Pharmacy 4 Less; Decision and Order, 54550-54585 [2021-21429]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54550-54585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21429]



[[Page 54549]]

Vol. 86

Friday,

No. 188

October 1, 2021

Part III





Department of Justice





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Drug Enforcement Administration





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Pharmacy 4 Less; Decision and Order; Notice

Federal Register / Vol. 86 , No. 188 / Friday, October 1, 2021 / 
Notices

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 18-41]


Pharmacy 4 Less; Decision and Order

    On July 5, 2018, a former Assistant Administrator of the Drug 
Enforcement Administration (hereinafter, DEA or Government), issued an 
Order to Show Cause (hereinafter, OSC) to Pharmacy 4 Less, 
(hereinafter, Respondent) of Altamonte Springs, Florida. Administrative 
Law Judge Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at 1. The OSC 
proposed to revoke its DEA Certificate of Registration (hereinafter, 
COR) No. FP5459082, and deny any pending applications for renewal or 
modification of such registration pursuant to 21 U.S.C. 823(f) and 
824(a)(4) for the reason that Respondent's ``continued registration is 
inconsistent with the public interest.'' Id.
    In response to the OSC, Respondent timely requested a hearing 
before an Administrative Law Judge. ALJ Ex. 2. The hearing in this 
matter was held in Orlando, Florida, on November 5-7, 2018, and 
continued in Arlington, Virginia, on February 25, 2019. On May 22, 
2019, Administrative Law Judge Mark M. Dowd (hereinafter, the ALJ) 
issued the Recommended Rulings, Findings of Fact, Conclusions of Law 
and Decision (hereinafter, Recommended Decision or RD), and on June 11, 
2019, the Government timely filed exceptions (hereinafter, Govt 
Exceptions) to the Recommended Decision. On June 23, 2019, the 
Respondent filed what it styled as a response to the Government's 
Exceptions (hereinafter, Resp Exceptions).\*A\ According to the ALJ, 
the Respondent Pharmacy did not request an extension of time to file 
exceptions, nor did it request an extension of time to file a response 
to the Government's Exceptions pursuant to 21 CFR 1316.66(c). See ALJ 
Transmittal Letter dated June 25, 2019. Even though Respondent did none 
of those things, I have decided to address the Exceptions filed by 
Respondent as part of my review of the record.\*B\ Having reviewed the 
entire record, I find the Respondent's Exceptions are without merit and 
I adopt the ALJ's rulings, findings of fact, as modified, conclusions 
of law and recommended sanction with minor modifications, where noted 
herein.\*C\
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    \*A\ Despite the title, Respondent's filing appears to assert 
its own Exceptions to the RD rather than respond to the Government's 
Exceptions.
    \*B\ My decision to consider the Respondent's Exceptions is 
based on the particular circumstances of this case, including but 
not limited to, the withdrawal of Respondent's counsel after the 
conclusion of the hearing.
    \*C\ I have made minor modifications to the RD. I have 
substituted initials or titles for the names of witnesses and 
patients to protect their privacy, I have corrected an occasional 
citation, and I have made minor, non-substantive, grammatical 
changes. Where I have made substantive changes, omitted language for 
brevity or relevance, or where I have added to or modified the ALJ's 
opinion, I have noted the edits with an asterisk, and I have 
included specific descriptions of the modifications in brackets 
following the asterisk or in footnotes marked with an asterisk and a 
letter.
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Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. 
FP5459082 issued to Pharmacy 4 Less. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby 
deny the pending application for renewal or modification of this 
registration by Pharmacy 4 Less in Florida. This Order is effective 
November 1, 2021.

Anne Milgram,
Administrator.

The Government's Exceptions

    The Government, though in agreement with much of the ALJ's opinion, 
filed exceptions to the RD on June 11, 2019. The Government described 
its primary concern as being delay caused by the ALJ's conditional 
admission of documents and proffer testimony, and asked that I 
``specify the manner in which the ALJ is to balance the risk of delay 
with the risk of being reversed, and to, where appropriate, allow only 
limited proffers.'' Govt Exceptions, at 3. The presiding ALJ has the 
``duty to conduct a fair hearing, to take all necessary action to avoid 
delay, and to maintain order'' and has the power to ``[r]eceive, rule 
on, exclude, or limit evidence.'' 21 CFR 1316.52 and (f). In other 
words, he possesses discretion to ``regulate the course of the 
hearing.'' 5 U.S.C. 556(c)(5) (West 2021). As such, I decline to 
broadly instruct ALJs in the manner requested by the Government.
    Next, the Government alleged that the ALJ erroneously admitted 
Respondent Exhibits 18-37, which consisted of due diligence files for 
the patients at issue in this case which had been updated by Respondent 
after the dates relevant to this case (and after a Government subpoena 
for these same records). Govt Exceptions, at 3-6. The Government 
conceded that the records could have been relevant to establish 
remedial measures taken by Respondent Pharmacy, but argues that they 
would have been relevant only if Respondent Pharmacy first accepted 
responsibility for its actions. Id. The Government alleges that the 
ALJ's admission of RX 18-37, even conditionally, was improper without 
Respondent first establishing responsibility or proffering that 
acceptance of responsibility was forthcoming. As I have already 
discussed, I decline to instruct the ALJs on how to balance the risk of 
delay against the need to receive evidence as it lies within their 
discretion, because every case will be different. Here, the ALJ 
ultimately found that the Respondent Pharmacy did not accept 
responsibility for its actions, but it would have been difficult for 
the ALJ to have reached that conclusion at the beginning of the 
evidentiary hearing.
    The remainder of the Government's exceptions are addressed in the 
relevant sections of the RD as footnoted below.

The Respondent's Exceptions

    On June 23, 2019, the Respondent filed its exceptions to the 
Recommended Decision. Exceptions ``shall 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, the Respondent's Exceptions 
not only fail to comply with this regulatory requirement, but also lack 
evidentiary support in the Administrative Record. Some of Respondent's 
Exceptions \*D\ repeat facts which were already raised at the hearing 
in this matter and addressed by the ALJ in the adopted Recommended 
Decision herein.
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    \*D\ Respondent's Exceptions ] 1 asserting that starting doses 
for opioid patients were not high and that the Pharmacy had detailed 
medical records; ] 7 regarding the initial inventory; ] 8 asserting 
the accuracy of the perpetual inventory; ] 12 claiming the opioid 
naivety red flag was resolved by checking e-FORCSE. Respondent's 
Exceptions, at 2-3.
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    Most of Respondent's Exceptions introduce evidentiary facts that 
Respondent Pharmacy appears to be offering to establish remedial 
measures.\*E\ Many of these facts are not

[[Page 54551]]

supported by the record and were not under oath or subject to cross 
examination when they were presented for the first time in Respondent's 
Exceptions. Moreover, where a registrant has not accepted 
responsibility it is not necessary to consider evidence of the 
registrant's remedial measures. Jones Total Health Care Pharmacy, 
L.L.C. & SND Health Care, L.L.C., 81 FR 79188, 79202-03 (2016).'' As 
Respondent Pharmacy has failed to unequivocally accept responsibility 
for its actions, the purported remedial measures offered by Respondent 
in its Exceptions, even if they were part of the evidentiary record, 
would have no impact on my decision in this case.
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    \*E\ Respondent's Exceptions ] 4 asserting that the pharmacy can 
now bill insurance companies and that 80% of the Schedule II 
controlled substances prescriptions it fills are through insurance 
now; ] 5 asserting the pharmacy now fills only 10% of the Schedule 
II controlled substances prescriptions it was filling in 2015 and 
2016, admitting they filled too many Schedule II prescriptions in 
the past and claiming they are not ``extremely due diligent in 
filling;'' ] 6 asserting that the pharmacy does not fill 
prescriptions from a neighboring pain doctor who will not share 
medical records; ] 7 asserting that Respondent Pharmacy passed every 
Department of Health inspection from 2015 to 2019; ] 9 asserting 
that Patient A.R. has been discharged; ] 11 asserting that Patient 
A.V. was successfully taken off of opioids. Resp Exceptions, at 2-3.
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    Similarly, the Respondent's Exceptions contained a number of 
factual assertions regarding Owner Richard Sprys' purported work with 
law enforcement bodies to report illegal pharmacy operations and 
provide testimony, seemingly for the DEA in one instance, to hold those 
pharmacies accountable. Id. at 3. None of these facts were given under 
oath and none were subject to cross-examination; therefore, they are 
simply not part of the evidentiary record. Even if Respondent's 
assertions had been appropriately submitted through testimonial 
evidence, they could only have been relevant in assessing whether 
Respondent Pharmacy could be entrusted with a registration. Here, as 
Respondent Pharmacy has failed to unequivocally accept responsibility 
for its actions, such assertions would have had no impact on my 
decision.
    The remainder of the Respondent's Exceptions are addressed in their 
relevant sections of the Recommended Decision as footnoted below.
    The decision below is based on my consideration of the entire 
administrative record, including all of the testimony, admitted 
exhibits, and the oral and written arguments of both parties. I adopt 
the ALJ's Recommended Decision with noted modifications.

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

    The Assistant Administrator, Drug Enforcement Administration (DEA), 
issued an Order to Show Cause,\1\ dated July 5, 2018, seeking to deny 
the Respondent's Certificate of Registration, number FP5459082, on the 
ground that the Respondent's registration would be inconsistent with 
the public interest, pursuant to 21 U.S.C. 824(a)(4), and as defined in 
21 U.S.C. 823(f). The Respondent requested a hearing on August 2, 
2018,\2\ and prehearing proceedings were initiated.\3\ A hearing was 
conducted in this matter on November 5-7, 2018, in Orlando, Florida, 
and resumed on February 25, 2019, at the DEA Hearing Facility in 
Arlington, Virginia.
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    \1\ ALJ Ex. 1.
    \2\ ALJ Ex. 2.
    \3\ ALJ Ex. 3.
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    The issue ultimately to be adjudicated by the Administrator,\*F\ 
with the assistance of this Recommended Decision, is whether the record 
as a whole establishes by a preponderance of the evidence that the 
Respondent's subject registration with the DEA should be revoked 
pursuant to 21 U.S.C. 824(a)(4).
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    \*F\ All references to ``Acting Administrator'' have been 
changed to ``Administrator.''
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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

    In the OSC, the Government contends that the DEA should revoke the 
Respondent's DEA COR because it failed to comply with 21 U.S.C. 
824(a)(4) and its registration is inconsistent with the public 
interest, see 21 U.S.C. 823(f). Specifically, the Government alleges 
the following:
    1. The Respondent failed to ensure that it only filled 
prescriptions issued for legitimate medical purposes and repeatedly 
filled prescriptions in the face of obvious red flags of diversion, in 
violation of both federal and state law (including 21 CFR 1306.06, 
1306.04(a); Wheatland Pharmacy, 78 FR 69411, 69445 (2013); Fla. Admin. 
Code r. 64B16-27.810, 64B16-27.831 \4\), specifically from at least 
October 27, 2015 to at least June 19, 2017, to at least ten different 
patients. ALJ Ex. 1 at ]] 2-4.
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    \4\ It was noted that there was a scrivener's error by the 
Government citing to r. 64B16-27.821. The Government later corrected 
the cite to reflect the correct citation to r. 64B16-27.831.
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    2. The Respondent routinely filled Schedule II controlled 
substances without resolving the ``red flag'' of patients with ``very 
high starting dosages,'' both with respect to the individual dose being 
prescribed and with respect to the number of tablets being prescribed, 
which is potentially fatal for a patient. ALJ Ex. 1 at ] 5.
    3. The Respondent routinely filled controlled substance 
prescriptions without resolving the ``red flag'' of immediate release 
pain medication over long periods of time. A chronic pain patient 
should be moved to a long acting medication. ALJ Ex. 1 at ] 6.
    4. The Respondent routinely filled controlled substance 
prescriptions without resolving the ``red flag'' of extremely high cash 
prices. ALJ Ex. 1 at ] 7.
    5. The Respondent routinely filled prescriptions without resolving 
the ``red flag'' for patients who traveled long distances to visit the 
Respondent's pharmacy. ALJ Ex. 1 at ] 8.
    6. The Respondent would fill prescriptions without resolving the 
``red flag'' for drug combinations that needed to be questioned, such 
as the combination of buprenorphine and oxycodone. ALJ Ex. 1 at ] 9.

Treatment of Patients

Patient A.E.
    From November 19, 2015, to at least June 1, 2017, the Respondent 
filled at least 21 prescriptions for hydromorphone for A.E. outside the 
usual course of professional practice, in violation of 21 CFR 1306.06, 
and in violation of its corresponding responsibility under 21 CFR 
1306.04(a). Specifically:
    a. A.E.'s prescriptions were for 84 tablets of hydromorphone 8 mg, 
which is a large amount of tablets at the highest dosage strength.
    b. A.E. filled his prescriptions for short acting hydromorphone 
since at least November 19, 2015, even though hydromorphone is not 
prescribed for long-term use or chronic conditions.
    c. A.E. paid cash for his prescriptions at inflated prices, paying 
$500.00 for 84 tablets of hydromorphone 8 mg, approximately $5.95 per 
pill, at a time when legitimate pharmacies were charging approximately 
$1.50.
Patient A.R.
    From March 17, 2016, to at least June 7, 2017, the Respondent 
filled at least 17 prescriptions for oxycodone for A.R. outside the 
usual course of professional practice, in violation of 21 CFR 1306.06, 
and in violation of its corresponding responsibility under 21 CFR 
1306.04(a). Specifically:
    a. A.R. filled his prescriptions for immediate release oxycodone 
since at least March 17, 2016, even though oxycodone is not prescribed 
for long-term use or chronic conditions.
    b. A.R. drove extremely long distances to fill oxycodone 
prescriptions. A.R. drove approximately 37 miles southwest to visit the 
prescribing doctor, an additional 17.9 miles further southwest

[[Page 54552]]

to the Respondent's pharmacy, an additional 45.4 miles to A.R.'s home, 
for a total of 97.3 miles round-trip to fill the oxycodone 
prescriptions.
Patient A.V.
    From April 12, 2016, to at least April 10, 2017, the Respondent 
filled at least 9 prescriptions for buprenorphine and at least 12 
prescriptions for oxycodone for A.V. outside the usual course of 
professional practice, in violation of 21 CFR 1306.06, and in violation 
of its corresponding responsibility under 21 CFR 1306.04(a). 
Specifically:
    a. A.V.'s prescriptions were for 112 tablets of oxycodone 20 mg and 
60 tablets buprenorphine 8 mg, which are large amounts of tablets at a 
high dosage strength.
    b. A.V. was filling prescriptions for opioid withdrawal at the same 
time he was filling a prescription for an opioid.
    c. A.V. filled his prescriptions for short acting oxycodone since 
at least April 12, 2016, even though oxycodone was not prescribed for 
long-term use or chronic conditions.
Patient B.F.
    From October 27, 2015, to at least May 15, 2017, the Respondent 
filled at least 17 prescriptions for hydromorphone and at least 5 
prescriptions for oxycodone for B.F. outside the usual course of 
professional practice, in violation of 21 CFR 1306.06, and in violation 
of its corresponding responsibility under 21 CFR 1306.04(a). 
Specifically:
    a. B.F.'s prescriptions were for 84 tablets of hydromorphone 8 mg, 
which is a large amount of tablets at the highest dosage strength.
    b. B.F. filled his prescriptions for short acting hydromorphone 
since at least October 27, 2015, even though hydromorphone is not 
prescribed for long-term use or chronic conditions.
    c. B.F. paid cash for his prescriptions at inflated prices, paying 
$490.00 for 84 tablets of hydromorphone 8 mg, approximately $5.93 per 
pill, at a time when legitimate pharmacies were charging approximately 
$1.50.
Patient B.N.
    From January 22, 2016, to at least June 2, 2017, the Respondent 
filled at least 9 prescriptions for hydromorphone and at least 10 
prescriptions for oxycodone for B.N. outside the usual course of 
professional practice, in violation of 21 CFR 1306.06, and in violation 
of its corresponding responsibility under 21 CFR 1306.04(a). 
Specifically:
    a. B.N.'s prescriptions were for 100 tablets of hydromorphone 8 mg, 
which is a large amount of tablets at the highest dosage strength. In 
September 2016, B.N. switched to 120 tablets of oxycodone 30 mg, which 
is an even higher number of tablets at the highest dosage strength of 
oxycodone.
    b. B.N. filled his prescriptions for immediate release oxycodone 
and hydromorphone since at least January 22, 2016, even though 
oxycodone and hydromorphone are not prescribed for long-term use or 
chronic conditions.
    c. B.N. paid cash for his prescriptions at inflated prices, paying 
up to $640.00 for 100 tablets of hydromorphone 8 mg, approximately 
$6.40 per pill, at a time when legitimate pharmacies were charging 
approximately $1.50. Similarly, B.N. paid prices up to $650.00 for 120 
tablets of oxycodone 30 mg, approximately $5.51 per pill, at a time 
when legitimate pharmacies were charging approximately $0.90 per 
tablet.
Patient K.Y.D.\5\
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    \5\ There are two patients with the same initials, K.D. In 
pretrial filings, the Government and Respondent referred to these 
patients as K.D.1 and K.D.2. However, the Government and Respondent 
referred to different patients as K.D.1 and K.D.2 (i.e., the 
Government's K.D.1 was Respondent's K.D.2). At the hearing, the 
parties discussed this issue and decided to refer to these two 
patients by the first two letters in their first name. All of the 
Government's pre-trial filings referring to K.D.1 are now discussed 
as K.Y.D. All of the Government's pre-trial findings referring to 
K.D.2 are now discussed as K.E.D. The opposite is true for the 
Respondent.
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    From February 4, 2016, to at least June 12, 2017, the Respondent 
filled at least 17 prescriptions for oxycodone and at least 17 
prescriptions for morphine sulfate for K.Y.D. outside the usual course 
of professional practice, in violation of 21 CFR 1306.06, and in 
violation of its corresponding responsibility under 21 CFR 1306.04(a). 
Specifically:
    a. K.Y.D.'s prescriptions for hydromorphone were for 84 tablets of 
oxycodone 30 mg, which is a large amount of tablets at the highest 
dosage strength.
    b. K.Y.D. paid cash for his prescriptions at inflated prices, 
paying up to $290.00 for 84 tablets of oxycodone 30 mg, approximately 
$3.45 per tablet, at a time when legitimate pharmacies were charging 
approximately $0.90 per tablet.
Patient K.E.D.
    From October 26, 2015, to at least June 7, 2017, the Respondent 
filled at least 20 prescriptions for oxycodone for K.E.D. outside the 
usual course of professional practice, in violation of 21 CFR 1306.06, 
and in violation of its corresponding responsibility under 21 CFR 
1306.04(a). Specifically:
    a. K.E.D.'s prescriptions for oxycodone were for 112 tablets of 
oxycodone 20 mg, which is a large amount of tablets at a high dosage 
strength.
    b. K.E.D. filled his prescriptions for immediate release oxycodone 
since at least October 26, 2015, even though oxycodone is not 
prescribed for long-term use or chronic conditions.
    c. K.E.D. paid cash for his prescriptions at inflated prices, 
paying up to $430.00 for 112 tablets of oxycodone, approximately $3.83 
per tablet, at a time when legitimate pharmacies were charging 
approximately $0.90 per tablet.
Patient R.R.
    From October 28, 2015, to at least May 30, 2017, the Respondent 
filled at least 21 prescriptions for oxycodone for R.R. outside the 
usual course of professional practice, in violation of 21 CFR 1306.06, 
and in violation of its corresponding responsibility under 21 CFR 
1306.04(a). Specifically:
    a. R.R.'s prescriptions for oxycodone were for 112 tablets of 
oxycodone 15 mg, which is a large amount of tablets at a high dosage 
strength.
    b. R.R. filled his prescriptions for immediate release oxycodone 
since at least October 28, 2015, even though oxycodone is not 
prescribed for long-term use or chronic conditions.
Patient R.V.
    From November 17, 2015, to at least June 19, 2017, the Respondent 
filled at least 21 prescriptions for oxycodone for R.V. outside the 
usual course of professional practice, in violation of 21 CFR 1306.06, 
and in violation of its corresponding responsibility under 21 CFR 
1306.04(a). Specifically:
    a. R.V.'s prescriptions for oxycodone were for 112 to 120 tablets 
of oxycodone 20 mg, which is a large amount of tablets at a high dosage 
strength.
    b. R.V. filled her prescriptions for immediate release oxycodone 
since at least November 17, 2015, even though oxycodone is not 
prescribed for long-term use or chronic conditions.
Patient V.W.
    From November 30, 2015, to at least May 31, 2017, the Respondent 
filled at least 20 prescriptions for oxycodone for V.W. outside the 
usual course of professional practice, in violation of 21 CFR 1306.06, 
and in violation of its corresponding responsibility under 21 CFR 
1306.04(a). Specifically:
    a. V.W.'s prescriptions for oxycodone were for 84 to 112 tablets of 
oxycodone 15 mg, which is a large amount of tablets at a high dosage 
strength.

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    b. V.W. filled his prescriptions for immediate release oxycodone 
since at least November 30, 2015, even though oxycodone is not 
prescribed for long-term use or chronic conditions.
    c. V.W. paid cash for his prescriptions at inflated prices, paying 
up to $400.00 for 112 tablets of oxycodone, approximately $3.57 per 
tablet, at a time when legitimate pharmacies were charging 
approximately $0.90 per tablet.

Recordkeeping Violations

    1. The Respondent did not have an initial inventory, when requested 
by DEA during an on-site inspection of June 6, 2017, in violation of 21 
CFR 1304.11(b).
    2. The Respondent's biennial inventory failed to indicate whether 
it was taken at the opening or closing of business as required by 21 
CFR 1304.11(a).
    3. The Respondent's pharmacist on duty, Amy Mincy, stated that the 
biennial inventory was performed over several days, in violation of 21 
CFR 1304.11(a).
    4. The Respondent's pharmacist on duty during the June 6, 2017 on-
site inspection admitted to using the pharmacy owner's, Mr. Richard 
Sprys, CSOS credentials to order controlled substances in violation of 
21 CFR 1311.30(a) & (c).
    5. The Respondent's receiving records showed that the Respondent 
failed to create an electronically linked record of a quantity and date 
received for its controlled substances in violation of 21 CFR 
1305.22(g). The Respondent also possessed 89 invoices without the date 
of receipt recorded in violation of 21 CFR 1304.22(c).

The Hearing

Preliminary Matters

    At the outset of the hearing, the Government confirmed that it was 
not going forward with pursuing any independent violation against the 
Respondent for a delay by the Respondent in complying with the July 
2018 administrative subpoena. Tr. 14-15.\6\ This Tribunal also noticed 
the Government that if it intended to assert a new allegation or expand 
the charges, it must inform this Tribunal at the time the new matter is 
broached at the hearing. Id. at 15-16. This would also give the 
Respondent the opportunity to either litigate the issue by consent or 
to object to the new allegation. Id. at 15-16. No supplemental 
allegations were broached by the Government.
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    \6\ Tr.--Refers to the hearing transcript. The number(s) 
immediately following refer to the transcript page numbers.
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    The Respondent noted that they would be withdrawing their motion to 
suppress evidence, a motion that this tribunal had only preliminarily 
ruled upon. Id. at 17; ALJ Ex. 35. This Tribunal noted that the 
preliminary evidentiary rulings were for guidance and that the parties 
would still need to make their objections at the time of the hearing to 
preserve those objections. Tr. 17. The Respondent further requested 
that this Tribunal take official notice of 21 CFR 1304.21(a) and 21 
U.S.C. 827(a)(3), to which this Tribunal acceded. Id. at 17-18. Next, 
the Respondent made preliminary objections as to authentication, 
failure to meet the business records exception, and improper burden 
shifting as to Government's Proposed Exhibits 9, 11, and 13. Id. at 18-
19. This Tribunal carried those objections over to the hearing. Id. at 
19. Then, the Respondent clarified that Government's Proposed Exhibit 
25 had been ruled inadmissible and excluded.\7\ Id. at 20. The 
Respondent then discussed a number of other matters related to proposed 
exhibits, which will be later discussed. Id. at 20-22. Finally, the 
Respondent objected to Government's Proposed Exhibit 26, which 
objection was also carried to the hearing. Id. at 23.
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    \7\ GX 25 consisted of over 1000 pages of an Excel spreadsheet 
involving records of patients additional to the ten patients who are 
the subject of the allegations. GX 25 was ruled inadmissible as 
generally irrelevant. The Government was permitted to reconstitute 
the exhibit reflecting only the ten subject patients. The 
Government's substitute exhibit was introduced as GX 35.
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Government's Opening Statement

    In the Government's Opening Statement, it previewed that the DEA 
conducted an audit of Pharmacy 4 Less on June 6, 2017. Id. at 25. The 
Government intended to explain the on-site audit through the testimony 
of DI1, including the findings from the audit, and explain the record 
keeping and regulatory violations that were discovered. Id. at 25. The 
Government also intended to offer the testimony of Dr. Hamilton 
regarding his review of the prescriptions and due diligence files that 
Pharmacy 4 Less maintained and how the Respondent filled prescriptions 
for controlled substances without resolving red flags. Id. at 25. 
Finally, the Government argued that the Respondent had not accepted 
responsibility for any of the alleged violations. Id. at 25-26.

Respondent's Opening Statement

    In the Respondent's Opening Statement, it described Pharmacy 4 Less 
as a small, independent pharmacy. Id. at 27. Pharmacy 4 Less has two 
pharmacists and a low volume of patients. Id. at 27. The Respondent 
contrasted it from Publix, the pharmacy where Dr. Hamilton is employed. 
Id. at 27-28. The Respondent stated that Pharmacy 4 Less cannot 
purchase in volume like other retail pharmacies, and cannot sell at the 
same prices as other larger pharmacies. Id. at 28.
    The Respondent described Mr. Richard Sprys, the owner and operator 
of Pharmacy 4 Less. Id. at 28. The Respondent detailed Mr. Sprys' 
community involvement in his capacity as a pharmacist, and how he has 
previously testified as a witness in several cases for the Government 
in whistleblower cases against pharmacies. Id. at 28. The Respondent 
further asserted that Mr. Sprys has always attempted to cooperate with 
the Government, including the process involving the July 9, 2018 
administrative subpoena. Id. at 28-29. The Respondent also described 
Ms. Amy Mincy, another pharmacist that works at Pharmacy 4 Less, 
including her extensive background and experience as a pharmacist. Id. 
at 30.
    The Respondent described the June 6, 2017 on-site inspection of 
Pharmacy 4 Less. Id. at 29. The Respondent asserted that the DEA 
diversion investigators related to Ms. Mincy, the pharmacist on-site at 
the time of the inspection, that the inspection would only last ten to 
fifteen minutes when the inspection actually lasted over six hours. Id. 
at 29.
    The Respondent asserted that the Government's portrayal that the 
Respondent has not accepted responsibility is misplaced. Id. at 30. The 
Respondent stated that they submitted a corrective action plan (which 
the DEA rejected), they have modified their behavior, they have reduced 
the number of patients they see and fill prescriptions for, and they 
have implemented a number of other remedial changes. Id. at 30.
    The Respondent further described the treatment of patients when 
they visit Pharmacy 4 Less. Id. at 30-32. The Respondent asserted that 
each patient receives specialized attention by the pharmacists because 
of Pharmacy 4 Less's small size. Id. at 31. The Respondent also stated 
that not only does Pharmacy 4 Less contact patients' doctors to resolve 
red flags, but Pharmacy 4 Less goes beyond that of other pharmacies 
because they will request and keep medical records of their patients to 
assist in the resolution of red flags. Id. at 31-32.
    Finally, the Respondent stressed that while Pharmacy 4 Less may not 
be

[[Page 54554]]

perfect, they keep their practice above-average. Id. at 32. The 
Respondent maintains that before and after the DEA on-site inspection, 
Pharmacy 4 Less has a clean record with the Florida Department of 
Health for their on-site inspections. Id. at 32.

Government's Case in Chief

    The Government presented its case in chief through the testimony of 
two witnesses. First, the Government presented the testimony of a 
Diversion Investigator (hereinafter DI1). Secondly, the Government 
presented the testimony of its expert, Dr. Thomas D. Hamilton.

Diversion Investigator DI1

    DI1 has been a Diversion Investigator for approximately seven 
years. Id. at 33. He is currently assigned to the Orlando District 
Office, in Orlando, Florida. Id. at 33. DI1 described his training and 
experience at the DEA Academy and in the field at the Baltimore and 
Orlando offices, including experience in at least 50-70 pharmacy 
investigations. Id. at 34-35.
    DI1 first met with the staff at Pharmacy 4 Less on June 6, 2017. 
Id. at 37. He explained that Diversion Investigators \8\ were doing 
regulatory inspections and Pharmacy 4 Less was randomly picked for a 
regulatory inspection. Id. at 37. When they arrived, the DIs showed 
their credentials and presented Ms. Amy Mincy, a pharmacist at Pharmacy 
4 Less, with a DEA Form 82 Notice of Inspection.\9\ Id. at 37-38; GX 
30.\10\ The form was signed by Ms. Mincy and the DIs began their on-
site inspection. Tr. 38-39.
---------------------------------------------------------------------------

    \8\ DI1 was accompanied by Group Supervisor DI2 during the on-
site inspection. Tr. 41.
    \9\ A Notice of Inspection is a DEA Form evidencing a voluntary 
consent to search.
    \10\ GX--Government's Exhibit.
---------------------------------------------------------------------------

    The DIs began by asking questions about Pharmacy 4 Less's customer 
base and prescriptions, and looked at the prescriptions records, log 
books, and other required records. Id. at 39. When DI1 asked Ms. Mincy 
about inventories, she could not locate the initial inventory; so Mr. 
Richard Sprys, the owner of Pharmacy 4 Less, was contacted via 
speakerphone by Ms. Mincy to determine where the initial inventory 
could be located. Id. at 39-40.\11\ DI1 asked Mr. Sprys over the phone 
if Pharmacy 4 Less had an initial inventory, and Mr. Sprys replied that 
it did not. Id. at 40.
---------------------------------------------------------------------------

    \11\ Richard Sprys was not present at Pharmacy 4 Less during the 
on-site inspection on June 6, 2017. Tr. 40.
---------------------------------------------------------------------------

    DI1 next inquired as to whether Pharmacy 4 Less had performed a 
biennial inventory. Id. at 40-41. Ms. Mincy provided DI1 with a 
document purported to be a biennial inventory. Id. at 41. DI1 concluded 
that the document did not comply with DEA regulations as the purported 
biennial inventory did not include a statement that it had been 
completed either at the opening or closing of business.\12\ Id. at 41-
42. Further, DI1 claimed that Ms. Mincy had indicated that she had 
completed it over several days. Id. at 41. DI1 indicated that biennial 
inventories need to be completed either at the opening or closing of 
business and it needs to be notated on the biennial inventory. Id. at 
41-42. DI1 claimed that during this exchange, Ms. Mincy said, ``what 
was [I] supposed to do, shut down the pharmacy? '' Id. at 42. As part 
of his later audit of the pharmacy's inventories, DI1 did not use the 
biennial inventory because he could not verify its accuracy due to the 
issues he had discovered during his review. Id. at 56, 61, 66, 154-56.
---------------------------------------------------------------------------

    \12\ See 21 CFR 1304.11(a).
---------------------------------------------------------------------------

    DI1 then inquired of Ms. Mincy as to recordkeeping and CSOS 
records.\13\ Id. at 42. DI1 asked Ms. Mincy how Pharmacy 4 Less 
documents and records their ordering of controlled substances and 
validation of a prescription's legitimacy. Id. at 43.\14\ When DI1 
asked Ms. Mincy to produce the CSOS records (including records of 
receipt for Schedule 2s), he observed that Ms. Mincy proceeded to a 
laptop in the pharmacy to log into the CSOS system. Id. at 45. DI1 
asked Ms. Mincy if she had her own CSOS credentials (which DI1 asserted 
is required for anyone accessing the CSOS system and cannot be shared 
with anyone else). Id. at 46. In response, Ms. Mincy stated she did not 
have her own credentials and did not have a power of attorney for 
anyone else's credentials. Id. at 46. Ms. Mincy stated to DI1 that she 
was using Mr. Richard Sprys credentials to log onto CSOS. Id. at 46.
---------------------------------------------------------------------------

    \13\ CSOS--Controlled Substance Ordering System.
    \14\ DI1 asserted during his testimony that when a pharmacy 
orders and receives controlled substances on-site, they are required 
to notate that they received them with the date and the initials of 
the person that received them. Tr. 44.
---------------------------------------------------------------------------

    DI1 later contacted Mr. Chris Jewell, one of the personnel in 
charge of the CSOS system at DEA Headquarters, to determine which 
personnel at Pharmacy 4 Less had access to the CSOS system. Id. at 47-
48. Mr. Jewell ran a report and the report stated that Ms. Mincy 
received her own CSOS credentials in July 2018. Id. at 48-49; GX 
29.\15\
---------------------------------------------------------------------------

    \15\ The Respondent objected to admission of GX 29 on the basis 
of lack of authentication and not meeting the exception of a 
business record. Tr. 49. DI1 made it clear that he did not 
personally produce this record, but requested it from Mr. Jewell. 
Id. at 49-50. This Tribunal noticed that it appears to be a 
government record and did not appear to have any indication of 
inaccuracy or unreliability. Id. at 50. The Respondent argued that 
portions of the document appeared to have inaccuracies as related to 
Mr. Sprys, but agreed that if the Government was only offering the 
document as related to Ms. Mincy, it would not object if the rest of 
the document was blackened out to only show Ms. Mincy's records. Id. 
at 50-52. The Government agreed that it was only offering the 
document for Ms. Mincy's records on the top line and would not 
object to blackening out Mr. Spry's records. Id. at 51-52. This 
Tribunal admitted GX 29 on that basis as altered and is only 
considering GX 29 for the top line as related to Ms. Mincy's 
records. Id. at 51-52.
---------------------------------------------------------------------------

    DI1 described the audit \16\ of Pharmacy 4 Less's records and 
inventories.\17\ Tr. 53-85, 919-26; GX 4, 31, 32.\18\ DI1 conducted an 
audit of Pharmacy 4 Less's records and inventories at a starting date 
of January 1, 2017. Tr. 55-56. DI1 selected this date because Pharmacy 
4 Less maintained handwritten Schedule 2 controlled substance logs, 
there was no initial inventory, and the investigating DIs were unsure 
of how accurate the biennial inventory was. Id. at 56, 61. For example, 
DI1 had used the pharmacy's handwritten perpetual inventory forms for 
Methadone 10 mg tablets and Oxycodone 30 mg tablets during the audit, 
which had been provided to DI1 by Ms. Mincy during the on-site 
inspection on June 6, 2017. Id. at 56-60; GX 31, 32.\19\
---------------------------------------------------------------------------

    \16\ The audit occurred both at the pharmacy and later during a 
review of Pharmacy 4 Less's records. Tr. 100.
    \17\ DI1 was later asked about his receipt and possession of 
records obtained from the pharmacy during the June 6, 2017 on-site 
inspection. Tr. 949-54; Proposed RX 10 (not offered into evidence) 
(The Government also had a standing objection to this line of 
questioning as outside the scope of redirect examination. Tr. 951.). 
Proposed RX 10 was a DEA-12, a receipt of items taken by the DIs 
after their inspection. Tr. 951. The DEA-12 forms indicated that the 
DEA had taken possession of six California folders containing C-2 
prescriptions, and 13 manila folders containing C-2 invoices. Tr. 
951-53.
    \18\ The Government initially offered GX 4 during the first 
portion of the hearing in Orlando, Florida. Tr. 67. The Respondent 
conducted voir dire and objected that it was unreliable. Tr. 68-81. 
This Tribunal initially admitted the exhibit. Tr. 81-85. However, 
this Tribunal reconsidered its ruling and found that GX 4 in its 
then present condition would not be helpful to the factfinder. Tr. 
146. This Tribunal then afforded the Government the opportunity to 
resubmit GX 4 at a later time. Tr. 146-48. During the portion of the 
hearing in Arlington, Virginia, the Government reintroduced a 
corrected version of GX 4. Tr. 925. The Respondent did not object 
and the corrected version of GX 4 was admitted. Tr. 925-26.
    \19\ For a full discussion of how DI1 conducted his audit, see 
Tr. 61-67.
---------------------------------------------------------------------------

    DI1 explained that under DEA regulations, records need to be 
readily retrievable and maintained at the pharmacy. Tr. 86. It does not 
satisfy the regulations that records may later be retrieved. Id. at 86. 
He discovered that

[[Page 54555]]

Pharmacy 4 Less did not have readily retrievable records available 
during the June 6, 2017 on-site inspection. Id. at 87.\20\
---------------------------------------------------------------------------

    \20\ DI1 explained that ``readily retrievable'' means that when 
DIs go into a pharmacy to perform an audit or to review a record, 
the pharmacy should be able to provide those records within a 
reasonable time. Tr. 87.
---------------------------------------------------------------------------

    Following the June 6, 2017 on-site inspection, DIs \21\ returned to 
Pharmacy 4 Less again on June 21, 2017. Id. at 88. Ms. Mincy was again 
at the pharmacy, and Mr. Richard Sprys joined them later that day. Id. 
at 88. DI1 stated that he discussed his findings from the initial on-
site inspection and audit (including the invoices and prescriptions) 
with Mr. Sprys and Ms. Mincy during this second visit. Id. at 88. 
During the discussion, DI1 asked Mr. Sprys and Ms. Mincy how they 
determined whether prescriptions were for a legitimate medical purpose, 
based on a review of the records the DIs had retrieved during the first 
on-site inspection. Id. at 89-90. The pharmacists (both Mr. Sprys and 
Ms. Mincy) responded that they checked E-FORCSE, the Florida 
prescription monitoring program website, and that they would verify 
prescriptions by contacting the doctor's office and/or requesting 
patient medical files. Id. at 90-91. When asked how this information is 
documented, one of the pharmacists (DI1 could not remember if it was 
Mr. Sprys or Ms. Mincy) provided a red folder that they maintained. Id. 
at 91-92. The red folder contained screenshots from the computer 
system, Rx30.\22\ Tr. 92. The red folder contained information related 
to multiple patients. Tr. 93, 119-31; GX 5, 7, 13, 17, 21, 23. DI1 did 
not find any ``due diligence files'' for Patients A.V., B.F., K.Y.D., 
or R.R. in the files provided to him by Pharmacy 4 Less. Tr. 131-36.
---------------------------------------------------------------------------

    \21\ DI1 noted that on this second visit, he was present, along 
with DI Debbie George, Group Supervisor Linda Stocum, and Division 
Program Manager of the State of Florida, Susan Langston. Tr. 88.
    \22\ Rx30 is a computer software that Pharmacy 4 Less used to 
maintain their inventory, the dispensing of controlled substances, 
and as DI1 testified, patient profile screens where the pharmacist 
can input notes about the patient, including information about the 
patient, treatment, injuries, and other diagnosis notes. Tr. 92-93. 
The Respondent identified this as the patient record maintenance 
form (PRM). Id. at 93.
---------------------------------------------------------------------------

    The following day on June 22, 2017, an administrative subpoena was 
served on Pharmacy 4 Less, requesting hard copy prescriptions for all 
Schedules 2-5 controlled substance prescriptions from October 2015 
through June 22, 2017, all controlled substance prescription data from 
Rx30, and all due diligence patient files. Tr. 93-94; GX 2. Pharmacy 4 
Less complied by delivering a gray tote container that contained 
``California'' folders filled with Schedule 2 hard copy prescriptions, 
a thumb drive containing all Rx30 data, and the red folder seen during 
the June 21 on-site inspection. Id. at 96. The Schedules 3-5 
prescriptions were delivered to the DIs by Pharmacy 4 Less at an 
unidentified later date. Id. at 97. The red folder contained 
screenshots from the Rx30 program. Id. at 96. The red folder also 
contained the pharmacists' notes on patients, referred to as ``due 
diligence files.'' Id. at 96-97. The ``California'' folders were 
organized by prescription number, which DI1 sorted through to locate 
prescriptions for the 10 charged patients at issue in this case. Tr. 
97-111; GX 6, 8, 10, 12, 14, 16, 18, 20, 22, 24.\23\ DI1 also discussed 
the Rx30 data retrieved from the thumb drive related to the 10 charged 
patients. Tr. 111-16; GX 35, 36.\24\
---------------------------------------------------------------------------

    \23\ These exhibits were admitted with the qualification that 
these exhibits only contained the Schedule 2 hard copy prescriptions 
for each of the 10 charged patients, not all of the prescriptions. 
Tr. 102-11. [The Government noted, that ``some of the prescriptions 
here are not Schedule 2s, but [the Government did] not litigat[e] 
those prescriptions,'' and they are therefore not relevant to the 
Government's prima facie case. Tr. 103.]
    \24\ GX 35 is a narrowed version of Government's Proposed 
Exhibit 25, which was previously ruled inadmissible during 
prehearing proceedings. GX 35 only included information related to 
the 10 charged patients. Tr. 116-18. See ALJ Ex. 32.
---------------------------------------------------------------------------

    Diversion Investigators (the DIs were not identified by DI1) 
returned to Pharmacy 4 Less during approximately February 2018. Tr. 
136. During this visit, DI1 acquired copies of invoices for controlled 
substances. Tr. 136. DI1 noted that a few of these invoices violated 
DEA regulations by failing to provide a date of receipt.\25 *G\ Tr. 
136-39.
---------------------------------------------------------------------------

    \25\ The Respondent conducted voir dire of DI1 on this point and 
argued that 21 CFR 1305 only applies to Schedule 2 controlled 
substances. Tr. 140-45. For further analysis, see infra section 
``Date of Receipt on Invoices.''
    \*G\ DI clarified his testimony to say that ``only a few of them 
actually contained the . . . date of receipt;'' specifically, there 
were only ``four that contain[ed] the actual date of receipt,'' and 
``eighty-five'' were not properly dated. Tr. 137-38.
---------------------------------------------------------------------------

    Another administrative subpoena was served on Pharmacy 4 Less on 
July 9, 2018. Tr. 95; GX 3.
    DI1 was recalled during the second portion of the hearing at the 
DEA Hearing Facility in Arlington, Virginia. DI1 credibly explained the 
purpose of the corrected GX 4, and how he arrived at his results during 
his audit of the pharmacy's records and inventories. Tr. 919-26. DI1 
also testified to GX 38--Redacted (Initial Response from Florida E-
FORCSE reflecting only the 10 charged patients) and GX 40 (A 
declaration by DI3 as to an administrative subpoena sent to the Florida 
E-FORCSE for user history), which was introduced at the second portion 
of the hearing. Tr. 929-36.\26\ DI3 was asked by DI1 to send an 
administrative subpoena to the Florida E-FORCSE program to request a 
user history report. Id. at 929-30. Based on a follow-up request by 
DI1, the Florida E-FORCSE personnel reviewed their system to see when 
Mr. Sprys and Ms. Mincy had accessed the Florida PDMP to look up 
patients. Tr. 931-32; GX 40, Att. C.
---------------------------------------------------------------------------

    \26\ GX 38--Redacted was admitted and substituted in place of 
the original GX 38. Tr. 934. GX 40, p. 1, Att. A, and Att. C. were 
also admitted into evidence. Tr. 935-36.
---------------------------------------------------------------------------

    DI1 also offered three arrest records for Patient K.Y.D. Tr. 937; 
GX 41-43. The arrest records were produced from ``arrest.org,'' a 
public website where members of the public can retrieve arrest 
information about individuals, which DI1 occasionally uses in the 
course of his employment. Id. at 938-39. DI1 indicated that this 
website is a tool that pharmacists or doctors can utilize to look up 
patients to see if they have ever been arrested for controlled 
substance violations. Id. at 940. According to the records, Patient 
K.Y.D. had previously been arrested on December 31, 2015, for 
possession of oxycodone with an intent to sell. Id. at 940; GX 43. 
Patient K.Y.D. had also previously been arrested on May 2, 2016, for 
operating with a suspended license, possession of Schedule 2 controlled 
substances, and possession of a Schedule 4 controlled substance. Tr. 
941; GX 41. Finally, Patient K.Y.D. had also previously been arrested 
on February 25, 2017, for possession of a Schedule 2 controlled 
substance and resisting an officer without violence. Tr. 941-42; GX 
42.\27\
---------------------------------------------------------------------------

    \27\ The Respondent objected and argued that the arrest records 
were unreliable and irrelevant to this matter. This Tribunal found 
that these records were available to the public, and not being 
offered for the truth of the matter of the arrests, but as a 
resource that an individual such as a doctor or pharmacist would be 
confronted with if they accessed this website. They were admitted 
over objection. Tr. 942-43. Reviewing such arrest websites is not 
required by the relevant standard of care, nor is it something that 
Dr. Hamilton or the other pharmacists did at Publix Pharmacies. Tr. 
1022-23.
---------------------------------------------------------------------------

Dr. Thomas Hamilton, Pharm. D.

    Dr. Hamilton received his Doctor of Pharmacy degree at Nova 
Southeastern University in Fort Lauderdale. Tr. 167. He has worked as a 
pharmacist for 18 years. Id. at 169; GX 27. After being licensed in 
1999, he worked for a short time at a small pharmacy before beginning 
full-time at Publix pharmacy as a pharmacist. Tr. 172. He served in

[[Page 54556]]

various capacities at Publix, including Pharmacist, Assistant Manager 
of the Pharmacy, and Pharmacy Manager. GX 27. He also served as a 
``fixer,'' or a temporary Pharmacy Manager, who would ``clean up'' 
pharmacies. Tr. 169. Dr. Hamilton later transitioned to a Pharmacy 
Supervisor, in which he oversaw up to 40-45 \*H\ pharmacies, in hiring, 
firing and daily operations. Tr. 170. Additionally, Dr. Hamilton 
evaluated stand-alone, independent pharmacies for purchase by Publix 
Supermarkets. Id. at 170. This evaluation included review of the drug 
invoices, the filled prescriptions, and the nature of the pharmacy's 
overall business. Id. at 170-71. In order to spend more time with his 
young family, Dr. Hamilton decreased his responsibilities with the 
company, gave up his supervisory role, and now serves as a Pharmacy 
Manager of a single pharmacy with Publix. Id. at 286-87.
---------------------------------------------------------------------------

    \*H\ Amended pursuant to Tr. 170.
---------------------------------------------------------------------------

    In connection with the investigation into Pharmacy 4 Less, Dr. 
Hamilton reviewed the materials sent to him by the Government, which 
included prescriptions (front and back), related patient medical notes, 
and patient addresses. Id. at 177, 380-81. Additionally, Dr. Hamilton 
reviewed prescription pricing via GoodRx. Id. at 177-78. Dr. Hamilton 
noticed ``red flags'' in connection with the reviewed prescriptions. 
Id. at 178. ``Red flags'' are concerns resulting from the review of the 
prescription. Id. at 178-79. These concerns can be resolved through 
some investigation by the pharmacist, such as speaking with the 
patient, reviewing the medical history, or checking with the 
prescriber. Id. at 179. Dr. Hamilton noted that the resolution of the 
``red flag'' had to be documented in the file as part of the Florida 
Standard of Care,\*I\ noting, ``[i]f it's not documented, there's no 
evidence that . . . it was resolved *[or a phone call was made, or an 
answer was given].'' Id. at 179-81, 306, 318, 337, 1006-11, 1016.\28\
---------------------------------------------------------------------------

    \*I\ Throughout the case, the Government's expert and all 
parties appear to have used the phrases ``standard of care'' and 
``corresponding responsibility'' and ``standard of pharmacy 
practice'' interchangeably. The testimony regarding the requirement 
to resolve red flags is clearly related to Respondent Pharmacy's 
corresponding responsibility under 21 CFR 1306.04. The 
interchangeable use of this terminology does not impact my ultimate 
finding that Respondent Pharmacy failed to resolve red flags in 
contravention of Respondent's corresponding responsibility under 21 
CFR 1306.04 and outside the usual course of professional practice in 
violation of 21 CFR 1306.06. For consistency purposes, I will use 
the language regarding standard of care to encompass the standard of 
pharmacy practice and corresponding responsibility herein.
    \28\ *[Omitted for clarity. The ALJ found that the Government 
did not allege a separate violation regarding the documentation of 
the resolution of red flags, but instead chose to consider such lack 
of documentation as an inference supporting a finding that the red 
flag was not resolved. In this case, I find that the Government's 
expert credibly testified that documenting the resolution of red 
flags was required by the standard of professional practice in 
Florida. Furthermore, the issue of whether documentation was 
required by the standard of practice in Florida was thoroughly 
addressed by both parties at the hearing. See id. 179-81, 434-38, 
1007-08. I find that it is unimportant to find an independent 
violation related to the lack of documentation, because such lack of 
documentation already supports the overall finding that Respondent 
filled these alleged prescriptions in violation of its corresponding 
responsibility and outside the usual course of professional practice 
in Florida.]
---------------------------------------------------------------------------

    Dr. Hamilton indicated the source of pharmacy standards in Florida 
included ``Florida Regulation 64B,'' \29\ and guidance from the 
National Board of Pharmacy Association. Id. at 180, 351-58. Dr. 
Hamilton noted these standards are enforced by the Board of Pharmacy in 
Florida. Id. at 180.
---------------------------------------------------------------------------

    \29\ See West's Florida Administrative Code, Title 64. 
Department of Health, Subtitle 64b16, Chapter 64B16-27--Pharmacy 
Practice.
---------------------------------------------------------------------------

    Dr. Hamilton explained that if the prescription involved a 
controlled substance, that in itself was a red flag. Id. at 182. The 
strength of medication and the duration of the medication therapy was a 
concern, which needed to be addressed. Id. The pricing structure of the 
controlled substance represented a concern, as well as the distance of 
travel. Id. at 182, 360-61.
    Dr. Hamilton noted ``red flags'' in a prescription to Patient A.E., 
for 84 tablets of 8 mg. of hydromorphone. Id. at 183-84; GX. 6, pp. 1-
2, GX. 5; RX 18, pp. 1-2, RX 19.\30\ Dr. Hamilton noted that 8 mg was 
the highest dosage made of hydromorphone, a Schedule 2 controlled 
substance. Tr. 184. Further, the number of dosage units prescribed, 84, 
was also concerning. Id. at 184. Dr. Hamilton noted that, based on the 
records, the first ``red flag'' involving a dangerously high dosage 
level, had not been resolved. Id. at 186. Dr. Hamilton noted the 
absence of any information relating to the patient's prescribing 
history suggesting the patient was acclimated to this significant 
dosage, and not ``opiate na[iuml]ve'' to this dosage. Id. at 188-90, 
316-17. Dr. Hamilton indicated the Florida standard of care required 
the starting date of the prescribed medication to be disclosed on the 
face of the prescription or in a note readily available to the 
pharmacist. Id. at 186-87, 350-51, 392-94. Dr. Hamilton acknowledged 
that a pharmacist had access to the Florida PDMP, or ``E-FORCSE'' 
database, which contained prescribing history. Id. at 348-49.
---------------------------------------------------------------------------

    \30\ Dr. Hamilton compared GX 5 with RX 18.
---------------------------------------------------------------------------

    Dr. Hamilton noted that an identical prescription for hydromorphone 
was issued to A.E. for two more consecutive months. Tr. 191-92; GX 6, 
pp. 3-6. Dr. Hamilton noted the Florida standard of care regarding 
``individualization'' required that the pharmacist consider whether an 
extended high dosage of controlled medication should be continued or 
should be reduced. Tr. 192-93. Dr. Hamilton expected to see a reduction 
in dosage over time, or an explanation by the pharmacist for continuing 
to dispense the same high dosage. Id. at 1013-14. Dr. Hamilton noted 
there was no evidence that any reevaluation of the patient's continued 
need for this strong medication had been made. Id. at 193. The fact 
that the patient was on immediate release tablets further heightened 
the ``red flag.'' GX 28, p. 6. Dr. Hamilton explained that immediate 
release tablets typically addressed acute versus chronic or long-term 
conditions, as suggested here by ongoing prescriptions for 
hydromorphone. Tr. 193-94, 1013-14. This ``red flag'' was not resolved 
on the face of the prescription, or in the medical notes. Tr. 194; GX 
5, GX 6, pp. 5-6. Dr. Hamilton was also concerned by the cash purchase 
of the prescription and the ``extremely high prices'' paid, of $5.95 
per pill. Tr. 194, 199; GX, 28, p. 6.
    Dr. Hamilton explained that medications are typically priced at the 
``average wholesale price'' plus 20%. Tr. 195. Dr. Hamilton explained 
that the appropriate price \*J\ of 8 mg. of hydromorphone was $1.50 per 
tablet. He cautioned that this was an approximation by reviewing 
pharmacy prices in his area, both of big chain pharmacies as well as 
independents. Id. at 195, 326, 330-31. Dr. Hamilton opined that prices 
per pill from wholesalers would be fairly consistent across the state. 
Id. at 195, 1011-13. However, he noted that, at the retail level, the 
purchase of just a few pills could result in an extremely high price 
per pill versus the purchase of a large number of pills. Tr. 198.
---------------------------------------------------------------------------

    \*J\ Dr. Hamilton referred to it as ``the market retail price.'' 
Tr. 195.
---------------------------------------------------------------------------

    On rebuttal, Dr. Hamilton compared versions of the same medical 
records as to A.E. See GX 5 and RX 18, 19. After pointing out 
differences in the two versions, and granting the reliability of the 
Respondent's versions, Dr. Hamilton opined that considering the GX 18, 
19 version, his previous opinions as to A.E.'s dispensing remained the 
same. Tr. 957-65. As related to the differences

[[Page 54557]]

between the Government and Respondent versions of the same records, Dr. 
Hamilton conceded that the Respondent versions could be updated 
versions of the Government versions. Id. at 1019-20. Dr. Hamilton 
observed that updating medical records was required by the standard of 
care. Id. at 1020.
    Turning to patient A.R., Dr. Hamilton noted a prescription for 112 
tablets of 15 mg of oxycodone represented several ``red flags'', citing 
significant dosage, high quantity, frequency of prescribed usage (4 
times daily), and high price.\31\ Id. at 204-05, 329; GX 8, pp. 1-2; RX 
20. Dr. Hamilton was unable to find that these ``red flags'' were 
resolved on the face of the prescription or on the ``information 
sheet'' within the patient record. Tr. 205-06; GX 7. Dr. Hamilton 
explained that, although the patient's ``information sheet'' contained 
information relating to diagnoses and medical conditions, it did not 
include information justifying the long-term use of the subject 
oxycodone prescription. Tr. 206, 329-30; GX 28, pp. 12-14. As relates 
to price per pill, Dr. Hamilton estimated the retail price to be 
approximately 90 cents. Tr. 330-31. The next prescription for A.R. also 
involved 15 mg of oxycodone, but for 140 tablets at a directed 
frequency of 5 times per day at a price of $350. Tr. 207-08; GX 8, pp. 
3-4. Dr. Hamilton noted the distance between A.R.'s residence and the 
prescribing doctor's office and Pharmacy 4 Less. Tr. 208. Dr. Hamilton 
estimated A.R. lived approximately 40 miles from the prescribing 
doctor, and another 13 miles further to the subject pharmacy. Id. at 
209. Dr. Hamilton indicated this distance represented a ``red flag,'' 
which went unresolved within the subject records. Tr. 209-10, 332-37; 
GX 7, GX 8, p. 3.
---------------------------------------------------------------------------

    \31\ Patient A.R. paid $280 for 112 pills of oxycodone in 
connection with this prescription, or $2.50 per pill. *[Later, 
Patient A.R. paid between $340 and $350 for 140 pills of oxycodone, 
or approximately $2.43-$2.50 per pill. GX 8, at 3-6, 33-34.]
---------------------------------------------------------------------------

    The next two prescriptions for A.R., which Dr. Hamilton indicated 
disclosed the same ``red flags'' were identical prescriptions for 15 mg 
of oxycodone, for 140 tablets, but at a price of $340. Tr. 212-14; GX 
8, pp. 5-6, 33-34. *[Omitted based on further review of the record]. 
Dr. Hamilton opined the subject oxycodone prescriptions for A.R. 
remained unresolved within the records reviewed, and were thus below 
the standard of care in Florida. Tr. 215-16; GX 7.
    On rebuttal, Dr. Hamilton compared versions of the same medical 
records as to A.R. See GX 7 and RX 20, 21. After pointing out 
differences in the two versions, and granting the reliability of the 
Respondent's versions, Dr. Hamilton opined that considering the GX 20 
and 21 version, his previous opinions as to A.R.'s dispensing remained 
the same. Tr. 965-69.
    As to Patient B.F., Dr. Hamilton reviewed a series of prescriptions 
for hydromorphone 8 mg, 84 count, 3 times daily. Tr. 216-22; GX 12, pp. 
13-14, 17-18, 21-22, 25-26; RX 24. The ``red flags'' revealed included 
the controlled substance itself, the dosage at the highest available, 
the high quantity (84 tablets), the immediate release, the ongoing 
length of time it is being prescribed, and the high price ($490).\32\ 
Tr. 216-22.
---------------------------------------------------------------------------

    \32\ Eighty-four tablets at $490 equals $5.83 per tablet. *[The 
ALJ then found that Dr. Hamilton estimated the expected retail price 
to be $0.90 per pill citing to Tr. 218-22 and GX 28, p. 11, but the 
record does not support this finding. Dr. Hamilton originally 
testified that hydromorphone had an estimated retail price of $0.90, 
Tr. 218; however, after he refreshed his recollection with his 
expert report he stated, ``I might have misspoke at $0.90. It's a 
little bit more expensive for [D]ilaudid, or [h]ydromorphone . . . 
.'' Tr. 222. Dr. Hamilton's export report stated that the estimated 
retail price of hydromorphone was approximately $1.50 per pill. GX 
28, at 11. Dr. Hamilton also testified elsewhere in the record that 
the market retail price for hydromorphone was $1.50 per pill. See 
e.g. Tr. 195-97. Moreover, albeit in a different context, Dr. 
Hamilton testified that to the extent numbers appearing in his 
expert report differed from numbers to which he was testifying based 
on his recollection, the numbers in the expert report would be 
``[m]ore accurate.'' Tr. 209. Based on the entirety of the record, I 
find that Dr. Hamilton estimated the expected retail price of 
hydromorphone to be $1.50 per pill.]
---------------------------------------------------------------------------

    On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored 
versions of medical records as to B.F., RX 24, 25. Dr. Hamilton noted 
references to a discharge date of May 15, 2017, a reference to liver 
cancer, stage 3, and the last fill of the subject prescription on May 
15, 2017. Tr. 976-77. Even granting the reliability of the records, Dr. 
Hamilton stuck with his original opinions as to B.F.'s dispensing. Id. 
at 975-80.
    As to Patient B.N., Dr. Hamilton identified ``red flags'' related 
to a series of prescriptions for hydromorphone. Id. at 223. The first 
was of 8 mg, 90 count, priced at $580. Tr. 222-23; GX 14, pp. 1-2; GX 
13; RX 26. Dr. Hamilton reiterated the hydromorphone itself represented 
an unresolved ``red flag,'' as well as the dosage, quantity and cost. 
Tr. 223, 226. The second and third prescriptions for hydromorphone, 
again with the same unresolved a ``red flags,'' involved 8 mg, 100 
count, priced at $640. Tr. 224-28; GX 14, pp. 3-6; GX 13. The fourth 
hydrocodone prescription, again with the same unresolved ``red flags,'' 
involved 8 mg, 100 count, priced at $600. Tr. 229-30; GX 14, pp. 15-16. 
This prescription prompted an additional ``red flag'' as it represented 
ongoing prescribing of hydromorphone without demonstrated 
justification. Tr. 230. Dr. Hamilton reviewed a prescription for 
oxycodone, 30 mg (the highest dosage available), 120 count, priced at 
$600. Id. at 231-32. Dr. Hamilton opined the medication itself 
represented a ``red flag,'' as well as the dosage, the quantity and the 
cost. Id.; GX 14, pp. 19-20, GX 13. Additionally, transitioning from 
hydromorphone to oxycodone required an explanation, which was not 
contained within the records reviewed by Dr. Hamilton. Tr. 232. A 
second prescription for oxycodone for B.N., for 30 mg, quantity 40, had 
the same unresolved ``red flags.'' Tr. 233; GX 14, pp. 21-22. As this 
represented the second consecutive prescription for oxycodone, an 
additional ``red flag'' was raised regarding the ongoing unjustified 
prescribing. Tr. 233-34. The next two oxycodone prescription for B.N. 
involving the same unresolved ``red flags,'' involved 30 mg, 120 count, 
priced at $600.\*K\ Tr. 234-36; GX 13; GX 14, pp. 23-24, 37-38.
---------------------------------------------------------------------------

    \*K\ Dr. Hamilton also testified that additional prescriptions 
falling between the November 11, 2016, and June 2, 2017, 
prescriptions had the same unresolved ``red flags.'' Tr. 236.

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

[[Page 54558]]

    On rebuttal, Dr. Hamilton compared versions of the same medical 
records as to B.N., GX 13 and RX 26, 27. After pointing out differences 
in the two versions, and granting the reliability of the Respondent's 
versions, Dr. Hamilton opined that considering the RX 26 and 27 
version, his previous opinions as to B.N.'s dispensing remained the 
same. Tr. 980-85.
    As to patient K.Y.D., Dr. Hamilton identified a series of oxycodone 
prescriptions with unresolved ``red flags.'' Tr. 237; GX16, pp. 1-2, 5-
6, 9-10, 63-64; RX 30, 31, pp. 2-4. The first three involved a dosage 
of 30 mg, quantity 84, price $290. Tr. 237-39 *[For these 
prescriptions, Dr. Hamilton testified that the red flags included the 
highest strength dosage, high quantity, frequency of prescribed usage 
(3 times daily), and high price.] By the third prescription, it also 
triggered an additional ``red flag'' involving the ongoing unjustified 
prescribing of oxycodone. Tr. 239. The fourth example for the identical 
prescription triggered the same unresolved ``red flags.'' \*L\ Id. at 
240.
---------------------------------------------------------------------------

    \*L\ Dr. Hamilton also testified that additional prescriptions 
issued between March 31, 2016, and June 12, 2017, had the same 
unresolved ``red flags.'' Tr. 241.
---------------------------------------------------------------------------

    On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored 
versions of medical records as to K.Y.D., RX 30, 31. Dr. Hamilton noted 
references to a discharge date of June 12, 2017. Tr. 990-91. Even 
granting the reliability of the records, Dr. Hamilton stuck with his 
original opinions as to K.Y.D.'s dispensing. Tr. 990-94.
    As to Patient K.E.D., Dr. Hamilton determined there were unresolved 
``red flags'' involved in a series of oxycodone prescriptions. The 
first was for 20.5 mg, quantity 112, for $430. Tr. 241-45; GX 17, GX 
18, pp. 1-2, 3-4, 5-6, 41-42; RX 28, RX 29, p. 2. For the first, the 
dosage of 20.5 mg represents a dosage outside common dosage units, and 
would have been a compounded dosage, a ``red flag'' in itself. Tr. 242. 
*[Additionally, Dr. Hamilton noted that the quantity, and price were 
unresolved red flags for this prescription. Id.] The second and third 
oxycodone prescription noted were for 20 mg, 112 quantity, priced at 
$430. Tr. 244-45. Again, the medication itself represented a ``red 
flag,'' as well as the dosage, quantity and price. Tr. 245. The fourth 
oxycodone prescription was identical to the second and third, except 
that the price was $400. Tr. 245-46. *[In addition to the ``red flags'' 
identified with the prior two prescriptions,] the fourth prescription 
triggered the ``red flag'' of an extended prescription without apparent 
justification.\*M\ Id. at 246.
---------------------------------------------------------------------------

    \*M\ Dr. Hamilton testified collectively regarding the remaining 
prescriptions in GX 18 issued between December 21, 2015, and June 7, 
2017, and opined that there were similar red flags for all of those 
prescriptions and that none of those red flags were resolved. Tr. 
246.
---------------------------------------------------------------------------

    On rebuttal, Dr. Hamilton compared versions of the same medical 
records as to K.E.D. See GX 17; RX 28, 29. After pointing out 
differences in the two versions, and granting the reliability of the 
Respondent's versions, Dr. Hamilton opined that considering the RX 28 
and 29 version, his previous opinions as to K.E.D.'s dispensing 
remained the same. Tr. 986-90.
    As to Patient R.R., Dr. Hamilton identified a series of oxycodone 
prescriptions, each which involved unresolved ``red flags.'' Tr. 247-
50; GX 20, pp. 1-6, 41-42; RX 32, p. 1; RX 33, p. 5. The first 
prescription was of 18 mg, 112 quantity, priced at $250. Tr. 247. The 
first ``red flag'' is that the dosage has been compounded, without 
explanation. Id. The high quantity is a ``red flag,'' as well as the 
high price paid. Id. The second and third prescriptions involved 15 mg, 
quantity of 112, priced at $270. Tr. 248. The fourth prescription is 
identical to the second and third, except for the price was $260. Tr. 
249-50. The third and fourth prescriptions *[had the same unresolved 
red flags as the earlier prescriptions, and] additionally triggered a 
``red flag'' as extended prescriptions without apparent 
justification.\*N\ Id.
---------------------------------------------------------------------------

    \*N\ Dr. Hamilton testified collectively regarding the remaining 
prescriptions in GX 20 issued between December 21, 2015, and May 30, 
2017, and opined that there were similar red flags for all of those 
prescriptions and that none of those red flags were resolved. Tr. 
250.
---------------------------------------------------------------------------

    On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored 
versions of medical records as to R.R. See RX 32, 33. Dr. Hamilton 
noted references to a discharge date of May 2, 2017, yet another 
prescription fill on May 30, 2017. Tr. 994-95. Even granting the 
reliability of the records, Dr. Hamilton stuck with his original 
opinions as to R.R.'s dispensing. Id. at 994-97.
    As to Patient R.V., Dr. Hamilton identified a series of oxycodone 
prescriptions, each which involved unresolved ``red flags.'' Tr. 251-
56; GX 21; GX 22, pp. 27-28, 31-32, 34-35, 78-79; RX 34, p. 1; RX 35. 
The first prescription was for 20 mg, 112 quantity, priced at $340. Tr. 
251; GX 28. The first ``red flag'' was the high dosage. Tr. 251. The 
next ``red flag'' was the quantity. Id. And the third was the high 
price paid. Id. *[Dr. Hamilton testified that there was no evidence on 
either the face of the prescription or in the patient record for R.V. 
that these ``red flags'' were resolved. Id. at 251-52.] The second 
prescription was identical to the first *[and had the same unresolved 
``red flags.'']. Id. at 253. The third was identical to the first two, 
except that it was priced at $310. Id. The third prescription *[had the 
same unresolved red flags as the earlier prescriptions, and] had the 
additional ``red flag'' as an extended prescription without apparent 
justification. Id. The fourth prescription for oxycodone was of 20 mg, 
quantity 120, priced at $340 *[and had the same unresolved red flags as 
the third].\*O\ Id. at 254-55.
---------------------------------------------------------------------------

    \*O\ Dr. Hamilton testified collectively regarding the remaining 
prescriptions in GX 22 issued between January 11, 2016, and June 19, 
2017, and opined that there were similar red flags for all of those 
prescriptions and that none of those red flags were resolved. Tr. 
255.
---------------------------------------------------------------------------

    On rebuttal, Dr. Hamilton compared versions of the same medical 
records as to R.V. See GX 21 and RX 34, 35. After pointing out 
differences in the two versions, and granting the reliability of the 
Respondent's versions, Dr. Hamilton opined that considering the RX 34 
and 35 version, his previous opinions as to R.V.'s dispensing remained 
the same. Tr. 997-1001.
    As to Patient V.W., Dr. Hamilton identified a series of oxycodone 
prescriptions, each which involved unresolved ``red flags.'' Tr. 256-
60; GX 23, GX 24, pp. 1-2, 3-4, 5-6, 41-42; RX 36. The first 
prescription was for 15 mg, quantity of 84, priced at $300. Tr. 256. 
The first ``red flag'' was the relatively high dosage. Tr. 256. The 
next ``red flag'' was the quantity. Id. And the third was the high 
price paid. Id. The second prescription involved 15 mg, quantity 112, 
priced at $400. Tr. 257. The third prescription was identical to the 
second, but was priced at $350. Tr. 258. The third prescription had 
*[the same unresolved ``red flags'' as prior prescriptions based on the 
dose and quantity] and additional [unresolved] ``red flags'' *[because 
the prescription was written for four times a day and filled for only 
three times a day and] as an extended prescription without apparent 
justification. Id. The fourth prescription was identical to the third, 
except priced at $285. Id. at 259. *[The fourth prescription shared the 
``red flags'' arising based on the dose, quantity, price, and ``length 
of time for immediate-release medication.'' \*P\ Id. at 259-60.
---------------------------------------------------------------------------

    \*P\ Dr. Hamilton testified collectively regarding the remaining 
prescriptions in GX 24 issued between January 25, 2016, and May 21, 
2017, and opined that each had the same red flags as the fourth 
prescription discussed herein and that none of those red flags were 
resolved. Tr. 260.

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

[[Page 54559]]

    On rebuttal, Dr. Hamilton compared versions of the same medical 
records as to V.W. See GX 23 and RX 36, 37. After pointing out 
differences in the two versions, and granting the reliability of the 
Respondent's versions, Dr. Hamilton opined that considering the RX 36 
and 37 version, his previous opinions as to R.V.'s dispensing remained 
the same. Tr. 1001-04.
    As to Patient A.V., Dr. Hamilton discovered a series of controlled 
substance prescriptions that were filled by Pharmacy 4 Less despite 
unresolved ``red flags.'' Tr. 261-67; GX 10, pp. 1-2, 3-4, 5-6, 9-10, 
15-16, 37-38, 41-42, 43-44, 45-46, 47-48, 59-60; RX 22. The first such 
prescription involved 29 tablets of 8 mg of buprenorphine. Tr. 261-62. 
The second prescription, filled 9 days after the buprenorphine was 
filled, involved 112 tablets of oxycodone, 20 mg each, priced at $290. 
Tr. 262. The oxycodone prescription itself presented ``red flags,'' 
which needed to be resolved, as discussed earlier, including the drug 
itself, the large quantity, the relatively high dosage, and the price. 
Id. Additionally, Dr. Hamilton observed the 20 mg oxycodone was being 
prescribed in conjunction with the buprenorphine. Id. at 263. 
Buprenorphine is used to wean someone off of an opiate, such as 
oxycodone. Id. The prescribing of buprenorphine along with an opioid 
prescription creates a ``red flag,'' which needs to be resolved. Id. at 
262-63. The acceptable protocol would be to introduce the buprenorphine 
as the dosage of oxycodone is reduced, until the oxycodone is 
completely replaced by the buprenorphine. Id. at 262-65. Here, the 
buprenorphine is introduced, yet nine days later the 20 mg of oxycodone 
was filled, which is inconsistent with the typical detoxification 
protocol, and can present some contraindication issues. Id. at 266-67. 
Additionally, detoxification would require physician monitoring. Id. at 
265. Dr. Hamilton noted there was no indication in the reviewed records 
\*Q\ *[that the ``red flag'' was resolved]. Id. at 265-66. Another 8 mg 
buprenorphine prescription of 60 tablets was filled almost two months 
after the first buprenorphine prescription. Id. at 267-68. On the same 
day, a second identical prescription for 20 mg of oxycodone was filled, 
triggering the same set of ``red flags'' as previously described *[and, 
according to Dr. Hamilton, there was no documentation that those ``red 
flags'' were resolved]. Id. at 268-69. This second prescription for 
oxycodone,\*R\ *[according to Dr. Hamilton, raised the same unresolved 
``red flags'' as the first one, and an additional unresolved ``red 
flag'' because the medication dosage and frequency remained unchanged 
and ``[y]ou would see a de-escalation of medication with a patient 
going through detox.'' Id. at 268-69. The next month saw a repeat of an 
8 mg buprenorphine prescription *[for 60 tablets], along with a 20 mg 
prescription for oxycodone, thus repeating the same unresolved ``red 
flags.'' Id. at 271-72. Less than one month later, dual prescriptions 
for 8 mg of buprenorphine and 20 mg of oxycodone were filled, repeating 
the same unresolved ``red flags'' as described earlier. Id. at 271-73. 
Additionally, as to the oxycodone, the repeated prescribing created the 
unresolved ``red flag'' related to *[the length of time] without a 
reduction in dosage. Id. at 273-74. Dr. Hamilton addressed another set 
of dual prescriptions for 8 mg of buprenorphine and 20 mg of oxycodone, 
thus repeating the same unresolved ``red flags'' discussed earlier.\*S\ 
Id. at 274-77.
---------------------------------------------------------------------------

    \*Q\ The ALJ found that ``Dr. Hamilton noted that there was no 
indication in the reviewed records that the physician was monitoring 
any attempted detoxification.'' I have omitted the finding because I 
do not see support for it in the record and find it to be 
irrelevant. The record is clear that Dr. Hamilton did not see any 
documentation of resolution of the ``red flag,'' which is ultimately 
the fact at issue in this case.
    \*R\ The ALJ found that the second prescription ``highlighted 
the `red flag' relating to the absence of any evaluation as to the 
reduction in the dosage or frequency of the oxycodone.'' I have 
revised this finding to quote Dr. Hamilton.
    \*S\ Dr. Hamilton testified collectively regarding the remaining 
prescriptions for buprenorphine and oxycodone in GX 10 issued 
between August 2, 2016, and February 13, 2017, and opined that each 
oxycodone prescription had the same red flags as the other oxycodone 
prescriptions discussed herein and that there was no documentation 
that these red flags were resolved. Tr. 276.
---------------------------------------------------------------------------

    On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored 
versions of medical records as to A.V. See RX 22, 23. Dr. Hamilton 
noted references to a consultation with Dr. Seaford, to ``tapering'' 
and to ``detox.'' Tr. 970-72. Even granting the reliability of the 
records, Dr. Hamilton stuck with his original opinions as to A.V.'s 
dispensing. Id. at 970-75.
    Again on rebuttal, Dr. Hamilton confirmed that nothing in the 
testimony of Mr. Parrado or Ms. Mincy has caused Dr. Hamilton to change 
his previously offered opinions in this case. Id. at 1004-05. Dr. 
Hamilton did agree with Mr. Parrado's observation that it was proper to 
fill a pain prescription up to a month after the patient was released 
from the hospital. Id. at 1017. Dr. Hamilton further commended the 
Respondent's practices of maintaining medical records within their 
pharmacy files. Id. at 1015-16.

Respondent's Case in Chief

    The Respondent presented its case through the testimony of two 
witnesses. First, the Respondent presented the testimony of Ms. Amy 
Mincy (Ms. Mincy). Second, the Respondent presented the testimony of 
its expert, Robert M. Parrado (Mr. Parrado).

Ms. Amy Mincy, R.Ph.\33\
---------------------------------------------------------------------------

    \33\ Ms. Mincy testified the entire day of November 7, 2018. She 
was recalled to the stand during the second portion of the hearing 
at the DEA Hearing Facility in Arlington, Virginia on February 25, 
2019, for the remainder of her testimony.
---------------------------------------------------------------------------

    Ms. Mincy testified to the following. Several of Ms. Mincy's claims 
were contested by the government and will be discussed later. As 
background, Ms. Mincy graduated from Mercer University in Atlanta, 
Georgia, and has been a pharmacist since 1983. Tr. 569. She is licensed 
in the State of Florida and has inactive licenses in Tennessee and 
Virginia. Id. She has worked for a number of pharmacies for varying 
lengths of time, including independent pharmacies, as a relief 
pharmacist, and as a pharmacy consultant, over the course of her 
career. Id. at 569-76, 579-83; RX 1.\34\ She has also previously been 
disciplined by the Florida Board of Pharmacy for filling a prescription 
for her mother, was placed on probation, and successfully completed the 
terms of her probation in 1998. Id. at 579-82. She began working as a 
pharmacist at Pharmacy 4 Less in January 2016. Id. at 576-77. She is 
one of two pharmacists that works at Pharmacy 4 Less, along with Mr. 
Sprys. Id. at 577. She works at Pharmacy 4 Less four days per week, 
Monday through Thursday, with Mr. Sprys working on Friday. Id. at 822.
---------------------------------------------------------------------------

    \34\ Ms. Mincy's CV was admitted over objection with the 
corrections noted through Ms. Mincy's testimony. Tr. 584.
---------------------------------------------------------------------------

    Ms. Mincy was working as the pharmacist on duty at Pharmacy 4 Less 
on June 6, 2017, when the DEA conducted its on-site inspection at the 
pharmacy. Id. at 584. She testified that DI1 and another Diversion 
Investigator (hereinafter DI2) arrived at the pharmacy sometime between 
10:00 a.m.-12:00 p.m. that day. Id. at 585. She did not know the DEA 
was planning to conduct the on-site inspection that day. Id. at 585-86. 
She was told that the inspection would take between 20-30 minutes or up 
to an hour. Id. at 586.\35\ She related that Mr. Sprys' son, William 
Sprys, was also in the pharmacy. Id. at

[[Page 54560]]

587. William Sprys acts as the administrator for the pharmacy, but is 
not a registered pharmacist, so he primarily handles clerical 
administrative duties. Id. at 587-88.
---------------------------------------------------------------------------

    \35\ When asked, Ms. Mincy said that it was primarily DI1 that 
spoke to her and asked her questions during the inspection. Tr. 586. 
She stated that DI2 was primarily observing. Tr. 587.
---------------------------------------------------------------------------

    During the inspection, Ms. Mincy was handed a DEA Form 82, Notice 
of Inspection. Tr. 589; GX 30. She was uneasy about consenting to an 
inspection because she only works as an independent contractor at 
Pharmacy 4 Less, not as a regular employee. Tr. 590-91. She asked to 
contact Mr. Richard Sprys to ask about the form and whether she should 
consent and sign the form. Id. at 591-92. She had William Sprys contact 
Mr. Richard Sprys on the telephone because Richard was out of the 
country at the time of the inspection. Id. at 592. The DIs were also 
present during the telephone call. Id. She spoke to Mr. Richard Sprys 
on speakerphone about the DEA inspection and the DIs request to inspect 
the pharmacy. Id. Mr. Sprys then gave permission and directed Ms. Mincy 
to sign the form. Id. at 592-93. Ms. Mincy then signed the Form 82. Tr. 
594.
    After signing the form, Ms. Mincy was taken into a separate room in 
the pharmacy. Id. at 596. DI1 asked to see the pharmacy's perpetual 
inventory. Id. at 598. DI1 proceeded to count pills of controlled 
substances contained in the pharmacy. Id. DI1 asked for the perpetual 
inventory pages for January 1, 2017, through June 6, 2017. Tr. 604-05. 
The perpetual inventory was handwritten and was designed to keep track 
of the pharmacy's prescription inventory. Tr. 630-31; RX 31 
(Methadone), 32 (Oxycodone).
    He then requested the pharmacy's biennial inventory. Tr. 605-06, 
773-74; GX 37; RX 38.\36\ The pharmacy keeps its inventories in a 
binder that is located inside the locked medication room. Tr. 607. The 
Respondent's version of the biennial inventory indicated that it was 
completed on April 26, 2017, at 8:00 a.m. by Ms. Mincy and Mr. Sprys. 
Id. at 617-18, 767-73; RX. 38, pp. 1, 2, 3, 8-16. The inventory was 
completed by entering the drug room, verifying the number of pills, 
scanning the prescription bottles, and verifying their entry into the 
pharmacy's computer system. Tr. 626-27. Ms. Mincy testified she 
completed the biennial inventory in about three hours. Id. at 628. Ms. 
Mincy indicated her understanding that the biennial inventory must be 
completed either in the morning before the start of business or at the 
end of the day at the close of business, and that it was completed 
before the opening of business. Id. at 620-21, 817-19. The biennial 
inventory was kept inside a binder with the C-2 perpetual inventory. 
Id. at 622. The biennial inventory was later sent by the pharmacy to 
DI1 after he left it at the pharmacy following the inspection. Id. at 
638-42; 782-88. She indicated she was not aware that a biennial 
inventory containing Schedule 2 prescriptions needed to be separate 
from an inventory containing Schedules 3 through 5 prescriptions. Id. 
at 818. To complete the biennial inventory, she would open the narcotic 
cabinet and would hand-count the Schedule 2 pills inside. Id. at 820-
21.
---------------------------------------------------------------------------

    \36\ Each version was admitted following the Government's voir 
dire and request to admit GX 37 if this Tribunal were to admit RX 
38. The Government agreed to redact the pricing information 
contained at the Respondent's request. Tr. 775-82. However, the 
Government later requested to withdraw the original GX 37 and offer 
an alternative version of GX 37, with only pages 1-7 considered for 
record. Tr. 912-17.
---------------------------------------------------------------------------

    For the inventories in the pharmacy, Ms. Mincy would keep a 
perpetual inventory of the prescriptions that had been filled. Id. at 
628-34; GX 31, 32. The perpetual inventories were usually filled out by 
Ms. Mincy, but were sometimes updated by Mr. Sprys. Tr. 628-29. Every 
time a prescription was filled, it would be noted by either Mr. Sprys 
or Ms. Mincy so that they could keep up with their inventory that was 
on hand. Id. at 631. These were provided by Ms. Mincy to DI1 when he 
asked to see the pharmacy's inventory to determine if it was correct. 
Id. at 634-35. Ms. Mincy explained from the perpetual inventories how 
it can be determined how many pills were currently in the inventory. 
Id. at 635.
    DI1 also asked to see the pharmacy's computer software, including 
print-outs and reports. Id. at 609-11. DI1 then requested to inspect 
the pharmacy's CSOS system. Id. at 612-13. CSOS is the pharmacy's 
electronic controlled substance ordering system. Id. at 611, 865-66. 
The pharmacy uses the CSOS system sourced through AmerisourceBergen. 
Id. at 612. Ms. Mincy showed DI1 the steps to order, but could not 
order because she did not have CSOS credentials at the time of the 
inspection. Id. at 613, 839-40, 867. Each authorized user receives an 
individual code that must be kept confidential to that user. Id. at 
613. When showing the program to DI1, Ms. Mincy stated she did not put 
in any credentials because she did not have any at the time. Id. at 
615, 867-68. DI1 then accused her of ordering with Mr. Richard Spry's 
credentials, which she promptly denied. Id. at 615. DI1 then proceeded 
to take all the original copies of the pharmacy's Schedule 2 
prescriptions and some of the Schedules 3-5 prescriptions from January 
1, 2017, to June 6, 2017. Id. at 615-17, 891-93, 894-96; RX 59, 60.\37\ 
Ms. Mincy could not explain how there were differences between the 
original copy of RX 59 she had maintained at the pharmacy and the 
version that the Government had introduced into evidence, as the 
version the Government had seized on June 6, 2017. Tr. 901-903; compare 
GX 26, pg. 50 with RX 59.
---------------------------------------------------------------------------

    \37\ Testimony related to RX 59 and 60 were objected to by the 
Government for lack of notice and being beyond the scope of cross-
examination that was conducted on November 7, 2018. This Tribunal 
permitted the Respondent to make a record of the testimony for the 
Administrator's consideration, but sustained the Government's 
objection as to being beyond the scope of cross examination. Tr. 
885-91, 893, 896-900.
---------------------------------------------------------------------------

    Ms. Mincy would use the Florida E-FORCSE system as part of her 
resolution of red flags. Tr. 642-43. It is used to assist medical 
personnel in keeping track of medications individuals are taking. Id. 
at 642, 870-71. It contains a log of a patient's controlled substances 
that are disbursed from a prescription written by a doctor and filled 
by a pharmacist. Id. Pharmacies upload prescriptions daily into the E-
FORCSE system. Id. at 643. E-FORCSE contains prescriptions for 
Schedules 2-4 controlled substances. Id. Ms. Mincy would use it daily 
and prior to every fill of a new prescription for clients. Id. at 643. 
E-FORCSE allows a pharmacist to immediately access a patient's name, 
date of birth, address, and the aforementioned prescriptions. Id. at 
645. It also allows a pharmacist to see which pharmacies a patient goes 
to, or if the patient is doctor shopping or trying to fill 
prescriptions early. Tr. 645.
    At the pharmacy each morning, either Mr. Sprys or Ms. Mincy would 
log on to the E-FORCSE system and it would be left open on the computer 
to be accessed. Id. at 871. Ms. Mincy understood that when E-FORCSE 
started, it was permissible to use another person's login since the 
pharmacy manager or pharmacist would log in first thing in the morning 
and it could be used throughout the day under that person's login 
information. Id. at 903-908.\38\ The login systems for CSOS and E-
FORCSE are two separate systems. Id. at 872. CSOS is regulated directly 
by the DEA and individual authorization and access has to be

[[Page 54561]]

granted by the DEA. Id. at 872. Ms. Mincy had a key and certificate 
specific to her that had to be used to access the CSOS system. Id. at 
872. On the other hand, E-FORCSE could be properly accessed by either 
Mr. Sprys or Ms. Mincy and could be left open on the computer for 
either person to access. Id. at 872.
---------------------------------------------------------------------------

    \38\ Ms. Mincy explained that this is why sometimes another 
person's E-FORCSE number would appear on the search records when she 
had actually done the search. Tr. 908-09. There was further 
testimony about the pharmacy's use of E-FORCSE and Ms. Mincy's 
understanding of its use, along with discussion about proposed RX 
57. Tr. 903-09. However, proposed RX 57 was later withdrawn by the 
Respondent and GX 38 (redacted) was used instead after its 
introduction during DI1's rebuttal testimony. Tr. 927-34; 1024-25.
---------------------------------------------------------------------------

    Ms. Mincy would turn away patients if she found discrepancies on 
the E-FORCSE, and did so, up to 10 to 12 times per month. Id. at 646. 
She would turn them away if she suspected their ID was not legitimate, 
if they were also filling their prescriptions somewhere else, if it 
appeared they were doctor shopping, or if there were signs of diversion 
or abuse. Id. at 647. She would also call the patient's doctor and 
discuss the patient's medical needs and the prescriptions that had been 
provided to her. Id. at 648. She would send patients away if there were 
discrepancies between the identification provided and the information 
provided on the prescription. Id. at 648. She would also look to see if 
any of the patients had overdosed, which would help her determine 
whether to fill a prescription. Id. at 841. She would also investigate 
whether there was any indication that any of the patients were selling 
their prescribed medications. Id. at 841-45.\39\ She would then place a 
sticker on the prescription to signify that she had resolved any 
potential red flags for the prescription. Id. at 648-49, 827-28.
---------------------------------------------------------------------------

    \39\ The Government confronted Ms. Mincy with arrest records of 
Patient K.Y.D. during its cross-examination. She was surprised to 
hear that he had been arrested on December 31, 2015, for possession 
of oxycodone with intent to sell, and later arrested on February 25, 
2017, for possession of a Schedule 2 controlled substance. She said 
he had later been discharged as a patient and that he was unruly. 
Tr. 845-84; GX 41-43.
---------------------------------------------------------------------------

    Ms. Mincy was familiar with each of the 10 charged patients in this 
matter. Id. at 649. She has filled prescriptions for controlled 
substances for each of the 10 subject patients. Id. at 830. She would 
try to resolve red flags for each of the 10 subject patients by using 
the previously discussed methods, including determining whether any of 
them were opiate na[iuml]ve.\*T\ Id. at 813-14. One way she would do so 
was by accessing E-FORCSE. Id. at 814, 831.\40\ Her E-FORCSE number is 
*[redacted]. Id. at 831. She conceded there was no documentary evidence 
that indicated that any of the subject ten patients started at lower 
doses of opioids, including oxycodone and hydromorphone, and worked 
their way up because they become opioid tolerant. Id. at 815-16. She 
had medical release forms for Patient K.Y.D., but not for the other 9 
charged patients. Id. at 828-29. Ms. Mincy confirmed she had previously 
reviewed E-FORCSE in relation to the 10 charged patients. Id. at 875-
79. Ms. Mincy indicated that while the policy at the pharmacy was 
presently (at the time of the hearing) to run each controlled substance 
patient through E-FORCSE, it had previously been only to run each 
Schedule 2 prescription. Id. at 880-81.
---------------------------------------------------------------------------

    \*T\ Ms. Mincy, responded ``No'' to the question ``Did you ever 
fill any prescription the first time for a patient where it was 
contra-indicated for the amount because a patient might have been 
opiate na[iuml]ve?'' Tr. 649-50.
    \40\ When asked, Ms. Mincy stated that she had not printed out 
any documents from E-FORCSE that would show she had looked at the 10 
charged patients. Tr. 814-15.
---------------------------------------------------------------------------

    The pharmacy used the Rx30 computer software to fill prescriptions. 
Id. at 650. This was an internal system the pharmacy used to collect 
information, such as patient's names, addresses, phone numbers, 
allergies, and diagnostic codes. Id. at 650-51, 687-90; see, e.g., GX 
5; RX 18, p. 1; RX 19. It is also used to input information related to 
the patient's doctor, prescriptions, directions for the prescriptions, 
and number of days for the supply. Tr. 652. Each prescription was 
entered into the program one at a time, even if the doctor had put 
multiple substances on a single prescription form. Id. at 652-53. The 
Rx30 program would flash red with an alert if there was a contra-
indication that something in the prescription did not match with the 
information on file to let Ms. Mincy know that some follow up was 
necessary. Id. at 652-54.
    The pharmacy maintained patient record maintenance files through 
their internal system. Id. at 687-90, 706-09, 713-16, 722-31, 733-67; 
RX 18-37. These records were also used to maintain due diligence on the 
pharmacy's patients and resolve red flags as they arose. Id. at 707-08, 
840-41.
    Ms. Mincy had been present at Pharmacy 4 Less during inspections by 
the Florida Department of Health, including on February 28, 2017. Id. 
at 657-58. Ms. Mincy assisted the DOH inspector throughout the state 
inspections. Id. at 659-60. There were no deficiencies found during the 
February 28, 2017 inspection. Id. at 662; RX 15. She was also present 
during an inspection of the pharmacy on September 5, 2017. Tr. 669, 
674. This inspection was done by the Board of Pharmacy. Id. at 667, 
671-72. Ms. Mincy was given an inspection report at the end of that 
inspection, although the inspection report appeared to be incomplete. 
Tr. 675-81; RX 14.
    At the end of the DEA inspection, DI1 took ten ``California 
folder'' files of Schedule 2 prescriptions dated between January 1, 
2017, through June 6, 2017. Tr. 799-801. A ``California file'' consists 
of bundles of prescriptions that the pharmacy keeps for its records. 
Id. at 801. DI1 later requested twenty-four additional ``California 
files'' from Mr. Sprys. Id. at 801-02. The pharmacy kept a receipt that 
documented originals of the Schedule 2 prescriptions in the pharmacy. 
Tr. 802-03; RX 12.
    Ms. Mincy was present during the inventory taken by DI1 on June 6, 
2017. Tr. 835. She signed a DEA closing inventory sheet, confirming 
that the drug counts were correct. Tr. 835-37; GX 39.\41\
---------------------------------------------------------------------------

    \41\ While she could not recall signing the inventory sheet, she 
stated that it was her signature on the document. Tr. 837.
---------------------------------------------------------------------------

Mr. Robert M. Parrado, BPharm., R.Ph.

    Robert Parrado graduated from the University of Florida in 1970 
with a B.S. in Pharmacy. Tr. 401. Mr. Parrado has been licensed in 
Florida as a Pharmacist since 1971. Id.; RX 5, at 1. He was formerly 
licensed as a Consulting Pharmacist by the State of Florida up until 
1989, which involved work with institutional facilities. Tr. 401; RX5, 
at 1. Mr. Parrado has received several awards over the years: The R.Q. 
Richards Award from the Florida Pharmacy Association for pharmaceutical 
public relations, and the Generation Rx Award in the field of 
prescription drug abuse and drug diversion from Cardinal Health. Tr. 
402. He is presently President and CEO of Parrado Pharmacy Consultants, 
Inc., which involves pharmacy consulting with pharmacies, pharmacists, 
and with government agencies. Id. at 402-03; RX 5. Mr. Parrado 
previously worked for CVS Pharmacy from 2000 to 2009 as a Pharmacist. 
Tr. 403. For nine months in 2007, Mr. Parrado was a Regional 
Acquisition Specialist, involved in acquiring independent pharmacies by 
CVS. Id. Prior to working for CVS, Mr. Parrado worked for approximately 
three years for Eckerd Drugs and Albertson's. Id. at 404. Previously, 
Mr. Parrado worked for St. Joseph's Hospital as an Inpatient Staff 
Pharmacist, during which time he consulted with physicians on a daily 
basis. Id. Prior to St. Joseph's, Mr. Parrado was the Director of 
Pharmacy at Centro Hispano Hospital in Tampa. Id. at 404-05. Prior to 
that, for a few months, Mr. Parrado worked as a Pharmacist at SupeRx 
Drugs. Id. at 405.
    From 2001 to 2004, Mr. Parrado was a member of the Florida Board of

[[Page 54562]]

Pharmacy. Id. at 406. From 2003 to 2009, he was on the Board's 
Accreditation Council on Pharmacy Education. Id. As such, Mr. Parrado 
was involved in the accreditation of Florida schools of pharmacy. Id. 
While on the Board, Mr. Parrado was on the Rules Committee. Id. at 407. 
He also served on the Legislative Affairs Committee, which wrote 
proposed legislation for presentation to the Florida Department of 
Health, and for consideration by the Florida legislature. Id. During 
2004, Mr. Parrado was Chairman of the Florida Board of Pharmacy. Id. at 
408. Since 2001, Mr. Parrado has been a perpetual member of the 
National Association of Boards of Pharmacy. Id. Mr. Parrado was a 
member of the National ``Rules Committee,'' which developed ``model 
rules'' for consideration by individual states. Id. at 408-09. For 18 
months, ending in 2001, Mr. Parrado was President-elect of the Florida 
Pharmacy Association. Id. at 409. Later, Mr. Parrado served as Speaker 
of the House of Delegates for the Association. Id. at 410. Since 2014, 
Mr. Parrado has been guest lecturer on pharmacy law at the University 
of South Florida College of Pharmacy. Id. As part of a recurring 
continuing education course, Mr. Parrado taught ``Resolving Red Flags, 
Allowing Patients to Legally Obtain Their Lawful Medical 
Prescriptions.'' Id. at 411. He has taught this course at universities, 
to county and state pharmacy associations, and other professional 
organizations. Id. at 411-12. He has presented to various professional 
organizations a course on ``Identifying Drug Diversion.'' Id. at 412. 
Mr. Parrado has testified as an expert witness previously, including an 
estimated eight or nine times as an expert called by DEA. Id. at 414-
16.
    Mr. Parrado had last prescribed a controlled substance 
approximately three or four years prior to the instant hearing when 
working as a substitute pharmacist at Genoa Healthcare. Id. at 418. 
Regarding his most recent dispensing of opioids on a regular basis, Mr. 
Parrado estimated it to be 2011. Id. at 419. Mr. Parrado was certified 
as a pharmacy expert. Id. at 431.
    As relates to opioid na[iuml]ve patients, Mr. Parrado described 
various scenarios in which a patient, even one who has been dispensed 
opioids in the past but who has been deprived of opioids for a month or 
two, can become dangerously opioid na[iuml]ve. Id. at 433. To ensure a 
patient prescribed opioids is not opioid na[iuml]ve, Mr. Parrado 
described several tools available to the pharmacist. Id. at 433-34. The 
pharmacist should ask a number of questions to alleviate concerns. Id. 
at 434. He can also reference the E-FORCSE database. Id.
    Mr. Parrado was critical of the limited records Dr. Hamilton 
reviewed to form his opinion in this case. Id. at 434. Mr. Parrado 
suggested he would have asked the DEA to share more documentation with 
him than was shared with Dr. Hamilton. Id. at 443.
    As related to resolving red flags, Mr. Parrado opined that in 
addition to consulting the E-FORCSE database, a pharmacist may obtain 
medical records directly from the physician, or access the ``patient 
record maintenance'' from the Rx30 computer program. Id. at 435-36. As 
to Dr. Hamilton's opinion that the resolution of ``red flags'' had to 
be documented under Florida law, either on the prescription or 
somewhere else readily available to the pharmacist, Mr. Parrado 
disagreed, claiming there was no such requirement under Florida law. 
Id. at 434, 438. Mr. Parrado conceded documenting the resolution of 
``red flags'' may represent the ``best practice.'' \*U\ Id. at 434. As 
to the subject documentation, Mr. Parrado observed that most 
pharmacists do ``document somewhat.'' Id. at 435. Most document on the 
back of the prescription. Id. However, if that wasn't possible, Mr. 
Parrado opined that it was acceptable to ``document'' in a card file 
system, or in the ``note'' field on your computer system. Id. Mr. 
Parrado also noted he created a computer program, called ``Red Flag 
Resolver,'' which would preserve such documentation on the computer 
server. Id. Mr. Parrado suggested diagnostic codes could be used on the 
prescription to demonstrate the medication was justified on the basis 
of the medical condition. Id.
---------------------------------------------------------------------------

    \*U\ Mr. Parrado testified that there is ``no regulation that 
says you have to document . . . It may be a best practice to do 
that. But it [does not] say you have to.'' Tr. 434. When asked by 
the ALJ whether ``documenting the resolution of this red flag issue 
might be the best practice,'' Mr. Parrado testified ``It might be, 
[it is] a good, I do it.'' Id. at 436. Later, Mr. Parrado testified 
that, ``[y]ou have to resolve the flag . . . . Does it say anywhere 
that you have to document it? No. Should you? Of course. How are you 
going to remember; how is your partner coming going to know, because 
there [are] many pharmacists coming in and out of the pharmacy.'' 
Id. at 438.
---------------------------------------------------------------------------

    Mr. Parrado explained that to resolve any red flag regarding 
``immediate release'' medication, the physician can be consulted. Id. 
at 447-48. Mr. Parrado noted that ``immediate release'' medications are 
cheaper than the extended release versions, and that the insurance 
company may not pay for extended release. Id. at 448.
    Mr. Parrado also disagreed with Dr. Hamilton's estimated price for 
each pill of oxycodone at .90 cents. Id. at 449. Mr. Parrado suggested 
the price of Schedule 2 controlled substances are often inflated to 
accommodate the added expenses inherent in dispensing them, such as 
additionally scrutiny, legwork, record-keeping, and inventories. Id. 
Mr. Parrado conceded that pharmacy pricing was very competitive. Id. at 
449-50. Mr. Parrado explained that insurance issues can explain why a 
pharmacy may only accept cash payments \*V\ *[omitted]. Id. at 450-51. 
Mr. Parrado explained that ``cash'' in the pharmacy business may 
include by credit card or even by check. Id. at 460.
---------------------------------------------------------------------------

    \*V\ The ALJ further found that the insurance issues can explain 
why a customer would pay cash. That portion of the finding is 
neither relevant to the alleged conduct nor did I find support for 
it in the record. Tr. 450-51.
---------------------------------------------------------------------------

    The only explanations Mr. Parrado could give for a pharmacy 
charging different prices for the same medication was a potential 
higher cost from a different wholesaler, the use of discount coupons, 
or indigent pricing programs. Id. at 451-52.
    Regarding inordinate travel to fill a prescription, Mr. Parrado 
agreed it was a red flag, which needed to be resolved. Id. at 453. 
*[But Mr. Parrado did not go on to opine as to whether or not the red 
flag was resolved with regard to the patient file for A.R. at issue in 
this case. Id.] As to the 8.5 mg prescription for hydromorphone, Mr. 
Parrado did not recognize it as requiring any investigation.\*W\ Id. at 
454. Prescriptions for compounded medications are a normal part of 
pharmacy work. Id. at 453-54; GX 12, p. 17-18.
---------------------------------------------------------------------------

    \*W\ Mr. Parrado did not testify in the positive or the negative 
regarding the need for an investigation, and he was never asked 
whether an 8.5 mg prescription for hydromorphone raised a red flag 
that needed to be resolved. Tr. 454.
---------------------------------------------------------------------------

    As to Patient B.F., who was apparently suffering from stage 3 
hepatic cancer, Mr. Parrado opined that absent an inconsistent physical 
presentation by the patient at the pharmacy, the diagnosis itself 
resolved any ``red flag'' created by the large amount of opioids 
prescribed. Id. at 455-56.
    Mr. Parrado disagreed with Dr. Hamilton's concept of the ``minimum 
standard of care,'' which Dr. Hamilton attributed to both the Florida 
Administrative Code, specifically ``Florida Regulation 64B,'' \42\ and 
guidelines from the National Board of Pharmacy Association. Id. at 180, 
351-58. Mr. Parrado understood the ``minimum standard of care'' as a 
violation of a law or rule of the Pharmacy Act, or of the Florida

[[Page 54563]]

Administrative Code. Id. at 456. Mr. Parrado did not recognize any 
violation of the Florida minimum standard of care by Pharmacy 4 Less in 
the documents he reviewed and interviewing the two pharmacists 
involved. Id. at 456-58. Mr. Parrado reviewed favorable Florida 
Department of Health Inspection Reports dated February 28, 2017, 
September 5, 2017. Id. at 475-80, 546; RX 14, 15, 16, 17. One of the 
documents Mr. Parrado reviewed at Pharmacy 4 Less was their biennial 
inventory completed April 26, 2017. Tr. 489.
---------------------------------------------------------------------------

    \42\ See West's Florida Administrative Code, Title 64. 
Department of Health, Subtitle 64b16, Chapter 64B16-27--Pharmacy 
Practice.
---------------------------------------------------------------------------

    Mr. Parrado disagreed with Dr. Hamilton's opinion that 84 or 112 
opioid tablets, *[for 30 mg of oxycodone,] represented ``red flags,'' 
which needed to be resolved. Id. at 461-63. He did not consider these 
to be inordinate amounts. Id. at 463.
    Mr. Parrado agreed that the simultaneous prescribing of oxycodone 
and buprenorphine to Patient A.V. represented a ``red flag'' which 
needed to be resolved. Id. at 463. Mr. Parrado was able to resolve it 
by reviewing the PRM records. Id. at 464. It revealed the pharmacy had 
contacted the physician, who advised he was attempting to wean the 
patient off of the oxycodone. Id. at 463-65.
    In reviewing the PRM for each of the ten subject patients, Mr. 
Parrado found evidence that Pharmacy 4 Less contacted or attempted to 
contact the physician in each of ten cases to resolve red flags, and 
that each ''red flag'' described by Dr. Hamilton was properly resolved. 
Id. at 490-92.
    Mr. Parrado found none of the dosage units inordinately high, not 
even the 8 mg of hydromorphone. Id. at 491. He actually deemed 15 to 20 
mg of oxycodone a ``very low dose,'' in contrast to Dr. Hamilton's 
assertion that those doses were relatively high. Id. at 510. As to the 
high prices charged, Mr. Parrado disagreed that the subject prices were 
suspiciously high. Id. at 492-93, 534. Mr. Parrado explained that 
following the crackdown on ``pill mills'' in Florida, opioids became 
more difficult for patients to obtain. Id. at 457, 539. They may have 
to travel to multiple pharmacies to even find the medication, so they 
would be willing to pay higher prices for them. Id. at 457, 539.
    Mr. Parrado did not address the ``red flag'' described by Dr. 
Hamilton for the ongoing opioid prescriptions without considering a 
reduction in dosage, ``individualization.'' \*X\ Id. at 492.
---------------------------------------------------------------------------

    \*X\ Though Mr. Parrado did not specifically address this red 
flag, he did testify generally that assuming there were red flags 
with every one of the patients, those red flags ``seemed to be'' 
resolved in every case and that he ``saw documentation where they 
had written down the resolutions.'' Tr. 492.
---------------------------------------------------------------------------

    On cross-examination, Mr. Parrado was confronted with Florida 
Administrative Code Section 64(B)16-27.800, requiring pharmacies to 
maintain patient records. Id. at 495-96. It specifically requires the 
pharmacy 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,'' *[and requires that a ``reasonable effort is made to 
obtain, record and maintain . . . pharmacist comments relevant to the 
individual's drug therapy, including any other information peculiar to 
the specific patient or drug.'' Tr. 496.]
    Mr. Parrado indicated the ``red flag'' identified by Dr. Hamilton 
regarding whether patients could be opioid na[iuml]ve had been resolved 
by the subject pharmacists. Id. at 497. Mr. Parrado learned this by 
interviewing the pharmacists, and being satisfied with the steps they 
*[told Mr. Parrado that they generally] took, including checking with 
the PDMP. Id. at 496-99.
    Mr. Parrado did not observe the ten patients increasing their 
dosage above the norm. Id. at 511. Most appeared to remain at 
``maintenance levels.'' Id. at 511-12.
    As to Patient R.V., who, according to the pharmacy notes, was 
suffering from a neoplasm, Mr. Parrado was not ``concerned'' by a 
medical record from the pain doctor, which described her condition as 
cervicalgia resulting from a ``fender bender.'' Id. at 516-22, 549; RX 
34, p. 1, RX 35, p. 2.
    As to Patient B.F., who Mr. Parrado testified was suffering from 
liver cancer, however, Mr. Parrado was unable to identify the cancer 
diagnosis by virtue of the diagnostic codes contained in the records. 
Id. at 514. However, he recalled seeing the cancer diagnosis in a 
medical note. Id. at 513-16.
    Regarding RX 22, pp. 2-3; GX 10, Mr. Parrado discovered the 
pharmacists resolved the red flag by speaking with the subject 
pharmacists, who advised they confirmed they contacted the physician, 
who advised he was weaning the patient off of oxycodone with 
buprenorphine. Tr. 522-25. However, in GX 10, it appears the 
buprenorphine was prescribed for sciatica pain. Id. at 524-25. Mr. 
Parrado dismissed the medical codes as likely erroneous, choosing to 
rely on the conversation between the pharmacist and the physician. Id. 
at 525-26. As to the nearly one year period of *[unchanged strength] 
oxycodone prescriptions from April 12, 2016 to April 10, 2017, in 
conjunction with the buprenorphine intervention, Mr. Parrado recognized 
it to be a red flag, which would require the pharmacist to investigate 
by contacting the physician, pursuant to Fla. Admin. Code Sec.  16-
27.810. Tr. 526-27. *[Mr. Parrado did not testify specifically as to 
whether or not this ``red flag'' was in fact resolved with a call to 
the physician. Tr. 527.]
    As to Patient R.R., who apparently suffered a ``broken back'' and 
fractured tibia from a car accident, Mr. Parrado was not concerned that 
the patient was discharged from the hospital on May 2, 2017, yet the 
final prescription was issued on May 30, 2017. Id. at 527-28, 551; RX 
32, pp. 1-2. Mr. Parrado did not consider a prescription issued a month 
after discharge unusual, and assumed the patient had not yet found 
another doctor. Tr. 528. Mr. Parrado was not concerned by the medical 
report denying any surgical history for R.R., as it was not 
contradictory of the above pharmacy notes, explaining a broken tibia 
does not necessarily require surgery. Tr. 529.
    As to Patient A.E., although Mr. Parrado reviewed the relevant 
medical records, which contained some obvious contradictions, including 
the patient claiming a pain level of 10 of 10, yet the physical 
examination by the physician showed no physical restrictions. Id. at 
532. Mr. Parrado did not appear to have evaluated the substance of the 
medical records, but only the fact that the pharmacist had obtained the 
records and verified the patient was being treated for pain.\*Y\ Tr. 
529-32; RX 18, RX 19, pp. 2, 3.
---------------------------------------------------------------------------

    \*Y\ Mr. Parrado testified, that he was not considering the 
medical records with specificity for their content, but ``was 
looking to see that they had gotten something from the doctor to 
help them resolve [red flags]. . . . [he] considered the fact that 
they had [the medical record], and that the doctor was treating pain 
and that they had gotten that.'' Tr. 532.
---------------------------------------------------------------------------

    As to Patient K.E.D., who was reportedly suffering from ``chronic 
pain'' as the result of a ``severe auto accident,'' yet the medical 
records deny past hospitalization, Mr. Parrado focused on the key 
findings of ``chronic pain'' and ``auto accident'' and not on 
contradictions in the medical records. Tr. 532-33, 552; RX 28, 29, p. 
3.
    As to Patient A.R., who apparently drove 45.4 miles *[one way] to 
see his physician and to obtain his medications at Pharmacy 4 Less, Mr. 
Parrado did not find that distance unusual, citing the difficulty in 
locating pharmacies which carried opioids. Tr. 539. Mr. Parrado 
conceded he has testified in other cases that driving 40 miles was a 
red flag. Id. at 541-42. Mr. Parrado distinguished his prior testimony 
as the distance was also part of a suspicious pattern. Id. at 542.

[[Page 54564]]

    Mr. Parrado conceded that dual prescriptions for hydromorphone and 
methadone represented a red flag, but one which could be resolved by 
contacting the physician. Id. at 542-43. As to Patient B.F., Mr. 
Parrado did not consider multiple different opioid prescriptions 
concerning, explaining that physicians often try different medications 
to find an effective treatment. Id. at 543-44; RX 24, pp. 2-3. Further, 
Mr. Parrado did not view the simultaneous prescription of methadone and 
hydromorphone concerning, as methadone could be used as an extended 
release reliever, while the hydromorphone was an immediate release. Id. 
at 544. Mr. Parrado conceded he had testified previously that that 
combination was a red flag, but a resolvable red flag. Id.
    As to Patient A.V., the prescription bore a code for sciatica. Id. 
at 545. Mr. Parrado \*Z\ *[testified that the diagnostic code for 
sciatica was inherently reliable because it was handwritten as opposed 
to created by a computer.] Id. at 545-46, 551; GX 10, p. 15.
---------------------------------------------------------------------------

    \*Z\ The ALJ found that Mr. Parrado was not concerned by the 
sciatica code, as errors happen. I understand, and have edited this 
finding accordingly, Mr. Parrado's testimony to be that here the 
sciatica code was inherently reliable because it was handwritten 
rather than generated by a computer error, which he previously 
testified occurs frequently. Tr. 545.
---------------------------------------------------------------------------

    Mr. Parrado testified that ``due diligence files'' in a pharmacy 
would include all information used by the pharmacists to resolve red 
flags. Tr. 546.
Mr. Parrado's Sur-Rebuttal Testimony
    During the second part of the hearing, the Respondent recalled Mr. 
Parrado to give sur-rebuttal testimony to the Government's rebuttal 
case. The Government objected to the testimony by Mr. Parrado and 
argued that sur-rebuttal testimony was not permitted by the rules. Id. 
at 1027. This Tribunal sustained the government's objection, but 
permitted the Respondent to continue questioning Mr. Parrado to make 
his record for the Administrator's consideration should the 
Administrator find this Tribunal's evidentiary ruling in error. Id. at 
1028-29.
    This Tribunal instructed the parties to brief the issue as to the 
propriety of sur-rebuttal testimony. In their Posthearing Brief, the 
Government concedes that there is no express prohibition of sur-
rebuttal testimony, however, the regulations provide that unduly 
repetitious testimony will not be admitted. Govt Posthearing Brief at 
46-47; 21 CFR 1316.59(a). The Government argues that the Respondent did 
not identify what was being proffered and the additional testimony 
``was doing nothing more than seeking to bolster [the Respondent's] 
case.'' Govt Posthearing Brief at 46.
    Upon a review of the Government's brief and the transcript of the 
proceedings, I find that sustaining the Government's objection to sur-
rebuttal testimony was ill-advised. Although there is no relevant 
regulation or rule authorizing sur-rebuttal, neither is there a 
regulation or rule authorizing rebuttal testimony.\43\ However, the 
Attorney General's Manual on the APA finds in Presentation of Evidence, 
Section 7 (c) that ``[e]very party shall have the right to present his 
case or defense by oral or documentary evidence, to submit rebuttal 
evidence, and to conduct such cross-examination as may be required for 
a full and true disclosure of the facts.'' Accordingly, this Tribunal 
recommends that the Administrator find the subject ruling in error and 
fully consider Mr. Parrado's sur-rebuttal testimony as direct evidence, 
to the extent it does not exceed the scope of rebuttal evidence.\44\
---------------------------------------------------------------------------

    \43\ The Agency has permitted and considered surrebuttal 
evidence in the past. Flavio D. Gentile, M.D.; 55 FR 3113 (1990).
    \44\ Sur-rebuttal evidence is permitted to confront the opposing 
party's rebuttal evidence.
---------------------------------------------------------------------------

    On sur-rebuttal, in explaining the differences between the 
Government's and the Respondent's versions of the medical record 
exhibits, Mr. Parrado affirmed the propriety of updating pharmacy 
records as relevant information is learned. Id. at 1029-30. Mr. Parrado 
further affirmed the propriety of including Schedules 3-5 prescriptions 
within the pharmacy records to reflect the totality of the dispensing, 
and not just the Schedule 2 prescriptions.\*AA\ Id. at 1033-34.
---------------------------------------------------------------------------

    \*AA\ Mr. Parrado testified that when considering the ``total 
profile'' of all prescriptions for these patients, ``the patients 
were getting all their medications there . . . . [that is] what you 
want. . . . You [do not] want him just buying controls from you 
because now you [do not] know what else is going on with that 
patient. . . . It essentially resolved that red flag'' meaning the 
person is not ``just trying to obtain narcotics from [the 
pharmacy].'' Tr. 1033-34.
---------------------------------------------------------------------------

    Mr. Parrado further opined that many of the medical conditions and 
diagnoses noted in Pharmacy 4 Less files, ``chronic pain, cancer, 
neoplasms, broken backs'' are conditions which cannot be treated by 
surgery, but rather by opioid therapy. Id. at 1029-31. The dosage and 
frequency of such opioid therapy is designed to permit the patient to 
operate at a normal level. Id. at 1032. As to Dr. Hamilton's 
expectation of the tapering down of opioid doses, Mr. Parrado noted 
tapering in chronic pain patients was often difficult and ineffective. 
Id. at 1036. Finally, Mr. Parrado offered that the Respondent issued a 
below average number of oxycodone tablets as compared to other Florida 
pharmacies during the relevant period. Id. at 1037-40. Mr. Parrado 
conceded there were no pharmacy records explaining that the long 
distances traveled by customers of the Respondent was due to pharmacies 
going out of business. Id. at 1041. Nor did Mr. Parrado observe records 
in this case suggesting patients could not afford extended release 
medications. Id. at 1041.

The Facts

Stipulations of Fact

    The Government and the Respondent, through counsel, have agreed to 
thirteen stipulations, which I recommend be accepted as fact in these 
proceedings:
    1. Pharmacy 4 Less, LLC, is registered with the DEA to handle 
controlled substances under Schedules II to V under DEA COR No. 
FP5459082. Its registered address is: 805 Douglas Avenue, Suite 159, 
Altamonte Springs, Florida 32714.
    2. Pharmacy 4 Less's COR was issued on February 2, 2018.
    3. Richard Sprys, R.Ph., C.Ph., is the owner and manager of 
Pharmacy 4 Less.
    4. Amy Mincy, R.Ph., is a pharmacist at Pharmacy 4 Less.
    5. On June 6, 2017, DEA conducted an audit of Pharmacy 4 Less.
    6. Proposed Government's Exhibit 2 is a true and correct copy of 
the June 22, 2017 Administrative Subpoena served upon Pharmacy 4 Less.
    7. Pharmacy 4 Less completed its compliance with the administrative 
subpoena on July 11, 2017.
    8. DEA served Pharmacy 4 Less with an Order to Show Cause on July 
5, 2018.
    9. Pharmacy 4 Less submitted a Corrective Action Plan to John J. 
Martin, Assistant Administrator for the Diversion Control Division of 
DEA, on July 31, 2018.
    10. Pharmacy 4 Less submitted a Request for Hearing to the Office 
of the Administrative Law Judges at DEA Headquarters on August 1, 2018.
    11. On August 8, 2018, Mr. Martin denied Respondent's request to 
discontinue or defer administrative proceedings.
    12. Ms. Amy Mincy signed the DEA Form 82, Notice of Inspection of 
Controlled Premises on behalf of Pharmacy 4 Less during the June 6, 
2017 on-site inspection. Tr. 38.
    13. RX 19, 21, 23, 25, 27, 29, 31, 33, 35, 37 were supplied to the 
DEA in response to the July 9, 2018 administrative subpoena. Tr. 812-
13.

[[Page 54565]]

Findings of Fact

    The factual findings below are based on a preponderance of the 
evidence, including the detailed, credible, and competent testimony of 
the aforementioned witnesses, the exhibits entered into evidence, and 
the record before me.
    1. The Respondent currently holds active COR FP5459082. ALJ Ex. 1.
    2. DI1 conducted an on-site inspection of Pharmacy 4 Less on June 
6, 2017. Tr. 37.
    3. Pharmacy 4 Less was randomly picked for regulatory inspection by 
the DEA. Tr. 37.
    4. Ms. Amy Mincy signed the Notice of Inspection presented to her 
by DI1. Tr. 38-39; GX 30.
    5. Ms. Mincy could not locate an initial inventory, and Mr. Richard 
Sprys confirmed via speakerphone with DI1 that Pharmacy 4 Less did not 
have an initial inventory. Tr. 39-40.
    6. Ms. Mincy provided DI1 with a purported biennial inventory, but, 
*[according to DI1,] it did not indicate whether it had been completed 
either at the opening or closing of business. Tr. 41-42; GX 37.
    7. When asked about the pharmacy's CSOS system, Ms. Mincy 
demonstrated to DI1 how the pharmacy ordered controlled substances on 
the system. Tr. 43-45.
    8. DI1 contacted Mr. Chris Jewell, one of the personnel in charge 
of the CSOS system at DEA Headquarters. Mr. Jewell ran a report which 
stated that Ms. Mincy received her own CSOS credentials in July 2018. 
Tr. 47-49; GX 29.
    9. DI1 conducted an audit of Pharmacy 4 Less's records and 
inventories. Tr. 53-93, 919-26; GX 4, 31, 32. DI1 selected a starting 
date of January 1, 2017, due to discrepancies in the biennial 
inventory, the lack of an initial inventory, and Pharmacy 4 Less 
maintained handwritten Schedule 2 controlled substance logs. Tr. 56, 
61.
    10. DI1 and other personnel returned to Pharmacy 4 Less on June 21, 
2017. Both Ms. Mincy and Mr. Sprys were present. Tr. 88-89.
    11. DI1 asked Ms. Mincy and Mr. Sprys how they determined whether 
prescriptions were for a legitimate medical purpose. Both pharmacists 
responded they would check E-FORCSE and that they would verify 
prescriptions by contacting the patients' doctors. The DIs were 
provided with a red folder that contained screenshots from the 
pharmacy's computer system, Rx30. Tr. 89-92. The red folder contained 
screenshots from the Rx30 program. Id. at 96. The red folder also 
contained the pharmacists' notes on patients, referred to as ``due 
diligence files.'' Id. at 97.
    12. On June 22, 2017, an administrative subpoena was issued to 
Pharmacy 4 Less, requesting hard copy prescriptions for all Schedules 
2-5 controlled substance prescriptions from October 2015 through June 
22, 2017, all controlled substance prescription data from Rx30, and all 
due diligence patient files. Id. at 93-94; GX 2. Pharmacy 4 Less 
complied by delivering a gray tote container that contained 
``California'' folders filled with Schedule 2 hard copy prescriptions, 
a thumb drive containing all Rx30 data, and the red folder seen during 
the June 21 on-site inspection. Id. at 96. The Schedules 3-5 
prescriptions were delivered to the DIs by Pharmacy 4 Less at an 
unidentified later date. Id. at 97.
Treatment of Patient A.E.
    13. Pharmacy 4 Less dispensed hydromorphone 8 mg to Patient A.E. on 
21 occasions between November 19, 2015, and June 1, 2017. GX 6.
    14. On November 19, 2015, Pharmacy 4 Less dispensed Patient A.E. 84 
tablets of hydromorphone 8 mg without determining whether Patient A.E. 
was opioid na[iuml]ve. Tr. 183-86; GX 28, p. 6; GX 37, p. 11.
    15. Between November 19, 2015, and June 1, 2017, Pharmacy 4 Less, 
on 21 separate occasions, dispensed hydromorphone 8 mg tablets to 
Patient A.E. at a price of approximately $5.95 per tablet, even though 
other retail pharmacies were selling hydromorphone 8 mg at 
approximately $1.50 per tablet. Tr. 195-99; 200-03; GX 28, pp. 6-7.
    16. Between December 17, 2015, and June 1, 2017, Pharmacy 4 Less, 
on 20 separate occasions, dispensed hydromorphone to Patient A.E. 
without determining why hydromorphone was being prescribed on a long-
term basis without the presence of a long-acting pain medication. Tr. 
192-95; 200-03; GX 28, p. 6.
Treatment of Patient A.R.
    17. Pharmacy 4 Less dispensed oxycodone 15 mg to Patient A.R. on 17 
occasions between March 17, 2016, and June 7, 2017; GX 8.
    18. On March 17, 2016, Pharmacy 4 Less dispensed Patient A.R. 112 
tablets of oxycodone 15 mg without determining whether Patient A.R. was 
opioid na[iuml]ve. Tr. 205-07; GX 28, p. 12.
    19. Between March 17, 2016, and June 7, 2017, Pharmacy 4 Less, on 
17 separate occasions, dispensed oxycodone 15 mg tablets to Patient 
A.R. at a price of approximately $2.23 to $2.50 per tablet, even though 
other retail pharmacies were selling oxycodone 15 mg at approximately 
$0.90 per tablet at the time. Tr. 205-07, 212-14; GX 28, pp. 12-13.
    20. Between May 11, 2016, and June 7, 2017, Pharmacy 4 Less, on 15 
separate occasions, dispensed oxycodone 15 mg to Patient A.R. without 
determining why oxycodone was being prescribed on a long-term basis 
without the presence of a long-acting pain medication. Tr. 212-14, GX 
28 p. 12.
    21. Between March 17, 2016, and June 7, 2017, Pharmacy 4 Less, on 
17 separate occasions, dispensed oxycodone 15 mg tablets to Patient 
A.R., even though Pharmacy 4 Less's records do not show that Pharmacy 4 
Less ever addressed why Patient A.R. traveled southwest approximately 
37 miles from his house in Daytona Beach, Florida to his doctor's 
office in Sanford, Florida; traveled approximately 15 miles further 
southwest to buy his controlled substances from Pharmacy 4 Less, and 
then returned approximately 45 miles northeast to his home in Daytona 
Beach, Florida. Tr. 207-14, 334-35, GX 28, p. 13.
Treatment of Patient A.V.
    22. Pharmacy 4 Less dispensed buprenorphine and/or oxycodone to 
Patient A.V. on 14 occasions between April 12, 2016, and April 10, 
2017. GX 10.
    23. On March 17, 2016, Pharmacy 4 Less dispensed Patient A.V. 112 
tablets of oxycodone 20 mg without determining whether Patient A.V. was 
opioid na[iuml]ve. Tr. at 262, 267-68; GX 28, p. 8.
    24. Between April 12, 2016, and February 13, 2017, on 8 separate 
occasions, Pharmacy 4 Less filled prescriptions for Patient A.V. for 
112 tablets of oxycodone 20 mg, an opioid, within nine days of filling 
a prescription for 29-60 tablets of buprenorphine 8 mg, a controlled 
substance used to treat opioid addiction. Seven of the eight fills took 
place on the same day. Tr. at 261-76; GX 28, p. 8.
    25. Between April 21, 2016, and April 10, 2017, Pharmacy 4 Less, on 
12 separate occasions, dispensed oxycodone 20 mg tablets to Patient 
A.V. at a price of approximately $2.59 per tablet, even though other 
retail pharmacies were selling oxycodone 20 mg at approximately $1.25 
per tablet at the time. Tr. at 262-76; GX 28, pp. 8-9.
    26. Between July 5, 2016, and April 10, 2017, Pharmacy 4 Less, on 
10 separate occasions, dispensed oxycodone to Patient A.V. without 
determining why oxycodone was being

[[Page 54566]]

prescribed on a long-term basis without the presence of a long-acting 
pain medication. Tr. at 268-76; GX 28, p. 8.
Treatment of Patient B.F.
    27. Pharmacy 4 Less dispensed hydromorphone to Patient B.F. on 17 
occasions between October 27, 2015, and May 15, 2017. GX 12.
    28. On October 27, 2015, Pharmacy 4 Less dispensed Patient B.F. 64 
tablets of hydromorphone 8 mg without determining whether Patient B.F. 
was opioid na[iuml]ve. Tr. at 217-18; GX 28, p. 10; GX 38, p. 5.
    29. Between November 24, 2015, and May 15, 2017, Pharmacy 4 Less, 
on 16 separate occasions, dispensed hydromorphone 8 mg tablets to 
Patient B.F. at a price of approximately $5.70 to $5.83 per tablet, 
even though other retail pharmacies were selling hydromorphone 8 mg at 
approximately $1.50 per tablet at the time. Tr. at 218-22; GX 28, p. 
11.
    30. Between December 30, 2015, and May 15, 2017, Pharmacy 4 Less, 
on 15 separate occasions, dispensed hydromorphone to Patient B.F. 
without determining why hydromorphone was being prescribed on a long-
term basis without the presence of a long-acting pain medication. Tr. 
219-22; GX 28, p. 10.
Treatment of Patient B.N.
    31. Pharmacy 4 Less dispensed either hydromorphone or oxycodone to 
Patient B.N. on 19 occasions between January 22, 2016, and June 2, 
2017. GX 14.
    32. On January 22, 2016, Pharmacy 4 Less dispensed to Patient B.N. 
90 tablets of hydromorphone 8 mg without determining whether Patient 
B.F. was opioid na[iuml]ve. Tr. 222-27; GX 28, p. 14.
    33. Between January 22, 2016, and August 15, 2016, Pharmacy 4 Less, 
on nine separate occasions, dispensed hydromorphone 8 mg tablets to 
Patient B.N. at a price of approximately $5.95 to $6.45 per tablet, 
even though other retail pharmacies were selling hydromorphone 8 mg at 
approximately $1.50 per tablet at the time. Tr. 222-35; GX 28, p. 15.
    34. Between September 9, 2016, and June 2, 2017, Pharmacy 4 Less, 
on ten separate occasions, dispensed oxycodone 30 mg tablets to Patient 
B.N. at a price of approximately $5.00 per tablet, even though other 
retail pharmacies were selling oxycodone 30 mg tablets at approximately 
$0.90 per tablet at the time; Tr. 232-35; GX 28, p. 15.
    35. Between March 15, 2016, and June 2, 2017, Pharmacy 4 Less, on 
17 separate occasions, dispensed hydromorphone and oxycodone to Patient 
B.N. without determining why hydromorphone and oxycodone were being 
prescribed on a long-term basis without the presence of a long-acting 
pain medication. Tr. 222-35; GX 28, pp. 14-15.
Treatment of Patient K.E.D.
    36. Pharmacy 4 Less dispensed oxycodone to Patient K.E.D. on 21 
occasions between October 26, 2015, and June 7, 2017. GX 18.
    37. On October 26, 2015, Pharmacy 4 Less dispensed to Patient 
K.E.D. 112 tablets of oxycodone 20.5 mg without determining whether 
Patient K.E.D. was opioid na[iuml]ve. Tr. 241-44; GX 28, p. 16; GX 38, 
p. 7.
    38. Between October 26, 2015, and June 7, 2017, Pharmacy 4 Less, on 
21 separate occasions, dispensed oxycodone 20 mg tablets to Patient 
K.E.D. at a price of approximately $3.57 to $3.84 per tablet, even 
though other retail pharmacies were selling oxycodone 20 mg at 
approximately $0.90 per tablet at the time. Tr. 241-47; GX 28, p. 17.
    39. Between December 21, 2015, and June 7, 2017, Pharmacy 4 Less, 
on 19 separate occasions, dispensed oxycodone to Patient K.E.D. without 
determining why oxycodone was being prescribed on a long-term basis 
without the presence of a long-acting pain medication. Tr. 244-47; GX 
28, pp. 16-17.
Treatment of Patient K.Y.D.
    40. Pharmacy 4 Less dispensed oxycodone to Patient K.Y.D. on 17 
occasions between February 4, 2016, and June 12, 2017. GX 16.
    41. On February 4, 2016, Pharmacy 4 Less dispensed to Patient 
K.Y.D. 84 tablets of oxycodone 30 mg without determining whether 
Patient K.Y.D. was opioid na[iuml]ve. Tr. 237-38; GX 28, p. 20.
    42. Between February 4, 2016, and June 12, 2017, Pharmacy 4 Less, 
on 17 separate occasions, dispensed oxycodone 30 mg tablets to Patient 
K.Y.D. at a price of approximately $3.45 per tablet, even though other 
retail pharmacies were selling oxycodone 30 mg at approximately $0.90 
per tablet at the time. Tr. 237-41; GX 28, pp. 20-21.
    43. Between March 31, 2016, and June 12, 2017, Pharmacy 4 Less, on 
15 separate occasions, dispensed oxycodone to Patient K.Y.D. without 
determining why oxycodone was being prescribed on a long-term basis 
without the presence of a long-acting pain medication. Tr. 237-41; GX, 
p. 20.
Treatment of Patient R.R.
    44. Pharmacy 4 Less dispensed oxycodone to Patient R.R. on 21 
occasions between October 28, 2015, and May 30, 2017. GX 20.
    45. On October 28, 2015, Pharmacy 4 Less dispensed to Patient R.R. 
112 tablets of oxycodone 18 mg without determining whether Patient R.R. 
was opioid na[iuml]ve. Tr. 247-50; GX 28, p. 18; GX 38, p. 8.
    46. Between November 23, 2015, and May 30, 2017, Pharmacy 4 Less, 
on 20 separate occasions, dispensed oxycodone 15 mg tablets \*BB\ to 
Patient R.R. at a price of approximately $2.28 to $2.41 per tablet, 
even though other retail pharmacies were selling oxycodone 15 mg at 
approximately $0.90 per tablet at the time. Tr. 247-50; GX 28, p. 19.
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    \*BB\ Additionally, on October 28, 2015, Pharmacy 4 Less, 
dispensed oxycodone 18 mg tablets to Patient R.R. at a price of 
approximately $2.23.
---------------------------------------------------------------------------

    47. Between December 21, 2015, and May 30, 2017, Pharmacy 4 Less, 
on 19 separate occasions, dispensed oxycodone to Patient R.R. without 
determining why oxycodone was being prescribed on a long-term basis 
without the presence of a long-acting pain medication. Tr. 248-50; GX 
28, pp. 18-19.
Treatment of Patient R.V.
    48. Pharmacy 4 Less dispensed oxycodone to Patient R.V. on 22 
occasions between November 17, 2015, and June 19, 2017. GX 22.
    49. On November 17, 2015, Pharmacy 4 Less dispensed to Patient R.V. 
112 tablets of oxycodone 20 mg without determining whether Patient R.V. 
was opioid na[iuml]ve. Tr. 251-53; GX 28, p. 22; GX 38, p. 7.
    50. Between November 17, 2015, and June 19, 2017, Pharmacy 4 Less, 
on 21 separate occasions,\45\ dispensed oxycodone 20 mg tablets \*CC\ 
to Patient R.V. at a price of approximately $2.23 to $3.04 per tablet, 
even though other retail pharmacies were selling oxycodone 20 mg at 
approximately $0.90 per tablet at the time. Tr. 251-55; GX 28, pp. 22-
23.
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    \45\ The Government is not alleging that the price charged on 
March 27, 2017 was unreasonable.
    \*CC\ Except for on April 22, 2017, when Oxycodone 15 mg was 
dispensed at a price of $2.23 per tablet. GX 22, p. 71.
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    51. Between January 11, 2016, and June 19, 2017, Pharmacy 4 Less, 
on 20 separate occasions, dispensed oxycodone to Patient R.V. without 
determining why oxycodone was being prescribed on a long-term basis 
without the presence of a long-acting pain medication. Tr. 252-55; GX 
28, p. 22.
Treatment of Patient V.W.
    52. Pharmacy 4 Less dispensed oxycodone to Patient V.W. on 21 
occasions between November 30, 2015, and May 31, 2017. GX 24.

[[Page 54567]]

    53. On November 30, 2015, Pharmacy 4 Less dispensed to Patient V.W. 
84 tablets of oxycodone 15 mg without determining whether Patient V.W. 
was opioid na[iuml]ve. Tr. 256-57; GX 28, p. 24; GX 38, p. 9.
    54. Between November 30, 2015, and May 31, 2017, Pharmacy 4 Less, 
on 21 separate occasions, dispensed oxycodone 15 mg tablets to Patient 
V.W. at a price of approximately $2.54 to $3.57 per tablet, even though 
other retail pharmacies were selling oxycodone 15 mg at approximately 
$0.90 per tablet at the time. Tr. 256-60; GX 28, pp. 24-25.
    55. Between January 25, 2016, and May 31, 2017, Pharmacy 4 Less, on 
19 separate occasions, dispensed oxycodone to Patient V.W. without 
determining why oxycodone was being prescribed on a long-term basis 
without the presence of a long-acting pain medication. Tr. 258-60; GX 
28, pp. 24.
Recordkeeping
    56. Pharmacy 4 Less did not have an initial inventory readily 
available during DI1's on-site inspection. Tr. 39-40.
    57. [According to DI1, the copy of Pharmacy 4 Less's biennial 
inventory that he viewed in-person during the inspection on June 6, 
2017, did not notate whether the inventory was completed at the opening 
or closing of business. Tr. 41-42.] \*DD\
---------------------------------------------------------------------------

    \*DD\ Finding of fact modified for clarity.
---------------------------------------------------------------------------

    58. Pharmacy 4 Less's biennial inventory (apparently revised 
sometime after June 6, 2017) did not indicate whether it was conducted 
at the ``close'' or ``opening of business,'' instead listing the time 
that it was completed. Compare GX 37, p. 2 with RX 38, p. 1. 
*[Specifically, the content appeared on a blank document that Ms. Mincy 
described as a cover page with handwriting stating ``Biennial 
Inventory; Completed April 26, 2017; 8AM'' and with signatures by both 
pharmacists. Id. The cover page was included in a fax to DI1 from 
Respondent pharmacy on June 7, 2017.] \*EE\
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    \*EE\ There is insufficient information in the record for me to 
conclusively determine whether or not the cover page was attached to 
the biennial inventory at the time of DEA's inspection. On the one 
hand, I fully credit DI1's testimony that the biennial inventory did 
not notate whether the inventory was ``completed at either the 
opening or closing of business.'' Tr. 41-42. However, I cannot tell 
whether DI was testifying that the specific words ``opening or 
closing of business'' did not appear on the biennial inventory 
(which I agree is true) or if he was testifying that the cover page 
at GX 37, p. 2 was not included on the biennial inventory that DI1 
was handed on the date of the inspection. If DI1's testimony meant 
the latter, it was unclear, and unfortunately, the biennial 
inventory was not seized during the inspection. Instead, the 
biennial inventory was faxed to DI1 the following day and the cover 
page was included. Notably, Mr. Sprys was out of the country at the 
time of the inspection and subsequent fax. As Mr. Spry's signature 
appears on the biennial inventory cover page that was faxed, it does 
not seem implausible to conclude that the cover page existed prior 
to Mr. Sprys leaving the country and prior to the inspection. 
Therefore, I cannot find substantial evidence to support the 
Government's allegation that the biennial inventory lacked the 
notation regarding whether it was conducted at the opening or 
closing of business.
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    59. Pharmacy 4 Less's records were inaccurate, and included 
shortages and overages. GX 4. Specifically, the shortages and overages 
are as follows

a. Oxycodone 15 mg: Shortage of 73 tablets
b. Oxycodone 20 mg: Shortage of 212 tablets
c. Oxycodone 30 mg: Shortage of 731 tablets
d. Hydromorphone 8 mg: Shortage of 149 tablets
e. Methadone 10 mg: Overage of 1,488 tablets
f. Suboxone 8 mg/2 mg: Overage of 224 tablets
g. Carisoprodol 350 mg: Shortage of 526 tablets

    60. Pharmacy 4 Less's [invoices] \*FF\ did not include the date the 
order was received for 84 invoices. Tr. 137-38; GX 26.
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    \*FF\ Modified because he ALJ referred to these documents as 
``222 Forms,'' but I find that they are more accurately described as 
``invoices.''
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Analysis

Credibility Analysis of Fact Witnesses

Ability To Recall Events
DI1
    Generally speaking, individuals experiencing an event out of the 
ordinary, such as an on-site inspection as occurred here, are likely to 
have a better memory of those events than the Government Diversion 
Investigator, who performs similar inspections on any number of 
clinics. It seems to me, all other factors being equal, it would be 
easier for a DI to forget or confuse events than the person inspected. 
However, in this matter, DI1 presented an overall clear description of 
events surrounding the June 6, 2017, and June 21, 2017 on-site 
inspections of Pharmacy 4 Less.
    DI1 occasionally had difficulty recalling the specific individual 
who responded to his questions. See, e.g., Tr. 90-91. This cuts 
slightly against his reliability. However, he was generally able to 
recall the key events as to what had occurred during the on-site 
inspections and the substance of the relevant conversations. His 
testimony is also generally corroborated by the documentary evidence.
    Further, DI1 demonstrated a basic understanding of the relevant DEA 
regulations as provided in the Code of Federal Regulations in order to 
properly perform his duties.\46\ He had some difficulty citing specific 
relevant provisions of the CFR when asked, which is quite 
understandable. However, part of DI1's testimony involved an issue 
contested by the Respondent regarding the necessity of the date of 
receipt on invoices maintained by the pharmacy, which this Tribunal 
finds necessary to separately analyze and discuss.\47\ Tr. 136-39.
---------------------------------------------------------------------------

    \46\ While this Tribunal heard testimony from DI1 about the 
regulations, it does not rely on DI1's understanding of the 
regulations in this Recommended Decision.
    \47\ See infra at section ``Date of Receipt on Invoices.''
---------------------------------------------------------------------------

    Based on a complete review of DI1's presentation of testimony, 
ability to recall events, and comparison with the other evidence, I 
find his testimony to be credible and should be afforded considerable 
weight.
Ms. Amy Mincy
    Ms. Amy Mincy's credibility presents more of a challenge for this 
Tribunal to address. During the first portion of the hearing in 
Orlando, Florida, Ms. Mincy appeared on the stand for the entire 
duration of the third day of testimony. At the beginning of her 
testimony, Respondent's counsel attempted to cover Ms. Mincy's 
professional background and C.V. Ms. Mincy struggled greatly 
remembering details about pharmacies where she had previously worked, 
and other details about her own professional background. While the 
transcript does not fully capture Ms. Mincy's difficulties in 
discussing her background, there are indications within the transcript 
that demonstrate these issues.\48\
---------------------------------------------------------------------------

    \48\ ``MR. INDEST: And since she's having a little bit of 
difficulty remembering some of these, I'd like the clerk to give her 
the hearing book and let her, if she needs to refer to the CV.
    THE WITNESS: I'm good.
    MR. INDEST: No, let's have it in front of you so we've got the 
dates right and everything, okay?'' Tr. 571.
    ``Q Okay, but where did you work next after that? Where did you 
work next? If you're having trouble remembering, if you need to 
refresh your recollection, please look at the CV because you're 
taking a long, long pause before you answer my questions. This might 
help speed things up.'' Tr. 572-73.
    ``Q Okay, and did you work as a pharmacy consultant after that?
    A For some places, yes.
    Q According to your CV, Ms. Mincy, listen, these are simple 
straightforward questions, and if you can't remember the answers.'' 
Tr. 573.
    ``MR. INDEST: Your Honor, I'd like the record to reflect I'm 
asking the questions and she's taking a long, long pause.'' Tr. 574.

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[[Page 54568]]

    Following the testimony of Ms. Mincy's background, Respondent's 
counsel moved on to the facts of this matter. Throughout her testimony, 
Ms. Mincy appeared to encounter great difficulty in remembering details 
of the June 6, 2017 on-site inspection. While Ms. Mincy appeared to 
remember some details, her presentation and delivery of those details 
appeared sometimes confused and disoriented. Throughout the direct 
examination, I noticed that Respondent's counsel had trouble eliciting 
answers from Ms. Mincy about the June 6, 2017 on-site inspection.\49\ 
Further, Respondent's counsel made a number of statements on the record 
that demonstrated his difficulty in eliciting testimony from Ms. Mincy, 
leading to a number of objections by Government counsel for leading the 
witness.\50\ While understandable that a lay witness may have some 
difficulties due to being nervous or anxious about her time on the 
witness stand, Ms. Mincy's inability to answer questions posed by her 
own attorney suggest issues with Ms. Mincy's ability to reliably recall 
events one would expect to be otherwise fairly memorable. Her 
presentation in Orlando clearly diminishes her reliability as a 
witness, especially as relates to her Orlando testimony.
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    \49\ ``ADMIN. LAW JUDGE DOWD: And I know you're having some 
difficulty with Ms. Mincy, but try not to lead, Mr. Indest.'' Tr. 
588.
    \50\ ``MR. MANN: She needs to answer his questions and not 
listen to him repeat the answers to her.
    MR. INDEST: Your Honor, she's having a very difficult time 
answering these questions.
    ADMIN. LAW JUDGE DOWD: It is what it is. But I'm going to 
sustain the objection as to leading.
    MR. INDEST: And, Your Honor, with that understanding, a witness 
that is hard to answer the questions should be given some, the 
counsel should be given some leeway to at least get the basic 
information.
    ADMIN. LAW JUDGE DOWD: I think I've given you leeway, Mr. 
Indest.
    MR. INDEST: Okay, thank you.
    ADMIN. LAW JUDGE DOWD: We have to have the testimony come from 
the witness.
    MR. INDEST: Okay, we'll try.'' Tr. 595-96.
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    During the second portion of the hearing in Arlington, Virginia, 
Ms. Mincy appeared to be more relaxed on the stand, which appeared to 
increase her ability to recall and to reliably convey her perception of 
the relevant events.
    Overall, I find that the reliability of her testimony was 
significantly diminished by her inability to recall details about both 
her own personal history and those surrounding the events of the on-
site inspections at Pharmacy 4 Less.\51\
---------------------------------------------------------------------------

    \51\ In its Posthearing Brief, the Government argues that Ms. 
Mincy's false testimony should not be credited. Govt Posthearing 
Brief at 33-36. The Government argues that she ``lied'' about 
checking E-FORCSE every time before she filled a prescription. I 
will not go to the extreme the Government suggests, especially in 
light of Ms. Mincy's demonstrated memory deficits. *[However, I do 
find that when comparing the testimony to GX 38, Ms. Mincy 
overstated her use of E-FORCSE and that her credibility on the 
subject is diminished. Remainder of footnote omitted for brevity.]
---------------------------------------------------------------------------

    The parties only presented one fact witness each as to the events 
surrounding the on-site inspections at Pharmacy 4 Less. It will 
therefore be necessary for me to compare and weigh the testimony of DI1 
and Ms. Mincy regarding the factual circumstances surrounding the on-
site inspections of Pharmacy 4 Less and the subsequent 
investigation.\52\ Physical evidence is more corroborative of DI1's 
testimony than that of Ms. Mincy's. When their testimony is in 
conflict, I find that it is proper to give greater weight to the 
testimony of DI1 over that of Ms. Mincy.
---------------------------------------------------------------------------

    \52\ As to the lack of corroboration of portions of Ms. Mincy's 
testimony, the owner of Pharmacy 4 Less and the only other 
pharmacist at the pharmacy, Mr. Richard Sprys, had the ability to 
corroborate crucial details about the pharmacy Ms. Mincy's testimony 
about the pharmacy's operations, details regarding the June 6, 2017 
phone call, and the June 21, 2017 on-site inspection. However, 
neither the Government nor the Respondent decided to call Mr. Sprys 
as a witness during the hearing. This Tribunal will not question 
either parties' trial strategy or determination of which witnesses 
to call, and notes that neither party has suggested any inference 
should be drawn regarding the failure to present evidence through 
Mr. Sprys. As such, we are without the benefit of Mr. Sprys 
testimony and are left only with the testimony evidence of DI1 and 
Ms. Mincy.
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Motivation to Color Testimony
    DI1, as a public servant, typically has no personal stake in the 
outcome of the instant inspection or in the revocation of the 
Respondent's Registration. The instant investigation was initiated at 
random. I noted no animus on his part as to the Respondent, its owner, 
or employees. Although he may be viewed as being part of the 
prosecution team, I saw no indication from his testimony that any 
partiality interfered with his reliable testimony.
    On the other hand, Ms. Mincy appeared to be very defensive of 
Pharmacy 4 Less and the pharmacy's practices. As one of the two 
pharmacists on staff at the pharmacy, the investigation directly 
implicates her practices and her employment at the pharmacy. I suspect 
that she would be more likely to color her testimony than would DI1.
    Ms. Mincy made statements during her testimony that make her 
motivation to color her testimony more likely. When confronted about 
the testimony of DI1, recalling statements made by Ms. Mincy during the 
June 6, 2017 on-site inspection, Ms. Mincy seemed to personalize the 
conflict. Ms. Mincy claimed that DI1 would have been ``lying,'' or that 
``he was confused.'' Tr. 823-25. Ms. Mincy said that DI1 ``was like a 
kid in a candy store.'' Id. at 824-25. She said that ``the longer he 
was there and the more he got access to, the wilder and crazier he 
got.'' Id. at 825. Ms. Mincy described her interactions with DI1 as 
``tormenting'' and ``almost, like, harassment'' of the Respondent. Id. 
at 825-26. While Ms. Mincy may have been testifying as to how she felt 
during the surprise on-site inspection with DI1, this colorful 
language, along with her description and characterization of the 
inspection, makes her testimony suspect as a possible attempt to 
improperly discredit DI1's testimony and his characterization of the 
on-site inspection.\53\ In combination with the previous discussion of 
Ms. Mincy's ability to recall events, I find that Ms. Mincy has more 
motivation to color her testimony than DI1.
---------------------------------------------------------------------------

    \53\ In its Posthearing Brief, the Government asserts that Ms. 
Mincy's testimony should be discredited when it is contradicted by 
DI1. Govt Posthearing Brief at 37. While I cannot reach the 
Government's assertion that Ms. Mincy is ``lying,'' I have already 
found that greater weight will be given to DI1's testimony whenever 
there is conflict between DI1 and Ms. Mincy's testimony.
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Credibility Analysis of Expert Witnesses and Opinions

    The relevant standard of care may be established by an expert 
witness through his experience in the field, and through his reliance 
upon and application of state and federal professional standards. 
*[Omitted for brevity.]
Dr. Thomas Hamilton, Pharm.D.
    Dr. Hamilton testified as the Government's expert witness in this 
matter. Dr. Hamilton was offered and was qualified as an expert in the 
practice of pharmacy in Florida. Tr. 174. Dr. Hamilton has worked as a 
pharmacist for 18 years. Id. at 167-69. His experience includes time at 
a small pharmacy before moving to work full-time as a pharmacist for 
Publix, where he has served in a variety of roles, including as a 
Pharmacist, the Assistant Manager of the Pharmacy, and as the Pharmacy 
Supervisor. He has served as a ``fixer'' or temporary Pharmacy Manager 
in order to ``clean up'' pharmacies. Id. at 169. In his role as 
Pharmacy Supervisor, he was in charge of overseeing up to 60 
pharmacies, and his duties included the hiring and firing of employees, 
and overseeing daily operations. Id. at 170. Additionally, Dr. Hamilton 
evaluated stand-alone, independent pharmacies for purchase

[[Page 54569]]

by Publix. This evaluation included review of the drug invoices, filled 
prescriptions and the nature of each pharmacy's overall business. Id. 
at 170-71. In order to spend more time with his young family, Dr. 
Hamilton decreased his responsibilities with the company, gave up his 
supervisory role, and now serves as a Pharmacy Manager of a single 
pharmacy. Id. at 286-87.
    During the hearing in this matter, Dr. Hamilton reviewed a number 
of materials provided to him by the DEA, including prescriptions (front 
and back), related patient medical notes, and patient addresses. Id. at 
177, 380-81. Additionally, Dr. Hamilton reviewed prescription pricing 
via GoodRX. Id. at 177-78. Dr. Hamilton also prepared an expert report 
in this matter based on the information and materials provided to him. 
GX 28.
    In general, Dr. Hamilton provided detailed assessments of each of 
the 10 charged patients in this matter. He detailed his review of the 
prescriptions provided for each of the 10 charged patients and any 
``red flags'' that he noticed through his review. His explanation that 
``red flags'' can be resolved through a review of the prescription and 
some investigation, including speaking with the patient, reviewing 
medical history, or speaking with the prescriber, were all consistent 
with his ultimate opinions in this matter. His opinions in this matter 
were bolstered by his knowledge and experience in this field, as well 
as his knowledge of ``Florida regulation 64B'' and guidance provided by 
the National Board of Pharmacy Association, which provide the source of 
pharmacy standards of care in Florida. Id. at 180, 351-58.
    On cross-examination, Dr. Hamilton's credibility was bolstered by 
his willingness to provide straightforward answers that were consistent 
with those opinions he had provided on direct examination. Dr. Hamilton 
conceded that he only reviewed the documents provided to him by the 
Government, but he was present throughout the hearing and was present 
to observe the testimony from the Respondent's witnesses. He indicated, 
when recalled during the Government's rebuttal case, that even after 
hearing the testimony and opinions from the Respondent's witnesses, his 
opinions in this matter had not changed. Tr. 1005. Further, Dr. 
Hamilton demonstrated objectivity. While Dr. Hamilton had differing 
opinions from Mr. Parrado in a variety of subjects, he was willing to 
concede areas in which he agreed with Mr. Parrado and did not appear to 
form opinions solely to favor the Government.
    Overall, I find Dr. Hamilton's testimony and opinions in this 
matter to be credible and reliable.
Mr. Robert Parrado, BPharm., R.Ph.
    Mr. Parrado testified as the Respondent's expert witness in this 
matter. Mr. Parrado was offered and qualified as a pharmacy expert. Id. 
at 431. Mr. Parrado has an extensive history in the pharmacy field. He 
appears to be approaching legend status in the field in Florida. He has 
been a licensed pharmacist in Florida since 1971. He was formerly 
licensed as a Consulting Pharmacist by the State of Florida until 1989. 
He has received numerous awards during his career. He is currently 
President and CEO of Parrado Pharmacy Consultants, Inc., which involves 
consulting with pharmacies, pharmacists, and with government agencies. 
Id. at 399-402; RX 5. He has previously worked at several pharmacies.
    From 2001 to 2004, Mr. Parrado was a member of the Florida Board of 
Pharmacy. From 2003 to 2009, he was on the Board's Accreditation 
Council in Pharmacy Education. While on the Board, Mr. Parrado also 
served on the Rules Committee and the Legislative Affairs Committee. 
During 2004, Mr. Parrado was Chairman of the Florida Board of Pharmacy. 
Since 2001, Mr. Parrado has been a perpetual member of the National 
Association of Boards of Pharmacy. Mr. Parrado was a member of the 
National ``Rules Committee'' which developed ``model rules'' for 
consideration by individual states. Id. at 409. For 18 months, ending 
in 2001, Mr. Parrado was President-elect of the Florida Pharmacy 
Association. Later, Mr. Parrado served as Speaker of the House of 
Delegates for the Association.
    Since 2014, Mr. Parrado has been guest lecturer on pharmacy law at 
the University of Florida College of Pharmacy. Id. at 410. As part of a 
recurring continuing education course, Mr. Parrado taught ``Resolving 
Red Flags, Allowing Patients to Legally Obtain Their Lawful Medical 
Prescriptions.'' Id. at 411. He has also presented to various 
professional organizations a course on ``Identifying Drug Diversion.'' 
Id. at 412. Mr. Parrado has testified as an expert witness previously, 
including an estimated eight or nine times as an expert called by DEA 
in these administrative proceedings. Id. at 414-16.
    It is undisputed that Mr. Parrado has an extensive and impressive 
background in the pharmacy field. In particular, Mr. Parrado has a vast 
amount of experience in the practice of pharmacy within the state of 
Florida. His experience as a member of the Board of Pharmacy, including 
as a member of the Rules and Legislative Affairs Committees and as the 
Chairman of the Board, are highly instructive as to the Florida 
standard of care and those regulations governing Florida pharmacists. 
Mr. Parrado even noted that he was a co-author of Rule 64B16-27.831, 
which is the Florida state requirement that pharmacists question 
prescriptions that may not be valid and only fill the prescriptions if 
the pharmacist is able to validate the prescription. Id. at 420.
    As it has been noted, Mr. Parrado has previously testified in 
similar DEA administrative proceedings. In Superior Pharmacy I and II, 
the Agency found that the ALJ in that matter properly qualified Mr. 
Parrado as an expert witness in that proceeding given his extensive 
experience in the pharmacy field. See Superior Pharmacy I and II, 81 FR 
31,309, 31,322 n.16 (2016). Mr. Parrado was also previously certified 
as an expert in community pharmacy practice. Hills Pharmacy, LLC, 81 FR 
49,815, 49,820 (2016). The Agency also gave credit to Mr. Parrado's 
expertise in Edge Pharmacy, 81 FR 72,092 (2016). As such, I further 
find that Mr. Parrado's background and expertise is more than 
sufficient to lend weight towards his testimony in this matter.
    In this matter, Mr. Parrado provided generally reliable statements 
as to his review of the materials and his ultimate opinions. He 
testified that he had reviewed not only the Respondent's exhibits, but 
also was provided and reviewed the DEA's exhibits. Tr. 432. Mr. Parrado 
suggested that if he were in Dr. Hamilton's position, he would have 
asked the Government to provide more documentation.\54\ As to ultimate 
opinions, while Dr. Hamilton generally provided specific answers to the 
questions posed by the parties, Mr.

[[Page 54570]]

Parrado would occasionally provide more summary or conclusory opinions 
to the questions posed to him. For example, Mr. Parrado gave the 
blanket conclusory opinion that based on the discussions between Mr. 
Parrado and Mr. Sprys and Ms. Mincy, of which there was no record or 
report, Mr. Parrado opined that in every instance of a red flag, they 
properly resolved the red flag prior to dispensing the subject 
controlled substance.
---------------------------------------------------------------------------

    \54\ There was a question as to what requirement, if any, an 
expert witness has in requesting additional documents. Mr. Parrado 
indicated that it was his experience from Superior Pharmacy I and II 
that he should request more documents. Respondent's counsel argued 
that Superior Pharmacy I and II holds that if information to resolve 
red flags is not documented in materials provided to the expert, the 
additional documentation should be requested and provided to the 
expert if it exists. Tr. 444-45. The Government's objection to the 
question was sustained and the parties were invited to brief this 
issue in their Posthearing Brief. The Government argues in its 
Posthearing Brief that Superior Pharmacy I and II do not stand for 
the argument that the Respondent asserted. Govt Posthearing Brief at 
42-43. Upon a review of Superior Pharmacy I and II, this Tribunal 
agrees with that assessment. It was not established that Superior 
Pharmacy I and II have created such an obligation on the part of an 
expert witness to request additional documentation.
---------------------------------------------------------------------------

    There were also a number of disagreements between Dr. Hamilton and 
Mr. Parrado in a number of areas, which will be discussed infra.
    However, Mr. Parrado's testimony was diminished by his failure to 
include important details as to the bases of his opinions in this 
matter. First, Mr. Parrado failed to disclose that he interviewed Mr. 
Sprys and Ms. Mincy in forming his opinions in this matter. Tr. 497-
500, 504-06. As bases for his opinions and having testified as an 
expert in a number of these proceedings, Ms. Parrado should be well 
aware of his obligations and the necessity to disclose the bases of his 
opinions, particularly if interviewing witnesses in this matter formed 
the bases of his opinions. My Order for Prehearing Statements 
specifically requires witnesses who rely on hearsay statements to 
identify those individuals in the prehearing statement. ALJ Ex. 3. Mr. 
Parrado's opinions were further diminished by the fact that Mr. Sprys 
did not testify, so he could not be subject to cross-examination on 
this issue. Therefore, Mr. Parrado's subject opinions are based on 
hearsay statements that were not subject to cross-examination. The 
Government was given an opportunity to cross examine Ms. Mincy. 
Additionally, Mr. Parrado testified that Ms. Mincy and Mr. Sprys 
confirmed to him that checking the E-FORCSE database was instrumental 
in their resolving certain red flags. As GX 38 reveals, Mr. Sprys and 
Ms. Mincy's access of the E-FORCSE was not as diligent as claimed. See 
infra section ``Opioid Tolerance High Starting Dosages.'' This suggests 
that Mr. Parrado's opinions in this regard are diminished by less than 
reliable claims made to him by Mr. Sprys and Ms. Mincy. Additionally, 
as there was little or no documentary support for Mr. Sprys and Ms. 
Mincy's claims to Mr. Parrado that they appropriately resolved each of 
the subject red flags, one would have to credit them with extraordinary 
memory, based on specific events over a few year period which the 
record does not establish.
    Secondly, when cross-examined about his conclusions regarding the 
distance traveled by Patient A.R., Mr. Parrado was asked why he did not 
provide certain details about his opinions in his expert report. Tr. 
540-41. When asked why he didn't put anything in his report about the 
pharmacist's relationship with Patient A.R., he stated ``I didn't see 
cause for that. My eloquence is not that great.'' These statements 
further diminish Mr. Parrado's bases for his opinions in this matter. 
Further, there was an inconsistency in Mr. Parrado's evaluation. In 
defending the Respondent's resolution of red flags, Mr. Parrado often 
relied on the PRM records maintained in the pharmacy file to justify 
the resolution. However, in instances where the PRM did not establish 
justification of the red flag, Mr. Parrado dismissed this fact and 
credited the Respondent's resolution by virtue of the mere effort of 
contacting the physician. This is contrary to the pharmacist's 
corresponding responsibility. The pharmacist must resolve red flags. An 
unsuccessful attempt to resolve red flags is insufficient.
    However, overall, I do not find that Mr. Parrado was disingenuous 
or lacking candor in his testimony, even when he occasionally failed to 
answer questions in a direct manner or to provide notice of all facts 
and materials upon which he relied in making his opinions. I do find 
his testimony to be generally credible and reliable, to the extent the 
information upon which he relied was accurate.
    As to both experts in this matter, I consider their opinions and 
the merits of each when weighing the factors and the law. Here, the 
experts had differing strengths. Mr. Parrado has a tremendous amount of 
experience in Florida Pharmacy law and practice, while Dr. Hamilton 
seems to have the edge regarding existing pharmacy practice and market 
forces. However, as with any battle of experts, it is the expert's 
justification, or explanation for his opinion, which is key. As 
developed in detail infra, generally Dr. Hamilton's justifications and 
explanations for his opinions appeared more consistent with existing 
market forces, the relevant law, and Agency precedent than those of Mr. 
Parrado.
    *[Omitted for clarity.]
Conflicting Findings of Dr. Hamilton and Mr. Parrado
Florida Minimum Standard of Care
    Dr. Hamilton provided testimony that he understood the Florida 
minimum standard of care to be guided by the Florida Administrative 
Code, specifically ``Regulation 64B'' and guidelines provided by the 
National Board of Pharmacy Association. Tr. 180-81. Specifically, Dr. 
Hamilton noted that the Florida standard of care included 
responsibilities not specifically included within the relevant Florida 
regulations. Id. at 1007-08. On the other hand, Mr. Parrado testified 
that he understood the minimum standard of care to be set strictly and 
exclusively by the [Florida] Pharmacy Act or the Florida Administrative 
Code. Id. at 456. Further, the experience that Mr. Parrado has in the 
creation and implementation of these standards give his testimony 
significant weight in determining the import and scope of Florida 
law.\*GG\
---------------------------------------------------------------------------

    \*GG\ Sentence was relocated for clarity.
---------------------------------------------------------------------------

    A careful review of Florida law and regulations guiding the 
practice of pharmacy within the State of Florida shows that the 
practice is generally guided by Chapter 465 of the Florida Pharmacy 
Act,\55\ and Florida Administrative Code rule 64B16, which governs 
pharmacy practice. Based strictly on this review, Mr. Parrado's 
testimony as to the law and regulations governing the practice of 
pharmacy in Florida appears to be correct. While Dr. Hamilton may also 
be correct about the guidelines set by the National Board of Pharmacy 
Association that have guided the State of Florida in its implementation 
of laws and regulations setting the minimum standard of care, it cannot 
be ascertained from the literal text of relevant Florida regulations 
where the Association's guidelines have been given any legal force 
beyond those provided for in the statutes and regulations cited to by 
Mr. Parrado. *[However, I likewise find no support for the proposition 
that Florida law encompasses the entirety of the standard of care in 
the State of Florida. Here, Mr. Parrado testified that Florida 
pharmacists are required to take thirty hours of continuing education 
every two years, and that ``two of those hours have to be on the . . . 
opioid abuse and resolving red flags.'' Tr. 413. In this case, I find 
that Florida state law can be reasonably interpreted to support both 
Dr. Hamilton's and Mr. Parrado's testimony.]
---------------------------------------------------------------------------

    \55\ Fla. Stat. Sec.  465.001 et seq.
---------------------------------------------------------------------------

    Mr. Parrado's testimony would generally be credited as to the 
governing laws and regulations within the Florida Pharmacy Act and the 
Florida Administrative Code. *[And Dr. Hamilton's testimony would 
generally be credited as to the usual course of existing pharmacy 
practice.] However, individual scrutiny will be given to the sections 
of the Florida Administrative

[[Page 54571]]

Code under which the Government has raised allegations against the 
Respondent for failing to meet the minimum standard of care.
Requirement To Document Resolution of Red Flags
    Dr. Hamilton provided testimony that resolution of each ``red 
flag'' had to be documented somewhere in a patient's file to 
demonstrate that the ``red flag'' had been resolved. He noted that this 
would be required under the Florida standard of care and that ``[i]f 
[it is] not documented, there's no evidence that . . . it was 
resolved.'' Id. at 179-81. Dr. Hamilton conceded that although this 
requirement was not specifically written in the relevant Florida 
regulations, it was without question required in the context of the 
Florida regulations as part of the Florida standard of care. Id. at 
1007-08.
    Despite its obvious logic, Mr. Parrado disagreed with Dr. 
Hamilton's assertion that such documentation is required in Florida. 
Mr. Parrado conceded that documenting the resolution of ``red flags'' 
may represent ``best practice,'' including that he would also do it as 
a pharmacist, but that it is not required under Florida law or the 
standard of care. He provided that most pharmacists complete at least 
some kind of documentation to indicate resolution of ``red flags.'' He 
also stated that he had created a computer program called ``Red Flag 
Resolver'' to assist pharmacists in documenting the resolution of red 
flags in their own practice.
    *[Omitted. Here both experts agree that documentation of red flag 
resolution is not explicitly required by Florida law. However, the 
regulations generally support the testimony of Dr. Hamilton regarding 
the importance of documentation in the usual course of professional 
practice in Florida. See also Suntree Pharmacy and Suntree Medical 
Equipment, L.L.C., 85 FR 73,753, 73,772.\*HH 56\]
---------------------------------------------------------------------------

    \*HH\ In Suntree, the Respondent implied that the Government's 
expert's ``inability to draw a solid conclusion as to where the 
requirement to document the resolution of red flags is written 
somehow demonstrated that there is no such requirement in the 
standard of practice.'' Id. The Acting Administrator rejected that 
reasoning and found ``that Florida state law can be reasonably 
interpreted to support [the Government expert's] testimony, but that 
her testimony [was] independently credible that documentation of the 
resolution of red flags is a requirement of the practice of pharmacy 
in the State of Florida.'' Id. I find the same. Here, Dr. Hamilton 
clearly testified that the resolution of the ``red flag'' had to be 
documented in the file as part of the Florida Standard of Care, 
noting, ``[i]f it's not documented, there's no evidence that . . . 
it was resolved, or a phone call was made, or an answer was given.'' 
Id. at 179-80; see also id. at 306, 318, 337, 1006-11, 1016.
    \56\ *[Omitted text where original footnote was included.]
---------------------------------------------------------------------------

    Therefore, under Florida regulations and findings of the Agency on 
this issue, I credit Dr. Hamilton's testimony that pharmacists are 
required under the Florida standard of care to document the resolution 
of ``red flags.''
Pricing of Prescriptions \*II\
---------------------------------------------------------------------------

    \*II\ I have made modifications as indicated throughout this 
section to more directly address the issue in this case--that the 
patients identified in the OSC were paying cash, and excessively 
high prices at that, for controlled substances which created a red 
flag.
---------------------------------------------------------------------------

    Dr. Hamilton expressed concerns that *[the patients' willingness to 
pay cash for these] \*JJ\ highly priced prescriptions was a ``red 
flag'' that should be addressed. Dr. Hamilton indicated that it does 
not make sense that a patient would continue to go to a pharmacy that 
is charging high prices when there are pharmacies that sell the same 
medications for much less. Tr. 194. For example, high prices were a red 
flag for Patient A.E. (paying up to $500 a month) because A.E. was 
paying up to $5.95 per pill *[in cash when he could have gotten the 
controlled substances elsewhere for 1.50 per pill]. Tr. 199; GX 28, pp. 
6-7. He opined that patients do not want to pay more than they have to, 
and if the same prescription was offered at a lower price at a 
different pharmacy, the patient would have gone to that other pharmacy. 
Tr. 199. Dr. Hamilton also noted he has observed different pricing 
schemes for the same prescriptions for the same person, *[paying cash] 
for which he could not provide a rational explanation. Id. at 203-04.
---------------------------------------------------------------------------

    \*JJ\ See infra n. NN.
---------------------------------------------------------------------------

    Mr. Parrado disagreed with Dr. Hamilton's assertion that the prices 
on the prescriptions should be much lower than that charged by Pharmacy 
4 Less. He opined that every pharmacy can determine their own prices, 
which may be more expensive when filling a controlled substance 
prescription based on the added work load (including checking E-FORCSE, 
better maintenance of records, and additional inventories). Id. at 449. 
He stated that pharmacy pricing can be very competitive. Id. at 450. 
The only explanations Mr. Parrado could give for a pharmacy charging 
different prices for the same medication was a potential higher cost 
from a different wholesaler, the use of discount coupons, or indigent 
pricing programs. Id. at 451-52. There was no evidence offered that 
these exceptional circumstances existed here.
    As to Mr. Parrado's claim that opioids had become scarce, difficult 
to locate, and involved additional expense to the pharmacies, thus 
warranting higher prices, neither party introduced documentary evidence 
to support or to counter this claim. Id. at 451-52, 539. Mr. Parrado 
did not offer the actual reason the Respondent charged the prices they 
did, or whether the Respondent recognized their prices were 
significantly higher than other like-situated pharmacies. For example, 
we don't know if there was a pharmacy much closer to the patients' 
homes or doctor offices charging less, from any direct evidence. We are 
left with conflicting, sometimes anecdotal, evidence by Mr. Parrado and 
Dr. Hamilton.
    Dr. Hamilton personally surveyed pharmacy prices in his area, near 
Fort Lauderdale, while Pharmacy 4 Less is located just north of 
Orlando. Id. at 178. Dr. Hamilton's formula to determine average prices 
by large and small pharmacies involved a survey of wholesale prices of 
opioids sold to pharmacies, generally increased by 20% for pharmacy 
mark up, does not rebut the justifying explanations given by Mr. 
Parrado. To be more accurate, the survey should have been limited to 
small pharmacies. However, Dr. Hamilton's reliance upon a GoodRx 
program to determine prices charged by pharmacies for opioids does 
provide objective support for his assertions that the prices charged by 
Pharmacy 4 Less for the various subject opioids were considerably in 
excess of what other pharmacies were charging. Id. at 177-78.
    Based on a review of this record, I find that Dr. Hamilton provided 
a more reliable basis in support of his opinion of unusually high 
prices of opioids charged by Pharmacy 4 Less than the uncorroborated 
and more anecdotal and historical explanations given by Mr. Parrado. I 
do not discount the market forces cited by Mr. Parrado, although I 
reject the extent to which he opined they affected the prices charged 
by the Respondent.
    Having found that Respondent's *[cash-paying patients at issue in 
this case were paying] unusually high prices for the subject opioids, 
triggering a red flag, the next inquiry is whether the Respondent 
resolved the red flag. There was no evidence introduced that the 
Respondent performed any inquiry or investigation as to why the subject 
patients were willing to pay such high *[cash] prices for the subject 
opioids. Dr. Hamilton's opinion that this red flag repeatedly went 
unresolved is fully supported by this record.

[[Page 54572]]

Long Distances Traveled by Patients
    Both Dr. Hamilton and Mr. Parrado agreed that long distances 
traveled by patients to fill their prescriptions at Pharmacy 4 Less was 
a ``red flag'' that needed to be resolved before the prescription was 
filled. Id. at 209-10, 453. As to Patient A.R., Dr. Hamilton gave the 
opinion that there were multiple red flags. Id. at 209. He said that 
the distance from A.R.'s home to the physician was a red flag because 
A.R. had to explain the reason to be going to that physician. Further, 
the distance from the physician to the pharmacy is a red flag, because 
it was taking A.R. even further away from A.R.'s home, approximately 50 
miles from his home. A.R. needed to explain why he was traveling so far 
to fill the subject prescriptions. Id. at 209-10. Dr. Hamilton first 
opined that this red flag was not resolvable, but later conceded that 
there may be circumstances in which it could be resolved, but that it 
would need to be notated in the pharmacy file. Id. at 210.
    Mr. Parrado gave the opinion that while the long distance traveled 
would be a red flag, it was one that could be resolved. Id. at 453. He 
said that it only needed to be resolved once as long as the pharmacist 
knew the patient and knew why they are coming to the pharmacy. Further, 
he stated that it would not need to be re-resolved each time if the 
patient was ``coming from the same place, he's seeing the same doctors, 
coming to the same pharmacy.'' Id. at 453. When asked about this red 
flag on cross-examination, Mr. Parrado said that from his review, 
Patient A.R. appeared to have a relationship with a pharmacy that would 
fill his prescriptions when it was difficult to find places to fill 
prescriptions. Id. at 539. He observed that Pharmacy 4 Less had 
developed a relationship with A.R., was monitoring and checking up on 
him, and gave all other indications which would resolve that red flag, 
in his opinion. Id. at 539.
    While there appears to be no dispute that long distances traveled 
can constitute a red flag, there is a dispute as to its resolution in 
this matter. Mr. Parrado claimed that in his review, he believed this 
red flag had been resolved. Mr. Parrado based his finding on A.R. 
having developed a relationship with the Respondent and the difficulty 
in locating pharmacies which carried opioids. Mr. Parrado's finding 
appears to rely significantly on a scarcity of pharmacies carrying 
opioids. Based on the existing record, such scarcity has not been 
directly established. That the Respondent pharmacy has developed a 
relationship with A.R. would certainly not justify the first few 
dispensing without resolving the distance traveled red flag. In the 
absence of any other evidence resolving this red flag, I credit Dr. 
Hamilton's testimony that even if the red flag is resolvable, it was 
not resolved in this case.
Opioid Tolerance and High Starting Dosages
    I did not recognize significant disagreement between Dr. Hamilton 
and Mr. Parrado regarding the red flag evident at the initial 
dispensing of any significant strength of opioids. Dr. Hamilton 
testified that a high initial opioid prescription is a red flag that 
must be resolved. He asserted that if a starting dose is too high and a 
pharmacist fails to identify the patient as being opioid na[iuml]ve to 
that dosage level, the prescription could potentially prove to be 
fatal. Id. at 188. While Mr. Parrado did not appear to disagree that 
this is a red flag that should be resolved, he differed in his 
assessment of the patients in this matter receiving high starting 
dosages such that they would fail to meet the minimum standard of care. 
For example, when asking about prescribing 84 pills of oxycodone 30 mg 
to a patient, Dr. Hamilton testified that it would have been too high 
of a starting dosage for some of the charged patients. On the other 
hand, Mr. Parrado observed that there is no upper limit on the quantity 
that can be prescribed to a patient or how many milligrams. He stated 
that each would depend on the patient and their individual tolerance 
level. Id. at 461-62. Their previous opioid medication levels would 
fairly suggest their level of tolerance. Essentially, Mr. Parrado took 
the position that initial subject opioid dispensing of a significant 
dosage represented a red flag, which was resolvable. I do not recognize 
significant conflict between the two experts in this regard.
    The credibility of Ms. Mincy's testimony as relates to her 
investigating the opioid naivet[eacute] of the 10 subject patients 
deserves some analysis. Here, Ms. Mincy testified that she used E-
FORCSE at the pharmacy to look at patients' histories and records 
before filling a prescription. Id. at 643. She indicated that she uses 
it daily and prior to every fill of a new prescription of her patients. 
Id. She even stated that E-FORCSE ``is the best system to resolve red 
flags, in [her] opinion.'' Id. at 645. She made multiple comments about 
the usefulness of the E-FORCSE system and how she uses it on a daily 
basis during her work in the pharmacy. Finally, she indicated that she 
uses it before she fills every controlled substance prescription. Id. 
at 645-46.
    The Government introduced evidence of the E-FORCSE searches 
conducted by Pharmacy 4 Less between January 1, 2015, and June 6, 2017, 
for the 10 charged patients in this matter. GX 38. For six patients, 
A.E., B.F., K.E.D., R.R., R.V., and V.W., this exhibit shows that 
Pharmacy 4 Less conducted initial opioid fills for the six patients, 
but did not run a search on E-FORCSE on the corresponding date of the 
fill. For example, Patient A.E. first filled a prescription on November 
19, 2015, but Pharmacy 4 Less did not check E-FORCSE for Patient A.E. 
until April 7, 2016. GX 38, p. 11. Apart from being able to run checks 
through E-FORCSE, Pharmacy 4 Less did not introduce any evidence that 
it otherwise completed or documented its resolution of any potential 
red flags for Patient A.E before doing an initial fill of the 
prescription. The evidence shows this to be true for Patients B.F., 
K.E.D., R.R., R.V., and V.W., as well. GX 38.
    The E-FORCSE records introduced do substantiate that either Ms. 
Mincy or Mr. Sprys checked the E-FORCSE database for the initial opioid 
dispensing for the following subject patients: A.R. on March 16, 2016; 
A.V. on April 21, 2016; B.N. on January 22, 2016; and K.Y.D. on 
February 4, 2016. See GX 38; RX 21, p. 4, 23, p. 3, 27, p. 3, 31, p. 7. 
However, Ms. Mincy conceded there was no documentary evidence that 
indicated that any of the subject ten patients started at lower doses 
of opioids, including oxycodone and hydromorphone, and worked their way 
up because they become opioid tolerant. Tr. 815-16. To the extent that 
Mr. Parrado credited Ms. Mincy's and Mr. Sprys' claims that they 
checked E-FORCSE to resolve opioid na[iuml]vet[eacute] for the six 
patients noted above, this significantly diminishes Mr. Parrado's 
opinion.
    The E-FORCSE records further belie Ms. Mincy's claim that she 
checked the E-FORCSE prior to filling each prescription. Tr. 645-46; GX 
38. According to my math, of the 190 charged dispensed prescriptions 
within the subject record, the Respondent checked the E-FORCSE database 
31 times, or 16.3% of the time. Ms. Mincy later testified that she 
checked E-FORCSE for each Schedule 2 prescription, and only recently 
began checking it for all controlled substance prescriptions. This 
significantly diminishes Ms. Mincy's reliability as a witness.

[[Page 54573]]

Findings as to Allegations

    The Government alleges that the Respondent's COR should be revoked 
because the Respondent failed to ensure that it only filled 
prescriptions issued for legitimate medical purposes, and within the 
course of professional practice, in violation of its corresponding 
responsibility, and repeatedly filled prescriptions in the face of 
obvious red flags of diversion, and its registration would be 
inconsistent with the public interest, as provided in 21 U.S.C. 
824(a)(4) and 21 U.S.C. 823(f), and in violation of state law under the 
Florida Administrative Code and state requirements for the minimum 
standard of care.
    In the adjudication of a revocation or suspension of a DEA COR, DEA 
has the burden of proving that the requirements for such revocation or 
suspension are satisfied. 21 CFR 1301.44(e) (2010). Where the 
Government has sustained its burden and made its prima facie case, a 
respondent must both accept responsibility for her actions and 
demonstrate that she will not engage in future misconduct. Patrick W. 
Stodola, M.D., 74 FR 20,727, 20,734 (2009). Acceptance of 
responsibility and remedial measures are assessed in the context of the 
``egregiousness of the violations and the [DEA's] interest in deterring 
similar misconduct by [the] Respondent in the future as well as on the 
part of others.'' David A. Ruben, M.D., 78 FR 38,363, 38,364 (2013). 
Where the Government has sustained its burden, that registrant must 
present sufficient mitigating evidence to assure the Administrator that 
he can be entrusted with the responsibility commensurate with such a 
registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008).\*KK\
---------------------------------------------------------------------------

    \*KK\ Text omitted for brevity.
---------------------------------------------------------------------------

    The Agency's conclusion that ``past performance is the best 
predictor of future performance'' has been sustained on review in the 
courts, Alra Labs., Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as 
has the Agency's consistent policy of strongly weighing whether a 
registrant who has committed acts inconsistent with the public interest 
has accepted responsibility and demonstrated that he or she will not 
engage in future misconduct. Hoxie, 419 F.3d at 482-83; see also 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 C. Aycock, M.D., 74 FR 17,529, 17,543 (2009) 
(finding that much of the respondent's testimony undermined his initial 
acceptance that he was ``probably at fault'' for some misconduct); 
Krishna-Iyer, 74 FR at 463 (noting, on remand, that despite the 
respondent's having undertaken measures to reform her practice, 
revocation had been appropriate because the respondent had refused to 
acknowledge her responsibility under the law); Med. Shoppe-
Jonesborough, 73 FR at 387 (noting that the respondent did not 
acknowledge recordkeeping problems, let alone more serious violations 
of federal law, and concluding that revocation was warranted).
    The burden of proof at this administrative hearing is a 
preponderance-of-the-evidence standard. Steadman v. SEC, 450 U.S. 91, 
100-01 (1981). The Administrator's factual findings will be sustained 
on review to the extent they are supported by ``substantial evidence.'' 
Hoxie, 419 F.3d at 481. The Supreme Court has defined `substantial 
evidence' as such relevant evidence as a reasonable mind might accept 
as adequate to support a conclusion. Consolidated Edison Co. of New 
York v. National Labor Relations Board, 305 U.S. 197, 229, 59 S.Ct. 
206, 217 (1938). While ``the possibility of drawing two inconsistent 
conclusions from the evidence'' does not limit the Administrator's 
ability to find facts on either side of the contested issues in the 
case, Shatz v. U.S. Dep't of Justice, 873 F.2d 1089, 1092 (8th Cir. 
1989); Trawick, 861 F.2d at 77, 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); Humphreys v. 
DEA, 96 F.3d 658, 663 (3rd Cir. 1996). The ultimate disposition of the 
case must be in accordance with the weight of the evidence, not simply 
supported by enough evidence to justify, if the trial were to a jury, a 
refusal to direct a verdict when the conclusion sought to be drawn from 
it is one of fact for the jury. Steadman, 450 U.S. at 99 (internal 
quotation marks omitted).
    Regarding the exercise of discretionary authority, the courts have 
recognized that gross deviations from past agency precedent must be 
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in 
application does not, standing alone, render a particular discretionary 
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (D.C. Cir. 2008) 
(citing Butz v. Glover Livestock Comm'n Co., 411 U.S. 182, 188 (1973)). 
It is well-settled that since 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. v. NLRB, 340 
U.S. 474, 496 (1951), and that this recommended decision constitutes an 
important part of the record that must be considered in the 
Administrator's decision. Morall, 412 F.3d at 179. However, any 
recommendations set forth herein regarding the exercise of discretion 
are by no means binding on the Administrator and do not limit the 
exercise of that discretion. 5 U.S.C. 557(b) (2006); River Forest 
Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); Attorney 
General's Manual on the Administrative Procedure Act 8 (1947).
Red Flags of Diversion
    The Government has alleged that Pharmacy 4 Less failed to resolve 
and document ``red flags'' of diversion outside the usual course of 
professional practice (21 CFR 1306.06) and the pharmacy's corresponding 
responsibility (21 CFR 1306.04(a)) and in violation of meeting the 
Florida minimum standard of care under Florida law.
High Starting Dosages
    The Government has alleged that Pharmacy 4 Less routinely filled 
Schedule 2 controlled substances for patients with high starting 
dosages, including both the dosage being prescribed and the number of 
tablets being prescribed.
    The Government presented evidence by Dr. Hamilton that the initial 
starting dosages for at least six of the charged patients (Patients 
A.E., B.F., K.E.D., R.R., R.V., and V.W.) were too high and potentially 
fatal to opioid na[iuml]ve patients. Dr. Hamilton gave his opinion that 
the starting dosages for these charged patients were too high given the 
nature of the patients' medical records and other documents that he had 
reviewed. Mr. Parrado appeared to agree with Dr. Hamilton that it is 
necessary to determine whether a patient is opioid na[iuml]ve and that 
it should be factored into the determination of what a proper starting 
dosage would be, but disagreed that the starting dosages were 
necessarily too high. Both experts agreed that in order to determine if 
a patient is opioid na[iuml]ve, a pharmacist can check E-FORCSE, talk 
to the patient, consult with the prescribing doctor, or take other 
steps the pharmacist determines to be necessary.
    Here, Ms. Mincy testified that she used E-FORCSE at the pharmacy to 
look at patients' histories and records before

[[Page 54574]]

filling a prescription. Tr. 643. She indicated that she uses it daily 
and prior to every fill of a new prescription of her patients. Id. She 
even stated that E-FORCSE ``is the best system to resolve red flags, in 
[her] opinion.'' Id. at 645. She made multiple comments about the 
usefulness of the E-FORCSE system and how she uses it on a daily basis 
during her work in the pharmacy. Finally, she indicated that she uses 
it before she fills every controlled substance prescription. Id. at 
645-46.
    The Government introduced evidence of the E-FORCSE searches 
conducted by Pharmacy 4 Less between January 1, 2015, and June 6, 2017, 
for the 10 charged patients in this matter. GX 38. For the six patients 
previously mentioned, this exhibit shows that Pharmacy 4 Less conducted 
initial opioid fills for the six patients, but did not run a search on 
E-FORCSE on the corresponding date of the fill. For example, Patient 
A.E. first filled a prescription on November 19, 2015, but Pharmacy 4 
Less did not check E-FORCSE for Patient A.E. until April 7, 2016. GX 
38, p. 11. Apart from being able to run checks through E-FORCSE, 
Pharmacy 4 Less did not introduce any evidence that it otherwise 
completed or documented its resolution of any potential red flags for 
Patient A.E before doing an initial fill of the prescription. The 
evidence shows this to be true for Patients A.E., B.F., K.E.D., R.R., 
R.V., and V.W. GX 38.
    Therefore, the Government has met its burden of proof as to this 
allegation as to these six patients.
    As to the remaining four subject patients, the E-FORCSE records 
introduced reflect that either she or Mr. Sprys checked the E-FORCSE 
database for the first charged prescriptions for the following subject 
patients:\*LL\ A.R. on March 16, 2016; A.V. on April 21, 2016; B.N. on 
January 22, 2016; and K.Y.D. on February 4, 2016. See GX 38; RX 21, p. 
4, RX 23, p. 3, RX 27, p. 3, RX 31, p. 7. Ms. Mincy conceded there was 
no documentary evidence that indicated that any of the subject ten 
patients started at lower doses of opioids, including oxycodone and 
hydromorphone, and worked their way up because they become opioid 
tolerant. Tr. 815-16. *[Consistent with Dr. Hamilton's testimony, I 
find that Respondent acted outside of the usual course of professional 
practice and in violation of its corresponding responsibility when it 
failed to resolve and/or to document resolution of the opioid 
na[iuml]vet[eacute] red flag as to each of the ten patients at issue in 
this case.]\*MM\
---------------------------------------------------------------------------

    \*LL\ In its exceptions, the Government argued that merely 
running a name through E-FORCSE was insufficient to resolve the 
opioid na[iuml]ve red flag, and that the pharmacist needed to 
affirmatively review the report, determine that the report addressed 
the red flag, and document the resolution. Govt Exceptions, at 9-10. 
I agree with the Government's position, but do not find that the ALJ 
erred. The ALJ considered the E-FORCSE records along with Ms. 
Mincy's testimony that she was using E-FORSCE to resolve the red 
flag in exactly the manner the Government said was required. There 
are credibility issues with Ms. Mincy's testimony, but ultimately, 
the ALJ in a different section of the RD found that Respondent 
Pharmacy's failure to document resolution of this red flag 
demonstrated a violation of its corresponding responsibility. Infra 
section ``Failure to Document Resolution of Red Flags.'' I have 
modified this section of the RD to clarify that the ALJ found that 
the Respondent Pharmacy's failure to document resolution of this red 
flag demonstrated a violation of Respondent Pharmacy's corresponding 
responsibility and was outside the usual course of pharmacy 
practice.
    \*MM\ This replaces the ALJ's original finding that the 
Government failed to carry its burden that the opioid 
na[iuml]vet[eacute] red flag went unresolved for four of the ten 
patients.
---------------------------------------------------------------------------

[Cash Paid and] Excessive Pricing \*NN\
---------------------------------------------------------------------------

    \NN\ Throughout the testimony in this case and in its 
Posthearing Brief, the Government emphasized the excessively high 
prices charged by the pharmacy. However, the Government's expert 
also opined that the customer's cash payment at excessively high 
prices created red flags that were not resolved prior to dispensing. 
See also OSC, at 3-7; Govt Supp. Prehearing, at 7-15 GX 28, at 5-6; 
Tr. 194-98. I have made modifications throughout this section as 
noted in brackets to account for the ``cash payment'' portion of the 
issue.
---------------------------------------------------------------------------

    The Government has alleged that Pharmacy 4 Less routinely filled 
controlled substance prescriptions *[for patients who were paying cash 
at] extremely high prices.
    As previously discussed, I credit Dr. Hamilton's opinion that 
Pharmacy 4 Less charged unusually high prices. Using his calculations 
in relation to large and small pharmacies, and his findings as to 
average prices charged in the surrounding area, Dr. Hamilton determined 
that there is generally only a slight difference between large and 
small pharmacies prices, with the difference generally amounting to a 
few dollars per prescription. Id. at 194-98. However, the Government's 
evidence suggests that Pharmacy 4 Less was charging prices much higher 
than that expected by a pharmacy within the surrounding area, whether 
it be a small independent pharmacy or a large retail pharmacy. *[Most 
concerning, the patients at issue in this case were paying for these 
over-priced controlled substances with cash which created a red flag. 
When Dr. Hamilton was asked at the hearing what he meant by the red 
flag he labeled ``paid cash, extremely high prices'' in his report, see 
GX 28, at 6, Dr. Hamilton explained that absent diversion, ``[t]here is 
no reason for a . . . patient to continue to go to a pharmacy that 
has'' ``extremely high prices when there [are] pharmacies that would 
sell it for much less.'' Id. at 194.]
    While the Respondent put on evidence by Mr. Parrado as to the 
excessive pricing, I note that Mr. Parrado did not reveal the actual 
reasons the Respondent charged such prices, nor reveal similar prices 
by pharmacies closer to the subject patients' homes or physicians. 
*[Mr. Parrado further testified that some pharmacies only take cash, 
they ``do not take insurance . . . it's hard to get on some of these 
insurance networks,[\*OO\] then [you are] subject to their audits.'' 
Tr. 450.] I have found that his opinions on this allegation were more 
anecdotal and historical, and did not provide a sufficient basis to 
completely refute Dr. Hamilton's more objective and timely analysis.
---------------------------------------------------------------------------

    \*OO\ In its exceptions, Respondent asserted that ``[i]t takes 
almost 2 years for a new pharmacy to be accepted by all insurance 
companies.'' Respondent's Exceptions, at ] 3. Though this specific 
factual assertion lacks evidence in the record, I find it is in line 
with Mr. Parrado's anecdotal testimony which was properly considered 
by the ALJ in reaching his decision.
---------------------------------------------------------------------------

    Therefore, I find that the Government has met its burden of proof 
as to this allegation. The record establishes that the Respondent's 
*[patients at issue in this case paid cash at] prices that were 
noticeably higher than market forces would explain and sufficient to 
create a red flag. However, the record does not support a finding that 
the Respondent prices were exorbitant to the extent those transactions 
represented ``knowing'' diversion by the Respondent.
    I do not find that solely on the basis of the high prices charged 
by the Respondent that Pharmacy 4 Less knowingly issued the 
prescriptions without a legitimate medical purpose. In their 
Posthearing Brief, the Government argues that ``[w]here a pharmacy is 
consistently charging exorbitant prices, DEA `may properly draw the 
inference that the pharmacy is charging those prices because it knows 
it is supplying persons who are seeking the drugs to either abuse them 
or divert them to others.' Jones Total Health Care Pharmacy, LLC, 81 FR 
79,188, 79,199-200 (2016).'' Govt Posthearing Brief at 39-40. The 
Government argues that, while there may be some variance in pricing, 
which the Administrator in Jones Total Health Care acknowledged, 
``exceeding the average retail price by more than 200% at times is not 
what one would expect to find at a legitimate pharmacy.'' Govt 
Posthearing Brief at 31. As noted in Jones Total Health Care, the view 
that prices charged by a

[[Page 54575]]

pharmacy in excess of average prices can support an inference that the 
pharmacy knew the prescriptions were not being issued for a legitimate 
medical purpose. Jones Total Health Care, 81 FR at 79,200 (citing 
United States v. Leal, 75 F.3d 219, 223 (6th Cir. 1996); United States 
v. Cooper, 868 F.2d 1505, 1512 (6th Cir. 1989); United States v. Hayes, 
595 F.2d 258, 261 (5th Cir. 1979)).
    Here, no direct evidence was offered by either party regarding the 
prices actually charged by alternate pharmacies near the patients' 
homes or physician's offices. *[Absent additional and more specific 
evidence,]\*PP\ I find that an inference based solely on the higher 
prices charged herein *[omitted] that Pharmacy 4 Less knowingly filled 
the prescriptions without a legitimate medical purpose, would not be 
warranted. *[Still, as I found above, the record establishes that the 
Respondent's patients at issue in this case paid cash at prices 
sufficiently high to create red flags, which were not resolved. And 
there is sufficient evidence to support a finding that the pharmacists 
who filled those prescriptions without documenting resolution of those 
red flags violated their corresponding responsibility due to their 
willful blindness to the prescriptions' potential illegitimacy. See 
Suntree, 85 FR at 73,770.]
---------------------------------------------------------------------------

    \*PP\ Original text modified for clarity and brevity.
---------------------------------------------------------------------------

Long-Term Fill for Immediate Release Pain Medication
    The Government has alleged that Pharmacy 4 Less routinely filled 
controlled substance prescriptions for immediate release pain 
medication over long periods of time.
    Dr. Hamilton testified that a patient receiving short-acting 
medications over a long period of time is a red flag that must be 
resolved before the prescription is filled. He stated that immediate-
release medication should not be taken over long periods of time, with 
the medication being ``immediate-release for a reason.'' Tr. 193. He 
further testified that if it is prescribed over a long period of time, 
there needs to be documentation from the physician about the patient as 
to why a long-acting medication failed or other circumstance that would 
demonstrate why a short-acting medication was being prescribed over a 
long-period of time. Id. at 194.
    The Respondent did not present evidence to directly counter the 
Government's evidence. Mr. Parrado agreed that this was a red flag that 
needed to be resolved. He only generally asserted that the physician 
determines what medication the patient will be on, that many insurance 
companies will not pay for extended release medication, and the charged 
patients may have had insurances that did not cover them. Id. at 447. 
However, he did counter that oxycodone can be used for extended periods 
of time, based upon academic literature, and that there was no set 
duration of time which oxycodone should stop being used. Id. at 447. He 
did concede that as a pharmacist, he questioned whether a short acting 
versus a long acting prescription was properly prescribed. Id. at 447-
48. Without evidentiary corroboration,\*QQ\ Mr. Parrado's testimony in 
this regard is little more than speculation. It does not meaningfully 
counter Dr. Hamilton's subject opinion.
---------------------------------------------------------------------------

    \*QQ\ In its Exceptions, Respondent asserted that ``[p]atients 
are on immediate release because the price of long term is 3 to 5 
times as much and their insurance does not pay for it. Almost all 
patients had forms that we filled out and signed for reimbursement 
from their insurance companies.'' Resp Exceptions, at ] 2. This 
factual assertion, again without evidence in the record to support 
it, fails to qualify as the evidentiary corroboration needed to 
establish Dr. Parrado's testimony as anything other than 
speculation.
---------------------------------------------------------------------------

    Therefore, I find that the Government has met its burden of proof 
as to this allegation. *[Specifically, I find that Respondent pharmacy 
acted outside of the usual course of professional practice and in 
contravention of its corresponding responsibility when it failed to 
resolve and/or document resolution of the red flag arising from long-
term use of immediate-release pain medications.]
Long Distance Traveled by Patient A.R.
    The Government has alleged that Pharmacy 4 Less filled 
prescriptions for Patient A.R., who traveled long distances (fifty 
miles from his home) to fill his prescriptions.
    Both Dr. Hamilton and Mr. Parrado agreed that long distances 
traveled by patients to fill their prescriptions at Pharmacy 4 Less was 
a ``red flag'' that needed to be resolved before the prescription was 
filled. Id. at 209-10, 453. As previously discussed, while there 
appears to be no dispute that long distances traveled can constitute a 
red flag, Dr. Hamilton and Mr. Parrado did disagree about the potential 
for resolution of the red flag in this matter as to Patient A.R. 
However, Mr. Parrado again gave general opinions on this matter as to 
why Patient A.R. may have been traveling such long distances to fill 
his prescriptions at Pharmacy 4 Less. Without proper documentation to 
show if Pharmacy 4 Less even attempted to resolve such a red flag, Mr. 
Parrado's assertions remain speculative and cannot be definitively 
shown.\57\ Further, I find that the distances traveled by Patient A.R. 
were long enough that Dr. Hamilton's opinion is to be credited that 
this is a red flag that needed resolution, which Pharmacy 4 Less has 
failed to do.
---------------------------------------------------------------------------

    \57\ Mr. Parrado testified that all of the red flags were 
resolved to his satisfaction by his speaking with Ms. Mincy and Mr. 
Sprys, as their explanations resolved all of the charged red flags. 
Without more specificity, I cannot attribute significant probative 
value to this blanket opinion.
---------------------------------------------------------------------------

    Therefore, I find that the Government has met its burden of proof 
as to this allegation. *[Specifically, I find that Respondent pharmacy 
acted outside of the usual course of professional practice and in 
contravention of its corresponding responsibility when it failed to 
resolve and/or to document resolution of the red flag arising from the 
long distance A.R. traveled to fill his prescription.]
Drug Combination Prescriptions
    The Government has alleged that Pharmacy 4 Less filled 
prescriptions for drug combinations that needed to be questioned. In 
particular, the Government has alleged that Pharmacy 4 Less improperly 
filled prescriptions for Patient A.V. that combined buprenorphine along 
with oxycodone.
    Dr. Hamilton testified that buprenorphine issued with oxycodone 
presents a red flag that needs to be resolved. Id. at 263-76. He 
explained that buprenorphine is a medication used for opiate 
withdrawal, and issuing it along with oxycodone, an opioid, would 
present a red flag because the opioid would no longer be of any use. 
Id. at 263. He testified that when these combinations are used, it 
would be expected to see that the patient, would *[within a few days to 
a few weeks, Id. at 974] be weaned off of the opioid and it would be 
substituted with the buprenorphine. Id at 263. Dr. Hamilton indicated 
that he did not see any evidence that Pharmacy 4 Less had resolved this 
red flag before issuing the prescriptions to Patient A.V. Id. at 266. 
When confronted with the Respondent sponsored PRM file, which included 
references to tapering the patient off of opioids, Dr. Hamilton opined 
that such cryptic reference was insufficient to resolve the red flag or 
be sufficient documentation within the pharmacy record. Id. at 972. 
*[Specifically, Dr. Hamilton testified that ``the note says that the . 
. . physician is tapering the patient off of medications that [he is] 
addicted to, but [there is] a continuation of the oxycodone fill in the 
same amounts, same quantity, same timeframe. It continues over the 
course of the whole year.'' Id. It is clear from

[[Page 54576]]

Dr. Hamilton's testimony that the drug combination red flag arises 
twice in this case: first, when the buprenorphine and oxycodone are 
prescribed together; and again, when the drug combination continues 
over time without tapering.]
    Mr. Parrado agreed with Dr. Hamilton that this drug combination is 
a red flag ``that [he] would have wanted to look into very carefully.'' 
Id. at 463. However, Mr. Parrado indicated that he believed the red 
flag had been resolved because he found that Pharmacy 4 Less had 
contacted Patient A.V.'s doctor, in which the doctor explained that he 
was trying to get A.V. off of the oxycodone by intermittently using 
buprenorphine. Id. at 463-64. When I asked where Mr. Parrado had seen 
this red flag resolved in the records he reviewed, he stated that he 
had seen it in the patient's record maintenance folder. Id. at 464; RX 
22, 23.
    Upon a review of the evidence, I find that Patient A.V.'s patient 
record maintenance file maintained by Pharmacy 4 Less does give some 
indication that Pharmacy 4 Less contacted A.V.'s doctor. In the Patient 
Memo, it states ``PATIENT DC'D 4/17/17 CONTINUED DETOX WITH COM. DRUGS 
FOR HIS SPECIFIC LEVEL OF ADDICTION TAPERING PER DR. W SEIFERT--MD 
CONSULTED AND RESULTED IN CONTINUED THERAPY.'' RX 22, p. 1.\*RR\ 
However, what cannot be ascertained is when this information was 
entered into the system.
---------------------------------------------------------------------------

    \*RR\ The Government argued in its exceptions that the ALJ 
improperly relied on RX 22 because the exhibit was admitted only 
conditionally and the condition for its admission was ultimately not 
met. While I understand the Government's argument regarding reliance 
on the exhibit in this way, the ALJ did not rely on RX 22 standing 
alone, rather he relied on it as support for Mr. Parrado's opinion 
which was that the Respondent Pharmacy had contacted the patient's 
physician and resolved the initial red flag. Ultimately, in light of 
the preponderance of the evidence, RX 22 is of little importance to 
the finding on this red flag.
---------------------------------------------------------------------------

    It is clear from at least the face of the prescriptions that 
Pharmacy 4 Less did not provide additional documentation beyond what is 
shown in the patient record maintenance file. With the impossibility of 
determining when this information was entered, it cannot be 
definitively ascertained whether Pharmacy 4 Less resolved the 
*[initial] red flag at the time the prescriptions were issued or 
whether this information was inserted at a later time. *[However, even 
if the Respondent Pharmacy did resolve the initial red flag arising 
from the drug combination, there is no evidence in the record that the 
red flag arising from the continual prescribing of the drug combination 
without proper tapering was resolved.
    Therefore, I find that the Government has met its burden of proof 
as to this allegation by establishing that Respondent Pharmacy failed 
to resolve the red flag of arising from the long-term use of this drug 
combination without tapering.]\*SS\
---------------------------------------------------------------------------

    \*SS\ I have omitted the ALJ's original finding in Respondent's 
favor based on his uncertainty over whether or not the Respondent 
had resolved the initial drug combination red flag as may have been 
documented in RX 22. The ALJ did not evaluate the red flags that 
arose as a result of the continued filling of the drug combination 
prescriptions without signs of proper tapering, and having so 
evaluated them, I have reached a different result.
---------------------------------------------------------------------------

Failure To Document Resolution of Red Flags
    I have presented my findings as to each of the five allegations set 
out by the Government as to Pharmacy 4 Less's failure to resolve red 
flags. The Government has argued that not only has Pharmacy 4 Less 
failed to resolve these red flags, but their failure to document 
resolution of red flags warrants an inference that the red flag was 
never resolved.
    As I have already discussed, *[Omitted. I credit Dr. Hamilton's 
testimony that pharmacists are required under the course of 
professional practice in Florida to document the resolution of ``red 
flags.'']\*TT\ As such, I make my recommendation that the Administrator 
find Pharmacy 4 Less was required to document the resolution of red 
flags, and that it failed to do so.
---------------------------------------------------------------------------

    \*TT\ See also supra ``Requirement to Document Resolution of Red 
Flags.''
---------------------------------------------------------------------------

    During the hearing, Mr. Parrado provided testimony about the 
Florida laws and regulations that underpin the standard of care for 
Florida pharmacists. As one of the individuals involved with the 
drafting of Florida regulations in question, he gave insightful 
comments about the creation and basis for the rules. However, as I 
noted during the hearing, Mr. Parrado's comments were instructive, but 
not dispositive. Tr. 468. I am foremost guided by the text of the law 
and regulations,\*UU\ *[and by the Government's expert testimony 
regarding the standard of care in the State of Florida.]
---------------------------------------------------------------------------

    \*UU\ Omitted for clarity.
---------------------------------------------------------------------------

    Based upon the evidence provided, I find that Pharmacy 4 Less has 
failed to document or show other evidence that demonstrates resolution 
of the red flags \58\ as alleged by the Government in the previous five 
allegations, excluding the *[allegation related to the initial red flag 
arising from] Patient A.V.'s prescribed drug combination.\*VV\
---------------------------------------------------------------------------

    \58\ Further, the Government offered evidence that DI and the 
rest of his team did ask Ms. Mincy if they documented their 
resolution of red flags and where they did so. DI was provided 
documents by the Respondent at DI's request upon which records were 
identified that failed to indicate the resolution of red flags. 
*[This footnote was relocated for preservation after the original 
text to which it referenced was omitted].
    \*VV\ Omitted, for brevity, the inference that Respondent 
Pharmacy's failure to document resolution of the red flags supported 
a finding that the red flags were in fact not resolved. Here, there 
is ample evidence of red flags that were unresolved and/or 
undocumented.
---------------------------------------------------------------------------

Recordkeeping Violations
Initial Inventory
    The Government has charged that Pharmacy 4 Less did not have an 
initial inventory in violation of 21 CFR 1304.11(b). Section 1304.11(b) 
provides that ``[e]very person required to keep records shall take an 
inventory of all stocks of controlled substances on hand on the date 
he/she first engages in the . . . distribution, or dispensing of 
controlled substances. . . .''
    The Government provided the testimony of DI1 that on June 6, 2017, 
during the on-site inspection, DI1 asked Ms. Mincy if Pharmacy 4 Less 
had an initial inventory. Tr. 39. When asked, Ms. Mincy could not 
locate the initial inventory and did not know where it was, and 
contacted Mr. Sprys to ask about the initial inventory. Id. at 39-40. 
This was done in the presence of DI1 and DI2. Tr. 39. DI1 explained to 
Mr. Sprys what an initial inventory was and asked if Pharmacy 4 Less 
had one, to which Mr. Sprys stated that he did not. Tr. 40. *[Omitted 
for brevity.]
    The Respondent did not put on any evidence to confront this 
allegation,\*WW\ although the Respondent, during cross-examination of 
DI1, questioned whether DI1 spoke to Mr. Sprys over the telephone 
regarding the initial inventory. Tr. 154.
---------------------------------------------------------------------------

    \*WW\ In its exceptions, Respondent claimed that it opened in 
2015 with ``zero narcotics'' and that ``[t]his report was shown to 
DEA agents on initial inspection in 2015.'' Resp Exceptions, at ] 7. 
This assertion is not supported by the evidentiary record. Moreover, 
the reference to ``this report'' is ambiguous and may or may not 
refer to an initial inventory, but even if an initial inventory was 
taken, there is no assertion that Respondent had an initial 
inventory during the 2017 inspection. This exception is simply 
without merit.
---------------------------------------------------------------------------

    As noted, the Government has the burden of proof in these 
proceedings to prove the charges alleged in the OSC and those later 
raised in the prehearing statements. The Government must meet its 
burden by a preponderance of the evidence for its burden to be 
satisfied as to each allegation. Here, the Government produced the 
testimony of DI1 that Ms. Mincy did not know where the initial 
inventory was, and that Mr. Sprys indicated that the pharmacy did

[[Page 54577]]

not have one. This evidence went essentially uncontested.
    The Agency has previously found that ``testimony alone provides 
substantial evidence'' to support a finding that a registrant failed to 
properly prepare records. Jones Total Health Care Pharmacy, L.L.C., & 
SND Health Care, L.L.C., 81 FR 79,188, 79,191 (2016), pet. for rev. 
denied, 881 F.3d 823 (11th Cir. 2018). The Agency rejected the 
respondent's argument that because the DEA bears the burden of proof, 
it must provide independent evidence towards such allegations. Id.
    As previously discussed, I find that DI1's testimony in these 
proceedings was credible and indicated trustworthiness. The Government 
has submitted testimonial proof sufficient to satisfy its burden, that 
the Respondent did not have an initial inventory. Further, while the 
Respondent has no burden to disprove the Government's allegation, it 
would not benefit the Respondent to withhold such a document if such 
document existed. Based on DI1's testimony and the lack of physical 
evidence presented by either party, I find that the Government has met 
its burden to show that the Respondent has failed to keep an initial 
inventory as required under Sec.  1304.11(b).
Biennial Inventory
    The Government has charged that Pharmacy 4 Less failed to indicate 
whether the biennial inventory was taken at the opening or closing of 
business as required by 21 CFR 1304.11(a). Section 1304.11(a) provides, 
in part, that ``[t]he inventory may be taken either as of opening of 
business or as of the close of business on the inventory date and it 
shall be indicated on the inventory.''
    The Government presented testimony from DI1 that the biennial 
inventory was provided to him by Ms. Mincy during the June 6, 2017 on-
site inspection. DI1 testified that the biennial inventory given to him 
did not meet the requirements as set in the DEA regulations. Tr. 41. 
One failing that DI1 noted was that, by Ms. Mincy's statements, the 
biennial inventory was not completed during a single day, but over the 
course of several days. Tr. 41. Another defect was that there was no 
notation on the biennial inventory as to whether it was completed at 
the opening or closing of business. Id. at 41-42. DI1 was unsure about 
the accuracy of the biennial inventory due to these issues, which 
caused him not to use it as part of his audit of the pharmacy's 
inventory. Id. at 56, 61, 66, 154-56.
    The Respondent presented testimony from Ms. Mincy that DI1 had 
asked to see the biennial inventory, which she produced and gave him a 
copy. Id. at 605. She indicated that the biennial inventory was located 
in a binder in the locked medication room along with the perpetual 
inventory. Id. at 607, 622-23. Ms. Mincy testified that on June 6, 
2017, she gave DI1 the biennial inventory at the pharmacy. Id. at 773-
74. She indicated that he had left it at the pharmacy after the 
inspection, and that he called back looking for it because he had 
forgotten to take it with him. Id. at 774.
    The Respondent then introduced a copy of the biennial inventory. RX 
38. The exhibit included a cover sheet that noted that the biennial 
inventory was completed on April 26, 2017, at 8:00 a.m., and was 
completed by Ms. Mincy and Mr. Sprys. Tr. 617-18, 767-68; RX 38, p. 1. 
The following page was the actual first page of the printed out 
biennial inventory. Tr. 619, 767; RX 38, p. 2. The remaining pages are 
all part of the biennial inventory, and the printout indicates a date 
of April 26, 2017. Tr. 620-22; RX 38, pp. 2-16. The exhibit contains 
handwriting that indicates that the biennial inventory was completed on 
April 26, 2017, at 8:00 a.m. and was signed by Mr. Sprys and Ms. Mincy. 
Tr. 767-69; RX 38, pp. 1, 2, 8.
    Ms. Mincy testified that the biennial inventory had been completed 
at 8:00 a.m. because it must be completed in the morning before 
business or at the end of the day at the close of business to avoid 
discrepancies in the pharmacy's counts. Tr. 620. She further testified 
that she and Mr. Sprys had signed and dated the biennial inventory to 
validate that the information was true and correct, and that she had 
completed it during that date and time. Id. at 624-25. She indicated 
that it took her approximately three hours to complete the biennial 
inventory, so she would have arrived at the pharmacy at approximately 
5:00 a.m. Id. at 628. She testified that she personally prepared both 
reports contained within the biennial inventory, and personally entered 
all of the information herself on the date listed on the form. Id. at 
772. As for the date indicated at the top of each page, Ms. Mincy 
stated that it reflects the date on which the report was run. Id. at 
772-73; RX 38, pp. 2-7, 9-16.
    The Government conducted a voir dire of Ms. Mincy as to RX 38. Tr. 
774. She testified that RX 38 was a true and correct copy of what she 
had given DI1 on June 6, 2017, and that there had not been any 
alterations made to the document after she gave it to him. Id. at 774-
75. She claimed that no one had written on the document to include the 
handwriting at the top of RX 38, p. 2 after she had given it to DI1 or 
after it had been faxed to him. Id. at 775. She testified that the 
biennial inventory had later been faxed to DI1 by Bill Sprys. Id. at 
776-77. The Government showed Ms. Mincy another version of a copy of 
the biennial inventory that did not contain the handwriting written on 
RX 38. Id. at 778-81. The Government's copy was admitted as GX 37. Ms. 
Mincy indicated that there must be two versions of the inventory, one 
labeled complete and one that was not labeled. Id. at 780.
    The Government later conducted cross-examination of Ms. Mincy about 
the biennial inventory. Id. at 817. She admitted that while the 
biennial inventory did not indicate that it was conducted at the close 
of business, she asserted that it was completed before the opening of 
business at 8:00 a.m. Id. at 817. When asked on cross-examination, she 
changed her earlier testimony to say that she completed the biennial 
inventory from 6:00 a.m. to 8:00 a.m. on April 26, 2017, an hour later 
than she had previously indicated. Id. at 822.
    Ms. Mincy was also confronted with statements DI1 testified she had 
said during the inspection. When asked if she had said during the on-
site inspection that she had completed the inventory over the course of 
several days, she claimed that DI1 was confused. Id. at 823-24. When 
asked if she had said that she would have to shut down the pharmacy to 
do the biennial inventory, she said that DI1 misunderstood. Id. at 825.
    Based on both parties' assertions, DI1 left the biennial inventory 
at the pharmacy after the on-site inspection. At that point, DI1 did 
not have a copy of the biennial inventory. I noted during the course of 
the hearing that DI1 had testified Ms. Mincy had provided a document 
that was represented as a biennial inventory, but that it didn't 
qualify because there was no indication that the document was prepared 
on a single occasion, so he left it at the pharmacy because he would 
not use it as part of his audit. Tr. 155.\*XX\
---------------------------------------------------------------------------

    \*XX\ Paragraph relocated for clarity.
---------------------------------------------------------------------------

    At the outset, I note the immediate differences between GX 37 and 
RX 38 as highlighted by the Government. Both GX 37, p. 7, and RX 38, p. 
2, present similarly printed material, but RX 38 contains handwritten 
material at the top of the page that purports to show that the biennial 
inventory was completed on ``4/26/17'' at ``8AM'' and is contains 
signatures purported to be Ms. Mincy

[[Page 54578]]

and Mr. Sprys. The Government represents that GX 37 is the biennial 
inventory that was faxed to DI1 from Bill Sprys at Pharmacy 4 Less on 
the day following the June 6, 2017 on-site inspection. While it cannot 
be ascertained when exactly the handwritten material was included on RX 
38, p.2, I find it inescapable that the handwritten notes were added 
after the inventory was faxed to the government. This is further 
supported by the assertion from Ms. Mincy that she did not appear to 
know where the handwritten notes came from.\*YY\ Tr. 786-88. In sum, 
the handwriting on RX 38 demonstrates that it is more likely that DI1 
was provided a clean copy by the Respondent through the fax on June 7, 
2017, and the handwriting on RX 38 was written at a later 
time.59 *ZZ I credit DI1's testimony as to the statements 
made during the June 6, 2017 on-site inspection, as well as the lack of 
indication on the biennial inventory when the inventory had taken 
place.
---------------------------------------------------------------------------

    \*YY\ Furthermore, I do not find credible Ms. Mincy's assertion 
that there were two or three versions of the inventory, one labeled 
complete and others that were not labeled. *[Content was moved for 
clarity.]
    \59\ In their Posthearing Brief, the Government asserts that Ms. 
Mincy has intentionally backdated documents, including RX 38. Govt 
Posthearing Brief, at 36. As discussed, I cannot determine exactly 
who added the additional handwriting included on RX 38 or when it 
was added, and cannot accept the Government's assertion that it was, 
in fact, Ms. Mincy who backdated it after it had been delivered to 
the Government.
    \*ZZ\ The preceding sentence and the following sentence were 
relocated for clarity.
---------------------------------------------------------------------------

    *[I agree with the ALJ's credibility finding regarding the 
handwriting on GX 37, p. 7 and RX 38, p.2. However, I also note that 
both the copy of the biennial inventory faxed to the Government, GX 37, 
p. 2, and the copy maintained by Respondent, RX 38, p. 1, contained 
what Ms. Mincy described as a ``cover page'' which stated ``Biennial 
Inventory, completed 4/26/17, 8am'' and was signed by both Ms. Mincy 
and Mr. Spry. Tr. 617-18. While the cover sheet contained the same 
information written in GX 37, p. 7 and RX 38, p. 2, there is simply 
insufficient information in the record for me to determine whether or 
not this ``cover page'' was attached to the Biennial Inventory at the 
time of inspection. Accordingly, I cannot say that there is enough 
evidence to support a violation of 1304.11(a). As my finding differs 
from the ALJ's in this regard, the remainder of the ALJ's discussion on 
this topic is omitted. Even without this violation, there is more than 
enough evidence on the record to indicate that Respondent pharmacy's 
registration is inconsistent with the public interest.
    Therefore, I find that the Government has not established by 
sufficient evidence that Respondent's biennial inventory failed to 
comply with the requirements of 21 CFR 1304.11(a) as alleged.]
Ms. Mincy's Access to CSOS
    The Government has charged that during DEA's review of Pharmacy 4 
Less's CSOS, Ms. Mincy admitted to using Mr. Spry's CSOS credentials to 
order controlled substances in violation of 21 CFR 1311.30(a), (c). 
Section 1311.30(a) provides that ``[o]nly the certificate holder may 
access or use his or her digital certificate and private key.'' Section 
1311.30(c) provides that ``[a] certificate holder must ensure that no 
one else uses the private key. While the private key is activated, the 
certificate holder must prevent unauthorized use of that private key.''
    The Government presented credible testimony from DI1 that he asked 
Ms. Mincy how Pharmacy 4 Less documents and records their ordering of 
controlled substances and validation of a prescription's legitimacy. 
Tr. 43.\60\ DI1 testified that he observed Ms. Mincy proceeded to a 
laptop in the pharmacy to log into the CSOS system. Id. at 45. DI1 
asked Ms. Mincy if she had her own CSOS credentials (which DI1 asserted 
is required for anyone accessing the CSOS system and cannot be shared 
with anyone else). Id. at 46. DI1 testified that Ms. Mincy stated she 
did not have her own credentials and did not have a power of attorney 
for anyone else's credentials. Id. Ms. Mincy stated to DI1 that she was 
using Mr. Richard Sprys credentials to log onto CSOS. Id. The 
Government put on further evidence that DI1 later contacted Mr. Chris 
Jewell, one of the personnel in charge of the CSOS system at DEA 
Headquarters, to determine which personnel at Pharmacy 4 Less had 
access to the CSOS system. Id. at 47-48. Mr. Jewell ran a report and 
the report stated that Ms. Mincy only received her own CSOS credentials 
in July 2018, after the on-site inspection. Id. at 48-49; GX 29.\61\
---------------------------------------------------------------------------

    \60\ DI1 asserted during his testimony that when a pharmacy 
orders and receives controlled substances on-site, they are required 
to notate that they received them with the date and the initials of 
the person that received them. Tr. 44.
    \61\ See supra n.15.
---------------------------------------------------------------------------

    The Respondent presented testimony from Ms. Mincy that she was 
asked by DI1 to look at the pharmacy's CSOS system. Id. at 612-13. The 
pharmacy uses the CSOS system sourced through AmerisourceBergen. Id. at 
612. Ms. Mincy testified that she showed DI1 the steps to order, but 
could not order because she did not have CSOS credentials at the time 
of the inspection. Id. at 613, 839-40, 867. *[During her testimony, Ms. 
Mincy went into some detail explaining how the system worked; \*AAA\ 
she testified that she logged into AmerisourceBergen and demonstrated 
how controlled substances could be added to an order without the CSOS 
credentials. Id. at 840, 867. She explained that upon completion of the 
order, Schedule III-V medications are submitted to AmerisourceBergen, 
but that Schedule II controlled substances are not submitted without 
taking extra steps to verify the CSOC certificate. Id. at 867.] When 
showing the program to DI1, Ms. Mincy stated she did not put in any 
credentials *[to complete the process of ordering Schedule II 
controlled substances], because she did not have any at the time. Id. 
at 615, 867-68. Ms. Mincy stated she then heard DI1 say that she had 
been ordering with Mr. Spry's credentials, which she followed up by 
telling him that was not correct. Tr. 615.
---------------------------------------------------------------------------

    \*AAA\ Respondent, in its exceptions, made additional factual 
assertions regarding Mr. Sprys' ability to access CSOS and order 
controlled substances, which are not only missing from the 
evidentiary record but are entirely irrelevant to the issue at hand 
and have no impact on my decision in this case. Resp Exceptions, at 
] 10.
---------------------------------------------------------------------------

    It is extremely difficult to reconcile the testimony and evidence 
presented by the parties regarding this allegation. On one hand, the 
Government presented testimony of DI1 indicating that he observed Ms. 
Mincy log onto the CSOS system, and that Ms. Mincy stated during the 
on-site inspection that she had ordered controlled substances using Mr. 
Sprys' credentials. On the other hand, the Respondent presented 
testimony of Ms. Mincy that [she logged in to the AmerisourceBergen 
system, not CSOS,] that she never [said she was using Mr. Sprys' 
credentials,] and that she told DI1 that his assertion was not correct. 
Both versions cannot be correct. Based on the previous analysis of the 
witnesses' credibility, DI1's version is [generally] more credible, 
considering Ms. Mincy's memory issues and motivation to color her 
testimony. *[However, Ms. Mincy testified in much greater detail than 
DI regarding the system and the steps she took to demonstrate it to DI, 
and this testimony was not addressed by DI when he later took the stand 
as a rebuttal witness. The Agency is clear that CSOS is the ``only 
method for ordering Schedule I and II controlled substances 
electronically,'' and can be used for other Schedules, but there is no 
information on the record about at what point during the purchasing 
process the credentials are necessary. https://www.deaecom.gov/

[[Page 54579]]

qanda.html.\*BBB\ Further had Ms. Mincy actually purchased controlled 
substances using the CSOS account during the inspection, I find it 
confusing that the Government did not include evidence related to such 
purchase.
---------------------------------------------------------------------------

    \*BBB\ ``What is a CSOS Certificate? A CSOS Certificate is a 
digital identity issued by the DEA's CSOS Certification Authority 
(CSOS CA) that allows for electronic ordering for Schedule I and II 
(as well as III-V) controlled substances. A CSOS Certificate is the 
digital equivalent of the identification information contained on a 
DEA Form-222. CSOS Certificates are issued to individuals and are 
required for electronic ordering of Schedule I and II controlled 
substances.''
---------------------------------------------------------------------------

    Despite the credibility issues present in this case,\*CCC\ the 
Government's evidence lacked basic information regarding the CSOS 
system and what the DI actually observed (as opposed to what he heard 
Ms. Mincy say) that led to his conclusion that Ms. Mincy had used Mr. 
Sprys' credentials to log into the CSOS system. Without that 
information it is difficult to determine the weight of the evidence, 
and as the Government has the burden of proof, I simply cannot find 
substantial evidence to support violations of Sec.  1311.30 (a) & (c).]
---------------------------------------------------------------------------

    \*CCC\ The Recommended Decision stated that ``it is more 
believable than not, from this record, that Ms. Mincy was given 
access to Mr. Sprys' digital certificate and private key. Despite 
her contractor status, she ran the pharmacy Monday through Thursday. 
She used Mr. Sprys' credentials to log onto the CSOS system in the 
presence of DI1, before she had her own credentials.'' Although I 
agree with the ALJ's credibility findings generally, I believe that 
the Government could have easily produced evidence to support this 
claim, and I decline to find a violation.
---------------------------------------------------------------------------

Electronically Linked Record of Quantity and Date Received
    The Government has charged that Pharmacy 4 Less's receiving records 
showed that Pharmacy 4 Less failed to create an electronically linked 
record of a quantity and date received for its controlled substances in 
violation of 21 CFR 1305.22(g). Section 1305.22(g) provides that 
``[w]hen a purchaser receives a shipment, the purchaser must create a 
record of the quantity of each item received and the date received. The 
record must be electronically linked to the original order and 
archived.''
    After a thorough review of the evidence and testimony presented by 
the parties, I have found a lack of any evidence presented towards this 
charge by the Government. While the DI1 extensively testified about the 
Government's charge of a lack of a date of receipt on the pharmacy's 
invoices, the Government did not probe into the allegation that 
Pharmacy 4 Less failed to create electronically linked records under 
Sec.  1305.22(g). While DI1 indicated that Pharmacy 4 Less did not have 
PDF copies of the CSOS records, he did testify that the CSOS is online 
and can be a totally electronic record. Tr. 44-45. However, there was 
no evidence that Pharmacy 4 Less had failed to create an electronically 
linked record of any shipments of controlled substances.
    However, the Respondent, while brief, presented some evidence of 
their compliance with Sec.  1305.22(g). The Respondent presented 
testimony by Ms. Mincy towards two inspections at Pharmacy 4 Less by 
the Florida Department of Health Investigative Services. Tr. 658-81; RX 
14, 15. One inspection report, dated February 28, 2017, before the 
DEA's on-site inspection, indicated that the investigator from the 
Florida Department of Health had found that Pharmacy 4 Less was 
compliant with the requirement that ``DEA 222 forms properly completed 
or records of receipt of CSOS orders electronically completed, archived 
and retrievable.'' Tr. 661; RX 15, p. 2. This requirement then directly 
cites to 21 CFR 1305.22(g). RX 15, p. 2. The second inspection report, 
dated September 5, 2017, after the DEA's on-site inspection, indicated 
that the investigator from the Florida Department of Health again found 
that Pharmacy 4 Less was compliant with the requirement under Sec.  
1305.22(g). RX 14, p. 2.
    While the Respondent's evidence will ultimately go towards the 
analysis of Factor Two under the public interest factors, it is also 
relevant to rebut the Government's charge under Sec.  1305.22(g). While 
the DIs may have had some indication that Pharmacy 4 Less was not in 
compliance with the requirements under Sec.  1305.22(g), the record is 
void of any testimony or evidence to support such a charge. Further, 
the Respondent has offered evidence, at least from the viewpoint of an 
inspector with the Florida Department of Health, that Pharmacy 4 Less 
was in compliance with the requirements under Sec.  1305.22(g) before 
and after the DEA's on-site inspection. Therefore, I find that the 
Government has not met their burden of proof as to this allegation.
Date of Receipt on Invoices
    The Government has charged that Pharmacy 4 Less possessed 85 
invoices without the date of receipt recorded in violation of 21 CFR 
1304.22(c). Section 1304.22(c) provides, in part, that ``[e]ach person 
registered or authorized to dispense or conduct research with 
controlled substances shall maintain records with the same information 
required of manufacturers pursuant to paragraph (a)(2)(i), (ii), (iv), 
(vii), and (ix) of this section. In addition, records shall be 
maintained of the number of units or volume of such finished form 
dispensed, including the name and address of the person to whom it was 
dispensed, the date of dispensing, the number of units or volume 
dispensed, and the written or typewritten name or initials of the 
individual who dispensed or administered the substance on behalf of the 
dispenser.''
    I note at the outset that a review of the Government's charge in 
the OSC and in their Prehearing Statements presents a problem. Upon a 
careful review of the language of Sec.  1304.22(c), it becomes apparent 
to me that this section has no requirement that the pharmacy must 
indicate a date of receipt of controlled substances. Section 1304.22(c) 
relates to ``Records for dispensers and researchers'' and requires 
certain records be maintained, both those provided in Sec.  1304.22(c) 
and those required under Sec.  1304.22(a)(2)(i), (ii), (iv), (vii), and 
(ix). None of these subsections indicate any requirement to maintain a 
date of receipt.
    I find that the Government's subject allegation does not cite to a 
regulation which proscribes the conduct alleged. Substituting a 
different regulation post-hearing would create daunting notice and due 
process issues. To allow the Government to do so would create an 
improper burden-shifting beyond those recognized by the APA and the 
fundamental tenets of notice and due process. See Farmacia Yani, 80 FR 
29,053, 29,059-60 (2015). One of the fundamental tenets of Due Process 
is that an Agency must provide a Respondent with notice of those acts 
which the Agency intends to rely on in seeking the revocation of its 
registration so as to provide a full and fair opportunity to challenge 
the factual and legal basis for the Agency's action. See NLRB v. 
I.W.G., Inc., 144 F.3d 685, 688-89 (10th Cir. 1998); Pergament United 
Sales, Inc. v. NLRB, 920 F.2d 130, 134 (2d Cir. 1990). Because the 
Government apparently did not allege in the Order to Show Cause or in 
its Prehearing Statements the applicable citation to the law on which 
it bases its allegation, before proceeding to address whether the 
evidence supports the Government's factual contention, it is necessary 
determine whether the Government otherwise provided adequate notice of 
its intent to litigate the issue. See 5 U.S.C. 554(b) (``Persons 
entitled to notice of an agency hearing shall be timely informed of . . 
. the matters of fact and law asserted.''). ``The primary function of 
notice is to afford [a] respondent an opportunity to prepare a defense 
by investigating the basis of the

[[Page 54580]]

complaint and fashioning an explanation that refutes the charge of 
unlawful behavior.'' Pergament United Sales, 920 F.2d at 135 (citation 
omitted). While the issue of whether an allegation ``has been fully and 
fairly litigated [by consent] is so peculiarly fact-bound as to make 
every case unique,'' id. at 136, ``the simple presentation of evidence 
important to an alternative [allegation] does not satisfy the 
requirement'' that a respondent be afforded with a full and fair 
opportunity to litigate the alternative allegation. I.W.G., 144 F.3d at 
688 (quoting NLRB v. Quality C.A.T.V., Inc., 824 F.2d 542, 547 (7th 
Cir. 1987) (citation omitted)).
    From the outset, the Government has consistently cited to Sec.  
1304.22(c) as the basis of this charge for Pharmacy 4 Less failing to 
record the date of receipt on 85 invoices. However, as discussed, Sec.  
1304.22(c) does not contain any such requirement. In this proceeding, 
it is not the responsibility of the Respondent, this Tribunal, or the 
Administrator to substitute a different regulation than charged to fit 
the evidence the Government has presented.\62\ The Government has been 
given multiple opportunities to amend its pleadings, but it has not 
done so.
---------------------------------------------------------------------------

    \62\ ``[I]t 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.'' Top RX Pharmacy, 78 FR 26,069, 26070 n.7 
(2013) (quoting Gregg & Son Distribs., 74 FR 17,517-18 n.1 (2009)); 
James William Eisenberg, M.D., 77 FR 45,663, 45,674 n.47 (2012).
---------------------------------------------------------------------------

    [Moreover, the record does not support a finding that the issue was 
litigated by consent.] To further confuse the matter, the Respondent 
conducted voir dire of DI1 as to GX 26. The Respondent questioned 
whether the federal regulations require that invoices had to be signed 
and dated by the person receiving the controlled substances shipment. 
Tr. 141. DI1 stated that while he could not accurately quote the 
regulations off the top of his head, he had a general understanding 
that the regulations required these things. Id. at 140-41. The 
Respondent then argued that if the Government were offering GX 26 to 
prove a violation of Sec.  1305, the exhibit should not be admitted 
because Sec.  1305 only requires a signature and date by the receiver 
for Schedule 2 controlled substances.\63\ Id. at 142. The Government 
responded that it offered the entire exhibit into evidence for all 
controlled substances, but stated that it may have cited an improper 
section and would limit their ability to prove that charge. Id. at 142-
43. The Respondent argued that the Government cited to Sec.  1305.22 
throughout the Order to Show Cause, the Government's Prehearing 
Statement, and the Government's Supplemental Prehearing Statement, and 
that they had been given notice of their citation mistake by the 
Tribunal during the prehearing conference. Id. at 143. The Government 
said that it may have intended to limit itself to strictly Schedule 1 
and 2 controlled substances, but that it could not cite that at that 
moment. Tr. 144. [Here, although Respondent pharmacy clearly believed 
that the Sec.  1304.22 citation in the OSC was incorrect, they 
proceeded with the litigation believing that the Government had 
intended to cite Sec.  1305.22(g).*DDD 64 21 CFR 1305.22 
deals strictly with electronic (as opposed to paper) orders for 
Schedules I and II controlled substances (as opposed to Scheduled III-
V), so it also does not provide a legal basis for the allegation that 
Respondent violated the law by failing to record a receipt date on its 
paper invoices. I suspect the Government intended to charge Respondent 
with a violation of Sec.  1304.21,\*EEE\ but I will not consider it 
based on lack of notice.]
---------------------------------------------------------------------------

    \63\ Upon review of the OSC and the Government's Prehearing 
Statements, I believe that the Respondent misstated Sec.  1305 as 
the basis for this charge and questioned DI1 on the basis of a 
regulation not charged. The Government charged a failure to indicate 
a date of receipt under Sec.  1304.22.
    \*DDD\ [This text was relocated for clarity.] When I later asked 
about Sec.  1305.22, DI1 was provided a copy of the Code of Federal 
Regulations to determine if it was the section that requires a 
person receiving a shipment of controlled substances must initial 
and date. Tr. 163. While looking at the regulations, DI1 indicated 
that it was not Sec.  1305.22. Tr. 163-64. He stated that Sec.  
1305.22 refers to the procedure for filling electronic orders, which 
refers to CSOS. Tr. 164-65. After looking through the regulations, 
he indicated that he didn't know the actual regulation, but that 
Sec.  1305.22 was not what he was talking about. Tr. 165.
    \64\ The following morning on the second day of the hearing, 
before the start of testimony, I inquired with the Government as to 
whether they still intended to include all scheduled controlled 
substances or limit the evidence to only those invoices including 
Schedules 1 and 2 controlled substances. The Government indicated 
that they wanted to proceed with all scheduled controlled 
substances. The Respondent objected and again raised his argument 
that Sec.  1305 only provides requirements for Schedules 1 and 2 
controlled substances. However, upon a review of the hearing 
transcripts, I have found that these conversations were not recorded 
and transcribed. This recitation of the discussion is from my 
memory, but should be provided in the context of the analysis as to 
any ultimate due process concerns.
    \*EEE\ At one point, DI identified and read 21 CFR 1304.21(d) 
into the record, but agreed that section did not require the 
recording of the date of receipt (and he did not identify 1304.21(a) 
which does require pharmacies to keep records regarding the date of 
receipt of controlled substances). Tr. 164. Ultimately DI's 
testimony was that he did not know which regulation required 
pharmacies to document the date controlled substances were received. 
Tr. 165.
---------------------------------------------------------------------------

    While the Government has presented a sufficient amount of evidence 
towards their allegation that Pharmacy 4 Less possessed invoices 
without the date of receipt (as the Government claims the cited 
regulation requires), the Respondent has consistently objected to the 
Government's legal basis for its allegation [and there has been no 
notice of a proper legal basis.] Therefore, I find that the Government 
cannot sustain their burden in their allegation under Sec.  1304.22(c) 
as charged. [Therefore, it is not necessary to review the evidence and 
testimony in support of this allegation, and I have omitted it 
accordingly.]
Inaccurate Inventory
    The Government has charged that Pharmacy 4 Less maintained an 
inaccurate inventory \*FFF\ in violation of 21 CFR 1304.22(c). Section 
1304.22(c) again provides, in part, that ``[e]ach person registered or 
authorized to dispense or conduct research with controlled substances 
shall maintain records with the same information required of 
manufacturers pursuant to paragraph (a)(2)(i), (ii), (iv), (vii), and 
(ix) of this section.[\*GGG\] In addition, records shall be maintained 
of the number of units or volume of such finished form dispensed, 
including the name and address of the person to whom it was dispensed, 
the date of dispensing, the number of units or volume dispensed, and 
the written or typewritten name or initials of the individual who 
dispensed or administered the substance on behalf of the dispenser.''
---------------------------------------------------------------------------

    \*FFF\ The Government's reference to an ``inaccurate inventory'' 
in this section does not seem to refer to any specific inventory 
document such as the initial inventory, biennial inventory, or even 
the perpetual inventory. Rather, the Government seems to be using 
the phrase generally to state that the Pharmacy's records and the 
quantity of controlled substances on hand at the pharmacy did not 
align.
    \*GGG\ These required records include, amongst other things, the 
name, quantity, and strength of controlled substances and the number 
of units that are acquired to inventory or distributed or disposed. 
Id.
---------------------------------------------------------------------------

    The Government included this new charge, after the issuance of the 
Order to Show Cause, in its Prehearing Statement. The Government's 
Supplemental Prehearing Statement states that ``DI1 will testify that 
he conducted an audit of Pharmacy 4 Less's inventory, and found that it 
was inaccurate, a violation of 21 CFR 1304.22(c). The way that the 
audit was performed depended on the controlled substance involved. For 
Schedule II Controlled Substances, Pharmacy 4 Less maintained a 
handwritten perpetual inventory which was used to audit the controlled 
substances with a start date

[[Page 54581]]

of January 1, 2017. For other controlled substances, the start of 
business was used. Among other inaccuracies, DI1's audit found that 
Pharmacy 4 Less had a shortfall of 731 tablets of oxycodone 30 mg, a 
shortfall of 526 tablets of carisoprodol 350 mg, and a surplus of 1,488 
tablets of methadone HCL 10 mg. DI1 will authenticate his computation 
chart. DI1 will also authenticate the handwritten oxycodone and 
methadone perpetual inventories that were used to conduct the oxycodone 
and methadone audits.'' Government's Supplemental Prehearing Statement, 
at 4-5.
    During the Prehearing Conference, I inquired with the Government as 
to the addition of this new allegation and whether they intended this 
to act as a new charge. The Government said that it did intend it as a 
new charge. The Respondent objected and argued that it should not be 
required to answer to charges not listed in the Order to Show Cause. I 
informed the Respondent as to the Agency's liberal notice requirements 
and provided them with the opportunity to address any new allegations 
in a Supplemental Prehearing Statement provided the Government amended 
or added to its new allegation. I find the Government provided 
sufficient notice to satisfy due process as to this supplemental 
charge.
    In the Respondent's Amended Supplemental Prehearing Statement, the 
Respondent not only offered a proposed stipulation that their inventory 
was correct, but also indicated that Ms. Mincy's proposed testimony 
would include testimony that Pharmacy 4 Less's inventory was accurate. 
As it will be discussed, Respondent both cross-examined DI1 on his 
audit of Pharmacy 4 Less's inventory, as well as provided testimony 
from Ms. Mincy about the pharmacy's inventory.
    The Government presented evidence from DI1 about the audit he 
conducted of Pharmacy 4 Less's perpetual inventories in order to find 
if their inventories were accurate. As previously noted, DI1 did not 
use either an initial inventory or biennial inventory as the starting 
point for the audit.\*HHH\ DI1 created a computation chart of the 
controlled substances in order to conduct an audit of the pharmacy's 
inventories. GX 4.
---------------------------------------------------------------------------

    \*HHH\ Respondent argued during the hearing that there is no 
requirement to maintain a perpetual inventory and that the perpetual 
inventory was thus an improper document upon which to base the 
audit. Tr. 18, 58, 630-31, 925. I agree that Respondent was not 
required to create a perpetual inventory. However, what matters here 
is that Respondent could not account for a significant number of 
controlled substances by adequate documentation. See Ideal Pharmacy 
Care, Inc., d/b/a Esplanade Pharmacy, 76 FR 51,415, 51,416 (2011). 
These significant variances were present both where the perpetual 
inventory was used in the audit and where it was not. Notably, 
Respondent Pharmacy made no attempt to rebut the government's prima 
facie case demonstrating inaccurate recordkeeping aside from bald 
assertions that its on-hand inventory was accurate.
---------------------------------------------------------------------------

    DI1 indicated January 1, 2017, as the starting point for the audit. 
Tr. 55. This date was selected because it was the date in which the 
pharmacy had used in its handwritten Schedule 2 controlled substance 
inventories. Tr. 56; GX 31, 32. These include the perpetual inventory 
form for Methadone 10 mg tablets (GX 31) and Oxycodone 30 mg tablets 
(GX 32). Id. at 57. He testified that he used the pharmacy's 
inventories and made sure that the inventories received or filled prior 
to January 1, 2017 were correct to use as a starting point. Id. at 61-
62. Then he would take records from the pharmacy for the period of the 
audit and correlate those with invoices and any other records showing 
when the pharmacy had received additional controlled substances. Id. at 
62. Once those numbers were verified, DI1 then looked at what the 
pharmacy had on hand according to their records, took all the received 
controlled substances within that timeframe, and then added those 
numbers together to find a total accountable number. Id. at 63.
    DI1 then determined how many controlled substances Pharmacy 4 Less 
actually had on site during the June 6, 2017 on-site inspection. Id. 
This was done by hand counting the tablets located on hand in the 
pharmacy at the time of the inspection. Id. He also determined the 
number of sales for each controlled substance during the audit period 
by looking at documentation provided to him by Ms. Mincy. Id. at 63-64. 
DI1 then added up the total number of the inventory that had been 
counted in the store on June 6 and the sales that had been accounted 
for by the records to determine the total amount of tablets accounted 
for. Id. at 65. DI1 then compared the ``total accountable for'' number 
and the ``total accounted for'' number to determine if there was a 
shortfall or surplus, indicated as the ``total difference.'' Id. The 
same process was completed for Schedules 3 through 5 controlled 
substances, but the starting number at the beginning of business was 
zero because the pharmacy had no controlled substances on hand when 
they started as a pharmacy. Id. at 66.
    As previously noted, the Respondent conducted a cross-examination 
as to the computation chart revealing some formatting errors. This 
Tribunal allowed the Government to substitute a more legible copy of 
it. Tr. 919-26. A check of the mathematics done within GX 4 demonstrate 
that the mathematics have been done correctly and demonstrate 
discrepancies between the pharmacy's records as used by DI1 and the 
amount that DI1 accounted for during his count at the pharmacy during 
his on-site inspection.
    The Respondent presented testimony from Ms. Mincy about the 
pharmacy's inventories. Ms. Mincy confirmed that DI1 had asked to see 
the pharmacy's biennial and perpetual inventories,\*III\ along with DI1 
and DI2 conducting a pill count during the June 6, 2017 on-site 
inspection.\*JJJ\
---------------------------------------------------------------------------

    \*III\ Ms. Mincy testified that the perpetual inventory was a 
handwritten document. Tr. 631. As for its purpose, she stated 
``[e]very time we fill a prescription we like to note it so that we 
can keep up with our inventory on hand, to make sure that we are 
keeping enough drugs in stock like for the next day, you know, we 
[do not] want to run out.'' Id.
    \*JJJ\ Omitted information regarding the biennial inventory for 
brevity and inserted information regarding the perpetual inventory.
---------------------------------------------------------------------------

    Based on the testimony and evidence presented by the parties, I 
find the audit conducted by DI1 to be consistent with his portrayal of 
events during the June 6, 2017 on-site inspection and that it credibly 
shows discrepancies between the records maintained by the pharmacy and 
the actual count of tablets as determined by DI1. For example, DI1's 
calculations determined that Pharmacy 4 Less has 1,488 more tablets of 
Methadone HCL 10 mg on hand than was provided for in their records. 
This large of a disparity between the amount counted and the records 
show that it cannot be the result of miscounting the tablets on hand at 
the pharmacy during the on-site inspection.
    While Ms. Mincy may have testified to her role at the pharmacy in 
maintaining the supplies and inventories, I find, in light of my 
previous reliability analysis of Ms. Mincy, that her explanations 
regarding inventory procedure and practice do not overcome the 
Government's evidence showing the pharmacy inventories were inaccurate. 
The failure of the pharmacy to maintain an initial inventory and 
failure to maintain an accurate biennial inventory, along with the 
great potential for error that a handwritten perpetual inventory 
provides, also lend weight to the Government's allegation that Pharmacy 
4 Less maintained inaccurate inventories.
    *[The Government has demonstrated that Respondent's on-hand 
inventory had overages and shortages when compared to Respondent's 
records at the time of the inspection. The Agency has found that such 
overages and shortages create a risk for diversion. It is clear that

[[Page 54582]]

there were unexplained discrepancies between Respondent's records and 
the amount of inventory on hand. Such discrepancies provide substantial 
evidence that Respondent has violated 21 CFR 1304.22(c). See e.g., 
Ester Mark, M.D., 56 FR 16,760, 16,774 (2021); Wayne Pharmacy, 85 FR 
63,579, 63,582 (2020).]
Government's Burden of Proof and Establishment of a Prima Facie Case
    Based upon my review of each of the allegations by the Government, 
it is necessary to determine if it has met its prima facie burden of 
proving the requirements for a sanction pursuant to 21 U.S.C. 824(a). 
At the outset, I find that the Government has demonstrated and met its 
burden of proof in support of revocation through its case that the 
Respondent has failed to resolve red flags of diversion and document 
the resolution of red flags of diversion. Further, the Government has 
additionally demonstrated, that Pharmacy 4 Less has violated certain 
recordkeeping requirements of the Code of Federal Regulations. Inasmuch 
as the Government has established by a preponderance of the evidence 
that the Respondent *[acted outside of the usual course of professional 
practice and beneath the applicable standard of care in the state of 
Florida, and] violated federal laws relating to controlled substances 
on numerous occasions,\*KKK\ it has met its prima facie burden of 
proving that the requirements for a sanction pursuant to 21 U.S.C. 
824(a) are satisfied.
---------------------------------------------------------------------------

    \*KKK\ Omitted text for clarity.
---------------------------------------------------------------------------

Public Interest Determination: The Standard

    Pursuant to 21 U.S.C. 823(f) (2006 & Supp. III 2010), the 
Administrator \65\ may revoke a DEA Certificate of Registration if 
persuaded that the maintaining such registration would be inconsistent 
with the public interest. Evaluation of the following factors have been 
mandated by Congress in determining whether maintaining such 
registration would be inconsistent with the ``the public interest'':
---------------------------------------------------------------------------

    \65\ This authority has been delegated pursuant to 28 CFRSec.  
0.100(b) and 0.104 (2008).
---------------------------------------------------------------------------

    (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 . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Any one or a combination 
of factors may be relied upon, and when exercising authority as an 
impartial adjudicator, the Agency may properly give each factor 
whatever weight it deems appropriate in determining whether a 
registrant's registration should be revoked. Id. (citation omitted); 
David H. Gillis, M.D., 58 FR 37,507, 37,508 (1993); see also Morall v. 
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005); Henry J. Schwarz, Jr., 
M.D., 54 FR 16,422, 16,424 (1989). Moreover, the Agency is ``not 
required to make findings as to all of the factors,'' Hoxie v. DEA, 419 
F.3d 477, 482 (6th Cir. 2005); see also Morall, 412 F.3d at 173, and is 
not required to discuss consideration of each factor in equal detail, 
or even every factor in any 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).
Factors 2 and 4: Experience in Dispensing, and Compliance With 
Applicable State, Federal, or Local Laws Relating to Controlled 
Substances
    The Government's case invoking the public interest factors of 21 
U.S.C. 823(f) seeks the revocation of the Respondent's COR based 
primarily on conduct most aptly considered under Public Interest 
Factors 2 and 4.66 *LLL 67 68 69
---------------------------------------------------------------------------

    \66\ 21 U.S.C. 823(f)(2), (4). There is nothing in the record to 
suggest that a state licensing board made any recommendation 
regarding the disposition of the Respondent's DEA COR (Factor 1). 
Likewise, the record contains no evidence that the Respondent has 
been convicted of (or charged with) a crime related to controlled 
substances (Factor 3).
    \*LLL\ For brevity and keeping with recent cases, I have removed 
the legal standard used originally by the ALJ throughout this 
section to analyze Factors 2 and 4 and have replaced it with this 
text.
    \67\ *[Omitted text where footnote was included.]
    \68\ *[Omitted text where footnote was included.]
    \69\ *[Omitted text where footnote was included.]
---------------------------------------------------------------------------

    *[Factors Two and Four are often analyzed together. See, e.g., Fred 
Samimi, M.D., 79 FR 18,698, 18,709 (2014); John V. Scalera, M.D., 78 FR 
12,092, 12,098 (2013). Under Factor Two, the DEA analyzes a 
registrant's ``experience in dispensing . . . controlled substances.'' 
21 U.S.C. 823(f)(2). Factor Two analysis focuses on an applicant's acts 
that are inconsistent with the public interest, rather than on an 
applicant's neutral or positive acts and experience.\*MMM\ Randall L. 
Wolff, M.D., 77 FR 5106, 5121 n.25 (2012) (explaining that ``every 
registrant can undoubtedly point to an extensive body of legitimate 
prescribing over the course of [the registrant's] professional 
career'') (quoting Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (2009)). 
Similarly, under Factor Four, the DEA analyzes an applicant's 
compliance with federal and state controlled substance laws. 21 U.S.C. 
823(f)(4). Factor Four analysis focuses on violations of state and 
federal laws and regulations. Volkman v. DEA, 567 F.3d 215, 223-24 (6th 
Cir. 2009) (citing Gonzales v. Oregon, 546 U.S. 243, 272, 274 (2006)); 
see Joseph Gaudio, M.D., 74 FR 10,083, 10,090-91 (2009).]
---------------------------------------------------------------------------

    \*MMM\ As it is not relevant, I have removed the ALJ's analysis 
regarding the history of Pharmacy 4 Less and its impact on the local 
community which, according to the ALJ, was based on very little 
evidence in the record.
---------------------------------------------------------------------------

    Here, Pharmacy 4 Less provided evidence of its compliance with 
state and federal law through the introduction of two Florida 
Department of Health Inspection reports.\70\ RX 14, 15. One of the 
reports, dated February 28, 2017, occurred before the June 6, 2017 on-
site inspection by the DEA. RX 15. The report appears to show that 
Pharmacy 4 Less was in compliance with all applicable portions of the 
state inspector's report, which not only cites to Florida 
administrative regulations, but also to federal regulations. While the 
thoroughness and thus full significance of the Florida state 
inspections cannot be gleaned from the inspection reports, and the 
Florida inspector cannot be held to determine compliance with federal 
regulations in the same manner as DEA DIs, it is sufficient evidence to 
show that the Florida inspector not only determined at least some 
sufficient maintenance of required standards under federal regulations, 
but particularly with Florida administrative regulations under Florida 
state law. This gives indication that Pharmacy 4 Less was in compliance 
with, at a minimum,

[[Page 54583]]

applicable Florida state law (based on the requirements by the State of 
Florida Department of Health Investigative Services) before the DEA's 
on-site inspection.
---------------------------------------------------------------------------

    \70\ *[Omitted text where footnote was included.]
---------------------------------------------------------------------------

    Further, Pharmacy 4 Less also introduced a second state report 
dated September 5, 2017, which occurred after the DEA's on-site 
inspection. RX 14. The report has a few discrepancies when compared to 
RX 15. The second report does not appear to be completely filled out, 
particularly at the end of the second page. Further, it does not have a 
signature page as that provided for in RX 15. However, when comparing 
both documents, it is clear that RX 14 was completed by a computer or 
some sort of electronic device, while RX 15 was completed by hand. This 
second report also demonstrates, in the same manner as RX 15, that the 
Florida inspector not only found Pharmacy 4 Less to be compliant with 
some federal regulations, but particularly with sections of Florida 
administrative regulations.
    Both of these reports weigh in favor of Pharmacy 4 Less as evidence 
of their compliance with federal and state law, as determined by 
inspectors from the Florida Department of Health Investigative 
Services. [However, the reports are not dispositive of the issues in 
this case, in particular the resolution of red flags, and the specific 
allegations in this case must still be addressed.]
Standard of Care as to Charged Violations \*NNN\
---------------------------------------------------------------------------

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

    A physician's standard of care for prescribing is guided by federal 
and state law. ``A prescription for a controlled substance may only be 
filled by a pharmacist, acting in the usual course of his professional 
practice.'' 21 CFR 1306.06. [According to the CSA's implementing 
regulations, a lawful controlled substance order or prescription is one 
that is ``issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional practice.'' 
21 CFR 1306.04(a). While the ``responsibility for the proper 
prescribing and dispensing of controlled substances is upon the 
prescribing practitioner, . . . a corresponding responsibility rests 
with the pharmacist who fills the prescription.'' Id. The regulations 
establish the parameters of the pharmacy's corresponding 
responsibility.

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

Id. ``The language in 21 CFR 1306.04 and caselaw could not be more 
explicit. A pharmacist has his own responsibility to ensure that 
controlled substances are not dispensed for non-medical reasons.'' 
Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730 
(1990) (citing United States v. Hayes, 595 F.2d 258 (5th Cir. 1979), 
cert. denied, 444 U.S. 866 (1979); United States v. Henry, 727 F.2d 
1373 (5th Cir. 1984) (reversed on other grounds)). As the Supreme Court 
explained in the context of the CSA's requirement that schedule II 
controlled substances may be dispensed only by written prescription, 
``the prescription requirement . . . ensures patients use controlled 
substances under the supervision of a doctor so as to prevent addiction 
and recreational abuse . . . [and] also bars doctors from peddling to 
patients who crave the drugs for those prohibited uses.'' Gonzales v. 
Oregon, 546 U.S. 243, 274 (2006).
    To prove a pharmacist violated her corresponding responsibility, 
the Government must show that the pharmacist acted with the requisite 
degree of scienter. See 21 CFR 1306.04(a) (``[T]he person knowingly 
filling [a prescription issued not in the usual course of professional 
treatment] . . . shall be subject to the penalties provided for 
violations of the provisions of law relating to controlled 
substances.'') (emphasis added). DEA has also consistently interpreted 
the corresponding responsibility regulation such that ``[w]hen 
prescriptions are clearly not issued for legitimate medical purposes, a 
pharmacist may not intentionally close his eyes and thereby avoid 
[actual] knowledge of the real purpose of the prescription.'' 
Bertolino, 55 FR at 4730 (citations omitted); see also JM Pharmacy 
Group, Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR 28667, 
28670-72 (2015) (applying the standard of willful blindness in 
assessing whether a pharmacist acted with the requisite scienter). 
Pursuant to their corresponding responsibility, pharmacists must 
exercise ``common sense and professional judgment'' when filling a 
prescription issued by a physician. Bertolino, 55 FR at 4730. When a 
pharmacist's suspicions are aroused by a red flag, the pharmacist must 
question the prescription and, if unable to resolve the red flag, 
refuse to fill the prescription. Id.; Medicine Shoppe-Jonesborough, 300 
F. App'x 409, 412 (6th Cir. 2008) (``When pharmacists' suspicions are 
aroused as reasonable professionals, they must at least verify the 
prescription's propriety, and if not satisfied by the answer they must 
refuse to dispense.'').
    Finally, ``[t]he corresponding responsibility to ensure the 
dispensing of valid prescriptions extends to the pharmacy itself.'' 
Holiday CVS, 77 FR at 62341 (citing Med. Shoppe--Jonesborough, 73 FR at 
384; United Prescription Servs., Inc., 72 FR 50397, 50407-08 (2007); 
EZRX, L.L.C., 69 FR 63178, 63181 (2004); Role of Authorized Agents in 
Communicating Controlled Substance Prescriptions to Pharmacies, 75 FR 
61613, 61617 (2010); Issuance of Multiple Prescriptions for Schedule II 
Controlled Substances, 72 FR 64921, 64924 (2007) (other citations 
omitted)). The DEA has consistently held that the registration of a 
pharmacy may be revoked as the result of the unlawful activity of the 
pharmacy's owners, majority shareholders, officers, managing 
pharmacist, or other key employee. EZRX, L.L.C., 69 FR at 63181; Plaza 
Pharmacy, 53 FR 36910, 36911 (1988). Similarly, ``[k]nowledge obtained 
by the pharmacists and other employees acting within the scope of their 
employment may be imputed to the pharmacy itself.'' Holiday CVS, 77 FR 
at 62341.
    In this matter, the Government did not allege that Respondent 
dispensed the subject prescriptions having actual knowledge that the 
prescriptions lacked a legitimate medical purpose. Instead, the 
Government alleged that Respondent violated the corresponding 
responsibility regulation for each of the patients at issue in this 
matter by filling prescriptions ``in the face of [numerous] red flags 
for which there [was] no evidence that they were ever resolved.'' Govt 
Prehearing, at 8, and 9-14. Agency decisions have consistently found 
that prescriptions with the same red flags at issue here were so 
suspicious as to support a finding that the pharmacists who filled them 
violated the Agency's corresponding responsibility rule due to actual 
knowledge of, or willful blindness to, the prescriptions' illegitimacy. 
21 CFR 1306.04(a); see, e.g., Pharmacy Doctors Enterprises d/b/a Zion 
Clinic Pharmacy, 83 FR 10876, 10898, pet. for rev. denied, 789 F. App'x 
724 (11th Cir. 2019) (long distances; pattern prescribing; customers 
with the same street address presenting the same prescriptions on the 
same day; drug cocktails; cash payments; early refills); Hills 
Pharmacy, 81 FR 49816, 49836-39

[[Page 54584]]

(2016) (multiple customers presenting prescriptions written by the same 
prescriber for the same drugs in the same quantities; customers with 
the same last name and street address presenting similar prescriptions 
on the same day; long distances; drug cocktails); The Medicine Shoppe, 
79 FR 59504, 59507, 59512-13 (2014) (unusually large quantity of a 
controlled substance; pattern prescribing; irregular dosing 
instructions; drug cocktails); Holiday CVS, 77 FR 62316, 62317-22 
(2012) (long distances; multiple customers presenting prescriptions 
written by the same prescriber for the same drugs in the same 
quantities; customers with the same last name and street address 
presenting virtually the same prescriptions within a short time span; 
payment by cash); East Main Street Pharmacy, 75 FR 66149, 66163-65 
(2010) (long distances; lack of individualized therapy or dosing; drug 
cocktails; early fills/refills; other pharmacies' refusals to fill the 
prescriptions). Here, the Government established the presence of red 
flags on the prescriptions that Respondent Pharmacy filled.]
    Further, under Florida law, [which is supportive of the applicable 
standard of care in Florida,] a pharmacist is required to conduct a 
prospective drug use review before filling or refilling any 
prescription for controlled substances. Fla. Admin. Code r. 64B16-
27.810. Florida also requires that pharmacists question prescriptions 
that may not be valid and only fill the prescriptions if the pharmacist 
is able to validate the prescription. Fla. Admin. Code r. 64B16-
27.831.\*OOO\
---------------------------------------------------------------------------

    \*OOO\ Omitted, for brevity, text regarding the legal standard 
requiring a nexus between the state law that has been violated and 
the CSA's purpose of preventing drug abuse and diversion. I find 
that, here, Florida law was used to support determination of the 
standard of care, but that the Government did not allege independent 
violations of state law.
---------------------------------------------------------------------------

    This leads me to the conclusion that Pharmacy 4 Less \*PPP\ has 
operated outside the usual course of professional practice (in 
violation of 21 CFR 1306.06) and in violation of its corresponding 
responsibility (in violation of 21 CFR 1306.04(a)). Further, as the 
Florida laws and regulations provide for the standards of practice for 
pharmacists and pharmacies, including requiring certain standards of 
review and documentation, I find that the charged regulations bear a 
substantial relationship to the CSA's purposes of drug abuse and 
diversion. As such, I find that Pharmacy 4 Less has failed to meet the 
standard of care as provided for under Florida law and regulations [and 
as I have found above].
---------------------------------------------------------------------------

    \*PPP\ Omitted finding of a violation of Florida law.
---------------------------------------------------------------------------

    In light of the record as to this factor, I find that the favorable 
evidence introduced through the Respondent is overwhelmed by the 
evidence introduced through the Government that the Respondent has 
failed to comply with federal *[omitted] law [and has violated its 
corresponding responsibility]. Therefore, I find [factors 2 and 4] 
significantly favor revoking the Respondent's registration.
Due Process Right of the Respondent
    *[Omitted.] The Government asserts in its Posthearing Brief that 
Pharmacy 4 Less has been ``disingenuous'' during the course of this 
matter and should be penalized for its decision to file a motion to 
suppress, and to withhold subpoenaed records from the Government when 
it asserted HIPAA privacy issues and was preparing to contest the DEA's 
administrative subpoena in United States District Court. Govt 
Posthearing, at 44. *[Omitted. The ALJ found] that the Respondent's 
decision to contest the DEA's administrative subpoena should not be 
held against the Respondent as either an adverse inference or as an 
independent violation. [I decline to make any findings regarding the 
Government's argument and have omitted the analysis accordingly.]
Acceptance of Responsibility
    The Government's prima facie burden having been met, the Respondent 
must present sufficient mitigating evidence to assure the Administrator 
that he can be entrusted with the responsibility incumbent with such 
registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008), 
Samuel S. Jackson, 72 FR 23,848, 23,853 (2007).\*QQQ\ This feature of 
the Agency's interpretation of its statutory mandate on the exercise of 
its discretionary function under the CSA has been sustained on review. 
MacKay, 664 F.3d at 822. As, past performance is the best predictor of 
future performance, DEA has repeatedly held that where an applicant has 
committed acts inconsistent with the public interest, the applicant 
must accept responsibility for his actions and demonstrate that he will 
not engage in future misconduct. ALRA Labs, Inc. v. DEA, 54 F.3d 450, 
452 (7th Cir.1995); Medicine Shoppe, 73 FR 387; see also Hoxie, 419 
F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' by DEA to 
be an ``important factor[ ]'' in the public interest determination). So 
too, in making the public interest determination, ``this Agency places 
great weight on an [applicant's] candor, both during an investigation 
and in [a] subsequent proceeding.'' Robert F. Hunt, 75 FR 49,995, 
50,004 (2010); Hoxie, 419 F.3d at 483.
---------------------------------------------------------------------------

    \*QQQ\ This sentence was relocated and replaced existing text 
for clarity and brevity.
---------------------------------------------------------------------------

    While an applicant must accept responsibility and demonstrate that 
he will not engage in future misconduct in order to establish that his/
her continued registration is consistent with the public interest, DEA 
has repeatedly held these are not the only factors that are relevant in 
determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 FR 
10,083, 10,094 (2009); Southwood Pharmaceuticals, Inc., 72 FR 36,487, 
36,504 (2007). The egregiousness and extent of an applicant's 
misconduct are significant factors in determining the appropriate 
sanction. See Jacobo Dreszer, 76 FR 19,386, 19,387-88 (2011) 
(explaining that a respondent can ``argue that even though the 
Government has made out a prima facie case, his conduct was not so 
egregious as to warrant revocation''); Paul H. Volkman, 73 FR 30,630, 
30,644 (2008); see also Gregory D. Owens, 74 FR 36,751, 36,757 n.22 
(2009). [Likewise, DEA considers its interest in deterring future 
misconduct by both the registrant as well as other registrants. Ruben, 
78 FR at 38,364.] \*RRR\
---------------------------------------------------------------------------

    \*RRR\ Inserted text for completeness.
---------------------------------------------------------------------------

    The Respondent argued during the hearing that it had accepted 
responsibility by virtue of its submission of a corrective action plan 
(which the DEA rejected), modification of its behavior, a reduction in 
the number of patients they see and for whom it fills prescriptions, as 
well as the implementation of a number of other remedial changes. Tr. 
30. However, no one from Pharmacy for Less has admitted any wrongdoing 
regarding the vast majority of infractions I found.
    I find that Ms. Mincy, the only fact witness for the Respondent, 
did not accept responsibility for either her actions or on behalf of 
Pharmacy 4 Less. Additionally, I find that Ms. Mincy was sometimes a 
less than reliable witness. Although correcting violative behavior and 
practices is very important to establish acceptance of responsibility, 
conceding wrongdoing is critical to reestablishing trust with the 
Agency. Holiday CVS, L.L.C., 77 FR 62,316, 62,346 (2012), Daniel A. 
Glick, D.D.S., 80 FR 74,800, 74,801 (2015). As such, I find that 
Pharmacy 4 Less has failed to unequivocally accept any responsibility 
in this matter.\71\
---------------------------------------------------------------------------

    \71\ During this proceeding, this Tribunal conditionally 
admitted RX 18-37 as potentially related to remedial measures taken 
by the Respondent. See Tr. 702; 1047. As I find that the Respondent 
has failed to accept any responsibility, I find that RX 18-37 should 
not be considered by the Administrator towards remedial measures 
taken by the Respondent. See Ajay S. Ahuja, 84 FR 5479, 5498 n.33 
(2019) (``[A] registrant does not accept responsibility for its 
actions simply by taking remedial measures. Holiday CVS, L.L.C., d/
b/a CVS/Pharmacy Nos. 219 & 5195, 77 FR 62,316, 62,346 (2012). 
Further, where a registrant has not accepted responsibility it is 
not necessary to consider evidence of the registrant's remedial 
measures. Jones Total Health Care Pharmacy, L.L.C. & SND Health 
Care, L.L.C., 81 FR 79,188, 79,202-03 (2016)'').

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[[Page 54585]]

Loss of Trust
    Where the Government has sustained its burden and established that 
a registrant has committed acts inconsistent with the public interest, 
that registrant must present sufficient mitigating evidence to assure 
the Administrator that he can be entrusted with the responsibility 
commensurate with such a registration. Medicine Shoppe-Jonesborough, 73 
FR 364, 387 (2008). Here, Pharmacy 4 Less has failed to establish that 
it can be entrusted with maintaining its registration.\*SSS\
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    \*SSS\ For brevity and keeping with recent cases, I have 
modified the legal standard used originally by the ALJ regarding 
loss of trust and have replaced it with this text.
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    [The CSA authorizes the Attorney General to ``promulgate and 
enforce any rules, regulations, and procedures which he may deem 
necessary and appropriate for the efficient execution of his functions 
under this subchapter.'' 21 U.S.C. 871(b). In efficiently executing the 
revocation and suspension authority delegated to me under the CSA for 
the aforementioned purposes, I review the evidence and argument 
Respondents submitted to determine whether or not they have presented 
``sufficient mitigating evidence to assure the Administrator that 
[they] can be trusted with the responsibility carried by such a 
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (2007) 
(quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988)). 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 or behavior and the nature of the misconduct that 
forms the basis for sanction, while also considering the Agency's 
interest in deterring similar acts. See Arvinder Singh, M.D., 81 FR 
8247, 8248 (2016).
    Regarding all of these matters, there is nothing in the record 
establishing that Respondent Pharmacy has accepted responsibility for 
its actions.] The Respondent's only fact witness, Ms. Mincy, conveyed 
that she was resentful at the Agency's intervention at the pharmacy. 
She seemed to maintain a confrontational attitude with DI1, suggesting 
he was harassing the Respondent and that he was lying during testimony. 
[The closest Respondent came to accepting responsibility was in its 
Exceptions, in which Respondent ``admit[ted] that [it was] filling too 
many c2 [Schedule II] prescriptions in the past.'' Resp Exceptions, at 
] 5. Even if this admission were part of the evidentiary record, the 
entirety of the record lacks the unequivocal acceptance of 
responsibility necessary to establish Respondent' trustworthiness with 
a registration.
    The egregiousness of Respondent Pharmacy's conduct and the 
interests of specific and general deterrence support a sanction of 
revocation. RD, at 99. Respondent Pharmacy filled many prescriptions 
over multiple years for these patients without resolving numerous red 
flags. There is nothing in the record that lends support to the 
proposition that Respondent Pharmacy's future behavior will deviate in 
any positive respect from its past behavior. Due to the fact that 
Respondent Pharmacy has accepted no responsibility nor offered any 
remedial measures,\*TTT\ it has given me no reassurance that I can 
entrust it with a registration and no evidence that it will not repeat 
its egregious behavior.
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    \*TTT\ I have already addressed that Respondent Pharmacy 
presented factual assertions related to remedial measures for the 
first time in Respondent's Exceptions, but most of those facts are 
not supported by the record and were not under oath or subject to 
cross examination.
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    Regarding general deterrence, the Agency bears the responsibility 
to deter similar misconduct on the part of others for the protection of 
the public at large. David A. Ruben, 78 FR at 38,385. Based on the 
number and egregiousness of the established violations in this case, a 
sanction less than revocation would send a message to the regulated 
community that compliance with the law is not a condition precedent to 
maintaining registration.
    A balancing of the statutory public interest factors, coupled with 
consideration of Respondent Pharmacy's failure to accept 
responsibility, the absence of any evidence of remedial measures to 
guard against recurrence, and the Agency's interest in deterrence, 
support the conclusion that Respondent Pharmacy should not continue to 
be entrusted with a registration.]
    As such, I find from the course of these proceedings that Pharmacy 
4 Less has lost a significant amount of trust and has failed to prove 
to the Agency that it can be entrusted to maintain its COR in lawful 
fashion.

Recommendation

    Considering the entire record before me, the conduct of the 
hearing, and observation of the testimony of the witnesses presented, I 
find that the Government has met its burden of proof and has 
established a prima facie case for revocation. Further, I find that the 
Respondent has not accepted responsibility, or presented sufficient 
evidence demonstrating that the Agency can entrust it to maintain its 
COR.
    Therefore, I recommend the Respondent's DEA COR FP5459082 should be 
revoked and any pending applications for renewal or modification of 
such registration be denied.

    Signed: May 22, 2019.

Mark M. Dowd,
U.S. Administrative Law Judge.

[FR Doc. 2021-21429 Filed 9-30-21; 8:45 am]
BILLING CODE 4410-09-P