[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2905-2936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00955]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-08]


AARRIC, Inc. d/b/a at Cost RX; Decision and Order

    On January 3, 2020, 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) to AARRIC, Inc. d/b/a AT COST RX (hereinafter, 
Respondent). Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1, 
(OSC) at 1. The OSC/ISO informed Respondent of the immediate suspension 
of its DEA Certificate of Registration Number FA2125640 (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 November 16-20, 2020, at the DEA Hearing 
Facility in Arlington, Virginia, with the parties and their witnesses 
participating through video-teleconference.*\A\ On April 7, 2021, 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

[[Page 2906]]

December 15, 2020, the Government and Respondent filed exceptions to 
the Recommended Decision (hereinafter, Gov Exceptions and Resp 
Exceptions, respectively). Having reviewed the entire record, I find 
Respondent's Exceptions without merit and I adopt the ALJ's Recommended 
Decision with minor modifications, as noted herein. I have addressed 
each of Respondent's Exceptions and I issue my final Order in this case 
following the Recommended Decision.
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    *\A\ [This footnote has been relocated from RD n.5.] At all 
times prior to and during the hearing, the Respondent was 
represented by multiple, able counsel. The Respondent's (then) 
counsels raised no issue during the proceedings or in the 
Respondent's closing brief regarding the fairness of the 
proceedings. The day after its closing brief was filed, the 
Respondent sought to discharge its lawyers and opted to have itself 
represented by its (non-lawyer) owner. ALJ Ex. 56. Acting as a non-
attorney representative (see 21 CFR 1316.50), the Respondent's owner 
moved to disqualify the Government's expert and to recuse me [the 
Chief ALJ]. ALJ Exs. 57, 58, 61. These motions have been disposed of 
in separate orders issued contemporaneously with this recommended 
decision. ALJ Exs. 67, 68. A joint motion to be excused from further 
representation of the Respondent (ALJ Ex. 60) filed by his lawyers 
(at the request of the tribunal) was granted for the reasons stated 
therein. ALJ Ex. 62.
    [I agree with the Chief ALJ's procedural rulings in this case, 
including his dismissal of Respondent's two recusal motions. In 
these motions, Respondent argued that the Chief ALJ ``den[ied] 
Respondent [the] right to a fair trial'' by ``creat[ing] an 
atmosphere of prejudice and lack of impartiality.'' ALJ Ex. 57, at 
3. Respondent further argued that the Chief ALJ ``morphed [the 
Government's case] into a plausible case'' by ``w[earing] the hat of 
the Government's lawyer during most of the witness examination.'' 
Id. at 2. Respondent's motions reference portions of the record 
where the Chief ALJ assisted the Government in authenticating 
documents and questioning its witnesses. Although Respondent 
acknowledged that ALJs are permitted to question witnesses, 
Respondent argues that the Chief ALJ used his questioning authority 
to buttress the Government's case and ``patch[ ] up areas where 
there were obvious gaps in the Government's case,'' while not 
``provid[ing] the same helping hand to Respondent when Respondent 
was attempting to authenticate documents that Respondent believes 
were critical to its defense. Id. at 5, 10. Additionally, Respondent 
alleged that it was inappropriate for the Chief ALJ to ask 
Respondent's representative, Dr. Howard, whether he agreed with 
certain testimony by Respondent's expert, because it ``placed . . . 
Dr. Howard in an awkward position to have to incriminate his own 
expert just to appease the ALJ.'' Id. at 26, 30.
    I find that Respondent's recusal motions are without merit. As 
the Chief ALJ stated in his neutral and carefully-reasoned dismissal 
order, Respondent--the proponent of the recusal motion--has the 
burden of demonstrating that the Chief ALJ exhibited a ``deep-seated 
favoritism or antagonism that would make fair judgment impossible.'' 
Order Denying the Respondent's Recusal Motions, at 6. Respondent did 
not identify any evidence of favoritism or antagonism, much less the 
type of deep-seated favoritism or antagonism that would make fair 
judgment impossible. Rather, Respondent identified instances where 
the Chief ALJ was exercising his discretionary authority to regulate 
the hearing, by asking clarifying questions of counsel and witnesses 
and issuing evidentiary rulings. See Order, at 7 (citing 5 U.S.C. 
556(c)(5); 21 CFR 1316.52(e)). Courts have uniformly held that 
judicial rulings issued during the course of litigation rarely 
constitute evidence of cognizable bias. Id. (citing Liteky v. United 
States, 510 U.S. 540, 555 (1994), Hamm v. Members of Bd. of Regents, 
708 F.2d 647, 651 (11th Cir. 1983), Dewey C. Mackay, M.D., 75 FR 
49,956, 49,958-59 (2010)). Additionally, as the Chief ALJ 
highlighted in his dismissal order, the Chief ALJ frequently 
clarified the record for Respondent's benefit and overwhelmingly 
issued evidentiary rulings in Respondent's favor. Id. at 8-9. 
Furthermore, Respondent's recusal motions were untimely, which is an 
independent basis for their dismissal. Id. at 7, 15-16.
    Beyond the substantive and procedural defects of Respondent's 
recusal motions, the motions convey a contemptuous tone towards the 
Chief ALJ, which supports my decision that Respondent's registration 
is inconsistent with the public interest. Respondent was 
particularly outraged that the Chief ALJ questioned Respondent's 
representative about whether he agreed with the Respondent's 
expert's expressions of hostility towards DEA as a regulator. Based 
on Respondent's attitude towards DEA and the Chief ALJ, I find it 
unlikely that Respondent would modify its behavior and become a law-
abiding, cooperative registrant. Certainly, Respondent's focus on 
repudiating the Chief ALJ rather than acknowledging its own 
misconduct shows that it falls far short of the ``true remorse'' 
that is required when a registrant has committed acts that are 
inconsistent with the public interest. Michael S. Moore, M.D., 76 FR 
45,867, 45,877 (2011).
    For the same reasons stated above, I find that Respondent's 
Exceptions to ALJ's Denial of Respondent's Motions for Recusal and 
Request for Expedited Ruling on the Order Denying Recusal are 
without merit. ALJ Ex. 69 (dated April 27, 2021).]
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Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge *<SUP>B 1 2 3</SUP>
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    *\B\ I have omitted the RD's discussion of the procedural 
history to avoid repetition with my introduction.
    \1\ [Footnote relocated, see infra n. *M.]
    \2\ [Footnote relocated, see supra n.*A.]
    \3\ [Omitted for brevity.]
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    After carefully considering the testimony elicited at the hearing, 
the admitted exhibits, the arguments of counsel, and the record as a 
whole, I have set forth my recommended findings of fact and conclusions 
of law below.

The Allegations

    The Government alleges that the Respondent Pharmacy's COR should be 
revoked because on numerous occasions between February 2018 and 
September 2019, it repeatedly dispensed prescriptions to ten patients 
(collectively, the Ten Patients) \4\ without addressing or resolving 
factual indicia (i.e., ``red flags'') of potential drug diversion and 
in contravention of its corresponding responsibility to ensure the 
prescriptions were issued for a legitimate medical purpose. ALJ Ex. 1 
at 2.
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    \4\ In this recommended decision, initials have been substituted 
for the names of the Respondent's customer-patients to preserve 
their personally identifiable information. The Ten Patients include 
Patients JA, EA, SD, LH, DH, DK, JM, ST, JW, and CW.
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The Evidence

The Stipulations

    The parties entered into factual stipulations prior to the 
litigation of this matter, which were accepted by the tribunal.\5\ By 
virtue of those stipulations, the following factual matters are deemed 
conclusively established in this case:
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    \5\ ALJ Ex. 38.
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    1. The Respondent is registered with DEA to handle controlled 
substances in Schedules II through V under DEA COR No. FA2125640 at 
16970 San Carlos Boulevard, Suite 110, Fort Myers, Florida 33908.
    2. DEA COR No. FA2125640 will expire by its own terms on June 30, 
2022.
    3. DEA lists Adderall (amphetamine-dextroamphetamine mixture) as a 
Schedule II controlled substance under 21 CFR 1308.12(d)(1).
    4. DEA lists Ambien (zolpidem tartrate) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(57).\6\
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    \6\ Multiple incorrect citations set forth in the proposed 
stipulations propounded by the parties have been corrected in this 
RD to reflect the current regulatory designation.
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    5. DEA lists Ativan (lorazepam) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(32).
    6. DEA lists hydromorphone as a Schedule II controlled substance 
under 21 CFR 1308.12(b)(1)(vii).
    7. DEA lists Klonopin (clonazepam) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(12).
    8. DEA lists methadone as a Schedule II controlled substance under 
21 CFR 1308.12(c)(15).
    9. DEA lists MS Contin (morphine sulfate extended release) as a 
Schedule II controlled substance under 21 CFR 1308.12(b)(1)(ix).
    10. DEA lists Norco (hydrocodone-acetaminophen) as a Schedule II 
controlled substance under 21 CFR 1308.12(b)(1)(vi).
    11. DEA lists oxycodone as a Schedule II controlled substance under 
21 CFR 1308.12(b)(1)(xiv).
    12. DEA lists Percocet (oxycodone-acetaminophen) as a Schedule II 
controlled substance under 21 CFR 1308.12(b)(1)(xiv).
    13. DEA lists Restoril (temazepam) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(53).
    14. DEA lists Soma (carisoprodol) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(7).
    15. DEA lists Valium (diazepam) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(17).
    16. DEA lists Xanax (alprazolam) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(2).
    17. Between February 19, 2018, and at least September 2, 2019, the 
Respondent filled at least 21 prescriptions for Patient JA for 90-120 
units of hydromorphone 8 mg. These prescriptions were filled on or 
about the following specific occasions:

----------------------------------------------------------------------------------------------------------------
                   Fill date                                 Drug dispensed                  Prescription No.
----------------------------------------------------------------------------------------------------------------
2/19/2018......................................  112 units of hydromorphone 8 mg.......                   535081
3/19/2018......................................  112 units of hydromorphone 8 mg.......                   535597
4/16/2018......................................  120 units of hydromorphone 8 mg.......                   536108
5/14/2018......................................  120 units of hydromorphone 8 mg.......                   536635
6/11/2018......................................  120 units of hydromorphone 8 mg.......                   537027
7/10/2018......................................  120 units of hydromorphone 8 mg.......                   537292
8/7/2018.......................................  120 units of hydromorphone 8 mg.......                   537539
9/4/2018.......................................  120 units of hydromorphone 8 mg.......                   537922
10/2/2018......................................  120 units of hydromorphone 8 mg.......                   538321
10/30/2018.....................................  120 units of hydromorphone 8 mg.......                   538758
11/26/2018.....................................  120 units of hydromorphone 8 mg.......                   539235
12/21/2018.....................................  120 units of hydromorphone 8 mg.......                   539671
1/21/2019......................................  120 units of hydromorphone 8 mg.......                   540097
2/18/2019......................................  120 units of hydromorphone 8 mg.......                   540569
3/18/2019......................................  120 units of hydromorphone 8 mg.......                   541028
4/15/2019......................................  120 units of hydromorphone 8 mg.......                   541503
5/13/2019......................................  105 units of hydromorphone 8 mg.......                   541983
6/10/2019......................................  90 units of hydromorphone 8 mg........                   542444
7/8/2019.......................................  90 units of hydromorphone 8 mg........                   542892
8/5/2019.......................................  90 units of hydromorphone 8 mg........                   543372
9/2/2019.......................................  90 units of hydromorphone 8 mg........                   543802
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[[Page 2907]]

    18. Patient JA paid cash for all of the above-listed prescriptions 
for controlled substances that he filled with the Respondent.
    19. Between September 19, 2018, and at least September 16, 2019, 
the Respondent filled at least 42 prescriptions for Patient EA for 28 
units of MS Contin 30 mg, 120 units of oxycodone 30 mg, and 30 units of 
Xanax 1 mg. These prescriptions were filled on or about the following 
specific occasions:

----------------------------------------------------------------------------------------------------------------
            Fill date                      Drug(s) dispensed                      Prescription Nos.
----------------------------------------------------------------------------------------------------------------
9/19/2018........................  28 units of MS Contin 30 mg; 120  538184-538186
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
10/17/2018.......................  28 units of MS Contin 30 mg; 120  538570-538572
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
11/15/2018.......................  28 units of MS Contin 30 mg; 120  539086-539088
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
12/13/2018.......................  28 units of MS Contin 30 mg; 120  539524-539525; 539527
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
1/9/2019.........................  28 units of MS Contin 30 mg; 120  539931-539932; 539935
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
2/5/2019.........................  28 units of MS Contin 30 mg; 120  540377-540378; 540381
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
3/4/2019.........................  28 units of MS Contin 30 mg; 120  540812-540814
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
4/1/2019.........................  28 units of MS Contin 30 mg; 120  541310-541311; 541314
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
4/24/2019........................  28 units of MS Contin 30 mg; 120  541726-541728
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
5/22/2019........................  28 units of MS Contin 30 mg; 120  542191; 542193-542194
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
6/25/2019........................  28 units of MS Contin 30 mg; 120  542751-542753
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
7/24/2019........................  28 units of MS Contin 30 mg; 120  543220-543221; 543223
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
8/20/2019........................  28 units of MS Contin 30 mg; 120  543644-543646
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
9/16/2019........................  28 units of MS Contin 30 mg; 120  544051-544053
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
----------------------------------------------------------------------------------------------------------------

    20. Patient EA paid cash for all of the above-listed prescriptions 
for controlled substances that he filled with the Respondent.
    21. Between February 20, 2018, and at least September 4, 2019, the 
Respondent filled at least 56 prescriptions for Patient SD for 21-30 
units of MS Contin 30 mg, 60 units of MS Contin 60 mg, 92-135 units of 
oxycodone 30 mg, 30 units of Xanax 0.5 mg, and 30 units of Xanax 1 mg. 
These prescriptions were filled on or about the following specific 
occasions:

----------------------------------------------------------------------------------------------------------------
            Fill date                      Drug(s) dispensed                      Prescription Nos.
----------------------------------------------------------------------------------------------------------------
2/20/2018........................  60 units of MS Contin 60 mg; 135  535123-535125
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
3/21/2018........................  60 units of MS Contin 60 mg; 135  535637-535638; 535643
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
4/17/2018........................  60 units of MS Contin 60 mg; 135  536133-536135
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
5/15/2018........................  30 units of Xanax 1 mg..........  536670
8/9/2018.........................  30 units of MS Contin 30 mg; 120  537591-537592; 537606
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 0.5 mg.
9/7/2018.........................  30 units of MS Contin 30 mg; 120  538017-538019
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 0.5 mg.
10/4/2018........................  30 units of MS Contin 30 mg; 120  538376-538377; 538379
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
10/31/2018.......................  30 units of MS Contin 30 mg; 120  538811-538813
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
11/7/2018........................  92 units of oxycodone 30 mg.....  538974
11/27/2018.......................  30 units of MS Contin 30 mg; 120  539262; 539264-539265
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
12/24/2018.......................  30 units of MS Contin 30 mg; 120  539680-539682
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
1/22/2019........................  30 units of MS Contin 30 mg; 120  540132-540134
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
2/19/2019........................  30 units of MS Contin 30 mg; 120  540597-540598; 540600
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
3/18/2019........................  30 units of MS Contin 30 mg; 120  541054; 541056-541057
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
4/15/2019........................  30 units of MS Contin 30 mg; 120  541524; 541526-541527
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
5/13/2019........................  30 units of MS Contin 30 mg; 120  542001-542003
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
6/11/2019........................  30 units of MS Contin 30 mg; 120  542498-542500
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
7/8/2019.........................  30 units of MS Contin 30 mg; 120  542917-542919
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
8/6/2019.........................  30 units of MS Contin 30 mg; 120  543410-543412
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
9/4/2019.........................  30 units of MS Contin 30 mg; 120  543858-543860
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 0.5 mg.
----------------------------------------------------------------------------------------------------------------

    22. Patient SD paid cash for all of the above-listed prescriptions 
for controlled substances that he filled with the Respondent on or 
after April 16, 2018.
    23. Between March 6, 2018, and at least September 11, 2019, the 
Respondent filled at least 34 prescriptions for Patient LH for 28-60 
units of MS Contin 30 mg and 120-140 units of oxycodone 30 mg. These 
prescriptions were filled on or about the following specific occasions:

----------------------------------------------------------------------------------------------------------------
            Fill date                      Drug(s) dispensed                      Prescription Nos.
----------------------------------------------------------------------------------------------------------------
3/6/2018.........................  60 units of MS Contin 30 mg; and  535451-535452
                                    140 units of oxycodone 30 mg.
4/3/2018.........................  60 units of MS Contin 30 mg; and  535887-535888
                                    140 units of oxycodone 30 mg.
5/8/2018.........................  60 units of MS Contin 30 mg; and  536542-536543
                                    140 units of oxycodone 30 mg.
8/28/2018........................  28 units of MS Contin 30 mg; and  537859-537860
                                    120 units of oxycodone 30 mg.
10/10/2018.......................  28 units of MS Contin 30 mg; and  538473-538474
                                    120 units of oxycodone 30 mg.
11/7/2018........................  28 units of MS Contin 30 mg; and  538955-538956
                                    120 units of oxycodone 30 mg.
12/5/2018........................  28 units of MS Contin 30 mg; and  539397-539398
                                    120 units of oxycodone 30 mg.
1/3/2019.........................  28 units of MS Contin 30 mg; and  539816-539817
                                    120 units of oxycodone 30 mg.
1/30/2019........................  28 units of MS Contin 30 mg; and  540243-540244
                                    120 units of oxycodone 30 mg.
2/27/2019........................  28 units of MS Contin 30 mg; and  540720-540721
                                    120 units of oxycodone 30 mg.
3/27/2019........................  28 units of MS Contin 30 mg; and  541246-541247
                                    120 units of oxycodone 30 mg.
4/24/2019........................  28 units of MS Contin 30 mg; and  541706-541707
                                    120 units of oxycodone 30 mg.

[[Page 2908]]

 
5/22/2019........................  28 units of MS Contin 30 mg; and  542196-542197
                                    120 units of oxycodone 30 mg.
6/19/2019........................  28 units of MS Contin 30 mg; and  542646-542647
                                    120 units of oxycodone 30 mg.
7/17/2019........................  28 units of MS Contin 30 mg; and  543112-543113
                                    120 units of oxycodone 30 mg.
8/14/2019........................  28 units of MS Contin 30 mg; and  543557-543558
                                    120 units of oxycodone 30 mg.
9/11/2019........................  28 units of MS Contin 30 mg; and  543979; 543982
                                    120 units of oxycodone 30 mg.
----------------------------------------------------------------------------------------------------------------

    24. Patient LH paid cash for all of the above-listed prescriptions 
for controlled substances that he filled with the Respondent.
    25. Between March 8, 2018, and at least September 11, 2019, the 
Respondent filled at least 59 prescriptions for Patient DH for 60 units 
of MS Contin 30 mg, 120 units of hydromorphone 8 mg, and 60 units of 
Xanax 2 mg. These prescriptions were filled on or about the following 
specific occasions:

----------------------------------------------------------------------------------------------------------------
            Fill date                      Drug(s) dispensed                      Prescription Nos.
----------------------------------------------------------------------------------------------------------------
3/8/2018.........................  60 units of MS Contin 30 mg.....  535478
3/13/2018........................  120 units of hydromorphone 8 mg;  535525-535526
                                    and 60 units of Xanax 2 mg.
4/10/2018........................  60 units of MS Contin 30 mg; 120  536047; 536050; 536053
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 2 mg.
5/8/2018.........................  60 units of MS Contin 30 mg; 120  536566-536567; 536571
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 2 mg.
6/5/2018.........................  120 units of hydromorphone 8 mg;  536993-536994
                                    and 60 units of Xanax 2 mg.
6/15/2018........................  60 units of MS Contin 30 mg.....  537081
7/4/2018.........................  120 units of hydromorphone 8 mg;  537254; 537257
                                    and 60 units of Xanax 2 mg.
7/13/2018........................  60 units of MS Contin 30 mg.....  537339
7/31/2018........................  120 units of hydromorphone 8 mg;  537486; 537489
                                    and 60 units of Xanax 2 mg.
8/28/2018........................  120 units of hydromorphone 8 mg;  537853; 537857
                                    and 60 units of Xanax 2 mg.
8/31/2018........................  60 units of MS Contin 30 mg.....  537906
9/25/2018........................  120 units of hydromorphone 8 mg;  538255; 538258
                                    and 60 units of Xanax 2 mg.
10/5/2018........................  60 units of MS Contin 30 mg.....  538386
10/23/2018.......................  120 units of hydromorphone 8 mg;  538663; 538666
                                    and 60 units of Xanax 2 mg.
11/2/2018........................  60 units of MS Contin 30 mg.....  538879
11/20/2018.......................  120 units of hydromorphone 8 mg;  539162; 539165
                                    and 60 units of Xanax 2 mg.
12/3/2018........................  60 units of MS Contin 30 mg.....  539350
12/18/2018.......................  120 units of hydromorphone 8 mg;  539596; 539599
                                    and 60 units of Xanax 2 mg.
12/31/2018.......................  60 units of MS Contin 30 mg.....  539743
1/15/2019........................  120 units of hydromorphone 8 mg;  540031; 540035
                                    and 60 units of Xanax 2 mg.
1/28/2019........................  60 units of MS Contin 30 mg.....  540191
2/12/2019........................  120 units of hydromorphone 8 mg;  540467; 540473
                                    and 60 units of Xanax 2 mg.
2/25/2019........................  60 units of MS Contin 30 mg.....  540670
3/11/2019........................  120 units of hydromorphone 8 mg;  540938-540939
                                    and 60 units of Xanax 2 mg.
3/25/2019........................  60 units of MS Contin 30 mg.....  541179
4/8/2019.........................  120 units of hydromorphone 8 mg;  541428-541429
                                    and 60 units of Xanax 2 mg.
4/22/2019........................  60 units of MS Contin 30 mg.....  541661
5/6/2019.........................  120 units of hydromorphone 8 mg;  541914-541915
                                    and 60 units of Xanax 2 mg.
5/20/2019........................  60 units of MS Contin 30 mg.....  542133
6/3/2019.........................  120 units of hydromorphone 8 mg;  542349; 542358
                                    and 60 units of Xanax 2 mg.
6/17/2019........................  60 units of MS Contin 30 mg.....  542587
7/1/2019.........................  120 units of hydromorphone 8 mg;  542839-542840
                                    and 60 units of Xanax 2 mg.
7/15/2019........................  60 units of MS Contin 30 mg.....  543059
7/29/2019........................  120 units of hydromorphone 8 mg;  543275-543276
                                    and 60 units of Xanax 2 mg.
8/12/2019........................  60 units of MS Contin 30 mg.....  543489
8/26/2019........................  120 units of hydromorphone 8 mg;  543703-543704
                                    and 60 units of Xanax 2 mg.
9/11/2019........................  60 units of MS Contin 30 mg.....  543975
----------------------------------------------------------------------------------------------------------------

    26. Patient DH paid cash for all of the above-listed prescriptions 
for controlled substances that he filled with the Respondent.
    27. Between February 16, 2018, and at least September 12, 2019, the 
Respondent filled at least 59 prescriptions for Patient DK for 60 units 
of MS Contin 30 mg, 60 units of MS Contin 60 mg, 90-120 units of 
hydromorphone 8 mg, 90 units of Xanax 0.5 mg, 60 units of Xanax 1 mg, 
and 35-60 units of Soma 350 mg. These prescriptions were filled on or 
about the following specific occasions:

----------------------------------------------------------------------------------------------------------------
            Fill date                      Drug(s) dispensed                      Prescription Nos.
----------------------------------------------------------------------------------------------------------------
2/16/2018........................  60 units of MS Contin 60 mg; 120  535071-535074
                                    units of hydromorphone 8 mg; 60
                                    units of Xanax 1 mg; and 60
                                    units of Soma 350 mg.
3/14/2018........................  60 units of MS Contin 60 mg; 120  535552; 535557-535558
                                    units of hydromorphone 8 mg;
                                    and 35 units of Soma 350 mg.
3/16/2018........................  60 units of Xanax 1 mg..........  535590
5/16/2018........................  60 units of MS Contin 60 mg; 120  536704; 536707-536708
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
5/18/2018........................  60 units of Soma 350 mg.........  536732
6/13/2018........................  60 units of MS Contin 60 mg; 120  537054-537056
                                    units of hydromorphone 8 mg;
                                    and 60 units of Soma 350 mg.
6/20/2018........................  60 units of Xanax 1 mg..........  537145

[[Page 2909]]

 
7/11/2018........................  60 units of MS Contin 60 mg; 120  537307-537309
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
8/8/2018.........................  60 units of MS Contin 60 mg; 120  537565-537566; 537568
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
9/18/2018........................  60 units of MS Contin 60 mg; 120  538219-538221
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
10/17/2018.......................  60 units of MS Contin 60 mg; 120  538548-538550
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
11/16/2018.......................  60 units of MS Contin 60 mg; 120  539113; 539115-539116
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
12/14/2018.......................  60 units of MS Contin 60 mg; 120  539557-539558; 539560
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
1/11/2019........................  60 units of MS Contin 60 mg; 120  539990-539991; 539993
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
2/13/2019........................  60 units of MS Contin 60 mg; 120  540509-540510; 540512
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
3/12/2019........................  60 units of MS Contin 60 mg; 120  540971; 540977-540978
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
4/11/2019........................  60 units of MS Contin 60 mg; 120  541496; 541498; 541500
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
5/9/2019.........................  60 units of MS Contin 60 mg; 120  541975-541977
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
6/6/2019.........................  60 units of MS Contin 60 mg; 120  542430-542431; 542433
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
7/5/2019.........................  60 units of MS Contin 60 mg; 120  542882-542883; 542889
                                    units of hydromorphone 8 mg;
                                    and 60 units of Xanax 1 mg.
8/13/2019........................  60 units of MS Contin 30 mg.....  543528
8/30/2019........................  90 units of hydromorphone 8 mg;   543798; 543800
                                    and 90 units of Xanax 0.5 mg.
9/12/2019........................  60 units of MS Contin 30 mg.....  544003
----------------------------------------------------------------------------------------------------------------

    28. Patient DK paid cash for all of the above-listed prescriptions 
for controlled substances that she filled with the Respondent.
    29. Between February 28, 2018, and at least September 17, 2019, the 
Respondent filled at least 78 prescriptions for Patient JM for 60 units 
of MS Contin 30 mg, 120 units of hydromorphone 8 mg, 60 units of 
Restoril 15 mg, 30 units of Restoril 30 mg, and 60 units of Xanax 2 mg. 
These prescriptions were filled on or about the following specific 
occasions:

----------------------------------------------------------------------------------------------------------------
            Fill date                      Drug(s) dispensed                      Prescription Nos.
----------------------------------------------------------------------------------------------------------------
2/28/2018........................  30 units of Restoril 30 mg; and   535267; 535269
                                    60 units of Xanax 2 mg.
3/5/2018.........................  120 units of hydromorphone 8 mg.  535393
3/9/2018.........................  60 units of MS Contin 30 mg.....  535492
3/28/2018........................  30 units of Restoril 30 mg; and   535799-535800
                                    60 units of Xanax 2 mg.
4/2/2018.........................  120 units of hydromorphone 8 mg.  535842
4/9/2018.........................  60 units of MS Contin 30 mg.....  536038
5/1/2018.........................  120 units of hydromorphone 8 mg;  536422; 536424-536425
                                    30 units of Restoril 30 mg; and
                                    60 units of Xanax 2 mg.
5/8/2018.........................  60 units of MS Contin 30 mg.....  536574
5/29/2018........................  120 units of hydromorphone 8 mg;  536909-536911
                                    30 units of Restoril 30 mg; and
                                    60 units of Xanax 2 mg.
6/4/2018.........................  60 units of MS Contin 30 mg.....  536967
6/26/2018........................  120 units of hydromorphone 8 mg;  537182-537183; 537189
                                    30 units of Restoril 30 mg; and
                                    60 units of Xanax 2 mg.
7/5/2018.........................  60 units of MS Contin 30 mg.....  537266
7/24/2018........................  120 units of hydromorphone 8 mg;  537451; 537452; 537455
                                    30 units of Restoril 30 mg; and
                                    60 units of Xanax 2 mg.
8/1/2018.........................  60 units of MS Contin 30 mg.....  537508
8/21/2018........................  120 units of hydromorphone 8 mg;  537773; 537778-537779
                                    30 units of Restoril 30 mg; and
                                    60 units of Xanax 2 mg.
8/31/2018........................  60 units of MS Contin 30 mg.....  537909
9/18/2018........................  120 units of hydromorphone 8 mg;  538160; 538162
                                    and 60 units of Xanax 2 mg.
9/24/2018........................  30 units of Restoril 30 mg......  538235
9/28/2018........................  60 units of MS Contin 30 mg.....  538302
10/17/2018.......................  120 units of hydromorphone 8 mg;  538541; 538543
                                    and 60 units of Xanax 2 mg.
10/26/2018.......................  60 units of MS Contin 30 mg; and  538728; 538730
                                    30 units of Restoril 30 mg.
11/13/2018.......................  120 units of hydromorphone 8 mg;  539024; 539026
                                    and 60 units of Xanax 2 mg.
11/26/2018.......................  60 units of MS Contin 30 mg; and  539245; 539247
                                    30 units of Restoril 30 mg.
1/9/2019.........................  60 units of MS Contin 30 mg; 120  539924-539925; 539927-539928
                                    units of hydromorphone 8 mg; 30
                                    units of Restoril 30 mg; and 60
                                    units of Xanax 2 mg.
2/6/2019.........................  60 units of MS Contin 30 mg; 120  540415; 540417; 540419-540420
                                    units of hydromorphone 8 mg; 30
                                    units of Restoril 30 mg; and 60
                                    units of Xanax 2 mg.
3/7/2019.........................  60 units of MS Contin 30 mg; 120  540900-540903
                                    units of hydromorphone 8 mg; 60
                                    units of Restoril 15 mg; and 60
                                    units of Xanax 2 mg.
4/3/2019.........................  60 units of MS Contin 30 mg; 120  541355-541358
                                    units of hydromorphone 8 mg; 60
                                    units of Restoril 15 mg; and 60
                                    units of Xanax 2 mg.
4/30/2019........................  120 units of hydromorphone 8 mg;  541815-541816
                                    and 60 units of Xanax 2 mg.
5/3/2019.........................  60 units of MS Contin 30 mg.....  541878
5/28/2019........................  120 units of hydromorphone 8 mg;  542248-542249; 542252
                                    30 units of Restoril 30 mg; and
                                    60 units of Xanax 2 mg.
5/30/2019........................  60 units of MS Contin 30 mg.....  542315
6/25/2019........................  120 units of hydromorphone 8 mg;  542726; 542729
                                    and 60 units of Xanax 2 mg.
6/27/2019........................  60 units of MS Contin 30 mg.....  542801
7/23/2019........................  120 units of hydromorphone 8 mg;  543189-543190; 543194
                                    30 units of Restoril 30 mg; and
                                    60 units of Xanax 2 mg.
7/25/2019........................  60 units of MS Contin 30 mg.....  543238
8/20/2019........................  120 units of hydromorphone 8 mg;  543628-543630
                                    30 units of Restoril 30 mg; and
                                    60 units of Xanax 2 mg.
8/23/2019........................  60 units of MS Contin 30 mg.....  543696
9/17/2019........................  120 units of hydromorphone 8 mg;  544074-544076
                                    30 units of Restoril 30 mg; and
                                    60 units of Xanax 2 mg.
----------------------------------------------------------------------------------------------------------------


[[Page 2910]]

    30. Patient JM paid cash for all of the above-listed prescriptions 
for controlled substances that she filled with the Respondent.
    31. Between March 7, 2018, and at least August 21, 2019, the 
Respondent filled at least 40 prescriptions for Patient ST for 60 units 
of MS Contin 60 mg and 150 units of oxycodone 30 mg. These 
prescriptions were filled on or about the following specific occasions:

----------------------------------------------------------------------------------------------------------------
            Fill date                      Drug(s) dispensed                      Prescription Nos.
----------------------------------------------------------------------------------------------------------------
3/7/2018.........................  60 units of MS Contin 60 mg; and  535465-535466
                                    150 units of oxycodone 30 mg.
4/4/2018.........................  60 units of MS Contin 60 mg; and  535928-535929
                                    150 units of oxycodone 30 mg.
5/2/2018.........................  60 units of MS Contin 60 mg; and  536448-536449
                                    150 units of oxycodone 30 mg.
5/30/2018........................  60 units of MS Contin 60 mg; and  536925; 536934
                                    150 units of oxycodone 30 mg.
6/27/2018........................  60 units of MS Contin 60 mg; and  537209-537210
                                    150 units of oxycodone 30 mg.
7/25/2018........................  60 units of MS Contin 60 mg; and  537471-537472
                                    150 units of oxycodone 30 mg.
8/22/2018........................  60 units of MS Contin 60 mg; and  537781-537782
                                    150 units of oxycodone 30 mg.
9/19/2018........................  60 units of MS Contin 60 mg; and  538182-538183
                                    150 units of oxycodone 30 mg.
10/17/2018.......................  60 units of MS Contin 60 mg; and  538555-538556
                                    150 units of oxycodone 30 mg.
11/14/2018.......................  60 units of MS Contin 60 mg; and  539062-539063
                                    150 units of oxycodone 30 mg.
12/12/2018.......................  60 units of MS Contin 60 mg; and  539505-539506
                                    150 units of oxycodone 30 mg.
1/9/2019.........................  60 units of MS Contin 60 mg; and  539913-539914
                                    150 units of oxycodone 30 mg.
2/6/2019.........................  60 units of MS Contin 60 mg; and  540400-540401
                                    150 units of oxycodone 30 mg.
3/7/2019.........................  60 units of MS Contin 60 mg; and  540894-540895
                                    150 units of oxycodone 30 mg.
4/3/2019.........................  60 units of MS Contin 60 mg; and  541363-541364
                                    150 units of oxycodone 30 mg.
5/1/2019.........................  60 units of MS Contin 60 mg; and  541831-541832
                                    150 units of oxycodone 30 mg.
5/29/2019........................  60 units of MS Contin 60 mg; and  542282-542283
                                    150 units of oxycodone 30 mg.
6/26/2019........................  60 units of MS Contin 60 mg; and  542762-542763
                                    150 units of oxycodone 30 mg.
7/24/2019........................  60 units of MS Contin 60 mg; and  543217-543218
                                    150 units of oxycodone 30 mg.
8/21/2019........................  60 units of MS Contin 60 mg; and  543650-543651
                                    150 units of oxycodone 30 mg.
----------------------------------------------------------------------------------------------------------------

    32. Patient ST paid cash for all of the above-listed prescriptions 
for controlled substances that he filled with the Respondent on or 
after April 4, 2018.
    33. Between April 19, 2018, and at least May 2, 2019, the 
Respondent filled at least 30 prescriptions for Patient JW for 28-90 
units of methadone 10 mg, 112-120 units of oxycodone 30 mg, and 30 
units of Xanax 1 mg. These prescriptions were filled on or about the 
following specific occasions:

----------------------------------------------------------------------------------------------------------------
            Fill date                      Drug(s) dispensed                      Prescription Nos.
----------------------------------------------------------------------------------------------------------------
4/19/2018........................  90 units of methadone 10 mg; 120  536190-536191; 536194
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
5/23/2018........................  90 units of methadone 10 mg; 120  536860-536862
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
8/29/2018........................  28 units of methadone 10 mg; 112  537877-537878; 537881
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
11/12/2018.......................  28 units of methadone 10 mg; 112  539000-539002
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
12/11/2018.......................  28 units of methadone 10 mg; 112  539482-539484
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
1/8/2019.........................  28 units of methadone 10 mg; 112  539875; 539877-539878
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
2/6/2019.........................  28 units of methadone 10 mg; 112  540394; 540397-540398
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
3/7/2019.........................  28 units of methadone 10 mg; 112  540886-540888
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
4/3/2019.........................  28 units of methadone 10 mg; 112  541369-541370; 541374
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
5/2/2019.........................  28 units of methadone 10 mg; 112  541863-541865
                                    units of oxycodone 30 mg; and
                                    30 units of Xanax 1 mg.
----------------------------------------------------------------------------------------------------------------

    34. Patient JW paid cash for all of the above-listed prescriptions 
for controlled substances that she filled with the Respondent.
    35. Between February 26, 2018, and at least August 28, 2019, the 
Respondent filled at least 33 prescriptions for Patient CW for 30 units 
of methadone 5 mg, 30-60 units of methadone 10 mg, 90-120 units of 
hydromorphone 8 mg, 30 units of Xanax 0.5 mg, 30 units of Xanax 1 mg, 
and 90 units of Xanax 2 mg. These prescriptions were filled on or about 
the following specific occasions:

----------------------------------------------------------------------------------------------------------------
            Fill date                      Drug(s) dispensed                      Prescription Nos.
----------------------------------------------------------------------------------------------------------------
2/26/2018........................  90 units of hydromorphone 8 mg..  535206
3/26/2018........................  90 units of hydromorphone 8 mg..  535720
4/23/2018........................  90 units of hydromorphone 8 mg..  536247
5/21/2018........................  90 units of hydromorphone 8 mg..  536776
7/24/2018........................  60 units of methadone 10 mg; 120  537446-537448
                                    units of hydromorphone 8 mg;
                                    and 30 units of Xanax 1 mg.
8/24/2018........................  30 units of methadone 5 mg......  537818
9/25/2018........................  30 units of methadone 10 mg; 120  538259; 538261; 538266
                                    units of hydromorphone 8 mg;
                                    and 90 units of Xanax 2 mg.
10/23/2018.......................  30 units of methadone 10 mg; and  538675-538676
                                    120 units of hydromorphone 8 mg.
10/24/2018.......................  30 units of Xanax 1 mg..........  538714
11/19/2018.......................  30 units of methadone 10 mg; and  539145-539146
                                    120 units of hydromorphone 8 mg.
11/20/2018.......................  30 units of Xanax 0.5 mg........  539154
12/17/2018.......................  30 units of methadone 10 mg; and  539591-539592
                                    120 units of hydromorphone 8 mg.
1/15/2019........................  30 units of methadone 5 mg; and   540015-540016
                                    120 units of hydromorphone 8 mg.
2/19/2019........................  120 units of hydromorphone 8 mg;  540583; 540585
                                    and 30 units of Xanax 1 mg.
3/19/2019........................  120 units of hydromorphone 8 mg;  541065; 541069
                                    and 30 units of Xanax 1 mg.
4/16/2019........................  120 units of hydromorphone 8 mg;  541548-541549
                                    and 30 units of Xanax 1 mg.

[[Page 2911]]

 
6/4/2019.........................  120 units of hydromorphone 8 mg;  542374-542375
                                    and 30 units of Xanax 1 mg.
7/31/2019........................  120 units of hydromorphone 8 mg;  543329-543330
                                    and 30 units of Xanax 1 mg.
8/28/2019........................  120 units of hydromorphone 8 mg;  543773-543774
                                    and 30 units of Xanax 1 mg.
----------------------------------------------------------------------------------------------------------------

    36. Patient CW paid cash for all of the above-listed prescriptions 
for controlled substances that she filled with the Respondent.

The Government's Case *<SUP>C</SUP>
---------------------------------------------------------------------------

    *\C\ Throughout the Chief ALJ's description of both the 
Government's Case and the Respondent's Case, I have made some minor 
adjustments to the wording where noted for brevity and for clarity 
and to reflect more of my style. I agree with the Chief ALJ on the 
astute points that he made and I have left in the content.
---------------------------------------------------------------------------

    In addition to its reliance on the agreed factual stipulations 
reached by the parties in this case, the Government presented its case 
through the testimony of a DEA Diversion Investigator and an expert 
pharmacy witness.

Diversion Investigator

    The Government presented the testimony of a DEA Diversion 
Investigator (DI). DI testified that, as of the date of the hearing, he 
has been a DI for approximately three years and is currently stationed 
at the Miami field office. Tr. 19. The investigation that culminated in 
the present administrative charges was initiated by DI's predecessor, 
DI 2. Tr. 22. Upon DI 2's retirement from DEA, DI assumed 
responsibility as the lead DEA investigator on the case and inherited 
both open and closed evidence requests, as well as the balance of the 
investigative case file. Tr. 22-23. According to DI, the Respondent 
became the focus of DEA's attention after an on-site inspection by DEA 
in 2015. Tr. 24. DI's testimony was also used to authenticate a number 
of Government Exhibits, consisting of documents obtained during the 
course of the investigation. Tr. 31, 35, 38, 40-41, 46, 48-49, 62, 65, 
67, 76, 79-80, 109-10, 364.
    DI presented as an objective regulator and investigator with no 
discernable motive to fabricate or exaggerate. As a successor 
investigator, he demonstrated candor in teasing out which aspects of 
the investigation were initiated/controlled by him, and which aspects 
were inherited. Where he was unsure of an answer, he presented a good-
faith effort but made no attempt to supply a convenient contrivance. 
The testimony of this witness, viewed in toto, was sufficiently 
detailed, plausible, and internally consistent to be afforded full 
credibility in this case.

Dr. Tracey Schossow, Pharm.D.

    The Government presented the expert testimony of Dr. Tracey 
Schossow. Dr. Schossow's curriculum vitae (CV) \7\ reflects that she 
received a Doctorate in Pharmacy in 2001, has practiced,\8\ managed, 
consulted, trained, and taught pharmacy for twenty-six years in a 
variety of settings, and even authored the pharmacy portion of a manual 
for a hospice company. Tr. 135, 155; Gov't Ex. 17. In fact, the witness 
testified that her introduction to the pharmacy profession commenced 
with work as a pharmacy technician in her father's independent pharmacy 
back in 1982. Tr. 136.
---------------------------------------------------------------------------

    \7\ Gov't Ex. 17.
    \8\ Dr. Schossow testified that she has practiced as a clinical 
pharmacist and a retail pharmacist. Tr. 145. In her words, ``a 
retail pharmacist does most of the actual dispensing of the 
medications into the bottles, versus a clinical pharmacist is more 
involved with the patient and the doctor, working more closely with 
them, usually offering recommendations on managing the patient.'' 
Id. The witness testified that she practiced retail pharmacy for 
about twelve years. Id.
---------------------------------------------------------------------------

    In the midst of a largely uneventful presentation, there arose a 
bizarre twist of events that bears special mention. During a cross-
examination conducted by the Respondent's (then) counsel, Dr. Schossow 
[testified] that she was familiar with the composition of the Florida 
Board of Pharmacy, and volunteered that ``It's made up of pharmacists. 
I sat on the Board one time so--a long time ago.'' Tr. 455. Since 
neither Dr. Schossow's CV,\9\ nor her direct testimony regarding her 
qualifications, reflected past employment as a Board member, [this 
testimony was unexpected. On cross examination, Respondent's counsel 
followed up on this issue with Dr. Schossow, and they had the following 
exchange:
---------------------------------------------------------------------------

    \9\ Gov't Ex. 17.

    Q: I understood you to say that you sat on the Board of Pharmacy 
for a period of time? Is that right?
    A: When I first graduated from pharmacy school, yes. I was--this 
was a long time ago. I don't know if it was--I don't remember the 
position, exactly. It wasn't, like,--I wasn't the head of the Board, 
or anything like that. But I did sit on the Board in the meetings.
    Q: Okay. And did you vote and participate in the process?
    A: I participated in the process, but I didn't have any voting--
I didn't do any voting.
    Q: Okay. So, what you're talking about is, maybe, internship-
type position with the board of pharmacy?
    A: I don't recall the exact title of it. It was not an intern 
position. I was a licensed pharmacist at the time.
    Q: All right. And so, this was, when? After you received your 
initial degree as a registered pharmacist, or during your Pharm D 
program?
    A: No, it was after I received my initial pharmacy degree back 
in '94.

Tr. 546-47. Dr. Schossow then confirmed that she ``wasn't sitting on 
the board'' and ``didn't have a title like that,'' but she did 
participate. Id. at 547. She continued, ``It was a long time ago, so I 
do not recall the official, whatever I was doing at that time.'' Id. As 
discussed in more detail below, this testimony was inconsistent and 
confusing.
    Dr. Schossow also testified that she could not recall particular 
sources that she reviewed prior to her testimony in this case, but 
stated that she is constantly reviewing a variety of information from 
legal sources, federal guidelines, as well as clinical data and studies 
to stay current on the applicable standard of care for Florida 
pharmacists.\10\ Tr. 152-53, 163; see also id. at 193. Dr. Schossow 
also volunteered that she ``also had a lot of patients in the community 
arrested for opioid and other controlled substance fraud and abuse.'' 
\11\ Tr. 137. The witness testified that she has also served as a 
pharmacy expert reviewer in federal agency cases involving controlled 
substances \12\ and has been recognized as an expert witness on 
multiple occasions in administrative enforcement cases. Tr. 145-47. Dr. 
Schossow was tendered \13\ and, over the Respondent's

[[Page 2912]]

objection, was accepted as an expert witness in the standard of care 
for Florida pharmacists and pharmacy practice in the State of Florida. 
Tr. 166-67.
---------------------------------------------------------------------------

    \10\ The witness testified that the Florida requirement for 
continuing education is limited to one hour every two years. Tr. 
197.
    \11\ This portion of the witness's testimony was objected to as 
irrelevant by the Respondent's counsel, and the tribunal 
subsequently sustained the objection. Thus, while no part of this 
statement will be considered to the detriment of the Respondent, it 
does present some potential insight into the mindset of the 
Government's expert. Its consideration is limited to that narrow 
point.
    \12\ Dr. Schossow testified that she has been compensated for 
her professional work as an expert, including by DEA in this case. 
Tr. 530. She also testified that although thus far her expert 
opinion has been exclusively sought by DEA, she would be willing to 
``give [her] opinion to anybody who asks [her] regarding pharmacy.'' 
Tr. 162-63.
    \13\ Tr. 149.
---------------------------------------------------------------------------

    According to Dr. Schossow, the applicable standard of care for 
dispensing controlled substances in Florida requires a pharmacist to 
evaluate every prescription presented by a patient.\14\ Tr. 168-69. Dr. 
Schossow encapsulated her view of applicable statutes governing state 
corresponding responsibility in Florida as follows:
---------------------------------------------------------------------------

    \14\ Throughout her testimony, the witness would refer to 
various Florida statutes that, according to her, inform her opinion 
on the standard of care for a Florida pharmacist. In evaluating the 
role of an expert witness in the pharmacy context, the Agency has 
held that a pharmacy expert is ``not [expected to be] an expert in 
the details of state law, but she is required as a pharmacist to 
understand what conduct is outside of the usual course of 
professional practice in her state, whether that is derived from 
state law, mandatory training, standards of care or otherwise.'' 
Suntree Pharmacy, 85 FR 73,753, 73,772 (2020).

    [T]he responsibility of a [Florida] pharmacist is to ensure the 
safety and efficacy of the therapy for that person and also to 
protect that person in regards to safety for the patient and the 
---------------------------------------------------------------------------
community. It's very clear.

Tr. 171. Less helpfully, at another point in her testimony, the witness 
defined the applicable standard of care as ``[w]hat usually a normal 
pharmacist would do in a pharmacy or how they would practice the 
profession of pharmacy.'' Tr. 181; see also id. at 336.

    According to the Government's expert, in evaluating a prescription, 
a Florida pharmacist is required to perform a drug utilization review 
(DUR),\15\ which is a process by which a pharmacist analyzes a 
prescription to check for red flags signaling a potential diversion 
issue, and to ``assure that the prescription is for a legitimate 
medical purpose.'' Tr. 169; see id. at 189-90. Dr. Schossow defined a 
red flag as ``something on the prescription that alerts the pharmacist 
that the prescription may be being diverted or abused and that the 
pharmacist must do their due diligence to determine whether that red 
flag can be cleared or not.'' Tr. 189-90. When a pharmacist \16\ is 
faced with a red flag, the red flag must be addressed and documented. 
Tr. 189-90, 198. Documented findings can be recorded on the 
prescription itself, within a patient profile, or in a note section of 
a pharmacy software program. Tr. 177. The witness opined that a lack of 
documentation indicates that the required analysis of a red flag was 
not performed by the dispensing pharmacist. Tr. 199-200. The witness 
conceded that she did not know whether any of the red flags she 
identified were actually analyzed and resolved by the Respondent,\17\ 
but she made her opinion clear that a deficit in the adequacy of the 
documentation setting forth the pharmacist's DUR analysis brings a 
dispensing event below the Florida minimum standard of care, and that 
the DUR analysis can be set forth on the prescription itself or in a 
pharmacy's electronic records. Tr. 177, 740. According to Dr. Schossow, 
the mere existence of a red flag, in and of itself, does not always 
prohibit a pharmacist from filing a prescription; \18\ it was her view 
that upon sufficient documented analysis, all red flags are potentially 
resolvable. Tr. 237. The Government's expert clarified early in her 
testimony that she was restricting her opinions to the minimum Florida 
standard of care, and not elucidating on best practices in the field of 
pharmacy. Tr. 175-76.
---------------------------------------------------------------------------

    \15\ During her testimony, the witness used the term ``DUR'' 
interchangeably to mean the process of a drug review, as well as for 
a finding made during the review that would warrant further review 
(i.e., a red flag); this was confusing and unhelpful. See, e.g., Tr. 
187-88.
    \16\ It is Dr. Schossow's view that a diversion red flag may 
only be resolved by a pharmacist, never a pharmacy technician. Tr. 
200.
    \17\ Tr. 446.
    \18\ Tr. 198.
---------------------------------------------------------------------------

    The Government's expert testified that she reviewed prescriptions 
and patient profiles corresponding to the Ten Patients \19\ and 
determined that dispensing events depicted in those profiles and 
records presented numerous red flags, with no documented indications on 
the part of the Respondent of any attempts to resolve those red flags 
prior to filling the prescriptions in accordance with the standard of 
care for a Florida pharmacist. Tr. 431. One such red flag identified by 
the witness through the Respondent's paperwork was present in 
dispensing events where controlled substances were filled in high-risk 
combinations \20\ that significantly elevate the risk for such things 
as central nervous system (CNS)/respiratory depression, overdose, coma, 
and death. Gov't Exs. 6, 7, 9-11, 13, 14, 22, 23, 25-27, 29; Tr. 215-
16, 218-21; Stip. 33 (Patient JW); Tr. 268-69; Stip. 19 (Patient EA); 
Tr. 287-91, 294-95; Stip. 21 (Patient SD); Tr. 309-12; Stip. 25 
(Patient DH); \21\ Tr. 321-26; Stip. 27 (Patient DK); \22\ Tr. 330-32; 
Stip. 29 (Patient JM); \23\ Tr. 243-45; Stip. 35 (Patient CW). 
According to Dr. Schossow, under the Florida standard of care, filling 
these prescriptions would require documented indicia that the 
pharmacist reviewed the patient's history, reviewed the patient's 
information on the Electronic-Florida Online Reporting of Controlled 
Substance Evaluation database (E-FORCSE),\24\ spoke with the doctor, 
spoke with the prescriber, inquired about the patient treatment plan, 
discussed function improvement of the patient, and discussed whether 
the patient had been apprised of the associated risks.\25\ Tr. 204, 
213-14, 216. The witness explained that there was no indication in the 
Respondent's records that the documentation requirement had been 
completed or addressed for the high-risk combination red flags that she 
identified. Gov't Exs. 6, 7, 9-11, 13-15, 22, 23, 25-27, 29, 32; \26\ 
Tr. 240-41, 424-25 (Patient JW); Tr. 286, 371-75 (Patient EA); Tr. 295-
300, 375-78 (Patient SD); Tr. 319, 321, 385-88, 397-98, 408-09 (Patient 
DH); \27\ Tr. 329-30,

[[Page 2913]]

409-13 (Patient DK); Tr. 346-47, 425-30 (Patient CW). Dr. Schossow's 
testimony regarding the absence of documentation also extended to 
Patient JM. Tr. 338-39, 413-16, 419-20; Gov't Exs. 11, 15, 27, 32. 
However, as highlighted in her testimony, the Respondent's records did 
contain notes documenting combination medication discussions between 
the pharmacy and Patient JM. Tr. 414-418, 471; Gov't Ex. 32 at 69. 
Specifically, the pharmacy notes include, inter alia, the following 
entries:
---------------------------------------------------------------------------

    \19\ Patients JA, EA, SD, LH, DH, DK, JM, ST, JW, and CW.
    \20\ Dr. Schossow identified combinations of opioids and 
benzodiazepines that, when taken together, can potentially result in 
a dangerous suppression of the central nervous system. Tr. 204.
    \21\ Dr. Schossow testified that her opinion would not be 
altered by a brief temporal break such as two weeks between the in-
conflict medications. Tr. 318.
    \22\ Dr. Schossow testified that her opinion was not altered by 
the fact that the prescriptions in conflict were not dispensed on 
the same day. Tr. 324.
    \23\ Dr. Schossow testified that her opinion was not altered by 
the fact that the prescriptions in conflict were dispensed several 
days apart. Tr. 338.
    \24\ E-FORCSE is the prescription drug monitoring program (PDMP 
or PMP) maintained by the State of Florida.
    \25\ The Government's expert also referenced guidelines (CDC 
Guidelines) issued on March 18, 2016 by the Centers for Disease 
Control and Prevention (CDC) regarding morphine equivalent dosages 
(MMEs). Tr. 205-06. The CDC Guidelines were the subject of official 
notice during the proceedings. ALJ Ex. 39. While the CDC Guidelines 
were the subject of some level of pre-hearing notice by the 
Government, ALJ Ex. 4 at 23, there was no specific notice that an 
MME at any particular level, standing on its own, constitutes a red 
flag requiring action by a pharmacy registrant. During her 
testimony, Dr. Schossow accepted the proposition that the CDC 
Guidelines were issued primarily to guide prescribers, not 
pharmacies. Tr. 503-04.
    \26\ During the hearing, Proposed Government Exhibit 16 was 
initially offered in the form of a compact disc and admitted with 
the condition that the Government provide a hard-copy version of the 
subset of pages that it seeks to rely upon. ALJ Ex. 44. After the 
hearing, the Government discovered that the relevant information 
within Proposed Government Exhibit 16 was also contained within 
Government Exhibit 32, and subsequently withdrew Proposed Government 
Exhibit 16. ALJ Ex. 47.
    \27\ Although the Respondent pharmacy's notes did reflect that 
its personnel conducted a conversation with the prescriber, the 
Government's expert held the view that the documentation was so 
lacking in detail that the applicable standard was not met. Tr. 387-
95. Dr. Schossow was steadfast in her opinion that the level of 
documentation was wanting, but was unable or unwilling to specify 
any sort of a generic standard as to what the level of documentation 
needs to be to pass muster. Id.

12/12/19 SPOKE TO MD OFFICE: PT HAS BIPOLAR SCHIZOPHRENIA/ANXIETY. 
MD IS AWARE OF COMBO DRUG (XANAX, TEMAZEPAM, HYDRO-MORPHONE, 
TIZANIDINE, MS CONTIN) NO SIGNS OF ABUSE. PT HAS BEEN ON MEDS SINCE 
---------------------------------------------------------------------------
2010. PT HAS BUILT UP TOLERANCE.

12/16/19 SPOKE TO MD OFFICE: ABOUT COMBINATION OF OXYCO-DONE, MS 
CONTIN, XANAX, TIZANI-DINE, TEMAZEMAM. MD IS AWARE PT HAS BIPOLAR 
MORBIDITY. STATES MONITORS PT FOR ABUSE. NO SIGNS OF REPIRATORY 
DEPRESSION. PT HAS BEEN ON MEDS FOR OVER 5 YEARS.

Gov't Ex. 32 at 69. Similarly, a pharmacy note regarding Patient CW 
provides:

12/18/19 SPOKE TO MD ABOUT COMBINATION OF HYDROMORPHONE/ALPRAZOLAM. 
PT HAS NO SIGNS OF SIQUALE. NO SIGNS OF ABUSE PT HAS BEEN ON MEDS 
FOR SEVERAL YRS. OK TO FILL. . . .

Id. at 13. To be sure, on their face, these highlighted pharmacy notes 
are temporally outside the Government's allegations related to Patients 
JM \28\ and CW,\29\ but they clearly do appear to contain analysis 
regarding the combination prescribing issue and coordination with the 
prescriber. These notes demonstrate that at some point the Respondent 
did commence documenting conversations with the prescribers on this 
issue, [which is a positive development that indicates an attempt by 
Respondent's pharmacists to fulfill their corresponding responsibility 
and operate within the usual course of professional practice. However,] 
inasmuch as the documented resolutions are dated after the charged 
misconduct, they supply no defense to the registrant in this case.
---------------------------------------------------------------------------

    \28\ OSC/ISO Allegation 7.e charges that combination 
prescriptions between January 9, 2019 and August 23, 2019 were 
dispensed by the Respondent to Patient JM without documented 
evidence that the identified combination red flag was resolved. ALJ 
Ex. 1 ] 7.e.
    \29\ OSC/ISO Allegation 7.g charges that combination 
prescriptions between February 19, 2019 and August 28, 2019 were 
dispensed by the Respondent to Patient CW without documented 
evidence that the identified combination red flag was resolved. ALJ 
Ex. 1 ] 7.g.

    In reviewing the prescriptions that were filled by the Respondent, 
Dr. Schossow also identified anomalies in regard to dosages of 
controlled substance prescriptions that raised red flags. Specifically, 
the witness explained that certain prescriptions did not ``make 
pharmacological sense'' \30\ because of the dosing combinations of 
long-acting and short-acting opioids.\31\ Gov't Exs. 6-9, 11, 12; Tr. 
274-76, 281-83; Stip. 19 (Patient EA); Tr. 296-97; Stip. 21 (Patient 
SD); Tr. 302-05; Stip. 23 (Patient LH); \32\ Tr. 315-16; Stip. 25 
(Patient DH); \33\ Tr. 333-34; Stip. 29 (Patient JM); Tr. 339-41; Stip. 
31 (Patient ST). And for at least one patient, Dr. Schossow testified 
that there were instances of therapeutic duplication,\34\ which also 
presented a dosage-anomaly red flag. Gov't Ex. 11; Tr. 335-38; Stip. 29 
(Patient JM). The witness testified that to address a dosage-anomaly 
red flag, a Florida pharmacist acting within the standard of care is 
required to speak with the physician to discuss the potential dangers 
and the patient's treatment plan, and then document the 
conversation.\35\ Tr. 284-855, 318, 336-37. Through her testimony, the 
witness explained that she saw no indication in her review of the 
Government exhibits that the Respondent resolved, addressed, or 
documented the dosage-anomaly red flags. Gov't Exs. 6-9, 11, 12, 15, 
22-25, 27, 28, 32; Tr. 286, 371-75 (Patient EA); Tr. 298-300, 375-78 
(Patient SD); Tr. 308, 378-80, 384 (Patient LH); Tr. 319, 321, 385-88, 
397-98, 408-09 (Patient DH); Tr. 338-39, 413-16, 419-20 (Patient JM); 
Tr. 342-43, 420-23 (Patient ST).
---------------------------------------------------------------------------

    \30\ Tr. 281.
    \31\ Certain controlled substances are prescribed to be taken 
scheduled, in order to maintain the medication at a certain level in 
the body consistently. Tr. 275-76. While other controlled substances 
are prescribed to address breakthrough pain, or episodic pain, on an 
as-needed basis. Tr. 276-77. Here, Dr. Schossow testified that the 
Respondent was filling prescriptions where controlled substances 
that are usually prescribed for breakthrough pain were prescribed on 
a scheduled basis. Tr. 274-75.
    \32\ The witness was unmoved by the fact that the prescription 
sig was marked ``PRN,'' signifying that the medication was to be 
taken on an ``as needed'' basis. Tr. 302-03.
    \33\ Regarding Patient DH, Dr. Schossow's opinion is that to 
resolve an identified dosing red flag within the standard of care, a 
Florida pharmacy registrant would be required to demonstrate 
documented ``careful justification of why [the patient] would need 
so much [medicine] or the attempt of trying to lower it to a safer 
dose with the physician.'' Tr. 409. [The Chief ALJ determined that 
the standard outlined by Dr. Schossow was too onerous to impose on 
pharmacists. However,] there is a sufficient lack of documentation 
in this case that it is not necessary to reach the issue of whether 
Dr. Schossow's elevated standard of documentation delivered here 
meets or exceeds the required threshold. [Respondent's failure to 
document any resolution of this red flag was outside the usual 
course of professional practice, and a violation of its 
corresponding responsibility.]
    \34\ The witness defined therapeutic duplication as when two 
controlled substances that act pharmacologically the same are 
prescribed together. Tr. 335-36.
    \35\ [Omitted for clarity].
---------------------------------------------------------------------------

    Dr. Schossow also testified that instances where customer-patients 
of the Respondent drove long distances to obtain and/or fill controlled 
substance prescriptions were red flags that must be addressed and 
resolved. Tr. 232-34; Gov't Exs. 5, 8, 10, 12, 13, 21, 24, 26, 28; Tr. 
232-36 (Patient JW); Tr. 248-50 (Patient JA); Tr. 305-06 (Patient LH); 
Tr. 326-28 (Patient DK); Tr. 341-42 (Patient ST); ALJ Ex. 19, Attachs. 
A, C. [Dr. Schossow testified that] a patient driving long distances to 
fill a controlled substance prescription presents a red flag because of 
concerns ``for the safety of the patient'' as they could potentially be 
driving under the influence of controlled substances. Tr. 232-34. In 
order to address this long-distance red flag, a Florida pharmacist 
acting within the standard of care, at least according to Dr. Schossow, 
would need to question the patient on whether they were personally 
driving, question the prescriber on whether they ``discussed the 
dangers of the dosing of the medication in regards to operating a motor 
vehicle,'' \36\ and then document the conversation/resolution.\37\ Tr. 
238-39; see also id. at 306-07, 328. [Omitted as superfluous. As 
discussed in more detail below, the Chief ALJ found that Dr. Schossow's 
testimony regarding the distance red flag was not convincing. I agree, 
and I do not give any weight to this testimony in my Decision. I have 
omitted portions of the RD's discussion of this red flag for brevity.]
---------------------------------------------------------------------------

    \36\ Tr. 307.
    \37\ In one particular note for Patient LH, the Respondent wrote 
that the patient lived in Naples, Florida. Tr. 380; Gov't Ex. 32 at 
80. The witness testified that this type of notation is insufficient 
and that the standard of care requires communication and 
documentation regarding whether the patient is actually driving. Tr. 
380.
---------------------------------------------------------------------------

    Cash payments for controlled substances were also identified by Dr. 
Schossow as a red flag of potential diversion. Tr. 222-23, 457; Gov't 
Exs. 5-14, 21-29; Tr. 229-30; Stip. 34 (Patient JW); Tr. 242, 244; 
Stip. 18 (Patient JA); Tr. 269-70; Stip. 20 (Patient EA); Tr. 296-97; 
Stip. 22 (Patient SD); Tr. 305; Stip. 24 (Patient LH); Tr. 313; Stip. 
26 (Patient DH); Tr. 326; Stip. 28 (Patient DK); Tr. 332-33; Stip. 30 
(Patient JM); Tr. 341; Stip. 32 (Patient ST); Tr. 346; Stip. 36 
(Patient CW). Dr. Schossow explained that an indication on a

[[Page 2914]]

particular prescription of ``cash'' means that the price of the 
prescription was not ``charged to an insurance company, or worker's 
comp.'' \38\ Tr. 222-23. The Government's expert explained that, in her 
opinion, if a patient did pay in ``cash'' that she would assume the 
patient had insurance but was choosing not to utilize their insurance; 
a scheme she explained, in her experience, is practiced by drug 
diverters.\39\ Tr. 223-28. Dr. Schossow admitted that she could not 
know for certain whether a patient had insurance or not simply by 
seeing the notation ``cash'' on a prescription. Tr. 226. The witness 
also acknowledged that where a pharmacy is out of network, the customer 
patient can submit the insurance reimbursement claim to the insurer. 
Tr. 537. According to Dr. Schossow, in order to resolve a cash red 
flag, within the standard of care, a Florida pharmacist is required to 
ask the prescribing physician whether the patient has insurance and 
document the finding.\40\ Tr. 228-29, 239, 306. A notation by the 
pharmacy staff that a customer-patient did not have insurance coverage 
\41\ was, in Dr. Schossow's view, insufficient to resolve the red flag 
of cash payment. Tr. 367, 374, 428. Even a case where the registrant 
pharmacy documented that it was not contracted with the customer-
patient's insurance carrier was insufficient to satisfy the standard 
outlined by Dr. Schossow based on her expressed innate suspicion of a 
customer who would not, on that occasion, seek out a different pharmacy 
that accepted the prescription coverage benefit.\42\ Tr. 411. [Omitted 
for brevity. The Chief ALJ found that Dr. Shossow's testimony about 
this red flag was not convincing and that her standard for resolving 
this red flag was too burdensome and illogical to set the minimum 
standard of care in Florida. The Chief ALJ did not sustain the 
Government's allegations regarding this red flag, and the Government 
took Exception to this finding. As discussed below, I find that it is 
unnecessary for me to reach this issue because there is substantial 
other evidence on the record that demonstrates that Respondent's 
registration is inconsistent with the public interest. 
<SUP>43 44 45 46 47 48 49 50</SUP>
---------------------------------------------------------------------------

    \38\ During the course of his testimony on the issue, the 
Respondent's owner testified that ``cash'' can mean currency, a 
credit card, or a check. Tr. 635.
    \39\ The Government presented no evidence that any of the Ten 
Patients were or are drug diverters. This assumption played no role 
in the Government's noticed theory of its case. ALJ Ex. 1.
    \40\ According to Dr. Schossow, a notation that simply states 
that the patient does not have insurance is insufficient to meet the 
standard of care in Florida. Tr. 374. Dr. Schossow explained that 
even where a prescription contains such a notation, it is incumbent 
upon the pharmacist to contact the prescriber to ensure a true lack 
of insurance, Tr. 374, but conceded that ``many'' of the 
prescriptions she reviewed in this case did have an indication from 
the prescriber that the customer-patient was uninsured, Tr. 471. 
Thus, by Dr. Schossow's view, even where the pharmacy has apparently 
determined that the customer-patient is without prescription 
insurance coverage and documented that conclusion on the relevant 
scrip, the additional step of contacting the prescriber and 
documenting the results of that conversation are required to meet 
the minimum standard of care in Florida. As discussed, infra, this 
makes no sense.
    \41\ See, e.g., Gov't Ex. 32 at 13 (pharmacy note entered 
outside the charged conduct period reflecting the Respondent's 
conclusion that Patient CW paid cash because she did not have 
insurance).
    \42\ [Footnote omitted where text was deleted.]
    \43\ [Footnote omitted where text was deleted.]
    \44\ [Footnote omitted where text was deleted.]
    \45\ [Footnote omitted where text was deleted.]
    \46\ [Footnote omitted where text was deleted.]
    \47\ [Footnote omitted where text was deleted.]
    \48\ [Footnote omitted where text was deleted.]
    \49\ [Footnote omitted where text was deleted.]
    \50\ [Footnote omitted where text was deleted.]
---------------------------------------------------------------------------

    Overall, Dr. Schossow's testimony, although not without its warts, 
was generally authoritative and amply supported by the admitted 
evidence of record. While her overall presentation was generally 
objective, her [testimony that she] ``had a lot of patients in the 
community arrested for opioid and other controlled substance fraud and 
abuse,'' \51\ and her underlying assumption that customer-patients 
should be assumed to be abusers \52\ (although she had no information 
that this may have been the case regarding any of the Ten 
Patients),\53\ were certainly concerning aspects of her testimony. [It 
was also concerning that Dr. Schossow testified that] she had been a 
member of the Florida Board of Pharmacy and then denied that this was 
ever the case. [Omitted for brevity. I agree with the Chief ALJ that 
this testimony was confusing, but there is insufficient evidence on the 
record about how the Board operates and what role Dr. Schossow was 
referring to that would permit me to ascribe any level of intent to Dr. 
Schossow regarding this statement. Based on my review of the record, I 
did not discern any intent to mislead the Tribunal, but certainly at 
least her initial statement gave an incorrect impression and I consider 
this statement in the same manner as the Chief ALJ did below.]
---------------------------------------------------------------------------

    \51\ Tr. 137.
    \52\ Tr. 368.
    \53\ Tr. 444-45.
---------------------------------------------------------------------------

    Dr. Schossow's testimony also contained isolated occasions where 
she arguably presented as confusing,\54\ defensive, even bordering on 
evasive,\55\ and the ``on-the-Board''/``not-on-the-Board'' feature was 
[confusing], but she has no objective stake in the outcome of the 
proceedings, and there is nothing present in the record or her 
testimony that would mortally undermine her credibility and 
reliability. On those points where her testimony was found reliable and 
persuasive in this RD, the witness provided sufficient, detailed, 
cogent support for her views. Of the two experts who testified in these 
proceedings, her shortcomings notwithstanding, she is the more reliable 
and persuasive, and where her testimony was at variance with the 
Respondent's expert, it is Dr. Schossow's opinion which will be relied 
upon.
---------------------------------------------------------------------------

    \54\ See, e.g., Tr. 399-408. The witness volunteered that the 
pharmacy notes she was reviewing on the stand were not the same as 
the notes she reviewed prior to her testimony. Id. This anomaly was 
never cogently explained by the witness. [Omitted for brevity. I 
agree with the Chief ALJ that there was no ``cognizable prejudice to 
the interests of justice or the Respondent's case'' from Dr. 
Schossow's confusion about which notes she reviewed before the 
hearing, because Dr. Schossow was clear during her testimony about 
what materials she reviewed and how she formed her opinions.]
    \55\ See, e.g., Tr. 243-44 (multiple attempts taken to get the 
witness to state that the paperwork she examined did not have any 
indication as to whether the customer-patients had insurance with 
prescription drug coverage); Tr. 291-93 (significant equivocation on 
whether identified red flags are resolvable, and if yes, how so); 
Tr. 448-49 (significant equivocation on answering whether, during 
her analysis, she had identified violations beyond failure to 
document red flag resolutions); Tr. 451-52 (significant equivocation 
in addressing the straightforward question of whether she had ever 
read the footnotes, any of the footnotes, in a specified guidance 
document issued by the CDC).
---------------------------------------------------------------------------

The Respondent's Case \*D\
---------------------------------------------------------------------------

    \*D\ Throughout the Respondent's case, I have made some minor 
adjustments to the wording where noted for brevity and for clarity 
and to reflect more of my style. See supra n. *C.
---------------------------------------------------------------------------

    The Respondent's case consisted of testimony from the Respondent's 
owner and an expert witness.

Dr. Daniel E. Buffington, Pharm.D.

    The Respondent presented the testimony of Dr. Daniel Buffington, 
Pharm.D. Dr. Buffington's CV \56\ reflects that he earned his Doctorate 
in Pharmacy in 1987, completed a pharmacy residency in 1988, and 
concluded a pharmacy fellowship in 1989 that focused on pharmacy 
practice and clinical pharmacology. Tr. 792-94; Resp't Ex. 12. The 
witness testified that he has held a faculty position at the University 
of South Florida, Colleges of Medicine and Pharmacy since the early 
1990s, along with various other academic appointments and positions 
where he has taught a myriad of topics regarding pharmacotherapy and 
clinical pharmacology. Tr. 792, 794-95. Dr. Buffington explained that, 
although he is not licensed as a consultant

[[Page 2915]]

pharmacist in Florida,\57\ his pharmacy background has included some 
consultation, clinical research, and pharmacy work as both a clinical 
and retail pharmacist. Tr. 796-97. His current business, Clinical 
Pharmacology Services ``is a licensed pharmacy [that] also provides 
direct patient consultation, manages clinical research trials, and 
provides drug information support for health systems, medical 
practices, but also forensics for law enforcement, government 
agencies.'' \58\ Tr. 796. The witness testified that he has also served 
as an expert in numerous state and federal cases and has participated 
on panels relative to Florida legislative initiatives regarding 
administrative code provisions. Tr. 814-15. Dr. Buffington was tendered 
\59\ and, without objection from the Government, accepted \60\ as an 
expert witness in Florida pharmacy practice under Florida and federal 
standards, and the standard of care for pharmacists practicing in the 
state of Florida.\61\ Tr. 813.
---------------------------------------------------------------------------

    \56\ Resp't Ex. 12.
    \57\ Tr. 793.
    \58\ Dr. Buffington explained that his work includes consulting 
with retail pharmacies regarding their compliance with relevant 
Florida law provisions. Tr. 816.
    \59\ Tr. 799-800.
    \60\ During voir dire, the witness was combative and evasive 
even in answering straightforward questions regarding his 
qualifications. See, e.g., Tr. 805-09.
    \61\ Tr. 799.
---------------------------------------------------------------------------

    According to Dr. Buffington, under the applicable standard of care 
for dispensing controlled substances in Florida, a pharmacist is 
expected to assess every new and refill prescription presented to them 
by a patient.\62\ Tr. 823. Dr. Buffington summarized his view of 
applicable statutes governing the standard in Florida as follows:
---------------------------------------------------------------------------

    \62\ The witness testified that in preparation for his testimony 
he reviewed relevant Florida administrative code sections. Tr. 815. 
In evaluating the role of an expert witness in the pharmacy context, 
the Agency has held that a pharmacy expert is ``not [expected to be] 
an expert in the details of state law, but [ ]he is required as a 
pharmacist to understand what conduct is outside of the usual course 
of professional practice in [his] state, whether that is derived 
from state law, mandatory training, standards of care or 
otherwise.'' Suntree Pharmacy, 85 FR 73,772.

    [T]he pharmacist as the specialist in this area of pharmacology 
and drug-related issues is expected, per Florida Board of Pharmacy 
and regulations, to do [sic] on each new and refill prescription, to 
evaluate, prior to dispensing, seven key criterions that look at 
common drug-related problems. Some of those may be drug interactions 
---------------------------------------------------------------------------
or duplications in therapy, dosing, drug allegories, wide variety.

Tr. 823. Regarding the issue of documentation, the witness holds the 
view that there is essentially no requirement that a pharmacist 
document any analysis employed for resolving any red flag issue that 
arises relative to potential controlled substance diversion so long as 
the medication is ultimately dispensed. According to Dr. Buffington, 
the Florida state standard of care is also apparently dependent upon 
whichever commercial software system any pharmacy elects to purchase 
and utilize. The colloquy between the Respondent's counsel and its 
expert is [notable]:

    Q. Does the standard of care in Florida require that a 
pharmacist document, at all, resolution of any issues by the 
prospective drug utilization review?
    A. No, sir. It's the pharmacist's individual prerogative and up 
to their system. In some cases, their pharmacy software system may 
afford some of that by process. Others, there's data entry fields. 
It doesn't have to be solely contained in the pharmacy software. It 
can be in secondary software. It can be hand-written. It can be 
maintained in a variety of ways. They leave that up to the personal 
judgment and prerogative and systems at each pharmacy.

    Tr. 823-24. When asked to clarify if the standard really depends on 
something as subjective and unregulated as what commercial software is 
employed by individual pharmacies, the [Respondent's expert testified]:

    No, sir. I'm saying it's up to the pharmacist as to which 
method, or collective methods, they wish to document. There is no 
format. There is no content-specific requirements with which a 
pharmacist has to document the addressing of those issues.

    Tr. 824. By this view, a pharmacy that elects to purchase a 
substandard software system apparently can generate a lower standard of 
care than a pharmacy that acquires a more vigilant system. By this same 
reasoning, a pharmacy could even potentially escape regulatory scrutiny 
by the acquisition of a subpar software system. Suffice it to say that 
the notion that state and federal regulators intended to design a 
system that creates a perverse incentive to deploy bad software to 
dodge responsibility is unpersuasive. When asked again for 
clarification, the Respondent's expert, after some [discussion] about 
whether DURs and red flags \63\ are homonyms, stated his opinion:
---------------------------------------------------------------------------

    \63\ In fact, the Respondent's expert communicated a certain 
hostility to even the concept of red flags, pointing out during his 
testimony that red flags is ``a colloquial term,'' Tr. 832, and in 
the guidance issued by Florida and DEA ``there are no definitions of 
red flags, nor is there any published requirement that guides 
pharmacy practice on what, and how, to document those,'' Tr. 825. At 
another point in his testimony, the witness stated he would not 
document the resolution of a controlled substance red flag because 
he ``can't find a consistent definition of that colloquial term.'' 
Tr. 936-37. This proposition [is inconsistent with] many years of 
Agency adjudication addressing red flags of potential diversion 
[supported by credible expert testimony] and longstanding acceptance 
of the term. See, e.g., Suntree Pharmacy, 85 FR 73,769 (``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.'') (collecting cases); 
Morning Star Pharmacy & Medical Supply 1, 85 FR 51,045, 51,060 
(2020) (same).

    [T]here is no requirement for the documentation of red flags, or 
DURs, in the State of Florida. There is opportunity to document. 
There is a requirement, or a duty, to address those items. The--
the--the DURs. There is no Florida-based, or DEA-based recognition 
---------------------------------------------------------------------------
for documenting red flags.

Tr. 825.
    The Respondent's expert later clarified that while processing a 
DUR, that even when a pharmacist encounters a potential red flag issue 
through its software, if ``it didn't need resolved, there's no need to 
record it.'' Tr. 913. Documentation, according to Dr. Buffington, is 
only required ``[i]f there's something to resolve.'' Tr. 914. When 
asked if a heightened level of suspicion that supported a decision to 
decline to dispense would ever merit some level of documentation, Dr. 
Buffington [testified]: ``Well, first of all, I'm going to work through 
whatever that question or suspicion is, and it's not going to be 
documented--or, it's not going to be dispensed.'' Tr. 917 (emphasis 
supplied). Following this approach, a pharmacist can subjectively 
determine that there is no issue to be resolved, document nothing, and 
be within the Florida standard of care. And since nothing is 
documented, the only correct assumption available to regulators, 
according to the Respondent's expert's view, is that everything was 
correctly assessed and resolved. [Omitted.] Thus, according to Dr. 
Buffington, there is no requirement under the applicable standard of 
care to document any resolution regarding any indication of diversion 
on the part of any patient or prescriber, no matter how egregious or 
how potentially dangerous, so long as the decision was ultimately made 
to dispense.
    Dr. Buffington [also testified that the phrase] ``if it wasn't 
documented, it wasn't done'' has no application to a pharmacy's 
obligation to document the resolution of red flags because there is no 
obligation to document the resolution of red flags.\64\ Tr. 825-26. 
[Dr.

[[Page 2916]]

Buffington testified that pharmacists are not obligated] to document 
the resolution of any controlled substance red flag because he ``can't 
find a consistent definition of that colloquial term.'' Tr. 936-37; see 
also id. at 940, 945. The witness suggested that requiring a level of 
documentation beyond this minimalist view would require the use of 
``court reporters in the pharmacy.'' Tr. 939. [Omitted for brevity.] 
For, as Dr. Buffington reasoned, it is the pharmacist alone who 
exercises ``professional prerogative,'' and as he, himself put it, 
``someone else not understanding the core facts of [his] job doesn't 
make what [he's] doing incorrect.'' Tr. 915-16
---------------------------------------------------------------------------

    \64\ The witness was unpersuaded by the argument that without 
adequate documentation another pharmacist encountering the same 
customer-patient would be without knowledge of a red flag 
determination made by a predecessor pharmacist or be able to pass 
down information to a successor pharmacist. Tr. 960-61.
---------------------------------------------------------------------------

    Dr. Buffington [offered an interpretation of Florida law that was 
not persuasive. Tr. 826-27, 924 (discussing subsection (3)(a) of rule 
64B16-27.831 of the Florida Administrative Code (Florida Pharmacy 
Standards Statute or FPSS).] Subsection (3)(a) of the FPSS lists steps 
to be taken by a pharmacist before declining to dispense a controlled 
medication. Fla. Admin. Code Ann. r. 64B16-27.831(3)(a). The FPSS 
requires a pharmacist to reach out to the patient and prescriber, or 
check E-FORCSE in place of either (but not both) of those contacts 
prior to declining to dispense a controlled substance. Id. r. 64B16-
27.831(3)(a), (b). [Although Dr. Buffington agrees that a pharmacist 
must document his decision to decline to fill a prescription, see Tr. 
827, he does not believe that a Florida pharmacist has a] duty to 
evaluate the validity of the prescription or to document his/her 
analysis or findings [if the pharmacist ultimately fills the 
prescription.] There is no exposure so long as he/she dispenses the 
drugs. [This testimony is inconsistent with the] FPSS and other 
provisions of Florida law. The FPSS specifically instructs:

    There are circumstances that may cause a pharmacist to question 
the validity of a prescription for a controlled substance; however, 
a concern with the validity of a prescription does not mean the 
prescription shall not be filled. Rather, when a pharmacist is 
presented with a prescription for a controlled substance, the 
pharmacist shall attempt to determine the validity of the 
prescription and shall attempt to resolve any concerns about the 
validity of the prescription by exercising his or her independent 
professional judgment.

Id. r. 64B16-27.831(2) (emphasis supplied). It is clear that in its 
description of ``circumstances that may cause a pharmacist to question 
the validity of a prescription for a controlled substance,'' the 
Florida legislature was referring to what has been ubiquitously 
referred to by DEA, the regulated community, and the industry, as a red 
flag of potential diversion. Upon encountering one of these, the FPSS 
directs pharmacy practitioners to consult with the prescribers, 
patients, and/or E-FORCSE. The opening section of the FPSS instructs 
that ``[p]harmacists shall attempt to work with the patient and the 
prescriber to assist in determining the validity of the [controlled 
substance] prescription.'' Id. r. 64B16-27.831. Thus, upon encountering 
a ``circumstance that may cause a pharmacist to question the validity 
of a prescription for a controlled substance'' \65\ (i.e., a red flag 
of potential diversion), a pharmacist must reach out to either the 
prescriber or the patient, and where appropriate, in place of one of 
those two sources (but not both) the pharmacist may resolve a red flag 
by utilizing E-FORCSE. Id. The Florida legislature has also directed 
that ``[t]he pharmacist shall record any related information indicated 
by a licensed health care practitioner.'' Fla. Admin. Code Ann. r. 
64B16-27.800(2) (Florida Pharmacy Patient Record Statute or FPPRS). The 
FPPRS also directs pharmacists to create a record of ``[p]harmacist 
comments relevant to the individual's drug therapy, including any other 
information peculiar to the specific patient or drug.'' Id. r. 64B16-
27.800(1)(f). Hence, contrary to Dr. Buffington's view, under Florida 
law and the applicable standard of care, a pharmacist who encounters a 
red flag is required, before resolving the red flag [and filling the 
prescription], to contact the prescriber and/or patient and is required 
to document both of those interactions.<SUP>66 *E</SUP>
---------------------------------------------------------------------------

    \65\ Id. r. 64B16-27.831(2).
    \66\ Dr. Buffington's opinion that there is no requirement for a 
Florida pharmacist to consult with prescribers regarding the 
existence of a clinical plan, tapering, or titration (Tr. 828) [is 
also not credible].
    \*E\ The Chief ALJ's interpretation that Florida law requires 
pharmacists to document the resolution of red flags is supported by 
a plain language reading of the various provisions of the Florida 
Administrative Code and by credible expert testimony about the 
importance of documentation in Florida. I agree with the Chief ALJ's 
interpretation, and I agree with his conclusion that Respondent 
violated Florida law by failing to document the resolution of red 
flags. However, my Decision does not rely on any interpretation of 
Florida law, because, in failing to document the resolution of red 
flags, Respondent violated federal law in addition to state law. Dr. 
Schossow offered credible expert testimony that failing to document 
red flag resolution is outside the usual course of professional 
practice in Florida. Although Dr. Buffington offered conflicting 
testimony that documentation is not required in the usual course of 
professional practice, I agree with the Chief ALJ that Dr. 
Schossow's testimony regarding documentation requirements was 
considerably more credible. Thus, as discussed in more detail infra, 
I find that Respondent repeatedly violated federal law by filling 
numerous prescriptions outside the usual course of professional 
practice without adequately addressing, resolving, or documenting 
red flags in violation of its corresponding responsibility. See 21 
CFR 1306.04(a) and 1306.06. Respondent's violations of federal law 
serve as an independent basis for my conclusion that Respondent's 
registration is inconsistent with the public interest and that 
revocation is the appropriate remedy in this case.
---------------------------------------------------------------------------

    Contrary to Dr. Buffington's testimony that [it should be assumed 
that a pharmacist has resolved any potential red flags if he decides to 
fill the prescription], the Agency has made it clear that it is 
unwilling to credit ``[p]ost hoc written or oral justifications'' for 
actions taken as a registrant that were not documented, George Pursley, 
M.D., 85 FR 80,162, 80,171 n.28 (2020); see Lesly Pompy, M.D., 84 FR 
57,749, 57,760 (2019). In fact, the Agency has accepted the premise 
that ``it would be reasonable to draw an adverse inference that a 
pharmacist failed to resolve a red flag (or flags) from the failure to 
document the resolution in any manner . . . .'' Superior Pharmacy I and 
Superior Pharmacy II, 81 FR 31,310, 31,335 (2016). [Omitted for 
brevity].
    Dr. Buffington also testified that filling combination 
prescriptions of higher dosages of short-acting medications and lower 
dosages of long-acting medications does not fall below the standard of 
care.\67\ Tr. 877. Likewise, the witness rejected medication 
combinations referred to as ``cocktails'' as a red flag, stating that 
``[e]very patient who has multiple drugs in their regiment is a 
cocktail [sic].'' Tr. 955. The witness opined that simultaneously 
dispensing such combinations (either opioids and benzodiazepines, or 
opioids, benzodiazepines, and muscle relaxers) ``[a]bsolutely [does] 
not'' fall below the applicable standard of care for Florida 
pharmacists. Tr. 863-64. Dr. Buffington explained that the presentation 
of such controlled substance combinations is ``not a potential issue, 
the fact that it may have been flagged in a DUR, unless the patient is 
experiencing complications.'' Tr. 865. This view is not only 
inconsistent with the opinion of Dr. Schossow, but also the view of the 
Agency, which has sustained cocktail combinations as red flags of 
potential diversion requiring documented resolution. See, e.g., Suntree 
Pharmacy, 85 FR 73,756 (acknowledging that DEA ``has long discussed 
cocktails'' as a red

[[Page 2917]]

flag issue). Furthermore, Dr. Schossow's view of the appropriate uses 
of immediate-release and extended-release medications is more 
persuasive than Dr. Buffington's summary dismissal of the issue.
---------------------------------------------------------------------------

    \67\ The witness reasoned that such occurrences can happen 
because ``[y]ou build a therapeutic regimen that meets that 
patient's specific needs and lifestyle.'' Tr. 876. ``[Y]ou don't see 
that and assume that it's somehow indicative of inappropriate 
patient care.'' Tr. 878.
---------------------------------------------------------------------------

    The witness was likewise dismissive in considering the 
applicability of the CDC Guidelines issued in 2016 regarding controlled 
substance dispensing. Dr. Buffington testified that the CDC Guidelines 
had no impact on the standard of care for pharmacists practicing in 
Florida. Tr. 819, 907-08. According to the Respondent's expert, the CDC 
Guidelines amount only to a ``recommendation to help educate 
physicians,'' and a mere ``guideline, or recommendation.'' Tr. 820; see 
also id. at 903 (``Typically all guidelines are recommendations, or 
instructional for--they're not thresholds or limitations on 
practitioners.'').
    [However,] the CDC Guidelines reveal considerable specificity in 
their guidance to prescribers (and by extension, to pharmacists 
[filling prescriber's prescriptions]), including advisals to commence 
opioids at the ``lowest effective dosage,'' preferences for immediate-
release over extended-release opioids at the commencement of opioids as 
a pain treatment modality, specific guidance regarding MME levels 
exceeding 50, and a preference for ``[n]onpharmacologic therapy and 
nonopioid pharmacologic therapy'' for chronic pain. ALJ Ex. 39, Attach. 
A at 16. Although the issue in this case is whether a particular 
prescription raises a red flag of potential diversion, Dr. Buffington 
altered the subject into whether the CDC Guidelines imposed a ``hard 
stop, hard block, or change'' on prescribers,\68\ which [is not 
relevant to the Government's allegations. Although Dr. Buffington is 
correct that the CDC Guidelines do not impose a ``hard stop,'' the 
Guidelines issue clear guidance to medical professionals about 
prescribing high dosages of opioids:]
---------------------------------------------------------------------------

    \68\ Tr. 830, 862-64.

    Clinicians should use caution when prescribing opioids at any 
dosage, should carefully reassess evidence of individual benefits 
and risks when increasing dosage to >= 50 morphine milligram 
equivalents (MME)/day, and should avoid increasing dosage to >= 90 
MME/day or carefully justify a decision to titrate dosage to >= 90 
---------------------------------------------------------------------------
MME/day.

ALJ Ex. 39, Attach. A at 16. At another point in his testimony, Dr. 
Buffington allowed that the CDC Guidelines advise practitioners to 
``use caution if [they]'re getting to 90 [MME], or be very clear that 
[they] understand and have a rationale for doing that.'' Tr. 908. 
Whatever be the limits of the finer points of the CDC's guidance, to 
dismiss an encountered titration that exceeds 90 MME/day as an 
insignificant non-issue to pharmacy practice is not a fair inference 
that can or should be drawn by the plain language of the CDC 
Guidelines. Neither is the subsequent policy clarification \69\ (CDC 
Clarification) issued by the CDC particularly supportive of Dr. 
Buffington's premise that it was issued to address ``key areas where 
the [CDC] realized people, or courts, may be misrepresenting the [CDC 
G]uidelines as a fixed or regulatory threshold.'' Tr. 830-31. The 
principal focus of the CDC Clarification was focused on ensuring that 
practitioners did not read the CDC Guidelines as supporting dangerous, 
sudden, and drastic discontinuations of opioid therapy to the detriment 
of patients. ALJ Ex. 39, Attach. B at 1-2. There is nothing in the 
plain language of the document that runs counter to identifying a red 
flag of potential diversion under the appropriate circumstances based 
in some part on high opioid dosages.
---------------------------------------------------------------------------

    \69\ ALJ Ex. 39, Attach. B.
---------------------------------------------------------------------------

    The witness was similarly dismissive in addressing a warning \70\ 
issued by the U.S. Food and Drug Administration (FDA) concerning the 
extreme dangers posed by combining opioids and benzodiazepines (the 
Black Box Warning). ALJ Ex. 39, Attach. C. The Respondent's expert 
acknowledged that a black box warning connotes a ``heightened level of 
warning,'' that should inform a pharmacist's decision making, but 
insisted (despite the FDA's decision to issue the warning) that it 
contained no new information and was merely an advisal to prescribers 
that these ``very low incident'' complications could occur. Tr. 909. 
Although in its drug safety communication setting for the Black Box 
Warning, the FDA refers to black box warnings as its ``strongest 
warnings,'' \71\ the Respondent's expert [did not consider the warning 
to be notable, and further testified that ``the combined use of the two 
[medications] presents no complication or problem for healthcare 
professionals specifically in chronic pain . . . .'']. Tr. 909, 959. 
This view arguably stands in some tension with the plain language 
contained in the Black Box Warning:
---------------------------------------------------------------------------

    \70\ Also known as a boxed warning.
    \71\ ALJ Ex. 39, Attach. C at 1.

    Health care professionals should limit prescribing opioid pain 
medicines with benzodiazepines or other CNS depressants only to 
patients for whom alternative treatment options are inadequate. If 
these medicines are prescribed together, limit the dosages and 
duration of each drug to the minimum possible while achieving the 
desired clinical effect. Warn patients and caregivers about the 
risks of slowed or difficult breathing and/or sedation, and the 
associated signs and symptoms. Avoid prescribing prescription opioid 
cough medicines for patients taking benzodiazepines or other CNS 
---------------------------------------------------------------------------
depressants, including alcohol.

ALJ Ex. 39, Attach. C at 1 (emphasis supplied). Although Dr. Buffington 
reads the Black Box Warning as an authorization to continue to use (not 
limit) this combination,\72\ the FDA apparently holds the view that 
health care officials should limit the combined prescribing of opioids 
and benzodiazepines to situations where other treatment options are 
inadequate. Id. Notwithstanding this limitation (couched in directive, 
not passive language), Dr. Buffington's position is apparently that the 
``avoid'' aspect of the warning should be deemphasized over a 
recognition that the two medications can be prescribed together. In any 
event, the Government never argued that the combination is per se 
prohibited, but rather that the combination raises a dispensing red 
flag that requires documented resolution to meet the standard of care. 
[Relocated]
---------------------------------------------------------------------------

    \72\ Tr. 909.
---------------------------------------------------------------------------

    In specifically addressing cash red flags, the Respondent's expert 
opined that ``the method of payment is somewhat irrelevant'' and that 
the standard of care ``[a]bsolutely [does] not'' require pharmacists to 
investigate the rationale for a customer-patient utilizing cash 
payments or insurance. Tr. 833-34; see also id. at 953. Dr. Buffington 
reasoned that pharmacists ``have that capacity to understand that 
patients' payment methods often ebb and flow based on [insurance] 
coverage. . . . There are just so many variables that there is no 
predictive validity, or use, of presuming cash payment to be a 
problem.'' \73\ Tr. 833. Regarding the position of the Government's 
expert that a pharmacy is required to contact a prescriber to confirm 
prescription coverage details, Dr. Buffington persuasively testified 
that a ``medical benefit does not always coincide with a drug-spend 
benefit.'' Tr. 834. While this perspective is reasonable, declaring 
cash as never a relevant consideration [is not balanced and not 
credible]. The view of the Respondent's expert that cash is always 
patently irrelevant to the evaluation of dispensing events is in 
considerable

[[Page 2918]]

tension with the Agency's view based on credible expert testimony. See, 
e.g., Suntree Pharmacy, 85 FR 73,757 n.13 (sustaining ALJ's finding 
based on credible expert testimony ``that cash is a red flag in 
combination with other red flags''); Pharmacy Doctors Enters., 83 FR 
10,876, 10,891 (2018) (same). As can fairly be stated about other 
aspects of Dr. Buffington's presentation, he was inconsistent regarding 
this issue. At another point in his testimony the witness seemed to 
nominally retreat from this absolutist opinion and suggested that cash 
could indeed potentially be a red flag. Tr. 955. This was confusing. As 
discussed elsewhere in this recommended decision, although the 
rationale of the Government's case for cash as a red flag in the 
present case (to wit, the pharmacy must call the doctor regarding 
pharmacy insurance coverage) was unpersuasive, [I also decline to 
credit Dr. Buffington's testimony that cash payments are never a red 
flag.\74\ See infra for further discussion of cash payments. Omitted 
for brevity].
---------------------------------------------------------------------------

    \73\ Dr. Buffington reasonably opined that requiring a pharmacy 
registrant to reach out to a physician's office to investigate a 
patient's insurance coverage is idiosyncratic because the insurance 
coverages are different. Tr. 834.
    \74\ [Omitted.]
---------------------------------------------------------------------------

    The Respondent's expert similarly dismissed any considerations of 
long travel distances as a potential red flag. When asked whether 
distance could be a potential red flag, his response was ``[a]bsolutely 
not.'' Tr. 948. Beyond his eminently valid point that a pharmacist 
possesses no capacity to limit the driving habits of its customer-
patients beyond recommendations,\75\ Dr. Buffington was unequivocal in 
his rejection of the whole concept, declaring:
---------------------------------------------------------------------------

    \75\ Tr. 873.

    There's no logical rationale, or supportable--and certainly no 
regulatory--oversight over that. You could live in the [Florida] 
Keys and fill in the [Florida] Panhandle. You could fill at a 
pharmacy you prefer, or have worked with, where you lived 
previously. One that's--there are just so many variables, from your 
home, your office, your doctor's office--it's purely your choice as 
a consumer. There's no predictive validity that where--in fact, you 
can fill out-of-state. There's not a problem for your prescription. 
---------------------------------------------------------------------------
So, there is just no utility in attempting to use that as a metric.

Tr. 834-35. The witness opined that ``distance is of no predictive 
value in and of itself . . . .'' Tr. 949. [He testified that he was not 
obligated] to document a distance red flag, adding ``I have no 
obligation to take someone else's variable and write something down.'' 
\76\ Tr. 951. Certainly, Dr. Buffington's broad denunciation of 
distance as a red flag is directly contrary to [prior Agency decisions 
based on credible expert testimony]. See, e.g., Heavenly Care Pharmacy, 
85 FR 53,402, 53,417 (2020) (recognizing based on credible expert 
testimony long distance as a valid red flag); Pharmacy Doctors Enters., 
83 FR 10,885 (same); Hills Pharmacy, LLC, 81 FR 49,816, 49,839 (2016); 
Holiday CVS, L.L.C., 77 FR 62,316, 62,321-22 (2012) (same); E. Main St. 
Pharmacy, 75 FR 66,149, 66,163-65 (2010) (same). [Omitted for brevity.] 
As was not uncommon throughout the course of his presentation, Dr. 
Buffington produced an answer favorable to the Respondent by changing 
the question. When asked if distance could support a diversion red flag 
(i.e., an issue to be resolved prior to dispensing), the witness 
answered the question of whether such an issue was potentially 
resolvable, which was a premise that comprised no part of the 
Government's case. [Omitted for brevity.] Although the rationale 
employed by the Government's expert (motor safety) was unpersuasive in 
this case, the categorical dismissal of distance as a red flag under 
all circumstances detracted from the reliability that should be 
afforded to Dr. Buffington's testimony.
---------------------------------------------------------------------------

    \76\ After repeatedly [testifying that distance was not] a 
potential red flag issue, the witness testified that he ``already 
said it could'' be a red flag. Tr. 952. At another point in his 
testimony, the witness, in response to a direct query of whether 
distance could ever be a red flag, [testified]: ``It could, but I've 
already stated we already have methods for dealing with that, and I 
wouldn't call it a red flag.'' Id. at 954. [Omitted for brevity.] 
The inconsistencies further denigrated any ability to credit Dr. 
Buffington's opinions.
---------------------------------------------------------------------------

    The witness similarly transposed the issue of illogical medication 
dosing combinations as a red flag. When queried on the subject, Dr. 
Buffington [changed] the issue into whether such dosing variations 
between extended-release and short-acting medications were 
inappropriate under all circumstances, which was [not the Government's 
or Dr. Schossow's theory]. Tr. 877-81. The issue in the case is whether 
the Respondent pharmacy was presented with a red flag that required 
follow-up, resolution, and documentation. Like most red flags, the 
question presented may be (and often is) subject to resolution. Dr. 
Buffington's view on the issue of illogical medication dosing is 
divergent from that of Dr. Schossow, but the Government expert's 
testimony on this issue was better explained, more persuasive, less 
evasive, and more reliable.
    [The Chief ALJ questioned the credibility of Dr. Buffington's 
testimony that he performs physical examinations on pharmacy customers. 
Tr. 920-21. I agree that this testimony was unusual, but I have omitted 
the discussion as it does not ultimately impact my Decision.]
    The Respondent's expert testified that he reviewed the relevant 
documents \77\ for the Ten Patients from the Respondent pharmacy and 
testified that the Respondent's controlled substance dispensing did, in 
his opinion, meet the standard of care in Florida for each of the 
prescriptions at issue in this matter. Tr. 845, 850-51, 859, 881. Dr. 
Buffington testified that he saw no deviation from the standard of care 
on the part of the Respondent in terms of over-utilization and under-
utilization,\78\ therapeutic duplication,\79\ drug-disease 
interactions, drug-drug interactions,\80\ drug dosages or 
treatment,\81\ drug-allergy interactions, and clinical abuse and 
misuse.\82\ Tr. 845, 854, 863, 865, 868-69.\83\ Although it was never

[[Page 2919]]

entirely explained how he reached this supposition, Dr. Buffington 
testified that it was his understanding that each of the prescribers 
associated with the Ten Patients was a pain management specialist. Tr. 
867. Whether this was the case or not, or how heavily this factor may 
have weighed into his metric, this assumption appears to have 
[impacted] his analysis. For each category, Dr. Buffington testified 
that a showing or ``hit'' of one of these categories simply requires an 
evaluation on whether the patient is experiencing complications or 
side-effects, and the absence of complications or side-effects means 
the ``hit'' does not rise to the level of a clinical problem. Tr. 855-
58, 860, 862-63, 865, 870. The witness testified that ``[t]hese are 
categories that the Board of Pharmacy is saying you should evaluate 
these issues [sic] and determine in your professional judgment if there 
is something to avoid or resolve and that's the issue.'' Tr. 862. When 
Dr. Buffington was asked whether the presence of an opioid and a 
benzodiazepine would present a drug-drug interaction DUR, he replied in 
the following confusing way:
---------------------------------------------------------------------------

    \77\ Dr. Buffington testified that, in addition to the 
Government Exhibits, he also reviewed Proposed Respondent Exhibits 
that were not offered or admitted during the course of the hearing. 
Tr. 845, 880.
    \78\ The witness testified that this is ``a patient-specific 
issue.'' Tr. 852. This is another instance where the witness 
replaced the issue posed with one that [he preferred to discuss]. 
When asked about under-utilization, something that could potentially 
be a red flag of abuse requiring resolution, the witness substituted 
his analysis that the CDC Guidelines placed no hard cap on MME 
levels, Tr. 853-57, which was not among the Government's theories. 
The issue in the case was never whether a prescriber can elect to 
use his/her professional judgment, but whether a particular dosage 
strength can raise a potential red flag requiring inquiry, 
resolution, and documentation. The witness's responses on this issue 
were also (as many other answers were) seemingly dependent upon the 
limits of the commercial software purchased by an individual 
pharmacy, which, as discussed in detail, supra, cannot serve as a 
reasonable, objective yardstick for whether a DEA pharmacy 
registrant has met the applicable standard of care.
    \79\ The witness defined therapeutic duplication as when two 
medications of the same class, or two medications with the same 
pharmacologic effect, are prescribed together. Tr. 854-55.
    \80\ Dr. Buffington explained that when a pharmacist encounters 
a drug-drug interaction, they are ``looking for predominantly 
metabolism, secondarily effects as to whether or not that potential 
for conflict is going to either create an adverse side-effect or 
potentially, some medications may bind to the other'' rendering it 
therapeutically useless. Tr. 861.
    \81\ This specific category was explained by the witness to 
typically be presented as a miss-fill on the part of the pharmacist 
or a scrivener's error on the part of the prescriber. Tr. 868.
    \82\ Dr. Buffington differentiated between abuse and misuse by 
explaining that ``abuse could have the ill intent to produce some 
effect . . . that that medication has,'' while ``[m]isuse may in 
fact be that the individual is not taking the medication properly, 
so poor compliance.'' Tr. 870.
    \83\ Regarding Patient JM, Dr. Buffington testified that the 
customer-patient receiving Restoril and Xanax at the same time 
``would not present a problem that needed resolved, unless, in fact, 
in the dialogue and counseling with that patient, you've identified 
a clinical concern where the patient is expressing they're not 
getting therapeutic benefit or possibly too much therapeutic 
benefit.'' Tr. 856.

    No. Because those two are used routinely together. Now, could 
you--in other words there's no certainty that that software system 
is going to flag the two of those--that's something that the 
practitioner will understand. It may, based on the vendor who made 
the software or the pharmacy who added an additional manual edit to 
be part of that process, but none of these are hard stops with any 
---------------------------------------------------------------------------
regulatory oversight.

Tr. 862. In specifically addressing duplicate therapy in regards to 
Patient JM, Dr. Buffington provided, ``The mere presence of the two 
together do[es] not create the red flag. It's as though someone is 
creating or propagating the fact that if the two appear, materialize in 
the same regiment that it is wrong. It is not wrong unless problems 
ensue . . . .'' Tr. 968-69. The witness consistently alluded to a high 
level of deference and prerogative left, at least in his view, 
exclusively (and apparently un-reviewably) to the dispensing 
pharmacist, when he explained that for any of the categories, 
documentation is required only if an issue is identified (by the 
pharmacist). Tr. 866.
    As discussed, supra, a recurrent theme in the testimony of this 
witness was to eschew the issue at hand and substitute an issue he 
would prefer to address. At one point during his testimony, the witness 
was asked whether ``patient questionnaires that were presented by [the 
Respondent] to new patrons . . . [is] something that [pharmacies are] 
required to maintain by any statute or regulation.'' Tr. 851-52. Dr. 
Buffington's answer was ``No, just routine practice.'' Tr. 852. 
Unanswered by the expert here is whether patient questionnaires are 
required to meet the applicable standard of care as subsumed by both 
federal and state statutes and regulations, and/or whether the 
``routine practice'' employed by Florida pharmacies in his estimation 
comprises any portion of the applicable standard of care. Similarly, 
when asked whether there is a requirement for Florida pharmacists to 
document resolution of over-utilization, under-utilization, therapeutic 
duplication, and drug-disease contraindications, the witness's answer 
again injected an intentional level of equivocation:

    Only if you in the course of, normal course of your practice 
identified there was an issue, a clinical presentation, a concern, 
something that might be hindering medication compliance and the 
likes, then, upon recognizing those, if it's a concern during your 
evaluation, then you could take the steps to avoid and resolve the 
problem.

Tr. 866. The framework of the witness's answer here, like many of his 
answers, was unhelpful, and seemingly deliberately so. A red flag 
indicating a potential diversion issue is ``a concern'' or ``an 
issue,'' or even ``something that might be hindering medication 
compliance and the likes.'' \84\ Thus, the interpretation that nothing 
is required of the pharmacist upon encountering a red flag creates an 
unhelpful level of a sort of plausible deniability. Another example of 
this is apparent in the witness's explanation of subsection (1)(g) of 
rule 64B16-27.810 of the Florida Administrative Code (Florida DUR 
Statute), which requires the identification of ``[c]linical abuse/
misuse.'' Although the statute supplies no limitation regarding the 
nature of clinical abuse/misuse, the Respondent's expert explained this 
aspect of the operation of the Florida DUR Statute in this circuitous 
manner:

    \84\ Tr. 866.

    That means if you've identified as a practitioner that the 
patient is abusing or misusing the medication, and we state it that 
way for very specific reasons, abuse could have the ill intent to 
produce some effect, some main effect or side-effect, that the 
medication has. Misuse may in fact be that the individual is not 
---------------------------------------------------------------------------
taking the medication properly, so poor compliance.

Tr. 869-70. When juxtaposed, Dr. Buffington's dismissal of almost all 
red flags of potential diversion as nonissues with the pragmatic 
operation of his interpretation of the Florida DUR Statute is quite 
interesting. There are virtually no red flags that can or should 
motivate the pharmacist to resolve prior to dispensing a controlled 
substance (as opposed to declining to do so), so to the extent the 
pharmacist intends to fill the prescription, there is no need to 
contact the prescriber or discuss any issues with the patient.\85\ 
Thus, there is no real way (perhaps short of some extreme demonstration 
of intoxication or other drug-seeking behavior exhibited by a customer-
patient which is observed and conveyed to the pharmacist by pharmacy 
staff, or other equally unlikely scenario) for the pharmacist to 
identify abuse or misuse. The pharmacist's obligation under the Florida 
DUR Statute is [minimized to virtually no obligation, under Dr. 
Buffington's view].\86\ Under an interpretation where there is no 
obligation to do anything beyond inexorably dispensing medications 
(with as substandard a software system as can be found), the pharmacy 
registrant [does not have a meaningful role of oversight]. [Omitted for 
brevity.]
---------------------------------------------------------------------------

    \85\ Dr. Buffington restricts a pharmacist's obligation to 
``doing a valid check on the legitimacy of the prescription in terms 
of having done your homework and understanding the prescriber, 
having done your homework and understanding the patient . . . .'' 
Tr. 867. There was no clarification from the witness as to what 
objective steps could or must be invested in ``understanding'' the 
patient and prescriber, or what any of that means. At another point 
in his testimony, the Respondent's expert explained his view that 
validating a prescription would include an evaluation of the scrip, 
the completeness of the scrip, the prescriber's authority, and 
whatever evaluation steps are included in the pharmacy software. Tr. 
909-10. When pressed upon the issue of whether risk plays a role in 
the assessment, Dr. Buffington stated that ``every medication has 
risk'' and based his answer, not on whether a red flag is triggered 
by the level of risk, but whether a risk, standing alone, 
constitutes ``a preclusion,'' which he naturally answered in the 
negative. Tr. 911-12. The issue with red flags in this case, as 
alleged by the Government, never included a hard preclusion 
component, but only whether the evidence demonstrated unresolved red 
flags of potential diversion which remained unresolved and 
undocumented prior to dispensing.
    \86\ In responding to a hypothetical, the Respondent's expert 
[testified] that even if newly-issued CDC guidelines indicated that 
a medication at a particular dosage level could result in physical 
harm to the patient, he would continue to dispense based on nothing 
more than the prescriber's unexplained insistence. Tr. 905.
---------------------------------------------------------------------------

    In opining that the Respondent met its corresponding 
responsibility, the witness stated that ``corresponding responsibility 
is specific to that if either party, the prescriber, or the dispenser, 
knowingly fills a medication that is illegitimate; I saw no evidence 
that there was any illegitimate medications, prescriptions that were 
filled in this case.'' Tr. 881. Dr. Buffington made it clear that the 
decisions made by the pharmacist, in his view, are not amenable to 
review by others. To the witness, a controlled substance

[[Page 2920]]

prescription becomes invalid, potentially unfillable, only when there 
is a ``[k]nowing that the patient was using the product 
inappropriately--they were abusing. Knowing that the patient was going 
to be handed the prescription but was misusing.'' Tr. 914. 
Interestingly, Dr. Buffington explained that the concept of knowing is 
based purely on ``professional prerogative,'' \87\ that the dispensing 
pharmacist is ``the one that has to discern if [they] know, or have 
reason to know--not a third party who's evaluating that.'' Tr. 917. The 
witness's standard strikes as an unreviewable judgment call on the part 
of the dispensing pharmacist. [Dr. Buffington appears to believe] that 
every pharmacy registrant is possessed of essentially un-regulatable, 
unreviewable authority. [This position is inconsistent with the] 
highly-regulated field such as pharmacy and the dispensing of 
controlled substances.
---------------------------------------------------------------------------

    \87\ Tr. 915.
---------------------------------------------------------------------------

    When questioned on an objective component of the concept of 
knowing, Dr. Buffington explained that, in his opinion, ``[t]he Florida 
Board of Pharmacy defines that.'' Tr. 921. Dr. Buffington suggested at 
one point in his testimony that the state standard of care bears no 
correlation to the regulatory administration of a DEA registration. Tr. 
922-23. When pressed on whether his opinion would change to any extent 
if the Agency had interpreted knowing in a certain way, Dr. Buffington 
discounted DEA's authority in this way:

    Well they don't have--the DEA doesn't have the training or the 
expertise, and has never provided a valid instrument that is 
predictively--with predictive valid--validity--that demonstrates the 
method they would use to discern that.

Tr. 928.
    [The Chief ALJ found that Dr. Buffington was hostile to DEA as a 
regulator, based on Dr. Buffington's testimony that he does not believe 
that DEA regulations or Agency decisions inform pharmacy practice in 
Florida, or that Agency decisions ``even translate[] to something that 
is enforceable.'' Tr. 930, 947, 983. I agree with the Chief ALJ that 
this testimony is legally incorrect to the extent that it implies that 
DEA has no relevance to a pharmacist's corresponding responsibility in 
dispensing controlled substances. Because of DEA's role in ensuring 
that controlled substances are distributed only through lawful 
channels, and its authority to revoke or suspend DEA registrations, it 
is incumbent on pharmacies to be familiar with DEA decisions and create 
pharmacy policies that ensure that pharmacists are fulfilling their 
corresponding responsibility. See Suntree Pharmacy, 85 FR 73,753, 
73,770 (2020); see also S&S Pharmacy, Inc., 46 FR 13,051, 13,052 
(1981). DEA publishes final orders in administrative proceedings 
involving doctors, pharmacies, and other DEA registrants, which provide 
final adjudications on the public record of DEA's expectations for 
current and prospective members of the registrant community regarding 
their obligations under the CSA, in particular how the provisions of 
the CSA are adjudicated in enforcement actions.] [Omitted for brevity.]
    Overall, even setting aside the multiple inconsistencies, 
evasiveness, and views he espoused that are directly contrary to the 
Agency's prior decisions, Dr. Buffington's expressed antagonism for the 
regulatory authority vested in DEA and the Administrator undermines the 
weight that can be attached to his presentation. While there is no 
question that the witness's credentials were impressive, Dr. Buffington 
[presented as an advocate for Respondent rather than as an impartial 
expert]. That is not to say that Dr. Buffington is entirely unreliable. 
This witness is an experienced and well-credentialed professional. 
There were certainly aspects of his biographical information, the 
progress of his career, and even some testimony regarding dispensing in 
general that presented as sensible and consistent with the record. 
However, where Dr. Buffington's views conflict with the views expressed 
by Dr. Schossow, at least where her views have been deemed reliable and 
well-supported in this RD, it is her expert opinion that must be 
afforded greater weight.

Dr. Aaron Howard, Pharm.D.

    The Respondent (while still represented by qualified counsel) 
presented the testimony of Dr. Aaron Howard, the owner and pharmacist-
in-charge (PIC) of the Respondent pharmacy. The witness (Dr. Howard, 
the Respondent's owner, or the owner) testified that he received his 
Doctorate in Pharmacy in 2003 and has spent the vast majority of his 
career as a licensed pharmacist working as a retail pharmacist. Tr. 
583-84. His experience consists of work in chain and independent 
pharmacies, work in a hospital pharmacy,\88\ as well as opening and 
establishing various pharmacies (including the Respondent pharmacy in 
2010). Tr. 584-89.
---------------------------------------------------------------------------

    \88\ The Respondent testified that in 2003 he worked as a 
clinical pharmacist at Jackson Memorial Hospital. Tr. 589.
---------------------------------------------------------------------------

    The Respondent, doing business under the name ``At Cost RX,'' is an 
independent pharmacy and the witness explained that its business model 
was designed ``to target patients who need prescription drugs who do 
not have insurance or are under insured.'' Tr. 589-90. Dr. Howard 
testified that the Respondent pharmacy operates a membership program 
wherein the majority of its customer-patients pay for their 
prescriptions in cash. Tr. 590-91. ``[T]hat's [its] whole niche.'' Tr. 
591. According to Dr. Howard, upon paying a membership fee, a customer-
patient can purchase medications at the Respondent pharmacy for prices 
below those found in chain pharmacies in the local area. Tr. 591. The 
discounted price is extended as a benefit of the membership. Id. The 
witness explained that the Respondent's discounted price system and 
business model is designed to target ``patients who are underserved or 
do[ ] not have insurance.'' Tr. 1212. The ``At Cost'' name of the 
pharmacy is designed to convey the Respondent's primary business 
objective of offering medications to its customer-patients at a 
discounted price. Tr. 1213. [However, there is] no evidence of record 
that any of the Ten Patients held memberships to this purported 
discount program, which renders the force of this evidence as only 
marginally relevant. While the Respondent employs multiple pharmacists, 
Dr. Howard testified that he is the owner and the only pharmacist in 
the organization that dispenses controlled substances. Tr. 605.
    Dr. Howard outlined the Respondent's pre-dispensing processes, or 
drug utilization review (DUR). He testified that he is the person who 
conducts the DUR at the Respondent pharmacy,\89\ that the procedure is 
conducted as the prescription is being processed,\90\ and that these 
processes have been the subject of some level of evolution over time. 
Tr. 600. The owner testified that he places his initials on the 
prescription under review to signify that the DUR steps have been 
undertaken and completed. Tr. 735-37. Dr. Howard's depiction of the 
Respondent's DUR strikes as being strongly dependent upon queries 
generated by the commercial electronic software (RX30) utilized by the 
pharmacy.\91\ Tr. 607-10, 711-13, 736, 758, 1201-02, 1213-14. The owner 
indicated that the RX30

[[Page 2921]]

assists him in identifying red flags of over-utilization/under-
utilization, therapeutic duplication, and drug-disease 
contraindication. Tr. 712. When a patient presents at the Respondent 
pharmacy with a controlled substance prescription, Dr. Howard testified 
that there are a number of steps that he progresses through to verify 
the validity of the prescription. Tr. 596. However, he testified that 
there was no set order for the functions to be completed and 
memorialized on the prescription.\92\ Tr. 770. As initially explained 
by the witness, where he is unfamiliar with the prescriber, the 
verification process begins with consulting websites maintained by DEA 
and the state of Florida to ensure that the prescriber's state license 
and DEA registration are active and without discipline or 
restrictions.\93\ Tr. 596-97, 600-01. The owner testified that he also 
reviews the specialty of the prescriber. Tr. 601.
---------------------------------------------------------------------------

    \89\ Tr. 710-11.
    \90\ Tr. 711.
    \91\ Dr. Howard testified that the Respondent pharmacy has been 
using RX30 software since 2010. Tr. 1169.
    \92\ When pressed on the steps taken in the Respondent's DUR 
protocol, the Respondent's owner/PIC was either unable or unwilling 
to explain whether the steps occur in a defined order. Tr. 1192-95. 
There was arguably an evasive quality to the testimonial exchange 
with questions answered with questions and where a clear message was 
conveyed that the witness was unwilling to be locked into a set 
order of steps in the DUR process. Id.
    \93\ After the initial check, the prescriber verification 
process is performed annually. Tr. 605-06. No documentation was 
offered to support this step. [Omitted for clarity].
---------------------------------------------------------------------------

    The owner testified that he then converses with the customer-
patient regarding ``basic elements, how long they've been taking the 
medication, why they're taking the medication, things of that nature.'' 
Tr. 597; see id. at 737. To ensure that the presented patient is the 
patient for whom the prescription was written, the Respondent requires 
the presenting patient to show a government-issued photo identification 
card.\94\ Tr. 598-99, 737. The next step involves accessing E-FORCSE to 
ascertain when the patient last had a controlled substance prescription 
filled. Tr. 597, 736. The owner described the state E-FORCSE database 
as ``a great tool'' that he uses to look for evidence of patient 
doctor-shopping, duplicate or inappropriate therapy, as well as early 
refills, and that he notates the execution of a check of this system on 
the prescription itself.\95\ Tr. 611-13. If a customer-patient is 
accepted by the Respondent, Dr. Howard explained that he/she will fill 
out a questionnaire,\96\ which may prompt additional questions/
conversation with the patient. Tr. 598. Strangely, although the witness 
claims the questionnaires have been used by the pharmacy since 2015 and 
are maintained indefinitely,\97\ these documents were not produced by 
the Respondent when it was served with two successive DEA investigative 
subpoenas requiring, inter alia, production of:
---------------------------------------------------------------------------

    \94\ While Dr. Howard testified that he asks for a government 
photo ID to verify the identity of the customer-patient, he also 
volunteered that he does not know if this step is a state mandate. 
Tr. 599.
    \95\ The majority of these notations consisted of a check mark 
and ``PDMP'' or ``PMP.''
    \96\ Dr. Howard testified that the Respondent began utilizing 
questionnaires in 2015 and that copies of the questionnaires are 
maintained indefinitely at the pharmacy. Tr. 599-602, 1125.
    \97\ Tr. 599-602, 1125.

    [C]omplete medication or patient medication records/profiles 
that the pharmacy maintains which documents any and all 
prescriptions filled by the pharmacy; any and all additional records 
documenting the steps taken to avoid or resolve any issues with the 
prescriptions presented by [the named customer-patients] pursuant to 
the requirements of the Florida Statutes and Florida Administrative 
Code 64B16-27.800 . . . and, any other documentation kept by the 
pharmacy in connection with the filling of prescriptions or 
providing medical treatment for these individuals, including but not 
limited to dispensing reports, billing records, [E-FORSCE] reports 
---------------------------------------------------------------------------
and medical records.

Gov't Ex. 2 at 1; see Gov't Ex. 18 at 1. That the Respondent made a 
choice to hold these documents back from investigators, even in the 
face of a subpoena, does not further the strength of its position, or 
its efforts to rely on these items during the course of the hearing. In 
fact, the adverse inference sought by the Government in this case \98\ 
is appropriately taken here. The Agency has found it appropriate to 
take an adverse inference where a party has made a ``decision not to 
provide evidence within its control . . . .'' Morning Star Pharmacy, 85 
FR 51,063 n.38; see Pharmacy Doctors Enters., 83 FR 10,899. 
Accordingly, the decision to withhold the documents that were the 
subject of the subpoena gives rise to the inference (taken here) that 
the information therein would not be supportive of the Respondent's 
case; that is, that there was either no helpful documentation in those 
papers, or that the documentation reflected therein would be 
detrimental to the Respondent's case.
---------------------------------------------------------------------------

    \98\ ALJ Ex. 55 at 45.
---------------------------------------------------------------------------

    Although the owner testified that the Respondent's DUR protocol has 
no set order,\99\ he also testified at one point that the last step in 
the verification process involves reaching out to the prescribing 
physician's office.\100\ Tr. 598. Although, according to the owner, he 
routinely reaches out to prescribers, he conceded that he does not 
document the substance of those conversations. Tr. 602-03. He explained 
that because he is the only pharmacist at the Respondent pharmacy that 
dispenses controlled pain medication, he keeps this information in his 
head. Tr. 603-05. According to Dr. Howard, he discusses a wide range of 
information with the prescribing doctors, such as treatment plans, 
modifications, and red flags. Tr. 616. When pressed on the issue of 
whether anomalous information received from the prescriber ever raises 
a concern that triggers a decision to decline dispensing, the owner 
would only go so far as to say ``I have done that in the past,'' but he 
readily admitted that he keeps no list or other documentation 
concerning the occasions where that has occurred. Tr. 604-05. It is the 
owner's estimation that he has only run into a single prescriber that 
he would place in the category of suspicious to the point where the 
Respondent pharmacy would decline to dispense on his controlled 
substance prescriptions. Tr. 605. In further explaining the decision 
not to document prescriber concerns or keep a list of suspicious 
prescribers, the witness offered the following:
---------------------------------------------------------------------------

    \99\ Tr. 770.
    \100\ At another point in his testimony, he testified that the 
last step was filling the prescription. Tr. 1193.

    No, I don't keep a list, you know, because that's an independent 
judgment call. You know, you can't--well, I've seen people who've 
gotten in trouble for saying I'm not going to fill this particular 
physician because of X, Y, Z. I don't think that's legal. I think 
you can subject yourself to legal ramifications, but my protocol, 
since I'm the only pharmacist there, if it's something that I don't 
agree with that has happened with that particular physician, I don't 
fill it. I don't keep a printout stating that I don't fill these 
---------------------------------------------------------------------------
particular physicians.

Tr. 604-05. Thus, the decision not to document or maintain a list of 
suspicious prescribers is based on the owner's concern that by 
documenting his analysis or the result of the pharmacy's regulatory 
obligation to exercise its corresponding responsibility (which he is 
legally obligated to do), he and/or his pharmacy would be vulnerable to 
some theoretical legal exposure.\101\ This theoretical legal concern 
seems to be in some tension with the rational and non-theoretical 
concern that by failing to document the exercise of the pharmacy's

[[Page 2922]]

corresponding responsibility, the pharmacy would be subject to a 
sanction against its DEA registration.
---------------------------------------------------------------------------

    \101\ No legal theory was ever offered by the Respondent to 
support this hypothetical concern of legal exposure for doing its 
job.
---------------------------------------------------------------------------

    According to the owner, the RX30 is useful in checking for 
medication conflicts, allergies, and some treatment concerns, which, 
unlike the corresponding responsibility outcomes and analyses, Dr. 
Howard claims he does document. Tr. 613-15. Further, the RX30 system 
automatically prints out some drug-specific information and cautionary 
information for each patient. Tr. 618-19. The owner testified that, in 
addition to the RX30-generated patient information, he interacts with 
and counsels ``each patient'' regularly, inquiring about side effects, 
efficacy, and observing any overt signs of mobility limitations. Tr. 
619-20.
    Regarding distance as a potential red flag, Dr. Howard testified 
that the extent of the Respondent's distance-curiosity extends only to 
the zip code supplied by the patient-customer. Tr. 635. The witness 
provided the following elaboration on the subject:

    I look at the patient's Florida ID and I look at the zip code. 
If it's within the same three-digit zip code of our location, then 
there's nothing for me to ask pertaining to the patient. If it 
doesn't, then what I do is I inquire what's the reason why they're 
coming to our pharmacy . . . [, to ascertain t]he specific reason 
why they would travel to our pharmacy[.] Is it because of the 
prices? Is it because, you know - that's pretty much it.

Tr. 635-36; see also id. at 738, 1173-74. Thus, it appears that the 
Respondent looks at the customer-patient's zip code,\102\ and if the 
distance is outside the three digits of the pharmacy's location, the 
patient is asked whether it is the Respondent's (presumably discounted) 
prices that has attracted the person to make the trip.\103\
---------------------------------------------------------------------------

    \102\ Since no evidence was received regarding the significance 
of postal zip code digits, this process could not be the subject of 
any intelligent analysis on the issue of whether it rationally 
furthered the objective of identifying distance red flags concerning 
the customer-patients.
    \103\ [Omitted based on the Chief ALJ's finding that the 
Government did not adequately prove that long distances traveled 
were a red flag in this case.]
---------------------------------------------------------------------------

    Dr. Howard presented some more specific testimony concerning the 
Ten Patients that are the subject of the OSC/ISO. He testified that he 
had some familiarity with Patient JA's medical conditions. Tr. 714-15. 
According to Dr. Howard he spoke to this patient every month, and 
discussed his ailments and medications with Patient JA's multiple 
treating physicians.\104\ Tr. 714-716, 739, 750-51. The witness 
testified that through his review of a prescriber's note on the 
prescriptions,\105\ he was aware that Patient JA had no insurance. Tr. 
752-54. His representation of some patient familiarity notwithstanding, 
beyond being led through some of the Government-supplied prescriptions, 
the only litigation vehicle apparently available to discuss Patient 
JA's treatment was to have his (then) counsel repeatedly refresh his 
recollection by allowing him to peruse excluded/inadmissible pharmacy 
patient records as he was testifying by VTC.\106\ Tr. 741-51, 755-57. 
Obviously, the weight that can be attached to testimony borne of the 
essentially ministerial act of a witness reading comments from 
documents that were insufficiently reliable to introduce into evidence 
is gravely diminished, but this evidentiary contrivance was endured at 
the hearing to afford the Respondent every possible measure of due 
process.\107\
---------------------------------------------------------------------------

    \104\ The witness's memory was refreshed with an excluded 
exhibit (Resp't Ex. 1(ID) at 49) to relate the existence of a 
Patient JA questionnaire (and essentially read from it). Tr. 733-34.
    \105\ See, e.g., Gov't Ex. 5 at 11.
    \106\ As discussed, infra, the Respondent initially offered into 
the record a set of Proposed Respondent Exhibits (Resp't Ex. 1(ID) 
at 41-90) that purportedly related to Patient JA. Although untimely, 
the Government's timeliness objections were overruled to afford the 
Respondent the maximum level of due process. Tr. 642-60. However, 
other fundamental issues regarding inadequate foundation and 
reliability precluded the admission of the tendered evidence as 
being sufficiently reliable to be considered in this adjudication. 
See 5 U.S.C. 556(d). It is telling that after the anomalies 
regarding Respondent Exhibit 1(ID) were discovered, the Respondent's 
(then) counsel did not seek to offer the balance of the Proposed 
Respondent Exhibits that related to the nine other charged customer-
patients. It is reasonable to assume that the unoffered documents 
suffered from the same reliability issues, but as they were not 
offered, such an assumption or further discussion is not required. 
Instead, the balance of those unoffered and outside-of-record (OOR) 
documents were used by the Respondent to refresh the recollection of 
the owner for each of the Ten Patients.
    \107\ No attempt was made by the Respondent to seek to introduce 
any of the refreshing documents as past recollection recorded. See 
Fed. R. Evid. 803(5). Ironically, on the last day of his testimony, 
when asked about whether he even remembered his testimony being 
refreshed on the previous day, the owner snapped ``That was 
yesterday. I can't remember. What--I guess what's your question?'' 
and ``I don't recall yesterday, but whatever --.'' Tr. 1189. Suffice 
it to say that announcing under oath that he has no recollection of 
events occurring on the previous day is singularly unhelpful to the 
credibility of a witness asking the tribunal and the Agency to 
credit his recollection of events that occurred months and years 
prior.
---------------------------------------------------------------------------

    Evidence was presented in like manner regarding his understanding 
of Patient EA. The Respondent's owner recalled that the customer-
patient was overweight, complained of leg pain, worked as a shutter 
installer, and that he spoke with him monthly. Tr. 762-63. He also 
recalled having conversations with Patient EA's prescribing doctor. Tr. 
772. The remainder of the details were furnished by refreshing the 
owner's recollection through Government-furnished prescriptions, OOR 
documents, and reviewing marks he testified that he had placed on 
dispensed prescriptions. Tr. 764-73, 777-90, 999-1006.
    The testimony followed the same pattern regarding Patient SD. The 
witness testified that he conversed with this customer-patient monthly 
and communicated with the prescriber. Tr. 1007, 1014. The owner again 
tracked along with the markings on the prescriptions as a guide to the 
DUR (which he presented as always being completed), he examined the 
prescriptions supplied by the Government in its exhibits, and refreshed 
his recollection with OOR documents as before.\108\ Tr. 1007-30.
---------------------------------------------------------------------------

    \108\ There was even a point during Dr. Howard's testimony where 
his counsel forgot to employ the contrivance of having his 
recollection refreshed and the process devolved to the witness 
simply reading content verbatim from the OOR documents pertaining to 
Patient SD into the record. Tr. 1025-27. Suffice it to say that this 
did not enhance the credibility and force of his testimony, or the 
weight to be accorded to it.
---------------------------------------------------------------------------

    The same general mechanics were again applied by the Respondent in 
addressing charged prescriptions regarding Patient LH. The witness 
testified that he also had monthly interactions with Patient LH, that 
he was familiar with his prescribing physician, that the handwritten 
markings on the Government-furnished prescriptions signified that he 
employed every step of the Respondent's DUR protocol, that he 
considered any and all red flags, and that he had them conclusively 
resolved by discussions with the customer-patient prior to dispensing. 
Tr. 1030-47. Regarding a drug-drug interaction flag that was presented 
in the OOR documents, and upon realizing that even the documents 
contained no articulated resolution, the witness [testified]: ``Yeah. I 
assessed it in my mind. There's no inter--there's no issue with him 
taking that medication.'' Tr. 1043. On the same red flag, when asked 
about how the issue was actually resolved, the witness merely added: 
``The [RX30] system flags it. I flagged it in my mind that that's not 
a[n] issue.'' Tr. 1044. Upon a third effort to attempt to help the 
witness explain how the red flag might have been analyzed and resolved, 
the owner became visibly impatient and said ``Well I don't know how 
else to explain it.'' Id. [Omitted for brevity.] The rationale here is 
apparently that because he dispensed the medicine he must have resolved 
whatever red flags may have been connected with the transaction. Either 
the witness was

[[Page 2923]]

being truthful and his analysis was really no cognizable analysis, or 
the red flag was never really considered before the medication was 
dispensed. Neither scenario furthers the Respondent's interests in 
avoiding a registration sanction in this case. Even the subsequent 
leading, rehabilitation questions from the Respondent's counsel about 
whether he believes he ``[w]ould [ ] have filled the prescription if 
[the red flag] had not been resolved'' \109\ [did not rehabilitate the 
witness on this issue].
---------------------------------------------------------------------------

    \109\ Tr. 1045.
---------------------------------------------------------------------------

    The testimony of the Respondent's owner regarding Patient DH 
followed the same general configuration. There was some testimony 
regarding the customer-patient's diagnoses.\110\ Tr. 1058. The 
witness's memory also was refreshed \111\ using a patient questionnaire 
that was also not offered or admitted into the record. Tr. 1059-64. At 
one point during the witness's testimony about Patient DH he testified 
that he spoke to the prescriber to resolve a drug-drug red flag, then 
when pressed, retreated to the language of the refreshing document, and 
corrected his testimony to reflect that he only consulted with the 
patient on the issue. Tr. 1068-71. It is reasonable to infer that a 
recurring theme for this witness was to somehow ascertain the most 
advantageous answer, which often came from the refreshing documents.
---------------------------------------------------------------------------

    \110\ [Omitted for brevity.]
    \111\ Even though this process had repeated itself numerous 
times, when asked by his counsel whether he had ``an independent 
recollection of the flags that were raised and resolved with respect 
to the first set of prescriptions that [he had been asked] about 
with [Patient] DH,'' he answered that he did. Tr. 1066. Thus, it 
would have appeared that the witness's memory was not in need of 
refreshing. When asked about it, the witness then immediately said 
``No, I don't recall.'' Id. Like many other features of this 
witness's testimony, this feature did not enhance the credibility of 
his presentation. This additional anomaly notwithstanding, the 
Respondent's counsel was permitted to continue to refresh the 
owner's recollection with excluded documentation to afford the 
Respondent the maximum margin of due process.
---------------------------------------------------------------------------

    The testimony was very much the same with respect to Patient JM. 
The owner averred that he saw the patient monthly, that he spoke with 
her prescribers, and while on the stand he had his recollection 
refreshed with OOR documents. Tr. 1102-35. The recognition of marks on 
prescriptions regarding Patient JM again allowed him to assure the 
tribunal that all appropriate steps were taken. Tr. 1118-19, 1129-35. 
One aspect that was unique to the witness's refreshed recollection 
regarding this patient is that, the testimony of the Government's 
expert notwithstanding, the owner insisted that prescribing two 
different benzodiazepines simultaneously to one patient is ``not a 
problem.'' Tr. 1111. The owner dismissed the entire issue this way: 
``So I did hear previous testimony stating that that's an issue, it's 
absolutely incorrect.'' Tr. 1111-12. Simultaneous prescribing of 
multiple opioids received the same treatment from the owner. When asked 
if this practice raised a red flag, his answer was ``[a]bsolutely 
not.'' Tr. 1112. He saw no red flags that required resolution. Tr. 
1116.
    The owner's testimony regarding Patient JW was more of the same. He 
said he spoke to the patient once a month, spoke with his prescriber, 
and read off of a litany of OOR documents purportedly to tender a more 
refreshed recollection. Tr. 1139-50. Interestingly, the owner opined 
that the administration of methadone for pain is common. Tr. 1146. 
Whether through disinterest, witness fatigue, self-interest, or some 
other cause, when asked by counsel whether his testimony regarding the 
significance of the prescription annotations extended to all the 
prescriptions received in the record, the witness first said ``No it 
wouldn't,'' but upon being pointedly re-asked the same question by the 
Respondent's counsel, the witness then agreed that it would. Tr. 1148-
49. This seeming recurrence of the witness's willingness to say 
whatever answer he believed would be most helpful to his cause was not 
a credibility-enhancing feature of his presentation. Sworn testimony 
where a witness definitively responds yes and then upon being abruptly 
asked the same question a second time responds no hardly presents a 
model for reliable evidence.
    The same pattern persisted regarding the witness's testimony 
concerning Patient CW. More refreshing that followed seemingly rote 
assurances that the customer-patient was seen monthly, and a blanket 
statement that no concerns regarding the dispensing events were 
encountered.\112\ Tr. 1151-64. Tellingly, when asked by the 
Respondent's counsel whether the owner specifically recalled any 
physical observations regarding Patient CW, the witness replied:
---------------------------------------------------------------------------

    \112\ The witness testified that he did see a PMP anomaly 
regarding a new prescriber, raising a conflict that he purportedly 
resolved through conversations with the customer-patient and the 
prescriber, some details of which were memorialized in a July 31, 
2019 handwritten note on the applicable prescription. Tr. 1163-64; 
Gov't Ex. 29 at 5.

    Well, yeah. I mean, I've been knowing her for probably since 
2012, so I can't remember like right off the top of my head, right 
now, as far as--I can't remember right of the top of my head. I'm 
---------------------------------------------------------------------------
not sure.

Tr. 1152. Thus, when first asked, the witness responded that he did 
recall some physical observations about the customer-patient, but then, 
apparently realizing that he might be called upon to relate some of 
those observations, reversed course and said he was not sure and could 
not remember them ``off the top of [his] head.'' Id. Prescribing 
multiple opioids simultaneously also was, in the opinion of the owner, 
undeserving of any particular heightened scrutiny. Tr. 1156. The 
witness's view of disregarding the Government expert's view regarding 
this red flag was merely that the patient-customer had ``been on pain 
management therapy for a very, very long time that I can remember . . . 
[for] a lot of different ailments . . . .'' Id. Thus, the owner's 
account presents a binary choice: Either there is no red flag inherent 
in prescribing multiple opioids and the Government's expert is wrong, 
or the mere fact that the patient has been receiving medications in the 
face of a long-term unresolved red flag of potential diversion is 
completely dissipated by the fact that the dispensing (from the 
Respondent pharmacy) has been conducted in this manner for a long time. 
Neither scenario is particularly persuasive. The testimony of the 
Government's expert regarding the validity of this multiple-opioid red 
flag is persuasive, and the fact that a red flag was ignored for a 
sustained period does not deprive the red flag of its soundness.
    The presentation pattern was substantially repeated regarding 
Patient DK. Tr. 1078-1101. The witness did convey some seemingly 
contemporaneous memory about Patient DK, remembering some particulars 
about her treatment and about the fact that (according to the owner) a 
caretaker regularly dropped her off to retrieve her medications. Tr. 
1086-88. But the Respondent resorted to the same recollection 
refreshing regarding the significant particulars of the dispensing 
events. One feature of the owner's testimony regarding Patient DK was 
particularly telling. When directed to one of the Government-furnished 
prescriptions issued to this patient, the Respondent's counsel invited 
his attention to what appeared to be a seemingly commendable notation 
on the prescription that purportedly synopsized a conversation between 
the owner and Patient DK concerning her diagnoses, weight loss, and 
pain

[[Page 2924]]

level.\113\ Gov't Ex. 26 at 17-18. After identifying his handwriting, 
the witness [offered testimony that devalued the importance of 
documentation]:
---------------------------------------------------------------------------

    \113\ The witness testified that the conversation with the 
customer-patient led to a resolved understanding of the prescriber's 
decision to titrate the customer-patient's medication downward. Tr. 
1097.

    Q. Dr. Howard, can you please tell the tribunal what was the 
intent and purpose of the note that you placed on this particular 
prescription?
    A. Basically, to document the conversations between the patients 
more. With this situation, what occurred is the patient had been in 
the hospital for probably about three weeks from a serious infection 
and what happened was is [that] the physician reduced the dosage for 
the patient based upon her weight loss. So I counseled the patient 
and explained to her the reason why the physician reduced her 
medication based upon that issue. So that was the reason why I 
documented it, it's just an extra compliance step. This is something 
that pharmacists do all the time, never to--never to thought to this 
point where you would have to do things like this, but this is what 
we do.
    Q. I'm sorry, when you say you never thought you had to do 
things like this, what did you mean by this?
    A. Document to this extent. I mean it's just--it's absolutely 
absurd because you would be doing more documenting than dispensing 
medication if you go by some of the previous testimonies that I've 
heard, being a pharmacist.
    Q. Let me stop you there. . . .

Tr. 1095-96 (emphasis supplied). When invited multiple times (by the 
tribunal and the Respondent's counsel) to explain what he meant about 
the documentation being ``absurd,'' the Respondent's owner stuck to his 
guns on the issue. Tr. 1098-1100. The owner asked the tribunal whether 
he had ever worked in a pharmacy, and upon procuring a negative 
response, he offered the following:

    Okay. So if you've ever worked in a pharmacy, you have a lot of 
patient interaction between yourself and the patient. And you have 
conversations every month. If you were to document every 
conversation, every incident that you have with a particular 
patient, you would not be able to fill prescriptions.

Tr. 1098. When invited again to explain the part of the documentation 
obligation that he found ``absurd,'' the Respondent's owner doubled 
down, stating:

    Well, I mean I think it's absurd to the sense where from 
testimony that I've heard, previous testimony that I've heard on you 
call a physician every time you almost fill a prescription or if you 
know that particular patient, you know their illness. You've had 
interaction with that patient over the years. To call a physician, 
and you know the physician and you know the patient, on every 
prescription is absurd.

Tr. 1099. The only testimony the Respondent's owner ``heard'' during 
the hearing on this subject emanated from the Government's expert 
witness, but to remove any ambiguity on that front, the witness 
clarified that the testimony he was referring to as ``absurd'' was 
``the expert witness for the DEA.'' Tr. 1100. Thus, the Respondent's 
owner was making it clear that the documentation requirements that 
underpin the standard of care are absurd in his view. [Omitted for 
brevity. I agree with the Chief ALJ that Respondent's statements as do 
not instill confidence in me that he will be compliant with the law in 
the future.]
    At one point during the witness's testimony, the Government 
conducted a voir dire regarding screen shots of RX30 pages (the RX30 
Screen Shots) regarding Patient JA that were purportedly generated in 
the ordinary course of business in the Respondent pharmacy at the time 
of the charged dispensing events.\114\ Resp't Ex. 1(ID) at 55-90. 
Although the Government's timeliness objections were overruled, the 
Respondent, as the proponent of the evidence,\115\ was ultimately 
unsuccessful in bearing its burden to establish admissibility. The 
Respondent's theory for admission of the RX30 Screen Shots was founded 
on the proposition that each tendered page was a screen shot of 
information created and inputted into the RX30 at the time of the 
dispensing event. Tr. 664-69. Dr. Howard testified that he created and 
prepared every one of the documents within the RX30 Screen Shots. Tr. 
669, 686-88. At one point he testified that the data entries were made 
either by himself or the pharmacy staff. Tr. 665. He also 
(inconsistently) said that he inputted all data into the system 
himself. Tr. 688. However, the witness was unequivocal that the screen 
shots in question were made by him personally. Tr. 687-88. Yet, when 
Dr. Howard was asked to explain, if he truly made all the RX30 entries, 
why various RX30 screens contained the initials of pharmacy techs who 
work at his pharmacy, his answers were [inconsistent and confusing]. 
The witness first said that the tech initials could be explained by 
``[i]t could've been a different screen that I had to open up, or 
something like that.'' Tr. 686. After an offer by Dr. Howard to 
``clarify so I can let you understand,'' he explained the presence of 
various tech initials by saying, ``That means that when I was logged 
into the system, I was logged in under just my initials.'' Id. When 
asked why some of the initial fields were blank, the Respondent offered 
that this was ``[b]ecause I was logged into my system.'' Tr. 687. When 
pressed on this and given another opportunity to explain, the owner 
stated that the initials from various pharmacy technicians appeared on 
the screens on different pages
---------------------------------------------------------------------------

    \114\ As it happens, these documents were not timely served on 
the tribunal or the Government, and the Government's timeliness 
objections were overruled to afford the Respondent the maximum level 
of due process. Tr. 642-60. However, other fundamental issues 
regarding foundation and reliability precluded the admission of the 
tendered evidence as being sufficiently reliable to be considered in 
this adjudication. See 5 U.S.C. 556(d). While the procedural 
timeliness objection could be (and was) overlooked by the tribunal 
in an effort to ensure the Respondent was able to present its case, 
the inherent unreliability of the tendered documents (as discussed, 
infra) prevented receipt into the record.
    \115\ See 5 U.S.C. 556(d). The untimely filing of the proposed 
evidence in the absence of any demonstration of good cause supplied 
good cause for the Government's at-hearing authenticity objection. 
See 21 CFR 1316.59(c).

[b]ecause I didn't generate them all in one day. I didn't sit there 
and go through these all in one day . . . . I just explained to you. 
Because when those would generate [sic], it was under that tech's--I 
---------------------------------------------------------------------------
guess, that computer.

Tr. 687. Whether the data was all inputted by Dr. Howard (as he said) 
or by Dr. Howard and pharmacy staff (which he also said), it is clear 
that this is yet another issue upon which Dr. Howard has provided 
inconsistent information under oath. Obviously, when taken together, 
none of these explanatory statements (made by a highly educated medical 
professional) made any sense whatsoever, raising the reasonable 
inference that he was being less than candid about the RX30 system, the 
identity of those who entered the data, and (most importantly) the 
integrity of the proffered evidence.
    Although the overwhelming majority of the tendered RX30 Screen 
Shots had a ``Print'' option at the bottom of the page, the owner at 
one point testified that the pages could not, in fact, be printed. Tr. 
672. Dr. Howard then stated that the pages could be printed so long as 
the print feature is accessed through the DUR screen related to a 
specific dispensing event. Tr. 672. He then reversed himself and 
adhered to his initial position that the screen could not be printed 
out. Tr. 673.
    The majority of these pages contained options for a variety of 
actions, to wit: ``F1 Return,'' ``F3 Select,'' ``F5 Print,'' ``F8 
Delete,'' and ``F9 Help.'' Resp't Ex. 1(ID) at 57-66, 68-90. 
Notwithstanding Dr. Howard's assurance that the pages could not be 
printed, the majority of the software pages he tendered for the

[[Page 2925]]

record clearly contained a print option for the operator on the screen. 
Page 67 of the RX30 Screen Shots (Page 67) had no option to print, but 
unlike any of the other pages, this page had a ``F4 Save'' option, 
which was clearly highlighted. Id. at 67. It is not unreasonable to 
infer that the appearance of a ``Save'' option that was unique to a 
single page signals that as yet unsaved information was entered or 
altered into the database and that this changed information is now 
amenable to being saved. In the absence of any explanation by the owner 
(the purportedly most knowledgeable person at the hearing about the 
RX30 system) to the contrary, the preponderant evidence supports the 
proposition that Page 67 in the proffered exhibit depicts data that was 
altered or supplemented prior to the printing of the page, and not when 
the dispensing event occurred. Another feature that was remarkable 
about the RX30 Screen Shots is that, notwithstanding the Respondent's 
admission theory that these documents represent unadulterated screen 
shots that merely and reliably depict information stored in the RX30 
system, the cursor is lit up on different fields depending on the page. 
Id. at 57, 63, 66, 68-90 (Intervention field), 58-62, 64-65 (Outcome 
field), 67 (Reason for Intervention field), 56 (Patient name field), 55 
(a listed diagnosis within the International Classification of Diseases 
(ICD) field). When asked why the cursor was resting in different fields 
depending on the page, the owner dismissively declared that he did not 
know, that he had ``no clue,'' that he had ``no idea,'' and that ``[i]f 
you're trying to imply that I changed things, you're wrong.'' Tr. 675-
78, 682-83. This was one of the points during the hearing where the 
witness's voice and demeanor reflected increasing agitation and volume 
as the inquiry progressed.
    The witness insisted that he did not know where the cursor 
ordinarily populates and was unable to explain why it migrated to 
different places on the RX30 Screen Shots.\116\ Tr. 671. Additionally, 
when asked why one of the pages contained text that bore a date about 
three and a half years beyond the dispensing event date,\117\ the 
witness was unable to explain, but just kept repeating that he did not 
understand the question, and defensively asked ``what are you trying to 
say?'' Tr. 670-71, 679, 681-82.
---------------------------------------------------------------------------

    \116\ Notwithstanding his testimony that he inputted all the 
information into the RX30 system, the owner did not seem to 
understand much about how the system actually works; and his lack of 
understanding extended beyond cursors and printing. At another point 
in his testimony, Dr. Howard testified that he was unsure if the 
customer-patients were presented with counseling screens at the time 
of medication dispensing. Tr. 758-59. When asked about it, he simply 
said ``I'm not aware of how it works.'' Tr. 758. Ultimately, he gave 
up on explaining whether the RX30 had such a feature, and 
volunteered that he provides a hardcopy paper counseling election 
sheet to each patient. Tr. 759. But when asked where such hardcopy 
counseling sheets are maintained at the pharmacy, he was unable to 
supply a coherent response. When asked if the counseling sheets are 
kept in a binder, his answer was: ``Well, it's not a binder. We keep 
it sort of--well, yeah, it's a binder.'' Tr. 760. The same confusion 
permeated the owner's testimony about other systems that he would 
have been expected to be conversant in. When asked about whether and 
where patient questionnaires are maintained and for how long, he 
testified that they were stored at the pharmacy, and joked that they 
were maintained ``[a]s long as we don't lose them.'' Tr. 601-03. 
Inasmuch as he testified that he is the owner, PIC, and exclusive 
controlled substance dispensing pharmacist, his general lack of 
awareness about the automation system utilized by his pharmacy, and 
even other filing systems used there, is surprising. Irrespective of 
whether the witness was being intentionally evasive, or genuinely 
lacks a basis for understanding the pharmacy systems (automated and 
manual) operating under the pharmacy he owns and supervises, this 
feature of his presentation was unhelpful in meeting the 
Government's evidence.
    \117\ Resp't Ex. 1(ID) at 57.
---------------------------------------------------------------------------

    Dr. Howard's contradictory and illogical statements, coupled with 
his dismissive declarations that he has no clue and no idea about how 
his own software system operates and why a host of anomalies were 
present in the tendered RX30 Screen Shots, were and are simply 
unpersuasive and detracted profoundly, not only from the Respondent's 
attempts to secure admission of the evidence, but more fundamentally 
from any credibility that could be accorded to the balance of his sworn 
testimony.
    The dynamic regarding the RX30 notes is rendered worse by the fact 
that, as discussed, supra, these purportedly contemporaneously-created 
notes fit squarely within the parameters of the DEA's multiple subpoena 
demands for:

    [C]omplete medication or patient medication records/profiles 
that the pharmacy maintains which documents any and all 
prescriptions filled by the pharmacy; any and all additional records 
documenting the steps taken to avoid or resolve any issues with the 
prescriptions presented by [the named customer-patients] pursuant to 
the requirements of the Florida Statutes and Florida Administrative 
Code 64B16-27.800 . . . and, any other documentation kept by the 
pharmacy in connection with the filling of prescriptions or 
providing medical treatment for these individuals, including but not 
limited to dispensing reports, billing records, [E-FORSCE] reports 
and medical records.

    Gov't Ex. 2 at 1; see Gov't Ex. 18 at 1. The Respondent's owner 
[testified that he was confused by what was required]. Tr. 1206-07. The 
Respondent's owner is and was a highly-educated, experienced 
registrant. The idea that this clear, directive language [was too 
confusing for him to comply with the subpoena was not credible]. 
Similarly unpersuasive was the Respondent's argument that the owner was 
unobligated to comply with the Government's multiple subpoenas because 
they were addressed to his counsel.\118\ Tr. 1208. The issue here was 
not a subpoena enforcement technicality being litigated in a United 
States District Court. See 5 U.S.C. 555(d). The Respondent is engaged 
in a dangerous, highly-regulated activity, and it and its (then) 
counsel well understood the documents the regulator was seeking. 
Likewise, the owner's preliminary response to whether he produced the 
customer-patient questionnaires that evolved from ``I think, at that 
time I think it was [produced], I believe so,'' to a solid declaration 
that in the course of several seconds of testimony that he somehow 
became sure that the questionnaires were provided, was unconvincing to 
say the least. Tr. 1168-73. Similarly, when asked in what format the 
questionnaires were supplied to the Government, and if they were 
supplied in hard copy, the witness first said, ``I'm not sure. I would 
assume. Yeah, they were in hard--well I don't know if they were in hard 
copy, but I, I guess they were sent electronically.'' Tr. 1172. This 
was shortly followed up by this more definitive declaration: 
``Electronically. We produced them electronically.'' Tr. 1173. This was 
immediately followed by the following statement:
---------------------------------------------------------------------------

    \118\ Tr. 1215.

    To be honest with you, I don't 100% know. I know that we 
provided them to you. You know, whatever question that you're trying 
to get at, I can tell you that we provided them to them, to you. Now 
the means that we provided it to you, I cannot remember, so I don't 
want to sit here and say something that I did or didn't do, when I 
totally don't remember. I can tell you we scanned them. They were in 
---------------------------------------------------------------------------
a binder, we scanned them in, and those were provided to you.

    Id. [This testimony was inconsistent and not credible. Omitted for 
brevity.] The questionnaires and the RX30 notes were not produced when 
demanded. They were produced late and with anomalies in the RX30 notes 
that precluded a finding that they were reliable and may even possibly 
have been altered; and notwithstanding all that, the witness was still 
permitted to have his recollections refreshed by mostly reading the 
content of the unreliable, untimely-filed documents. The inconsistency 
of the owner's

[[Page 2926]]

answers, the structure of the Respondent's actions in subpoena 
(non)compliance, and the refreshing use of the documents essentially 
precluded reasonable reliance on these late-discovered items and 
ultimately hurt the credibility of the Respondent's case.
    At another point in the owner's testimony, when asked the basic, 
straightforward question as to whether he ``would agree that there are 
red flags in pharmacy,'' the witness supplied the following convoluted 
response:

    Well if you want to deem it as a red flag, if you want to use 
the term red flag, that will be considered a red flag, or, if you 
check the PMP and you see that this patient that probably has a 
valid prescription but they went to two other physicians the day 
before, that's a red flag, for the same medication, those--if you 
wanna use the term red flag, that's a red flag.

Tr. 1182-83. While the witness did indicate that he would not dispense 
a prescription under the scenario his own reply created, his answer was 
[concerning in that he remains unwilling to acknowledge the importance, 
or even existence, of red flags. He dismissed the concept of a red 
flag] as a subjective exercise in whether the questioner (i.e., DEA) 
``want[s] to deem it as a red flag,'' whereby anything ``will be 
considered a red flag.'' Tr. 1182. [Omitted for brevity. I agree with 
the Chief ALJ that these statements do not instill confidence in me 
that Respondent will be compliant with the law in the future.]
    The Respondent's owner supplied another insightful window into his 
true amenability to regulatory oversight at another point in his 
testimony. This exchange commenced with an inquiry regarding whether 
the questionnaires used by the pharmacy had seen any level of 
modification over time. The owner impatiently replied that the 
documents were modified in format for ``[t]he same reason why we're 
sitting here.'' Tr. 1185. When asked to explain, the witness 
[testified]:

    All the documentation and things that we try to do to satisfy 
the DEA, it still does not matter, all the documentation, all the 
compliance that we've done, to show regulatory agencies we go over 
and beyond to try to, to make sure that we do our part, it did not 
matter. It did not matter. . . . I said it does not matter to the 
regulatory agencies. It does not matter as far as how much 
compliance the pharmacy does. We [changed the questionnaire] as a 
compliance issue to make sure that we're trying to stay in 
compliance. We asked for guidance. We try our best to do what's 
right.

Tr. 1185-86. Thus, even in this case where the record shows that the 
Respondent's documentation was inadequate [and outside the usual course 
of professional practice], the owner's response is that he believes he 
has done enough and it does not matter what steps his pharmacy takes in 
the future. This is not the voice of a registrant seeking to come into 
compliance, but essentially one who is communicating that he is 
[frustrated] with the efforts already invested to try to meet the state 
standards for dispensing controlled substances. The owner's mindset 
remained consistent when asked about why the Respondent's patient 
questionnaires queried about distance. The witness did not indicate 
that distance could be an important red flag of potential diversion, 
but rather affirmed that the question was included ``[b]ecause that's 
one of the things that the DEA has been targeting, is patients 
traveling long distances.'' Tr. 1218. [Omitted for brevity.]
    The witness was also unwilling to distance himself from Dr. 
Buffington's opinions that DEA has virtually no legitimate role in 
regulating the dispensing of controlled substances, notwithstanding 
invitations by the tribunal to do so in the best interests of his case. 
Tr. 1222-24. [The witness maintained throughout the hearing] that every 
single prescription that is the subject of these proceedings was 
dispensed correctly and with adequate documentation. Tr. 1224.
    On the issue of credibility, Respondent's owner, Dr. Howard, has 
the most at stake in these proceedings, as the DEA registration that is 
the subject of this litigation concerns his pharmacy. Even beyond that, 
the testimony of this witness was often evasive, internally 
inconsistent, defensive, implausible, and sometimes even objectively 
hostile in tone.\119\ As discussed in considerable detail, supra, 
during the course of his testimony, the witness [stated] that many of 
the efforts expended in the Respondent's dispensing practices were not 
geared toward identifying and targeting potential diversion, but to 
avoid professional scrutiny from DEA. [Additionally], the fact that the 
Respondent's owner declined to turn over subpoenaed documents until 
late in the proceedings, and sponsored documents that raised anomalies 
that were fatal to their reception into the record, further undermined 
his credibility, resulted in an adverse inference, and diluted the 
strength of his case. As discussed, supra, the Respondent's owner 
[declined] to distance himself from the testimony of its expert witness 
that DEA [does not have a significant role] in regulating pharmacy 
practice. To be sure, there were certain historical and/or biographical 
features of this witness's testimony that could be credited, but 
regrettably, the testimony presented by this witness cannot be afforded 
a positive credibility finding.
---------------------------------------------------------------------------

    \119\ Even beyond the words on the page of a sterile transcript 
(quite animated, even on their own in this case), the witness's tone 
and volume during his testimony was sometimes elevated and presented 
on multiple occasions as impatient and even visibly angry.
---------------------------------------------------------------------------

    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, through its pharmacists and employees, has committed acts 
that would render its 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 focus on the 
Respondent's alleged (1) dereliction in the exercise of its 
corresponding responsibility in dispensing of controlled substance 
prescriptions and (2) violations of federal and state laws relating to 
controlled substances.

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).
    ``These factors are to be considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Any one or a combination 
of factors may be relied upon, and when exercising authority as an 
impartial adjudicator, the Agency may properly give each factor 
whatever weight it deems appropriate in

[[Page 2927]]

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) (citing Morall, 412 
F.3d at 173-74), 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 the adjudication of a revocation of a DEA COR, 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, [a 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 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 38,363, 38,364, 38385 (2013).
    Normal hardships to the registrant, and even the surrounding 
community, which are attendant upon lack of registration, are not a 
relevant consideration. Heavenly Care Pharmacy, 85 FR 53,402, 53,420 
(2020) (principle conclusively applied to pharmacy registrants); Linda 
Sue Cheek, M.D., 76 FR 66,972, 66,972-73 (2011); Gregory D. Owens, 
D.D.S., 74 FR 36,751, 36,757 (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 future misconduct will not occur. Hoxie, 419 F.3d at 
483.\120\
---------------------------------------------------------------------------

    \120\ The Agency has consistently adhered to this policy in its 
adjudications. See, e.g., Ronald Lynch, M.D., 75 FR 78,745, 78,754 
(2010) (holding that the respondent's attempts to minimize 
misconduct undermined acceptance of responsibility); George Mathew, 
M.D., 75 FR 66,138, 66,140, 66,145, 66,148 (2010); George C. Aycock, 
M.D., 74 FR 17,529, 17,543 (2009); Krishna-Iyer, 74 FR 463; Steven 
M. Abbadessa, D.O., 74 FR 10,077, 10,078 (2009); Med. Shoppe-
Jonesborough, 73 FR 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) (citation omitted), 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, see 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. See 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).

Factors Two and Four: 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 Two and Four, and it is to those two factors 
that the evidence of record relates.\121\
---------------------------------------------------------------------------

    \121\ The record contains no recommendation from any state 
licensing board or professional disciplinary authority (Factor One). 
[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 19,434, 19,444 (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.'').] The 
record likewise contains no evidence of a specific recommendation by 
competent state authority or any action from which its intent could 
be discerned. See Jeanne E. Germeil, M.D., 85 FR 73,786, 73,799 
(2020) (Agency recognizes that its prior final orders have 
considered this dichotomy of sources for Factor One consideration). 
The Agency has recognized that the failure by a state to 
affirmatively take action against a registrant ``carries minimal to 
no weight under Factor One.'' Id. Similarly, there is no record 
evidence of a conviction record relating to regulated activity 
(Factor Three). Even apart from the fact that the plain language of 
this factor does not appear to place emphasis on the absence of such 
a conviction record, the myriad of considerations that are factored 
into a decision to initiate, pursue, and dispose of criminal 
proceedings by federal, state, and local prosecution authorities 
lessen the logical impact of the absence of such a record. See 
Robert L. Dougherty, M.D., 76 FR 16,823, 16,833 n.13 (2011); Dewey 
C. MacKay, M.D., 75 FR 49,956, 49,973 (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). The 
Agency has previously recognized the minimal impact of the absence 
of such a conviction in the Public Interest analysis. Germeil, 85 FR 
73,799. Therefore, the absence of criminal convictions militates 
neither for nor against the revocation sought by the Government. 
That the Government's allegations and evidence fit squarely within 
the parameters of Factors Two and Four and do not raise ``other 
conduct which may threaten the public health and safety,'' 21 U.S.C. 
823(f)(5) (Factor Five) (emphasis supplied), likewise militates 
neither for nor against the sanction sought by the Government in 
this case.
---------------------------------------------------------------------------

    Applying the record evidence to Factor Two (experience in 
dispensing controlled substances) in accordance with Agency 
precedent,\122\ the Respondent is owned by Dr. Howard, and has been 
licensed in Florida since 2010. Tr. 584. No evidence was introduced 
regarding the length of time

[[Page 2928]]

that the Respondent pharmacy has been in operation or any basis upon 
which to characterize its level of compliance prior to the allegations 
that form the basis of this litigation.
---------------------------------------------------------------------------

    \122\ JM Pharmacy Grp., Inc., 80 FR 28,667, 28,667 n.2 (2015); 
Krishna-Iyer, 74 FR 462.
---------------------------------------------------------------------------

    The lion's share of the evidence presented in this litigation is 
most readily considered under Factor Four (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). [Omitted.] \*F\
---------------------------------------------------------------------------

    \*F\ Omitted to reduce repetition with added text. See infra n. 
*H.
---------------------------------------------------------------------------

    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). 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 scrip) 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 66,149, 
66,157 n.30 (2010). [Omitted.] \*G\
---------------------------------------------------------------------------

    \*G\ Omitted to reduce repetition with added text. See infra n. 
*H.
---------------------------------------------------------------------------

    [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 4730 (citations omitted); see also JM Pharmacy Group, 
Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR 28,667, 
28,670-72 (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 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 of valid prescriptions extends to the pharmacy itself.'' 
Holiday CVS, 77 FR 62,341 (citing Med. Shoppe--Jonesborough, 73 FR 384; 
United Prescription Servs., Inc., 72 FR 50,397, 50,407-08 (2007); EZRX, 
L.L.C., 69 FR 63,178, 63,181 (2004); Role of Authorized Agents in 
Communicating Controlled Substance Prescriptions to Pharmacies, 75 FR 
61,613, 61,617 (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 63,181; Plaza 
Pharmacy, 53 FR 36,910, 36,911 (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 62,341.
    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. Agency decisions have 
consistently found that prescriptions with the similar 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 10,876, 
10,898, 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

[[Page 2929]]

payments; early refills); Hills Pharmacy, 81 FR 49,816, 49,836-39 
(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 59,504, 59,507, 59,512-13 (2014) (unusually large quantity of a 
controlled substance; pattern prescribing; irregular dosing 
instructions; drug cocktails); Holiday CVS, 77 FR 62,316, 62,317-22 
(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 66,149, 66,163-65 
(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.]\*H\
---------------------------------------------------------------------------

    \*H\ The supplemented text in this section clarifies my analysis 
of a pharmacist's corresponding responsibility under 21 CFR 
1306.04(a).
---------------------------------------------------------------------------

    The Florida Administrative Code requires pharmacists to conduct a 
prospective drug use review for each ``new and refill prescription 
presented for dispensing'' and identify, inter alia, ``[o]ver-
utilization or under-utilization,'' ``[t]herapeutic duplication,'' 
``[d]rug-drug interactions,'' and ``[c]linical abuse/misuse.'' Fla. 
Admin. Code Ann. r. 64B16-27.810(1) (Florida DUR Statute). Under the 
Florida DUR Statute, if such a matter is identified, ``the pharmacist 
shall take appropriate steps to avoid or resolve the potential problems 
which shall, if necessary, include consultation with the prescriber.'' 
Id. r. 64B16-27.810(2). A patient record system is required to be 
maintained in order to ``provide for the immediate retrieval of 
information necessary for the dispensing pharmacist to identify 
previously dispensed drugs at the time a new or refill prescription is 
presented for dispensing.'' Fla. Admin. Code Ann. r. 64B16-27.800(1). 
Significantly, within the patient record, a ``pharmacist shall ensure 
that a reasonable effort is made to obtain, record and maintain'' 
information including, inter alia, ``[p]harmacist comments relevant to 
the individual's drug therapy, including any other information peculiar 
to the specific patient or drug.'' Id. In regard to controlled 
substance prescriptions, under the Florida Pharmacy Standards Statute, 
a pharmacist in Florida must ``exercise[e] sound professional 
judgment'' in filling controlled substance prescriptions and ``shall 
attempt to work with the patient and the prescriber to assist in 
determining the validity of the prescription.'' Fla. Admin. Code Ann. 
r. 64B16-27.831. Specifically, ``when a pharmacist is presented with a 
prescription for a controlled substance, the pharmacist shall attempt 
to determine the validity of the prescription and shall attempt to 
resolve any concerns about the validity of the prescription by 
exercising his or her independent professional judgment.'' Id. r. 
64B16-27.831(2). A valid prescription for a controlled substance is 
defined as one ``based on a practitioner-patient relationship and when 
it has been issued for a legitimate medical purpose,'' while an invalid 
prescription is one ``the pharmacist knows or has reason to know that . 
. . was not issued for a legitimate medical purpose.'' Id. r. 64B16-
27.831(1)(a), (b). As discussed, supra, the concept of red flags is 
encapsulated in the FPSS as ``circumstances that may cause a pharmacist 
to question the validity of a prescription for a controlled 
substance.'' Id. r. 64B16-27.831(2). Upon encountering a ``circumstance 
that may cause a pharmacist to question the validity of a prescription 
for a controlled substance'' (i.e., a red flag of potential diversion), 
a Florida pharmacist must reach out to either the prescriber or the 
patient; and where appropriate, in place of one of those two sources 
(but not both) the pharmacist may resolve a red flag by an E-FORCSE 
query. The Florida Pharmacy Patient Record Statute directs that ``[t]he 
pharmacist shall record any related information indicated by a licensed 
health care practitioner.'' Fla. Admin. Code Ann. r. 64B16-27.800(2). 
The FPPRS also directs pharmacists to create a record of ``[p]harmacist 
comments relevant to the individual's drug therapy, including any other 
information peculiar to the specific patient or drug.'' Id. r. 64B16-
27.800(1)(f). Accordingly the substance of the contacts initiated by a 
Florida pharmacist to resolve encountered red flags (which is required) 
must be documented.\*I\ A failure to follow up on the red flags and the 
failure to document that follow-up falls below the applicable standard 
of care.
---------------------------------------------------------------------------

    \*I\ As explained above, see supra n. *E, I agree with the Chief 
ALJ's conclusion that Florida law requires pharmacists to document 
their attempts to address and resolve red flags. However, my 
Decision does not rely on any interpretation of Florida law, 
because, in failing to document the resolution of red flags, 
Respondent violated federal law in addition to state law. See 21 CFR 
1306.04(a) and 1306.06. Respondent's violations of federal law serve 
as an independent basis for my conclusion that Respondent's 
registration is inconsistent with the public interest and that 
revocation is the appropriate remedy in this case.
---------------------------------------------------------------------------

    Here,\123\ the Government has alleged and presented evidence that 
the

[[Page 2930]]

Respondent pharmacy violated federal and state law relating to 
controlled substances and dispensed prescriptions in such a way 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. 
See 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 the Ten 
Patients in the face of unresolved red flags indicating possible or 
even likely diversion. ALJ Ex. 1. The exact allegations charge that the 
Respondent ignored red flags based on: (1) High-risk combinations of 
controlled medications; (2) dosage anomalies; (3) cash payments; and 
(4) long distances between customers, prescribers, and the registrant 
pharmacy.
---------------------------------------------------------------------------

    \123\ As discussed, supra, the CSA authorizes the Agency to 
impose a sanction upon a finding that a registrant ``has committed 
such acts as would render [its] registration under [21 U.S.C. 823] 
inconsistent with the public interest as determined under such 
section.'' 21 U.S.C. 824(a)(4). Thus, for the Government to satisfy 
its prima facie burden, it must allege facts that, if sustained, 
would actually demonstrate that the registrant committed such acts 
as would render its registration inconsistent with the public 
interest. See id. Here, in a subset of allegations relating to the 
Ten Patients (the She-Opined Allegations), the Government does not 
allege actions, conduct, or omissions attributable to the 
Respondent, but rather conclusions or observations made by its own 
pharmacy expert. ALJ Ex. 1 ]] 5, 6, 8, 9, 10, 11, 12, 13. The plain 
language of each of the She-Opined Allegations points merely to the 
fact that (at some unspecified point in time) the Government's 
expert concluded that certain matters were true. Even if 
preponderantly established by the evidence, the fact that the 
Government's expert held a point of view on a fact (in the past or 
at any time) cannot and does not constitute evidence (or, as more 
relevant here, an allegation) that the Respondent engaged in acts 
that are inconsistent with the public interest. However, while the 
drafting of the She-Opined Allegations is certainly suboptimal, it 
is clear that these issues were litigated by consent. See Farmacia 
Yani, 80 FR 29,053, 29,059 (2015); Grider Drug #1 and Grider Drug 
#2, 77 FR 44,070, 44,078 n.23 (2012). The parties mutually 
understood that they were litigating the issue of whether the 
controlled-substance dispensing issues set forth in a subset of 
those allegations depicted conduct that fell below the applicable 
standard. Additionally, this issue was not raised by the Respondent 
in its closing brief. See ALJ Ex. 54. This case raises no realistic 
notice issues, and the OSC/ISO language related to the opinions of 
the Government's expert will be treated here as surplusage that does 
not impact the validity of the charges or the findings. Accordingly, 
based on the conduct of the parties at the hearing, as well as their 
post-hearing briefs, the She-Opined Allegations will be considered 
as if the underlying actions are alleged, not as if the conclusions 
of the Government's expert (at some unspecified time) are the single 
issue (that is: As they were drafted and served on the Respondent 
and this tribunal). [Furthermore, it is noted that the OSC/ISO did 
include overarching acts or omissions in addition to the more-
specific expert opinions. The OSC/ISO states that Respondent 
repeatedly filled prescriptions without addressing and resolving 
obvious red flags of drug abuse and diversion, which is conduct that 
constitutes ``acts [that] would render its registration . . . 
inconsistent with the public interest'' under the CSA. See, e.g., 
OSC, at 2 (alleging that Respondent ``repeatedly ignored obvious red 
flags of abuse or diversion and filled prescriptions without 
exercising its corresponding responsibility to ensure that 
prescriptions were issued for a legitimate medical purpose, in 
violation of federal and state law''); id. at 8 (``It is my 
preliminary finding that [Respondent] repeatedly dispensed 
controlled substances without attempting to address or resolve clear 
red flags of drug abuse or diversion, which is inconsistent with the 
public interest.''). Therefore, although I agree with the Chief ALJ 
that the drafting could be improved, I also agree with him that 
Respondent was adequately noticed of the allegations against it in 
this case.]
---------------------------------------------------------------------------

    The evidence of record demonstrates that on numerous occasions the 
Respondent pharmacy filled prescriptions in the face of unresolved 
high-risk combination red flags and dosage-anomaly red flags (i.e., 
illogical dosing combinations of long-acting and short-acting opioids, 
and therapeutic duplication). Gov't Exs. 6-14, 22, 23, 25-27, 29; Tr. 
215-16, 218-21; Stip. 33 (Patient JW); Tr. 268-69, 274-76, 281-83; 
Stip. 19 (Patient EA); Tr. 287-91, 294-97; Stip. 21 (Patient SD); Tr. 
302-05; Stip. 23 (Patient LH); Tr. 309-12, 315-16; Stip. 25 (Patient 
DH); Tr. 321-26; Stip. 27 (Patient DK); Tr. 330-38; Stip. 29 (Patient 
JM); Tr. 339-41; Stip. 31 (Patient ST); Tr. 243-45; Stip. 35 (Patient 
CW). Dr. Schossow persuasively testified that these red flags require 
documented resolution in order for the Respondent pharmacy to comply 
with its corresponding responsibility.\124\ Tr. 204, 213-14, 216, 284-
855, 318, 336-37. However, such adequate documentation was not present 
here. Tr. 431; Gov't Exs. 6-15, 22-29, 32; Tr. 240-41, 424-25 (Patient 
JW); Tr. 286, 371-75 (Patient EA); Tr. 295-300, 375-78 (Patient SD); 
Tr. 308, 378-80, 384 (Patient LH); Tr. 319, 321, 385-88, 397-98, 408-09 
(Patient DH); Tr. 329-30, 409-13 (Patient DK); Tr. 338-39, 413-16, 419-
20 (Patient JM); Tr. 342-43, 420-23 (Patient ST); Tr. 346-47, 425-30 
(Patient CW). The Respondent's countering argument that the relevant 
standard of care in Florida does not require documentation of the 
resolution of red flags is unsupported by the applicable statutes and 
unpersuasive on this record.\*J\ In specifically addressing high-risk 
combinations of controlled substances and controlled substance 
prescriptions with dosage anomalies, the Respondent's owner calmly and 
repeatedly explained that such occurrences did not raise any concern in 
his mind because such types of prescriptions are ``common.'' Tr. 1018, 
1025, 1056, 1087, 1112-13, 1131, 1146-47. The owner was firm in his 
belief that every prescription at issue was dispensed properly and that 
his documentation was adequate. Tr. 1224.
---------------------------------------------------------------------------

    \124\ Additionally, the Agency has consistently sustained 
allegations that centered around unresolved high-risk combination 
red flags. See, e.g., Suntree Pharmacy, 85 FR 73,770; Pharmacy 
Doctors Enters., 83 FR 10,876, 10,898 (2018); E. Main St. Pharmacy, 
75 FR 66,165.
    \*J\ As explained above, see supra ns. *E, *I, my Decision does 
not rely on any interpretation of Florida law.
---------------------------------------------------------------------------

    The evidence of record demonstrates that the Respondent has 
neglected its corresponding responsibility imposed by the CSA and the 
Florida Administrative Code. See 21 CFR 1306.04(a) (establishing 
corresponding responsibility under the Controlled Substances Act); 
Liddy's Pharmacy, 76 FR 48,895 (affirming that only lawful 
prescriptions may be dispensed); Fla. Admin. Code Ann. r. 64B16-27.831 
(establishing corresponding responsibility under Florida state law). 
The Respondent, through its PIC/owner, was derelict in executing its 
corresponding responsibility by dispensing in the face of an unresolved 
reason to believe that these prescriptions were not issued for a 
legitimate medical purpose in the usual course of professional 
practice. Cf. Med. Shoppe-Jonesborough, 73 FR 381 (requiring a 
pharmacist to refuse to fill such prescriptions); Medic-Aid Pharmacy, 
55 FR 30,044. 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, 76 FR 24,530 (stating that a pharmacist may not 
``close his eyes and thereby avoid [actual] knowledge'' of possible 
abuse or diversion) (quoting Bertolino, 55 FR 4730).
    [Omitted for clarity. The record evidence establishes that it was 
outside the usual course of professional practice for Respondent to 
dispense] the prescriptions detailed in the Government's evidence and 
agreed stipulations without resolving the red flags presented and 
documenting that resolution.\125\ The red flags detailed above required 
the Respondent and its owner/PIC to question these prescriptions, and 
they did not. See Bertolino, 55 FR 4730 (requiring pharmacists to 
question prescriptions that present red flags for abuse or diversion). 
[Omitted for clarity.]
---------------------------------------------------------------------------

    \125\ As discussed elsewhere in this RD, the allegations 
centered on distance and cash red flags cannot be sustained based on 
the underlying rationale supplied by the Government's expert.
---------------------------------------------------------------------------

    The Government has presented uncontroverted evidence that the 
Respondent pharmacy dispensed multiple controlled substances in the 
face of multiple red flags of potential diversion.
    Accordingly, OSC/ISO Allegations 6, 7.a, 7.b, 7.c, 7.e, 7.f, and 
7.g (pertaining to high-risk combinations) are sustained. For the 
allegation pertaining to Patient SD,\126\ the record contains 
insufficient quantitative evidence to support the amount of alprazolam 
specified for the alleged amount of dispensing events.\127\ 
Accordingly, OSC/ISO Allegation 7.d is sustained in part to the extent 
that the charge alleges ``a quantity of alprazolam,'' while the 
remaining alleged dosages/amounts within OSC/ISO Allegation 7.d are 
sustained as charged.
---------------------------------------------------------------------------

    \126\ ALJ Ex. 1 ] 7.d.
    \127\ See Gregg & Son Distribs., 74 FR 17517, 17517 n.1 (2009) 
(clarifying 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'').
---------------------------------------------------------------------------

    The record contains sufficient quantitative evidence to 
preponderantly sustain the ratio dosage anomaly (illogical dosing 
combinations of long-acting and short-acting opioids) allegations for 
Patients JM,\128\ ST,\129\ DH,\130\ and EA \131\ as charged. 
Accordingly, OSC/ISO Allegations 10.a, 10.b, 10.c, and 10.f are 
sustained. [Omitted.] *<SUP>K 132 133 134</SUP>
---------------------------------------------------------------------------

    \128\ ALJ Ex. 1 ] 10.a.
    \129\ ALJ Ex. 1 ] 10.b.
    \130\ ALJ Ex. 1 ] 10.c.
    \131\ ALJ Ex. 1 ] 10.f.
    *\K\ The Chief ALJ did not sustain the Government's improper 
dosing allegations related to Patients SD and LH. RD, at 78-79. The 
Government took Exception to this finding. Gov't Exceptions, at 5-7. 
I find that it is unnecessary for me to reach this issue because 
there is substantial other evidence on the record that demonstrates 
that Respondent's registration is inconsistent with the public 
interest.
    \132\ ALJ Ex. 1 ] 10.d.
    \133\ ALJ Ex. 1 ] 10.e.
    \134\ See Gregg & Son Distributors, 74 FR 17,517 n.1 (noting 
that ``it is the Government's obligation as part of its burden of 
proof . . . to sift through the records and highlight that 
information which is probative of the issues in the proceeding'').
---------------------------------------------------------------------------

    The Government alleges that on multiple occasions where the 
Respondent dispensed multiple

[[Page 2931]]

benzodiazepines (therapeutic duplication) to Patient JM, it failed to 
address or resolve this red flag in a way that would have been required 
to stay within the standard of care. Dr. Schossow's expert opinion has 
been deemed persuasive on this issue. Accordingly, OSC/ISO Allegation 
12 is sustained.
    Although Dr. Schossow's expert opinion has been held generally 
reliable, her theory regarding the basis for the cash red flag (to wit, 
that [Respondent failed to adequately resolve the cash red flag], even 
where lack of insurance was specifically noted by the pharmacy staff) 
was too logically challenged to serve as a basis for sanction. 
Certainly the Agency has consistently sustained supported allegations 
that centered around unresolved cash red flags in the past. See, e.g., 
Suntree Pharmacy, 85 FR 73770; Pharmacy Doctors Enters., 83 FR 10,891; 
The Medicine Shoppe, 79 FR 59,504, 59,507, 59,512-13 (2014); Holiday 
CVS, 77 FR 62,317-22. [Omitted for clarity.] As discussed elsewhere in 
this recommended decision, the red flag resolution proposed by the 
Government's expert, to wit, that a dispenser-registrant is required in 
all cases to contact a prescriber-registrant to ascertain whether the 
customer-patient had prescription drug coverage (a subject within the 
exclusive purview of the pharmacy), does not further the goal of 
minimizing the risk of diversion. [Omitted.] *\L\
---------------------------------------------------------------------------

    *\L\ Omitted. The Government has taken Exception to the RD's 
finding that allegation 13 was not sustained. Gov't Exceptions, at 
1-5. I agree with the Chief ALJ that Dr. Schossow's method for 
resolving the red flag was logistically problematic. Still, I find 
that Dr. Schossow credibly testified that cash payments are a red 
flag that requires documented resolution. Ultimately, I find that it 
is unnecessary for me to reach this issue because there is 
substantial other evidence on the record that demonstrates that 
Respondent's registration is inconsistent with the public interest.
---------------------------------------------------------------------------

    Further, it is beyond argument that there has been a long 
uncontradicted history of the Agency sustaining allegations relating to 
unresolved long-distance red flags. See, e.g., Heavenly Care Pharmacy, 
85 FR 53,417; Suntree Pharmacy, 85 FR 73,770; Pharmacy Doctors Enters., 
83 FR 10,885; Hills Pharmacy, 81 FR 49,839; Holiday CVS, 77 FR 62,317-
22; E. Main St. Pharmacy, 75 FR 66,163-65. The basis of that history is 
rooted in expert testimony explaining the common-sense proposition that 
traveling a great distance to fill a prescription that could have been 
dispensed around the block from the customer-patient raises a 
reasonable suspicion that the customer-patient may have chosen the 
remotely-located pharmacy for an improper purpose (e.g., to escape 
scrutiny from local, vigilant pharmacists, or to travel to a pharmacy 
believed to be less vigilant in its responsibilities). See, e.g., 
Holiday CVS, 77 FR 62,334. Under those circumstances, experts have 
testified that it is logical and required to explore and resolve the 
possibility that either the patient-customer is seeking to mask his/her 
diversion, or the pharmacy has been identified as an easy mark for 
improperly-authorized prescriptions. [Omitted for brevity.]
    This case presents a somewhat divergent issue. As discussed, supra, 
there is no genuine question that the distances between the customer-
patient, the correlating prescriber, and the Respondent pharmacy are 
sufficiently lengthy as to objectively raise a red flag requiring pre-
dispensing analysis and documentation. The fly in the ointment here is 
the primary rationale presented by Dr. Schossow as underlying the red 
flag. According to the Government's expert, a remarkable travel 
distance raises a concern, not founded in concerns related to drug 
diversion, but rather because a customer-patient filling prescriptions 
for opioids and benzodiazepines presents ``the risk for getting into a 
motor vehicle accident, [and] fractures, even death, [ ] could 
potentially occur.'' Tr. 232 [However, the witness testified] that she 
had no information regarding whether any of the customers in question 
drove to the Respondent pharmacy. Tr. 545. In addressing a distance red 
flag related to one of the customer-patients, Dr. Schossow supplied the 
following opinion about why the red flag stood unresolved:

    [I]f you're specifically talking about the red flag of distance, 
that would be asking the patient if he is actually driving a motor 
vehicle these distances while he's on these medications, back and 
forth, this long distance. And that was not addressed in this 
[pharmacy] note.

Tr. 380. Stated differently, if the Respondent had documented a 
representation by the customer-patient that someone drove him to the 
pharmacy the dispensing event would have met Dr. Schossow's standard. 
Even when closely pressed on the issue, Dr. Schossow held her ground, 
explaining that to resolve a distance red flag, when encountered, would 
require no more than the pharmacist to procure a representation from 
the customer-patient that someone else was doing the driving to the 
pharmacy.\135\ Tr. 237-39.
---------------------------------------------------------------------------

    \135\ The witness also allowed that the existence and resolution 
of a distance red flag could be different if the pharmacy and the 
prescriber were collocated in the same building. Tr. 238. But even 
where the dispenser and prescriber were located miles away, Dr. 
Schossow kept her focus on whether the patient-customer was doing 
the driving. Tr. 239.

    By the testimony of the Government's expert, the long-distance red 
flags in this case were not founded in controlled-substance diversion 
(which is the focus of this proceeding and which circumscribe the 
hardline limits of this Agency's jurisdiction); instead, the Government 
expert's explanation of long-distance red flags related to general 
patient safety concerns. Dr. Schossow's view paints safety with a 
broader brush than DEA's statutory authority allows.\136\ Safer roads 
do not translate into lack of drug diversion, and more dangerous road 
conditions do not likewise translate into establishing the applicable 
dispensing standard for a DEA pharmacy registrant. This Agency is 
charged with administering the Controlled Substances Act, with no 
mandate to supervise highway and traffic safety. Accordingly, OSC/ISO 
Allegations 8.a, 8.b, 8.c, 8.d, 8.e,\137\ and 8.f are not sustained.
---------------------------------------------------------------------------

    \136\ See Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (the 
setting of medical standards is a function of the police powers of a 
state, whereas DEA's authority under the CSA is limited to barring 
illicit drug dealing and trafficking as traditionally understood).
    \137\ While OSC/ISO Allegation 8.e charges the Respondent with 
dispensing controlled substances to Patient EA in the face of long-
distance red flags, the Government presented no evidence on this 
issue during the hearing and did not address the issue in its post-
hearing brief. Therefore, the Government has apparently abandoned 
OSC/ISO Allegation 8.e. See George Pursley, M.D., 85 FR 80,162, 
80,181-82, 80,185 (2020) (finding the Government abandoned 
allegation by not addressing it within its post-hearing brief).
---------------------------------------------------------------------------

    The Government further alleges that the Respondent filled 
prescriptions for alprazolam to Patients JW, EA, and SD in amounts that 
presented a red flag (because the dosages were pharmacologically 
illogical) without attempting to address the red flag. However, the 
Government presented no evidence that this occurred (nor did it address 
the issue in its post-hearing brief); \138\ thus, it appears the 
Government has abandoned these allegations, see Pursley, 85 FR 80,181-
82, 80,185. Accordingly, OSC/ISO Allegation 11 is not sustained.
---------------------------------------------------------------------------

    \138\ Again, see Gregg & Son Distributors, 74 FR 17,517 n.1 
(clarifying 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'').
---------------------------------------------------------------------------

    OSC/ISO Allegation 1 is sustained based on the evidence \139\ and 
stipulations \140\ of record.
---------------------------------------------------------------------------

    \139\ Gov't Ex. 1.
    \140\ Stips. 1, 2.

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[[Page 2932]]

    [Accordingly, I find that Respondent has operated outside the usual 
course of professional practice (in violation of 21 CFR 1306.06 and 
Fla. Admin. Code Ann. r. 64B16-27.831 and in violation of its 
corresponding responsibility (in violation of 21 CFR 1306.04(a) and 
Fla. Admin. Code Ann. r. 64B16-27.831). I further find that the 
Government has made a prima facie case that the Respondent has 
committed acts which render its registration inconsistent with the 
public interest.] *\M\ On consideration of the whole of the record, it 
is clear that Public Interest Factors Two and Four militate strongly in 
favor of the imposition of a registration sanction in this case.
---------------------------------------------------------------------------

    *\M\ 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 dispensed 
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. Thus, I find that 
at the time the Government issued the OSC/ISO, there was clear 
evidence of imminent danger.
---------------------------------------------------------------------------

[Sanction]

    The evidence of record preponderantly establishes that the 
Respondent has committed acts which render its continued registration 
inconsistent with the public interest. See 21 U.S.C. 824(a)(4). Since 
the Government has met its burden \141\ in demonstrating that the 
revocation it seeks is authorized, to avoid sanction, it becomes 
incumbent upon the Respondent to demonstrate that given the totality of 
the facts and circumstances revocation is not warranted. See Med. 
Shoppe-Jonesborough, 73 FR 387. That is, upon the preponderant 
establishment of the Government's prima facie case, the burden now 
shifts to the Respondent to show why it should continue to be entrusted 
with a DEA registration. See Kaniz F. Khan-Jaffery, M.D., 85 FR 45,667, 
45,689 (2020); Garrett Howard Smith, M.D., 83 FR 18,882, 18,910 (2018).
---------------------------------------------------------------------------

    \141\ See 21 CFR 1301.44(e).
---------------------------------------------------------------------------

    Although by no means the only requirement, in order to rebut the 
Government's prima facie case, the Respondent must demonstrate both an 
unequivocal acceptance of responsibility and also a demonstrable plan 
of action to avoid similar conduct in the future. See Hassman, 75 FR 
8236. While those two elements are key, the focus is, and must always 
be, rooted in a determination as to whether the Agency can have 
confidence that the Respondent can continue to be entrusted with the 
weighty and dangerous responsibilities of a registrant. Cf. Khan-
Jaffery, M.D., 85 FR 45,689; Smith, M.D., 83 FR 18,910. While 
analytical frameworks applied to prior Agency actions provide useful 
guidance and helpful structure, such tools cannot distract the Agency 
from its critical mission to keep the public safe by only issuing and 
maintaining CORs in cases where the public is adequately protected. The 
central issue is whether, based on the evidence of record, including 
the Respondent's established misdeeds, the Agency can trust the 
Respondent with the authority to handle dangerous controlled 
substances. The Agency has provided the following framework for its 
analysis in this regard:

    The issue of trust is necessarily a fact-dependent determination 
based on the circumstances presented by the individual respondent; 
therefore, the Agency looks at factors, such as the acceptance of 
responsibility and the credibility of that acceptance as it relates 
to the probability of repeat violations. A registrant's candor 
during the investigation and hearing is an important factor in 
determining acceptance of responsibility and the appropriate 
sanction; as is whether the registrant's acceptance of 
responsibility is unequivocal.

Heavenly Care Pharmacy, 85 FR 53,420 (internal citations omitted).

    Agency precedent is clear that a respondent must ``unequivocally 
admit fault'' as opposed to a ``generalized acceptance of 
responsibility.'' The Medicine Shoppe, 79 FR 59,510; see also Lon F. 
Alexander, M.D., 82 FR 49,704, 49,728 (2017). To satisfy this burden, 
the respondent must show ``true remorse'' or an ``acknowledgment of 
wrongdoing.'' Michael S. Moore, M.D., 76 FR 45,867, 45,877 (2011). The 
Agency has made it clear that unequivocal acceptance of responsibility 
is paramount for avoiding a sanction. Dougherty, 76 FR 16,834 (citing 
Krishna-Iyer, 74 FR 464). 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. Jones Total Health Care 
Pharmacy, LLC v. DEA, 881 F.3d 823, 830-31 (11th Cir. 2018); MacKay v. 
DEA, 664 F.3d 808, 822 (10th Cir. 2011); Hoxie, 419 F.3d at 483.
    For both prongs (acceptance of responsibility and remedial steps), 
the Respondent [did not present any evidence]. Arguably, as discussed, 
supra, at some point (outside the timeframe of the allegations) the 
evidence of record showed that the Respondent did appear to commence at 
least some documentation of some conversations with prescribers and 
patients.\142\ However, as discussed, supra, the Respondent's owner 
made his view unflinchingly clear that the documentation level required 
to dispense within the standard applicable in the State of Florida is 
``absolutely absurd.'' Tr. 1096. The Respondent's owner, in the 
clearest terms possible, like the expert he called to meet the 
Government's evidence, has demonstrated active hostility to applying 
this standard in the past, in the present, and in the future, as well 
as his amenability to Agency oversight. Thus, the Respondent accepts 
responsibility on no level, much less unequivocally. A change in this 
attitude is unlikely. The view of the Respondent's owner/PIC is that no 
misconduct or deficits occurred, and to the extent that the Agency and 
its expert thinks otherwise, it is mistaken.
---------------------------------------------------------------------------

    \142\ This is only an evidentiary observation, not a point 
propounded by the Respondent regarding remedial steps.
---------------------------------------------------------------------------

    While the transgressions alleged and proved here are certainly 
serious, it is arguable that an acceptance of responsibility, coupled 
with a thoughtful plan of remedial action on the part of the Respondent 
pharmacy, would have had the potential for a creditable case for 
lenity. The errant dispensing events that were sustained involved areas 
of prescribing and dispensing that may well have been amenable to a 
convincing case that the Respondent's owner re-educated himself and now 
understood that follow-up and documentation are required to bring his 
pharmacy within the applicable standard. The Respondent pharmacy was 
clearly operating below an acceptable and safe standard, but it could 
not fairly be said that the pharmacy was a pill mill. On these facts, 
an unequivocal acceptance of responsibility and meaningful remedial 
steps could conceivably have supported a more moderate sanction. To the 
extent that the Respondent's owner had expressed some level of 
contrition coupled with an expression of some understanding of why his 
pharmacy was operating below the applicable standard, it could have 
achieved much in empowering the Agency to exercise some measure of 
lenity as a matter of discretion. But in view of the present record, 
considering what could have been on a different record is of minimal 
utility.

[[Page 2933]]

    The Agency has frequently required unambiguous acceptance of 
responsibility and a remedial action plan as an essential component to 
avoid a sanction,\143\ and in this case it is clear that the 
Respondent's owner, acknowledging no deficiencies, has no plan to 
conform his conduct whatsoever. In his view, he and his pharmacy did 
nothing wrong and would presumably make all the same choices if faced 
with the same facts tomorrow. The Agency is thus faced with a choice of 
imposing a registration sanction or imposing none and therein creating 
a virtual guarantee that it will be instituting new proceedings, 
charging the same conduct, on the day it issues its final order. On 
this point there is little room for logical, dispassionate dissent. 
Thus, in the face of a prima facie case, without the Respondent meeting 
the evidence with an acceptance of responsibility and proposing 
remedial measures geared toward avoiding future transgressions, the 
record supports the imposition of a sanction.
---------------------------------------------------------------------------

    \143\ Hassman, 75 FR 8236. [Edited the footnoted sentence for 
clarity.]
---------------------------------------------------------------------------

    Further, inasmuch as the evidence of record fails to demonstrate an 
unequivocal acceptance of responsibility, the issue of remedial steps 
becomes irrelevant. The Agency has consistently held that for either 
prong (acceptance of responsibility and remedial steps) to be 
considered in sanction amelioration, both prongs must have been 
established. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019); Jones 
Total Health Care Pharmacy, L.L.C., & SND Health Care, 81 FR 79,188, 
79,202-03 (2016); Hassman, 75 FR 8236. If one prong is absent, the 
other becomes irrelevant. Both or neither has been the rule for many 
years. The view of the Respondent's owner that nothing is wrong with 
his pharmacy has virtually precluded him from establishing remedial 
steps of any kind. As noted, supra, there was some indication of a 
sporadic, mildly increased level of documentation beyond the temporal 
range of the allegations, but these were not even proffered as remedial 
steps. Thus, in view of the prima facie case established by the 
Government's evidence, 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.
    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 38,364, 
38,385. The issue of the egregiousness of the offense favors 
revocation. The Respondent dispensed many controlled substances for 
over a year without any regard for its obligations to identify blatant 
red flags of potential diversion. There was no indication during the 
hearing that the Respondent's owner did not understand his true 
obligations, only that he [resented those obligations.] The Respondent 
pharmacy [repeatedly dispensed controlled substances without 
appreciating that] further steps were required to resolve and document 
indications of potential diversion.
    Considerations of specific and general deterrence in this case 
militate in favor of revocation. Through the testimony of its owner, 
[it was clear that the Respondent did not feel that it had acted 
improperly, did not have a fulsome understanding of the requirements 
for operating in the usual course of professional practice, and did not 
believe that any actions the Respondent might take to curtail diversion 
would matter to DEA]. The Respondent's owner and its expert witness 
[apparently believe] that DEA has no proper oversight role in the 
operation of the Respondent pharmacy and pharmacy practice in 
general.\144\ The Respondent's owner [testified] that even the isolated 
instances of an increased level of documentation were effected, not in 
the interests of compliance with the applicable state standards, but to 
placate DEA. Tr. 1218-22, 1226-27. The Respondent's owner is not 
amenable to supervision by regulatory authorities, including DEA. He 
believes he is and has been correct, and it can be confidently assumed 
that the absence of a registration sanction will result in the 
continuation of business as usual at his pharmacy. Thus, the interests 
of specific deterrence, even standing alone, motivate powerfully in 
favor of the revocation of the Respondent's COR.
---------------------------------------------------------------------------

    \144\ As discussed, supra, the Respondent's owner received 
multiple unsubtle entreaties from the tribunal to distance himself 
from his expert's hostility to the exercise of regulatory authority 
by DEA, all of which were soundly declined. Tr. 1222-24.
---------------------------------------------------------------------------

    The interests of general deterrence compel a like result. As the 
regulator in this field, the Agency bears the responsibility to deter 
similar misconduct on the part of others for the protection of the 
public at large. Ruben, 78 FR 38,385. Where the record demonstrates 
that the Government has borne its burden and established that the 
Respondent has dispensed high numbers of controlled substances below 
the standard for over a year with no correction and no remorse, the 
unmistakable message to the regulated community would be that such 
conduct can be tried once (or more than once) with little or no 
consequence. Thus, on this record, the interests of general deterrence 
support the revocation sought by the Government.
    Another factor that weighs significantly in favor of the revocation 
sanction sought by the Government is the profound lack of candor 
demonstrated by the Respondent's owner during his testimony and his 
actions during the investigation. In making the public interest 
determination, this Agency places great weight on a respondent's candor 
both during an investigation and during a subsequent proceeding. Fred 
Samimi, M.D., 79 FR 18,698, 18,713 (2014); Robert F. Hunt, D.O., 75 FR 
49,995, 50,004 (2010). As discussed at length, supra, during the 
investigation in this matter, the Respondent declined to forward a 
large swath of material specifically subpoenaed by DEA investigators, 
and during the hearing there were marked and profound adverse issues 
regarding the credibility of the owner's testimony. Hence, the issue of 
candor to the Agency, and candor to the tribunal, undermine the 
confidence that the Agency can have in the Respondent's continuation as 
a DEA registrant.
    Accordingly, it is respectfully recommended that the Respondent's 
DEA COR should be revoked, and any pending applications for renewal 
should be denied.

Dated: April 7, 2021
John H. Mulrooney, II
Chief Administrative Law Judge

The Respondent's Exceptions

    On December 15, 2020, Respondent filed its exceptions to the 
Recommended Decision. DEA regulations require that Exceptions ``include 
a statement of supporting reasons for such exceptions, together with 
evidence of record (including specific and complete citations of the 
pages of the transcript and exhibits) and citations of the authorities 
relied upon.'' 21 CFR 1316.66. For the most part, Respondent's 
Exceptions not only fail to comply with this regulatory requirement, 
but they also lack evidentiary support in the Administrative Record. 
Several of

[[Page 2934]]

Respondent's Exceptions also reflect a misunderstanding of the CSA and 
its implementing regulations. Additionally, some of Respondent's 
Exceptions repeat arguments that were already raised in Respondent's 
Posthearing Brief, or in prehearing or posthearing filings, and have 
been adequately addressed in the adopted Recommended Decision or in the 
Chief ALJ's orders. Therefore, I reject Respondent's Exceptions and 
adopt the Recommended Decision of the Chief ALJ as amended above.

Exception A

    Respondent argues in its first Exception that the Government failed 
to demonstrate that Respondent's prescribing ``posed imminent harm to 
the public,'' and that the Chief ALJ ``departed from established 
standard'' by recommending that Respondent's registration be revoked 
without any evidence of public harm. Resp Exceptions, at 2-3. However, 
Respondent does not cite legal authority for the proposition that I 
must find evidence of diversion or harm before I may suspend or revoke 
a registration. Agency Decisions have found that DEA has the authority 
to revoke a DEA registration in the absence of evidence of diversion if 
the registrant's ``practices . . . create a substantial risk of 
diversion'' or even the ``opportunity for diversion.'' See, e.g., 
Garrett Howard Smith, M.D., 83 FR 18,882, 18,905 n.32 (2018) (citing 
Dewey C. Mackay, M.D., 75 FR 49,956, 49,974 n.35 (2010). Further, DEA 
has held that ``[c]areless or negligent handling of controlled 
substances creates the opportunity for diversion and could justify 
revocation or denial.'' Paul J. Caragine, Jr., 63 FR 51,592, 51,601).
    As discussed in more detail above, DEA is authorized to revoke a 
registration upon a finding that the registrant's registration is 
``inconsistent with the public interest,'' based on a consideration of 
five enumerated factors, including the registrant's ``experience 
dispensing . . . controlled substances'' and the registrant's 
``[c]ompliance with applicable State, Federal, or local laws relating 
to controlled substances.'' 21 U.S.C. 823(f). In this case, I find that 
the Government has met its burden of proving that Respondent's 
registration is inconsistent with the public interest by presenting 
evidence that Respondent repeatedly filled prescriptions that presented 
obvious and well-established red flags of drug abuse and diversion, in 
violation of federal and state law. Agency Decisions have consistently 
held that the repeated filling of prescriptions in violation of federal 
and state law constitutes acts that are inconsistent with the public 
interest, and establish grounds for DEA to revoke a registration. See, 
e.g., Suntree Pharmacy, 85 FR 73,776.
    Moreover, Respondent's Exception conflates the legal standard for 
issuing an immediate suspension order under 21 U.S.C. 824(d) with the 
legal standard for revoking a registration under 21 U.S.C. 823(f). 
Before issuing an ISO, the Government must demonstrate that the 
registrant has ``fail[ed] . . . to maintain effective controls against 
diversion or otherwise comply with the obligations of a registrant,'' 
and that those failures have created 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.'' 21 U.S.C. 824(d) 
(emphasis added).*\N\As discussed in more detail above, see supra n.*M, 
I find that at the time the Government issued the OSC/ISO, there was 
clear evidence of imminent danger.
---------------------------------------------------------------------------

    *\N\ In support of this argument, Respondent quotes from a West 
Virginia District Court order granting a pharmacy's motion to 
dissolve an immediate suspension order. The district court found 
that the Government had not adequately supported its imminent danger 
finding, because it had not ``demonstrat[ed] that actual or 
anticipated harm had occurred in patients.'' Id. (citing Oakhill 
Hometown Pharmacy v. Uttam Dhillon, 2:19-cv-00716, at 9). 
Respondent's reliance on this decision is misplaced, and it has no 
relevance to this proceeding. Respondent's legal course of action on 
this matter would have been to challenge the ISO in court. The 
subject of this proceeding is the revocation of Respondent's 
registration. I am finding in favor of revocation, and therefore, at 
the time that my order goes into effect, the immediate suspension 
will necessarily end.
---------------------------------------------------------------------------

Exception B

    Respondent next takes exception to the Chief ALJ's characterization 
of Dr. Schossow's expert testimony. Resp Exceptions, at 4-6. Respondent 
argues that Dr. Schossow's testimony should not be given any weight for 
several reasons. First, Respondent argues that Dr. Schossow cannot be 
trusted because she initially testified that she had sat on the Florida 
board of pharmacy in the 1990s, and later confirmed that she had not. 
Second, Respondent argues that Dr. Schossow's opinions were entitled to 
little weight because she did not speak to the physicians, pharmacists, 
and customers involved in Respondent's dispensing, and she had never 
been to Respondent pharmacy. Respondent identifies several additional 
concerns with Dr. Schossow's testimony, including that her opinions 
were illogical and based on speculation, that she did not identify any 
evidence that Respondent's customers were abusing controlled 
substances, and that she did not have adequate information to conclude 
whether there was imminent danger or public harm.
    I agree with the Chief ALJ's assessment of Dr. Schossow's 
credibility,*\O\ including his determination that Dr. Schossow's 
misstatement about the Florida board of pharmacy was not material. See 
ALJ Ex. 67 (Order Denying the Respondent's Motion to Disqualify Expert 
Witness). I also find that Dr. Schossow reviewed sufficient materials 
to provide relevant opinions on Respondent's compliance with the usual 
course of professional practice in Florida, and that her failure to 
speak to any of the involved pharmacists, physicians, or customers did 
not diminish the weight of her opinions. Dr. Schossow's opinions 
primarily focused on Respondent's failure to document a resolution of 
red flags of drug abuse and diversion. Respondent's failure to document 
was sufficient evidence that Respondent's dispensing was outside the 
usual course of professional practice, even without input from any of 
Respondent's pharmacists or customers, or the prescribing physicians.
---------------------------------------------------------------------------

    *\O\ 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, 
Universal Camera Corp., 340 U.S. at 496, and that this Recommended 
Decision constitutes an important part of the record that must be 
considered in the Administrator's decision. Morall, 412 F.3d at 179.
---------------------------------------------------------------------------

    Respondent's additional concerns about the allegedly illogical and 
inconsistent nature of Dr. Schossow's opinions are not adequately 
supported by citations to the record that would allow me to 
meaningfully respond. See 21 CFR 1316.66. As stated above, I agree with 
the Chief ALJ's credibility determinations and his analysis of Dr. 
Schossow's opinions. I find that the Chief ALJ thoroughly and neutrally 
analyzed Dr. Schossow's credibility and identified portions of her 
testimony that were illogical or internally inconsistent, and relied 
only on those portions that were logical and well-supported.
    Finally, as stated above, Respondent does not cite legal authority 
for the proposition that I must find evidence of diversion or harm 
before I may suspend or revoke a registration. It is therefore 
irrelevant to my Decision whether the Government's expert believed that 
there was actual harm.

Exception C

    Respondent next takes Exception to the Chief ALJ's questions to 
Respondent's representative, Dr.

[[Page 2935]]

Howard, about whether he agreed with certain testimony by Respondent's 
expert, Dr. Buffington. Resp Exceptions, at 6-8. Respondent believes 
that the Chief ALJ's questions to Dr. Howard misstated Dr. Buffington's 
opinions and that they put Dr. Howard in the uncomfortable position of 
deciding whether to agree with Dr. Buffington's opinions. Id.
    As discussed in more detail above, ALJs have authority to regulate 
the administrative hearing, which includes asking clarifying questions 
of counsel and witnesses and issuing evidentiary rulings. See supra n. 
*A (citing 5 U.S.C. 556(c)(5); 21 CFR 1316.52(e)). In this case, the 
Chief ALJ was questioning Dr. Howard for Respondent's benefit in an 
attempt to ascertain whether Respondent shared Dr. Buffington's 
criticisms of--and hostility towards--DEA as a regulator. Respondent's 
attitude towards DEA, and appreciation for the requirements for 
operating in the usual course of professional practice, are relevant to 
DEA's determination as to Respondent's likelihood of future compliance 
in determining whether a sanction is appropriate.*\P\ I therefore find 
that the Chief ALJ properly exercised his discretionary authority to 
regulate the hearing and that Respondent's Exception is without merit.
---------------------------------------------------------------------------

    *\P\ See, e.g., Jayam Krishna-Iyer, 74 FR 459, 463 (2009) 
(stating that ``where a registrant has committed acts inconsistent 
with the public interest, the registrant must . . . demonstrate that 
[it] will not engage in future misconduct'') (quoting Medicine 
Shoppe, 73 FR 364, 387 (2008)); see also Lisa Hamilton, N.P., 85 FR 
71,465, 71,473 (2019) (observing, in determining that revocation was 
the appropriate remedy, that the respondent had ``demonstrated a 
general disdain for the charges against her and the situation in 
which she had found herself'').
---------------------------------------------------------------------------

Exception D

    Respondent next argues that the Chief ALJ improperly excluded 
Respondent's Second Supplemental Prehearing Statement (hereinafter, 
Second SPS), which was filed approximately five months after the 
deadline set by the Prehearing Ruling. Resp Exceptions, at 8-9. 
Respondent's Second SPS was also not accompanied by a motion for good 
cause, which is a prerequisite for a late-filed prehearing 
statement.*\Q\ The Government filed a Motion to Strike (see ALJ Ex. 
34), and Respondent replied to that motion (see ALJ Ex. 35), arguing 
that there should be no prejudice to the Government from the late 
filing. The Chief ALJ determined that Respondent had not provided any 
rationale or good cause for its late filing.*\R\ Order Denying 
Respondent's Motion, at n. 3. As previously mentioned, the Chief ALJ 
has authority to regulate the hearing, which includes the authority to 
exclude evidence. 21 CFR 1316.52(e). I therefore defer to his decision 
to exclude Respondent's Second SPS.
---------------------------------------------------------------------------

    *\Q\ ALJ Ex. 36, at 2 (Order Denying the Respondent's Motion to 
File a Second Supplemental Prehearing Statement) (citing Prehearing 
Ruling, at 2; 21 CFR 1316.55 (stating that a prehearing ruling 
issued in an administrative enforcement action ``shall control the 
subsequent course of the hearing unless modified by a subsequent 
ruling'')).
    *\R\ Respondent disagrees with the Chief ALJ's determination 
that it did not provide good cause for the late filing. Resp 
Exceptions, at 8. Respondent argues that ``[t]here was good cause 
provided with the background setting of the pandemic that had caused 
the case to stay on hold for nearly a year,'' and ``[c]ounsel stated 
that there was no prejudice to the Government and that the pandemic 
and his recent notice of appearance in the case were the basis of 
the untimely Prehearing Statement.'' Id. However, the Chief ALJ was 
aware of the pandemic's impact on the litigation when he decided to 
exclude Respondent's Second SPS, and he determined that Respondent 
had not provided good cause. Order Denying Respondent's Motion, at 
2-3.
---------------------------------------------------------------------------

    I also find that there was no prejudice to the Respondent from the 
Chief ALJ's denial of its Second SPS. The Second SPS did not notice any 
new witnesses or testimony; it simply noticed Respondent's intention to 
amend ten of Respondent's previously-disclosed exhibits. Respondent 
stated that the amended exhibits contained additional ``[drug 
utilization review] data.'' See Second SPS, at 2. Although the Chief 
ALJ did not permit Respondent to amend these exhibits before the 
hearing, he allowed Respondent to attempt to authenticate the amended 
exhibits at the hearing ``to afford the Respondent the maximum level of 
due process.'' RD, at n. 106 (citing Tr. 642-60). Thus, the Chief ALJ 
essentially reversed his decision to deny the Second SPS by permitting 
the Respondent to offer the amended exhibits into evidence.
    In the RD, the Chief ALJ referred to the amended exhibits as the 
outside-of-record (OOR) documents. See RD, at n. 106. Respondent 
attempted to admit one of the OOR documents at the hearing, but the 
Chief ALJ declined to admit it because there were ``fundamental issues 
regarding inadequate foundation and reliability.'' Id. Respondent did 
not offer the remaining OOR documents into the record after the first 
document was denied. Id. However, Respondent's counsel repeatedly 
refreshed Dr. Howard's recollection with the OOR documents, which gave 
Dr. Howard the opportunity to testify about any notations in the OOR 
documents that evidenced attempts by Respondent to conduct a drug 
utilization review. See supra Respondent's Case, Summary of Dr. 
Howard's Testimony.*\S\ I find that Respondent was given ample 
opportunity at the hearing to provide the tribunal with all reliable 
evidence of its attempts to exercise due diligence efforts.
---------------------------------------------------------------------------

    *\S\ As the RD observes, Respondent could have sought to 
introduce the OOR documents into the record as past recollection 
recorded, but declined to do so. See RD, at 107 (citing Fed. R. 
Evid. 803(5)).
---------------------------------------------------------------------------

    Respondent further argues that the Chief ALJ's decision to exclude 
the Second SPS was arbitrary in light of his decision to take official 
notice of an FDA black box warning that cautions against concurrent 
prescribing of opioids and benzodiazepines, which was not identified in 
the Government's prehearing filings. Resp Exceptions, at 8-9. However, 
on this issue, Respondent's counsel did not object to the official 
notice and agreed that there was no serious notice issue. See ALJ Ex. 
39. I defer to the Chief ALJ's decision to take official notice of this 
document, which was an exercise of his authority to regulate the 
hearing. As stated above, courts have uniformly held that judicial 
rulings issued during the course of litigation rarely constitute 
evidence of cognizable bias. Order Denying the Respondent's Recusal 
Motions (citing Liteky v. United States, 510 U.S. 540, 555 (1994), Hamm 
v. Members of Bd. of Regents, 708 F.2d 647, 651 (11th Cir. 1983), Dewey 
C. Mackay, M.D., 75 FR 49,956, 49,958-59 (2010)). Further, the contents 
of this document should not have been a surprise to Respondent, because 
this document is publicly available and widely known, and the 
Government had notified Respondent that its expert would testify about 
the dangers of prescribing opioids and benzodiazepines concurrently. 
See e.g., ALJ Ex. 4 (Gov't Prehearing), at 20-21; see also OSC/ISO, at 
3.

Exception E

    Finally, Respondent argues that the Chief ALJ erred in finding that 
Dr. Howard's hearing testimony suffered from diminished credibility. 
Resp Exceptions, at 9-11. In support of this argument, Respondent cites 
to only one page of the transcript, where the Chief ALJ faulted Dr. 
Howard for failing to remember testimony from the day before. Resp 
Exceptions, at 9 (citing Tr. 53). Respondent's Exception fails because 
it does not ``include a statement of supporting reasons for such 
exceptions, together with evidence of record (including specific and 
complete citations of the pages of the transcript and exhibits) and 
citations of the authorities relied upon.'' 21 CFR 1316.66. 
Respondent's Exception also

[[Page 2936]]

fails because, after reviewing the entire record, I find that the Chief 
ALJ thoroughly and accurately analyzed Dr. Howard's credibility and his 
testimony, and I agree with his credibility findings.
    I therefore reject Respondent's Exceptions and issue the following 
Order.

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. FA2125640 issued to AARRIC, Inc. 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 AARRIC, Inc. for additional registration in 
Florida. Pursuant to the authority vested in me by 21 U.S.C. 824(f), as 
well as 28 CFR 0.100(b), I further order that any controlled substances 
seized pursuant to the Order of Immediate Suspension of Registration 
are forfeited to the United States. This Order is effective February 
18, 2022.

Anne Milgram,
Administrator.
[FR Doc. 2022-00955 Filed 1-18-22; 8:45 am]
BILLING CODE 4410-09-P