 94, 97-98.
---------------------------------------------------------------------------

\9\ The witness testified that cyclical investigations are
conducted without advance notice to the registrant. Tr. 94-95.
---------------------------------------------------------------------------

DI presented as an objective regulator/investigator with no
discernible motive to fabricate or exaggerate. Indeed, as a successor
investigator, she demonstrated commendable candor in teasing out which
aspects of her

[[Page 72036]]

investigation were initiated/controlled by her, and which aspects were
inherited. Where she was unsure of an answer (such as the odd inclusion
of the ARCOS data relative to the irrelevant zip code), she presented a
good-faith effort to analyze the possible basis for generating the
information, but made no attempt to supply a convenient
contrivance.\10\ Viewed in toto, the testimony of this witness is
sufficiently detailed, plausible, and internally consistent to be
afforded full credibility in this case.
---------------------------------------------------------------------------

\10\ This in no way relieves this witness or the Government from
the responsibility to actually understand the relevance of the
evidence put forth. Gregg & Son Distributors, 74 FR 17517, 17517 n.1
(2009) (Agency clarified that ``it is the Government's obligation as
part of its burden of proof and not the ALJ's responsibility to sift
through the records and highlight that information which is
probative of the issues in the proceeding.''). Stated differently,
the fact that the Government sponsored evidence under circumstances
where no one in the courtroom could intelligibly articulate a
reasonable basis for its relevance did not enhance the confidence
that can be placed in its witness or its case. This feature is made
even more inexplicable by the fact that the initial investigator is
currently stationed at DEA Headquarters, less than a mile from the
DEA Hearing Facility, and that all testimony in this case was taken
by VTC. Still, the irrelevant evidence had no impact, and the wound
was not mortal to the Government's case or the witness's
credibility.
---------------------------------------------------------------------------

Dr. Diane B. Ginsburg

The Government presented the testimony of Dr. Diane Ginsburg, a
clinical professor in the Pharmacy Practice Division of the College of
Pharmacy at the University of Texas at Austin.\11\ Gov't Ex. 2. Her
curriculum vitae (CV) reflects myriad teaching and administrative
appointments in academia,\12\ extensive authorship and publication in
pharmacy and educational administration, as well as approximately six
years of clinical experience practicing pharmacy in Texas.\13\ Id. The
witness testified that she maintains some level of active involvement
with the campus pharmacy at the University of Texas in addition to her
prior experience as a retail pharmacist.\14\ Tr. 212-14. The witness's
CV reflects no actual pharmacy practice or teaching appointments in
Louisiana,\15\ but she testified that in her view there are no
significant differences between the pharmacy standards applicable in
Texas versus in Louisiana.\16\ Tr. 215. Dr. Ginsburg was offered \17\
by the Government and accepted as an expert in the field of pharmacy
practice, and specifically pharmacy practice in Louisiana.\18\ Tr. 271.
---------------------------------------------------------------------------

\11\ Dr. Ginsburg testified that she is in her thirty-second
year on the University of Texas faculty. Tr. 207.
\12\ The witness testified that she currently teaches courses in
pharmacy law, inter-professional ethics, and foundations of
professional development. Tr. 214.
\13\ Dr. Ginsburg testified that she has been licensed to
practice pharmacy in Texas since 1984. Tr. 209.
\14\ Dr. Ginsburg testified that although she has filled in
sporadically (but not recently) as a line pharmacist at the campus
pharmacy (Tr. 213-14, 246-48), she is not the pharmacist-in-charge
(PIC) (Tr. 213), and her name does not appear on the campus pharmacy
license. Tr. 243-46.
\15\ Gov't Ex. 2. Past Agency precedent has not required that
expert witnesses maintain licensure in the state(s) where their
professional expertise is elicited. See, e.g., Wesley Pope, M.D., 82
FR 14944, 14976 (2017) (holding that testimony of the Government's
expert witness merited controlling weight notwithstanding lack of
applicable state licensure or experience. [omitted]. In fact, the
Agency has even held that there is no requirement that an expert
witness be licensed in any state at all. Trinity Pharmacy II, 83 FR
7304, 7324 n.48 (2018). [However, as is the case here, expert
witnesses from out of state generally demonstrate an understanding
of the applicable standard of care and usual course of professional
practice and the foundation for this understanding. In this case,
the expert witness's testimony was supported by Louisiana law.]
\16\ Dr. Ginsburg testified that during her academic tenure she
has had the opportunity to compare Louisiana and Texas pharmacy
practice standards. Tr. 216.
\17\ Tr. 219.
\18\ At the hearing and in its post-hearing brief, the
Respondent objected to the classification of Dr. Ginsburg as an
expert. Tr. 269-70; ALJ Ex. 20 at 8-10. The Respondent's objection
at the hearing was noted on the record and Dr. Ginsburg's expert
testimony was admitted over that objection. Tr. 271. [Respondent
again objected in his Exceptions and argued, in the alternative,
that her ``lack of qualifications should have been taken into
account in determining what weight to give her opinions.'' Resp
Exceptions, at 1. Repeating the arguments Respondent made before the
Chief ALJ, Respondent took exception to Dr. Ginsburg's lack of
recent work experience in retail pharmacy, her lack of research work
and publications, her lack of prior testimony regarding ``red
flags,'' and, amongst other things, her lack of any practice or
license in Louisiana. Id. at 1-5. Respondent also again pointed out
that Dr. Ginsburg rendered her opinion that Medical Pharmacy was
improperly filling prescriptions for controlled substances that had
one or more red flags without first having the pharmacy records from
which she could determine whether or not the red flags had been
resolved. Id. at 3-4. All of these issues were considered by the
Chief ALJ both during the hearing and in the RD and I agree with the
ALJ's determination. I find that Dr. Ginsburg was a credible
witness. I find that Dr. Ginsburg primarily relied on Louisiana law
and regulations to formulate her opinion regarding the usual course
of professional practice and a pharmacist's corresponding
responsibility and the laws provide extremely strong support for her
testimony. See infra The Analysis. For example, Dr. Ginsburg
testified that Louisiana requires pharmacists to exercise their
corresponding responsibility, Tr. 275, and indeed, Louisiana states
that ``[t]he responsibility for the proper prescribing of controlled
substances rests upon the prescribing practitioner; however, a
corresponding responsibility rests with the pharmacist who dispenses
the prescription.'' La. Admin Code tit. 46, Part LIII, Sec.
2745(b)(1). Also, Dr. Ginsburg testified that to ensure a
prescription is issued for a legitimate medical purpose, ``[y]ou
would look at some of the things that would, I guess, raise the red
flag, although that is not an official legal term. . . . [Y]ou would
look at quantity, . . . other medications being prescribed, . . .
duration of therapy . . . [you would] look also holistically in
terms of within that patient profile. Those are examples of a few
things.'' Tr. 275-76. This is supported by La. Admin Code tit. 46,
Part LIII, Sec. 515 which says ``[a] pharmacist shall review the
patient record and each prescription presented for dispensing for
purposes of enhancing pharmacy care and therapeutic outcomes by
recognizing the following potential situations: 1. Drug over-
utilization or under-utilization; 2. Therapeutic duplication; . . .
4. Drug-drug interactions; 5. inappropriate drug dosage or treatment
duration; 6. drug-allergy interactions; 7. or clinical abuse/
misuse.'' Moreover, it appears that the expert opinions generally
relied upon in this decision were largely uncontested.]
---------------------------------------------------------------------------

Dr. Ginsburg testified that the applicable standard of care
requires that before dispensing a controlled substance, a pharmacist
must engage in a defined protocol to ascertain whether the medicine was
prescribed for a legitimate medical purpose. Tr. 273. Specifically, in
Dr. Ginsburg's opinion, the dispensing pharmacist must perform the
following steps prior to dispensing: (1) Verify the prescriber's
licensure and DEA registration status; \19\ (2) verify that the dose is
correct; (3) verify that the drug is correct; (4) verify that the
patient directions are correct; (5) consult with the state PMP to check
for pharmacy and/or doctor shopping. Tr. 273-74. Additionally, Dr.
Ginsburg testified that there are multiple ``holistic'' \20\
considerations that a pharmacist must factor into the mix, such as the
quantity of medication being prescribed, other medications that may
have been simultaneously prescribed, and the duration of the therapy.
Tr. 275-76. In Dr. Ginsberg's opinion, it is incumbent upon the
dispensing pharmacist to contact the prescriber to resolve any issues
raised regarding any of the foregoing wickets, or even the state
medical board or law enforcement in some cases. Tr. 273-74, 276.
According to Dr. Ginsburg, documentation memorializing the resolution
of any conflict constitutes a minimum standard of conduct.\21\ Tr. 280.
Dr. Ginsburg also discussed a pharmacist's corresponding responsibility
to ensure that a controlled substance prescription is issued for a
legitimate medical purpose. Tr. 274-75.
---------------------------------------------------------------------------

\19\ [Omitted for relevance.]
\20\ At another point in her testimony, the witness testified
that checking the patient profile maintained by a pharmacy is
encompassed within her definition of a ``holistic'' analysis. Tr.
282-83.
\21\ The memorialization could be affixed to the back of a
prescription by handwritten note or entered electronically into a
pharmacy database. Tr. 281.
---------------------------------------------------------------------------

Although not included in the defined protocol that she outlined
early in her testimony, Dr. Ginsburg outlined various features, or
``red flags,'' that must (presumably in the manner of the other listed
potential anomalies in her

[[Page 72037]]

described protocol) be resolved prior to controlled substance
dispensing. Tr. 275-76. Dr. Ginsburg testified that because pharmacists
comprise a type of safety net, all encountered red flags of diversion
must be identified, resolved, and documented prior to any controlled
substance being dispensed. Tr. 711. In Dr. Ginsburg's view, a pharmacy
falls short of the applicable standard of care where red flags are not
addressed and documented prior to dispensing, irrespective of the
legitimacy of the prescription.\22\ Tr. 712-14. Specifically, she
discussed a phenomenon described as a ``prescription cocktail'' or a
``trinity'' combination. Tr. 284-87. According to Dr. Ginsburg, a
trinity or cocktail is defined by the simultaneous prescribing of an
opioid in combination with a benzodiazepine and a muscle relaxant. Tr.
287. This combination presents a heightened risk of respiratory and/or
central nervous system depression, but is sought after by drug abusers
for the gratuitous euphoric effect it produces.\23\ Tr. 286, 379-80.
---------------------------------------------------------------------------

\22\ [Omitted for relevance.]
\23\ The dangers of cocktail prescribing are outlined in a
guidance document issued by the Food and Drug Administration (FDA
Guidance Document), which was received in the record. Gov't Ex. 67;
Tr. 289. The FDA Guidance Document included the dangers of cocktail
prescribing as a ``black box warning,'' the most serious variety of
warning issued by that agency. Gov't Ex. 67 at 1; Tr. 290. Dr.
Ginsburg testified that a practicing pharmacist is responsible for
familiarity with the existence and content of the FDA Guidance
Document, including the details and nature of the black box warning.
Tr. 289. However, Dr. Ginsburg acknowledged that FDA did not attempt
to announce a prohibition on prescribing this combination of
medications under all circumstances or classify the combination as
per se illegitimate. Tr. 582-83. Dr. Ginsburg agreed that under some
circumstances, such as in end-of-life or palliative care scenarios,
the combination could be appropriate. Tr. 591.
---------------------------------------------------------------------------

Dr. Ginsburg testified that although dispensing events \24\ CH1-
CH4,\25\ JMB1-JMB4,\26\ JMB6-JMB8,\27\ JMB9-JMB13,\28\ JMB16-JMB19,\29\
JMB20-JMB22,\30\ JMB24-JMB26,\31\ JMB30-36,\32\ JMB40-JMB43,\33\ JMB49-
JMB51,\34\ TD1-TD4,\35\ DG1-DG6,\36\ DG7-DG-9,\37\ DG7-DG14,\38\ DG18-
DG20,\39\ DG24-DG30,\40\ DG33-DG35,\41\ DG45-DG56,\42\ JH1-JH26,\43\
RI1-RI5,\44\ RI19-RI25,\45\ JB2-JB3,\46\ PW1-PW6,\47\ LH1-LH3,\48\ AP1-
AP2,\49\ MA1-MA3,\50\ BB1-BB11,\51\ TD1-TD2,\52\ LD1-LD3,\53\ and RW1-
RW4 \54\ demonstrated evidence of prescription trinity cocktails, there
was no evidence in the electronic data provided by the Respondent that
this red flag was the subject of resolution or inquiry by pharmacists
or pharmacy staff with respect to these patients. Tr. 714-15. Dr.
Ginsburg rendered her expert opinion (not contradicted on this record)
that these prescriptions were not issued for a legitimate medical
purpose in the usual course of a professional practice in Louisiana.
Tr. 308, 312, 314, 316-20, 322, 325, 330, 336-43, 347-51, 358, 359-66,
376-88, 392-93, 395-96, 550-52.
---------------------------------------------------------------------------

\24\ Dispensing events such as those pertaining to specific
patients, are the subject of stipulation by the parties and are set
forth in a table in the Appendix to this recommended decision.
\25\ Tr. 306-08; Gov't Ex. 3. Dr. Ginsburg testified that an
additional opioid was also present. Tr. 307.
\26\ Tr. 309-13. Dr. Ginsburg testified that she noted two
opioids, a skeletal muscle relaxant, and a benzodiazepine. Tr. 311.
\27\ Tr. 313-14. Dr. Ginsburg testified that she also identified
an additional opioid. Tr. 314.
\28\ Tr. 314-16.
\29\ Tr. 316-17.
\30\ Tr. 317-18
\31\ Tr. 318-19.
\32\ Tr. 319-20.
\33\ Tr. 320-21.
\34\ Tr. 321-22. Dr. Ginsburg testified that JMB49 and JMB50 are
examples of drug combinations that are the subject of the FDA black
box warning. Tr. 367-72; Gov't Ex. 67. She further explained that an
FDA black box warning creates a red flag that requires resolution
prior to dispensing. Tr. 371-72.
\35\ Tr. 322-27.
\36\ Tr. 327-30.
\37\ Tr. 330-31.
\38\ Tr. 331-32.
\39\ Tr. 332-34.
\40\ Tr. 335-37.
\41\ Tr. 338-39.
\42\ Tr. 340-43.
\43\ Tr. 343-51; Gov't Ex. 15.
\44\ Tr. 352-363; Gov't Ex. 18.
\45\ Tr. 363-65.
\46\ Tr. 374-75; Gov't Ex. 19.
\47\ Tr. 375-78; Gov't Ex. 20.
\48\ Tr. 379-81; Gov't Ex. 21.
\49\ Tr. 381-83; Gov't Ex. 22.
\50\ Tr. 383-84; Gov't Ex. 23.
\51\ Tr. 385-88; Gov't Ex. 24. Dr. Ginsburg further testified
that the disparity in strength among the prescribed benzodiazepines
raised another variety of red flag that required (and did not
receive) documented resolution prior to dispensing by the
Respondent. Tr. 389-90.
\52\ Tr. 390-93; Gov't Ex. 7.
\53\ Tr. 393-94; Gov't Ex. 27.
\54\ Tr. 394-96; Gov't Ex. 28.
---------------------------------------------------------------------------

The second red flag described by Dr. Ginsburg is ``pattern
prescribing.'' Tr. 290-91. She described pattern prescribing as a
combination of certain medications in the same strength, combination,
and/or quantity, with sufficient regularity to cause a reasonable
pharmacist to ``question whether there is [an] individual patient-
physician relationship and [whether] those medications [are] being
prescribed for a legitimate purpose.'' Tr. 291-94; see also, id. at
434-35, 648-51. Dr. Ginsburg testified that this variety of red flag is
potentially resolvable by consulting with the prescriber and
documenting that resolution. Tr. 294-95.
Dr. Ginsburg testified that although dispensing events TD1-TD7,\55\
DG7-DG9,\56\ DG12-DG14,\57\ DG15-DG23,\58\ DG27-DG30,\59\ and DG45-DG56
\60\ demonstrated clear evidence of pattern prescribing, the records
procured from the Respondent pharmacy revealed no identification or
resolution of this red flag by pharmacists or pharmacy staff. Tr. 714.
Dr. Ginsburg rendered her expert opinion that these prescriptions were
not issued for a legitimate medical purpose in the usual course of a
professional practice in Louisiana. Tr. 327, 329-31, 336-37, 550-52.
---------------------------------------------------------------------------

\55\ Tr. 322-27; Gov't Ex. 8.
\56\ Tr. 330-31.
\57\ Tr. 331-32.
\58\ Tr. 332-35.
\59\ Tr. 335-37.
\60\ Tr. 340-43.
---------------------------------------------------------------------------

According to Dr. Ginsburg, a subset of pattern prescribing arises
when presented scrips show repeated prescriptions by the same
prescriber for the highest allowable strength and quantity of a
controlled substance (quantity and strength pattern prescribing). Tr.
302-03, 434-35, 600-01, 610. This is so, in her view, because
medications such as opioids are started at ``as low a dose as
possible.'' Tr. 303. In her testimony, Dr. Ginsburg described this
variety of pattern prescribing this way:

Pattern prescribing is prescribing [the] same medications for
multiple patients [with n]o deviation in terms of quantity, highest
strength, usually the same agents over and over for multiple people.

Tr. 473. Regarding this subset of pattern prescribing, Dr. Ginsburg
explained that:

[W]hen you start seeing prescription after prescription, after
prescription, from the same prescriber, and they're all the same for
the highest strength, and you know, a very, very large quantity, and
the quantity is consistent, that . . . speaks to it not being
individualized for a patient . . . [a]nd . . . potentially not being
legitimate.

Tr. 303. Dr. Ginsburg testified that this red flag is identifiable by
consulting with the state PMP and characterized this red flag as
potentially resolvable by contacting the prescriber. Tr. 304.

Dr. Ginsburg testified that although the Respondent had clear
evidence of quantity and strength pattern prescribing, the records
procured from the Respondent revealed no identification or resolution
of the issue. Tr. 714. Specifically, she identified quantity and
strength pattern prescribing relative to prescriptions filled that were
issued by a local

[[Page 72038]]

prescriber, Dr. GB. Tr. 435; Gov't Ex. 4 at 1. She identified pattern
prescribing by Dr. GB relative to dispensing events JMB41,\61\
JMB43,\62\ JMB44,\63\ JMB46,\64\ JMB50,\65\ PB2,\66\ BE1,\67\ TP1,\68\
IJ1,\69\ RS1,\70\ RW1,\71\ as well as multiple other dispensing events
\72\ that were not subject to stipulation, and thus, not contained in
the Appendix.\73\ The Government's expert also identified numerous
quantity and strength pattern prescribing events relative to
prescriptions that were issued by AH, a local nurse practitioner.\74\
Tr. 502. In Dr. Ginsburg's opinion, dispensing events JB3 \75\ and DL2
\76\ involving AH-issued controlled-substance prescriptions
demonstrated quantity and strength pattern prescribing indicia that
were not resolved in the documentation supplied by the Respondent. Tr.
714. Likewise, she identified the following dispensing events on
prescriptions issued by Dr. AP as reflecting the same red flag:
CS1,\77\ CS2,\78\ PR1,\79\ PR2,\80\ and other un-stipulated dispensing
events.\81\ Dispensing events effected in the face of unresolved
quantity and strength pattern prescribing red flags related to
prescriptions issued by Dr. MM were also identified. Tr. 516. The
following dispensing events on Dr. MM prescriptions were highlighted by
Dr. Ginsburg: BB2,\82\ KC1,\83\ GC1,\84\ VM1,\85\ KD1,\86\ as well as
other un-stipulated dispensing events related to this doctor.\87\
Additional dispensing events effected in the face of unresolved
quantity and strength pattern prescribing red flags related to
prescriptions issued by Dr. BJ were also identified. Tr. 527. The
following dispensing events on Dr. BJ prescriptions were testified to
by Dr. Ginsburg: JW1,\88\ MS1,\89\ PF1,\90\ DW1,\91\ and other non-
stipulated dispensing events as well.\92\ Dr. Ginsburg rendered her
expert opinion (not contradicted on this record), informed further by
her research based on the individual specialties of the respective
prescribers,\93\ that these prescriptions were not issued for a
legitimate medical purpose in the usual course of a professional
practice in Louisiana, and that none of the documented resolutions
required to meet the minimal standard of care in Louisiana were evident
in the paperwork supplied by the Respondent. Tr. 502-03, 505-06, 512-
16, 526, 535-38, 550-52.
---------------------------------------------------------------------------

\61\ Tr. 475-76; Gov't Ex. 4.
\62\ Tr. 476-77.
\63\ Tr. 477.
\64\ Tr. 477-78
\65\ Tr. 478-479; Gov't Ex. 4 at 1.
\66\ Tr. 479-80; Gov't Ex. 35 at 1.
\67\ Tr. 481-82; Gov't Ex. 50 at 23.
\68\ Tr. 493-94; Gov't Ex. 51 at 5.
\69\ Tr. 494-95; Gov't Ex. 52 at 7.
\70\ Tr. 495-96; Gov't Ex. 55 at 1.
\71\ Tr. 498-500; Gov't Ex. 28 at 2.
\72\ Tr. 482-84, 493-94, 496-97; Gov't Ex. 50 at 1.
\73\ This feature about the Government's case was less than
helpful.
\74\ Tr. 779.
\75\ Tr. 503-04; Gov't Ex. 19 at 14.
\76\ Tr. 504-05; Gov't Ex. 40 at 1.
\77\ Tr. 506-08; Gov't Ex. 37 at 1.
\78\ Tr. 508; Gov't Ex. 37 at 1.
\79\ Tr. 508-09; Gov't Ex. 39 at 1.
\80\ Tr. 508-09; Gov't Ex. 39 at 1.
\81\ Tr. 509-11; Gov't Ex. 39 at 1. See footnote 74.
\82\ Tr. 516-17; Gov't Ex. 24 at 3.
\83\ Tr. 519-20; Gov't Ex. 42 at 20.
\84\ Tr. 521-22; Gov't Ex. 43 at 2.
\85\ Tr. 522-23; Gov't Ex. 44 at 1.
\86\ Tr. 524-26; Gov't Ex. 60 at 1.
\87\ Tr. 519-22; Gov't Exs. 42 at 1, 43 at 2. See footnote 74.
\88\ Tr. 527-28; Gov't Ex. 56 at 3.
\89\ Tr. 529-30; Gov't Ex. 57 at 2.
\90\ Tr. 531-32; Gov't Ex. 58 at 1.
\91\ Tr. 533-34; Gov't Ex. 59 at 1.
\92\ Tr. 528-35; Gov't Exs. 56 at 1, 57 at 2, 58 at 1, 59 at 1.
See footnote 74.
\93\ Tr. 594. Curiously, although the witness testified that she
researched and factored in the practice areas of the prescribers
into her pattern-prescribing conclusions, she conceded that she
declined to include this analysis point in any of the prior reports
she supplied to DEA during the run up to the hearing. Tr. 638-39.
That said, Dr. Ginsburg gave credible and persuasive testimony that
the practice areas of the prescribers did properly form part of the
basis for the opinions she rendered during her testimony. Tr. 594,
639-41.
---------------------------------------------------------------------------

The third red flag presented by Dr. Ginsburg is distance
prescribing, or controlled substance prescriptions presented to
pharmacists by customers travelling a long distance to obtain
prescriptions and get them filled at a specific pharmacy. Tr. 295. She
described it as illogical that a customer, for no valid reason, would
travel a significant distance to pick up a prescription at a particular
pharmacy where others are closer. Tr. 296. According to Dr. Ginsburg,
distance prescribing suggests that the customer is traveling to a
particular ``pharmacy that would not question large quantities or large
doses of certain prescriptions.'' Tr. 538. Like pattern prescribing,
distance prescribing is a red flag that is amenable to resolution by
contacting the prescriber and documenting the outcome. Tr. 295-97. Dr.
Ginsburg testified that the distance information is generally procured
upon customer intake and generally available on the pharmacy's patient
profile. Tr. 296.
Dr. Ginsburg identified dispensing events PR1-PR2 (41.2 miles),\94\
TB1-TB4 (174.2 miles),\95\ KR1-KR2 (53 miles),\96\ LW1-LW4 (45.8
miles),\97\ and KJ1-KJ3 (80.3 miles) \98\ as indicating distance
prescribing red flags that were not the subject of documented
resolutions by the pharmacists or staff at the Respondent pharmacy. Tr.
714. Dr. Ginsburg rendered her expert opinion that based on the
unresolved distance red flags present, these prescriptions were not
issued for a legitimate medical purpose in the usual course of a
professional practice in Louisiana, and none of the documented
resolutions required to meet the minimal standard of care in Louisiana
were evident in the paperwork supplied by the Respondent. Tr. 549-52.
---------------------------------------------------------------------------

\94\ Tr. 539-41; Gov't Ex. 39.
\95\ Tr. 541-43; Gov't Ex. 46.
\96\ Tr. 543-45; Gov't Ex. 47.
\97\ Tr. 545-47; Gov't Ex. 48.
\98\ Tr. 547-49; Gov't Ex. 49.
---------------------------------------------------------------------------

A fourth red flag outlined by Dr. Ginsburg is alternating methods
of payment. Tr. 297. This red flag, according to Dr. Ginsburg, is
present when a customer utilizes multiple payment methods to procure
different medications, including but not limited to cash, private
insurance, Medicaid or Medicare. Tr. 297-98, 398-99. Dr. Ginsburg
opined that alternating methods of payment can be an indicator that a
pharmacy customer is attempting to shield particular medication
purchases, such as opioids, from insurance companies who may be on the
lookout for diversion red flags, such as duplicative therapies and/or
problematic medication combinations. Tr. 298-99. It is Dr. Ginsburg's
view that the standard of care requires a dispensing pharmacist to
identify, resolve, and document this type of diversion red flag, which
can be accomplished by either consulting with the prescriber, a
discussion with the customer, and/or analyzing the pharmacy patient
profile. Tr. 302-03, 401-02, 415-16. According to Dr. Ginsburg, benign
explanations for alternative methods of payment should be explained by
pharmacy staff in the comment section of the pharmacy's software and
there was no evidence of such documentation in the pharmacy records.
Tr. 667-68, 714-15.
Dr. Ginsburg identified alternating methods of payment red flags
regarding customers JMB,\99\ DM,\100\ KS,\101\ and TD \102\ but no
indication that this red flag was identified or resolved by any
pharmacist of pharmacy staff in any of the documentation procured from
the Respondent. Dr. Ginsburg rendered her

[[Page 72039]]

expert opinion that these prescriptions were not issued for a
legitimate medical purpose in the usual course of a professional
practice in Louisiana. Tr. 423-26, 434, 550-52.
---------------------------------------------------------------------------

\99\ Tr. 411-19, 422-24; Gov't Exs. 4, 68A at 3, 70A at 1.
\100\ Tr. 424-26; Gov't Exs. 34, 68A at 34. Dr. Ginsburg also
testified that in her opinion, there was evidence of duplication of
therapy that was not addressed by the Respondent pharmacy prior to
dispensing. Tr. 425-26.
\101\ Tr. 427-29; Gov't Ex. 68A at 41.
\102\ Tr. 429-34; Gov't Exs. 7, 8, 68A at 13.
---------------------------------------------------------------------------

Notwithstanding brief, inconsequential, passing flashes of mild
defensiveness exhibited during cross-examination, Dr. Ginsburg
presented as an authoritative, careful, persuasive expert witness who
provided her opinions dispassionately and without overt evidence of
agenda. Additionally, Dr. Ginsburg's expert testimony stands largely
uncontroverted, and for the most part unchallenged in any persuasive
way on this record, and will be afforded controlling weight.

The Respondent's Case

Daren L. Vicellio

Daren Vicellio is and has been the General Manager of both Medical
Pharmacy and Medical Pharmacy West (MP West) since 2011. Tr. 800. He
testified that he is not a pharmacist,\103\ but he is the son-in-law of
Audrey LeTard, the current owner of Medical Pharmacy, Incorporated (MP,
Inc.), the corporate entity which owns both pharmacies. Tr. 799, 803.
Mr. Vicellio testified that (like his father-in-law \104\) he grew up
in Zachary, Louisiana and attended Louisiana State University where he
majored in Industrial Technology Safety. Tr. 801-02.
---------------------------------------------------------------------------

\103\ Mr. Vicellio testified that he held various positions with
the United Parcel Service (UPS) and a hunting retreat called Bush
Hill Plantation. Tr. 804. Bush Hill Plantation, like the Respondent
pharmacy, was owned by the late Mr. LeTard. Tr. 805-06.
\104\ Tr. 807.
---------------------------------------------------------------------------

According to Mr. Vicellio, Zachary, Louisiana, where both the
Respondent pharmacy and MP West are located, is a town of 17,000 to
18,000 people that lies about twenty miles north of Baton Rouge. Tr.
802. The Respondent pharmacy was established in 1968 by his late \105\
father-in-law John LeTard, a pharmacist. Tr. 802, 805. Mr. Vicellio
related that Mr. LeTard had a long, distinguished career as a
pharmacist, first working for his own step-father (also a pharmacist)
before opening his own pharmacy (the Respondent pharmacy) that has been
doing business in the same location in Zachary since 1968. Tr. 803,
807-08. The late Mr. LeTard's accomplishments include a gubernatorial
appointment to the Louisiana Board of Pharmacy (Louisiana Pharmacy
Board or the Board) in 2008, serving as a board member at Lane Memorial
Hospital for over two decades (nineteen as the hospital board's
chairman), and a prestigious award from the American Pharmacists
Association. Tr. 808, 839. Mr. Vicellio's testimony credibly depicts
the late Mr. LeTard as a pillar of the local community, and the pride
he conveyed at the hearing about his late father-in-law's
accomplishments was palpable and genuine.
---------------------------------------------------------------------------

\105\ Mr. Vicellio testified that his father-in-law, Mr. LeTard,
passed away from cancer in 2016. Tr. 802-03.
---------------------------------------------------------------------------

Mr. Vicellio provided much helpful background regarding the history
of the Respondent pharmacy and MP, Inc. The two pharmacies operated by
MP, Inc. collectively employ eight pharmacists, eight pharmacy
technicians, six clerks, three office personnel, and two drivers. Tr.
842. Both pharmacies offer free delivery of prescriptions,\106\ and a
loyalty program for regular customers, which, according to the witness,
is frequently used when a customer's insurance will not cover certain
prescriptions. Tr. 845. Mr. Vicellio stated that there are several
other pharmacies in Zachary: Walmart, Walgreens, CVS, and another
independent pharmacy, Dry's Pharmacy. Tr. 808-09. He further stated
that the Respondent pharmacy has always been the largest pharmacy in
Zachary, ``more than double anybody else in town.'' Tr. 810. Within the
time period of the ISO, October 2016 through October 2019, the
Respondent pharmacy filled 798,255 prescriptions for 22,629 patients.
Tr. 810-12. Mr. Vicellio stated that prior to the OSC/ISO, the
Respondent pharmacy was ``very successful'' with a ``great reputation,
not only in Zachary, but in the whole state of Louisiana.'' Tr. 814. He
further stated that DEA has taken no action against the COR maintained
by MP West, and that the Respondent pharmacy is still open for
business; just not presently filling prescriptions for controlled
substances. Tr. 814-15.
---------------------------------------------------------------------------

\106\ Tr. 842.
---------------------------------------------------------------------------

Mr. Vicellio recounted that when he first began work for Mr. LeTard
at the Respondent pharmacy, he primarily handled scheduling and
maintenance. Tr. 806. He took on a more prominent role in 2010 when his
father-in-law was diagnosed with cancer. Tr. 806-07. As Mr. Vicellio
explained, Mr. LeTard ``didn't know how the cancer was going to go and
he wanted somebody that would be in place that he trusted and would
take care of everything for him.'' Tr. 807. Mr. Vicellio testified that
the Respondent pharmacy has a very large and loyal customer base and
that they ``come from miles away because of the relationship we have
with these customers.'' Tr. 815. After the OSC/ISO, The Respondent
pharmacy has referred customers to MP West to fill controlled substance
prescriptions but Mr. Vicellio explained that MP West ``is on the other
side of town and a lot of the patients are coming from the other side
that we're on and some of them do not want to go down there because
there's too much of an inconvenience.'' Tr. 815-16. This has led to the
Respondent pharmacy losing some customers. Tr. 816. By Mr. Vicellio's
estimation, the level of business at the Respondent pharmacy has gone
down from 900 prescriptions per day to about 600 prescriptions per day.
Id. He further testified that at the time the OSC/ISO was served,
controlled substance dispensing constituted about fifteen percent of
the prescriptions filled at the Respondent pharmacy. Tr. 817. Mr.
Vicellio also represented that the Respondent pharmacy was not making
significant profits from improperly filled controlled substances.\107\
Tr. 844. As a result of the OSC/ISO, the percentage of controlled
substance prescriptions filled at MP West has gone up. Tr. 818. Mr.
Vicellio testified that the DEA has been informed of this development
to account for the upswing in that pharmacy's controlled substance
traffic. Id. The Respondent pharmacy has also posted a notification in
their store informing customers that it is currently unable to fill
controlled substance prescriptions. Tr. 819. He describes the OSC/ISO
as a ``black eye in the community'' of pharmacists and pharmacies.\108\
Id.
---------------------------------------------------------------------------

\107\ According to Mr. Vicellio, the market is locally
competitive, with only a modest profit margin on drugs. Tr. 844.
\108\ Mr. Vicellio further related how painful it was to inform
his mother-in-law, Mrs. LeTard, the owner of MP, Inc., of the OSC/
ISO and its consequences. Tr. 834. According to Mr. Vicellio, his
father-in-law ``brought [him] into the [Respondent pharmacy] to be
the manager when he was gone and to also make sure the [Mrs. LeTard]
was taken care of.'' Tr. 833-34. Mr. Vicello explained his
relationship with Mrs. LeTard this way: ``[B]asically, she is the
owner. I am the general manager and I run both [MP, Inc.
pharmacies]. I report to her. But my job is to let her enjoy life
and not be worried about these [pharmacies] and that's what my goal
is to achieve here, and make sure we get everything up and running
correctly and do it the right way.'' Tr. 834. Mr. Vicellio testified
that he feels that he ``let [his mother-in-law] down by getting this
ISO.'' Tr. 854.
---------------------------------------------------------------------------

Mr. Vicellio testified that as a result of the OSC/ISO, the MP,
Inc. pharmacies no longer fill controlled substance prescriptions
issued by Dr. GB, a physician whom Dr. Ginsburg identified during her
testimony as a pattern prescriber. Tr. 820, 861. The Respondent
pharmacy also lost one of its wholesalers following the OSC/ISO. Tr.
821-23. According to Mr. Vicellio, because this wholesaler was no
longer able to claim rebates from manufacturers without the Respondent
pharmacy maintaining an active COR, it

[[Page 72040]]

sought to pass the added costs onto the Respondent pharmacy.\109\ Tr.
822-23. Mr. Vicellio also related that Morris & Dickson, a drug
distributor, also will no longer sell controlled substances to MP West
because of the OSC/ISO affecting the Respondent pharmacy. Tr. 823.
---------------------------------------------------------------------------

\109\ Mr. Vicellio testified that this added cost applied to
controlled and non-controlled drugs. Tr. 820-22.
---------------------------------------------------------------------------

Mr. Vicellio testified that when the first two administrative
subpoenas from DEA arrived, his sense was that prescribers, not the
Respondent pharmacy, were the focus of the investigation. Tr. 825. When
asked to supply data from the comment fields in response to one of the
administrative subpoenas, Mr. Vicellio testified that not all of the
requested information was provided because ``[i]t was probably nothing
to supply. There were no comments.'' Tr. 862. It was Mr. Vicellio's
position that blank comment sections were not supplied because of the
difficulty in retrieving that information from legacy software that had
been replaced. Tr. 864-65. He explained that the pharmacy ``[has] all
the prescription records like we're supposed to'' but in order to print
the comment sections ``we had to go back into the old software, which
we don't really have a license for anymore.'' Id. DEA personnel who
served the OSC/ISO seized paper documents but the pharmacy computers
were not imaged.\110\ Tr. 865.
---------------------------------------------------------------------------

\110\ Interestingly, although the CSA authorizes the seizure of
all controlled substances upon the service of an OSC/ISO, 21 U.S.C.
842(f), Mr. Vicellio testified that the DEA personnel on scene did
not confiscate the controlled substances on hand at the Respondent
pharmacy, but instead permitted the drugs to be transferred to MP
West. Tr. 828-29. This was an act of lenity for which Mr. Vicellio
acknowledged he was ``very thankful.'' Tr. 829.
---------------------------------------------------------------------------

During his testimony, Mr. Vicellio (a non-pharmacist) admitted that
he did not know what a diversion red flag was until the OSC/ISO was
served. Tr. 832-33. He stated that he is now aware that the trinity
cocktail prescriptions posed potential harm to the patients taking
them. Tr. 825-26. Although the Respondent pharmacy was presumably
manned by qualified pharmacists and staff, its manager, Mr. Vicellio,
testified that the first inkling that the organization had anything
amiss was upon the service of the OSC/ISO that forms the basis of this
case. Id.
Mr. Vicellio testified that upon studying the OSC/ISO, he
understood that the Respondent pharmacy was, as he put it, ``deficient
in some areas,'' and he began formulating a strategy to help ensure
compliance in the future. Tr. 830. Written policies and procedures for
both pharmacies were (for the first time) \111\ developed. Id.
Interestingly, Mr. Vicellio testified that prior to the written
policies generated by MP, Inc. after the OSC/ISO, ``[i]t was for the
pharmacists--each pharmacist's professional judgment to make the call
on prescriptions.'' \112\ Tr. 833. James Bryce (the Respondent's other
witness in this case), the MP West pharmacist in charge (PIC), was
designated as the newly-created compliance officer for both MP, Inc.
pharmacies. Tr. 830. Mr. Vicellio testified that Mr. Bryce was selected
for this role because he is ``the most knowledgeable'' of their
pharmacists and ``a stickler for rules.'' Tr. 831. On December 22,
2019, a mandatory training session \113\ was conducted for the
employees of both MP, Inc. pharmacies (although only MP West is
currently authorized to handle controlled substances) about new
policies and procedures where the staff was informed that ``if somebody
doesn't do it the right way they are not going to be employed with
us.'' Tr. 832, 850. Mr. Vicellio testified that the policies and
procedures recently adopted at MP West to handle the filling of
controlled substance prescriptions are ready to be implemented at the
Respondent pharmacy if its COR is reinstated.\114\ Tr. 848. All of the
pharmacists at both locations have learned these new protocols and
worked at MP West during the implementation phase. Tr. 848. Inasmuch as
no new staff members have been added since the mandatory training, all
MP, Inc. pharmacists and pharmacy technicians have had this training.
Resp't Ex. 2; Tr. 850.
---------------------------------------------------------------------------

\111\ Mr. Vicellio stated that prior to the OSC/ISO there were
no established procedures for identifying and resolving red flags.
Tr. 833. He acknowledged that prior to the OSC/ISO, neither of the
MP, Inc. pharmacies had written policies and ``that's on [him].''
Tr. 837. The Respondent pharmacy did not have written policies
because Mr. LeTard did not have written policies and Mr. Vicellio
did not previously appreciate their necessity. Tr. 838.
\112\ A disorganized document, which purports to be filled with
controlled substance scrips that had been presented to and rejected
by pharmacists and staff at the Respondent pharmacy, and which was
titled ``Medical Pharmacy's Due Diligence File--Pre-ISO,'' was
received into the record. Resp't Ex. 3; Tr. 857-58.
\113\ An attendance roster of MP, Inc. employees who attended
the training session was received into the record. Resp't Ex. 2; Tr.
849-51.
\114\ A 16-page controlled substance policy document for the MP,
Inc. pharmacies was received into the record. Resp't Ex. 1; Tr. 847-
49.
---------------------------------------------------------------------------

Mr. Vicellio acknowledged that he understands that the CSA and its
associated regulations did not suddenly materialize in 2019 and that
operating a pharmacy is a highly-regulated activity. Tr. 834-35. He is
likewise aware that pharmacists, as practitioners in this area, have
legal obligations that must be followed for them to engage in this
highly regulated activity. Tr. 835. Mr. Vicellio theorized that one
problem may have been that the previous practice of the staff at the
MP, Inc. pharmacies was to stay current by exclusively reviewing
publications from the Louisiana Pharmacy Board, which (apparently to
his knowledge) did not contain references to cocktail prescribing or
diversion red flags. Tr. 835, 840. Mr. Vicellio, somewhat
incongruently, acknowledged that the pharmacists he employs bear a
responsibility to follow not only Louisiana state law, but also the
CSA, its ensuing regulations, and rulings by the DEA Administrator. Tr.
866. Needless to say, shifting the blame for non-compliant pharmacists
and staff to the supposed quality of materials available from the
Louisiana Pharmacy Board did not serve to enhance the Respondent's
presentation in this regard.\115\ From his perspective, as a non-
pharmacist, Mr. Vicellio testified that he assumed that the pharmacists
he hired were properly trained and would ensure the business's
compliance with applicable laws. Tr. 836. However, even in the face of
Mr. Vicellio's acknowledgement that the pharmacists and staff he
employed at the Respondent pharmacy were clearly delinquent in
following unequivocal federal, state, and professional standards, not a
single pharmacist or employee from the Respondent pharmacy has been
fired or disciplined. Tr. 836-37. The past notwithstanding, Mr.
Vicellio testified that he has confidence in his employees and expects
that they will (now) comply with the new policies and procedures. Tr.
843.
---------------------------------------------------------------------------

\115\ At the behest of his counsel, Mr. Vicellio conceded that
the absence of these references does not constitute a defense to the
charges. Tr. 841.
---------------------------------------------------------------------------

As the general manager of both MP, Inc. pharmacies, Mr. Vicellio is
inherently and inescapably imbued with the greatest motive attached to
the outcome of the case. While his position, standing alone, is not
fatal to his credibility, it certainly must be factored into the
equation. Further, this witness acknowledged that he feels personally
responsible for the Respondent pharmacy's transgressions, and that he
let down his mother-in-law by running a pharmacy that was closed down
by an ISO. Tr. 833-34. Objectively, the motivations to minimize
culpability and maximize the scope of remedial steps and acceptance of
responsibility (all of which he arguably did) are certainly present. As
discussed, supra, Mr. Vicellio's subtle attempt to shift the
responsibility for substandard dispensing to reliance on his

[[Page 72041]]

subordinate pharmacists and staff, as well as perceived deficiencies
with materials published by the Louisiana Pharmacy Board undermined the
reliability that can be attached to his representations of contrition.
Tr. 836-37. Likewise, even accepting the fact that he is not a
pharmacist, to have so little professional curiosity in the regulatory
requirements of the pharmacies he manages that he plead complete
ignorance of the concept of red flags of diversion is hardly an
attribute that can inspire confidence in the Agency's decision to re-
entrust him with the weighty responsibility of a COR. Tr. 825-26. It is
quite telling that his newly-generated compliance program was
spearheaded by the MP West PIC, with virtually no input (at least none
apparent on this record) from the PIC assigned to run the Respondent
pharmacy. Tr. 830-32. More telling still is Mr. Vicellio's recognition
that he relied on the knowledge and professionalism of the Respondent
pharmacy's pharmacists and staff, but yet took no adverse action
against any employee when it became obvious that they fell far short of
their obligations. Tr. 836-37.*\D\ There were no perceptible
consequences to anyone responsible.
---------------------------------------------------------------------------

*\D\ Omitted for clarity.
---------------------------------------------------------------------------

That is not to say that Mr. Vicellio presented as a wholly
incredible witness; he certainly did not. There were many aspects of
his testimony that were helpful and merit belief, such as important
history and background information regarding the MP, Inc. pharmacies,
the progress of the investigation, the impact on the Respondent
pharmacy's operations, and the palpable regret he feels that the
Respondent pharmacy (his mother-in-law's pharmacy), received an OSC/ISO
from DEA to preserve public safety. Mr. Vicellio supplied testimony
that was detailed, internally consistent, and generally plausible, and
overall, he presented as a generally credible witness with no
pronounced contradictions from other sources in the record.

James W. Bryce, II

The Respondent presented the testimony of James W. Bryce who is and
has been the pharmacist in charge (PIC) for MP West, serves as a staff
pharmacist at the Respondent pharmacy, and was appointed by Mr.
Vicellio to the newly-created position of compliance officer for MP,
Inc. Tr. 873-74. Over Government objection,\116\ Mr. Bryce was tendered
\117\ and accepted \118\ as an expert witness in the areas of pharmacy
and pharmacy practice in Louisiana. Tr. 889, 893.
---------------------------------------------------------------------------

\116\ Tr. 891.
\117\ Tr. 889.
\118\ Tr. 894.
---------------------------------------------------------------------------

Mr. Bryce testified that after some service as an Army medic, he
enrolled in college, and in 1999 was awarded a degree in Pharmacy from
what is now the University of Louisiana Monroe. Tr. 874-76. Mr. Bryce
was first licensed to practice pharmacy in 1999, and has been
continuously employed as a pharmacist from that time forward. Tr. 878.
Soon after securing his first pharmacist position as a line
pharmacist as Walgreens, Mr. Bryce, by his recollection, was promoted
within the company to a pharmacy manager and various positions of
increased responsibility. Tr. 878-79. Mr. Bryce testified that after
his time at Walgreens, he spent two years working at an independent
mail-order pharmacy, and secured his current position from the late
John LeTard at the Respondent pharmacy in 2012. Tr. 880-82.
Mr. Bryce described the high level of business routinely
encountered at the Respondent pharmacy. He recalled specifically that
his first day on the job was ``quite eye-opening'' and that in his
twenty-one years of being a pharmacist he ``had never seen a single
pharmacy fill that many prescriptions.'' Tr. 885. He described the
situation as ``very intimidating at first'' and characterized what he
saw as ``controlled chaos.'' Id. On an average day at the Respondent
pharmacy, there would be four or five pharmacists working with six to
eight pharmacy technicians. Tr. 886. In describing the staffing at the
Respondent pharmacy, Mr. Bryce stated that, besides him, there are six
pharmacists on duty at that store and another two on the job at MP
West. Tr. 883. Shifts last the entire day for all pharmacists beginning
at 8:30 a.m. and finishing at 6:00 p.m. Id. The pharmacy is closed on
Sundays and has a shorter shift on Saturday from 8:30 a.m. to 4:00 p.m.
Tr. 884. While every pharmacist does not work every day, on busier days
all six are present. Tr. 883. Mr. Bryce described certain holiday
weekends, especially the Monday after Labor Day Weekend, as ``Black
Friday'' in which 1,700-1,800 or more prescriptions are filled in a
single day. Id. In Mr. Bryce's estimation, on a typical day before the
ISO, the Respondent pharmacy would fill approximately 1,000
prescriptions. Tr. 884.
Mr. Bryce testified that the position of compliance officer was
created by the MP, Inc. in response to the ISO, and that he is the
first person to hold the job. Tr. 887-888. Before the ISO, the
Respondent pharmacy had no procedures, written or otherwise, for
responding to diversion red flags. Tr. 895-96. Mr. Bryce acknowledged
that he is not, and has never been the PIC at the Respondent pharmacy,
a position that is, and at all times relevant to these proceedings has
been, held by Charles Blaine Fontenot, who was not called as a witness
by the Respondent.\119\ Tr. 896. Mr. Bryce did not know why Mr.
Fontenot was not present for the hearing or why he was not called as a
witness. Tr. 897-98. Even though Mr. Fontenot is still the PIC for the
Respondent pharmacy, there is no indication in the record that the
Respondent pharmacy PIC was involved in the post-ISO procedures, and
none that Mr. Bryce has been involved with the pre-ISO procedures at
the Respondent pharmacy. Tr. 899. In the absence of an established
policy (that is, prior to the ISO), it was for ``[e]ach pharmacist, up
to their discretion'' how to handle a red flag. Id. Pharmacists also
did not document resolution of any red flags. Id. [Omitted for
brevity.]
---------------------------------------------------------------------------

\119\ No explanation was offered by the Respondent as to why PIC
Fontenot was not called as a witness, and the record revealed no
indication of any issue regarding the availability of the Respondent
pharmacy PIC, or any issue that would make him unamenable to
process. Tr. 897-98, 1063-64.
---------------------------------------------------------------------------

Mr. Bryce admits that the pharmacy's documentation was ``one
hundred percent lacking in certain areas'' and that where there was
documentation, it was more akin to ``internal recordkeeping.'' Id. The
pharmacy kept something that Mr. Bryce referred to as the ``due
diligence binder'' to document instances when prescriptions were not
filled ``in anticipation of having problems.'' Tr. 899-900. In terms of
how it was used, Mr. Bryce said that he and the other pharmacists would
``add stuff'' to the binder if there was an issue with a prescription.
Tr. 901. This single voluminous binder was not in alphabetical order or
organized in a way where the pharmacists could reliably keep track of
problematic prescriptions. Id. He stated that when a pharmacist
accessed this binder, it was generally to put something in it. Tr. 902.
He could not recall for certain whether he ever accessed the binder in
deciding whether or not fill a particular prescription stating that
sometimes he would ``put certain items in there that triggered a memory
of a situation.'' Tr. 903. Thus, it appears that every time a
pharmacist at the Respondent pharmacy declined to fill a controlled
substance prescription, a copy of the prescription was placed

[[Page 72042]]

(in no particular order) into a binder and mostly ignored and
forgotten. Tr. 901-03. As described, it seems clear that the ``due
diligence'' file had very little do to with any diligence due, but was
essentially a vessel created to store declined scrips in no order that
was in any way amenable to retrieval or even monitoring. Tr. 900-04.
[Omitted for brevity.]
Mr. Bryce noted that he and the other pharmacists ``should have
documented more in the computer system'' but they failed to. Tr. 901.
He added that since the ISO, he has ``definitely learned a lot'' about
when and how documentation should occur. Tr. 900. He surmised that part
of the reason why he was put in charge of compliance was his
``willingness to hold people's feet to the fire'' in following the new
procedures. Id. According to Mr. Bryce, the computer system that the
pharmacy now uses (Pioneer) tracks the identity of the pharmacist who
dispensed a particular prescription. Tr. 911-13. Mr. Bryce noted his
obligations under the Louisiana Administrative Code \120\ to keep
records of dispensing events. Tr. 911-12.
---------------------------------------------------------------------------

\120\ This tribunal took official notice of the Louisiana
Administrative Code Sec. 1123. Tr. 914-15.
---------------------------------------------------------------------------

According to Mr. Bryce, even prior to the ISO, the Respondent
pharmacy would refuse to fill a prescription if upon checking the PMP
it was clear that the patient was filling prescriptions for controlled
substances at other pharmacies. Tr. 928. Mr. Bryce described using the
PMP to prevent ``pharmacy hopping'' or ``doctor shopping''. Id. The
Respondent pharmacy has also refused to fill prescriptions for pain
medication that did not come from a pain specialist. Tr. 929. Mr. Bryce
explained that if the patient profile and the PMP data both showed that
a patient was receiving pain medication from a physician who was not a
pain specialist, oncologist, hospice specialist, or physical
rehabilitation specialist, the pharmacists at the Respondent pharmacy
would refuse to fill the prescription and explain to the patient that
they need to be seeing a specialist. Tr. 930. The Respondent pharmacy
maintained no list of prescribers whose prescriptions it refused to
fill, but eventually concluded that there was an issue with a single,
local provider, Dr. GB, a practitioner whose name factored heavily in
the Government's case. Tr. 931. Mr. Bryce stated that the pharmacists
at the Respondent pharmacy were aware that Dr. GB was having potential
criminal issues with the DEA and would ``call daily'' to see if Dr.
GB's COR was still active. Id. Thus, it was not Dr. GB's pattern
prescribing that ultimately black-listed him from the Respondent
pharmacy, but his legal troubles with DEA and warnings from a
wholesaler.\121\ Tr. 1055. Mr. Bryce was likewise apparently
unimpressed with any indicia that Nurse Practitioner (NP) AH was, as
the Government's expert determined, a pattern prescriber because he was
familiar with her prescribing. Tr. 1034-40. Mr. Bryce discounted the
evidence of NP AH's pattern prescribing, with the assurance that he is
``familiar with her practice and her prescribing abilities.'' Tr. 1038.
The witness provided the following explanation about the opinions he
has formed in his community about prescribers, including NP AH:
---------------------------------------------------------------------------

\121\ There is no indication in the record that Dr. GB's on-
again-off-again DEA registration status provided any sort of a clue
to the Respondent's pharmacists and staff that dispensing controlled
substances for this prescriber might be problematic. It seems that
so long as Dr. GB held a current registration on the day the
prescription was presented, his patients could fill any number of
prescriptions at the Respondent pharmacy. The record is unclear as
to whether any of the written materials disseminated by the
Louisiana Pharmacy Board specifically informed its regulated
community that continuing to dispense for a practitioner who keeps
losing and regaining his DEA registration on a day-by-day basis
could potentially raise concerns for a pharmacist.

I would say that [our opinions on reputation] are reliable
opinions that we have on them. So we get a feel as far as whether we
would trust them personally as well. Because it's our family,
friends and our neighbors that are going to these prescribers, for
---------------------------------------------------------------------------
the most part.

Tr. 1040.
On the issue of pharmacy shopping, Mr. Bryce allowed that in the
past when he has encountered situations where Respondent pharmacy
customers were getting controlled substance prescriptions dispensed to
them at multiple pharmacies, he would insist that all controlled
substance prescriptions be filled at the Respondent pharmacy. Tr. 932.
Mr. Bryce testified that he was involved in Medication Therapy
Management (MTM) as part of managing Medicare Part D plans. Tr. 933. He
stated that Medicare would send lists of patients who needed a complete
medication review. Id. Mr. Bryce would review the patients' medications
with them and often explain to them, if only pain medications were on
file with the Respondent pharmacy, that unless they filled all of their
prescriptions at his pharmacy, they could not continue filling those
customers' pain medications. Id. Mr. Bryce testified that he was able
to ascertain that pharmacists at the Respondent pharmacy queried the
state PMP system over 18,000 times between 2016 and 2019. Tr. 934. Mr.
Bryce stated that checking the PMP prior to dispensing all controlled
substances is now a requirement under the new MP, Inc. post-ISO
protocols, and that this is a step beyond what is required under state
law. Tr. 935-36.
Mr. Bryce stated the new post-ISO procedure requires the
pharmacists to make a notation on the hard copy of a declined
controlled substance prescription, and the declined, annotated
prescription must be scanned into the Respondent pharmacy's computer
system. Tr. 938-39. He further explained that hard copies of this
information are currently in a box that he needs to alphabetize, but
the electronic information is available with the patient profile. Tr.
939. The new Pioneer software brings up a comments section anytime a
prescription is accessed which allows the pharmacist to document any
issues. Tr. 941. Under the post-ISO policies, the Respondent pharmacy
also will no longer fill prescriptions where there is a morphine
milligram equivalent (MME) greater than 90 without written prior
authorization. Tr. 942. As far as Mr. Bryce understands, a comment
section is not generated on a patient profile until a comment is
entered. Tr. 943. Mr. Bryce estimates that around fifteen percent of
the prescriptions that the Respondent pharmacy filled during the period
referenced in the ISO were for controlled substances. Tr. 945. He
confirmed that this information was of interest to the Respondent
pharmacy's wholesalers because they preferred their customers to remain
within a certain ratio. Tr. 946. Mr. Bryce indicated that he now
understands certain combinations of controlled substances, including
the ``trinity,'' to be a ``hard stop'' or unresolvable red flag. Tr.
950. He also indicated that prior to the ISO, the pharmacy's software
did not register the combination of an opioid, a benzodiazepine, and
carisoprodol as problematic and flag it accordingly. Tr. 952. The
pharmacists now have the ability to flag that combination for
individual patients. Tr. 952-53. They now ``won't touch a Soma \122\
prescription with a ten-foot pole.'' Tr. 953.
---------------------------------------------------------------------------

\122\ Soma is a common brand name for carisoprodol.
---------------------------------------------------------------------------

Under the post-ISO procedures, if a prescription is not filled, the
pharmacist will make a copy of it, log it in the PMP, and return the
prescription to the patient unless the prescribing physician cancels
it. Id. However, they will make

[[Page 72043]]

a notation on the prescription as a means of notifying the next
pharmacy where they may attempt to fill it. Tr. 954. Mr. Bryce created
the new policies and procedures which are now in effect at MP West,
over the weekend (that is, over one weekend) after the ISO was served
on the Respondent pharmacy. Tr. 957. He decided that MP, Inc.
pharmacies should no longer fill prescriptions from Dr. GB, because one
of their wholesalers indicated that they would no longer do business
with them if they continued to fill his prescriptions. Tr. 957, 1055.
Mr. Bryce explained how MME levels would be factored into
dispensing decisions in the post-ISO protocol. For an MME range of zero
to fifty, the pharmacist will look at the frequency of refills, which
pharmacies the patient has patronized, and the prescribing physician.
Tr. 961. For MME ranges between fifty and ninety, the prescription must
be from a specialist, and a PMP report must be generated. Tr. 959, 961.
For MMEs over ninety, all of the above precautions are taken but end-
of-life palliative care is given ``a little more leeway.'' Tr. 962. Mr.
Bryce described MMEs over ninety as a ``hard stop'' meaning that more
monitoring and discussion with the patient is required. Id. When faxing
the prescriber a prior authorization form, a copy of the patient's PMP
report is also sent as a way of confirming that the doctor is intending
to prescribe a given MME. Tr. 964-965. The pharmacists are instructed
to inform the prescribing physician that the prescription will not be
filled until they fill out the prior authorization form and send it
back to the pharmacy. Tr. 965. Mr. Bryce got a prior authorization form
from the Louisiana Pharmacy Board. Id.
Mr. Bryce mentioned that other pharmacists in the area have
contacted him about the post-ISO procedures and that some of those
pharmacists have indicated (to him) that he has a reputation in the
Baton Rouge area pharmacy community as a ``hard-ass.'' Tr. 969. He
admitted that prior to the ISO, the Respondent pharmacy was filling
``trinity'' cocktail prescriptions, a practice which he now has
concluded, in his new, enlightened estimation, ``we should never have
done.'' Tr. 975. He stated that ``even though it wasn't reported to us
through any state means,'' he now understands \*E\ he cannot fill
prescriptions of this type. Id. He recounted that he and the other
pharmacists at the Respondent pharmacy knew, for example, customer JMB
who had been in an accident and was prescribed the trinity cocktail as
part of treatment for injuries. Tr. 977. Because the Respondent
pharmacy staff had some measure of an existing relationship with
customer JMB, abuse or diversion was not suspected, and the medications
were dispensed. Id. The tenor of Mr. Bryce's testimony \*F\ in this
regard gave the clear impression that he feels that the decision to
dispense the trinity to JMB was not incorrect based on the Respondent
pharmacy's understanding of the customer and his injuries, but that the
pharmacy will simply no longer dispense this combination because this
is the only way (reason and judgment notwithstanding) to comply with
federal law.
---------------------------------------------------------------------------

\*E\ Omitted for clarity.
\*F\ Because the Administrative Law Judge has had the
opportunity to observe the demeanor and conduct of hearing
witnesses, the factual findings regarding demeanor set forth in his
recommended decision are entitled to significant deference.
Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951); Jeffery J.
Becker, D.D.S., and Jeffery J. Becker, D.D.S., Affordable Care, 77
FR 72387, 72403 (2012). I find the Chief ALJ's characterization of
Respondent's reaction in making these statements to be important in
this case, where, as I have addressed more thoroughly infra, at
Respondent's Exceptions, Respondent's witnesses have made general
statements that seem to accept full responsibility while also making
statements that tend to undermine that acceptance of responsibility.
---------------------------------------------------------------------------

Like Mr. Vicellio, Mr. Bryce found it significant that the
Louisiana Pharmacy Board has not put out any information about the
trinity cocktail in their published literature, but (accurately)
conceded that this lack of information did not excuse the Respondent
pharmacy's failures in this regard. Tr. 977-78. Mr. Bryce further
explained that the Texas Board of Pharmacy publications do provide, in
Mr. Bryce's view, a much more thorough treatment of this issue.\123\
Tr. 978. Regarding what Mr. Bryce (like Mr. Vicellio) perceives as a
failure on the part of the Louisiana Pharmacy Board with respect to the
absence of red flag treatment in its literature, he offered that the
Board had ``nothing published, and once again, [he] wish[ed] they would
emulate what the Texas [Pharmacy] Board has done.'' Tr. 979. Mr. Bryce
stated that the ISO experience has prompted him to become more involved
in the Louisiana pharmacy community because ``if neighboring states are
providing this information to their pharmacists, it should definitely
be available'' ``even though it's still no excuse for us filling
[controlled substances in the face of diversion red flags].'' Id. He
stated that he knows the trinity cocktail is filled at other pharmacies
in the area. Id. In fact, he is aware that customers who formerly
filled such prescriptions at the Respondent pharmacy are now filling
them elsewhere. Id.
---------------------------------------------------------------------------

\123\ Mr. Bryce was never offered or accepted as an expert in
the controlled substance prescribing standards in Texas. Based on
his background as represented, there is no basis upon which to find
an opinion as to his competence to speak to Texas law or controlled
substance dispensing in Texas. In the absence of objection, Mr.
Bryce provided an affirmative answer to the question of whether he
had ``seen [or] become exposed to the Texas Board of Pharmacy [ ] in
terms of [ ] the information that it was passing out to its
members.'' Tr. 978.
---------------------------------------------------------------------------

Mr. Bryce also agreed that combination prescribing of an opioid
with a benzodiazepine is ``definitely a concern'' to a patient's
health. Tr. 980. He stated that prior to the ISO, this was a ``common
combination'' that the pharmacy would see and now acknowledges that
dispensing this combination [without documenting warnings to the
patient] was ``a violation of our corresponding responsibility,'' but
his concession in this regard is hardly unqualified. Id. Mr. Bryce's
admission that Respondent pharmacy personnel ``did not document our
warnings to the patient or the prescriber,'' is interesting because the
record is devoid of any indication that such warnings were issued in
any manner.\*G\ Id. The witness's answer arguably supplies the
(unsupported) impression that such warnings were given, but not
documented.
---------------------------------------------------------------------------

\*G\ Edits were made to this sentence to conform to the
insertion in the previous sentence.
---------------------------------------------------------------------------

According to the Respondent pharmacy's post-ISO procedures,
carisoprodol will not be filled at all.\124\ Tr. 982. With respect to
combinations of opioids and benzodiazepines, Mr. Bryce is apparently
unconvinced that all such combinations constitute diversion red flags
that require scrutiny on the part of a DEA-registered pharmacy. Tr.
985, 989. According to Mr. Bryce, sometimes these prescription
combinations can emanate from two different prescribers. Tr. 985. For
example, sometimes a primary care provider will prescribe the
benzodiazepine and a pain management specialist will prescribe the
opioid such that the patient is not necessarily ``doctor shopping.''
Tr. 985. The witness explained that following the implementation of the
post-ISO policies that require prescriber contact, multiple prescribers
have discontinued benzodiazepine prescriptions. Tr. 986-87. Under the
Respondent's post-ISO

[[Page 72044]]

polices, if this combination is dispensed, a print-out of the FDA's
warning about this combination gets attached to the patient's
prescription package. Tr. 987-88. Mr. Bryce stated that his
interpretation of the FDA guidance was that there was no intended
``hard stop'' to trinity combination prescribing, and that based on an
article he read in the Journal of the American Medical Association
(JAMA), there has been only a modest national decline in prescribing
combinations of opioids and benzodiazepines since the publication of
the black box warning. Tr. 989. Thus, on the one hand, Mr. Bryce
acknowledges that the dispensing of trinity-combination prescriptions
is problematic,\125\ but on the other, he cites authority and his own
conclusions for the proposition that the black box warning was not a
definitive statement,\126\ and had a negligible impact on professional
prescribing. Indeed, much of Mr. Bryce's testimony strode an odd line
between contextualizing and minimizing responsibility [omitted for
brevity].
---------------------------------------------------------------------------

\124\ This new policy is puzzling. The record contains no
citation as to why declining to dispense an FDA-approved, DEA-
controlled medication, such as carisoprodol, would render a
registrant somehow in greater compliance. If anything, this policy
suggests that the Respondent pharmacy and its staff are essentially
throwing up their hands and banning the filling of potentially
legitimate prescriptions based presumably on a lack of ability to
discern legitimate carisoprodol prescriptions from illegitimate
ones.
\125\ Tr. 1061.
\126\ Tr. 989.
---------------------------------------------------------------------------

Regarding alternating payment methods, Mr. Bryce explained that
among the first steps taken by a pharmacy upon presentation of a
prescription is to input data and evaluate whether and to what extent
available insurance will cover the cost of the medication. Tr. 993.
According to Mr. Bryce, pharmacies ``get [insurance] rejections all day
long.'' Id. He further explained that on Medicare Part D and Medicaid
plans, the coverage is very restrictive and the plans sometimes require
prior authorizations or simply do not cover certain medications. Tr.
994. He explained that the Respondent pharmacy has a loyalty plan to
compensate for high co-pays or gaps in insurance coverage. Id.
Sometimes, customers will use the loyalty plan instead of insurance if
it is less expensive. Tr. 992. However, he stated that even before the
ISO, if a patient/customer asked the pharmacist to ``run it off [their]
insurance'' that always ``perked [their] ears up'' and prompted the
pharmacists to first run the prescription through insurance. Tr. 995.
If a drug is not covered, the pharmacist will give the option to pay
cash and use the loyalty program. Tr. 996. However, if a prior
authorization is required for insurance coverage of a medication, the
pharmacist will give the patient/customer the option of either waiting
for the prior authorization to come through or paying cash. Tr. 996-97.
Mr. Bryce was apparently unwilling to confess error regarding all
potential alternate payment method red flags cited by the Government's
case-in-chief. In reference to patient LC, who filled two prescriptions
for oxycodone-acetaminophen one week apart and used insurance for one
but cash for the other, Mr. Bryce remarked that he (still) believes
that no diversion red flag is indicated. Tr. 998. Rather, he stated
that, to him, these are no more than indicia of an opioid na[iuml]ve
patient or an insurance plan that will only pay for a seven day supply
of opioids. Tr. 999. He indicated that this a common phenomenon. Id. He
also stated that there was a recent change in Louisiana law limiting
opioid prescriptions to opioid na[iuml]ve patients to a seven day
supply. Id. Otherwise, the prescriber must indicate on the prescription
that the larger supply is medically necessary. Tr. 999-1000. Regarding
patient BB, who had two prescriptions filled close together for
benzodiazepines, Mr. Bryce recounted that one of those prescriptions
was from a cardiologist who routinely prescribes low doses of
benzodiazepines to help patients with the anxiety of getting a stent
procedure. Tr. 1005-06. Based on his knowledge of both the patient and
the prescriber, Mr. Bryce does not believe that this situation (ever)
presented as a red flag. Tr. 1006-07.
Mr. Bryce elaborated that in his entire time working at the
Respondent pharmacy, he has never had even an hour pass without an
insurance rejection. Tr. 1008. He further explained that employees at
the Respondent pharmacy have access to a system called Appriss, which
allows for the sharing of PMP data across state jurisdictions. Tr.
1010. If a patient comes in who is not local, the Respondent's
pharmacists, in the post-ISO environment, will now run PMP data through
Appriss to check the information from neighboring states. Id. Mr. Bryce
described how more complete information, including PMP reports, will
now be included in the new and improved due diligence file. Tr. 1014,
1018-25; Resp't Ex. 4 at 1-4. He additionally described how both
pharmacies [omitted] \*H\ subscribe to an FDA publication called Drug
Facts and Comparisons which lists [the recommended and maximum dosages
of controlled substances].\127\ Tr. 1032-34.
---------------------------------------------------------------------------

\*H\ Respondent objected to the Chief ALJ's statement that Mr.
Bryce, ``described how both pharmacies now subscribe to an FDA
publication called Drug Facts and Comparisons . . .'' Resp
Exceptions, at 13-15 (emphasis added). In a footnote, the Chief ALJ
went on to say ``it is bewildering to fathom why this important
source only became available to the Respondent's pharmacists after
the service of the ISO in this case.'' RD, at n. 127. As grounds for
its objection, Respondent explained that the Chief ALJ incorrectly
concluded that Respondent only started subscribing to the
publication after the ISO. Id. As the relevant testimony occurred
generally while Mr. Bryce was testifying regarding changes to
Respondent's policies and procedures following the ISO and the
testimony is not particularly clear on the issue, I understand how
the Chief ALJ reached his conclusion. However, I credit Respondent's
position that this was not the meaning of Mr. Bryce's testimony and
I have made edits accordingly. The Respondent further objected that
the publication's purpose is not to ``list available treatments for
various medical conditions,'' but to list ``the recommended and
maximum dosages for the controlled substances at issue.'' Resp
Exceptions, at 15. I agree with Respondent on this point and I have
made changes accordingly. However, these technical edits do not
impact my decision in this matter and I still find that Respondent's
remedial measures, particularly in light of Respondent's failure to
unequivocally accept responsibility, are insufficient to for me to
entrust Respondent with a registration.
\127\ Omitted as set forth in supra n. *H.
---------------------------------------------------------------------------

He also admitted that he believes the Louisiana standard prior
authorization form existed before the ISO, but he was not previously
aware of it.\*I\ Tr. 1057. He stated that he was previously aware that
the drugs which constitute the trinity cocktail are all drugs of
concern for abuse and diversion. Tr. 1061.
---------------------------------------------------------------------------

\*I\ Respondent, in its Exceptions, objected to the Chief
``ALJ's finding regarding the prior authorization form's purpose.''
Resp Exceptions, at 16. The Exception proceeds to address an
argument made by the Government in its Posthearing Brief that the
form existed to help pharmacists resolve potential red flags. Id.
The Exceptions explain the legislature's intent in creating the
form, including the intended purpose of the form, and claim that
``Medical Pharmacy is using this form in a creative way to fulfill
its corresponding responsibilities, but there has never been a
requirement for this form to be used to combat diversion and the
form was not created for that purpose.'' Id. However, the Chief ALJ
did not make any finding regarding the purpose of the prior
authorization form. Therefore, instead of objecting to the RD, the
Respondent appears to be responding to the Government's Posthearing
Brief. Ultimately, I find that the Chief ALJ's finding accurately
summarizes the testimony of Mr. Bryce. This Exception, even assuming
the truth of the assertions therein, is irrelevant to and has no
impact on my decision in this matter. The only relevance that this
form has to this proceeding is whether Respondent's use of it now
for the purpose Respondent has offered it, constitutes, in
combination with other proposed measures, adequate remedial measures
to demonstrate that I can entrust it with a registration, all of
which is addressed below in the Sanction Section.
---------------------------------------------------------------------------

[Omitted for brevity.] He testified that a number of Respondent
pharmacy patients who traveled long distances to fill their
prescriptions at the Respondent pharmacy had been customers for many
years. Tr. 1044-45. Mr. Bryce essentially chalked up distance
prescribing as it pertained to the Respondent pharmacy as outside the
realm of a legitimate red flag requiring analysis and documentation. In
discussing the issue on the stand, Mr. Bryce provided his thought
process:

[[Page 72045]]

. . . I would assume the reason [the distance customers] like us is
we do have great customer service. We know our patients when they
come in, we try to have the medication they need. We are a busy
pharmacy, we have high volume, but we take care of our customers.

Tr. 1044. Thus, to Mr. Bryce, it appears that he feels that the
Respondent pharmacy was justified in its distance prescribing. It may
have been a red flag for some pharmacies, but due to his self-described
``great customer service,'' it was never an issue for the Respondent
pharmacy. Presumably, ascribing to this view, this is just another
circumstance where the DEA regulators got it wrong. [However, Mr. Bryce
went on to testify that he ``definitely accept[s] the distance as a
potential red flag and [we should] definitely resolve it before we
dispense any medications for them. And that can be handled with a
discussion with a patient.'' Tr. 1046. Mr. Bryce, based on discussions
he has had with his customers, provided examples of reasons why
customers have filled prescriptions with Respondent despite living
further away. Tr. 1042-47. Mr. Bryce testified that distance is ``a
resolvable red flag,'' Tr. 1047, but that the past failures to document
the resolutions was ``[a]bsolutely wrong. We since learned we should
not, without the documentation to resolve the red flag, we should not
have filled [the prescription] . . . . [a]nd that's . . . where we've
failed and that's where we've made the adjustments to make sure that we
had documentation on those red flags moving forward.'' Tr. 1048.]
Mr. Bryce presented as a generally credible witness in terms of the
factual accuracy of some of the information he provided. [Omitted for
clarity. However, several of his positions were contrary to what the
Government's expert established as being the applicable usual course of
professional practice.] Mr. Bryce seems to disagree to varying degrees
that the Respondent pharmacy wrongfully dispensed in the face of
distance prescribing \128\ (they knew their customers), pattern
prescribing \129\ (they knew the prescribers and had positive opinions
of them), alternating payment methods \130\ (it is all really a cost-
saving and an insurance issue), doctor shopping \131\ (different
specialists prescribe for different ailments), and in some cases
trinity prescribing \132\ (other pharmacies are still filling these
drugs and the FDA never really called a ``hard stop''). On numerous
occasions, Mr. Bryce appeared to minimize the Respondent pharmacy's
non-compliance with clear state and federal pharmacy standards, and at
other times, by couching his testimony in terms of a simple failure to
adequately document, gave the unsupported impression that insightful
analysis of red flags was taking place but was regrettably not
adequately documented.
---------------------------------------------------------------------------

\128\ Tr. 1044-45.
\129\ Tr. 931, 1038-40.
\130\ Tr. 992-97.
\131\ Tr. 1005-07.
\132\ Tr. 989.
---------------------------------------------------------------------------

Even beyond minimization, the testimony of Mr. Bryce (like that of
Mr. Vicellio) repeatedly points to what he perceives as deficient
guidance from the Louisiana Pharmacy Board, literally because it
(apparently) does not invoke the magic words ``red flag.'' Tr. 979.
There appeared to be little recognition or understanding that markers
for diversion have been present since pharmacists have been practicing
their profession, and it was up to the pharmacists and staff at the
Respondent pharmacy to act as the controlled substance gatekeepers by
applying the principles that distinguish them from grocery store
clerks. [Omitted for brevity.] \133\
---------------------------------------------------------------------------

\133\ [Omitted]
---------------------------------------------------------------------------

Astonishingly, Mr. Bryce insisted that as a pharmacist he was
unaware that certain combinations of medications were dangerous and
even described some of these dangerous combinations as ``common.'' Tr.
980. Whether the Louisiana Pharmacy Board disseminated this information
to his personal satisfaction or not, as a seasoned pharmacist Mr. Bryce
and the rest of the Respondent pharmacy staff can reasonably have been
expected to know (well before the issuance of the ISO in this case)
that trinity combinations are dangerous and that they had a host of
concrete obligations as practitioners in a highly-regulated industry.
It is commendable that the Respondent pharmacy had awareness of its
prescribers, took steps to help its customers, knew their ailments,
knew some of their history, and even helped its customers in navigating
ways to afford their medications. These are admirable attributes for
any professional, community-based pharmacy. However, in his testimony
Mr. Bryce often conflates the laudable and professional practice of a
conscientious pharmacist knowing his patients and doctors, with
exercising the care, analysis, and documentation attendant with his
corresponding responsibility.
Taken as a whole, Mr. Bryce does not seem to appreciate that the
pharmacy operation he oversees as compliance manager actually had that
much of a serious problem. Mr. Bryce peppered his testimony with
periodic statements of ``100%'' taking responsibility and glib mentions
of being ``wrong,'' but those statements were not entirely consistent
with the content of his presentation. It is impossible and beyond the
scope of this recommended decision to understand whether Mr. Bryce was
motivated by pride in or loyalty to his place of employment, concern
for potential tertiary liability, the professional reputation of the
Respondent pharmacy (and himself) in his community, or some other
reason(s), but it is clear that his equivocations squarely undermined
the value of his testimony for the continuation of the COR he was
trying to save. Stated differently, if Mr. Bryce is convinced that the
established red flags were not really red flags for this pharmacy,
there would be no logical reason for him to insist on having those
issues identified, analyzed, and resolved by his staff in the future.
[Omitted for brevity.]
Even beyond Mr. Bryce's intermittent minimizing, the depth of the
remedial steps outlined by this witness does not really enhance the
Respondent pharmacy's position. Even fully crediting his account of
matters, the hundreds of transgressions persuasively outlined by the
Government in its case-in-chief was met here with a single weekend
staff training session \134\ and a 16-page bullet-point, large-
character, document that can be charitably described as sophomoric and
lacking in any serious analysis. Resp't Ex. 1; Resp't Ex. 2. Laudable
policies regarding increased documentation and scanning requirements
that are touted as state-of-the-art comprise a standard that should
have been present from the outset, and no person associated with the
Respondent pharmacy has been subject to a single consequence. On
balance, Mr. Bryce's hyperbolic characterizations of the organization's
efforts notwithstanding, the Respondent's efforts at remedial steps can
be fairly characterized as underwhelming.
---------------------------------------------------------------------------

\134\ To the extent that the Respondent's closing brief suggests
that ``[t]he pharmacy staff has been receiving training on these new
procedures'' (ALJ Ex. 20 at 7,] 12) (emphasis supplied), that is not
borne out by the evidence of record.
---------------------------------------------------------------------------

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

The Analysis

The Government seeks revocation based on its contention that the
Respondent pharmacy, through its pharmacists and employees, has
committed acts that would render its

[[Page 72046]]

continued registration inconsistent with the public interest as
provided in 21 U.S.C. 823(f). The gravamen of the Government's
allegations and evidence in this case focuses on the Respondent's
alleged (1) dereliction in exercising its corresponding responsibility
in dispensing controlled substance prescriptions and (2) violation of
federal and state laws relating to controlled substances.
The Respondent has assented to every factual stipulation offered by
the Government in this matter. Despite these numerous stipulations, the
Government offered additional evidence of dispensing events where red
flags were present and not resolved. For its part, the Respondent,
while facially acknowledging error, pushed back on some particulars of
the Government's case and challenged the underlying justifications for
numerous red flags of diversion (some of them long-established red
flags) cited in support of the Government's petition for sanction. The
Respondent also presented evidence on the issue of remedial steps.

Public Interest Determination: The Standard

Under 21 U.S.C. 824(a)(4), the Agency may revoke the COR of a
registrant if the registrant ``has committed such acts as would render
its registration . . . inconsistent with the public interest.'' 21
U.S.C. 824(a)(4). Congress has circumscribed the definition of public
interest in this context by directing consideration of the following
factors:

(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(3) The [registrant'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).
``[T]hese factors are to be considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (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 COR should be revoked. Id.; see Morall v. DEA, 412 F.3d
165, 173-74 (D.C. Cir. 2005). Moreover, the Agency is ``not required to
make findings as to all of the factors,'' Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); 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 given level of 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).
In adjudicating a revocation of a DEA COR, the DEA has the burden
of proving that the requirements for the revocation it seeks are
satisfied. 21 CFR 1301.44(e). Where the Government has met this burden
by making a prima facie case for revocation of a registrant's COR, the
burden of production then shifts to the registrant to show that, given
the totality of the facts and circumstances in the record, revoking the
registrant's COR would not be appropriate. Med. Shoppe-Jonesborough, 73
FR 364, 387 (2008). Further, ``to rebut the Government's prima facie
case, [the Respondent] is required not only to accept responsibility
for [the established] misconduct, but also to demonstrate what
corrective measures [have been] undertaken to prevent the re-occurrence
of similar acts.'' Jeri Hassman, M.D., 75 FR 8194, 8236 (2010); accord
Krishna-Iyer, 74 FR at 464 n.8. In determining whether and to what
extent a sanction is appropriate, consideration must be given to both
the egregiousness of the offense established by the Government's
evidence and the Agency's interest in both specific and general
deterrence. David A. Ruben, M.D., 78 FR 38363, 38364, 38385 (2013).
Normal hardships to the registrant, and even to the surrounding
community, which are attendant upon lack of registration, are not a
relevant consideration. See Linda Sue Cheek, M.D., 76 FR 66972, 66972-
73 (2011); Gregory D. Owens, D.D.S., 74 FR 36751, 36757 (2009).
Further, the Agency's conclusion that ``past performance is the best
predictor of future performance'' has been sustained on review in the
courts, Alra Labs., Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as
has the Agency's consistent policy of strongly weighing whether a
registrant who has committed acts inconsistent with the public interest
has accepted responsibility and demonstrated that he or she will not
engage in future misconduct. Hoxie, 419 F.3d at 483; see also Ronald
Lynch, M.D., 75 FR 78745, 78754 (2010) (holding that the respondent's
attempts to minimize misconduct undermined acceptance of
responsibility); George Mathew, M.D., 75 FR 66138, 66140, 66145, 66148
(2010); George C. Aycock, M.D., 74 FR 17529, 17543 (2009); Krishna-
Iyer, 74 FR at 463; Steven M. Abbadessa, D.O., 74 FR 10077, 10078
(2009); Med. Shoppe-Jonesborough, 73 FR at 387.
Although the burden of proof at this administrative hearing is a
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S.
91, 100-03 (1981), the Agency's ultimate factual findings will be
sustained on review to the extent they are supported by ``substantial
evidence.'' Hoxie, 419 F.3d at 481. 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); see Humphreys v. DEA, 96 F.3d
658, 663 (3d Cir. 1996). [Omitted for brevity.]
[Omitted for brevity.] 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 recommended decision are entitled to significant
deference, see 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 Agency's final
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(a) (1947).

[[Page 72047]]

Factors 2 and 4: The Respondent's Experience Dispensing Controlled
Substances and Compliance With Federal, State, and Local Law

The Government has founded its theory for sanction exclusively on
Public Interest Factors 2 and 4, and it is to those two factors that
the evidence of record relates.\135\
---------------------------------------------------------------------------

\135\ The record contains no recommendation from any state
licensing board or professional disciplinary authority (Factor 1).
[Where the record contains no evidence of a recommendation by a
state licensing board that absence does not weigh for or against
revocation. See Roni Dreszer, M.D., 76 FR 19434, 19444 (2011) (``The
fact that the record contains no evidence of a recommendation by a
state licensing board does not weigh for or against a determination
as to whether continuation of the Respondent's DEA certification is
consistent with the public interest.'').] Similarly, there is no
record evidence of a conviction record relating to regulated
activity (Factor 3). Even apart from the fact that the plain
language of this factor does not appear to emphasize the absence of
such a conviction record, myriad considerations are factored into a
decision to initiate, pursue, and dispose of criminal proceedings by
federal, state, and local prosecution authorities which lessen the
logical impact of the absence of such a record. See Robert L.
Dougherty, M.D., 76 FR 16823, 16833 n.13 (2011); Dewey C. MacKay,
M.D., 75 FR 49956, 49973 (2010) (``[W]hile a history of criminal
convictions for offenses involving the distribution or dispensing of
controlled substances is a highly relevant consideration, there are
any number of reasons why a registrant may not have been convicted
of such an offense, and thus, the absence of such a conviction is of
considerably less consequence in the public interest inquiry.''),
aff'd, MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011); Ladapo O.
Shyngle, M.D., 74 FR 6056, 6057 n.2 (2009). Therefore, the absence
of criminal convictions militates neither for nor against the
revocation sought by the Government. Since the Government's
allegations and evidence fit squarely within the parameters of
Factors 2 and 4 and do not raise ``other conduct which may threaten
the public health and safety,'' (Factor 5) Factor 5 militates
neither for nor against the sanction sought by the Government in
this case.
---------------------------------------------------------------------------

Applying the record evidence to Factor 2 (experience in dispensing
controlled substances) in accordance with Agency precedent,\136\ the
Respondent is operated by MP, Inc., and has been licensed in Louisiana
since 1968. Tr. 802, 805. No evidence was introduced regarding any
basis upon which to characterize its level of compliance prior to the
allegations that form the basis of this litigation.
---------------------------------------------------------------------------

\136\ JM Pharmacy, 80 FR at 28667 n.2; Krishna-Iyer, 74 FR at
462.
---------------------------------------------------------------------------

The lion's share of the evidence presented in this litigation is
most readily considered under Factor 4 (compliance with laws related to
controlled substances). To effectuate the dual goals of conquering drug
abuse and controlling both legitimate and illegitimate traffic in
controlled substances, ``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.''
Gonzales v. Raich, 545 U.S. 1, 13 (2005). Under the regulations,
``[t]he responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the
prescription.'' 21 CFR 1306.04(a).\*J\ The pharmacy registrant's
responsibility under the regulations is not coextensive or identical to
the duties imposed upon a prescriber, but rather, it is a corresponding
one. 21 CFR 1306.04(a); see Tewelde v. Louisiana Bd. of Pharmacy, 93
So.3d 801, 810 (La.App. 1 Cir. 2012) (affirming that Louisiana
pharmacies are required to adhere to the corresponding responsibility
requirements imposed by federal as well as state law). The regulation
does not require the pharmacist to practice medicine; it instead
imposes the responsibility to decline to dispense based upon an order
that purports to be a prescription, but may not be, because evidence
(either apparent on the prescription or attendant to the presentation
of that prescription) would lead a reasonable pharmacist to suspect
that the practitioner issued the prescription outside the scope of
legitimate medical practice. E. Main St. Pharmacy, 75 FR 66149, 66157
n.30 (2010).\*K\
---------------------------------------------------------------------------

\*J\ Omitted to reduce repetition with added text. See infra n.
*L.
\*K\ Omitted to reduce repetition with added text. See infra n.
*L.
---------------------------------------------------------------------------

[According to the CSA's implementing regulations, a lawful
controlled substance order or prescription is one that is ``issued for
a legitimate medical purpose by an individual practitioner acting in
the usual course of his professional practice.'' 21 CFR 1306.04(a).
While the ``responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, . . . a
corresponding responsibility rests with the pharmacist who fills the
prescription.'' Id. The regulations establish the parameters of the
pharmacy's corresponding responsibility.

An order purporting to be a prescription issued not in the usual
course of professional treatment . . . is not a prescription within
the meaning and intent of . . . 21 U.S.C. 829 . . . and the person
knowingly filling such a purported prescription, as well as the
person issuing it, shall be subject to the penalties provided for
violations of the provisions of law relating to controlled
substances.

Id. ``The language in 21 CFR 1306.04 and caselaw could not be more
explicit. A pharmacist has his own responsibility to ensure that
controlled substances are not dispensed for non-medical reasons.''
Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730
(1990) (citing United States v. Hayes, 595 F.2d 258 (5th Cir. 1979),
cert. denied, 444 U.S. 866 (1979); United States v. Henry, 727 F.2d
1373 (5th Cir. 1984) (reversed on other grounds)). As the Supreme Court
explained in the context of the CSA's requirement that schedule II
controlled substances may be dispensed only by written prescription,
``the prescription requirement . . . ensures patients use controlled
substances under the supervision of a doctor so as to prevent addiction
and recreational abuse . . . [and] also bars doctors from peddling to
patients who crave the drugs for those prohibited uses.'' Gonzales v.
Oregon, 546 U.S. 243, 274 (2006).
To prove a pharmacist violated her corresponding responsibility,
the Government must show that the pharmacist acted with the requisite
degree of scienter. See 21 CFR 1306.04(a) (``[T]he person knowingly
filling [a prescription issued not in the usual course of professional
treatment] . . . shall be subject to the penalties provided for
violations of the provisions of law relating to controlled
substances.'') (emphasis added). DEA has also consistently interpreted
the corresponding responsibility regulation such that ``[w]hen
prescriptions are clearly not issued for legitimate medical purposes, a
pharmacist may not intentionally close his eyes and thereby avoid
[actual] knowledge of the real purpose of the prescription.''
Bertolino, 55 FR at 4730 (citations omitted); see also JM Pharmacy
Group, Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR 28667,
28670-72 (2015) (applying the standard of willful blindness in
assessing whether a pharmacist acted with the requisite scienter).
Pursuant to their corresponding responsibility, pharmacists must
exercise ``common sense and professional judgment'' when filling a
prescription issued by a physician. Bertolino, 55 FR at 4730. When a
pharmacist's suspicions are aroused by a red flag, the pharmacist must
question the prescription and, if unable to resolve the red flag,
refuse to fill the prescription. Id.; Medicine Shoppe-Jonesborough, 300
F. App'x 409, 412 (6th Cir. 2008) (``When pharmacists' suspicions are
aroused as reasonable professionals, they must at least verify the
prescription's propriety, and if not satisfied by the answer they must
refuse to dispense.'').
Finally, ``[t]he corresponding responsibility to ensure the
dispensing

[[Page 72048]]

of valid prescriptions extends to the pharmacy itself.'' Holiday CVS,
77 FR at 62,341 (citing Med. Shoppe--Jonesborough, 73 FR at 384; United
Prescription Servs., Inc., 72 FR 50,397, 50,407-08 (2007); EZRX,
L.L.C., 69 FR 63178, 63181 (2004); Role of Authorized Agents in
Communicating Controlled Substance Prescriptions to Pharmacies, 75 FR
61613, 61617 (2010); Issuance of Multiple Prescriptions for Schedule II
Controlled Substances, 72 FR 64,921, 64,924 (2007) (other citations
omitted)). The DEA has consistently held that the registration of a
pharmacy may be revoked as the result of the unlawful activity of the
pharmacy's owners, majority shareholders, officers, managing
pharmacist, or other key employee. EZRX, L.L.C., 69 FR at 63181; Plaza
Pharmacy, 53 FR 36910, 36911 (1988). Similarly, ``[k]nowledge obtained
by the pharmacists and other employees acting within the scope of their
employment may be imputed to the pharmacy itself.'' Holiday CVS, 77 FR
at 62341.
In this matter, the Government did not allege that Respondent
dispensed the subject prescriptions having actual knowledge that the
prescriptions lacked a legitimate medical purpose. Instead, the
Government alleged that Respondent violated the corresponding
responsibility regulation for each of the patients at issue in this
matter by filling prescriptions ``without addressing or resolving
multiple red flags of abuse or diversion.'' Govt Prehearing, at 22.
Agency decisions have consistently found that prescriptions with the
same red flags at issue here were so suspicious as to support a finding
that the pharmacists who filled them violated the Agency's
corresponding responsibility rule due to actual knowledge of, or
willful blindness to, the prescriptions' illegitimacy. 21 CFR
1306.04(a); see, e.g., Pharmacy Doctors Enterprises d/b/a Zion Clinic
Pharmacy, 83 FR 10876, 10898, pet. for rev. denied, 789 F. App'x 724
(11th Cir. 2019) (long distances; pattern prescribing; customers with
the same street address presenting the same prescriptions on the same
day; drug cocktails; cash payments; early refills); Hills Pharmacy, 81
FR 49816, 49836-39 (2016) (multiple customers presenting prescriptions
written by the same prescriber for the same drugs in the same
quantities; customers with the same last name and street address
presenting similar prescriptions on the same day; long distances; drug
cocktails); The Medicine Shoppe, 79 FR 59504, 59507, 59512-13 (2014)
(unusually large quantity of a controlled substance; pattern
prescribing; irregular dosing instructions; drug cocktails); Holiday
CVS, 77 FR 62316, 62317-22 (2012) (long distances; multiple customers
presenting prescriptions written by the same prescriber for the same
drugs in the same quantities; customers with the same last name and
street address presenting virtually the same prescriptions within a
short time span; payment by cash); East Main Street Pharmacy, 75 FR
66149, 66163-65 (2010) (long distances; lack of individualized therapy
or dosing; drug cocktails; early fills/refills; other pharmacies'
refusals to fill the prescriptions). Here, the Government established
the presence of red flags on the prescriptions that Respondent pharmacy
filled.] ^{*L 137}
---------------------------------------------------------------------------

\*L\ The supplemented text in this section clarifies the
analysis of a pharmacist's corresponding responsibility under 21 CFR
1306.04(a).
\137\ [Omitted.]
---------------------------------------------------------------------------

The Louisiana Administrative Code largely mirrors the DEA
regulations in that it specifies that a prescription for a controlled
substance may only be issued ``for a legitimate medical purpose by an
individual practitioner acting in the usual course of professional
practice.'' LA. Admin. Code tit. 46, Sec. 2745(B)(1) (2019). Like the
DEA version, the pharmacy's responsibility references penalties for
knowingly dispensing ``[a]n order purporting to be a prescription
issued not in the usual course of professional treatment.'' Id. The
State of Louisiana specifically requires the dispensing pharmacy ``to
ascertain that [a controlled substance] prescription was issued for a
legitimate medical purpose.'' Id. at Sec. 2747(E)(2)(a). Further, a
pharmacist in Louisiana must ``exercise sound professional judgment
[in] ascertain[ing] the validity of a controlled substance
prescription, and ``[i]f, in the pharmacist's professional judgment, a
prescription is not valid, [a controlled substance] prescription shall
not be dispensed.'' Id. at Sec. 2747(E)(2)(b).
In this case, the Government alleged and presented evidence that
the Respondent pharmacy violated federal and state laws relating to
controlled substances and filled prescriptions in a manner that
violated its corresponding responsibility to ensure that controlled
substances are dispensed only upon an effective prescription by failing
to recognize and resolve red flags of diversion prior to dispensing. 21
CFR 1306.04(a). Specifically, the Government alleges that the
Respondent violated laws applicable to the dispensing of controlled
substances by dispensing multiple controlled substances to multiple
patients in the face of unresolved red flags indicating possible or
even likely diversion. ALJ Ex. 1. Specifically, the Government alleges
that the Respondent ignored diversion red flags based on: (1) Dangerous
combinations of controlled medications (cocktail prescribing and
combination prescribing); (2) cash payments made by pharmacy customers
for controlled medications; (3) patterns of controlled substance
prescribing that should alert a reasonable pharmacist that the
medications are not being prescribed for legitimate medical objectives;
(3) long distances between customers, prescribers, and the registrant
pharmacy; and (4) controlled substance prescriptions issued at
potencies and quantities that should alert a reasonable pharmacist that
the medications are likely not being prescribed for legitimate medical
objectives.
The CSA and its implementing regulations require that pharmacists
only dispense prescriptions that are issued for a legitimate medical
purpose in the usual course of professional practice. 21 CFR
1306.04(a). While prescribers are responsible for writing only legally
sound prescriptions, a corresponding responsibility rests with the
pharmacist to refuse to fill prescriptions that are not valid. Id.
Louisiana law imposes a similar responsibility and requires pharmacists
to exercise sound professional judgment in dispensing and respond with
``appropriate action'' where a prescription presents signs of
therapeutic duplication, possible abuse/misuse, or inappropriate
dosing. LA Admin. Code. tit. 46, Part LIII Sec. Sec. 515, 2745(B)(1),
2747(E)(2)(a).
The stipulated facts and additional problematic dispensing events
alleged by the Government point to a pattern and practice of dispensing
dangerous controlled substances in the face of numerous red flags. The
evidence of record demonstrates that on one hundred separate occasions,
the Respondent pharmacy dispensed ``cocktail'' medications, that is,
combinations of drugs that are known to be abused and diverted.\138\ On
an additional nineteen separate occasions, the Respondent pharmacy
dispensed combinations of medications that posed serious risks to
patients.\139\ On seven occasions the Respondent pharmacy also
dispensed controlled substances,

[[Page 72049]]

where alternating payment methods were employed, and customers tendered
cash for some medications and utilized insurance for others without any
scrutiny from the Respondent pharmacy's pharmacists or staff.\140\ The
Respondent pharmacy filled pattern prescriptions from problematic
prescribers on eighteen stipulated occasions and others highlighted by
Dr. Ginsburg.\141\ Its pharmacists additionally filled prescriptions
for customers in the face of unresolved distance red flags.\142\
Finally, the Respondent pharmacy filled prescriptions for quantities
and strengths of drugs that posed a risk to the patients who would be
taking them on twenty one separate occasions as well as others
explained by Dr. Ginsburg without identifying the combinations as
problematic and resolving and documenting any rationale.\143\
---------------------------------------------------------------------------

\138\ See Stip. 3(a)-(d); Stip. 4(a)-(d), (h)-(f), (i)-(m), (p)-
(yy); Stip. 5(a)-(g); Stip. 6(a)-(ddd); Stip. 7(a)-(z); Stip. 8(a)-
(dd).
\139\ See Stip. 4(rr)-(tt); Stip. 9(a)-(c); Stip. 10(a)-(f);
Stip. 11(a)-(c); Stip. 12(a)-(b); Stip. 13(a)-(c); Stip. 14(c)-(k);
Stip. 15(a)-(b); Stip. 16(a)-(c); Stip. 17(a)-(d).
\140\ See Stip. 4(n)-(o); Stip. 4(rr)-(tt); Stip. 18(a)-(b);
Stip. 19(a)-(b); Stip. 20(a)-(b); Stip. 21(a)-(b).
\141\ See Stip. 4(rr)-(tt); Stip. 9(a)-(b); Stip. 10(a)-(b);
Stip. 14(a)-(b); Stip. 18(a)-(b); Stip. 22(a)-(b); Stip. 23(a)-(b);
Stip. 24(a)-(b); Stip. 25(b); Stip. 26(a)-(c); Stip. 27(a)-(b);
Stip. 28(a); Stip. 29(a)-(b); Stip. 30(a)-(b); Stip. 31(a)-(b); Tr.
509-11; Gov't Ex. 39 at 1; Tr. 519-22; Gov't Exs. 42 at 1, 43 at 2;
Tr. 528-35; Gov't Exs. 56 at 1, 57 at 2, 58 at 1, 59 at 1.
\142\ Tr. 295-97.
\143\ See Stip. 10 (a)-(b); Stip. 14(l); Stip. 18(a)-(b); Stip.
22(a)-(b); Stip. 23(a)-(b); Stip. 24(a)-(b); Stip. 25(b); Stip.
26(a)-(c); Stip. 37; Stip. 38; Stip. 39; Stip. 40; Stip. 41; Stip.
42; Stip. 43; Stip. 44; Stip. 45; Stip. 46; Tr. 482-84, 493-94, 496-
97; Gov't Exs. 50 at 1.
---------------------------------------------------------------------------

The Respondent stipulated to one hundred occasions where it
dispensed cocktail medications and dangerous combinations of
medications, including but not limited to the ``trinity'' cocktail of
an opioid, a benzodiazepine, and carisoprodol.\144\ DI credibly
testified that the PMP data from the Respondent pharmacy demonstrated
that a high quantity of ``trinity'' cocktail prescriptions were being
dispensed. Tr. 71. Dr. Ginsburg persuasively testified that while not a
violation on its own, such prescriptions presented red flags that would
require documented resolution in order for the Respondent pharmacy to
comply with its corresponding responsibility. Tr. 308, 312, 314, 316-
20, 322, 325, 330, 336-43, 347-51, 358, 359-66, 376-88, 392-93, 395-96,
550-52. In response to administrative subpoenas, the Respondent
pharmacy did not produce patient records or profiles that provided any
identification or resolution of any red flags identified prior to
dispensing. Tr. 53-54; Gov't. Ex. 64; Gov't. Ex. 66. Mr. Bryce
testified that he and the other pharmacists ``should have documented
more in the computer system'' but they failed to. Tr. 900. Mr. Vicellio
further indicated that where records were not turned over to the DEA,
it was because they did not exist. Tr. 862.
---------------------------------------------------------------------------

\144\ See Stip. 3(a)-(d); Stip. 4(a)-(d), (h)-(f), (i)-(m), (p)-
(yy); Stip. 5(a)-(g); Stip. 6(a)-(ddd); Stip. 7(a)-(z); Stip. 8(a)-
(dd).
---------------------------------------------------------------------------

During the course of his guarded testimony, Mr. Bryce seemed intent
on giving the impression that the root of the problem here was limited
to inadequate documentation. To be clear, the lack of documentation
during the period in question was certainly deplorable [and outside the
usual course of professional practice], but the transgressions of the
Respondent pharmacy were not limited to documentation deficiencies. If
this case were limited to a failure to document (here serious enough to
warrant a sanction on its own), the Respondent could easily have
furnished the testimony of the Respondent pharmacy's PIC, Mr. Fontenot,
to explain that the proper analyses had been performed by his line
pharmacists but not documented. That did not happen, so no one really
knows what the PIC and his line pharmacists at the Respondent pharmacy
were thinking.\*M\
---------------------------------------------------------------------------

\*M\ [Text relocated.] No explanation was offered by the
Respondent as to why the PIC was not called as a witness, and the
record revealed no indication of any issue regarding the
availability of the Respondent pharmacy PIC, or any issue that would
make him unamenable to process. Tr. 897-98, 1063-64. The tribunal
may, as a matter of discretion, draw an adverse inference from Mr.
Fontenot's absence from the proceedings. Where a party fails to
produce relevant evidence within its control, it is appropriate to
draw an adverse inference. Int'l Union (UAW) v. NLRB, 459 F.2d 1329,
1338 (D.C. Cir. 1972) (holding that NLRB committed reversible error
by declining to apply the adverse inference rule where one of the
parties had relevant evidence within his control which he failed to
produce.); see also Callahan v. Schultz, 783 F.2d 1543, 1545 (11th
Cir. 1986) (applying the adverse inference rule against the
Government in quashing an IRS summons.); Pharmacy Doctors
Enterprises, d/b/a Zion Clinic Pharmacy, 83 FR 10876, 10899 (2018).
At the hearing, both sides were put on notice that the tribunal was
considering the issue of an adverse inference. Tr. 1077-78. [The
Chief ALJ concluded], as an evidentiary matter, [omitted] that if
this witness had presented testimony, that testimony would have
supported the proposition that not only did the Respondent pharmacy
staff neglect to document the actions they took in response to red
flags of potential diversion, but they also did not identify or
analyze these red flags in any serious way. [I, however, do not find
the drawing of an adverse inference to be necessary. The record
evidence established, and Respondent has largely conceded, that not
all red flags were resolved and in no instance was the potential
resolution of any red flag documented. Accordingly, there is ample
evidence without an adverse inference to establish that Respondent
pharmacy issued these prescriptions outside the usual course of
professional practice and in violation of its corresponding
responsibility.]
---------------------------------------------------------------------------

Regarding alternating payments, the Government alleged numerous
occasions on which the Respondent pharmacy filled prescriptions where
pharmacy customers used multiple payment methods to cover different
prescriptions. Tr. 297-98, 398-99. Dr. Ginsburg persuasively testified
that this a red flag requiring resolution prior to dispensing because a
patient electing such payment methods may be attempting to shield
certain prescriptions from scrutiny by insurance. Tr. 298-99. No reason
was offered for this practice other than an explanation of attempts to
save customers money through the use of the Respondent's loyalty plan.
Tr. 992-96. The Respondent's argument here is facially appealing but
analytically bankrupt. To the extent that a red flag of diversion
reveals itself during a controlled substance dispensing event, it is
incumbent upon the pharmacy registrant to identify the red flag and
resolve the issue prior to dispensing the medication. The holder of a
DEA pharmacy registration bears the obligation, by the exercise of its
corresponding responsibility, to act as a gatekeeper to the closed
controlled-substance system. Responsible actions by the registrant
protect the customer from dangerous abuse and the public from wholesale
diversion of powerful, dangerous drugs. Here, the Respondent argues
that in the face of this potential red flag, without any
circumspection, it evaluated a method whereby the drugs can be
dispensed in the cheapest way possible. A good monetary deal for the
prescription holder is not necessarily synonymous with the responsible
exercise of a registrant's obligations to discharge its corresponding
responsibility. [Furthermore, even if Respondent had legitimate reasons
why it was receiving different types of payments for controlled
substance prescriptions, the resolution of this red flag was not
documented anywhere.]
The Government established that the pharmacists at the Respondent
pharmacy repeatedly filled prescriptions from prescribers who exhibited
clear signs of being pattern prescribers. Dr. Ginsburg identified
several prescribers who repeatedly prescribed the same combinations of
high-dose opioids to many patients. Tr. 435, 502-04, 506-09. There were
no documented attempts to resolve this red flag. Tr. 327, 329-31, 336-
37, 550-52. Mr. Bryce further admitted that despite exhortation from
one of the Respondent pharmacy's distributors, the pharmacy continued
to fill prescriptions from Dr. GB. Tr. 931. He testified that the
pharmacy would have to call frequently in order to confirm whether Dr.
GB's DEA COR was still active, surely a sign of a problematic
prescriber (even

[[Page 72050]]

without threats from a distributor and before the issuance of the ISO
in this case). Id. Regarding this red flag, the Respondent was aware
that at least some of these prescriptions were problematic, dispensed
them nonetheless, and made no attempt to verify if these prescriptions
were issued for a legitimate medical purpose in the usual course of
professional practice.
Dr. GB's prescriptions, among others that were filled by the
Respondent pharmacy, presented potentially hazardous quantities and
strengths of opioid and benzodiazepine medications. Tr. 435; Gov't Ex.
4 at 1. According to Dr. Ginsburg's uncontroverted testimony, the
documentation provided by the Respondent pharmacy was insufficient to
demonstrate resolution of this red flag. Tr. 502-03, 505-06, 512-16,
526, 535-38, 550-52. While Mr. Bryce indicated some steps that MP West
has taken to better identify and resolve this red flag [in the future],
he provided no explanation, beyond a bland expression of contrition,
for why these prescriptions were filled. Tr. 952-62.
The evidence of record demonstrates that the Respondent has
neglected its corresponding responsibility imposed by the CSA and the
Louisiana Administrative Code. See 21 CFR 1306.04(a) (establishing
corresponding responsibility under the Controlled Substances Act);
Liddy's Pharmacy, 76 FR at 48895 (affirming that only lawful
prescriptions may be dispensed); LA. Admin. Code tit. 46, Sec.
2745(B)(1) (2019) (establishing corresponding responsibility under
Louisiana state law). The Respondent, through its pharmacists and
staff, demonstrably knew or had reason to know that these prescriptions
were not issued for a legitimate medical purpose in the usual course of
professional practice. See Med. Shoppe-Jonesborough, 73 FR at 381
(quoting Medic-Aid Pharmacy, 55 FR 30043, 30044 (1990)) (requiring a
pharmacist to refuse to fill such prescriptions). By dispensing these
prescriptions despite knowing that they were potentially dangerous and
failing to investigate further, the Respondent pharmacy failed to
follow its legal responsibilities. See Sun & Lake Pharmacy, Inc., 76 FR
at 24530 (quoting Ralph J. Bertolino, 55 FR 4729, 4730 (1990) (stating
that a pharmacist may not ``close his eyes and thereby avoid [actual]
knowledge'' of possible abuse or diversion).
[Omitted for clarity. The record evidence establishes that] the
prescriptions detailed in the Government's evidence and agreed
stipulations [were issued] without resolving the red flag(s) presented
and documenting that resolution.\145\ The red flags detailed above
required the Respondent and its pharmacists to question these
prescriptions and they did not. See Bertolino, 55 FR at 4730 (requiring
pharmacists to question prescriptions that present red flags for abuse
or diversion). [Omitted for brevity.]
---------------------------------------------------------------------------

\145\ See Appendix. [Footnote was relocated.]
---------------------------------------------------------------------------

The quantity of questionable prescriptions that the Respondent
pharmacy filled, coupled with the virtual absence of attempts,
documented or not, to resolve red flags points inexorably and
conclusively toward willful blindness. First, the Respondent, in
business for decades, maintained no formal procedures whatsoever for
responding to red flags. Tr. 833. Further, the evidence of record
demonstrates an astonishing level of ignorance (sincere or not) among
the Respondent's corporate officers and employees regarding their legal
obligations. Mr. Vicellio testified that although he has been aware
that operating a pharmacy is a highly-regulated activity, which
requires careful and diligent adherence to federal and state laws and
regulations, until the ISO he made no sustained effort to familiarize
himself with these requirements and, as a non-pharmacist, assumed his
pharmacy-trained employees would keep him out of trouble. Tr. 835-36.
Mr. Bryce, the newly-appointed compliance officer, also admitted
knowledge that many of these prescriptions presented dangerous
combinations of drugs and [yet they were dispensed.] *\N\ Tr. 1061.
[Omitted for brevity.] To be persuaded by the Respondent's case, it
would be necessary to assume there was no way that professional
pharmacists and pharmacy staff could be aware of their obligations to
avoid wholesale drug diversion without the issuance of an ISO by DEA,
or the use of the specific term ``red flag'' in the literature
disseminated by the Louisiana Pharmacy Board.\146\ The Respondent here,
through its pharmacists, staff, and management, ran the busiest
pharmacy in the local area, presided over ``controlled chaos,'' and
kept its foot on the gas until stopped by the DEA's ISO. [Omitted for
brevity.]
---------------------------------------------------------------------------

*\N\ Modified for clarity.
\146\ ALJ Ex. 20 at 9.
---------------------------------------------------------------------------

[Accordingly, I find that Respondent has operated outside the usual
course of professional practice (in violation of 21 CFR 1306.06 and La.
Admin Code tit. 46, Part LIII, Sec. Sec. 2745(b)(1), 2747(E)(2)(a))
and in violation of its corresponding responsibility (in violation of
21 CFR 1306.04(a) and La. Admin Code tit. 46, Part LIII, Sec. Sec.
515, 2745(b)(1), 2747(E)(2)(a).] Based on the foregoing, the Government
has made a prima facie case that the Respondent has committed acts
which render its registration inconsistent with the public
interest.*\O\ Accordingly, all allegations enumerated in the OSC/ISO
\147\ are sustained.
---------------------------------------------------------------------------

*\O\ For purposes of the imminent danger inquiry, my findings
lead to the conclusion that Respondent has ``fail[ed] . . . to
maintain effective controls against diversion or otherwise comply
with the obligations of a registrant'' under the CSA. 21 U.S.C.
824(d)(2). The substantial evidence that Respondent issued
controlled substance prescriptions outside the usual course of the
professional practice established ``a substantial likelihood of an
immediate threat that death, serious bodily harm, or abuse of a
controlled substance . . . [would] occur in the absence of the
immediate suspension'' of Respondent's registration. Id. There was
ample evidence introduced to establish that Respondent, without
first resolving red flags, repeatedly dispensed combinations of
medications that posed serious risks to patients. See supra n. 23.
Thus, as I have found above, at the time the Government issued the
OSC/ISO, there was clear evidence of imminent danger.
\147\ ALJ Ex. 1. At the hearing (Tr. 435-41, 774-91) and in its
closing brief (ALJ Ex. 20 at 2-5), the Respondent lodged an
objection as to notice. Specifically, the Respondent avers that the
Government's charging document (ALJ Ex. 1 at 11, ] 12) and
Prehearing Statement (ALJ Ex. 4 at 21-22) supplied a definition of
pattern prescribing that is at some variance with the definition
utilized by the Government through its expert, Dr. Ginsburg.
Specifically, the Respondent argues that the Government's noticed
definition refers to a pattern of scrips issued by ``a physician who
regularly prescribes common drugs of abuse and diversion in the same
dosages and quantities to many of his or her patients sharing the
same surnames and/or addresses and uses the same diagnosis codes to
justify these prescriptions.'' ALJ Ex. 4 at 21. The OSC/ISO in this
case informs that ``[p]attern prescribing refers to a practitioner
who regularly prescribes common drugs of abuse or diversion in the
same dosages and quantities to multiple patients where the patients
often share the same surnames and/or addresses, and/or where the
prescriber uses the same diagnosis codes to justify these
prescriptions.'' ALJ Ex. 1 at 11, ] 12. The objection was overruled
at the hearing (Tr. 439-40, 782-91), but the issue was timely raised
and preserved for appeal. In the APA, Congress provided that an
administratively-imposed sanction must be preceded by notice of,
inter alia, ``the matters of fact and law asserted.'' 5 U.S.C.
554(b)(3). The DEA regulations require the charging document to
supply ``a summary of the matters of fact and law asserted.'' 21 CFR
1301.37(c). [Omitted for relevance.] This is not a close case. The
Agency has long held that the parameters of its administrative
hearings are circumscribed by the allegations in its charging
documents and the prehearing statements filed by the parties. See,
e.g., Liddy's Pharmacy, L.L.C., 76 FR 48887, 48896 (2011); CBS
Wholesale Distribs., 74 FR 36746, 36750 (2009); Darrell Risner,
D.M.D., P.S.C., 61 FR 728, 730 (1996). Under the Agency's precedent,
``[p]leadings in administrative proceedings are not judged by the
standards applied to an indictment at common law'', Clair L.
Pettinger, M.D., 78 FR 61591, 61596 (2013), and ``[t]he rules
governing DEA hearings do not require the formality of amending a
[charging document] to comply with the evidence.'' Id.; Roy E.
Berkowitz, M.D., 74 FR 36758, 36759-60 (2009). The Agency has
interpreted the standard to be keystoned on whether the Respondent
had notice that a subject ``would be at issue in the proceeding.''
Pharmacy Doctors, 83 FR at 10898. The Agency has declined to find
inadequate notice, even where the Government has actually cited an
errant provision of the regulations. Wesley Pope, M.D., 82 FR 14944,
14946 (2017). Here, the charging document and Government's
Prehearing Statement provided a definition of pattern prescribing
with conjunctive terms and proceeded on a subset of its definition.
The language in the charging document included ``many'' patients
with the same surname and diagnosis codes (ALJ Ex. 1 at 11, ] 12)
and the language in the Government's Prehearing Statement alleged
that this was ``often'' the case. ALJ Ex. 4 at 21. It is
unpersuasive to argue that the Respondent was fatally misled because
some or even all of the pattern prescribing alleged by the
Government failed to contain every potential attribute listed in the
charging document and prehearing statement. Inclusion of all
elements all pattern prescribing was not alleged by the plain
language in either document. The Respondent received adequate notice
that pattern prescribing was an issue in the case, and its objection
in this regard is unfounded. In any event, even if every pattern
prescribing allegation set forth by the OSC/ISO and the Government's
Prehearing Statement were not sustained in this case, it would not
alter the outcome. The remaining massive volume of misconduct
alleged and preponderantly established by the Government even
without any of the pattern prescribing alleged and established in
this case would render the pattern prescribing evidence superfluous.

---------------------------------------------------------------------------

[[Page 72051]]

[Sanction] *^P
---------------------------------------------------------------------------

*\P\ I am replacing portions of the Sanction section in the RD
with preferred language regarding prior Agency decisions; however,
the substance is primarily the same.
---------------------------------------------------------------------------

The evidence of record preponderantly establishes that the
Respondent has committed a massive volume of acts which render its
continued registration inconsistent with the public interest. See 21
CFR 1301.44(e) (establishing the burden of proof in DEA administrative
proceedings). Since the Government has met its burden in demonstrating
that the revocation it seeks is proper, the Respondent must show that
given the totality of the facts and circumstances revocation is not
warranted. See Med. Shoppe-Jonesborough, 73 FR at 387. In order to
rebut the Government's prima facie case, the Respondent must
demonstrate not only an unequivocal acceptance of responsibility but
also a demonstrable plan of action to avoid similar conduct in the
future. Jeri Hassman, M.D., 75 FR 8236. It has accomplished neither
objective.
Agency precedent is clear that a Respondent must ``unequivocally
admit fault'' as opposed to a ``generalized acceptance of
responsibility.'' The Medicine Shoppe, 79 FR 59504, 59510 (2014); see
also Lon F. Alexander, M.D., 82 FR 49704, 49728 (2017). To satisfy this
burden, the Respondent must ``show true remorse'' or an
``acknowledgment of wrongdoing.'' Robert A. Leslie, 68 FR 15527, 15528
(2003). The Agency has made it clear that unequivocal acceptance of
responsibility is paramount for avoiding a sanction. Robert L.
Dougherty, M.D., 76 FR 16823, 16834 (2011) (citing Jayam Krishna-Iyer,
74 FR 459, 464 (2009)). 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, 822 (10th Cir. 2011).
The Respondent's incantations of ``regret[ ]'' \148\ in this case
are unconvincing and serve as something of a testament to the elevation
of form over substance.*\Q\ Simply put, the Government's prima facie
case has not been rebutted. Words purporting to accept responsibility
are planted into a mosaic of equivocation and qualification which, in
this case, undermines any attempt to demonstrate that the Respondent
understands what it did wrong in any meaningful way and diminishes
confidence in its future performance as a registrant. To be sure, the
Respondent assented to the Government's proposed stipulations,\149\ but
its case rested primarily on its pervasive view that every
transgression was not really all that bad. ALJ Ex. 5 at 2. As detailed
above, these stipulations include numerous dispensing events that
presented one or more unresolved red flags.\150\ As discussed, supra,
testimony from Mr. Vicellio and Mr. Bryce contained equal measures of
purported admissions of wrongdoing and justifications about why the red
flags should not be red flags, how even if the red flags were arguably
valid they did not really apply to the instances involving the
Respondent pharmacy, that even if the red flags did have some
application, the offense was again, really not all that bad, and even
if the offenses were bad, the Louisiana Pharmacy Board should have been
more like Texas and included the words ``red flag'' in its guidance
documents.
---------------------------------------------------------------------------

\148\ ALJ Ex. 4 at 23.
*\Q\ Prior Agency decisions have made it clear that in order to
avoid sanction once the Government has established a prima facie
case, a registrant must do more than say the right thing on the
stand and in filings. ``The degree of acceptance of responsibility
that is required does not hinge on the respondent uttering ``magic
words'' of repentance, but rather on whether the respondent has
credibly and candidly demonstrated that he will not repeat the same
behavior and endanger the public in a manner that instills
confidence in the Administrator.'' Jeffrey Stein, M.D., 84 FR 46968,
49973 (2019).
\149\ ALJ Ex. 5 at 2.
\150\ See Appendix.
---------------------------------------------------------------------------

Mr. Bryce provided some lip service to contrition, but continually
undermined those words by such propositions as distance prescribing was
justified in this case because the Respondent's staff knew their
customers,\151\ pattern prescribing evidence was dispatched with the
representation that the staff knew the prescribers,\152\ alternative
payment issues were dismissed by protestations that the pharmacy was
simply trying to make life affordable for its customers,\153\ doctor
shopping was addressed with a lecture that different specialists
prescribe for different ailments, and by Mr. Bryce's view of the facts,
trinity prescribing could not have been so bad (only a ``concern''
\154\), because the FDA's guidance was never really a ``hard stop,''
and trinity prescriptions, even after the black box warning, are still
alive and well.\155\ Perhaps the most discouraging of Mr. Bryce's
equivocations was his adoption of Mr. Vicellio's theme that the
Louisiana Pharmacy Board is somehow responsible for the Respondent's
troubles, because unlike Texas, the Louisiana Pharmacy Board has not
used the exact words ``red flag.'' \156\
---------------------------------------------------------------------------

\151\ Tr. 1044-45.
\152\ Tr. 931, 1038-40.
\153\ Tr. 992-97.
\154\ Tr. 980.
\155\ Tr. 987-89.
\156\ Tr. 977.
---------------------------------------------------------------------------

The Respondent's closing brief made it clear that its witnesses'
acceptances of responsibility equivocations (as ubiquitous as they
were) could not be easily dismissed as unartful or unintentional
misstatements borne of the pressure of testifying at a hearing. In its
brief, the Respondent prefixes its acceptance of flying through red
flags of diversion by highlighting that ``the Louisiana Board of
Pharmacy has not identified th[e trinity] combination as involving a
red flag (or discussed `red flags' or officially acknowledged that
there is such a thing for that matter). . . .'' ALJ Ex. 20 at 2.
Elsewhere in its closing brief, in the course of challenging the
credentials of the Government's expert, the Respondent makes the
following point:

The Louisiana Board of Pharmacy does not even mention the term
``red flag'' in any of its publications, policy statements or
regulations, and that term is not used in the statutes governing
pharmacy in Louisiana.

Id. at 9.\157\ Similarly, the FDA black box warnings are dismissed as
all but irrelevant because:
---------------------------------------------------------------------------

\157\ Ironically, the Respondent, in its closing brief, appears
to level criticism based on the fact that unlike Texas ``in both
Louisiana and federal law, the term `pill mill' is at most a
colloquial or slang term which is not used in any official way by
either the Louisiana Board of Pharmacy or the [DEA], and is not
found anywhere in Louisiana or federal statutory or regulatory
law.'' Id. at 9. In light of the evidence as developed in this case,
this observation, if assumed, arguendo, as valid, likely inures to
the Respondent's benefit.

[[Page 72052]]

---------------------------------------------------------------------------

The FDA never said any such thing about such a requirement being
imposed upon pharmacists. There is nothing within the FDA's 2016
statement that states or suggests that a pharmacist should
``carefully review'' anything about the purpose for which these
[trinity] prescriptions are issued.

Id. at 3. Thus, the Respondent, through its counsel, still actively
takes the position that the FDA warnings about the potential perils
attendant upon a particular combination of drugs should have no effect
whatsoever on its pharmacists' dispensing practices, or even impact
upon their analyses as professionals. The Respondent's closing brief
echoes Mr. Bryce's dismissal of the danger by pointing out that
``[t]here are literally millions of such [trinity] combinations of
these two medications being prescribed every year, and the FDA's 2016
statement has not significantly reduced this number.'' Id.
The Respondent's brief likewise makes quick work of the red flag of
alternative payment methods right before its incongruent purported
acceptance of responsibility in the following way:

Today, when all but one state has a PMP (including Louisiana) a
patient could not avoid detection of doctor-shopping through this
means, and there exist multiple commercial services which often
provide a lower price for medications than is available through
insurance--such services, such as Good RX advertise this feature.
Many of the instances in which cash payments were used [by the
Respondent pharmacy] occurred because the patient's health insurance
would not pay for the medication, or would only pay for a portion of
the prescription because the benefits available only covered a
shorter period.

Id. at 4. The Respondent is apparently not concerned here either. The
theory is that this should not even be a red flag for pharmacy
registrants because the PMP will pick up the issue anyway.

There is likely no more telling argument set forth in the
Respondent's brief than its handling of the DEA's exercise in
investigatory lenity in allowing the on-hand controlled substances at
the Respondent pharmacy to be transferred to MP West instead of seizing
the drugs.\158\ By the Respondent's reckoning, this discretionary act
of forbearance at the execution of the ISO ``is something that the
[DEA] agents would not have done had they believed that the pharmacy's
personnel were engaged in ongoing lawless behavior.'' Id. at 10. As it
happens, the evidence here preponderantly and convincingly established
that the Respondent's pharmacy personnel were in fact ``engaged in
ongoing lawless behavior.'' Id. It seems that it is the Respondent's
managers who are unwilling to believe it, and this interpretation of
events speaks volumes as to how an exercise in discretionary lenity in
the Agency's final order would likely be viewed by the Respondent.
---------------------------------------------------------------------------

\158\ 21 U.S.C. 824(f).
---------------------------------------------------------------------------

Notwithstanding the staggering volume of transgressions established
by the record, the Respondent dismisses the number as ``a very tiny
percentage of the almost 800,000 prescriptions filled during the time
period covered by the ISO.'' Id. at 20. The Respondent's acceptance of
responsibility is narrowly tailored (consistent with the testimony of
its witnesses) to ``its improper filling of certain controlled
substances including, in some instances, is failure to document the
resolution of red flags.'' Id. at 2. Suffice to say, the Respondent has
not supplied the Agency with an unequivocal acceptance of
responsibility. More than that, it is clear that beyond equivocating,
the Respondent somehow does not comprehend that it was wrong, and
egregiously and voluminously so.
While the transgressions alleged and proved here are serious and
numerous, it is arguable that a true, unequivocal acceptance of
responsibility, coupled with a thoughtful plan of remedial action could
have gone a long way to supporting a creditable case for sanction
lenity. The Agency has frequently required unambiguous acceptance of
responsibility and a remedial action plan as an essential component to
avoid a sanction,\159\ and in this case the reality that the
Respondent, truly acknowledging no deficiencies that are immune from
explanation, has limited its remedial action investments to increased
documentation requirements, a single staff training session, a sixteen-
page list of talking points, and stepping up internal documentation
rules to a point where they should always have been. Neither the
Respondent pharmacy PIC (who even yet remains the PIC), nor any other
employee or manager received any form of discipline or consequence as a
result of the wholesaling doling out of dangerous drugs for three years
with reckless abandon. Tr. 836-37. In the Respondent's view, its
pharmacists really did nothing wrong once the circumstances were
explained. Although the Respondent put in place some improved
documentation requirements, the remedial plan is by no means a
thoughtful or comprehensive one, staff training is not ongoing, and in
light of myriad excuses and explanations it is difficult to be
confident that the Respondent and its staff would make responsible
choices as a registrant in the future. [Omitted.]* \R\ Thus, in the
face of a prima facie case, without the Respondent meeting the evidence
with a convincing, unequivocal acceptance of responsibility and
proposing thoughtful, concrete remedial measures geared toward avoiding
future transgressions, the record supports the imposition of a
sanction. That a sanction is supported does not end the inquiry,
however.
---------------------------------------------------------------------------

\159\ Hassman, 75 FR at 8236. [Edited the footnoted sentence for
clarity.]
*\R\ Respondent took exception to this text claiming that the
Chief ALJ ``transformed his `difficult to be confident' finding into
a finding that absent a registration sanction the agency would be
`creating a likelihood that it will be instituting new proceedings,
charging the same conduct, soon thereafter.' '' Resp Exceptions, at
8. I adopt the Chief ALJ's finding that it is difficult to be
confident in Respondent's future compliance and therefore find that
I cannot trust Respondent with a registration. I find that the Chief
ALJ's further findings are irrelevant to my final decision in this
case and do not impact my sanctions determination.
---------------------------------------------------------------------------

In determining whether and to what extent imposing a sanction is
appropriate, consideration must also be given to the Agency's interest
in both specific and general deterrence and the egregiousness of the
offenses established by the Government's evidence. Ruben, 78 FR at
38364, 38385.
Considerations of specific and general deterrence militate in favor
of revocation. As discussed, supra, the Respondent has made it clear
that it feels that it was not so much wrong as misunderstood. Its
interpretation of the decision to forego drug seizure on the date of
the ISO execution reveals a thought process that leniency connotes lack
of trepidation on the part of the Agency. The interests of specific
deterrence, therefore, compel the imposition of a sanction.
Likewise, 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 at 38385. To
continue the Respondent's registration privileges on the present record
would send a message to the regulated community that so long as there
is some deficiency in the literature disseminated by state regulatory
authorities, or some contextual justification for the failure to
identify, resolve, and document dispensing in the face of clear red
flags, compliance that might bear some efficiency costs on a busy
pharmacy are optional. Even if the Agency discovers legions of improper
dispensing events, impactful consequences can be avoided merely by a
single training afternoon on

[[Page 72053]]

a pamphlet, and promising more documentation in the future.
Regarding the egregiousness of the Respondent's conduct, as
discussed, supra, the evidence demonstrates a staggering volume of
improper actions, and it is clear that this Respondent's pharmacists
had no interest in monitoring for, identifying, or resolving any
indicators of potential controlled substance diversion. The comparative
volume of controlled substance purchases uncovered by DEA during the
course of its investigation reveals staggering disparities between the
amount purchased by the Respondent pharmacy compared to other,
similarly-situated enterprises through multiple lenses. [Omitted for
relevance.] *\S\ Mr. Bryce's testimony gave the sense that the
Respondent views these charges as the failure of regulators to
understand the analysis that was naturally done by the pharmacists on
duty, and the venial sin of neglecting to adequately document.*\T\ As
it happens, this Respondent did fail to exercise the level of care in
dispensing and (equally importantly) documenting its dispensing
decisions in a manner that would allow a meaningful evaluation by those
charged with regulating controlled substances.
---------------------------------------------------------------------------

*\S\ The Respondent, in its Exceptions, objected to the Chief
ALJ's finding that ``[t]he Respondent's objective appeared to be to
inexorably dispense as many controlled substances as possible as
fast as possible, while asking as few questions as possible.''
Respondent points out that the record evidence does ``not reveal the
percentage of controlled substances versus non-controls being
dispensed at the pharmacy'' and that only 15% of Respondent's
dispensed prescriptions were controlled substances which was an
indication of proper pharmacy practice. Resp Exceptions, at 12. I
have omitted the Chief ALJ's finding because it is not relevant to
my decision in this matter. This case is about whether or not the
prescriptions at issue (which were largely stipulated to) were
issued outside the usual course of professional practice such that
Respondent's continued registration would be against the public
interest. This case is not about Respondent's dispensing of non-
controlled substances or about the percentage of controlled versus
non-controlled substances dispensed. While positive dispensing
experience can be considered under Factor Two, that experience is
limited to positive dispensing of controlled substances. For the
purpose of this case I have assumed that every prescription, other
than those at issue in this case, was lawfully issued. Still, I find
that Respondent's dispensing of the prescriptions at issue was
sufficiently egregious to support revocation of its registration and
my decision is not changed by Respondent's fourth Exception. Resp
Exceptions, at 11-13.
*\T\ Omitted for brevity.
---------------------------------------------------------------------------

A balancing of the statutory public interest factors, coupled with
consideration of the Respondent's failure to meaningfully accept
responsibility, the absence of record evidence of thoughtful and
continuing remedial measures to guard against recurrence, and the
Agency's interest in deterrence, supports the conclusion that the
Respondent should not continue to be entrusted with a
registration.*^{U 160}
---------------------------------------------------------------------------

*\U\ Omitted for clarity. I agree with the Chief ALJ's analysis
above which focuses on whether or not, in light of the egregiousness
of their actions, their equivocal acceptance of responsibility, and
their proposed remedial measures, Respondent's current ownership and
leadership can currently be entrusted with a registration. And I
agree with the Chief ALJ that they cannot. The Chief ALJ went on to
evaluate Respondent's historical circumstances, not as irrelevant
community impact evidence, but as evidence in support of
Respondent's ability to comply with the CSA at some unknown point in
the future. Although I credit Respondent for being a long-standing
fixture in the community, I do not find that there is any evidence
on the record that demonstrates that this is relevant to its
compliance with the CSA. As I have stated, I have assumed that all
controlled substance prescriptions not at issue in this case were
filled legitimately. Although logically the pressure of a long-
standing family business could provide some incentive towards
integrity, the fact is that the current owners and employees of
Respondent pharmacy have not convinced me that this pharmacy can be
entrusted with a registration.
\160\ Tr. 802-03.
---------------------------------------------------------------------------

Accordingly, the Respondent's DEA COR should be revoked, and any
pending applications for renewal should be denied.*\V\
---------------------------------------------------------------------------

*\V\ The Chief ALJ went on to state that if ``the Respondent
presents the Agency with a comprehensive remedial action plan truly
aimed at avoiding recurrence, and communicates credible indicia of
an unequivocal acceptance of responsibility, it is further
recommended that strong consideration be made to favorable
consideration of a COR application filed no earlier than two years
from the date of the publication of the Agency's final order in the
Federal Register.'' RD, at 67. This recommendation, which seems to
be related to the analysis in supra n.*U, is too theoretical to
include in my final decision, and I do not find that such inclusion
is warranted. Any new application in the future would be
appropriately evaluated on its own merits, to include Respondent
pharmacy's behavior in the intervening timeframe. See Robert L.
Doughtery, M.D., 76 FR 16823, 16835 (2011) (stating that when
determining whether to grant an application where misconduct has
already been proven, ``DEA has long held that the paramount issue is
not how much time has elapsed since his unlawful conduct, but
rather, whether during that time Respondent has learned from past
mistakes and has determined that he would handle controlled
substances properly if entrusted with a new registration'' (cleaned
up)).

---------------------------------------------------------------------------
John J. Mulrooney, II,

Chief Administrative Law Judge.

The Respondent's Exceptions

On July 22, 2020, Respondent filed its Exceptions to the RD. I find
that Respondent's six Exceptions *\W\ are largely without merit and I
have addressed the majority of them in footnotes added to the
corresponding parts of the RD above. The remaining Exceptions are
addressed herein. While I have made some modifications to the RD based
on the Exceptions, none of those changes and none of Respondent's
arguments persuaded me to reach a different conclusion than the Chief
ALJ in this matter. Therefore, I reject Respondent's Exceptions and
affirm the RD's conclusion that Respondent's continued registration is
inconsistent with the public interest, and that revocation is the
appropriate sanction.
---------------------------------------------------------------------------

*\W\ The exceptions are numbered 1-5, then 7, skipping 6.
---------------------------------------------------------------------------

Exception 3, Regarding Acceptance of Responsibility

Respondent takes exception to the Chief ALJ's finding that
Respondent failed to unequivocally accept responsibility for its
actions in this case. Resp Exceptions, at 9. First, Respondent
explained, the Government took the position that Respondent's
acceptance of responsibility in this case was sufficient to make out a
prima facie case against the Respondent.*\X\ Resp Exceptions, at 9
(citing Gov Posthearing, at 29-30). Respondent seems to be suggesting
that because of the Government's position (which was not relied upon in
reaching this decision), I am estopped from finding that Respondent's
acceptance of responsibility was not unequivocal. This argument is
unconvincing. In enforcement actions, it is my responsibility to
determine whether registrants can be entrusted with a registration and
my decision is not bound by an in-the-alternative *\Y\ argument
presented in a Posthearing Brief. Furthermore, DEA decisions have long
established that once the Government has made a prima facie case
establishing one or more grounds for revocation, I review the evidence
and argument Respondent submitted to determine whether or not it has
presented ``sufficient mitigating evidence to assure the Administrator
that [it] can be trusted with the responsibility carried by such a
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, M.D., 53 FR 21931, 21932 (1988)). Contrary to
Respondent's position, DEA decisions have frequently sanctioned
registrants who have stipulated to the full extent of the violations in
the Government's prima facie case based on DEA's inability to entrust
them with a registration in the face of egregious violations of law.
See William Ralph Kincaid, M.D., 86 FR

[[Page 72054]]

40636 (2021); Robert Wayne Locklear, 86 FR 33738 (2021); Jeffrey Stein,
M.D., 86 FR 46968 (2019). Next, Respondent argued that the Chief ALJ
used the Respondent's explanation of ``how it came to be in the
position of dispensing these prescriptions'' and identification of
``instances where it appeared that a claim was being made that was not
supported by the facts'' against Respondent in determining that
Respondent did not unequivocally accept responsibility. Resp
Exceptions, at 9-10. The two specific factual references that the
Respondent states should not have been weighed against its acceptance
of responsibility were that the ``Louisiana Board of Pharmacy failed to
provide any guidance for its pharmacists regarding `red flags' '' and
that ``literally millions of prescriptions for [an opiate and a
benzodiazepine] were being issued by doctors in the United States every
year.'' Id.
---------------------------------------------------------------------------

*\X\ I note that in its Posthearing, the Government seems to
have first set forth the evidence it produced to establish its prima
facie case and then argued, in the alternative, that the prima facie
case was also met through Respondent's admission. Gov Posthearing,
at 21-30.
*\Y\ The Government also argued that Respondent failed to
unequivocally accept responsibility, and Respondent is certainly not
suggesting that I be bound by that argument. Gov Posthearing, at 2.
---------------------------------------------------------------------------

I recognize that Respondent has every right to present its case and
defend its actions in this matter. However, the agency has long
considered statements that are aimed at minimizing the egregiousness of
its conduct to weigh against a finding of acceptance of full
responsibility. See Ronald Lynch, M.D., 75 FR 78745, 78754 (2010)
(Respondent did not accept responsibility noting that he ``repeatedly
attempted to minimize his [egregious] misconduct''; see also Michael
White, M.D., 79 FR 62957, 62967 (2014) (finding that Respondent's
``acceptance of responsibility was tenuous at best'' and that he
``minimized the severity of his misconduct by suggesting that he thinks
the requirements for prescribing Phentermine are too strict.''). The
Agency does not bar explanations or rationale as to why the misconduct
might have occurred, as long as the acceptance of responsibility is
unequivocal and credible, see Michele L. Martinho, M.D., 86 FR 24012,
24020 (2021), but the Agency analyzes such acceptance on a case-by-case
basis and the crucial aspect of a Respondent's acceptance of
responsibility is that it demonstrate to me that it can be entrusted
with a registration--that it will not repeat the egregious behavior
that occurred.
Here, Respondent through its two witnesses repeatedly made general
statements claiming full acceptance of responsibility. For example, Mr.
Vicellio testified, ``[b]efore we [did not] have [written policies and
procedures] and . . . [t]hat is on me, and I do apologize.'' Tr. 837.
Mr. Bryce testified ``we 100 percent acknowledge our failure on our . .
. corresponding responsibility and we are dedicated, devoted, going
overboard, as a matter of fact, because I can guarantee you [there is]
no pharmacy in Louisiana that we are aware of or that we even gather
you could find that is doing the level of documentation and fulfilling
their corresponding responsibilities like we are.'' Tr. 990-91.
However, when the testimony more narrowly focused on the specific
deficiencies at issue, it became clear that Respondent was minimizing
the extent of its misconduct as the Chief ALJ set forth fully in his
decision. See supra at The Respondent's Case. Mr. Bryce was
particularly unapologetic for the Respondent's failures with regard to
accepting alternating payment methods (a cost-saving and an insurance
issue), doctor shopping (different specialists prescribe for different
ailments), and in some cases trinity prescribing (other pharmacies are
still filling these drugs and the FDA never really called a ``hard
stop''). Respondent did not convince me that it believed that these red
flags were indicators of potential diversion that needed serious
consideration and proper resolution, and minimized the potential
harmful consequences of its actions by stating that the FDA never put a
``hard stop'' on prescribing the trinity cocktail and it is still being
prescribed. In this case, the Respondent's comments regarding red flags
demonstrate a lack of full understanding of the extent of its
wrongdoing. If I believed that it had demonstrated a complete
understanding of its misconduct and understood and accepted the
potential for harm that it caused, I would be less concerned about its
future compliance. See Robert Wayne Locklear, M.D., 86 FR 33738, 33745
(2021) (finding that a respondent's inability to understand the full
consequences of his actions weighed against a finding of acceptance of
responsibility). As it stands, I was not convinced that Respondent had
fully and unequivocally accepted responsibility for its actions. I
recognize that Respondent put policies in place that it believes will
better identify these potential red flags. Correcting unlawful behavior
and practices is very important to establish acceptance of
responsibility; however, conceding wrongdoing is critical to
reestablishing trust with the Agency. Holiday CVS, L.L.C., 77 FR 62316,
62346 (2012), Daniel A. Glick, D.D.S., 80 FR 74800, 74801 (2015). I
agree with the Chief ALJ's finding that Respondent failed to
unequivocally accept responsibility for its actions in this case.

Exception 2, Regarding Remedial Measures

Where a respondent has not credibly accepted responsibility for its
misconduct, I am not required to consider evidence of remedial
measures. See Jones Total Health Care Pharmacy, L.L.C., 81 FR 79202-03.
Even if Respondent's acceptance of responsibility for his wrongdoing
had been sufficient such that I would consider remedial measures,
Respondent has not offered adequate remedial measures here to assure me
that I can entrust it with a registration. See Carol Hippenmeyer, M.D.,
86 FR 33748, 33773 (2021). And if Respondent had offered adequate
remedial measures to assure me under other circumstances, my sanctions
analysis in this case would still have supported revocation as a
sanction. This is because remedial measures, when considered, are only
one of several elements that I evaluate when determining how to
exercise my discretionary authority to sanction a registrant.*\Z\ If,
following that analysis, I am not confident that I can entrust a
respondent with the weighty responsibility of maintaining a
registration, then I can only find that revocation is an appropriate
sanction.
---------------------------------------------------------------------------

*\Z\ ``While the CSA establishes parameters for issuing and
terminating registrations, the final registration-related decision,
such as granting or denying a registration, and continuing,
suspending, or revoking a registration, is left to the reviewable
discretion of the Attorney General. 21 U.S.C. 823 and 824 (using the
word ``may'' in provisions to confer discretion on the Attorney
General regarding the granting, denying, continuing, suspending, and
revoking of practitioner registrations).'' See Frank Joseph
Stirlacci, M.D., 85 FR 45229, n.18 (2019).
---------------------------------------------------------------------------

Respondent takes exception to the Chief ALJ's finding that
Respondent's remedial measures, namely new policies and procedures,
were not sufficient to prevent the recurrence of future CSA violations.
Respondent advances this argument from several different angles. First,
Respondent claims that there was no ``evidence challenging the facial
validity of these procedures.'' Resp Exceptions, at 6. Respondent
claims that no ``government witness addressed the content of the new
procedures,'' ``no evidence was offered to show [what] a set of
procedures that have been declared sufficient might look like,'' and
that ``the ALJ effectively acted as his own witness in making the
subject determination regarding the new procedures.'' Id. at 6-8.
Respondent has offered no support for its proposition that I am
required to accept its proposed policies and procedures as ``facially
valid'' or that I am required to receive counter evidence regarding the
efficacy of its proposed remedial measures.

[[Page 72055]]

Where the Government has established a prima facie case for revocation
of a registrant's COR, the burden of production then shifts to the
registrant to show that, given the totality of the facts and
circumstances in the record, revoking the registrant's COR would not be
appropriate. Med. Shoppe-Jonesborough, 73 FR 364, 387 (2008). Here, the
Respondent has not presented convincing evidence that I can entrust it
with a registration.
Next, Respondent argues, the Chief ALJ erred by speculating as to
whether or not the proposed remedial measures would be effective
because, ``[p]redictions [are not] needed when actual facts are
available.'' Resp Exceptions, at 8. The ``facts,'' which Respondent
claims were not considered by the ALJ, are that Respondent has
``invit[ed] the agency to check out the operations at Medical Pharmacy
West,'' because an investigation would capture whether or not ``the new
procedures were . . . effectively preventing prescriptions from being
filled despite these unresolved red flags.'' Id. Respondent has not
provided any support for the notion that DEA's lack of an inspection is
proof of the legality of a pharmacy's operation. It is clear that ``the
agency has discretion regarding whether to bring an enforcement
action.'' See Ester Mark, M.D., 86 FR 16760, 16762 (2021) (respondent
argued that a time lapse in the investigation and the renewal of her
registration during the investigation did not align with the DEA being
concerned about her prescribing behavior); (citing Stirlacci, 85 FR at
45236). I sincerely hope, as Respondent contests, that Respondent's
sister pharmacy is complying with the law as the Agency will continue
to regulate that pharmacy's controlled substances registration;
however, after numerous, egregious violations of federal and state law
were proven, it was incumbent on the Respondent pharmacy to present the
evidence required to demonstrate that its remedial measures were
adequate.
Finally, Respondent argues that Mr. Bryce, who was tendered as an
expert in the practice of pharmacy in Louisiana, offered uncontroverted
testimony that the new policies and procedures ``were designed to
address the red flags at issue in the case.'' Resp Exceptions, at 9.
Respondent goes on to suggest that I am bound by an uncontradicted
opinion of an expert. Id. However, Mr. Bryce's testimony on the matter
was:

Q: And the new policies and procedures adopted by Medical
Pharmacy West that will go into effect at the pharmacy, designed to
attempt to resolve, to handle those red flags and provide a set
means of doing so in the future?
A: Yes, sir. They're designed to provide guidance without any
question as to how we are going to handle the red flag and the
documentation as such, that they are to be resolved.

Tr. 1050. This testimony appears to be fact testimony explaining what
goals Mr. Bryce intended to accomplish when he drafted the new
policies. This does not appear to be expert testimony opining as to
whether or not the procedures are sufficient to ensure that any
prescriptions issued pursuant to policy will be in compliance with the
CSA. Even if Mr. Bryce did intend to testify to the latter, I must
consider a witness's credibility in determining what weight to give the
testimony. Here, I am not convinced that Mr. Bryce fully understands
Respondent's corresponding responsibility under the CSA *\AA\ such that
I would credit his opinions on the requirements necessary to comply
with the CSA.
---------------------------------------------------------------------------

*\AA\ For example, as the Chief ALJ set forth in supra n. 124,
rather than having in-depth, ongoing training on how to spot and
resolve red flags and verify the legitimacy of prescriptions,
Respondent decided they would no longer dispense, carisoprodol, a
legal controlled substance. Tr. 982. While this remedial measure may
prevent illegitimate prescriptions of carisoprodol from being
dispensed, it does not fill me with confidence that Respondent fully
understands the requirements of its corresponding responsibility.
Additionally, Respondent's minimization of the severity of the
potential dangers of prescribing the trinity cocktail by stating
that it is still being frequently filled do not demonstrate a
complete understanding of the misconduct that occurred.

Additionally, in assessing remedial measures, the Agency must
consider its mission in preventing the diversion and misuse of
controlled substances and the feasibility of monitoring and enforcing
such measures. DEA budgets for approximately 2000 Diversion positions
involved in regulating more than 1.9 million registrants overall. See
DEA FY2022 Budget Request available at https://www.justice.gov/jmd/page/file/1398361/download. 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. See
Jeffrey Stein, M.D., 84 FR at 46974.
Most importantly, the fact remains that, following my sanctions
analysis, I am not confident that I can entrust Respondent with the
weighty responsibility of maintaining a registration. If I cannot
entrust Respondent to implement its proposed remedial measures, then it
does not matter whether the measures themselves would adequately
address the misconduct. This is why generally I do not consider
remedial measures without first establishing an adequate acceptance of
responsibility. I need to be confident that the policies will be
followed, and I do not have such confidence that would persuade me to
place the burden on the Agency whose trust Respondent broke to monitor
its compliance with its remedial measures. See Kaniz Khan Jaffery, 85
FR 45667, 45690 (2020) (finding that respondent hid behind rote
diversion controls without legitimately attending to and documenting
red flags). Due to the extent and egregiousness of Respondent's
misconduct, its failure to adequately accept responsibility, Respondent
has not given me reassurance that it can be entrusted with a
registration. See Leo R. Miller, M.D., 53 FR 21931, 21932 (1988)
(describing revocation as a remedial measure ``based upon the public
interest and the necessity to protect the public from individuals who
have misused controlled substances or their DEA Certificate of
Registration and who have not presented sufficient mitigating evidence
to assure the Administrator that they can be trusted with the
responsibility carried by such a registration.''). Accordingly, I
reject Respondent's Exceptions and affirm the RD's conclusion that
Respondent's registration should be revoked.

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 revoke DEA Certificate of
Registration No. AL3398117 issued to Medical Pharmacy. 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 further hereby deny any pending applications for
renewal or modification of this registration, as well as any other
pending application of Medical Pharmacy for registration in Louisiana.
This Order is effective January 19, 2022.

Anne Milgram,
Administrator.

United States Department of Justice

Drug Enforcement Administration

In the Matter of: Medical Pharmacy.

Docket No. 20-04

Appendix to the Recommended Decision

The following dispensing events were established by the mutual
stipulation of the parties.

[[Page 72056]]

Patient CH

The Government's evidence established the following dispensing
events with respect to Patient CH:

Patient JMB

The Government's evidence established the following dispensing
events with respect to Patient JMB:

----------------------------------------------------------------------------------------------------------------
Dispensing event Date Medications Source
----------------------------------------------------------------------------------------------------------------
JMB1............................ 6/05/2017 Hydromorphone 8 mg, 120 Stip. 4(a).
tablets.
JMB2............................ 6/05/2017 Alprazolam 1 mg, 60 tablets. Stip. 4(b).
JMB3............................ 6/05/2017 Carisoprodol 350 mg, 120 Stip. 4(c).
tablets.
JMB4............................ 6/05/2017 Morphine SO4 ER 30 mg, 90 Stip. 4(d).
tablets.
JMB5............................ 7/05/2017 Hydromorphone 8 mg, 120 Stip. 4(h).
tablets.
JMB6............................ 7/05/2017 Alprazolam 1 mg, 60 tablets. Stip. 4(e).
JMB7............................ 7/05/2017 Carisoprodol 350 mg, 120 Stip. 4(g).
tablets.
JMB8............................ 7/05/2017 Morphine SO4 ER 30 mg, 90 Stip. 4(f).
tablets.
JMB9............................ 9/14/2017 Alprazolam 1 mg, 60 tablets. Stip. 4(i).
JMB10........................... 9/27/2017 Morphine SO4 ER 30 mg, 30 Stip. 4(j).
tablets.
JMB11........................... 9/27/2017 Morphine SO4 ER 30 mg, 60 Stip. 4(k).
tablets.
JMB12........................... 9/27/2017 Carisoprodol 350 mg, 120 Stip. 4(l).
tablets.
JMB13........................... 9/27/2017 Hydromorphone 8 mg, 120 Stip. 4(m).
tablets.
JMB14........................... 10/27/2017 Carisoprodol 350 mg, 120 Stip. 4(n).
tablets.
JMB15........................... 10/27/2017 Hydromorphone 8 mg, 120 Stip. 4(o).
tablets.
JMB16........................... 12/20/2017 Carisoprodol 350 mg, 120 Stip. 4(p).
tablets.
JMB17........................... 12/20/2017 Alprazolam 1 mg, 50 tablets. Stip. 4(q).
JMB18........................... 12/20/2017 Hydromorphone 8 mg, 120 Stip. 4(r).
tablets.
JMB19........................... 12/21/2017 Morphine SO4 ER 30 mg, 60 Stip. 4(s).
tablets.
JMB20........................... 8/16/2018 Alprazolam 1 mg, 60 tablets. Stip. 4(t).
JMB21........................... 8/30/2018 Hydromorphone 8 mg, 120 Stip. 4(u).
tablets.
JMB22........................... 8/30/2018 Carisoprodol 350 mg, 120 Stip. 4(v).
tablets.
JMB23........................... 9/10/2018 Morphine SO4 ER 30 mg, 60 Stip. 4(w).
tablets.
JMB24........................... 9/21/2018 Alprazolam 1 mg, 60 tablets. Stip. 4(x).
JMB25........................... 9/27/2018 Carisoprodol 350 mg, 120 Stip. 4(y).
tablets.
JMB26........................... 9/27/2018 Hydromorphone 8 mg, 120 Stip. 4(z).
tablets.
JMB27........................... 10/15/2018 Morphine SO4 ER 30 mg, 60 Stip. 4(aa).
tablets.
JMB28........................... 10/24/2018 Carisoprodol 350 mg, 120 Stip. 4(bb).
tablets.
JMB29........................... 10/24/2018 Hydromorphone 8 mg, 120 Stip. 4(cc).
tablets.
JMB30........................... 11/13/2018 Morphine SO4 ER 30 mg, 60 Stip. 4(dd).
tablets.
JMB31........................... 11/27/2018 Hydromorphone 8 mg, 120 Stip. 4(ee).
tablets.
JMB32........................... 11/27/2018 Carisoprodol 350 mg, 120 Stip. 4(ff).
tablets.
JMB33........................... 11/29/2018 Alprazolam 1 mg, 60 tablets. Stip. 4(gg).
JMB34........................... 12/24/2018 Carisoprodol 350 mg, 120 Stip. 4(hh).
tablets.
JMB35........................... 12/24/2018 Hydromorphone 8 mg, 120 Stip. 4(ii).
tablets.
JMB36........................... 12/28/2018 Alprazolam 1 mg, 60 tablets. Stip. 4(jj).
JMB37........................... 1/08/2019 Morphine SO4 ER 30 mg, 60 Stip. 4(kk).
tablets.
JMB38........................... 1/22/2019 Hydromorphone 8 mg, 120 Stip. 4(ll).
tablets.
JMB39........................... 1/22/2019 Carisoprodol 350 mg, 120 Stip. 4(mm).
tablets.
JMB40........................... 2/08/2019 Alprazolam 1 mg, 60 tablets. Stip. 4(nn).
JMB41........................... 2/08/2019 Morphine SO4 ER 30 mg, 60 Stip. 4(oo).
tablets.
JMB42........................... 2/19/2019 Carisoprodol 350 mg, 120 Stip. 4(pp).
tablets.
JMB43........................... 2/19/2019 Hydromorphone 8 mg, 120 Stip. 4(qq).
tablets.
JMB44........................... 7/01/2019 Morphine SO4 ER 30 mg, 60 Stip. 4(rr).
tablets.
JMB45........................... 7/08/2019 Carisoprodol 350 mg, 120 Stip. 4(ss).
tablets.
JMB46........................... 7/08/2019 Hydromorphone 8 mg, 120 Stip. 4(tt).
tablets.
JMB47........................... 8/05/2019 Hydromorphone 8 mg, 120 Stip. 4(uu).
tablets.
JMB48........................... 8/05/2019 Carisoprodol 350 mg, 120 Stip. 4(vv).
tablets.
JMB49........................... 8/20/2019 Alprazolam 1 mg, 60 tablets. Stip. 4(ww).
JMB50........................... 8/27/2019 Hydromorphone 8 mg, 120 Stip. 4(xx).
tablets.
JMB51........................... 8/27/2019 Carisoprodol 350 mg, 120 Stip. 4(yy).
tablets.
----------------------------------------------------------------------------------------------------------------

[[Page 72057]]

Patient TD

The Government's evidence established the following dispensing
events with respect to Patient TD:

Patient DG

The Government's evidence established the following dispensing
events with respect to Patient DG:

----------------------------------------------------------------------------------------------------------------
Dispensing event Date Medications Source
----------------------------------------------------------------------------------------------------------------
DG1............................. 2/10/2017 Hydrocodone-Acetaminophen 10 Stip. 6(a).
mg/325 mg, 120 tablets.
DG2............................. 2/10/2017 Carisoprodol 350 mg, 30 Stip. 6(b).
tablets.
DG3............................. 2/21/2017 Diazepam 10 mg, 60 tablets.. Stip. 6(c).
DG4............................. 3/09/2017 Carisoprodol 350 mg, 30 Stip. 6(d).
tablets.
DG5............................. 3/09/2017 Hydrocodone-Acetaminophen 10 Stip. 6(e).
mg/325 mg, 120 tablets.
DG6............................. 3/21/2017 Diazepam 10 mg, 60 tablets.. Stip. 6(f).
DG7............................. 4/06/2017 Carisoprodol 350 mg, 30 Stip. 6(g).
tablets.
DG8............................. 4/06/2017 Hydrocodone-Acetaminophen 10 Stip. 6(h).
mg/325 mg, 120 tablets.
DG9............................. 4/26/2017 Diazepam 10 mg, 60 tablets.. Stip. 6(i).
DG10............................ 5/04/2017 Carisoprodol 350 mg, 30 Stip. 6(j).
tablets.
DG11............................ 5/04/2017 Hydrocodone-Acetaminophen 10 Stip. 6(k).
mg/325 mg, 120 tablets.
DG12............................ 5/30/2017 Diazepam 10 mg, 60 tablets.. Stip. 6(l).
DG13............................ 6/01/2017 Carisoprodol 350 mg, 30 Stip. 6(m).
tablets.
DG14............................ 6/01/2017 Hydrocodone-Acetaminophen 10 Stip. 6(n).
mg/325 mg, 120 tablets.
DG15............................ 6/29/2017 Diazepam 10 mg, 60 tablets.. Stip. 6(o).
DG16............................ 6/29/2017 Hydrocodone-Acetaminophen 10 Stip. 6(p).
mg/325 mg, 120 tablets.
DG17............................ 6/29/2017 Carisoprodol 350 mg, 30 Stip. 6(q).
tablets.
DG18............................ 7/27/2017 Carisoprodol 350 mg, 30 Stip. 6(r).
tablets.
DG19............................ 7/27/2017 Hydrocodone-Acetaminophen 10 Stip. 6(s).
mg/325 mg, 120 tablets.
DG20............................ 7/28/2017 Diazepam 10 mg, 60 tablets.. Stip. 6(t).
DG21............................ 8/23/2017 Diazepam 10 mg, 60 tablets.. Stip. 6(u).
DG22............................ 8/24/2017 Carisoprodol 350 mg, 30 Stip. 6(v).
tablets.
DG23............................ 8/27/2017 Hydrocodone-Acetaminophen 10 Stip. 6(w).
mg/325 mg, 120 tablets.
DG24............................ 9/21/2017 Carisoprodol 350 mg, 30 Stip. 6(x).
tablets.
DG25............................ 9/21/2017 Hydrocodone-Acetaminophen 10 Stip. 6(y).
mg/325 mg, 120 tablets.
DG26............................ 9/25/2017 Diazepam 10 mg, 60 tablets.. Stip. 6(z).
DG27............................ 11/16/2017 Hydrocodone-Acetaminophen 10 Stip. 6(aa).
mg/325 mg, 120 tablets.
DG28............................ 11/16/2017 Carisoprodol 350 mg, 30 Stip. 6(bb).
tablets.
DG29............................ 11/20/2017 Diazepam 10 mg, 60 tablets.. Stip. 6(cc).
DG30............................ 12/14/2017 Hydrocodone-Acetaminophen 10 Stip. 6(dd).
mg/325 mg, 120 tablets.
DG31............................ 12/14/2017 Carisoprodol 350 mg, 30 Stip. 6(ee).
tablets.
DG32............................ 12/14/2017 Diazepam 10 mg, 60 tablets.. Stip. 6(ff).
DG33............................ 1/12/2018 Carisoprodol 350 mg, 30 Stip. 6(gg).
tablets.
DG34............................ 1/12/2018 Hydrocodone-Acetaminophen 10 Stip. 6(hh).
mg/325 mg, 120 tablets.
DG35............................ 1/24/2018 Diazepam 10 mg, 60 tablets.. Stip. 6(ii).
DG36............................ 2/09/2018 Carisoprodol 350 mg, 30 Stip. 6(jj).
tablets.
DG37............................ 2/09/2018 Hydrocodone-Acetaminophen 10 Stip. 6(kk).
mg/325 mg, 120 tablets.
DG38............................ 2/21/2018 Diazepam 10 mg, 60 tablets.. Stip. 6(ll).
DG39............................ 3/09/2018 Hydrocodone-Acetaminophen 10 Stip. 6(mm).
mg/325 mg, 120 tablets.
DG40............................ 3/09/2018 Carisoprodol 350 mg, 30 Stip. 6(nn).
tablets.
DG41............................ 3/26/2018 Diazepam 10 mg, 60 tablets.. Stip. 6(oo).
DG42............................ 6/06/2018 Carisoprodol 350 mg, 30 Stip. 6(pp).
tablets.
DG43............................ 6/06/2018 Hydrocodone-Acetaminophen 10 Stip. 6(qq).
mg/325 mg, 120 tablets.
DG44............................ 6/14/2018 Diazepam 10 mg, 60 tablets.. Stip. 6(rr).
DG45............................ 7/05/2018 Carisoprodol 350 mg, 30 Stip. 6(ss).
tablets.
DG46............................ 7/05/2018 Hydrocodone-Acetaminophen 10 Stip. 6(tt).
mg/325 mg, 120 tablets.
DG47............................ 7/16/2018 Diazepam 10 mg, 60 tablets.. Stip. 6(uu).
DG48............................ 8/02/2018 Carisoprodol 350 mg, 30 Stip. 6(vv).
tablets.
DG49............................ 8/02/2018 Hydrocodone-Acetaminophen 10 Stip. 6(ww).
mg/325 mg, 120 tablets.
DG50............................ 8/13/2018 Diazepam 10 mg, 60 tablets.. Stip. 6(xx).
DG51............................ 8/30/2018 Carisoprodol 350 mg, 30 Stip. 6(yy).
tablets.

[[Page 72058]]

DG52............................ 8/30/2018 Hydrocodone-Acetaminophen 10 Stip. 6(zz).
mg/325 mg, 120 tablets.
DG53............................ 9/08/2018 Diazepam 10 mg, 60 tablets.. Stip. 6(aaa).
DG54............................ 10/26/2018 Carisoprodol 350 mg, 30 Stip. 6(bbb).
tablets.
DG55............................ 10/26/2018 Hydrocodone-Acetaminophen 10 Stip. 6(ccc).
mg/325 mg, 120 tablets.
DG56............................ 11/06/2018 Diazepam 10 mg, 60 tablets.. Stip. 6(ddd).
----------------------------------------------------------------------------------------------------------------

Patient JH

The Government's evidence established the following dispensing
events with respect to Patient JH:

Patient RI

The Government's evidence established the following dispensing
events with respect to Patient RI:

[[Page 72059]]

RI23............................ 11/23/2018 Zolpidem Tartrate 10 mg, 30 Stip. 8(w).
tablets.
RI24............................ 11/24/2018 Carisoprodol 350 mg, 30 Stip. 8(x).
tablets.
RI25............................ 11/24/2018 Oxycodone-Acetaminophen 10 Stip. 8(y).
mg/325 mg, 30 tablets.
RI26............................ 12/06/2018 Alprazolam 1 mg, 90 tablets. Stip. 8(z).
RI27............................ 12/24/2018 Oxycodone-Acetaminophen 10 Stip. 8(aaa).
mg/325 mg, 30 tablets.
RI28............................ 12/24/2018 Hydrocodone-Acetaminophen 5 Stip. 8(bbb).
mg/325 mg, 10 tablets.
RI29............................ 12/24/2018 Carisoprodol 350 mg, 30 Stip. 8(ccc).
tablets.
RI30............................ 1/04/2019 Alprazolam 1 mg, 90 tablets. Stip. 8(ddd).
----------------------------------------------------------------------------------------------------------------

Patient JB

The Government's evidence established the following dispensing
events with respect to Patient JB:

Patient PW

The Government's evidence established the following dispensing
events with respect to Patient PW:

Patient LH

The Government's evidence established the following dispensing
events with respect to Patient LH:

Patient AP

The Government's evidence established the following dispensing
events with respect to Patient AP:

[[Page 72060]]

Patient MA

The Government's evidence established the following dispensing
events with respect to Patient MA:

Patient BB

The Government's evidence established the following dispensing
events with respect to Patient BB:

Patient TD

The Government's evidence established the following dispensing
events with respect to Patient TD:

Patient LD

The Government's evidence established the following dispensing
events with respect to Patient LD:

Patient RW

The Government's evidence established the following dispensing
events with respect to Patient RW:

[[Page 72061]]

Patient LC

The Government's evidence established the following dispensing
events with respect to Patient LC:

Patient KW

The Government's evidence established the following dispensing
events with respect to Patient KW:

Patient DM

The Government's evidence established the following dispensing
events with respect to Patient DM:

Patient KS

The Government's evidence established the following dispensing
events with respect to Patient KS:

Patient PB

The Government's evidence established the following dispensing
events with respect to Patient PB:

Patient CS

The Government's evidence established the following dispensing
events with respect to Patient CS:

[[Page 72062]]

Patient SN

The Government's evidence established the following dispensing
events with respect to Patient SN:

Patient DF

The Government's evidence established the following dispensing
events with respect to Patient DF:

Patient DL

The Government's evidence established the following dispensing
events with respect to Patient DL:

Patient ML

The Government's evidence established the following dispensing
events with respect to Patient ML:

Patient KC

The Government's evidence established the following dispensing
events with respect to Patient KC:

Patient GC

The Government's evidence established the following dispensing
events with respect to Patient GC:

[[Page 72063]]

Patient VM

The Government's evidence established the following dispensing
events with respect to Patient VM:

Patient PR

The Government's evidence established the following dispensing
events with respect to Patient PR:

Patient AG

The Government's evidence established the following dispensing
events with respect to Patient AG:

Patient TB

The Government's evidence established the following dispensing
events with respect to Patient TB:

----------------------------------------------------------------------------------------------------------------
Dispensing event Date Medications Source(s)
----------------------------------------------------------------------------------------------------------------
TB1............................. 5/22/2017 Oxycodone 15 mg, 90 tablets. Stip. 33(a);
Gov't Ex 46
TB2............................. 6/25/2018 Oxycodone 15 mg, 60 tablets. Stip. 33(b).
TB3............................. 7/09/2018 Oxycodone 15 mg, 60 tablets. Stip. 33(c).
TB4............................. 7/23/2018 Oxycodone 15 mg, 60 tablets. Stip. 33(d).
----------------------------------------------------------------------------------------------------------------

Patient KR

The Government's evidence established the following dispensing
events with respect to Patient KR:

[[Page 72064]]

Patient LW

The Government's evidence established the following dispensing
events with respect to Patient LW:

Patient KJ

The Government's evidence established the following dispensing
events with respect to Patient KJ:

Patient VE

The Government's evidence established the following dispensing
events with respect to Patient VE:

Patient TP

The Government's evidence established the following dispensing
events with respect to Patient TP:

Patient IJ

The Government's evidence established the following dispensing
events with respect to Patient IJ:

Patient RS

The Government's evidence established the following dispensing
events with respect to Patient RS:

[[Page 72065]]

Patient RW

The Government's evidence established the following dispensing
events with respect to Patient RW:

Patient JW

The Government's evidence established the following dispensing
events with respect to Patient JW:

Patient MS

The Government's evidence established the following dispensing
events with respect to Patient MS:

Patient PF

The Government's evidence established the following dispensing
events with respect to Patient PF:

Patient DW

The Government's evidence established the following dispensing
events with respect to Patient DW:

Patient KD

The Government's evidence established the following dispensing
events with respect to Patient KD:

[FR Doc. 2021-27416 Filed 12-17-21; 8:45 am]
BILLING CODE 4410-09-P