Medical Pharmacy Decision and Order, 72030-72065 [2021-27416]

Agencies

• Drug Enforcement Administration
• Department of Justice

[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





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





Drug Enforcement Administration





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





Medical Pharmacy Decision and Order; Notice

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

[[Page 72030]]


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

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.
---------------------------------------------------------------------------

    *\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.
---------------------------------------------------------------------------

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge *B
---------------------------------------------------------------------------

    *\B\ I have omitted the RD's discussion of the procedural 
history to avoid repetition with my introduction.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.'').
---------------------------------------------------------------------------

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:

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
CH1.............................       9/12/2017  Carisoprodol 350 mg, 120      Stip. 3(a).
                                                   tablets.
CH2.............................       9/12/2017  Alprazolam 1 mg, 90 tablets.  Stip. 3(b).
CH3.............................       9/12/2017  Hydrocodone-Acetaminophen 10  Stip. 3(c).
                                                   mg/325 mg, 120 tablets.
CH4.............................       9/12/2017  Oxycodone-Acetaminophen 10    Stip. 3(d).
                                                   mg/325 mg, 30 tablets.
----------------------------------------------------------------------------------------------------------------

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:

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
TD1.............................       7/13/2017  Hydrocodone-Acetaminophen 10  Stip. 5(a).
                                                   mg/325 mg, 180 tablets.
TD2.............................       8/08/2017  Clonazepam 0.5 mg, 60         Stip. 5(b).
                                                   tablets.
TD3.............................       8/08/2017  Carisoprodol 350 mg, 60       Stip. 5(c).
                                                   tablets.
TD4.............................       8/12/2017  Hydrocodone-Acetaminophen 10  Stip. 5(d).
                                                   mg/325 mg, 180 tablets.
TD5.............................       7/11/2018  Hydrocodone-Acetaminophen 10  Stip. 5(e).
                                                   mg/325 mg, 180 tablets.
TD6.............................       7/18/2018  Clonazepam 0.5 mg, 60         Stip. 5(f).
                                                   tablets.
TD7.............................       7/18/2018  Carisoprodol 350 mg, 60       Stip. 5(g).
                                                   tablets.
----------------------------------------------------------------------------------------------------------------

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:

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
JH1.............................       2/07/2017  Hydrocodone-Acetaminophen 10  Stip. 7(a).
                                                   mg/325 mg, 45 tablets.
JH2.............................       2/07/2017  Diazepam 10 mg, 18 tablets..  Stip. 7(b).
JH3.............................       2/07/2017  Zolpidem Tartrate 10 mg, 30   Stip. 7(c).
                                                   tablets.
JH4.............................       2/09/2017  Carisoprodol 350, 90 tablets  Stip. 7(d).
JH5.............................       7/13/2017  Diazepam 10 mg, 90 tablets..  Stip. 7(e).
JH6.............................       7/13/2017  Hydrocodone-Acetaminophen 10  Stip. 7(f).
                                                   mg/325 mg, 40 tablets.
JH7.............................       7/13/2017  Carisoprodol 350, 120         Stip. 7(g).
                                                   tablets.
JH8.............................       7/31/2017  Hydrocodone-Acetaminophen 10  Stip. 7(h).
                                                   mg/325 mg, 40 tablets.
JH9.............................       8/11/2017  Diazepam 10 mg, 90 tablets..  Stip. 7(i).
JH10............................       8/11/2017  Carisoprodol 350, 120         Stip. 7(j).
                                                   tablets.
JH11............................       9/29/2017  Hydrocodone-Acetaminophen 10  Stip. 7(k).
                                                   mg/325 mg, 90 tablets.
JH12............................      10/10/2017  Carisoprodol 350, 120         Stip. 7(l).
                                                   tablets.
JH13............................      10/11/2017  Diazepam 10 mg, 90 tablets..  Stip. 7(m).
JH14............................      10/26/2017  Hydrocodone-Acetaminophen 10  Stip. 7(n).
                                                   mg/325 mg, 120 tablets.
JH15............................       4/26/2018  Carisoprodol 350, 120         Stip. 7(o).
                                                   tablets.
JH16............................       4/26/2018  Hydrocodone-Acetaminophen 10  Stip. 7(p).
                                                   mg/325 mg, 90 tablets.
JH17............................       4/26/2018  Diazepam 10 mg, 35 tablets..  Stip. 7(q).
JH18............................       5/24/2018  Hydrocodone-Acetaminophen 10  Stip. 7(r).
                                                   mg/325 mg, 90 tablets.
JH19............................       5/24/2018  Carisoprodol 350, 120         Stip. 7(s).
                                                   tablets.
JH20............................       5/24/2018  Diazepam 10 mg, 35 tablets..  Stip. 7(t).
JH21............................       9/20/2018  Hydrocodone-Acetaminophen 10  Stip. 7(u).
                                                   mg/325 mg, 90 tablets.
JH22............................       9/20/2018  Carisoprodol 350, 120         Stip. 7(v).
                                                   tablets.
JH23............................       9/20/2018  Diazepam 10 mg, 35 tablets..  Stip. 7(w).
JH24............................      10/18/2018  Hydrocodone-Acetaminophen 10  Stip. 7(x).
                                                   mg/325 mg, 120 tablets.
JH25............................      10/18/2018  Carisoprodol 350, 120         Stip. 7(y).
                                                   tablets.
JH26............................      10/18/2018  Diazepam 10 mg, 35 tablets..  Stip. 7(z).
----------------------------------------------------------------------------------------------------------------

Patient RI

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
RI1.............................       8/17/2017  Alprazolam 1 mg, 120 tablets  Stip. 8(a).
RI2.............................       8/25/2017  Zolpidem Tartrate 10 mg, 30   Stip. 8(b).
                                                   tablets.
RI3.............................       8/25/2017  Carisoprodol 350 mg, 30       Stip. 8(c).
                                                   tablets.
RI4.............................       8/25/2017  Oxycodone-Acetaminophen 10    Stip. 8(d).
                                                   mg/325 mg, 30 tablets.
RI5.............................       9/11/2017  Alprazolam 1 mg, 120 tablets  Stip. 8(e).
RI6.............................       9/25/2017  Carisoprodol 350 mg, 30       Stip. 8(f).
                                                   tablets.
RI7.............................       9/25/2017  Oxycodone-Acetaminophen 10    Stip. 8(g).
                                                   mg/325 mg, 30 tablets.
RI8.............................      10/12/2017  Alprazolam 1 mg, 120 tablets  Stip. 8(h).
RI9.............................      10/25/2017  Carisoprodol 350 mg, 30       Stip. 8(i).
                                                   tablets.
RI10............................      10/25/2017  Oxycodone-Acetaminophen 10    Stip. 8(j).
                                                   mg/325 mg, 30 tablets.
RI11............................      11/13/2017  Zolpidem Tartrate 10 mg, 30   Stip. 8(k).
                                                   tablets.
RI12............................      11/13/2017  Alprazolam 1 mg, 120 tablets  Stip. 8(l).
RI13............................      11/24/2017  Carisoprodol 350 mg, 30       Stip. 8(m).
                                                   tablets.
RI14............................      11/24/2017  Oxycodone-Acetaminophen 10    Stip. 8(n).
                                                   mg/325 mg, 30 tablets.
RI15............................      12/09/2017  Zolpidem Tartrate 10 mg, 30   Stip. 8(o).
                                                   tablets.
RI16............................      12/13/2017  Alprazolam 1 mg, 120 tablets  Stip. 8(p).
RI17............................      12/23/2017  Oxycodone-Acetaminophen 10    Stip. 8(q).
                                                   mg/325 mg, 30 tablets.
RI18............................      12/27/2017  Carisoprodol 350 mg, 30       Stip. 8(r).
                                                   tablets.
RI19............................       8/15/2018  Alprazolam 1 mg, 90 tablets.  Stip. 8(s).
RI20............................       8/24/2018  Carisoprodol 350 mg, 30       Stip. 8(t).
                                                   tablets.
RI21............................       8/24/2018  Oxycodone-Acetaminophen 10    Stip. 8(u).
                                                   mg/325 mg, 30 tablets.
RI22............................      11/08/2018  Alprazolam 1 mg, 90 tablets.  Stip. 8(v).

[[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:

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
JB1.............................       7/02/2019  Dextroamphetamine-            Stip. 9(a).
                                                   Amphetamine 20 mg, 90
                                                   tablets.
JB2.............................       7/02/2019  Alprazolam 0.5 mg, 60         Stip. 9(b).
                                                   tablets.
JB3.............................       7/02/2019  Hydrocodone-Acetaminophen 10  Stip. 9(c).
                                                   mg/325 mg, 60 tablets.
----------------------------------------------------------------------------------------------------------------

Patient PW

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
PW1.............................       4/04/2019  Alprazolam 0.5 mg, 60         Stip. 10(a).
                                                   tablets.
PW2.............................       4/04/2019  Hydrocodone-Acetaminophen 10  Stip. 10(b).
                                                   mg.325 mg, 30 tablets.
PW3.............................       8/01/2019  Alprazolam 0.5 mg, 60         Stip. 10(c).
                                                   tablets.
PW4.............................       8/01/2019  Hydrocodone-Acetaminophen 10  Stip. 10(d).
                                                   mg.325 mg, 30 tablets.
PW5.............................       8/29/2019  Alprazolam 0.5 mg, 60         Stip. 10(e).
                                                   tablets.
PW6.............................       8/29/2019  Hydrocodone-Acetaminophen 10  Stip. 10(f).
                                                   mg.325 mg, 30 tablets.
----------------------------------------------------------------------------------------------------------------

Patient LH

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
LH1.............................       6/14/2017  Alprazolam 1 mg, 360 tablets  Stip. 11(a).
LH2.............................       6/22/2017  Dextroamphetamine-            Stip. 11(b).
                                                   Amphetamine 30 mg, 30
                                                   tablets.
LH3.............................       6/22/2017  Hydrocodone-Acetaminophen 10  Stip. 11(c).
                                                   mg/325 mg, 20 tablets.
----------------------------------------------------------------------------------------------------------------

Patient AP

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
AP1.............................       8/02/2017  Hydrocodone-Acetaminophen 10  Stip. 12(a).
                                                   mg/325 mg, 25 tablets.
AP2.............................       8/02/2017  Zolpidem Tartrate 10 mg, 30   Stip. 12(b).
                                                   tablets.
----------------------------------------------------------------------------------------------------------------


[[Page 72060]]

Patient MA

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
MA1.............................      10/12/2017  Alprazolam 1 mg, 30 tablets.  Stip. 13(a).
MA2.............................      10/12/2017  Dextroamphetamine-            Stip. 13(b).
                                                   Amphetamine 30 mg, 60
                                                   tablets.
MA3.............................      10/12/2017  Hydrocodone-Acetaminophen 10  Stip. 13(c).
                                                   mg/325 mg, 120 tablets.
----------------------------------------------------------------------------------------------------------------

Patient BB

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
BB1.............................      10/19/2017  Alprazolam 1 mg, 90 tablets.  Stip. 14(a).
BB2.............................      10/19/2017  Hydrocodone-Acetaminophen 10  Stip. 14(b).
                                                   mg/325 mg, 60 tablets.
BB3.............................       1/11/2017  Alprazolam 0.5 mg, 2 tablets  Stip. 14(c).
BB4.............................       1/11/2017  Diazepam 10 mg, 2 tablets...  Stip. 14(d).
BB5.............................       1/12/2017  Hydrocodone-Acetaminophen 10  Stip. 14(e).
                                                   mg/325 mg, 60 tablets.
BB6.............................        2/8/2017  Alprazolam 0.5 mg, 2 tablets  Stip. 14(f).
BB7.............................        2/8/2017  Diazepam 10 mg, 2 tablets...  Stip. 14(g).
BB8.............................       2/10/2017  Alprazolam 0.5 mg, 60         Stip. 14(h).
                                                   tablets.
BB9.............................       2/10/2017  Hydrocodone-Acetaminophen 10  Stip. 14(i).
                                                   mg/325 mg, 60 tablets.
BB10............................        3/9/2017  Hydrocodone-Acetaminophen 10  Stip. 14(j).
                                                   mg/325 mg, 60 tablets.
BB11............................        3/9/2017  Alprazolam 0.5 mg, 60         Stip. 14(k).
                                                   tablets.
BB12............................        5/4/2017  Hydrocodone-Acetaminophen 10  Stip. 14(l).
                                                   mg/325 mg, 60 tablets.
----------------------------------------------------------------------------------------------------------------

Patient TD

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
TD1.............................       3/07/2018  Hydrocodone-Acetaminophen 10  Stip. 15(a).
                                                   mg/325 mg, 180 tablets.
TD2.............................       3/07/2018  Clonazepam 0.5 mg, 60         Stip. 15(b).
                                                   tablets.
----------------------------------------------------------------------------------------------------------------

Patient LD

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
LD1.............................       8/19/2019  Oxycodone-Acetaminophen 10    Stip. 16(a).
                                                   mg/325 mg, 90 tablets.
LD2.............................       8/19/2019  Lorazepam 0.5 mg, 60 tablets  Stip. 16(b).
LD3.............................       8/19/2019  Morphine SO4 ER 30 mg, 60     Stip. 16(c).
                                                   tablets.
----------------------------------------------------------------------------------------------------------------

Patient RW

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
RW1.............................       8/12/2019  Hydrocodone-Acetaminophen 10  Stip. 17(a).
                                                   mg/325 mg, 120 tablets.
RW2.............................       8/12/2019  Diazepam 5 mg, 30 tablets...  Stip. 17(b).
RW3.............................       9/09/2019  Hydrocodone-Acetaminophen 10  Stip. 17(c).
                                                   mg/325 mg, 120 tablets.
RW4.............................       9/09/2019  Diazepam 5 mg, 30 tablets...  Stip. 17(d).
----------------------------------------------------------------------------------------------------------------


[[Page 72061]]

Patient LC

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
LC1.............................       3/21/2019  Oxycodone-Acetaminophen 7.5   Stip. 18(a).
                                                   mg/325 mg, 14 tablets.
LC2.............................       3/21/2019  Oxycodone-Acetaminophen 7.5   Stip. 18(b).
                                                   mg/325 mg, 16 tablets.
----------------------------------------------------------------------------------------------------------------

Patient KW

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
KW1.............................       4/16/2019  Alprazolam 0.25 mg, 60        Stip. 19(a).
                                                   tablets.
KW2.............................       4/16/2019  Dextroamphetamine-            Stip. 19(b).
                                                   Amphetamine 20 mg, 90
                                                   tablets.
----------------------------------------------------------------------------------------------------------------

Patient DM

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
DM1.............................       6/08/2017  Alprazolam 1 mg, 60 tablets.  Stip. 20(a).
DM2.............................       6/08/2017  Dextroamphetamine-            Stip. 20(b).
                                                   Amphetamine, 60 tablets.
----------------------------------------------------------------------------------------------------------------

Patient KS

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
KS1.............................       6/26/2017  Dextroamphetamine-            Stip. 21(a).
                                                   Amphetamine 30 mg, 60
                                                   tablets.
KS2.............................       6/26/2017  Oxycodone-Acetaminophen 10    Stip. 21(b).
                                                   mg/325 mg, 60 tablets.
----------------------------------------------------------------------------------------------------------------

Patient PB

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
PB1.............................       6/26/2019  Methadone 10 mg, 60 tablets.  Stip. 22(a).
PB2.............................       6/26/2019  Oxycodone-Acetaminophen.....  Stip. 22(b).
----------------------------------------------------------------------------------------------------------------

Patient CS

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
CS1.............................       6/11/2019  Oxycodone 30 mg, 90 tablets.  Stip. 23(a).
CS2.............................       7/09/2019  Oxycodone 30 mg, 90 tablets.  Stip. 23(b).
----------------------------------------------------------------------------------------------------------------


[[Page 72062]]

Patient SN

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
SN1.............................       6/05/2019  Hydrocodone-Acetaminophen     Stip. 24(a).
                                                   7.5 mg/325 mg, 30 tablets.
SN2.............................       6/19/2019  Hydrocodone-Acetaminophen     Stip. 24(b).
                                                   7.5 mg/325 mg, 30 tablets.
----------------------------------------------------------------------------------------------------------------

Patient DF

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
DF1.............................       6/04/2019  Alprazolam 0.5 mg, 120        Stip. 26(a).
                                                   tablets.
DF2.............................       6/04/2019  Dextroamphetamine-            Stip. 26(b).
                                                   Amphetamine 30 mg, 60
                                                   tablets.
DF3.............................       6/04/2019  Butalbital-Acetaminophen-     Stip. 26(c).
                                                   Caffeine 50 mg/325 mg/40
                                                   mg, 60 tablets.
----------------------------------------------------------------------------------------------------------------

Patient DL

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
DL1.............................       8/09/2017  Diazepam 10 mg, 90 tablets..  Stip. 27(a).
DL2.............................       8/09/2017  Hydrocodone-Acetaminophen 10  Stip. 27(b).
                                                   mg/325 mg, 60 tablets.
----------------------------------------------------------------------------------------------------------------

Patient ML

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
ML1.............................       8/02/2017  Diazepam 10 mg, 45 tablets..  Stip. 28(a).
----------------------------------------------------------------------------------------------------------------

Patient KC

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
KC1.............................      10/09/2017  Hydrocodone-Acetaminophen 10  Stip. 29(a).
                                                   mg/325 mg, 75 tablets.
KC2.............................      10/09/2017  Alprazolam 1 mg, 60 tablets.  Stip. 29(b).
----------------------------------------------------------------------------------------------------------------

Patient GC

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
GC1.............................      10/10/2017  Hydrocodone-Acetaminophen 10  Stip. 30(a).
                                                   mg/325 mg, 120 tablets.
GC2.............................      10/10/2017  Alprazolam 1 mg, 90 tabelts.  Stip. 30(b).
----------------------------------------------------------------------------------------------------------------


[[Page 72063]]

Patient VM

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
VM1.............................      10/20/2017  Hydrocodone-Acetaminophen 10  Stip. 31(a).
                                                   mg.325 mg, 120 tablets.
VM2.............................      10/20/2017  Alprazolam 1 mg, 60 tablets.  Stip. 31(b).
----------------------------------------------------------------------------------------------------------------

Patient PR

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
PR1.............................      10/24/2017  Hydrocodone-Acetaminophen 10  Stip. 25(a).
                                                   mg.325 mg, 112 tablets.
PR2.............................       6/13/2019  Hydrocodone-Acetaminophen 10  Stip. 25(b).
                                                   mg.325 mg, 112 tablets.
----------------------------------------------------------------------------------------------------------------

Patient AG

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
AG1.............................       9/06/2016  Oxycodone 15 mg, 90 tablets.  Stip. 32(a).
AG2.............................       6/27/2019  Oxycodone 15 mg, 120 tablets  Stip. 32(b).
AG3.............................       7/24/2019  Oxycodone 15 mg, 120 tablets  Stip. 32(c).
AG4.............................       8/22/2019  Oxycodone 15 mg, 120 tablets  Stip. 32(d).
----------------------------------------------------------------------------------------------------------------

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:

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
KR1.............................       4/09/2019  Oxycodone-Acetaminophen 10    Stip. 34(a).
                                                   mg/325 mg, 90 tablets.
KR2.............................       8/04/2018  Oxycodone-Acetaminophen 10    Stip. 34(b).
                                                   mg/325 mg, 90 tablets.
----------------------------------------------------------------------------------------------------------------


[[Page 72064]]

Patient LW

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
LW1.............................       7/27/2017  Hydrocodone-Acetaminophen 10  Stip. 35(a).
                                                   mg/325 mg, 120 tablets.
LW2.............................       7/27/2017  Alprazolam 1 mg, 90 tablets.  Stip. 35(b).
LW3.............................       7/27/2017  Dextroamphetamine-            Stip. 35(c).
                                                   Amphetamine 20 mg, 60
                                                   tablets.
LW4.............................       7/27/2017  Phentermine 37.5 mg, 30       Stip. 35(d).
                                                   tablets.
----------------------------------------------------------------------------------------------------------------

Patient KJ

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
KJ1.............................       5/21/2018  Hydrocodone-Acetaminophen 10  Stip. 36(a).
                                                   mg/325 mg, 120 tablets.
KJ2.............................       7/21/2018  Hydrocodone-Acetaminophen 10  Stip. 36(b).
                                                   mg/325 mg, 120 tablets.
KJ3.............................      11/19/2018  Hydrocodone-Acetaminophen 10  Stip. 36(c).
                                                   mg/325 mg, 120 tablets.
----------------------------------------------------------------------------------------------------------------

Patient VE

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
VE1.............................       5/22/2017  Hydrocodone-Acetaminophen 10  Stip. 37.
                                                   mg/325 mg, 120 tablets.
----------------------------------------------------------------------------------------------------------------

Patient TP

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
TP1.............................       5/22/2017  Hydrocodone-Acetaminophen 10  Stip. 38.
                                                   mg/325 mg, 120 tablets.
----------------------------------------------------------------------------------------------------------------

Patient IJ

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
IJ1.............................       5/23/2017  Hydrocodone-Acetaminophen 10  Stip. 39.
                                                   mg/325 mg, 90 tablets.
----------------------------------------------------------------------------------------------------------------

Patient RS

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
RS1.............................       5/26/2017  Hydrocodone-Acetaminophen 10  Stip. 40.
                                                   mg/325 mg, 120 tablets.
----------------------------------------------------------------------------------------------------------------


[[Page 72065]]

Patient RW

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
RW1.............................       6/01/2017  Hydrocodone-Acetaminophen 10  Stip. 41.
                                                   mg/325 mg, 120 tablets.
----------------------------------------------------------------------------------------------------------------

Patient JW

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
JW1.............................       5/12/2017  Oxycodone-Acetaminophen 10    Stip. 42.
                                                   mg/325 mg, 60 tablets.
----------------------------------------------------------------------------------------------------------------

Patient MS

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
MS1.............................       5/12/2017  Oxycodone-Acetaminophen 10    Stip. 43.
                                                   mg/325 mg, 60 tablets.
----------------------------------------------------------------------------------------------------------------

Patient PF

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
PF1.............................       5/22/2017  Hydrocodone-Acetaminophen 10  Stip. 44.
                                                   mg/325 mg, 90 tablets.
----------------------------------------------------------------------------------------------------------------

Patient DW

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
DW1.............................       5/22/2017  Hydrocodone-Acetaminophen 10  Stip. 45.
                                                   mg/325 mg, 90 tablets.
----------------------------------------------------------------------------------------------------------------

Patient KD

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

----------------------------------------------------------------------------------------------------------------
        Dispensing event               Date                Medications                       Source
----------------------------------------------------------------------------------------------------------------
KD1.............................       5/04/2017  Hydrocodone-Acetaminophen 10  Stip. 46.
                                                   mg/325 mg, 60 tablets.
----------------------------------------------------------------------------------------------------------------

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