Suntree Pharmacy and Suntree Medical Equipment, LLC; Decision and Order, 73753-73777 [2020-25531]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73753-73777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25531]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket Nos. 17-09 and 17-10]


Suntree Pharmacy and Suntree Medical Equipment, LLC; Decision and 
Order

I. Procedural History

    On October 5, 2016, a former Assistant Administrator for Diversion 
Control of the Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause (hereinafter, OSC) to 
Suntree Pharmacy (hereinafter, Respondent Pharmacy) and Suntree Medical 
Equipment LLC (hereinafter, Respondent LLC) (hereinafter collectively, 
Respondents), of Melbourne, Florida. Administrative Law Judge 
(hereinafter, ALJ) Exhibit (hereinafter, ALJX) 1, (OSC) at 1. The OSC 
proposed the revocation of and denial of any pending application to 
modify or renew Respondents' Certificates of Registration Nos. 
BS7384174 and FS2194289 ``pursuant to 21 U.S.C. 823(f) and 824(a)(4) 
for the reason that [Respondents'] continued registrations are 
inconsistent with the public interest, as that term is defined in 21 
U.S.C. 823(f).'' Id.
    Specifically, the OSC alleged that ``over the course of the 
seventeen month period from October 2013 through March 2015, 
[Respondents'] pharmacists filled over 200 controlled substances 
prescriptions outside the usual course of pharmacy practice in 
violation of 21 CFR 1306.06, and in contravention of their 
`corresponding responsibility' under 21 CFR 1306.04(a).'' OSC, at 2. 
The OSC further alleged that Respondent Pharmacy's failure to exercise 
its corresponding responsibility was evidenced by its ``repeatedly 
fill[ing] controlled substance prescriptions that contained multiple 
red flags of diversion and/or abuse without addressing or resolving 
those red flags, and under circumstances indicating that the 
pharmacists were willfully blind or deliberately ignorant of the 
prescriptions' illegitimacy.'' Id. (citing JM Pharmacy Group, Inc., d/
b/a Farmacia Nueva and Best Pharma Corp., 80 FR 28,667, 28,670 (2015)). 
The OSC listed seven red flags of diversion that Respondent Pharmacy 
allegedly did not resolve prior to filling prescriptions and listed 
twenty-two \1\ patients whose prescriptions indicated red flags. Id. at 
4, 5-9. Furthermore, the OSC alleged that Respondent Pharmacy was 
dispensing controlled substances to a physician who wrote prescriptions 
to himself in violation of Florida law and violated federal law in 
dispensing controlled substances to an office. Id. at 4 (citing Fla. 
Stat. Sec.  458.331(1)(r) and 21 CFR 1306.04(b)).
---------------------------------------------------------------------------

    \1\ The OSC listed allegations related to three patients, R.A., 
A.B., and E.A., which the Government withdrew during the hearing 
``to save time.'' Tr. 689.
---------------------------------------------------------------------------

    The OSC alleged additional violations of Florida state law 
including: Title XLVI, Fla. Stat., Ch. 893.04(2)(a) (requiring a 
pharmacist filling a prescription to determine ``in the exercise of her 
or his professional judgment, that the order is valid''); Fla. Bd. of 
Pharm. Rule 64B16-21.810(1) (requiring a pharmacist to review the 
patient record before filling a new or refilling a prescription for 
therapeutic appropriateness); Fla. Administrative Rule 64B16-27.800 
(requiring the maintenance of retrievable records including 
```[p]harmacist comments relevant to the individual's drug therapy''' 
and ```any related information

[[Page 73754]]

indicated by a licensed health care practitioner.'''); Id. at 3.
    The OSC notified Respondents of the right to request a hearing on 
the allegations or to submit a written statement, while waiving the 
right to a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. at 10-11 (citing 
21 CFR 1301.43). The OSC also notified Respondents of the opportunity 
to submit a corrective action plan. Id. at 11 (citing 21 U.S.C. 
824(c)(2)(C)).
    On November 8, 2016, Respondents filed an appearance and a Motion 
for Extension of Time to File a Request for a Hearing, which the 
Administrative Law Judge (hereinafter, ALJ) granted in part on November 
29, 2016. ALJX 2 (Extension Request), ALJX 5 (Order Granting in Part 
Extension). Respondents filed a Request for Hearing on November 29, 
2016. ALJX 6 (Request for Hearing). The matter was placed on the docket 
of the Office of Administrative Law Judges and assigned to ALJ Charles 
W. Dorman (hereinafter, the ALJ). On November 29, 2016, the ALJ 
established a schedule for the filing of prehearing statements. ALJX 7 
(Order for Prehearing Statements). The Government filed its Prehearing 
Statement on December 20, 2016, and Respondent filed its Prehearing 
Statement on January 26, 2017.\2\ ALJX 8 (hereinafter, Govt Prehearing) 
and ALJX 12 (hereinafter, Resp Prehearing). On January 31, 2017, the 
ALJ issued his Prehearing Ruling that, among other things, ordered that 
the two matters of Respondent LLC and Respondent Pharmacy would be 
heard in a consolidated hearing, to which both parties consented, and 
set out six stipulations already agreed upon and established schedules 
for the filing of additional joint stipulations and supplemental 
prehearing statements, which were filed by both the Respondent and the 
Government on March 8 and 20, 2017, respectively. ALJX 14 (Prehearing 
Ruling), at 1-5; ALJX 17 (hereinafter, Resp Supp Prehearing); ALJX 16 
(hereinafter, Govt Supp Prehearing). During the prehearing proceedings, 
the Government filed a Motion In Limine, requesting that certain 
portions of the Respondents' testimony and evidence be excluded at the 
hearing. See ALJX 21 (hereinafter, Govt Mot In Limine). In response to 
the Government's Motion and Respondents' response, the ALJ ruled that 
the proposed testimony of customer J.S.3 was irrelevant, because the 
issue is ``legal, rather than factual, in nature.'' \3\ ALJX 27, at 3 
(Order Granting in part Govt Mot In Limine). The ALJ denied the 
Government's request to exclude the testimony of several practitioners, 
the legitimacy of whose prescriptions was at issue in the case, but 
Respondents ultimately did not present testimony from these 
individuals. I have reviewed and agree with the procedural rulings of 
the ALJ with the exception of some of the bases for the findings in the 
Order Granting in part Govt Mot In Limine as explained infra Section 
III(A)(1)(c) and (d). The parties agreed to stipulations about the 
distances between patients and doctors and Respondent Pharmacy, the 
schedules and brand names of controlled substances, all of which are 
incorporated herein. RD, at 16-21.
---------------------------------------------------------------------------

    \2\ Respondent filed for an extension, which the ALJ granted in 
part over the Government's objections. ALJX 9-11.
    \3\ The ALJ also excluded the testimony of a pharmacy employee 
who was proposed by Respondent to testify about an audit report that 
had not been offered as evidence and another individual who had 
provided a report that was not relevant to the proceedings. ALJX 27, 
at 4.
---------------------------------------------------------------------------

    The hearing in this matter spanned three days.\4\ The Government 
filed its Proposed Findings of Fact, Conclusions of Law and Argument on 
June 19, 2017. ALJX 35 (hereinafter, Govt Posthearing). Respondent 
filed its Closing Argument, Proposed Findings of Fact, and Conclusions 
of Law on June 19, 2017. ALJX 36 (hereinafter, Resp Posthearing). The 
Recommended Rulings, Findings of Fact, Conclusions of Law and Decision 
of the Administrative Law Judge (hereinafter, RD) is dated August 15, 
2017. Both the Government and the Respondents filed exceptions to the 
RD on September 5, 2017 (hereinafter, Govt Exceptions) and September 1, 
2017 (hereinafter, Resp Exceptions) (respectively). ALJ Transmittal 
Letter, at 1. On September 18, 2017, the ALJ transmitted his RD, along 
with the certified record, to me. Id.
---------------------------------------------------------------------------

    \4\ Hearings were held in Daytona Beach, FL from April 24-26, 
2017.
---------------------------------------------------------------------------

    Having considered this matter in the entirety, I find that the 
record as a whole established by substantial evidence that Respondent 
Pharmacy committed acts that render its continued registration 
inconsistent with the public interest. Respondent Pharmacy filled 
hundreds of prescriptions without fulfilling its corresponding 
responsibility and acting outside of the usual course of professional 
practice in Florida, in violation of federal and state law. I conclude 
that revocation of Respondents' registrations and denial of any pending 
application to renew or modify Respondents' registrations are 
appropriate sanctions.
    I issue this Decision and Order based on the entire record before 
me. 21 CFR 1301.43(e). I make the following findings of fact.

II. Findings of Fact

A. Respondents' DEA Registrations

    Respondents are registered with the DEA as retail pharmacies in 
schedules II through V under DEA Certificate of Registration Nos. 
FS2194289 and BS7384174 at the registered addresses of 7640 North 
Wickham Road, Suites 116 and 117, Melbourne, FL 32940. Government 
Exhibit (hereinafter, GX) 1.

B. The Government's Case

    The Government's documentary evidence consists primarily of 
prescriptions and profile information for twenty-five patients. The 
Government called four witnesses: an expert, Dr. Tracey Gordon 
(hereinafter, Dr. Gordon), a DEA Diversion Investigator (hereinafter, 
the DI), an employee at Respondent LLC (hereinafter, M.P.), and Dr. 
Diahn Clark, Respondents' Owner and Pharmacist in Charge (PIC) 
(hereinafter, Respondents' Owner and PIC), whose testimony is 
summarized under the Respondents' Case section.
1. Dr. Gordon
    Dr. Gordon has a bachelor's degree and a doctorate in pharmacy and 
is currently employed as a clinical hospice pharmacist. RD, at 7; 
Transcript (hereinafter, Tr.) at 22; GX 26 (Dr. Gordon's resume). She 
holds a Florida pharmacy license and Florida consultant license and she 
also has twelve years of experience as a retail pharmacist, but she has 
not practiced as a retail pharmacist in a few years. Tr. 24. As a 
consultant pharmacist, Dr. Gordon inspects facilities like nursing 
homes and hospices to make sure that they are following Florida laws. 
Id. at 30. She is familiar with federal and Florida laws regarding 
dispensing controlled substances and was accepted as ``an expert who is 
familiar with the practice of pharmacy in the State of Florida.'' RD, 
at 7; Tr. 26, 31-32. The matters to which Dr. Gordon testified included 
a pharmacist's corresponding responsibility in the State of Florida 
including the resolution of prescriptions presenting red flags, what 
constitutes a red flag, and her review and analysis of the 
prescriptions presented by the Government. Tr. 21- 311. She reviewed a 
series of prescriptions, the Florida Prescription Drug Monitoring 
Program (hereinafter, E-FORCSE), documents, letters of medical 
necessity, medical records, computer printouts given to her by DEA from 
both the Agency and the Respondent ``to determine if [Respondents were] 
exercising their

[[Page 73755]]

corresponding responsibility by practicing within the normal scope of 
pharmacy practice.'' Tr. at 46-47. The ALJ found, and I agree, that Dr. 
Gordon's testimony was ``sufficiently objective, detailed, plausible, 
and internally consistent to be considered credible in this recommended 
decision.'' \5\ RD, at 7.
---------------------------------------------------------------------------

    \5\ Respondents argue that Dr. Gordon's testimony was 
inconsistent and should not be afforded weight. As explained herein, 
I reject Respondents arguments regarding Dr. Gordon and I agree with 
the ALJ's credibility assessment. Resp Posthearing, at 53-58.
---------------------------------------------------------------------------

2. The DI
    The Government also presented the testimony of a DI who 
participated in the administrative investigation of the Respondents. 
Tr. 312-92. He testified to his training as a DEA DI and his experience 
in investigating over 100 pharmacies. He testified that Respondent 
Pharmacy was identified as ``an extremely high purchaser of oxycodone, 
hydromorphone and methadone.'' Id. at 316-17. He further testified as 
to the events that transpired pursuant to the two administrative 
inspections of Respondent Pharmacy. Id. at 318-19. The DI testified 
that DEA investigators traveled to Respondent Pharmacy to conduct an 
administrative inspection on September 13, 2013, during which time M.P. 
signed a DEA Form 82, Notice of Inspection, in which M.P. consented to 
the inspection of the premises. Tr. 317; GX 32 (DEA Form 82). The DI 
testified that, based on the report issued by the DEA inspectors at the 
time, Respondents' Owner and PIC arrived at the pharmacy approximately 
ninety minutes afterwards. Tr. 318. During that inspection, the DI 
testified that the DEA inspectors expressed their intent to remove 
prescriptions from the pharmacy to make photocopies, but Respondents' 
Owner and PIC told them that she would provide them with copies later, 
which M.P. delivered to DEA on September 23, 2013. Tr. 318, 323; GX 33 
(DEA Form 12 signed by M.P. confirming delivery). The DI also testified 
that he served Respondents' attorney D.M. with a subpoena in February 
of 2015 to obtain approximately a year and a half of prescriptions, but 
D.M. ``questioned the validity of our ability to even issue a subpoena 
for records to him and stated, as far as he knew, there was no penalty 
for noncompliance, so he had privacy concerns, and he ended up not 
giving us the records.'' Tr. 324-27. Thereafter, in April of 2015, DEA 
obtained and executed an Administrative Inspection Warrant, during 
which DEA investigators copied portions of Respondent Pharmacy's 
database that it used when filling prescriptions and provided 
Respondent Pharmacy with an exact copy. Id. at 323, 326-32; RD, at 8. 
The DEA investigators also removed, copied and returned paper medical 
records for patients. Tr. at 332-33. The DI additionally testified to 
his research into the ownership of Respondents and his observations of 
the Respondents' location and business interactions. Id. at 323-60. The 
ALJ found, and I agree, that the DI's testimony was ``sufficiently 
objective, detailed, plausible, and internally consistent. Therefore, I 
merit it as credible . . . .'' RD, at 8.

C. Respondents' Case

1. Respondents' Owner and PIC
    Respondents' Owner and PIC testified on behalf of Respondents. Tr. 
529-767; 854-58. She testified that she held a degree in pharmacy and 
practiced until she went to law school, after which she practiced 
mostly in intellectual property law until she assumed sole ownership of 
the Respondents in or around 2009 or 2010. Tr. 530. She testified to 
her duties at the pharmacy, including supervising several part-time 
pharmacists who fill in while she is ``doing other duties as the 
owner.'' Id. at 533. She testified generally as to the policies and 
procedures of Respondent Pharmacy when she took over.

    At that time, the only statute we identified initially was 
legitimate medical necessity. So my interpretation of that was to 
derive that from the physicians. So we created a policy where the 
patient would have to have a Brevard County license, a general 
policy. Of course, exceptions allowed, but the general policy was a 
Brevard County patient. If they saw a physician in an adjacent 
county, they would be required to obtain for me, directed to me 
individually at the pharmacy, not a group of medical records but a 
letter to me describing the legitimate medical necessity or the 
diagnosis that I could then glean the medical necessity from.

Id. at 536.
    Respondents' Owner and PIC additionally testified that Respondent 
Pharmacy had ``broad policies that [Respondent Pharmacy's pharmacists] 
better have a good reason for not following or be subject to 
counseling. But outside of those broad policies that are stated there 
or that were developed over time, they had their independent judgment . 
. . .'' Id. at 676-77. Respondents' Owner and PIC testified that 
Respondent Pharmacy has a ``policy and procedure handbook that 
employees do receive''; however, Respondents did not produce the 
handbook in their defense.\6\ Id. at 710-11. She also stated that the 
policy is ``updated regularly, but it's generally just a day-to-day 
hands-on training. I'm there all the time.'' Tr. 709. Respondents 
particularly focused on the employment of one of their employee B.S., 
whom Respondents' Owner and PIC had hired as a part-time pharmacist in 
spite of knowing that ``he had been suspended by the Board of Pharmacy 
for a period of time'' and he had a prior criminal conviction, and whom 
she later fired. Id. at 553; RX G (employment file for B.S.).
---------------------------------------------------------------------------

    \6\ This Agency has applied, and I apply here, the ``adverse 
inference rule.'' As the D.C. Circuit explained, ``Simply stated, 
the rule provides that when a party has relevant evidence within his 
control which he fails to produce, that failure gives rise to an 
inference that the evidence is unfavorable to him.'' Int'l Union, 
United Auto., Aerospace & Agric. Implement Workers of Am. (UAW) v. 
Nat'l Labor Relations Bd., 459 F.2d 1329, 1336 (DC Cir. 1972). The 
Court reiterated this rule in Huthnance v. District of Columbia, 722 
F.3d 371, 378 (DC Cir. 2013). According to this legal principle, 
Respondents' decision not to provide evidence within their control 
gives rise to an inference that any such evidence is unfavorable to 
Respondents. Therefore, I give little weight to instances where 
Respondents' Owner and PIC testified that she relied solely on her 
policies to ensure that red flags were resolved, such as that cash 
is not a red flag, ``because he would have been asked if he had 
insurance.'' Tr. 719
---------------------------------------------------------------------------

    Respondents' Owner and PIC also testified as to her involvement 
with the resolution of red flags for her patients. As to the red flag 
regarding the distance her customers traveled, she testified that her 
wholesaler would allocate a certain amount of controlled substances to 
pharmacies and that ``is why people drive farther than they normally 
would.'' Tr. 766. She testified that she would look at the letters of 
medical necessity to help resolve the red flags regarding the distance 
traveled to obtain prescriptions, Tr. 701, ``that would be one thing we 
would look at, in addition to a conversation with the patient.'' Tr. 
706.
    The ALJ found, and I agree, Respondents' Owner and PIC's 
``testimony to be generally objective, detailed, and with some 
exceptions it was plausible, and internally consistent. Certain aspects 
of [Respondents' Owner and PIC's] testimony, however, detracted from 
her overall credibility. Those aspects included unnecessary 
contentiousness, exaggeration, and a lack of familiarity with the 
Pharmacy's records.'' RD, at 13. Specifically, the ALJ noted that she 
exaggerated her relationships with her customers, stating that she 
always had conversations with D.B. even though she had only filled 
prescriptions for him three times and similar exaggerations related to 
M.B., K.B.2, K.B.3 and A.G.

[[Page 73756]]

He further noted that her testimony contained inconsistencies, such as 
that she stated the pharmacy had not filled any prescriptions after 
April 30, 2014, but the records showed that it had, and she stated that 
D.B.'s dosage had decreased when it had not. RD, at 14. The ALJ 
concluded, and I agree, that ``to the extent, her testimony conflicts 
with other testimony, or exhibits, [] I find that the exhibits and the 
other testimony merit greater weight.'' RD, at 15.
2. Dr. Grant
    Respondents presented testimony of an expert, Dr. Wayne Grant, who 
has been a pharmacist since 1990 and has a bachelor's degree and 
Doctorate in pharmacy. Tr. 425-527. Dr. Grant works in a ``hospice and 
palliative care organization,'' where he has been employed for twelve 
years. Id. at 427. He also testified that he teaches a course online as 
an adjunct faculty at the University of Florida.\7\ Tr. 428. Dr. Grant 
also worked in an ``in-house, closed pharmacy'' for about fifteen years 
and a retail pharmacy for about five years. Tr. 431-32. Dr. Grant is 
licensed as a pharmacist in Ohio, and he has never worked in or been 
licensed as a pharmacist in Florida, although he has reviewed ``mostly 
for comparative reasons,'' but not taken, some of the continuing 
education courses in Florida. Tr. 433, 437; RD, at 11. The Government 
objected to accepting Dr. Grant as an expert witness, because he lacked 
experience in the standard of practice in the state of Florida, but the 
ALJ accepted Dr. Grant as ``an expert in the field of pharmacy.'' Tr. 
237; 442.
---------------------------------------------------------------------------

    \7\ The ALJ found, and I agree that Dr. Grant's faculty status 
at the University of Florida is not clear from his testimony. RD, at 
10. Although he testified that he was an adjunct professor, he later 
testified that he only lectures in Florida once a year, for an 
``hour, hour and a half.'' Tr. 517-18.
---------------------------------------------------------------------------

    The ALJ found, and I agree, that although generally Dr. Grant 
``appeared to be an honest and candid witness,'' his testimony merited 
``little weight'' based on six reasons. RD, at 11. First, the ALJ 
reasoned that Dr. Grant was ``deceptive even when answering questions 
about his qualifications.'' Id. Dr. Grant touted the benefits of 
working for the University of Florida as including continuing 
education, stating, ``I get a lot of continuing education,'' but when 
asked whether he had taken Florida continuing education, he stated that 
he ``had reviewed a number of those,'' but ``mostly for comparative 
reasons.'' Tr. 433; RD, at 11. The ALJ further noted that ``while 
professing to be an adjunct faculty member at the University of 
Florida, it turns out [Dr. Grant] does not teach, but only occasionally 
lectures.'' RD, at 11 (citing Tr. 428, 516-17). Second, the ALJ noted 
that Dr. Grant's testimony that he did not know if he had been 
qualified in Florida was not credible, because when the ALJ asked him 
if he had ever testified in Florida, he stated that he had not. Id. 
(citing Tr. 438). Third, in describing ``corresponding duty,'' Dr. 
Grant stated, ``It looks at a standard in which pharmacy practice is 
when we're reviewing prescriptions that come into our care.'' Tr. 445. 
I agree with the ALJ's finding that Dr. Grant's ```expert' explanation 
of the phrase `corresponding duty' is almost incomprehensible.'' RD, at 
11. Fourth, Dr. Grant initially testified that he had reviewed the 
prescriptions at issue in the case and there did not seem to be any 
prescriptions on their face that appeared to be a violation of 
corresponding responsibility such that there needed to be ``a 
conversation with the patient and the prescriber,'' but then, on cross 
examination, admitted in several instances that there should have been 
follow up. Tr. 445, 478-79, 508-11; RD, at 12. Fifth, the ALJ took 
issue with Dr. Grant's testimony that the term ``cocktail'' was not ``a 
common term used in pharmacology.'' When asked if he knew what a 
cocktail was, Dr. Grant said ``I'm familiar with what I think that 
terminology is'' and then later answered the same question, ``Other 
than a drink, I'm not really sure.'' Tr. 455-56. Then, Dr. Grant 
contradicted himself by explaining what a cocktail was, stating ``[i]n 
more nefarious [sic] perhaps, they're looking at trying to lump benzos 
and opioids and a whole host of skeletal muscle relaxers in there too. 
But we don't teach about cocktails. We don't make cocktails.'' Id. at 
456. I agree with the ALJ that not only was his testimony 
contradictory, but also, DEA ``has long discussed drug cocktails.'' RD, 
at 12. Contrary to his own statements, that he had not heard of ``drug 
cocktails'' or that the term was not used in pharmacology, he later 
described them accurately and the federal agency that regulates 
controlled substance registrations uses the term regularly. Finally, 
the ALJ noted that Dr. Grant ``even seemed unwilling to use the term 
red flag.'' RD, at 12. Dr. Grant testified that he was ``familiar with 
the concept,'' but that he does not ``teach anything about red flags'' 
and that he had not heard the term in relation to opioids until about 
two or three years ago. Tr. 449, 518. The ALJ noted that Respondents' 
Owner and PIC had ``no trouble using the term and understanding its 
meaning,'' and that DEA has used the term for many years. RD, at 12 
(citing Tr. 587, 597-98, 610-11, 617-18, 642, 650, 671-72, 676, 681, 
688, 701, 727, 730).
    Based on the issues with the merits and credibility of Dr. Grant's 
testimony, the ALJ found, and I agree, that ``where there is conflict 
between the testimony of Dr. Grant and the testimony of Dr. Gordon, I 
find that Dr. Gordon's testimony is more credible and is entitled to 
greater weight.'' RD, at 13. As such, I rely on Dr. Gordon's testimony 
to accurately describe a pharmacist's corresponding responsibility and 
the usual course of professional practice in the State of Florida.
3. D.M.
    D.M. is an attorney who initially was representing Respondents, but 
who withdrew and became a fact witness prior to the start of the 
hearing. ALJX 28 (Motion to Withdraw); Tr. 799. He testified that he 
was retained by Respondent Pharmacy around 2008 to give advice on 
``compliance and keeping up with what the rules are, regulations, and 
policies and procedures.'' Id. at 801. As part of his advice, he stated 
that he researched and communicated red flags. Id. at 804-06. D.M. 
testified that he gave advice \8\ to Respondent Pharmacy in 2008 that 
it was generally legal for a doctor to self-prescribe,\9\ but that 
following the Florida Board of Pharmacy's statement to Respondent 
Pharmacy that it ``wasn't allowed,'' he still thought it was legal, but 
recommended that Respondent Pharmacy ``should not do that anymore.'' 
Id. at 809-10. He further testified regarding policies that he helped 
Respondent Pharmacy write in 2008 to not ``fill for an out of county, 
out of the area customer'' or ``out of the county doctor'' unless it 
was an established patient in which case they would ``look at other 
factors.'' Id. at 807. D.M. also testified that in 2012 or 2013, he 
helped to write policies for schedule II controlled substances on 
letters of medical necessity. Id. at 821. However, D.M. also testified 
that he does not ensure or check compliance with the policies that he 
wrote. Id. at 825.
---------------------------------------------------------------------------

    \8\ Although D.M. and Respondents' Owner and PIC claim this 
advice was given via email, neither could produce the emails. Tr. 
829-30.
    \9\ D.M. later clarified that the question in 2008 was not 
specific to controlled substances, but all prescription drugs. Tr. 
823. He addressed controlled substances in his advice in 2015 after 
the Board of Pharmacy had told Respondent Pharmacy that the 
prescriptions could not be filled. Id. at 827.
---------------------------------------------------------------------------

    The ALJ found, and I agree that ``D.M.'s testimony is consistent 
with other testimony of record. He testified in a candid and forthright 
manner and he was a credible witness.'' RD, at 15.

[[Page 73757]]

D. Corresponding Responsibility and Course of Professional Practice in 
Florida

    Dr. Gordon credibly testified that before filling a prescription 
``a pharmacist should assure that the medication is safe and exercise 
their corresponding responsibility to make sure the medication is for a 
legitimate medical purpose, to look at things like drug interactions, 
appropriateness of dose, what doctor is writing the prescription, how 
far the patients traveled,\10\ is it appropriate, is it safe for 
themselves and the community.'' Tr. 33. She further testified that in 
exercising a pharmacist's corresponding responsibility, ``there's not 
just one or two red flags you specifically look for.'' Id. at 34. She 
testified that such red flags include, ``the type of medication,'' 
whether the dose is appropriate, combinations of controlled substances, 
whether the patient is in the local community, what type of doctor is 
prescribing, the distance from the doctor and the pharmacy.\11\ Id. at 
34-37. Dr. Gordon further testified about short-acting and immediate 
release medication, and specifically stated that ``it does not make 
pharmacological sense to prescribe two short-acting opioids,'' for 
example hydromorphone and oxycodone, ``because they are doing the same 
thing,'' and therefore such prescriptions are red flags. Id. at 36-
39.\12\ Additionally, Dr. Gordon testified that pattern prescribing by 
a doctor who prescribes the same dosage and medication to all of his 
patients is a red flag, and there is also a red flag when those 
prescriptions are filled sequentially, one after the other. Id. at 39. 
Further, she testified that another red flag is a prescription 
cocktail, which she described as ``the issuance of two or more 
prescriptions that do the same thing or enhance the effects of the 
other.'' Id. She gave examples of prescription cocktails, such as 
``Soma, a benzodiazepine, like Ativan or Xanax, and an oxycodone or 
hydromorphone,'' but that more recently she sees ``just a Benzo with a 
opioid,'' such as ``Alprazolam or Xanax or Lorazepam or Ativan, plus 
hydromorphone or oxycodone, or both.'' Id. at 40. Dr. Gordon testified 
that other red flags were when patients appeared to come from the same 
household and received similar medications, when patients are going to 
multiple doctors or pharmacies, and that prescriptions purchased with 
cash \13\ were a ``big red flag.'' Id. at 41-42. She stated that 
pharmacists can detect doctor shopping through ``E-FORCSE,'' which is a 
``computer program set up by the State of Florida that a pharmacy is 
supposed to report all of their controlled substances: the quantity, 
the medication, the doctor, and the pharmacy where it was filled, for 
every patron'' and which started around 2010. Id. at 43.
---------------------------------------------------------------------------

    \10\ Dr. Gordon testified that she had searched for local pain 
management doctors and Respondents' Owner and PIC testified that 
there were not enough local practitioners in the area. Tr. 568. I 
agree with the ALJ, who determined that neither party submitted 
adequate support for their testimony and therefore gave the 
testimony of each little weight. RD, at 24 n.10.
    \11\ Respondents argued that Dr. Gordon was inconsistent 
regarding whether the red flag of distance was resolvable. Resp 
Posthearing, at 53 (citing Tr. 36, 110--however, the quoted material 
is on page 111). I disagree that this testimony was inconsistent. 
Dr. Gordon testified that in ``this particular scenario'' of the 
group of Dr. R.'s patients coming in together with prescriptions 
written on the same day and travelling a far distance, one after 
another in this case, the red flags were not resolvable. Tr. 111. 
She stated that there is room to clear red flags and gave an extreme 
example of all of the patients getting into the same car wreck and 
needing a short supply of something being a possible reason that a 
pharmacist could still fill the prescription, but she clearly 
testified that the scenario presented by Dr. R.'s patients coming in 
together did not present any facts that could have resolved the red 
flags. Id. Furthermore, these prescriptions contained multiple red 
flags, not solely the red flag regarding distance.
    \12\ Respondents argued that Dr. Gordon testified that it was a 
red flag to prescribe two short acting opioids and also to prescribe 
a long and a short acting opioid. Resp Posthearing, at 54 (citing 
Tr. 38, 83). I disagree with their characterization of Dr. Gordon's 
testimony. Regarding the long and the short acting opioids, she 
testified that ``it's a red flag to see the dosage has changed or 
there is a different drug.'' Tr. 84.
    \13\ Respondents stated that Dr. Gordon was inconsistent on 
whether cash was a red flag, but I find that she credibly testified 
that ``[i]t's the combination of the red flags, the cash and the 
opioid, not just the point that they're paying cash.'' Tr. 295; Resp 
Posthearing, at 55. I agree with this statement and the ALJ's 
finding that cash is a red flag in combination with the other red 
flags. RD, at 31 n.13.
---------------------------------------------------------------------------

    Dr. Gordon testified that a pharmacist can resolve these red flags 
``by either talking to the patient and/or speaking to the physician'' 
and in some cases ``you may need to do both.'' She further clearly 
testified that the resolution of the red flag ``must be documented \14\ 
before you dispense the medication so that you can let other 
pharmacists know what happened the time before'' and that documentation 
must be ``either on the prescription itself or in the computer 
system.'' \15\ Id. at 44-45. When pressed by Respondents' counsel 
regarding whether a pharmacy was required by statute to document the 
resolution of the red flag, Dr. Gordon stated that ``it's not an 
opinion. It's the standard of practice'' and further clarified ``[t]he 
standard of practice, if there's something questionable about a 
prescription, you document it after you speak with the patient or the 
doctor.'' Id. at 215. Finally, Dr. Gordon testified that if it is 
impossible to resolve a red flag, such as a prescription written by a 
physician to himself or to a business or office, the standard of 
practice of pharmacy in Florida would require a pharmacist to ``not 
dispense the medication.'' Id. at 46.
---------------------------------------------------------------------------

    \14\ Respondents suggested that Dr. Gordon ``did not testify 
that the resolution of every red flag must be documented,'' but that 
``she testified that a pharmacist is required to `document if you 
need more information to clear a red flag.''' Resp Posthearing, at 4 
(citing Tr. 206). Respondents took Dr. Gordon's quote out of 
context. During the hearing, Respondents' counsel clarified the 
statement that he quoted in his brief, stating, ``Okay. So document 
the resolution of red flags?'' to which Dr. Gordon responded, ``Yes. 
To show that--for each red flag, if there was a specific situation 
where you felt that the medication was for a legitimate medical 
purpose, that should be documented.'' Tr. 206. I find that Dr. 
Gordon was very clear that the standard of practice and usual course 
of professional practice in Florida required a pharmacist to 
document the resolution of every red flag before dispensing.
    \15\ Respondents argued that Dr. Gordon would require a 
pharmacist with multiple red flags ``to write paragraphs of data 
regarding why the patient travelled to the next county, had back 
pain, was seeking a `highly abused medication,' and had insurance 
but was not using it to fill the medication.'' Resp Posthearing, at 
58. There is no evidence or testimony in this case that what Dr. 
Gordon was proposing to be documented would be ``paragraphs of 
data.'' I reject this characterization of Dr. Gordon's testimony. 
Respondents are trying to absolve themselves of responsibility to 
take any notes on their resolution of red flags by exaggerating the 
burden. The fact is that there was rarely any documentation as to 
the red flags in this case other than letters of medical necessity, 
so there is nothing on which to testify to or assess Respondent 
Pharmacy's level of detail in resolving them.
---------------------------------------------------------------------------

    Regarding red flags, Dr. Grant stated, ``the only place that I've 
really seen this again is with the continuing education, which I have 
not completed, in regards to Florida, where they list in--this group 
lists and they put red flags, and they list a whole bunch of things 
down there as being red flags. And they suggest pharmacists should be 
looking at that. But it's their process. It's nothing I'm familiar with 
teaching.'' Tr. 450. As explained above, I credit Dr. Gordon's 
testimony over Dr. Grant's.
    Respondents' Owner and PIC testified that she was aware that when a 
pharmacist spots a red flag for a prescription, that she must ``resolve 
it, and if [she] cannot resolve it, not to fill it.'' Tr. 566; RD, at 
24. She testified that she trained her pharmacists to identify and 
resolve red flags. RD, at 24; Tr. 556-57. She also testified that she 
understands the concept of red flags and that she recognized that there 
are red flags in Respondent Pharmacy's prescriptions. Tr. 796. 
Respondents' Owner and PIC stated that, ``I don't believe we did as 
well with documentation. I do believe we did resolve red flags. Even 
then, I think we

[[Page 73758]]

could have done better at it.'' Id. at 796. Finally, she stated that 
she received the letters of medical necessity, because she ``knew that 
was an absolute requirement. That's a statutory requirement. The others 
seemed to gradually evolve. And in my opinion, it was continued 
professional practice. So documentation of them was innate in my job 
even prior to the pain epidemic or the requirement of red flags.'' Id. 
at 797.
    I agree with the ALJ that Dr. Gordon's testimony should be given 
the most weight on a pharmacy's corresponding responsibility and the 
ordinary course of professional practice in Florida to resolve red 
flags and document the resolution on the prescription or in the patient 
record. RD, at 13.

E. Allegation That Respondent Pharmacy Filled Prescriptions Written by 
a Practitioner to Himself in Violation of Florida Law

    The OSC alleged that Respondent Pharmacy dispensed controlled 
substances to a physician that were prescribed to himself in violation 
of Florida Statute Section 458.331(1)(r). The relevant Florida law 
states that it is grounds for disciplinary action or denial of a 
license to ``dispens[e] . . . any medicinal drug appearing on any 
schedule set forth in chapter 893 by the physician to himself or 
herself, except one prescribed, dispensed or administered to the 
physician by another practitioner . . . .'' Fla. Stat. Sec.  
458.331(1)(r).
1. Patient J.S.3
    The Government alleged that between March 2014 and December 2014, 
Respondent Pharmacy violated its corresponding responsibility and 
Florida law when it dispensed six prescriptions for controlled 
substances to a doctor, J.S.3, who was prescribing controlled 
substances to himself in violation of Florida law. OSC, at 4; RD, at 
27. It further alleged violations of Respondent Pharmacy's 
corresponding responsibility for filling twelve additional 
prescriptions written by J.S.3 to himself from June 2012 to June 2013. 
Govt Prehearing, at 8. The Government's evidence demonstrates that 
Respondent Pharmacy filled prescriptions written by J.S.3 to himself 
for various controlled substances to include: Percocet, Ambien and 
testosterone. GX 2, at 1-34.
    Dr. Gordon testified that the prescription to J.S.3 for Ambien 
filled on June 12, 2012, contained a red flag \16\ because ``the name 
of the patient is the same as the name of the physician'' and that 
``it's against the law for a physician to write a controlled substance 
for himself.'' Tr. 49-50; GX 2, at 1, 2. She additionally testified 
that a prescription for oxycodone/Tylenol with the brand name Percocet 
filled on July 13, 2012, and all of the other prescriptions filled by 
Respondent Pharmacy for J.S.3 presented red flags and were in violation 
of Florida law for the same reason.\17\ Tr. 51-61; GX 2, at 1-34. Dr. 
Gordon testified that the fact that ``the patient is the physician'' is 
a red flag and that the red flags were unresolved. Tr. 59-60. In 
response to the Government's question regarding whether a pharmacist 
applying ``the minimal acceptable standard of practice of pharmacy'' in 
Florida should have filled these prescriptions, Dr. Gordon stated that 
``[a] pharmacist should not have filled any prescription written by a 
physician that wrote it for himself, a controlled substance.'' Id. at 
62.
---------------------------------------------------------------------------

    \16\ Respondents' counsel objected to Dr. Gordon's testimony 
that the J.S.3 prescriptions were unresolved red flags, stating that 
``the Government represented that the issue with J.S.3's 
prescriptions was only an issue as a matter of law, that a 
pharmacist cannot fill a physician's prescription as a matter of 
law.'' Tr. 60. The OSC clearly stated that the J.S.3 prescriptions 
raised red flags, but Respondents' counsel alleged that there was 
discussion of this issue in pretrial conferences related to 
Respondents' request to provide testimony of J.S.3. Id. at 61. This 
issue became confused when Respondent proposed the testimony of 
J.S.3, which the ALJ excluded on the basis that ``the ultimate issue 
with regard[] to this allegation is legal, rather than factual, in 
nature.'' ALJX 27 (Order Granting In Part the Government's Motion In 
Limine), at 3. The Government's attorney at the hearing stated that 
``the red flag seems to be a matter of law, and I'm simply asking 
the expert whether there's any indication whether the pharmacist was 
able to justify in its mind the dispensing of these prescriptions.'' 
Tr. 61. The ALJ sustained the Respondents' objection; however, he 
overruled the objection related to Dr. Gordon's opinion regarding 
whether filling the prescriptions was within the standard of 
practice. Id. Despite this argument at the hearing, I find that Dr. 
Gordon appropriately testified that the physician's prescription to 
himself was a red flag. I do not find that the ALJ erred in 
excluding the testimony of J.S.3 as irrelevant. The testimony of 
J.S.3 as described by the Respondent could not have added any 
additional facts that would alter the finding herein. However, I 
disagree that the issue here was solely about whether these 
prescriptions violated Florida law, as explained further herein. I 
further discuss this issue in Section III(A)(1)(c).
    \17\ Dr. Gordon also identified other red flags with these 
prescriptions, such as that the prescriptions lacked a DEA number, 
the prescriptions were paid for by cash, the physician called in the 
prescription with no hard copy in violation of Florida law; however, 
these red flags were not identified in the OSC or the Government's 
Prehearing statements, so I am not basing my decision on these red 
flags. Tr. 52-59.
---------------------------------------------------------------------------

    Respondents' Owner and PIC testified that she had sought advice 
from her attorney, D.M. about whether it was lawful for a doctor to 
self-prescribe and D.M. had told her it was lawful in an email.\18\ Tr. 
571, 777, 809; RD, at 28. She further testified that she had received 
this advice ``early on in my ownership of the business,'' which ``might 
even have been prior to my ownership of the business. 2008, 2009.'' Id. 
at 777. She stated that she did not revisit his advice after that time 
and that she ``probably should have, but [she] did not.'' Id. D.M. 
testified that he researched and gave advice to Respondents' Owner and 
PIC ``in 2008, generally'' regarding ``could a doctor self-prescribe.'' 
Tr. 809. D.M. concluded that it was permissible and when asked what 
advice he communicated to Respondent Pharmacy, he stated, ``At that 
point in time, we were not using the words red flag. The word was 
scrutiny. And that it should pass the sniff test, but it wasn't 
prohibited and it was permissible but required scrutiny.'' Id. at 810. 
Respondents' Owner and PIC testified that the Board of Pharmacy visited 
in 2015 \19\ and told Respondents' Owner and PIC that ``it was not 
lawful'' to fill a prescription that a doctor had written for himself, 
after which D.M. confirmed his original legal advice, but recommended 
that Respondent Pharmacy stop filling these prescriptions, and 
Respondent Pharmacy did not fill any further prescriptions. Tr. 573, 
763, 777, 809. The last prescription filled for J.S.3 was on January 
14, 2015. GX 2, at 33-34; Tr. 762; RX H, at 2-3; RD, at 28.
---------------------------------------------------------------------------

    \18\ The Respondent did not submit the email as evidence.
    \19\ It is noted that Respondents' version of the Patient 
profile for J.S.3 included in the E.O.M. or ``end of month'' 
statement a typed note that stated ``cannot write personal scripts. 
DC'' and the date the record was printed is covered by a photocopied 
sticky note. RX H, at 1; Tr. 698. The Government noted that the copy 
in the Government's evidence that was seized on April 7, 2015, and 
contains a print date of ``April 7, 2015'' does not include the same 
language in the E.O.M. statement. Tr. 699; GX 2, at 35. 
Nevertheless, Respondents' PIC and Owner stated that she made that 
sticky note in January of 2015 and offered no explanation for why 
the Government's evidence did not include the typed note in the 
database. Tr. 699-700. Respondents argued in their Posthearing Brief 
that there were no prescriptions filled for J.S.3 after January 14, 
2015. Resp Posthearing, at 9 n.1. This argument does not explain why 
the documents in the Government's possession that were printed three 
months after the last prescription to J.S.3 did not contain the same 
typed E.O.M. note. The ALJ found, and I agree, that Respondents' PIC 
and Owner did not testify credibly that the document in RX H was the 
same record that was available to the Government on the date of 
seizure in April 7, 2015, because the sticky note obscures the date 
that the document was printed. RD, at 28 n.11. This appears to me to 
be a falsification of records and further undermines my ability to 
trust Respondents' Owner and PIC.
---------------------------------------------------------------------------

    Based on the evidence in the record, I find that from 2012-2015, 
Respondent filled numerous prescriptions from prescriber J.S.3 to 
himself without resolving the red flag that he was self-

[[Page 73759]]

prescribing in violation of state law. See infra Section III(A)(1)(c).

F. Allegation That Respondent Pharmacy Filled Prescriptions Written for 
``Office Use'' in Violation of 21 CFR 1306.04(b)

    The OSC alleged that Respondent ``dispensed testosterone on at 
least fourteen different occasions pursuant to invalid prescriptions 
which indicated that the ultimate user was an `office' in violation of 
21 CFR 1306.04(b).'' OSC, at 4. The Government submitted evidence of 
prescriptions and fill stickers, which demonstrated that between 
September 23, 2014, and January 28, 2015, Respondent Pharmacy filled 
prescriptions for office use to Dr. I's office on 8 occasions and to 
Dr. A's office once. GX 3; RD, at 29.\20\ The Government's expert 
witness Dr. Gordon testified that ``written for office use'' means that 
``the pharmacy filled prescriptions for controlled substances not for 
an individual but for a facility.'' Tr. 64. She testified that the 
prescriptions ``for office use'' were not purchases by a medical 
office, but the evidence demonstrated that they were prescriptions 
because they were ``assigned a prescription number,'' and had the 
office name in the place of a ``patient's name,'' and further the 
pharmacy generated ``fill stickers.'' Id. at 65. She stated that 
``according to the standards set by Florida, a controlled substance 
should be issued to an individual patient, not an office to be 
distributed through unknown patients,'' and therefore, she testified 
that the prescriptions dispensed for office use were dispensed outside 
the usual course of professional practice. Id. at 64, 66. Upon 
prompting by Respondents' counsel, Dr. Gordon further testified that 
``if there were an invoice and the prescription was issued to a 
practitioner,'' it would have resolved the issue, but clarified that it 
was not within the acceptable standard of practice to order controlled 
substances from a pharmacy to be distributed to a dispensing 
practitioner and then report it to E-FORCSE. Id. at 278-79; 288-89.
---------------------------------------------------------------------------

    \20\ Respondents' Owner and PIC and the RD mentioned thirteen 
prescriptions to Dr. I's office, but the Government's evidence 
appeared to contain only eight and one to Dr. A's office and sixteen 
fill stickers. GX 3; Tr. 577; RD, at 29. The prescription for Dr. A. 
was filled by the Respondent Pharmacy to [A's] Office on the fill 
sticker. GX 3, at 4.
---------------------------------------------------------------------------

    Respondents' Owner and PIC testified that when she ``had an 
interest to wholesale some compounding,'' she asked her counsel (D.M.) 
about whether she could fill prescriptions for an office and that ``he 
said it was lawful between 3 and 5 percent'' of her total 
inventory.\21\ Id. at 583. She also admitted that she did not ask D.M. 
specifically about dispensing in the context of the prescriptions to 
Dr. I.'s office and that she had not specifically shown him or asked 
him about using blank prescriptions and fill stickers. Id. at 696-97, 
777. She testified that she had accessed the accreditations for Dr. I. 
and found that Dr. I. was a dispensing practitioner.\22\ Id. at 578. 
However, she testified that after the Board of Pharmacy visited in 2015 
and told her that wholesaling was not allowed, Respondent Pharmacy 
stopped dispensing to practitioners and her counsel changed his advice. 
Id. at 584.
---------------------------------------------------------------------------

    \21\ Respondents' Owner and PIC stated that she received this 
legal advice in writing, but Respondent offered no evidence of the 
advice. Tr. 695-696; RD, at 29.
    \22\ It is noted that Respondents' Owner and PIC did not offer a 
similar justification for the prescription to Dr. A's Office.
---------------------------------------------------------------------------

    I find that Respondent Pharmacy filled prescriptions for Dr. A.'s 
office and for Dr. I.'s office for office use. See infra Section 
III(A)(1)(b) for further discussion.

G. Allegation That Respondent Pharmacy Failed To Exercise Its 
Corresponding Responsibility When it Dispensed Controlled Substances 
Pursuant to Prescriptions Not Issued in the Usual Course of 
Professional Practice or for a Legitimate Medical Purpose

    The OSC alleged that Respondent Pharmacy failed to exercise its 
corresponding responsibility under 21 CFR 1306.04 as evidenced by its 
having dispensed controlled substances without resolving ``red flags of 
diversion'' that were present, including prescriptions: For highly 
abused narcotics; written to individuals travelling long distances; 
from groups of individuals who travelled long distances, from the same 
doctor, presented at the same time; for multiple drugs designed to 
treat the same condition in the same manner; constituting obvious early 
refills; and, for ``costly narcotic medications, which the customer 
repeatedly purchased with cash.'' OSC, at 4.
1. Red Flags Associated With Patients of Dr. R.
    The OSC alleged that between February 12, 2014, and May 3, 2014, 
Respondent Pharmacy ``dispensed narcotic medications to groups of 
customers who resided in close proximity to [Respondent Pharmacy], but 
who obtained their prescriptions from a physician located in Miami, 
Florida, more than 170 miles from their homes.'' OSC, at 4. The 
Government alleged that the distance between the prescribing 
practitioner and his patients constituted red flags and Respondent 
Pharmacy did not adequately resolve the red flags prior to dispensing 
prescriptions. Id. Furthermore, the Government alleged that Dr. R.'s 
prescriptions presented additional red flags that were unresolved by 
the pharmacy.
    The Government's evidence includes a letter from Dr. R., dated May 
22, 2014, which explains that Dr. R. moved his practice from Broward 
County to Miami, but his Broward County patients had decided to 
continue under his care. GX 29, at 1. The letter provided high level 
details about his office protocols to ensure against diversion. Id. The 
ALJ noted that the letter did not provide any names of Dr. R.'s 
patients. RD, at 30. Respondents' Owner and PIC stated that the letter 
``was issued after [Respondents' Owner and PIC] decided to no longer 
accept [Dr. R's] prescriptions.'' Resp Posthearing, at 11 (citing RX H, 
at 61). Dr. Gordon opined that the letter did not resolve any of the 
red flags for patients ``because it still doesn't explain why they're 
going to be driving further, putting the patients at risk.'' Tr. 193. 
She testified that although the fact that Dr. R. discusses his 
practice's controls \23\ could help a pharmacist evaluate the red 
flags, ``[i]t still doesn't justify them traveling three hours.'' Id. 
at 272. Further, Dr. Gordon testified that nothing in the pharmacy 
records confirmed Dr. R.'s practice controls were actually implemented 
and there were no written statements from the patients as to why they 
chose to travel to see Dr. R., and there was no documentation of any 
pharmacists' discussion with Dr. R. necessitating the letter in 
Respondent Pharmacy's records. Tr. 270, 286-87; RD, at 72.
---------------------------------------------------------------------------

    \23\ Dr. Gordon also testified that there was no information in 
Respondent Pharmacy's files that demonstrated that any of the 
controls mentioned in the letter had been implemented, except for a 
urine screen, but ``[i]t was not monthly'' as Dr. R.'s letter had 
claimed. Tr. 286.
---------------------------------------------------------------------------

    Respondents' Owner and PIC testified that she had spoken on the 
phone to Dr. R. and ``found him legitimate.'' Tr. 555. However, she 
stated that she had made a policy not to fill Dr. R.'s prescriptions, 
around the time that she received a letter from him on May 22, 2014, 
and she counseled B.S.\24\ for filling those prescriptions ``because we 
don't want the scrutiny of it.'' Id. at 560, 770; 557; RX H, at 62. 
However, she stated that despite that policy, there were two

[[Page 73760]]

instances where Respondents' Owner and PIC had decided to fill Dr. R.'s 
prescriptions as an exception to that policy. Tr. 771; 560. One was on 
April 7, 2014 to J.S.2. Id. at 773; GX 6, at 7.
---------------------------------------------------------------------------

    \24\ Respondents' Owner and PIC testified that B.S. was later 
terminated for other reasons in 2016. Tr. 564.
---------------------------------------------------------------------------

a. Pattern of Filled Prescriptions for Dr. R.'s \25\ Patients
---------------------------------------------------------------------------

    \25\ All of the patients in this section are patients of Dr. R., 
but some of the patients also received prescriptions from other 
doctors, which also presented red flags as described herein.
---------------------------------------------------------------------------

    The Government presented evidence that not only did Dr. R.'s 
patients travel long distances to receive their medication, but also 
they often filled the prescriptions on the same date and ``at the same 
time, one after another.'' RD, at 71. On February 12, 2014, Patients 
J.S.1, A.J., and S.P. presented prescriptions for oxycodone and 
hydromorphone from Dr. R. GX 6, at 1-2; GX 5, at 3-4; GX 4, at 3-4; RD, 
at 70. Dr. Gordon testified that the pattern of filling in groups is a 
red flag, because ``that's a group of patients going to see the same 
doctor, getting the same type of medication, same class of medication, 
and going to the pharmacy on the same day to get their prescriptions 
filled.'' Tr. 106. Similarly, on March 11, 2014, Patients D.G. and 
J.S.1 presented prescriptions from Dr. R. for oxycodone and their 
prescription numbers indicate that ``[r]ight after one another they 
were filled.'' Tr. 107; GX 9, at 5-6; GX 6, at 3-4. On March 15, 2014, 
Respondent Pharmacy filled prescriptions for hydromorphone from Dr. R., 
for Patients E.H., S.P., and A.J, with sequential fill numbers. GX 8, 
at 1-2; GX 4, at 5-6; GX 5, at 5-6. On April 11, 2014, Respondent 
Pharmacy filled prescriptions for S.P., A.J. and E.H. for 
hydromorphone. GX 4, at 1-2; GX 5, at 7-8; GX 8, at 3-4. Finally, on 
May 3, 2014, Respondent Pharmacy filled prescriptions for J.S.1 and 
D.G. for oxycodone and hydromorphone with sequential fill numbers. GX, 
6, at 11-12; GX 9, at 9-10.
    Dr. Gordon further explained that under normal pharmacy procedures, 
these Schedule II controlled substances must be locked up and ``the 
lock and key belongs to the pharmacist,'' and therefore, the pharmacist 
would have been aware of the pattern of group filling. Tr. 109-10. She 
opined that the red flags for these prescriptions were not resolvable 
and that she would not have filled them, because ``it's an effort to 
take--to get that drug and take it out. And then one right after it is 
for the same thing.'' Id. at 110-11.
b. S.P.
    On February 2, 2014, March 11, 2014, and April 11, 2014, Respondent 
Pharmacy filled prescriptions for hydromorphone for S.P. GX 4, at 4, 2, 
6. Dr. Gordon testified that the first red flag in the initial 
prescription was that the prescription for hydromorphone was ``written 
for the highest strength the drug is available.'' Tr. 67. Further, the 
prescription was ``from a doctor who is about three hours away from 
where the patient resides.'' \26\ Id. Finally, the fill stickers 
indicate that the patient paid with cash. Id. at 68; GX 4, at 2, 4, 6. 
The prescription dated February 2, 2014, includes a note on the 
prescription stating that it was ``verified by Nicole.'' GX 4, at 3. 
Dr. Gordon explained that ``when a technician calls the doctor's office 
to verify the validity of the prescription itself, that the 
prescription was written and issued by the physician.'' Tr. 68. S.P.'s 
file also contains a form letter with handwritten blanks filled in from 
Dr. R. faxed on February 12, 2014, that states that Dr. R. ``examined 
and prescribed narcotic medications'' to S.P. GX 4, at 8. Dr. Gordon 
opined that the letter provides the ``reasoning for issuing this 
prescription,'' but does not resolve any of the red flags discussed and 
stated, ``[i]t makes it worse because it's providing a diagnosis that 
we see a lot with prescriptions that are associated with diversion of 
chronic pain syndrome or some kind of back reason, and would also make 
me wonder how a patient could sit in a car for three hours one way to 
go to a doctor . . . .'' Tr. 70. She concluded that the prescriptions 
dispensed to S.P. were not dispensed within the usual course of 
professional practice and the pharmacist did not fulfill his or her 
corresponding responsibility. Tr. at 70.
---------------------------------------------------------------------------

    \26\ The Parties stipulated that the distance from S.P.'s home 
in Malabar, Florida to Dr. R. in Miami is 170 miles. RD, at 31 
(citing Stipulation (hereinafter, Stip.) 7).
---------------------------------------------------------------------------

c. A.J.
    From January 21, 2014, to April 11, 2014, Respondent Pharmacy 
filled prescriptions from Dr. R. for customer A.J. GX 5, at 1-8. A.J.'s 
address on the prescriptions is Palm Bay, Florida and the distance from 
Dr. R's office in Miami is 176 miles. GX 5, at 3, 5, 7; RD, at 31 
(citing Stipulation 8). From December 5, 2014, to March 27, 2015, 
Respondent Pharmacy filled eight prescriptions for A.J. from another 
doctor, Dr. D. GX 5, at 9-28. Dr. D.'s office in Orlando, Florida was 
74 miles from A.J.'s address. RD, at 32 (citing Stipulation 9). Dr. 
Gordon testified that the prescriptions from Dr. R. raised numerous 
flags, including: the type of medication; the fact that it was the 
highest strength dosage available (hydromorphone eight milligrams); 
``the distance traveled by the patient to go see the doctor and that 
the patient was paying cash.'' Tr. 77. Dr. Gordon also testified that 
it was a red flag that the prescriptions from Dr. D. included a 
prescription for morphine in addition to the hydromorphone at the 
highest dosage, both of which treat the same condition. Id. at 80, 84; 
e.g., GX 5, at 9, 11. She further testified that the prescriptions from 
Dr. D. raised red flags because of the type of medications, the fact 
that A.J. was paying cash and the fact that the ``codes that are on 
here are all back pain or chronic pain syndrome,'' which are ``commonly 
seen on diverted medications.'' \27\ Id.
---------------------------------------------------------------------------

    \27\ Respondents argue that Dr. Gordon ``seems to have an 
overall bias against patients with back pain.'' Resp Posthearing, at 
54. I disagree. She testified that it had been her ``experience'' 
that people who commonly abuse medications present with 
prescriptions related to back pain. Tr. 220. It is noted that there 
are numerous red flags on the prescriptions where Dr. Gordon flagged 
back pain as an additional red flag.
---------------------------------------------------------------------------

    A.J.'s profile contains an entry that states, ``Dr. D. called 
personally about patient & will send letter over next week.'' GX 5, at 
29. There is no letter from Dr. D. in the file and the Respondents' 
Owner and PIC testified that it was ``generally'' the policy to note 
the receipt of a letter in the system.\28\ Tr. 735-36. The file also 
contains a form letter faxed on January 23, 2014,\29\ from Dr. R. with 
the patient's name, diagnosis and last MRI filled in by hand. GX 5, at 
30; RX H, at 59. Dr. Gordon testified that neither the notation 
regarding Dr. D., nor the letter from Dr. R. resolved the red flags 
associated with A.J.'s prescriptions, because there was no 
documentation explaining the long distances that A.J. traveled to see 
these doctors. Tr. 85-86; see GX 5, at 29, 30; RX H, at 59. She 
concluded that the prescriptions dispensed to A.J. were not dispensed 
within the usual course of professional practice and the pharmacist did 
not fulfill his or her corresponding responsibility. Tr. at 86.
---------------------------------------------------------------------------

    \28\ However, there was a letter from Dr. R. for patient A.J. 
and no corresponding notation regarding its receipt in A.J.'s 
profile. GX 5, at 29, 30; RD, at 32.
    \29\ It is noted that this letter was faxed on January 23, 2014, 
but the first prescription for A.J. was filled on January 21, 2014; 
therefore, even had this letter resolved some of the red flags for 
future prescriptions, which I find it did not, it was not received 
in time to resolve the red flags for the first prescription. See GX 
5, at 2.
---------------------------------------------------------------------------

d. D.G.
    From January 14, 2014, to May 3, 2014, Respondent Pharmacy filled 
prescriptions for customer D.G. written

[[Page 73761]]

by Dr. R. GX 9, 1-10. D.G.'s address on the prescriptions is in Palm 
Bay, Florida and the distance from Dr. R.'s office in Miami is 175 
miles. GX 9, at 2, 4, 6, 8; RD, at 33 (citing Stipulation 13). D.G.'s 
customer file also includes a prescription, dispensed on October 15, 
2014, written by another doctor, Dr. B., in Winter Garden, Florida, 
which is 76 miles from D.G.'s address. GX 9, at 11; RD, at 33 (citing 
Stipulation 17). Dr. Gordon testified that these prescriptions raised 
multiple red flags including: ``the type of medication, which is an 
opioid, the strength \30\ of the medication, the distance traveled from 
the patient's home to the doctor, and cash.'' Tr. 94-95. Further, she 
testified that the prescriptions from Dr. B. had the same red flags and 
that the patient was traveling an hour away, which would still trigger 
a red flag. Tr. 97. The Government's evidence includes a form letter 
from Dr. R. stating that the date of visit was February 11, 2014,\31\ 
and a diagnosis of lower back pain. GX 9, at 14. Dr. Gordon testified 
that nothing in the file,\32\ including the letter, resolves the red 
flags, because it does not explain why he is traveling such a distance, 
particularly considering that he allegedly had lower back pain. Tr. 98. 
She concluded that the prescriptions dispensed to D.G. were not 
dispensed within the usual course of professional practice and the 
pharmacist did not fulfill his or her corresponding responsibility. Id. 
at 98.
---------------------------------------------------------------------------

    \30\ Dr. Gordon further explained that the strength is a concern 
``because it's the highest dose the drug is available in in an 
immediate-release form.'' Tr. 94.
    \31\ It is noted that although the letter was undated, it had to 
have been sent after the last visit identified in the letter as 
February 11, 2014, which was after Respondent Pharmacy's first fill 
on January 17, 2014, for this patient. GX 9, at 2.
    \32\ The patient profile for D.G. includes a note in the memo 
section that states ``3/17/2015 must have new letter of med 
necessity for any further fills.'' GX 9, at 13. However, that note 
was dated long after the last prescription in the record for D.G. of 
October 15, 2014. Id. at 12.
---------------------------------------------------------------------------

e. E.H.
    From March 15, 2014, to May 9, 2014, Respondent Pharmacy filled 
prescriptions for customer E.H. written by Dr. R. GX 8, 1-6. E.H.'s 
address on the prescriptions is in Palm Bay, Florida and the distance 
from Dr. R's office in Miami is 175 miles. Id. at 2, 4, 6; RD, at 34 
(citing Stipulation 20). E.H.'s customer file also includes 
prescriptions filled July 23, 2014, to April 1, 2015, written by 
various doctors at a pain management clinic in Orlando, Florida, which 
is 74 miles from E.H.'s address. GX 8, at 7-24; RD, at 34 (citing 
Stipulation 21). Dr. Gordon testified that these prescriptions raised 
multiple red flags including: ``the type of medication, the strength of 
the medication, the distance traveled, and cash.'' Tr. 100. Further, 
she testified that the prescriptions from the practice in Orlando had 
the same red flags and that the patient was still traveling a 
distance.\33\ Id. at 102. The Government's evidence includes a form 
letter with the patient, diagnosis and last MRI filled in from Dr. R. 
faxed on March 14, 2014. GX 8, at 26. Dr. Gordon testified that nothing 
in the file, including the letter, resolves the red flags. Tr. 105. She 
concluded that the prescriptions dispensed to E.H. were not dispensed 
within the usual course of professional practice and the pharmacist did 
not fulfill his or her corresponding responsibility. Id.
---------------------------------------------------------------------------

    \33\ One of the prescriptions includes a Rockledge address for 
the Orlando practice, which Dr. Gordon testified is still far away 
from E.H.'s home. Tr. 103-04.
---------------------------------------------------------------------------

f. J.S.1 and J.S.2
    From February 12, 2014, to May 5, 2014, Respondent Pharmacy filled 
prescriptions for customers J.S.1 and J.S.2 written by Dr. R. GX 6, at 
1-14. According to the prescriptions, J.S.1 and J.S.2 live at the same 
address in Palm Bay, Florida. RD, at 34 (citing Tr. 585); compare GX 6, 
at 1-2, with GX 6, at 5-6. The distance from the residence of J.S.1 and 
J.S.2 to Dr. R's office in Miami is 174 miles. GX 6; RD, at 35 (citing 
Stipulation 10). They lived 22 miles from Respondent Pharmacy. RD, at 
35 (citing Stipulation 12). Dr. Gordon testified that the prescriptions 
to J.S.1 and J.S.2 raised the same red flags as the other patients 
including, ``the type of medication, the strength is the highest 
strength of the medication, the distance traveled, and cash.'' Tr. 87, 
113. The Government's evidence includes a form letter for J.S.2 with 
the patient, diagnosis and last MRI filled in from Dr. R. faxed on 
March 10, 2014. GX 6, at 16. Dr. Gordon testified that nothing in the 
file, including the letter, resolves the red flags. Tr. 113. No such 
letter is in the file for J.S.1. See generally GX 6. She concluded that 
the prescriptions dispensed to J.S.2 \34\ were not dispensed within the 
usual course of professional practice and the pharmacist did not 
fulfill his or her corresponding responsibility. Id. at 113-114. Dr. 
Gordon further testified that the fact that J.S.1 and J.S.2 reside at 
the same address raises an additional red flag, ``because that shows 
that they're a group. They both live at the same address, they're 
getting the same type of chronically sought after narcotic from the 
same doctor, both traveling an hour or three hours south one way to get 
their medication, both have a similar diagnosis of back pain.'' Id. at 
114.
---------------------------------------------------------------------------

    \34\ Dr. Gordon's testimony did not include a specific 
conclusion regarding corresponding responsibility for J.S.1 separate 
and apart from J.S.2; however, I find that the record is clear that 
the red flags for both of these patients were the same and therefore 
I draw the same conclusion for J.S.1 that I do for J.S.2.
---------------------------------------------------------------------------

    Respondents' Owner and PIC stated that the majority of the 
prescriptions Respondent Pharmacy filled for J.S.1 and J.S.2 were 
filled by B.S, but that she had filled some of J.S.2's prescriptions. 
Id. at 586. She recalled having a conversation with J.S.2 about the 
distance driven and that it was ``short-term'' and ``[h]e did tell me 
the diagnosis. I don't recall about the time.'' Id. at 588. She also 
testified that she had encouraged J.S.2 to find a local pain physician 
and he had found one in Orlando, which she considered to be local 
despite being 50 miles away, because ``there weren't the availability 
of a lot of pain management doctors, period, but there were even less 
that had openings.'' Tr. 593-94.
g. C.C.
    From December 28, 2013, to May 5, 2014, Respondent Pharmacy filled 
prescriptions for customer C.C. written by Dr. R. GX 11, at 1-12. 
C.C.'s address on the prescriptions is in Melbourne, Florida and the 
distance from Dr. R's office in Miami is 176 miles. GX 11; RD, at 36 
(citing Stipulation 28). C.C.'s customer file also includes 
prescriptions filled from August 18, 2014, to March 30, 2015, written 
from a practice in Rockledge, Florida. GX 11, at 13-44; RD, at 36. Dr. 
Gordon testified that the prescriptions from Dr. R. to C.C. raised the 
same red flags as the other patients.\35\ Tr. 123. Dr. Gordon also 
testified that even though the doctor in Rockledge was local to C.C., 
the prescriptions still raised red flags because the prescriptions were 
``still the short-acting opioid at the highest dose, the chronic back 
pain, and cash.'' Id. at 125; GX 11, 13-44. The Government's evidence 
includes a form letter for C.C. from Dr. R. with the patient name 
diagnosis and last MRI filled in by hand, which although undated, 
appeared to be received April 7, 2014, according to the notes in the 
Respondent Pharmacy's files. GX 11, at 45-46. Dr. Gordon testified that 
nothing in the file, including the letter, resolves the red flags for 
the prescriptions for C.C. Tr.

[[Page 73762]]

126-127. She concluded that the prescriptions dispensed to C.C. from 
Dr. R.\36\ were not dispensed within the usual course of professional 
practice and the pharmacist did not fulfill his or her corresponding 
responsibility. Id.
---------------------------------------------------------------------------

    \35\ The Government noted that the fill sticker on one of the 
prescriptions gives an address in Boynton Beach for Dr. R., but Dr. 
Gordon said that although ``it probably shaves off maybe an hour and 
a half drive,'' it still raises the same red flags. Tr. 123-24.
    \36\ Although Dr. Gordon testified that the prescriptions from 
the physician in Rockledge raised red flags, she limited her opinion 
that Respondent had not fulfilled its corresponding responsibility 
or acted within the usual course of professional practice to the 
prescriptions to C.C. by Dr. R. I am limiting my findings to Dr. R's 
prescriptions, because most of the other prescriptions included a 
red flag of distance and Dr. Gordon did not explain how or whether 
the absence of that red flag in this instance might affect the 
pharmacist's corresponding responsibility and professional practice.
---------------------------------------------------------------------------

h. P.P.
    From January 31, 2014, to April 10, 2014, Respondent Pharmacy 
filled prescriptions for customer P.P. written by Dr. R. GX 12, at 1-6. 
P.P.'s address on the prescriptions is in Palm Bay, Florida and the 
distance from Dr. R's office in Miami is 173 miles. GX 12; RD, at 36 
(citing Stipulation 30). Dr. Gordon testified that the prescriptions 
from Dr. R. to P.P. raised the same red flags as the other patients for 
the strength, type of medication, ``a highly sought after opioid,'' and 
the distance traveled. Tr. 128. She further stated that P.P. charged 
his insurance for some of the prescriptions, but paid cash for the 
prescription filled on February 18, 2014, which indicates a red flag 
when patients are ``maybe trying to hide something from the pharmacist. 
They get it filled somewhere else and bill their insurance.'' Id. at 
128. The Government's evidence includes a form letter for P.P. from Dr. 
R. with the patient name, diagnosis and last MRI filled in by hand, 
which was faxed on January 23, 2014. GX 12, at 8; RX H, at 264. Dr. 
Gordon testified that nothing in the file, including the letter, 
resolves the red flags for the prescriptions for P.P. Tr. 129-130. She 
concluded that the prescriptions dispensed to P.P. prescribed by Dr. R. 
were not dispensed within the usual course of professional practice and 
the pharmacist did not fulfill his or her corresponding responsibility. 
Id.
    Although the letter of necessity from Dr. R. was included in the 
Government's evidence, there was no corresponding note of receipt in 
his patient file and there was no note that Respondent Pharmacy would 
not take out of county prescriptions.\37\ GX 12, at 7. Respondents' 
Owner and PIC stated that no prescriptions were filled for patient P.P. 
after May 14, 2014, but the ALJ found, and I agree, that Respondents' 
own exhibits demonstrate that not to be the case. Tr. 633; RD, at 37; 
RX H, at 265 (showing that the last prescription filled for P.P. by 
Respondent Pharmacy was on September 22, 2016). Respondents' Owner and 
PIC also testified that the prescriptions for P.P. were filled by 
Pharmacist B.S.,\38\ a former employee of Respondent Pharmacy. Tr. 632-
33.
---------------------------------------------------------------------------

    \37\ The ALJ noted, and I agree, that the Respondents' Owner and 
PIC testified that even though there was no notation, a pharmacist 
filling a prescription for P.P. could check the paper file for the 
letter of necessity; however, without a notation, a pharmacist would 
not know that the letter existed to know to check the paper file. 
RD, at 37 n.17 (citing Tr. 748-49)
    \38\ Although B.S. may have filled the prescriptions in the 
Government's evidence, it is noted that Respondents' evidence 
demonstrates that B.S. was terminated for potential diversion on 
April 23, 2016; therefore, a different pharmacist must have filled 
P.P.'s prescriptions following B.S.'s termination. RX G, at 5l; Tr. 
564.
---------------------------------------------------------------------------

i. K.P.
    From February 4, 2014, to April 8, 2014, Respondent Pharmacy filled 
prescriptions for customer K.P. written by Dr. R. GX 13, 11-16. 
Additionally, from April 22, 2013, to August 24, 2013, Respondent 
Pharmacy filled prescriptions for K.P. from a prescriber in Fort 
Lauderdale, Florida.\39\ K.P.'s address on the prescriptions varies; 
\40\ however, K.P.'s address on all of the fill stickers from 
Respondent Pharmacy indicates that he was located in Fort Lauderdale, 
Florida. GX 13, at 2, 4, 6, 8, 10, 12, 14, 16. The distance between 
K.P.'s address and Respondent Pharmacy is 164 miles. RD, at 38 (citing 
Stipulation 32). Dr. Gordon testified that these prescriptions raised 
numerous red flags including: ``the type of medication, the highly 
sought out opioid, the strength of the medication, the distance to the 
pharmacy [. . .] and that the patient was paying cash.'' Tr. 132. The 
Government's evidence includes a form letter with the patient name, 
diagnosis and last MRI filled in from Dr. R. faxed on January 31, 2014. 
GX 13, at 18; RX H, at 273. There was no documentation of the letter in 
the notes section of the patient profile in Respondent Pharmacy's 
system, but there was an undated note stating not to fill any more 
``out of county physicians.'' GX 13, at 17; RD, at 38. There was no 
letter of necessity or other notes regarding the prescriber in Fort 
Lauderdale. See generally GX 13; RD, at 38. Dr. Gordon testified that 
nothing in the file, including the letter, resolves the red flags. Tr. 
135-136. She concluded that the prescriptions dispensed to K.P. were 
not dispensed within the usual course of professional practice and the 
pharmacist did not fulfill his or her corresponding responsibility. Id. 
at 136.
---------------------------------------------------------------------------

    \39\ One of the fill stickers for the Fort Lauderdale prescriber 
indicates a Miami address, but I find this to be irrelevant because 
the red flag for K.P. related to location is the distance he lived 
from the pharmacy. See GX 13, at 10; Tr. 133.
    \40\ A few of the prescriptions show addresses in Sunrise 
Florida, which is west of Fort Lauderdale. RD, at 38 n.18. 
Additionally, one of the prescriptions indicates that K.P. lives in 
Palm Bay, which Dr. Gordon testified ``creates more of a red flag. 
Where does he live?'' GX 13, at 11; Tr. 134-35.
---------------------------------------------------------------------------

    Based on all of the record evidence, and the testimony of Dr. 
Gordon, which I credit, I find that the prescriptions issued by Dr. R. 
and other doctors for Dr. R.'s patients as detailed herein, raised red 
flags, including that customers arrived in groups, purchased 
prescriptions with cash, traveled long distances and because the 
prescriptions were for highly sought after controlled substances at 
highest strengths. I further find that the letters of medical necessity 
provided by Dr. R. did not resolve the multiple red flags on his 
prescriptions and that, even if these red flags were resolvable, there 
was no credible evidence in the record that Respondent Pharmacy 
resolved them before it filled the prescriptions. I conclude that the 
pharmacists filling the prescriptions did not fulfill their 
corresponding responsibility and the prescriptions were not dispensed 
in the usual course of professional practice.
2. Other Prescriptions Presenting Red Flags
a. J.C.
    From approximately October 11, 2013, to January 16, 2015, 
Respondent Pharmacy filled prescriptions for customer J.C. written by a 
prescriber in Fort Lauderdale, Florida. GX 10. Most of the 
prescriptions record only a street address for the patient without a 
city, but a few prescriptions list the city as Palm Bay, Florida.\41\ 
Compare, e.g., GX 10, at 1 with GX 10, at 71-82; RD, at 39. The address 
on all of the fill stickers states that J.C. lives in Indialantic, 
Florida, which is 158 miles from the prescriber's office in Fort 
Lauderdale. See, e.g., GX 10, at 2; RD, at 39 (citing Stipulation 22). 
There is nothing in the record evidence that resolves the discrepancy 
between the addresses on the prescriptions and the address on the fill 
stickers. RD, at 39. The first five prescriptions in the Government's 
exhibit were all issued on January 3, 2014, and are all for varying 
strengths and amounts of the same controlled substance, Roxicodone, 
including two prescriptions for 10 milligrams and two prescriptions for 
20 milligrams and one prescription for 5 milligrams. Tr. 115,

[[Page 73763]]

835; GX 10, at 1-10; RD, at 39. Dr. Gordon testified that the five 
prescriptions for Roxicodone ``just screams red flags.'' Tr. 117. 
``Furthermore, the instructions for taking these five prescriptions for 
the same controlled substance suggested that J.C. could have been 
taking all of these medications at the same time.'' RD, at 39 (citing 
Tr. 834-35). On the same date, January 3, 2014, in addition to the five 
prescriptions for the Roxicodone, Respondent Pharmacy also filled a 
sixth prescription for J.C. for the highest available dosage of 
diazepam, or Valium, which ``would now constitute a drug cocktail.'' 
Tr. 117; GX 10, at 175-76.
---------------------------------------------------------------------------

    \41\ Dr. Gordon testified that even if the patient had lived in 
Palm Bay, it would be a 2 to 2.5 hour trip to Fort Lauderdale. Tr. 
116.
---------------------------------------------------------------------------

    Furthermore, the ALJ found, and I agree, that Respondent Pharmacy 
additionally filled this same drug cocktail of oxycodone and diazepam 
for J.C. on January 28, 2014 (Tr. 118-19; GX 10, at 11-20, 177-78); 
July 19, 2014 (GX 10, at 95-96, 193-194); September 3, 2014 (GX 10, at 
111-14,\42\ 191-92); September 23, 2014 (GX 10, at 119-26, 193-94); 
December 22, 2014 (GX 10, at 141-44, 197-98); and January 16, 2015 \43\ 
(GX 10, at 145-48, 199-200).
---------------------------------------------------------------------------

    \42\ It was not alleged by the Government and is therefore not 
being considered, but is noted that the Government's exhibit also 
demonstrates that J.C. filled prescriptions written on September 2, 
2014 at Respondent Pharmacy on September 3, 2014, and September 5, 
2014, and September 10, 2014. GX 10, at 114, 116, 118.
    \43\ The prescriptions for oxycodone and Diazepam were all 
prescribed on January 16, 2015, but Respondent Pharmacy dispensed 
them on January 16, 2015, January 19, 2015, and January 28, 2015. GX 
10, at 145-152; 199-200. The evidence shows that Respondent Pharmacy 
dispensed prescriptions for oxycodone and diazepam, which 
constituted a drug cocktail, on January 19, 2015. Id. at 148, 200.
---------------------------------------------------------------------------

    Further, Respondent Pharmacy filled prescriptions for J.C. that 
constituted early refills. Tr. 121. For example, the ALJ found, and I 
agree, that Respondent Pharmacy filled multiple prescriptions for J.C. 
on January 28, 2014 (Tr. 121, GX 10, at 11-19) and then again filled 
prescriptions on February 11, 2014, and February 26, 2014. GX 10, at 
19-20, 21-26, 27-30. Dr. Gordon said this raised red flags because 
``[t]he patient already got like a ton of oxycodone, and this is just 
like twelve days later he just got a whole nother [sic] batch.'' Tr. 
122. She further testified that nothing in the patient records \44\ is 
written to resolve the red flags for J.C.'s prescriptions. Id.
---------------------------------------------------------------------------

    \44\ The Patient profile includes a note that says that someone 
spoke with the prescriber and verified medical necessity on October 
2, 2012. The notes also include a note on March 30, 2015, after 
several years of filling prescriptions, that the address on RX must 
match address on the driver's license and that there could be ``no 
more credit.'' GX 10, at 201.
---------------------------------------------------------------------------

    Respondents' Owner and PIC testified \45\ that if J.C. paid cash 
for a prescription, the fill sticker stated ``cash'' and if he used 
insurance it would read ``advance.'' Tr. 615. J.C. paid cash for his 
prescriptions 10 times. RD, at 40 (citing Tr. 613); see e.g., GX 10, at 
146. Respondents' Owner and PIC further testified that she knows J.C. 
and he was a customer for 10 years. Tr. 596, 740. She further testified 
that she had had a conversation with the prescribing doctor \46\ 
``about the therapy because it is different, so I particularly wanted 
to know about the use of several different strengths of oxycodone.'' 
Id. at 597. In speaking with the doctor, Respondents' Owner and PIC 
testified that ``[J.C.] was on a very tightly tailored pain management 
treatment plan where as his pain fluctuated, he would use a different 
dose to use the minimal amount to relieve the pain.'' Id. at 610. 
Later, she changed the rationale for the multiple prescriptions, 
stating, ``those were split scripts \47\ so that if the patient either 
didn't have the funds or if it wasn't available because of shortages . 
. . so that he could get a partial here and there.'' Tr. 855.
---------------------------------------------------------------------------

    \45\ Respondents' Owner and PIC also testified that she believed 
that the Government had not included all evidence from the patient 
memo in their exhibits, because she ``knew this patient well.'' Tr. 
612. Respondent did not offer additional evidence and the print out 
in her exhibits on J.C. contains the same information in the patient 
memo as the Government's print out. Compare RX H, at 145 with GX 10, 
at 201.
    \46\ Respondents' Owner and PIC testified that this doctor had a 
good reputation in the community. At first, Dr. Gordon testified 
that it is not within the standard of practice to rely on a 
physician's reputation to fill a prescription, but later amended her 
statement to allow that reputation ``will come into play.'' Tr. 832, 
838. I do not find this information particularly relevant, because 
there is nothing in the record documenting Respondents' Owner and 
PIC's belief that the physician's reputation resolved the multitude 
of red flags that these prescriptions presented.
    \47\ Some of the prescriptions did include a note indicating 
``split script;'' however, I find Dr. Gordon more credible that this 
could not resolve the red flag of the need for all of the 
prescriptions or the instructions on how to take them. See e.g., GX 
10, at 161. Additionally, on March 20, 2015, Respondent Pharmacy 
filled all of the prescriptions that appeared to be duplicative on 
the same day, which undermines the notion that they were split 
scripts. Id. at 159-64.
---------------------------------------------------------------------------

    Dr. Gordon testified that there were no instructions with these 
prescriptions about how to take them. Id. at 832-34. In order to 
address the prescriptions under the standard of practice, she said that 
a pharmacist would need to call to find out why the patient needs all 
of the prescriptions, ``and is the patient supposed to take one at a 
time or can they take all four at the same time.'' Id. at 835, 837. She 
concluded that the prescriptions dispensed to J.C. were not dispensed 
within the usual course of professional practice and the pharmacist did 
not fulfill his or her corresponding responsibility. Id. at 120
b. M.B.
    From October 3, 2013, to March 13, 2015, Respondent filled 
prescriptions for patient M.B., whose address on the prescriptions and 
fill stickers was listed in Palm Bay, Florida. GX 14, at 1-88. Dr. 
Gordon testified that these prescriptions raised multiple red flags. 
For example, the prescriptions filled for hydromorphone and lorazepam 
on December 30, 2013, constituted a drug cocktail. Tr. 137. Dr. Gordon 
noted many instances of drug cocktails dispensed to M.B., including 
Ativan and hydromorphone, MS Contin, or extended-release morphine. Tr. 
138. The ALJ noted that beginning in December 2014, Respondent Pharmacy 
was filling two prescriptions for hydromorphone for M.B. at the same 
time it filled prescriptions for lorazepam for him. RD, at 41; GX 14, 
at 65-88. Dr. Gordon testified that a further red flag was the location 
of the physician in Sanford, which is about an hour away from M.B.'s 
residence in Palm Bay. Id. at 138. The records for patient M.B. 
demonstrate that M.B. paid for his prescriptions ``cash for some things 
and insurance for others.'' Tr. 138; compare GX 14, at 10, with id. at 
12.
    The Government's Exhibit included a letter dated May 6, 2013, with 
a corresponding note in the patient profile from M.B.'s prescriber. GX 
14, at 89-92. The letter included a diagnostic code and list of 
medications, but ``provide[d] no information about why M.B. was making 
a 170 mile round trip to see'' the prescriber. RD, at 41; GX 14, at 90-
92. Dr. Gordon testified that nothing in the file, including the 
letter, resolved the red flags. Tr. 138-39. She concluded that the 
prescriptions dispensed to M.B. were not dispensed within the usual 
course of professional practice and the pharmacist did not fulfill his 
or her corresponding responsibility. Id. at 139-40.
    Respondents' Owner and PIC testified that she spoke to M.B.'s 
prescriber and ``had a general conversation, not patient specific.'' 
Tr. 640. She testified that ``63 out of 91 [of M.B.'s] prescriptions'' 
were paid by insurance, and that M.B.'s payment with cash ``raised a 
red flag that was resolved,'' because ``the insurance, if they won't 
pay for it, then we give them the option to pay cash.'' \48\ Id. at 
642. Respondents' Owner

[[Page 73764]]

and PIC testified that M.B. had ``presented with a prescription from a 
different physician,'' and that she had ``faxed Dr. [C]'s office to see 
the reason for his discharge'' and found out ``that he had been 
discharged for cause,'' so she refused to fill further prescriptions 
for M.B. Tr. 643 (citing RX H, at 274 (found at 283)).
---------------------------------------------------------------------------

    \48\ I note that M.B.'s patient records demonstrate that he paid 
cash for most of his prescriptions for hydromorphone and the other 
prescriptions with insurance, which would support Respondents' Owner 
and PIC's testimony regarding the resolution of the red flag; 
however, he used insurance to pay for ``hydromorphone 8 MG tablet'' 
on March 13, 2015 (GX 14, at 86) and Respondents offered no 
explanation to resolve this discrepancy. More importantly, 
Respondents provided no documentation of the alleged resolution of 
this red flag or any other of the red flags for patient M.B.
---------------------------------------------------------------------------

c. C.A.
    From December 17, 2013, to February 10, 2014, Respondent Pharmacy 
filled prescriptions for patient C.A., whose address on the fill 
stickers was listed as Sebastian, Florida,\49\ which was 86 miles from 
the prescriber in Orlando. GX 15, at 1-7; RD, at 41 (citing Stipulation 
35). Dr. Gordon testified that these prescriptions raised multiple red 
flags, including the type of medication, the distance traveled and that 
all of the prescriptions were paid for in cash. Tr. 141; GX 15, at 2, 
4, 6. ``Two of the three prescriptions that contain these red flags 
were filled by [Respondents' Owner and PIC].'' RD, at 42 (citing Tr. 
142; GX 15, at 1-2, 5-6). The patient's profile notes ``must have 
letter of med nec for March 2014 fill Dr. Kuhn.'' GX 15, at 7. The 
exhibits included an undated letter. GX 15, at 8. From the date of the 
note, it appears that this letter must have arrived around the time of 
the March 2014 fill and after the three prescriptions in the exhibit. 
Dr. Gordon testified that nothing in the file, including the letter, 
resolves the red flags. Tr. 143. She concluded that the prescriptions 
dispensed to C.A. were not dispensed within the usual course of 
professional practice and the pharmacist did not fulfill his or her 
corresponding responsibility. Id.
---------------------------------------------------------------------------

    \49\ As the ALJ noted, the address listed for C.A. on the 
prescriptions had the same street address as the fill stickers, but 
listed the city as Barefoot Bay, Florida instead of Sebastian, 
Florida. Compare GX 15, at 1, with id. at 2. The distance between 
these two cities is negligible and despite the Government trying to 
raise the difference as a red flag at the hearing, it does not 
appear to be relevant. Tr. 141.
---------------------------------------------------------------------------

d. D.B.
    From December 17, 2013, to March 26, 2015, Respondent Pharmacy 
filled prescriptions for patient D.B. GX 7, at 1-60. D.B.'s address on 
the fill stickers is in Port St. Lucie, Florida, which is 76 miles from 
Respondent Pharmacy; however, D.B.'s address on the prescriptions is in 
Jupiter, Florida. GX 7, at 1-60; RD, at 42 (citing Stipulation 27). The 
doctor's office in Jupiter, Florida is 111 miles from Respondent 
Pharmacy. RD, at 42 (citing Stipulation 26).
    Dr. Gordon testified that these prescriptions raised multiple red 
flags, including the type and strength of the medication, the distance 
traveled to the pharmacy and that many of the prescriptions were paid 
for with cash. Tr. 144. Additionally, many of the prescriptions filled 
were for drug cocktails. Id. at 144-47. For example, Respondent 
Pharmacy filled a drug cocktail of: Oxycodone and the highest dose of 
Xanax (filled by Respondents' Owner and PIC six days after the 
oxycodone prescription) in December 2013. GX 7, at 1-3; Tr. 145-46; RD, 
at 42. Respondents' Owner and PIC filled a prescription for oxycodone, 
Percocet and Xanax, which included two immediate release opioids, on 
July 1, 2014. Tr. 148; GX 7, at 21-26. Respondent Pharmacy filled 
prescriptions for Percocet, Xanax and Ambien on February 21, 2015. Tr. 
146-47; GX 7, at 51-56. Additionally, on October 24, 2014, Respondent 
Pharmacy filled two identical prescriptions for the highest dosage of 
oxycodone. Tr. 147; GX 7, at 35-38.
    Further, the record demonstrates early fills, which constitute red 
flags. For example, on June 19, 2014, Respondent Pharmacy filled a 
prescription for a 30 day supply of Percocet and 30 day supply of 
oxycodone, and Respondents' Owner and PIC re-filled both for a 30 day 
supply on July 1, 2014, despite that 30 days had not passed. Tr. 726-
27; GX 7, at 19, 20, 21-14. Respondents' Owner and PIC admitted that it 
was an early fill ``as to counting the days.'' Tr. 727. She further 
responded ``yes'' to the question as to whether the early fill 
constituted a red flag and admitted that nothing in the patient profile 
or on the prescription resolved the red flag. Tr. 727.\50\
---------------------------------------------------------------------------

    \50\ Respondents' Owner and PIC argued that the fact that the 
patient ``consistently saw the same doctor who wrote subsequent 
scripts which seemed to legitimize'' the prescriptions, because 
``that would suggest that a conversation was had about how much was 
used and why he was writing it yet again.'' Tr. 729. I reject the 
notion that a red flag that demonstrates that a prescription may be 
illegitimate is resolved because the practitioner who issued the 
initial potentially illegitimate prescription, issued another 
potentially illegitimate prescription.
---------------------------------------------------------------------------

    The patient memo box on D.B.'s patient profile includes a note from 
March 30, 2015, that ``address on RX must match driver's license.'' GX 
7, at 61; Tr. 733. Further, Respondents' Owner and PIC testified that 
she had resolved the red flag that he was traveling so far, because 
``he had a residence in Satellite Beach that he intended to move back 
to'' and Respondents provided a copy of what appears to be a scanned 
prescription, dated March 24, 2015, with a handwritten note in 
Respondents' Owner and PIC's handwriting, stating, ``Moving back to Sat 
Bch July.'' Tr. 619; RX H, at 192. However, the ALJ found, and I agree, 
that ``the pharmacy had been filling D.B.'s prescriptions since 
December of 2013, yet all of the prescription addresses indicated that 
D.B. lived in Jupiter, Florida, while the fill stickers indicated he 
lived in Port St. Lucie.'' RD, at 43.
    Dr. Gordon testified that nothing in the Government's evidence 
resolved the red flags on the prescriptions. Tr. 147-49. She concluded 
that the prescriptions dispensed to D.B. were not dispensed within the 
usual course of professional practice and the pharmacist did not 
fulfill his or her corresponding responsibility. Id. at 149.
e. J.D.
    From October 18, 2013, to April 3, 2015, Respondent Pharmacy filled 
prescriptions for patient J.D. whose address on the prescriptions and 
most of the fill stickers \51\ was listed as Cocoa Beach, Florida, 
which was 75 miles from the prescriber in Sanford, Florida. GX 16, at 
1-72; RD, at 43 (citing Stipulation 36). Dr. Gordon testified that 
these prescriptions raised multiple red flags, including the type of 
medication, the fact that the Xanax and hydromorphone were at high 
dosages, the distance traveled, paying for prescriptions with cash, and 
drug cocktails of hydromorphone and Xanax. Tr. 152-54; RD, at 43. The 
ALJ found, and I agree, that the Government's evidence demonstrates 
that Respondent Pharmacy filled prescriptions for both hydromorphone, 
at its highest dosage, and Xanax on 16 different dates. RD, at 43-44 
(citing GX 16, at 7-70). Furthermore, the ALJ found, and I agree, that 
Respondent Pharmacy provided J.D. with early refills on March 21, 2014, 
May 16, 2014, October 3, 2014, November 21, 2014, and January 9, 2015. 
RD, at 44 (citing GX 16, at 11-26, 39-62).
---------------------------------------------------------------------------

    \51\ The first two prescriptions list an address of Titusville, 
Florida on the fill stickers and not the prescriptions, but the rest 
of the prescriptions list Cocoa Beach on both. GX, 16, at 1-4.
---------------------------------------------------------------------------

    The patient's profile notes a May 14, 2013, letter of medical 
necessity from Dr. C., seven months after Respondent Pharmacy began 
filling J.D.'s prescriptions. GX 16, at 73. The letter provides a list 
of medications, a diagnosis code and the initial date of

[[Page 73765]]

treatment, but no explanation for the distance traveled, strength of 
the medication or the combination of medications. GX 16, at 74-75. Dr. 
Gordon testified that nothing in the file, including the letter, 
resolves the red flags. Tr. 154.\52\
---------------------------------------------------------------------------

    \52\ Dr. Gordon's testimony did not include a specific 
conclusion regarding corresponding responsibility for J.D.; however, 
I find that the record is clear that the red flags are the same as 
the other patients' prescriptions and therefore I draw the 
conclusion that these were not dispensed within the usual course of 
professional practice and the pharmacist did not fulfill his or her 
corresponding responsibility.
---------------------------------------------------------------------------

f. K.B.3
    From December 27, 2013, to January 23, 2015, Respondent Pharmacy 
filled prescriptions for patient K.B.3, whose address on the 
prescriptions and fill stickers was listed as Palm Bay, Florida, which 
was 88 miles from the prescriber, Dr. S., in Sanford, Florida. GX 17, 
at 1-27; RD, at 44 (citing Stipulation 37). Dr. Gordon testified that 
these prescriptions raised multiple red flags, including the type of 
medication, the fact that the hydromorphone was prescribed at its 
highest strength, the distance traveled to the prescriber, and paying 
for prescriptions with cash. Tr. 155-56; RD, at 44. The ALJ 
additionally noted that Respondents' Owner and PIC ``filled 
prescriptions for K.B.3 for the maximum available dosage of 
hydromorphone on June 25, 2014, and July 22, 2014.'' RD, at 44 (citing 
GX 17, at 29-35). Respondents' Owner and PIC testified that she did not 
see any red flags related to the distance traveled or any other red 
flags related to K.B.3's prescriptions and that she ``interacted with 
him regularly.'' Tr. 660.
    The patient's profile notes that on September 24, 2014, Respondent 
Pharmacy received a letter of medical necessity from Dr. S. GX 17, at 
28. The Government's Exhibits include three different letters dated 
September 24, 2014, January 30, 2013, and September 2, 2013, explaining 
that K.B.3 had been under various doctors' care for back pain,\53\ but 
they ``don't address why the patient's paying cash, they don't address 
why the patient's going such a long distance to obtain these sought 
after opioids, desirable opioids.'' Tr. 157; GX 17, at 29-34. Dr. 
Gordon testified that nothing in the file resolves the red flags. Tr. 
156-157. She concluded that the prescriptions dispensed to K.B.3 were 
not dispensed within the usual course of professional practice and the 
pharmacist did not fulfill his or her corresponding responsibility. Id. 
at 157.
---------------------------------------------------------------------------

    \53\ It is noted that one of the records contains a physical 
exam that notes that the patient's back is normal and does not 
identify any pain. GX 17, at 33.
---------------------------------------------------------------------------

g. K.B.2
    From October 21, 2013, to March 26, 2015, Respondent Pharmacy 
filled prescriptions for patient K.B.2, whose address on the 
prescriptions and fill stickers was listed as Melbourne, Florida, which 
was 67 miles from the prescriber in Orlando, Florida. GX 18, at 1-98; 
RD, at 45 (citing Stipulation 38). Dr. Gordon testified that these 
prescriptions raised multiple red flags, including the type of 
medication, the fact that the diazepam and hydromorphone were 
prescribed at its highest strength, the distance traveled to the 
prescriber, paying for prescriptions with cash. Tr. 158-64; RD, at 45. 
Dr. Gordon also testified that Respondent Pharmacy filled drug 
cocktails for K.B.2 consisting of diazepam, hydromorphone and morphine 
sulfate.\54\ Tr. 159-61. The ALJ concluded that Respondent Pharmacy 
filled this drug cocktail for K.B.2 13 times between January 13, 2014, 
and March 26, 2014. RD, at 45 (citing GX 18, at 11-98). He further 
noted that ``[a]lthough K.B.2 would normally receive his prescriptions 
for these three controlled substances on the same day, he would 
frequently present the prescriptions to the Pharmacy within a two or 
three day time frame.'' RD, at 45 (citing e.g., GX 18, at 11-16, 17-22, 
27-32, 33-38, 39-44, 45-50, 77-82, 93-98). Respondents' Owner and PIC 
also filled prescriptions for morphine sulfate and diazepam on June 10, 
2014. RD, at 45 (citing GX 18, at 41-44).
---------------------------------------------------------------------------

    \54\ The ALJ noted, and I agree, that although the Government 
did not allege the drug cocktails in the OSC for K.B.2, they were 
noticed in the prehearing statement. RD, at 45 n.23; Govt 
Prehearing, at 16.
---------------------------------------------------------------------------

    The patient's profile notes that on April 15, 2013,\55\ Respondent 
Pharmacy received a letter of medical necessity from Dr. P. GX 18, at 
99. The letter describes K.B.2's chronic pain and spine injuries and 
provides an MRI performed on July 30, 2012. Id. at 101. Dr. Gordon 
testified that nothing in the file, including the letter and MRI, 
resolves the red flags. Tr. 164-166. She stated, ``It's the distance. 
Why is somebody taking a long-acting opioid, immediate-release acting 
opioid, and Valium driving so far?'' \56\ Id. at 165.\57\
---------------------------------------------------------------------------

    \55\ The letter predates by several months any of the 
prescriptions in the Government's records; however, Respondent 
submitted evidence that it had been filling similar prescriptions 
for K.B.2 since November 2011. GX 18, at 100; GX 18, at 1; RX H, at 
324.
    \56\ The ALJ found, and I agree, that there was no evidence 
demonstrating that the patients themselves were driving their cars, 
but whether or not the patient was driving the car, the distances 
had to be traveled by some mode of transportation in order to obtain 
the prescriptions. Tr. 165. Further, I credit Dr. Gordon's testimony 
that traveling a long distance with lower back pain is a red flag. 
Tr. 98.
    \57\ Dr. Gordon's testimony did not include a specific 
conclusion regarding corresponding responsibility for K.B.2; 
however, I find that the record is clear that the red flags are the 
same as the other patients' prescriptions and therefore I draw the 
conclusion that these were not dispensed within the usual course of 
professional practice and the pharmacist did not fulfill his or her 
corresponding responsibility.
---------------------------------------------------------------------------

h. A.G.
    From December 20, 2013, to March 20, 2015, Respondent Pharmacy 
filled prescriptions for patient A.G., whose address on the fill 
stickers \58\ was listed as Indian Harbor, Florida, which was 65 miles 
from the prescriber in Orlando, Florida. GX 19, at 1-68; RD, at 46 
(citing Stipulation 39). Dr. Gordon testified that these prescriptions 
raised multiple red flags, including the fact that two immediate-
release opioids were prescribed and dispensed at the same time, the 
distance traveled to the prescriber, and paying for prescriptions with 
cash. Tr. 167-168; RD, at 46. Respondents' Owner and PIC filled 
prescriptions for A.G. for oxycodone and hydromorphone on February 21, 
2014. RD, at 46 (citing GX 19, at 9-12). The ALJ concluded that 
Respondent Pharmacy filled the two immediate-release opioids 17 times 
between December 20, 2013, and March 20, 2015. RD, at 46 (citing GX 19, 
at 1-68). The OSC alleged that A.G. presented both prescriptions every 
28 days based on his 28-day prescription for hydromorphone, even though 
his prescription for 5 oxycodone tablets a day was for a 30-day 
supply.\59\ OSC, at 8; RD, at 46 (citing GX 19, at 13-60). Therefore, 
the ALJ concluded, and I agree, that between March 21, 2014, and 
January 23, 2015, A.G. filled the oxycodone prescription early 11 times 
with 2 days of 5 tablets each amounting to 10 tablets extra each fill, 
and as a result, had received an extra 110 tablets of oxycodone over 
what had been prescribed. RD, at 46 (citing GX 19, at 19-20, 23-24, 27-
28, 31-32, 34-36, 39-40, 43-44, 47-50, 55-58). Dr. Gordon testified 
that two days early she would

[[Page 73766]]

let go, but she would not be willing to fill for a patient two days 
early repetitively. Tr. 233. Dr. Grant testified that ``after a long 
period of time . . . . There would be a considerable amount. But I 
don't know until I have the conversation.'' Tr. 510. He further 
testified that repeatedly filling a prescription two days early would 
require a conversation first with the patient and then with the 
prescriber. Tr. 510. Therefore, I agree with the ALJ that the record 
supports that the repeated filling of these prescriptions constituted 
an early refill and in accordance with the testimony of Respondents' 
Owner and PIC, an early refill is a red flag. Tr. 727. There is no 
evidence that this red flag was resolved.\60\
---------------------------------------------------------------------------

    \58\ There is no address on the prescriptions. GX 19.
    \59\ The oxycodone prescription was for 150 tablets of oxycodone 
30 milligrams to be taken 5 times a day. GX 19, at 14. Therefore, 
filling the prescription in full every 28 days resulted in A.G. 
receiving two days extra of tablets of oxycodone.
    \60\ Although I agree with the ALJ that these early fills were a 
red flag, I find that the other red flags for A.G. were egregious 
enough to demonstrate that filling his prescriptions violated the 
pharmacist's corresponding responsibility.
---------------------------------------------------------------------------

    The patient's profile notes a March 22, 2014, letter of medical 
necessity from Dr. K,\61\ four months after Respondent Pharmacy began 
filling A.G.'s prescriptions. GX 19, at 69. The letter stated that it 
was necessary for A.G. to use this medication, but did not identify the 
type of medication. GX 19, at 70; RX H, at 334. Dr. Gordon testified 
that nothing in the file resolves the red flags and the treatment plan 
``does not address why there's two--why the need for two immediate-
release opioids, because that doesn't make any pharmacological sense.'' 
Tr. 168-69; 171. Further, Dr. Gordon stated that the MRI that was 
included for A.G. raised additional questions, because it was from 2011 
and was ``dated.'' Tr. 305. She concluded that the prescriptions 
dispensed to A.G. were not dispensed within the usual course of 
professional practice and the pharmacist did not fulfill his or her 
corresponding responsibility. Id. at 169.
---------------------------------------------------------------------------

    \61\ Dr. Gordon remarked that Dr. K's residency was an OB-GYN 
and that a pharmacist should look up a practitioner's credentials 
where there is a red flag. Tr. 168, 177. She further explained in 
relation to other patients of this doctor that she thought that the 
education of the doctor as an OB-GYN was a red flag, because she 
``didn't specialize in pain management.'' Id. at 177. Although I 
accept Dr. Gordon's rationale as to why the doctor's education is a 
red flag, her practice at the time of the prescriptions was clearly 
in pain management, and therefore, I am not relying on this possible 
red flag in my final determination. See GX 19, at 70.
---------------------------------------------------------------------------

i. K.B.1 and C.K.
    Respondent Pharmacy filled prescriptions for patients K.B.1 and 
C.K., whose prescriptions lack addresses. GX 20. The address on fill 
stickers for K.B.1 was listed as Malabar, Florida, which is 73 miles 
from the prescriber in Orlando, and the address for C.K. is listed as 
Cocoa Beach, Florida, which is 51 miles from the same prescriber. GX 
20, at 1-64; RD, at 47 (citing Stipulations 40 and 42). Dr. Gordon 
testified that these prescriptions raised multiple red flags, including 
the type of medication being a commonly sought-after opioid (oxycodone) 
of the highest dosage,\62\ the distance traveled to the prescriber, and 
paying for prescriptions with cash. Tr. 172-175; RD, at 47. 
Furthermore, Dr. Gordon pointed out that these two patients obtained 
their prescriptions from the same provider on the same date, so it 
``seems this was a group, a small group of two going to the same doctor 
on the same date and filling similar prescriptions.'' Tr. 173. Further, 
on March 31, 2015, K.B.1 and C.K. filled a prescriptions for oxycodone 
prescribed on the same day from Dr. K. with sequential fill numbers. GX 
20, at 29-30, 64-65; Tr. 173-174. The ALJ further found that Respondent 
Pharmacy filled prescriptions for ``these two individuals on the same 
day 14 times between April 1, 2014, and March 31, 2015.'' RD, at 48; 
(citing GX 20, at 3-30, 37-64).\63\ Respondents' Owner and PIC filled 
two prescriptions for oxycodone for these two patients one minute apart 
on May 28, 2014, and November 11, 2014. RD, at 48 (citing GX 20, at 7-
8, 41-42, 19-20, 53-54).
---------------------------------------------------------------------------

    \62\ The ALJ noted and I agree that initially the prescription 
for K.B.1 was for 15 mg of oxycodone, but it was increased to 30 mg 
on September 16, 2014. RD, at 47 n.25 (citing GX 20, at 3-4, 15-16).
    \63\ Although Respondents argued that the Government had not 
presented evidence that the two patients were visiting Respondent 
Pharmacy as a group, Respondents' Owner and PIC testified that ``I 
don't know why they would come in at the same time. But in 
recollection, they do, I think they do know each other, but I don't 
know the relationship.'' Tr. At 671; Resp Posthearing, at 34. 
Respondents' Owner and PIC testified that she could resolve the red 
flag of coming in together ``by handling them individually.'' Tr. 
672. However, Dr. Gordon testified that the red flag was presented 
by the fact that they were a group--handling them individually would 
ignore the red flag entirely.
---------------------------------------------------------------------------

    The patient's profile for C.K. notes an April 15, 2013, letter of 
medical necessity from Dr. K. GX 20, at 67. The letter seemed to be in 
response to a letter from Respondent Pharmacy requesting medical 
necessity, because it was attached to the letter, and it referred to an 
attached MRI, which was not in the file. GX 20, at 68-69. The patient's 
profile for K.B.1 notes receipt of a letter of medical necessity on 
April 1, 2014, which gives his diagnosis and does not identify the 
medication. Id. at 65. Dr. Gordon testified that nothing in the file 
resolves the red flags. Tr. 174-76. She concluded that the 
prescriptions dispensed to C.K. and K.B.1 were not dispensed within the 
usual course of professional practice and the pharmacist did not 
fulfill his or her corresponding responsibility in dispensing these 
prescriptions. Id. at 175-76.
j. J.M. and M.M.
    Respondent Pharmacy filled prescriptions for patients J.M. and 
M.M., whose prescriptions lack addresses, but the address on fill 
stickers for both patients was listed as Satellite Beach, Florida, 
which is about 65 miles from Dr. K., the prescriber, in Orlando. GX 21, 
at 1-42; RD, at 49 (citing Stipulations 46-47). Dr. Gordon testified 
that these prescriptions raised multiple red flags, including the 
medication, the distance traveled to the prescriber, drug cocktails of 
Xanax and oxycodone and carisoprodol and oxycodone and that the 
doctor's education was not in pain management, but OB-GYN.\64\ Tr. 177-
80; RD, at 49. The OSC also alleged and the evidence clearly supports 
that ``M.M. always sought to pay cash for the prescriptions and J.M. 
occasionally sought to pay cash.'' OSC, at 8. Dr. Gordon also 
identified a red flag in that the records show a group of patients 
``going to the same doctor on the same day and then going to the 
pharmacy and getting their medications dispensed on the same day.'' Tr. 
178. The ALJ further found that Respondent Pharmacy filled 
prescriptions for ``these two individuals on the same day 15 times 
between January 7, 2014, and March 31, 2015.'' RD, at 49 (citing GX 21, 
at 3-30, 37-64). It is noted also that these individuals were coming in 
sequentially during the same timeframe as the C.K. and K.B.1 and all 
four were patients of Dr. K. The ALJ further found that ``many times 
the prescriptions [sic] numbers on the fill stickers were sequentially 
only one number apart, and other times they were separated only by a 
few numbers, and the prescriptions were frequently picked up within 
minutes of each other.'' Id. (citing GX 21, at 1-12, 15-30, 33-36, 39-
42, 57-60, 63-66, 69-76, 79-82, 85-88, 95-102, 105-116, 119-22, 129-32, 
135-38; RX H, at 419). Respondents' Owner and PIC filled sequential 
prescriptions for oxycodone for these two patients on January 7, 2014, 
May 27, 2014, July 22, 2014, December 9, 2014, January 6, 2015, March 
3, 2015, and March 31, 2015. RD, at 48 (citing GX 21, at 1-4, 23-26, 
33-36, 63-66, 69-72, 79-82, 85-88, 109-12, 135-38.). These 
prescriptions were dropped off within minutes of each other and the 
fill numbers were in sequence in all but one instance. Id. 
Additionally, the majority of the prescriptions that Respondent

[[Page 73767]]

Pharmacy filled for these two patients were for drug cocktails of 
oxycodone and Soma, and oxycodone and Xanax. RD, at 48-49. Respondents' 
Owner and PIC filled drug cocktail prescriptions for these two patients 
on January 7, 2014, May 27, 2014, July 22, 2014, December 9, 2014, 
January 6, 2015, March 3, 2015, and March 31, 2015. Id. (citing GX 21, 
at 3-4, 89-90, 25-26, 103-04, 33-34, 111-12, 35-36, 109-10, 63-64, 127-
28, 65-66, 125-26, 69-70, 133-34, 79-80, 137-38, 81-82, 135-36, 87-88, 
139-40).
---------------------------------------------------------------------------

    \64\ As explained above, I am not considering the doctor's 
training as a red flag.
---------------------------------------------------------------------------

    The patient's profile for J.M. notes a March 29, 2013 letter of 
medical necessity from Dr. K. GX 21, at 143. The letter states that Dr. 
K. ``feels it medically necessary to prescribe Roxicodone 15 mg'' and 
attaches an MRI stating Lumber IVD degeneration. Id. at 144-45. The 
patient's profile for M.M. notes receipt of a letter of medical 
necessity on March 14, 2013, which gives his diagnosis and attaches an 
MRI of his ankle showing mild-to-moderate arthritis and mild synovitis/
arthritis in his elbow. Id. at 147-49. Dr. Gordon testified that 
nothing in the file resolves the red flags. Tr. 181-82. She testified 
that the file contained a drug test for M.M., ``which is ``[g]etting 
better,'' but the ALJ noted, and I agree, that it is unclear what the 
drug test indicates as a ``pass.'' Id. Dr. Gordon concluded that the 
prescriptions dispensed to J.M and M.M. were not dispensed within the 
usual course of professional practice and the pharmacist did not 
fulfill his or her corresponding responsibility. Id. at 183-84.
k. H.B.
    From November 27, 2013, to March 31, 2015, Respondent Pharmacy 
filled prescriptions for patient H.B. whose address on some of the fill 
stickers \65\ was listed as Melbourne, Florida, which was approximately 
54 miles from multiple prescribers in Orlando, Florida.\66\ GX 22, at 
1-122; RD, at 51 (citing Stipulation 48). Dr. Gordon testified that 
these prescriptions raised multiple red flags. Tr. 185-190. She 
testified that H.B. was receiving ``uppers and downers'' including 
Adderall, which is an amphetamine and central nervous system 
(hereinafter, CNS) depressant, and a red flag was ``the necessity for 
Ambien and Xanax at the same time. Both suppress the CNS system.'' Id. 
at 185. She stated that the combination of an amphetamine with a 
depressant is contraindicated, ``because one suppresses the central 
nervous system and one stimulates the central nervous system. They're 
working against each other.'' Id. at 189. Further, Dr. Gordon noted 
that a doctor in Orlando was prescribing H.B. oxycodone and the 
distance traveled was a red flag. Id. at 186. H.B. was also obtaining 
prescriptions for both 15 mg. and 30 mg. of oxycodone at the same time, 
which Dr. Gordon testified is ``called therapeutic duplication.'' Id. 
at 186-87. Dr. Gordon testified that H.B. was also receiving the 
highest dose of Ambien, ``[s]o on top of the Xanax and on top of the 
oxys, it's just a dangerous combination. Cocktail.'' Id. at 187. The 
ALJ found that Respondents' Owner and PIC filled prescriptions 
constituting therapeutic duplication on July 1, 2014, and one \67\ of 
the two prescriptions constituting therapeutic duplication on September 
23, 2014. RD, at 51 (citing GX 22, at 15-26, 49-52, 71-72). She also 
filled one of the two prescriptions constituting therapeutic 
duplication on May 8, 2014--the other was dispensed on May 7, 2014. GX 
22, at 41 and 40.
---------------------------------------------------------------------------

    \65\ As the ALJ remarked, ``[i]t is unclear where H.B. actually 
lived, because [GX] 22 reports several different addresses;'' 
however, the OSC did not contain any allegations regarding H.B.'s 
address. RD, at 51; see GX 22.
    \66\ Respondents noted that, ``[O]n February 3, 2015, the 
patient transferred to another provider'' who prescribed the same 
medication and whose office was within Respondent Pharmacy's county. 
Resp Posthearing, at 37 (citing GX 22, at 109). It is noted that the 
prescriptions written on February 3, 2015, March 3, 2015, March 31, 
2015, appear to be written from a different physician in Merritt 
Island, FL, which does not pose the same distance concern from the 
pharmacy or residence. (GX 22, at 109, 111, 113). Respondents note 
that the new doctor prescribed H.B. Oxycodone 30 mg., ``the same 
medication prescribed by Dr. [S.] on previous occasions;'' however, 
Dr. S. notably did not prescribe the duplicative prescriptions of 
oxycodone that H.B. had received previously. RX H, at 435; Resp 
Posthearing, at 37. Furthermore, although I find that the 
prescriptions on March 3, 2015, and March 31, 2015, do not present 
the red flag of distance traveled or therapeutic duplication, the 
red flag of drug cocktail remained unresolved, and the February 3, 
2015 prescriptions were for a drug cocktail and one was refilled 
early.
    \67\ The ALJ noted and I agree that it appears that B.S. filled 
the other duplicative prescription. RD, at 51 n.32.
---------------------------------------------------------------------------

    I agree with the ALJ's findings that Respondent Pharmacy filled 
multiple drug cocktails for H.B. between February 12 and February 20, 
2014, for oxycodone, Xanax, and Ambien, on March 12, 2014, for two 
prescriptions of oxycodone and one of Adderall, and on February 3, 
2015, for oxycodone and Soma. RD, at 52 (citing Tr. 187-90; GX 22, at 
15-18, 21-26, 28-32, 109-112).
    The OSC alleged that H.B. also received early refills. OSC, at 9. 
The ALJ found, and I agree, that H.B. received early refills: On 
February 12, 2014, for Adderall, after having received a 30-day supply 
on January 31, 2014; on February 20, 2014, for alprazolam, after having 
received a 30-day supply on February 12, 2014; and on February 3, 2015, 
after having received a 30-day supply on January 13, 2015. RD, at 51-52 
(citing GX 22, at 13-14, 19-20, 21-22, 25-26, 107-10). Respondents' 
Owner and PIC admitted that a fill with a similar timeframe was an 
early fill and that an early fill was a red flag. See supra Section 
II(G)(2)(k) (citing Tr. 727).
    The records for H.B. include two letters of medical necessity for 
H.B. GX 22, at 124-25. The letter from Mid Florida Health stated that 
it was necessary for H.B. to have her medications, but did not identify 
the type of medication, nor was it clear which prescriptions in H.B.'s 
file originated from this practice. GX 22, at 124. The other letter is 
an unsigned form letter from Dr. S. describing office diversion 
protections with H.B.'s name and her diagnosis as a ``lumber tear'' and 
``lumbago,'' but does not, as the ALJ pointed out, explain why it was 
necessary to have the medications or what they were. Dr. Gordon 
testified that nothing in the file resolved the red flags. Tr. 190. Dr. 
Gordon also stated that she ``didn't see any documentation that showed 
that the pharmacy contacted one doctor and told them what was going on 
with the other doctor,'' which would be done under the normal standard 
of practice. Id. at 189.\68\
---------------------------------------------------------------------------

    \68\ Dr. Gordon's testimony did not include a specific 
conclusion regarding corresponding responsibility for H.B.; however, 
I find that the record is clear that the red flags are the same as 
the other patients' prescriptions and therefore I draw the 
conclusion that these were not dispensed within the usual course of 
professional practice and the pharmacist did not fulfill his or her 
corresponding responsibility.
---------------------------------------------------------------------------

    Based on all of the record evidence, I find that the prescriptions 
for J.C., M.B., C.A., D.B., J.D., K.B.3, K.B.2, A.G., K.B.1, C.K, J.M., 
M.M., H.B. raised red flags, because customers arrived in groups, 
purchased prescriptions with cash, traveled long distances, refilled 
their prescriptions early, and because the prescriptions were for 
highly sought after controlled substances at highest strengths. I 
further find that the letters of medical necessity in Respondents' 
files did not resolve the multiple red flags on these prescriptions and 
that, even if these red flags were resolvable, Respondent Pharmacy 
produced no contemporaneous documentary evidence to support its claim 
that it resolved them before it filled the prescriptions.

H. Relationship Between Respondent Pharmacy and Respondent LLC

    The OSC was addressed to both Respondent Pharmacy and Respondent 
LLC, but the allegations in the OSC

[[Page 73768]]

relate only to the actions of Respondent Pharmacy, and not Respondent 
LLC.\69\ OSC, at 1; RD, at 100; Resp Posthearing, at 77. However, the 
ALJ found, and I agree, that Respondents are ``essentially one and the 
same.'' RD, at 100. In particular, Respondent Pharmacy and Respondent 
LLC share the same Owner and PIC.\70\ RD, at 52 (citing Tr. 337-43; 
345-46; 348-52, 356; GX 27,\71\ 28). The DI testified that, although 
Respondents have separate doors, they share a lobby entrance, entering 
either door allows access to either business, and they are ``separated 
by a partition wall which comes approximately three-quarters of the way 
up through the business but stops just shy of the lobby.'' Tr. 347; RD, 
at 52. Further he testified that ``the offices in the back seem to be 
collocated,'' and that ``during the execution of the admin warrant, the 
computer that [DEA was] using to access [Respondent Pharmacy's] data 
was located on the [Respondent LLC] side of the wall in an office.'' 
Tr. 347.
---------------------------------------------------------------------------

    \69\ Respondents also argue that the claims against Respondent 
LLC should be ``dismissed as a matter of law for lack of notice.'' 
Resp Posthearing, at 77. The OSC clearly is addressed to both 
Respondents and the hearing proceeded with the consent of the 
Respondents to consolidate the two cases; therefore, I find this 
argument meritless.
    \70\ Records from the Florida Health Department show 
Respondents' Owner and PIC as the Supervising Pharmacist for both 
Respondents. GX 27, at 8-9; GX 28, at 8-9; Tr. 350-51. Additionally, 
she is listed as the point of contact on both DEA registrations. GX 
27, at 1; GX 28, at 1; Tr. 338-39.
    \71\ Respondents' counsel objected to Page 2 of GX 27, because 
he noted that it cannot be considered a business record due to its 
inclusion of notes related to the investigation. Tr. 363. This part 
of the exhibit was produced only to demonstrate that Respondents' 
Owner and PIC was listed as the point of contact for both DEA 
registrations. Respondents' Owner and PIC testified that she was 
``the sole owner of both;'' and the record does not reflect that 
there is any dispute of fact about the Respondents' Owner and PIC's 
ownership of both entities, to which she, herself, attested. Tr. 
529.
---------------------------------------------------------------------------

    The DI testified that he had confirmed through Florida Department 
of Revenue that M.P. was the only employee of Respondent LLC during the 
last two quarters of 2016. Tr. 354-55; RD, at 53. M.P. testified that 
he is the Manager of Respondent LLC and his boss is Respondents' Owner 
and PIC. Tr. 409-410. M.P. also handles human resources, discipline, 
interviewing, and payroll for Respondent Pharmacy, but he considers 
himself to be employed by Respondent LLC, because he is paid out of its 
funds.\72\ Id. at 395, 404, 410; RD, at 53. Additionally, M.P. has been 
engaged in ``managing marketing, and developing [Respondent Pharmacy] 
for over nine years'' and he is the senior individual in both 
Respondents other than the Respondents' Owner and PIC. GX 30, at 8; Tr. 
395, 416.
---------------------------------------------------------------------------

    \72\ M.P. testified that he had ``never been employed by 
Respondent Pharmacy,'' but to the extent that his statements were 
intended to demonstrate that he lacked authority over Respondent 
Pharmacy or support the notion that the two entities were distinct, 
I do not find his testimony to be credible. Tr. 395. He admitted 
that he was basing his definition of employment only on the origin 
of his paycheck. Id. He also admitted that he identified himself as 
the manager of Respondent Pharmacy on the Notice of Inspection. Id. 
at 320; GX 32. I do not find that the information related to which 
of Respondents employed M.P. to be relevant to the underlying issues 
in this case, because I do not find that the Government unlawfully 
searched Respondent Pharmacy. See infra III(B)(1).
---------------------------------------------------------------------------

    The DI testified that he inquired with Respondents' supplier and 
Respondent LLC had never purchased any controlled substances under its 
DEA registration; therefore, the ALJ concluded, and I agree, that 
Respondent LLC ``does not handle controlled substances.'' RD, at 53; 
Tr. 356.

III. Discussion

A. Allegation That Respondents' Registrations Are Inconsistent With the 
Public Interest

    Under Section 304 of the Controlled Substances Act (hereinafter, 
CSA), ``[a] registration . . . to . . . dispense a controlled substance 
. . . may be suspended or revoked by the Attorney General upon a 
finding that the registrant . . . has committed such acts as would 
render his registration under section 823 of this title inconsistent 
with the public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). In the case of a ``practitioner,'' defined in 21 U.S.C. 
802(21) to include a ``pharmacy,'' Congress directed the Attorney 
General to consider the following factors in making the public interest 
determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the . . . 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).
    According to Agency decisions, I ``may rely on any one or a 
combination of factors and may give each factor the weight [I] deem[ ] 
appropriate in determining whether'' to revoke a registration. Id.; see 
also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 
F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't 
Admin., 841 F.3d 707, 711 (6th Cir. 2016); MacKay v. Drug Enf't Admin., 
664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U. S. Drug Enf't Admin., 
567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d 
477, 482 (6th Cir. 2005). Moreover, while I am required to consider 
each of the factors, I ``need not make explicit findings as to each 
one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see 
also Hoxie, 419 F.3d at 482. ``In short, . . . 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; what 
matters is the seriousness of the registrant's misconduct.'' Jayam 
Krishna-Iyer, M.D., 74 FR 459, 462 (2009). Accordingly, as the Tenth 
Circuit has recognized, findings under a single factor can support the 
revocation of a registration. MacKay, 664 F.3d at 821.
    Under DEA's regulation, ``[a]t any hearing for the revocation . . . 
of a registration, the . . . [Government] shall have the burden of 
proving that the requirements for such revocation . . . pursuant to . . 
. 21 U.S.C. [Sec. ] 824(a) . . . are satisfied.'' 21 CFR 1301.44(e). In 
this matter, while I have considered all of the factors, the 
Government's evidence in support of its prima facie case is confined to 
Factors Two and Four.\73\ I find that the Government's

[[Page 73769]]

evidence with respect to Two and Four satisfies its prima facie burden 
of showing that Respondents' continued registrations would be 
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). I 
further find that Respondents failed to produce sufficient evidence to 
rebut the Government's prima facie case.
---------------------------------------------------------------------------

    \73\ Respondents note that the Florida Board of Pharmacy has not 
made a recommendation in this matter, nor have the Respondents been 
convicted of any state or federal crimes related to controlled 
substances. Resp Posthearing, at 50. As Respondents have noted, the 
record in this case contains no evidence of a recommendation 
regarding Respondent Pharmacy's privilege to operate as a pharmacy 
by the relevant state licensing board or professional disciplinary 
authority or any action by the state licensing board that 
demonstrates that it has considered the same facts in relation to 
Respondent Pharmacy's continued licensure. See John O. Dimowo, 85 FR 
15,800, 15,809 (2020). Prior Agency decisions have found that where 
the record contains no evidence of a recommendation by a state 
licensing board, that absence does not weigh for or against 
revocation. See, e.g., Ajay S. Ahuja, M.D., 84 FR 5479, 5490 (2019) 
(finding that ``where the record contains no evidence of a 
recommendation by a state licensing board that absence does not 
weigh for or against revocation.''); Holiday CVS LLC dba CVS 
Pharmacy Nos 219 and 5195, 77 FR 62,316, 62,340 (2012); Roni 
Dreszer, M.D., 76 FR 19,434, 19,444 (2011). Accordingly, I agree 
with the ALJ's finding that Factor One does not weigh for or against 
revocation in this matter. RD, at 61. I also agree with the ALJ 
that, because there is no evidence related to any convictions 
``relating to the manufacture, distribution, or dispensing of 
controlled substances,'' Factor Three does not weigh for or against 
revocation in this case. RD, at 61 (citing 21 U.S.C. 823(f)(3)).
---------------------------------------------------------------------------

1. Factors Two and Four--The Respondents' Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances
    Under the CSA, it is ``unlawful for any person knowingly or 
intentionally . . . to . . . distribute[ ] or dispense, or possess with 
intent to . . . distribute[ ] or dispense, a controlled substance'' 
``except as authorized'' by the Act. 21 U.S.C. 841(a)(1). A pharmacy's 
registration authorizes it to ``dispense,'' or ``deliver controlled 
substance to an ultimate user . . . by, or pursuant to the lawful order 
of . . . a practitioner.'' 21 U.S.C. 802(10).
(a) Allegations Regarding Respondent Pharmacy's Failure To Exercise its 
Corresponding Responsibility
    According to the CSA's implementing regulations, an effective 
controlled substance 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).
    The evidence in this case demonstrates that Respondent Pharmacy 
filled prescriptions from a group of Dr. R's patients repeatedly ``at 
approximately the same time, one after the other.'' RD, at 71; supra 
Section (II)(G)(1)(a). Dr. Gordon testified that these red flags are 
not resolvable and she would not have filled the prescriptions. Id.; 
Tr. 111. The record demonstrates numerous red flags associated with the 
prescriptions issued to patients of Dr. R. For example, S.P. and E.H. 
made a 340 and 350 mile-round trip respectively to see Dr. R. and 
received the highest dosage of opioids and paid cash. RD, at 72; supra 
Section (II)(G)(1)(a), (e). In addition, J.S.1 and J.S.2 lived at the 
same address, received their prescriptions often on the same day for 
highly diverted and abused controlled substances, and travelled long 
distances. RD, at 75. In accordance with the testimony of Dr. Gordon, 
these prescriptions should not have been filled and Respondent Pharmacy 
violated its corresponding responsibility in filling them. Further, the 
ALJ found, and I agree, that nothing in Respondent Pharmacy's files 
resolved any of the red flags for the prescriptions for the patients of 
Dr. R., where they may have been resolvable, and Respondent Pharmacy 
violated its corresponding responsibility by filling the prescriptions 
in the Government's evidence for Dr. R.'s patients. RD, at 71-80; supra 
Section (II)(G)(1).
    Further, the evidence shows that Respondent Pharmacy filled 
prescriptions written by other physicians that contained multiple red 
flags indicating that the prescriptions were not issued for a 
legitimate medical purpose. J.C. presented five prescriptions for the 
same short-acting opioid and the doctor's instructions allowed J.C. to 
be taking all of them at once. Dr. Gordon testified that she would not 
have filled these prescriptions. Respondents' Owner and PIC offered two 
different justifications for filling them. There is nothing in 
Respondent Pharmacy's records that resolves the red flags and 
Respondents' post-hoc justification is inconsistent, which clearly 
demonstrates that her memory of events is not adequate to determine 
whether the red flags were resolved. Section (II)(G)(2)(a). The 
prescriptions that Respondent Pharmacy filled for M.B. raised 
unresolved red flags for highly abused opioids and cocktails, payment 
by cash, long distances to obtain and fill prescriptions, and high 
dosages. Finally, the ALJ found, and I agree, that Respondent Pharmacy 
filled prescriptions for C.A., D.B., J.D., K.B.3, K.B.2, and A.G. in 
violation of its corresponding responsibility and outside the course of 
professional practice of pharmacies, because the numerous red flags of 
highly diverted and abused controlled substances, distance travelled, 
cash payments, early refills, and cocktails were unresolved.
    To prove a pharmacist violated his 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 
28,667, 28,670-72 (2015) (applying the standard of willful blindness in 
assessing whether a pharmacist acted with the requisite scienter). 
Pursuant to their corresponding responsibility, pharmacists must 
exercise ``common sense and professional judgment'' when filling a 
prescription issued by a physician. Bertolino, 55 FR 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.'').
    In this matter, the Government did not allege that Respondent 
dispensed the subject prescriptions having actual

[[Page 73770]]

knowledge that the prescriptions lacked a legitimate medical purpose. 
Instead, the Government alleged that Respondent violated the 
corresponding responsibility regulation as evidenced by it ``repeatedly 
distribut[ing] controlled substances pursuant to prescriptions that 
contained one or more unresolved red flags for diversion.'' Govt 
Posthearing, at 41.
    As I already found, many prescriptions from Respondent Pharmacy 
presented multiple, red flags including long distances, cash payments, 
drug cocktails, high doses/quantities of high-alert controlled 
substances, patients with the same address presenting the same 
prescription within a short period of time, patients sequentially 
presenting prescriptions prescribed by the same doctor on the same day, 
therapeutic duplication (two drugs in the same class prescribed 
together), and early refills. 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 10,876, 10,898, pet. for rev. denied, 789 F. 
App'x 724 (11th Cir. 2019) (long distances; pattern prescribing; 
customers with the same street address presenting the same 
prescriptions on the same day; drug cocktails; cash payments; early 
refills); Hills Pharmacy, 81 FR 49,816, 49,836-39 (2016) (multiple 
customers presenting prescriptions written by the same prescriber for 
the same drugs in the same quantities; customers with the same last 
name and street address presenting similar prescriptions on the same 
day; long distances; drug cocktails); The Medicine Shoppe, 79 FR 
59,504, 59,507, 59,512-13 (2014) (unusually large quantity of a 
controlled substance; pattern prescribing; irregular dosing 
instructions; drug cocktails); Holiday CVS, 77 FR 62,316, 62,317-22 
(2012) (long distances; multiple customers presenting prescriptions 
written by the same prescriber for the same drugs in the same 
quantities; customers with the same last name and street address 
presenting virtually the same prescriptions within a short time span; 
payment by cash); East Main Street Pharmacy, 75 FR 66,149, 66,163-65 
(2010) (long distances; lack of individualized therapy or dosing; drug 
cocktails; early fills/refills; other pharmacies' refusals to fill the 
prescriptions). Dr. Gordon credibly testified as to the presence of red 
flags on the prescriptions that Respondent Pharmacy filled. 
Respondents' Owner and PIC also testified that she recognized red flags 
on the prescriptions.
    I agree with the ALJ that Respondent Pharmacy ``repeatedly filled 
numerous prescriptions for highly abused and diverted controlled 
substances in the face of blatant red flags. The Pharmacy did little to 
nothing to resolve these numerous red flags, but instead relied on 
`rubber stamped' types of letters of medical necessity that were often 
not tailored towards a particular patient, and were obviously missing 
information.'' RD, at 97. When asked by Respondents' counsel if she 
``believe[d] pharmacists can make decisions about the treatment of 
patients' medical conditions,'' Dr. Gordon testified, ``Pharmacists are 
part of the medical care team. We're there, we're the stop gate to make 
sure that that patient is safe and taking a medication that's 
appropriate for them.'' Tr. 217. The evidence in this case shows that 
Respondent Pharmacy failed at the responsibility described by Dr. 
Gordon.
    Dr. Gordon credibly testified that a Florida pharmacist should have 
recognized these red flags and that a Florida pharmacist exercising his 
or her corresponding responsibility would not dispense controlled 
substances without investigating, documenting the investigation, and 
resolving any red flags. Respondents' Owner and PIC also admitted 
during her testimony that she had actual knowledge of some of the red 
flags on the prescriptions, but that she felt like she had resolved 
them.
    I have considered and reject Respondent Pharmacy's claim that it 
investigated and resolved the red flags on the subject prescriptions 
before they were filled and therefore complied with its corresponding 
responsibility. Tr. 796. Respondents' Owner and PIC testified that she 
relied on written policies and procedures that she stated Respondent 
Pharmacy had in place, which by virtue of being followed would have 
resolved the red flags prior to dispensing; however, Respondent 
Pharmacy produced neither the procedures themselves \74\ nor any 
evidence that, if they had been in place, they had been followed. For 
example, she stated that payment of cash is not a red flag because 
Respondent Pharmacy's policy was to ask for insurance from every 
customer, and then concluded that if a customer paid cash, it was a 
result of a negative answer regarding insurance, thereby resolving the 
red flag. Tr. 719. She stated that she is not assuming it happened, 
because ``it is the policy.'' Id. However, despite the policies that 
she so strongly asserted were in place, according to her testimony, 
B.S. filled dozens of prescriptions in violation of those policies and 
had to be counseled. Id. at 560, 770. In addition, she admitted to 
making exceptions to the policies herself without documenting her 
rationale for the departures. Tr. 773. The prescriptions or patient 
profiles from Respondent Pharmacy do not contain pharmacist remarks 
regarding the resolution of red flags on the prescriptions, and Dr. 
Gordon testified that the letters from the prescribers, which were 
often issued after controlled substances had already been dispensed, 
did not adequately resolve the red flags. See United States v. Hayes, 
595 F.2d at 260 (``Verification by the issuing practitioner on request 
of the pharmacist is evidence that the pharmacist lacks knowledge that 
the prescription was issued outside the scope of professional practice. 
But it is not an insurance policy against a fact finder's concluding 
that the pharmacist had the requisite knowledge despite a purported but 
false verification. . . . What is required by [a pharmacist] is the 
responsibility not to fill an order that purports to be a prescription 
but is not a prescription within the meaning of the statute because he 
knows that the issuing practitioner issued it outside the scope of 
medical practice.''). Furthermore, Dr. Gordon credibly testified that 
some of the prescriptions, particularly to groups of Dr. R.'s patients, 
contained red flags that were not resolvable and the prescriptions 
should not have been filled. Id. at 110-11. Finally, I agree with the 
ALJ that Respondents' Owner and PIC's testimony was not always 
credible, particularly where she exaggerated her relationship with her 
customers in order

[[Page 73771]]

to suggest that she had resolved red flags. RD, at 13-14.
---------------------------------------------------------------------------

    \74\ Respondents contest that requiring them to document their 
resolutions of red flags is inappropriately ``requiring Respondents 
to prove their innocence.'' Resp Exceptions, at 17. The Government 
in this case demonstrated that the standard of practice in Florida 
required documentation of the resolution of red flags and Respondent 
Pharmacy did not document. The Government proved that Respondent 
Pharmacy repeatedly filled multiple prescriptions with red flags 
demonstrating that Respondent Pharmacy had violated its 
corresponding responsibility and that Respondent Pharmacy's 
registration is inconsistent with the public interest. The burden 
shifts to the Respondents to show why they can be entrusted with the 
responsibility carried by their registrations. Garrett Howard Smith, 
M.D., 83 FR 18,882, 18,910 (2018) (citing Samuel S. Jackson, 72 FR 
23,848, 23,853 (2007)).
---------------------------------------------------------------------------

    Respondents further contest that when Respondents' Owner and PIC 
was confronted with one employee, B.S., who ``exercised his own 
independent judgment and filled prescriptions from South Florida, she 
halted the practice and counseled the employee.'' Resp Posthearing, at 
52. Although Respondents' Owner and PIC stated that, although she had 
no personal knowledge that the prescriptions were legitimate, she 
thought that Dr. R. was legitimate, but she also stated that she had 
counseled B.S., ``because we don't want the scrutiny of it.'' Id. at 
560, 770, 557; RX H, at 62. She clearly understood that there was a 
high probability that the prescriptions were illegitimate due to the 
red flags that they presented and that they suggested the need for 
``scrutiny.'' Yet in filling the prescriptions, neither she nor B.S. 
provided any documentation regarding the ``scrutiny'' that the 
prescriptions presented. As stated above, she also testified that she, 
herself, filled Dr. R.'s prescriptions twice. Tr. 771; 560.
    Further, I reject the insinuation that Respondent Pharmacy should 
not be held responsible for the actions of its pharmacist B.S. When 
considering whether a pharmacy has violated its corresponding 
responsibility, the Agency considers whether the entity, not the 
pharmacist, can be charged with the requisite knowledge. See Pharmboy 
Ventures Unlimited, Inc., 77 FR 33,770, 33,772 n.2 (2012) (``DEA has 
long held that it can look behind a pharmacy's ownership structure `to 
determine who makes decisions concerning the controlled substance 
business of a pharmacy.'''); S&S Pharmacy, Inc., 46 FR 13,051, 13,052 
(1981) (the corporate pharmacy acts through the agency of its PIC). 
Knowledge obtained by the pharmacists and other employees acting within 
the scope of their employment may be imputed to the pharmacy itself.
    At times during her testimony, Respondents' Owner and PIC stated 
that she relied on the personal judgment of her pharmacists, while also 
stating that the pharmacy's policy is ``updated regularly, but it's 
generally just a day-to-day hands-on training. I'm there all the 
time.'' Tr. 709. Ultimately, as the Owner and PIC, she is responsible 
for the actions of Respondents, and her own statements support that 
notion. She chose to hire someone while knowing that he had a criminal 
history and Board of Pharmacy disciplinary history, she had the means 
to meaningfully supervise his work because she was present at 
Respondent Pharmacy ``all the time,'' and further, as the individual 
responsible for the entity, she had a duty \75\ to ensure that the 
pharmacists she employed, while acting in the scope of their 
employment, were following her policies and the law. Finally, the 
violations of corresponding responsibility and standard of practice in 
this case are not limited to the actions of B.S. The Government's 
evidence clearly demonstrates that Respondents' Owner and PIC herself 
filled prescriptions with multiple red flags herself for customers such 
as H.B., C.A., D.B., K.B.2, and J.S.2.
---------------------------------------------------------------------------

    \75\ I reject Respondents' claim that imposing a duty on its 
pharmacists to ensure that they were meeting their corresponding 
responsibility would violate Florida Rule 64B16-27.831(2)(a), which 
provides that `` `[w]hen validating a prescription, neither a person 
nor a licensee shall interfere with the exercise of the pharmacist's 
independent professional judgment.' '' Resp Posthearing, at 69 
(quoting Fl. Admin Code Ann. r. 64B16-27.831(2)(a)). There is no 
evidence that the State of Florida's provision would prevent an 
employer from ensuring that an employee was resolving and 
documenting red flags. The judgment in question is resolving ``any 
concerns about the validity of the prescription,'' not complying 
with pharmacy policies, to include documenting the pharmacist's 
rationale for deciding to fill a prescription whose legitimacy was 
in question. Id. In fact, the regulation itself requires that the 
pharmacist resolve the concerns. Id. I decline to permit Respondent 
Pharmacy to hire an employee, whom it knew to have disciplinary 
issues and a criminal record, to fill dozens of prescriptions whose 
legitimacy was in question and then to relinquish all responsibility 
for that pharmacist's actions. The DEA registration is issued to the 
pharmacy, not the individual pharmacist, and the pharmacy has 
responsibility under federal law to ensure compliance with the law 
in order to maintain its registration.
---------------------------------------------------------------------------

    I have also considered and reject Respondents' argument that Dr. 
Gordon relied only on DEA decisions to identify red flags. Resp 
Exceptions, at 7. Dr. Gordon testified that ``[r]ed flags is just a 
term . . . that the lawyers and the Courts have come up with, but . . . 
there's always been red flags, since inception of pharmacy.'' Tr. 209-
10. She further stated that ``[t]he Courts called it red flags. 
Pharmacists just call it checking to make sure that that medication is 
safe or legitimate.'' Id. at 211. Dr. Gordon's testimony is further 
supported by Respondents' Owner and PIC's testimony, that she was aware 
that when a pharmacist spots a red flag for a prescription, that she 
must ``resolve it, and if [she] cannot resolve it, not to fill it.'' 
Tr. 566; RD, at 24. Respondents' Owner and PIC also testified that she 
understands the concept of red flags and that she recognized that there 
are red flags in Respondent Pharmacy's prescriptions. Tr. 796. There is 
no evidence that the Agency has set a standard independent of pharmacy 
practice as Respondents have contended. Resp Exceptions, at 9. Dr. 
Gordon testified repeatedly that documentation was ``the standard of 
practice, if there's something questionable about a prescription, you 
document it after you speak with the patient or the doctor,'' and 
further, she gave a credible rationale as to why it was the standard of 
practice, ``so that you can let other pharmacists know what happened 
the time before.'' Tr. 215, 44-45. If there were red flags on a 
prescription, which were necessary to be resolved in order to confirm 
the prescription's legitimacy, it is unclear how another pharmacist 
filling a subsequent prescription would know that they had been 
resolved without documentation. Dr. Gordon's testimony is supported by 
the facts in this case, because Respondents' Owner and PIC blamed B.S. 
for filling prescriptions not in accordance with policy, but then 
filled prescriptions for the same patients with the same red flags. 
Without documentation of the resolution of the red flags, there was no 
way for her to know whether B.S. had resolved them, or in fact, whether 
she had resolved them. Her memory of her own conversations with 
customers that supposedly resolved the red flags did not always prove 
to be reliable. See e.g., Tr. 596, 671, 673, 716, 720.
    Respondents argue in their Exceptions that DEA is acting outside of 
its statutory authority in determining that the course of professional 
practice in Florida requires a pharmacist to resolve and document red 
flags. Resp Exceptions, at 8-10. Part of Respondents' argument is that 
the Florida statutes cited by the Government do not require the 
documentation of red flags. Id. at 10. Respondents admit that under 
Florida law, ``if a pharmacist identifies one of the enumerated `red 
flags' in the regulations, `the pharmacist shall take appropriate steps 
to avoid or resolve the potential problems which shall, if necessary, 
include consultation with the prescriber.' '' Resp Exceptions, at 11 
(quoting Fla. Admin. Code Ann. r. 64B16-27.810.) However, Respondents 
argue that the regulations do not require the documentation of the 
resolution of such red flags. Id.
    The Florida Board of Pharmacy requires a pharmacist to conduct 
prospective drug use review on each prescription and identify such 
issues as ``[o]ver-utilization,'' ``[d]rug-drug interactions,'' 
``[i]ncorrect drug dosage,'' and ``[c]linical abuse/misuse,'' and shall 
take appropriate steps to avoid or resolve the potential problems which 
shall, if necessary, include consultation with the prescriber. Fla. 
Admin. Code Ann. r. 64B16-27.810 (2020). A preceding section of the 
regulations

[[Page 73772]]

states that ``a patient record system shall provide for the immediate 
retrieval of information necessary for the dispensing pharmacist to 
identify previously dispensed drugs at the time a new or refill 
prescription is presented for dispensing.'' Fla. Admin. Code r. 64B16-
27.800(1). The regulation further states that among the information 
required to be maintained in the patient records is the ``pharmacist 
comments relevant to the individuals' drug therapy, including any other 
information peculiar to the specific patient or drug.'' Id. at (1)(f). 
Respondents argue that ``there is no definition available as to what 
constitutes `peculiar' information'' and that it ``should be read to 
mean peculiar information relevant to treatment.'' Resp Exceptions, at 
11. The Government argued, and the ALJ found, that Florida law requires 
not only the resolution of red flags, but also a ``pharmacist is 
required to maintain a patient record, allowing for immediate retrieval 
of information relative to previously dispensed drugs and those records 
are to include comments peculiar to the patient, and information 
provided by a licensed health care provider.'' RD, at 65.
    Agency decisions have examined whether the resolution of red flags 
is required by these provisions of Florida law. See Trinity Pharmacy 
II, 83 FR 7304, 7329-30 (2018); Superior Pharmacy I and II, 81 FR 
31,310, 31,336 (2016) (stating that the regulation required 
documentation of the prospective drug review in the patient profiles). 
The Respondents do not argue that the drug review provision is 
inapplicable, merely that the documentation requirement is more 
appropriately read to require documentation of information ``relevant 
to treatment.'' Resp Exceptions, at 11. The drug review in Florida law 
appears to be an affirmative obligation on the part of the pharmacist, 
and therefore, it would be consistent with such an affirmative 
obligation to read the preceding section of the regulation to require 
documentation of the prospective drug review. As stated above, the 
documentation requirements in this section ``shall provide for the 
immediate retrieval of information necessary for the dispensing 
pharmacist to identify previously dispensed drugs at the time a new or 
refill prescription is presented for dispensing.'' Fla. Admin. Code r. 
64B16-27.800(1). In its Posthearing Brief, the Government cited to 
these regulatory provisions, not as an individual violation of Florida 
law,\76\ but as further evidence that Respondent Pharmacy filled 
prescriptions for controlled substances outside the usual course of 
practice in Florida. Gov Posthearing, at 44-45. I ultimately do not 
find it necessary to find a violation of this regulation in this case, 
because the Government has proven by substantial evidence that 
Respondent Pharmacy violated its corresponding responsibility and 
filled prescriptions outside the standard of practice in Florida by not 
documenting the resolution of the red flags through credible expert 
testimony. I do consider this regulation to further support the 
testimony of Dr. Gordon regarding the importance of documentation in 
the standard of practice of pharmacy in Florida.
---------------------------------------------------------------------------

    \76\ The Order to Show Cause alleged that in filling 
prescriptions with multiple red flags and not documenting their 
resolution, Respondent Pharmacy violated Fla. Admin. Code Ann. r. 
64B16-27.800 and 64B16-27.810. OSC, at 10.
---------------------------------------------------------------------------

    Dr. Gordon testified repeatedly that the standard of practice of 
pharmacy in Florida required documentation of the resolution of red 
flags. When Respondents' counsel summarized her testimony and asked if 
she was stating that documentation was ``a requirement for pharmacists 
in the State of Florida to document red flags,'' she stated, ``Yes. To 
show that--for each red flag, if there was a specific situation where 
you felt that the medication was for a legitimate medical purpose, that 
should be documented.'' Tr. 206. Dr. Gordon is not a lawyer and is not 
an expert in the details of state law, but she is required as a 
pharmacist to understand what conduct is outside of the usual course of 
professional practice in her state, whether that is derived from state 
law, mandatory training, standards of care or otherwise. Respondents 
imply that Dr. Gordon's inability to draw a solid conclusion as to 
where the requirement to document the resolution of red flags is 
written somehow demonstrates that there is no such requirement in the 
standard of practice. Resp Exceptions, at 10. I reject such fallacious 
reasoning. In this case, I find that Florida state law can be 
reasonably interpreted to support Dr. Gordon's testimony, but that her 
testimony is independently credible that documentation of the 
resolution of red flags is a requirement of the practice of pharmacy in 
the State of Florida.
    Accordingly, in summary, I agree with the ALJ's finding in the RD 
that the Government has proven by substantial evidence that Respondent 
filled prescriptions for controlled substances that the pharmacists 
knew were not prescribed for legitimate medical purposes, or were 
willfully blind to such, in violation of their corresponding 
responsibility under 21 CFR 1306.04(a) and outside the usual course of 
professional practice in violation of 21 CFR 1306.06. I find these 
violations of federal law and negative dispensing experience to weigh 
against the Respondents' continued registrations under Factors Two and 
Four.
    I further find that the Government has demonstrated that 
pharmacists at Respondent Pharmacy violated Fla. Stat. Sec.  
893.04(2)(a) (2009). During the time period covered by the Show Cause 
Order, Florida law required that a pharmacist, before dispensing a 
controlled substance listed in schedules II through IV, first determine 
``in the exercise of her or his professional judgment . . . that the 
order is valid.'' Fla. Stat. Sec.  893.04(2)(a) (2009); see also Fla. 
Stat. Sec.  893.02(22) (2011) (defining a ``prescription'' as an order 
for drugs ``issued in good faith and in the course of professional 
practice . . . and meeting the requirements of s. 893.04.''). In this 
case, I have found that the Government established by substantial 
evidence that pharmacists at Respondent Pharmacy filled prescriptions 
outside the usual course of professional practice of pharmacy. I find 
that the pharmacists did not exercise their professional judgment in 
acting outside of the usual course of practice and that this is 
evidence of Respondent Pharmacy's noncompliance with state law, which I 
consider under Factor Four and weigh against Respondents' continued 
registrations.
(b) Allegation That Respondent Pharmacy Filled Prescriptions Written 
for ``Office Use'' in Violation of 21 CFR 1306.04(b)
    DEA regulations state that ``[a] prescription may not be issued in 
order for an individual practitioner to obtain controlled substances 
for supplying the individual practitioner for the purpose of general 
dispensing to patients.'' 21 CFR 1306.04(b). As I found above, 
Respondent Pharmacy dispensed testosterone to Dr. I's office on eight 
occasions and Dr. A's office once, between September 23, 2014, and 
January 28, 2015. GX 3; RD, at 29; supra Section II(F). As I also found 
above, the Government's expert witness testified that the fact that the 
prescriptions were labeled ``for office use,'' assigned a prescription 
number, issued fill stickers, and included the office name in the place 
of a patient's name demonstrated that the prescriptions were issued 
outside of the usual course of professional practice. Tr. 64-65.

[[Page 73773]]

    The Government's expert testified that ``if there were an invoice 
and the prescription was issued to a practitioner,'' it would have 
resolved the issue, but clarified that it was not within the acceptable 
standard of practice to order controlled substances from a pharmacy to 
be distributed to a dispensing practitioner and then report it to the 
Florida Prescription Drug Monitoring Program (E-FORCSE). Id. at 278-79; 
288-89. Respondents' Owner and PIC maintained that these were 
``wholesale transactions'' and not prescriptions. Tr. 697. She 
maintained that Dr. I. was registered as a dispensing practitioner. Tr. 
578. Respondents also argued that Dr. I. was administering the 
controlled substances to patients in the office.\77\ Resp Posthearing, 
at 10. The Government argued that these claims were based solely on 
conjecture and that the clear evidence was that prescriptions with fill 
stickers were dispensed ``for office use.'' Govt Exceptions, at 1-2; 
id. at 2 n.1.
---------------------------------------------------------------------------

    \77\ It is noted that these two theories seem to contradict each 
other.
---------------------------------------------------------------------------

    The ALJ did not sustain the 21 CFR 1306.04(b) violation, because he 
found that in order to prove such a violation, ``it was incumbent upon 
the Government to prove that Drs. [I and A] were going to be dispensing 
the controlled substances to patients.'' RD, at 69. He noted that the 
prescriptions stated that they were ``for office use'' and that was 
consistent with Respondents' Owner and PIC's testimony that the 
practitioners were administering the testosterone and not dispensing it 
and that therefore, the prescriptions fell into an exception to the 
regulatory requirement. Id. at 69-70. The Government argued in its 
Exceptions that the ALJ had applied an exception to the regulation that 
does not exist and that the ALJ's reasoning related to his finding 
under 1306.04(b) incorrectly implied that it was ``incumbent upon the 
Government to prove that [the practitioners] were going to be 
dispensing the controlled substances to patients.'' RD, at 69; Govt 
Exceptions, at 3-4. The Government further argued that the ALJ's 
analysis of the ``office use'' prescriptions under Section 1306.04(b) 
was inconsistent with the Agency's decision in Roberto Zayas, M.D., 82 
FR 21,410, 21,424 (2017). Govt Exceptions, at 2.
    Dr. Gordon clearly testified that if the purpose was to transfer 
the controlled substances, there was a lawful way in which to conduct 
such transactions, but issuing and dispensing pursuant to a 
prescription, using fill stickers and reporting to E-FORCSE was not 
within the usual course of professional practice of pharmacy in 
Florida. If Respondent Pharmacy had intended these documents to be 
invoices, they facially did not appear to be so, and Respondent did not 
produce any additional documentation that justified the filling of 
these prescriptions issued for ``office use.'' \78\ I agree with the 
Government that the prescriptions themselves appeared to violate 21 CFR 
1306.04(b). See Roberto Zayas, M.D., 82 FR 21,410, 21,425 (2017) 
(holding that prescriptions written ``for office use'' violated 21 CFR 
1306.04(b) and holding the prescriber responsible for calling in the 
prescriptions).
---------------------------------------------------------------------------

    \78\ Respondents claim that in November 2014, Respondent 
Pharmacy started using invoices in lieu of prescription pads. Resp 
Posthearing, at 64 (citing GX 3, at 5-13). The documents in question 
appear different from the other pages of the exhibit, with the 
exception of GX 3, at 11, but they state ``Prescription Form'' at 
the top. The Respondents have not adequately explained the 
difference between the different forms and there are fill stickers 
associated with all of them. However, ultimately, I have not 
sustained this allegation, so I find it unnecessary to determine the 
accuracy of Respondents' unexplained claim that some of the exhibits 
may have been invoices.
---------------------------------------------------------------------------

    In this case, the Government initially stated that Dr. Gordon would 
testify that these prescriptions raised red flags that were not 
resolved. Govt Prehearing, at 8. The Government's expert did not 
discuss red flags related to these prescriptions, but did conclude that 
they were issued outside the usual course of professional practice. Tr. 
65-66. In its Posthearing Brief, the Government argued that the 
prescriptions were issued in violation of 1306.04(b) ``and accordingly 
were not dispensed in the usual course of professional practice.'' Govt 
Posthearing, at 9. However, the Government did not allege a violation 
of 21 CFR 1306.06 \79\ for these prescriptions, nor did it sufficiently 
establish through its expert witness that these prescriptions were 
dispensed in violation of Respondent Pharmacy's corresponding 
responsibility in violation of 21 CFR 1306.04(a), and even if the 
Government had established this, it appeared to abandon this theory in 
its Posthearing Brief. Therefore, I will not consider the allegation 
related to the prescriptions issued for ``office use,'' because the 
Government has not adequately established a legal basis for my finding 
of a violation for Respondent Pharmacy's filling ``office use'' 
prescriptions in this case. Pharmacy Doctors Enterprises d/b/a Zion 
Clinic Pharmacy, 83 FR 10,876, 10,900 (2018) (noting that 21 CFR 
1306.04(b) only prohibits the issuance of a prescription).
---------------------------------------------------------------------------

    \79\ Although the Government had alleged generally that 
Respondent Pharmacy acted outside the usual course of professional 
practice in the Order to Show Cause, the Government did not 
adequately notice a violation of 1306.06 in the context of the 
1304.04(b) violation. I have reviewed the Respondents' filings on 
this matter and I do not find evidence that they were on notice of 
this theory regarding the 1306.06 violation in order to have 
litigated the issue by consent. See Farmacia Yani, 80 FR 29,053, 
29,059 (2015).
---------------------------------------------------------------------------

    (c) Allegation That Respondent Pharmacy Filled Prescriptions That 
Were Issued by a Practitioner to Himself in Violation of Fla. Stat. 
Sec.  458.331(1)(r)
    The Order to Show Cause alleged that Respondent Pharmacy filled 
prescriptions for controlled substances ``despite unresolved red flags 
includ[ing] . . . . prescriptions [ ] written in violation of Florida 
law, Fla. Stat. 458.331(1)(r).'' The ALJ found that ``the Pharmacy 
violated its corresponding responsibility by filling prescriptions that 
J.S.3 wrote to himself . . . .'' RD, at 68. Respondents argued that the 
ALJ incorrectly interpreted Florida state law relating to Respondent 
Pharmacy's filling of J.S.3's prescriptions to himself. Resp 
Exceptions, at 5.
    Respondents' primary argument is that ``[a] plain reading of the 
statute holds that a physician can prescribe to himself, so long as he 
is not the one dispensing the medication.'' Resp Exceptions, at 5. In 
making this argument, Respondents state that ``the statute prohibits a 
physician from prescribing to himself, unless another practitioner 
`prescribed, dispensed, or administered' the controlled substances,'' 
\80\ \81\ Id. (citing Fla. Stat. Sec.  458.331(1)(r) (emphasis added by 
Respondents). Although the basis of the Respondents' argument that the 
term ``or'' would permit a physician to prescribe to himself as long as 
a different practitioner dispensed the controlled substance is well-
grounded in canons of statutory construction, Respondent submitted, and 
I can find, no evidence that the State of Florida permits such a 
loophole in its prohibition against self-prescribing.\82\ If

[[Page 73774]]

Respondents were correct in this interpretation, it would appear that a 
practitioner could only violate this law if he prescribed to himself 
and also dispensed the prescription to himself. Further, the testimony 
of Respondents' witnesses contradicts this reading of Florida law. D.M. 
and Respondents' Owner and PIC testified that the Board of Pharmacy 
visited in 2015 and told Respondents' Owner and PIC ``that it was not 
lawful'' to fill a prescription that a doctor had written for himself, 
after which D.M. changed his advice and Respondent Pharmacy did not 
fill any further prescriptions. Tr. 573; Tr. 809-10; supra Section 
(II)(E)(1). Therefore, the record contradicts Respondents' argument 
that the Florida Board of Pharmacy interprets the statute in the manner 
that Respondents suggest. However, as explained below, I do not believe 
that whether the law was or was not actually violated by J.S.3's self-
prescribing is essential to a finding that Respondent Pharmacy violated 
its corresponding responsibility for these prescriptions.
---------------------------------------------------------------------------

    \80\ The prescriptions to J.S.3 involved testosterone and 
oxycodone, which are controlled substances under Fla. Stat. Sec.  
893.03.
    \81\ The ALJ found that the Respondents' evidence included 
multiple documents that indicated that J.S.3 had not been treated by 
another doctor, but had been self-prescribing. RD, at 68 (citing RX 
H, at 2-3, 15-22, 40-41). I agree with the ALJ on this point. 
Respondents clarify in their Exceptions that their argument is not 
that there was another practitioner involved in the prescribing or 
treatment, but that Respondent Pharmacy itself created the exception 
by dispensing the controlled substances. Resp Exceptions, at 5.
    \82\ For example, there is no indication or discussion of a 
distinction made on Respondents' alleged exception in this Florida 
disciplinary case on point, just that he violated Fla. Stat. Sec.  
458.331(1)(r). Department of Health vs. Nader W. Said, M.D., DOH 
Case No. 2014-08153 (December 19, 2016), at 19. Available at https://appsmqa.doh.state.fl.us/MQASearchServices/Document/Mjk1Nzc5ODY%3D. 
If the statute were as limited as Respondents argue, then it would 
seem that a charge would necessitate including self-dispensing as 
well or additional facts related to the dispensing of the 
prescriptions.
---------------------------------------------------------------------------

    The second argument that Respondents proffered is that Fla. Stat. 
Sec.  458.331(1)(r) is only grounds for discipline of physicians, not 
pharmacists. The Florida statute specifically provides that its 
provisions do not apply to ``[o]ther duly licensed health care 
practitioners acting within the scope of their practice.'' Fla. Stat. 
Sec.  458.303(1)(a); Resp Exceptions, at 4. Fla. Stat. Sec.  456.001(4) 
includes pharmacists in the definition of ``health care 
practitioners.'' However, as established herein, Florida law clearly 
requires that a pharmacist, before dispensing a controlled substance 
listed in schedules II through IV, first determine ``in the exercise of 
her or his professional judgment . . . that the order is valid.'' Fla. 
Stat. Sec.  893.04(2)(a) (2009). Additionally, as found above, Dr. 
Gordon credibly testified that ``[a] pharmacist should not have filled 
any prescription written by a physician that wrote it for himself, a 
controlled substance'' and concluded that these prescriptions were not 
filled within the standard of practice of pharmacy in Florida. Tr. 62. 
Therefore, based on Dr. Gordon's testimony, I find that a pharmacist 
filling these prescriptions could not have been acting within the scope 
of his or her practice in order to meet the exception set forth in Fla. 
Stat. Sec.  458.303(1)(a), and the exception would not apply.
    Most importantly, the Government's legal theory about these 
prescriptions was not that Respondent Pharmacy had directly violated 
this Florida statute in filling these prescriptions, but instead that 
J.S.3 wrote the prescriptions in violation of the law and the 
prescriptions raised red flags, which Respondent failed to resolve, 
resulting in a violation of its corresponding responsibility. OSC, at 
4; Govt Prehearing, at 8; Govt Posthearing, at 7-8. See supra II(E)(1).
    As to the testimony of D.M. that he had provided legal advice to 
Respondents' Owner and PIC in which he maintained that a physician 
could prescribe controlled substances to himself as long as a 
pharmacist dispensed the prescription, I do not find that this alleged 
advice resolved the red flags that were presented by these 
prescriptions for several reasons. First, Respondent did not produce 
documentation of the advice. Second, per D.M.'s testimony the advice 
was general and did not pertain to the particular circumstance of 
J.S.3's prescriptions. Supra II(E)(1). Most importantly, D.M. testified 
that at the time he used the word ``scrutiny'' in lieu of the term red 
flag, and that his advice was that ``it wasn't prohibited and it was 
permissible but required scrutiny.'' Id.; Tr. 810. Dr. Gordon testified 
that the usual course of professional practice in Florida required that 
the red flags be resolved prior to the pharmacists' dispensing of the 
prescriptions and that those resolutions be documented. There is no 
evidence of Respondent Pharmacy's documentation regarding this red 
flag. As D.M. testified, the fact that there was even a question about 
whether the prescriptions violated Florida law presented such 
``scrutiny'' or a red flag, and the record evidence demonstrates that 
Respondent Pharmacy was advised by its attorney that this scrutiny was 
``required.'' Therefore, I find that Respondent Pharmacy violated its 
corresponding responsibility \83\ in dispensing prescriptions to J.S.3 
without resolving the red flag due to Fla. Stat. Sec.  458.331(1)(r), 
and that the filling of these prescriptions is appropriately considered 
under Factor Four as evidence that Respondent Pharmacy was not in 
``compliance with applicable State, Federal or local laws relating to 
controlled substances.'' 21 U.S.C. 823(f)(4).
---------------------------------------------------------------------------

    \83\ Respondents' final argument is that the Government did not 
demonstrate that the prescriptions to J.S.3 ``lack[ed] a legitimate 
medical purpose.'' Resp Exceptions, at 6. The Respondents cite to 
the footnote in Hills Pharmacy, LLC, 81 FR 49,816, 49,836 n.33 to 
support this notion, which is further discussed infra Section 
III(A)(1)(d). I reject this argument the reasons discussed in 
relation to Hills below.
---------------------------------------------------------------------------

(d) The Legitimacy of the Prescriptions
    Respondents cited,\84\ and the ALJ applied, a clause written by one 
of my predecessors as part of a footnote in a prior Agency decision 
(hereinafter, the Hills footnote). Hills Pharmacy, LLC, 81 FR 49,816, 
49,836 n.33 (2016) (``[I]t is true that a pharmacist cannot violate his 
corresponding responsibility if a prescription was nonetheless issued 
for a legitimate medical purpose.''). The clause is footnoted in one 
other subsequent Agency decision. Pharmacy Doctors Enterprises d/b/a 
Zion Clinic Pharmacy, 83 FR 10,876, 10,899 n.36 (2018), pet. for review 
den., 789 F. App'x 724 (11th Cir. 2019).
---------------------------------------------------------------------------

    \84\ Respondents argued that the Government must prove that the 
prescriptions Respondent Pharmacy filled lacked a legitimate medical 
purpose in order to show that Respondent Pharmacy violated its 
corresponding responsibility based on the language of the Hills 
footnote. Resp Exceptions, at 7.
---------------------------------------------------------------------------

    Although the sentence containing the clause is not entirely clear, 
the clause itself states as ``true'' that a pharmacist may not be found 
to violate his corresponding responsibility unless the prescription at 
issue violates 21 U.S.C. 829. The concept labeled ``true'' directly 
conflicts with DEA regulations and decades of Agency decisions 
interpreting those regulations.
    I unequivocally reject the clause and the notion that a pharmacist 
may not be found to violate his corresponding responsibility unless the 
prescription at issue violates 21 U.S.C. 829. I affirm the part of the 
footnote rejecting the respondent's argument, which stated, 
``Respondent argues that the Government cannot establish that a 
pharmacist has violated his corresponding responsibility unless it 
first establishes that the prescription lacked a legitimate medical 
purpose . . . . Respondent is mistaken.''
    A pharmacist's corresponding responsibility is to assess 
prescriptions according to the applicable standard of practice, which 
typically requires the pharmacist to recognize and resolve red flags on 
the prescriptions prior to filling them, and to act on that assessment 
by filling or declining to fill the prescription.
    The language in 21 CFR 1306.04 and relevant caselaw could not be 
more explicit. A pharmacist has his own responsibility to ensure 
that controlled substances are not dispensed for non-medical 
reasons. See,

[[Page 73775]]

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). A pharmacist must exercise 
professional judgment when filling a prescription issued by a 
physician.

Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730 
(1990). Respondents have presented no good reason for me to depart from 
DEA's decades-long statement of a pharmacist's corresponding 
responsibility, and I decline to do so.\85\
---------------------------------------------------------------------------

    \85\ In fact, I find compelling reasons to reject Respondents' 
proposed interpretation. For example, if I were to interpret a 
pharmacist's corresponding responsibility in the manner in which 
Respondents suggest, not only would it be a departure in the Agency 
position, but the administrative hearings would be mired in 
irrelevant complexity that is unnecessary given that a pharmacy must 
exercise its corresponding responsibility prior to the filling of a 
prescription in order to preserve the CSA's purpose of preventing 
addiction and abuse. See Cove Inc. D/B/A Allwell Pharmacy, 80 FR 
29,037, 29,049 (2015) (finding that ``[t]he obligations are referred 
to as `corresponding responsibilities,' as they impose duties on 
pharmacies and pharmacists that correspond with those of the 
treating sources.'')
---------------------------------------------------------------------------

B. Other issues

1. Unlawful Search Allegation
    Respondents alleged that many of the records in the Government's 
case were obtained as a result of an unlawful search. Resp Posthearing, 
at 77-78. As found above, the first inspection occurred on September 
18, 2013, during which M.P. signed a DEA Form 82, identifying himself 
as the ``manager'' and consenting to the search. GX 32. Respondents 
objected to this search claiming that ``21 CFR 880 mandates that the 
`owner, operator, or agent' in charge of such premises must receive 
notice of the inspection.'' \86\ Resp Posthearing, at 77. Respondents 
contest that DEA's service was improper because: M.P. was not an 
employee of Respondent Pharmacy; \87\ M.P. testified that he was never 
given authorization to sign the DEA Form 82; and Respondents' Owner and 
PIC confirmed that she did not authorize him to do so. Id. at 78 
(citing Tr. 395; 541); see also Tr. 402. The ALJ rejected Respondents' 
argument, because the ALJ did ``not find the testimonies of 
[Respondents' Owner and PIC] and [M.P.] to be credible that 
[Respondents' Owner and PIC] did not give [M.P.] authority to sign the 
Notice of Inspection on September 18, 2013.'' RD, at 60 n.36. The ALJ 
further noted that Respondents' Owner and PIC arrived at Respondent 
Pharmacy shortly after M.P.'s signature and told the agents that she 
would provide copies of the pharmacy's records to them later, after 
which M.P. brought the records to the DEA Orlando District Office on 
September 23, 2013. Id.; GX 33 (DEA Form 12, Receipt for Cash or Other 
Items, signed by M.P.). I agree with the ALJ's determination that ``it 
strains credulity \88\ to suggest that [Respondents' Owner and PIC] did 
not willingly consent to delivering the documents to the DEA five days 
later.'' RD, at 60 n.36
---------------------------------------------------------------------------

    \86\ I have assumed that Respondents intended to cite to 21 
U.S.C. 881.
    \87\ Although, M.P. stated, ``I do work for [Respondent] 
Pharmacy,'' Respondents' Counsel clarified with him that the work he 
does for Respondent LLC overlaps. Tr. 404.
    \88\ I agree with the ALJ that Respondents' argument strains 
credulity, because Respondents' Owner and PIC provided copies 
voluntarily five days later. I also find that the argument strains 
credulity, because M.P. signed the DEA Form 82 writing in the word 
``Manager'' in the blank in the statement ``I hereby certify that I 
am the for the premises described in this Notice of Inspection,'' 
and further stating that ``I have the authority to act in this 
matter and have signed this Notice of Inspection pursuant to my 
authority.'' GX 32 (DEA Form 82). M.P. admitted that he spoke with 
Respondents' Owner and PIC after DEA arrived and that he did not 
refuse entry or request that DEA ``strike his signature.'' Tr. 408. 
M.P. also signed two DEA Forms 12 on September 23, 2013, and October 
14, 2016, in which he listed his title as ``Manager.'' GX 33, 34. 
The record evidence shows that M.P. held himself out on numerous 
occasions to have the authority to act on behalf of both Respondents 
as its agent within the meaning of 21 U.S.C. 880(c).
---------------------------------------------------------------------------

    The second inspection was conducted as a result of an 
Administrative Inspection Warrant pursuant to 21 U.S.C. 880(d) in April 
of 2015, which the DI testified was obtained after Respondents' 
attorney D.M. failed to timely comply with a subpoena. Supra 
(II)(B)(2). Respondents did not appear to make any arguments related to 
the lawfulness of the second inspection.\89\ See generally Resp 
Posthearing. I agree with the ALJ and reject Respondents' allegations 
regarding the legitimacy of the consent in the first DEA inspection. 
Respondents' Owner and PIC had five days to withdraw consent to the 
first inspection or refuse to provide copies of the documents, but 
nevertheless, she voluntarily chose to provide the documents using the 
same agent who had signed the initial consent form to deliver them.
---------------------------------------------------------------------------

    \89\ Respondents seem to conflate the facts surrounding the two 
inspections, alleging that the DI ``presented the DEA Form 82 
directly to [Respondent Pharmacy] rather than go through the 
pharmacy's counsel'' and that the DI admitted to not knowing whether 
M.P. was authorized to sign the form. Resp Posthearing, at 78. 
However, the DI testified that he was not even present at the 
administrative inspection that occurred on September 18, 2013, so 
whether he knew about the status of M.P.'s authorization back in 
2013, when he served the administrative warrant in April 2015 is 
irrelevant. Tr. 317-18.
---------------------------------------------------------------------------

2. Respondents' Integrated Enterprise
    Respondents argue that DEA has not alleged a single violation 
against Respondent LLC, and therefore it is inappropriate to revoke 
Respondent LLC's registration ``simply because both companies share 
common ownership.'' Resp Posthearing, at 77. The ALJ found, and I 
agree, that ``Respondents' arguments ignore the obvious, that the 
Pharmacy and Suntree Medical are essentially one and the same.'' RD, at 
100. Agency decisions ``treat[ ] two separately organized business 
entities as one integrated enterprise . . . based on the overlap of 
ownership, management, and operations of the two entities.'' Jones 
Total Health Care Pharmacy, L.L.C., and SND Health Care, L.L.C., 81 FR 
79,188, 79,222 (2016) (citing MB Wholesale, Inc., 72 FR 71,956, 71,958 
(2007) (citing MB Wholesale, Inc., 72 FR 71,956, 71,958 (2007)). 
``[W]here misconduct has previously been proved with respect to the 
owners, officers, or key employees of a pharmacy, the Agency can deny 
an application or revoke a registration of a second or subsequent 
pharmacy where the Government shows that such individuals have 
influence over the management or control of the second pharmacy.'' 
Superior Pharmacy I and Superior Pharmacy II, 81 FR 31,310, 31,341, 
n.71 (2016). Further, the Agency may revoke a registration, even if 
there is no misconduct that can be attributed to the registration, if 
the Agency finds that the registrant committed egregious misconduct 
under a second registration. Roberto Zayas, M.D., 82 FR 21,410, 21,430 
(2017) (revoking physician's DEA registration in Florida due to conduct 
attributed to a Texas registration that had expired).
    Respondents argue that the terms of the CSA in requiring separate 
registrations for each entity or person and each principal place of 
business should be read to ``suggest two (2) separate entities are not 
to be considered as one (1).'' Resp Exceptions, at 18 (citing 21 U.S.C. 
802(49)(a), 802(38), and 822(e)). When a practitioner registrant acts 
in a manner inconsistent with the public interest, in determining 
whether to revoke, DEA looks to whether the practitioner can be 
entrusted with a registration. See e.g., Arvinder Singh, M.D., 81 FR 
8247, 8248 (2016). If a practitioner holding multiple registrations 
cannot be entrusted with one, it would be difficult to justify 
entrusting the same practitioner with another in a separate location. 
Similarly, if a corporate entity is owned and operated by the same 
individuals, who have acted inconsistently with the public interest, I 
cannot ignore the fact that these same individuals have used one of 
their registrations not in

[[Page 73776]]

accordance with the law. Respondents quoted the DI stating that 
Respondent LLC ```has never purchased any controlled substances under 
that DEA registration''' and that the two entities ``were two (2) 
separate businesses, one (1) supplying medication including controlled 
substances, the other involved in the sale of medical equipment;'' 
however, the lack of Respondent LLC's past use of the registration does 
not prevent it from using its registration in the future. Resp 
Exceptions, at 19-20.
    The lens through which Congress has instructed me to assess each 
registration is whether or not such registration is inconsistent with 
the public interest. 21 U.S.C. 823(f). In this case, if Respondents 
were allowed to simply shift their operations to an entity with the 
same owner and essentially the same employees, the effect of the 
violations found herein against Respondent Pharmacy would be a nullity, 
and there would be nothing to prevent Respondent LLC from continuing to 
act in a manner inconsistent with the public interest. Contrary to 
Respondents' contention, it would be inconsistent with the intent of 
the CSA to permit such an easily implementable loophole, and it is 
consistent with Agency decisions to close the loophole by treating the 
two overlapping entities as one integrated enterprise for purposes of 
sanction.
    Therefore, I agree with the ALJ that ``[b]ecause of the obvious 
commonality of ownership, management and operations, it is abundantly 
clear'' that if I revoke Respondent Pharmacy's registration, Respondent 
LLC ``could pick up where the Pharmacy left off without missing a beat. 
Accordingly, due to that commonality, it is appropriate to treat the 
[Respondent] Pharmacy and [Respondent LLC] as one integrated 
enterprise.'' RD, at 101.
    Finally, Respondents argue that they were given no notice as to the 
charges against Respondent LLC and therefore a finding against 
Respondent LLC would violate Constitutional due process. I reject this 
argument, because the grounds for revocation of Respondent LLC's 
registration are the precise grounds that form the basis of the 
revocation of Respondent Pharmacy's registration, and Respondent 
Pharmacy has been afforded due process of law through this proceeding. 
Furthermore, the OSC was clearly issued to both Respondent LLC and 
Respondent Pharmacy. See OSC, at 1. Each was initially docketed 
separately, but prior to the hearing, the ALJ ordered that the two 
cases would be consolidated, to which the Respondents consented. ALJX 
14 (Prehearing Ruling). Respondents simply cannot argue that they did 
not know that the adjudication of the alleged violations committed by 
Respondent Pharmacy were also being adjudicated against Respondent LLC.

C. Summary of the Public Interest Factors

    As found above, Respondent Pharmacy filled hundreds of controlled 
substance prescriptions in violation of its corresponding 
responsibility and Florida law and outside the usual course of 
professional practice. Thus, I conclude that Respondent Pharmacy has 
engaged in misconduct which supports the revocation of its 
registration, and as explained above, it would be inconsistent with the 
public interest to permit Respondent LLC to maintain its registration 
given that Respondents are an integrated enterprise. I therefore find 
that the Government has established a prima facie case that 
Respondents' continued registrations ``would be inconsistent with the 
public interest.'' 21 U.S.C. 823(f).

IV. Sanction

    Where, as here, the Government has met its prima facie burden of 
showing that the Respondents' continued registration is inconsistent 
with the public interest due to their violations pertaining to 
controlled substance dispensing, the burden shifts to the Respondents 
to show why they can be entrusted with the responsibility carried by 
their registrations. Garret Howard Smith, M.D., 83 FR 18,882, 18,910 
(2018) (citing Samuel S. Jackson, 72 FR 23,848, 23,853 (2007)). 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). This authority specifically relates ``to 
`registration' and `control,' and `for the efficient execution of his 
functions' under the statute.'' Gonzales v. Oregon, 546 U.S. at 259. A 
clear purpose of this authority is to ``bar[ ] doctors from using their 
prescription-writing powers as a means to engage in illicit drug 
dealing and trafficking.'' Id. at 270. 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)). 
```Moreover, because ``past performance is the best predictor of future 
performance,'' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 
1995), [the Agency] has repeatedly held that where a registrant has 
committed acts inconsistent with the public interest, the registrant 
must accept responsibility for [the registrant's] actions and 
demonstrate that [registrant] will not engage in future misconduct.''' 
Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting Medicine Shoppe, 73 
FR 364, 387 (2008)); see also Jackson, 72 FR at 23,853; John H. 
Kennnedy, M.D., 71 FR 35,705, 35,709 (2006); Prince George Daniels, 
D.D.S., 60 FR 62,884, 62,887 (1995). 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, I agree with the analyses and 
conclusions contained in the Recommended Decision. RD, at 101-04. I 
agree with the ALJ that there is nothing in the record that suggests 
Respondent Pharmacy has accepted responsibility for its actions. In 
fact, as the ALJ found, ``the evidence is clear in this case that the 
Pharmacy has taken no responsibility for its egregious and repeated 
failure to fulfill its corresponding responsibility to ensure the 
proper prescribing and dispensing of controlled substances. The 
evidence is clear because the Pharmacy has specifically denied 
responsibility.'' RD, at 101. In fact, Respondents' attorney made very 
clear that Respondents were not accepting any responsibility. He 
stated, ``I'm well aware that I can't go into remediation unless we 
were to accept responsibility, Your Honor. And we won't unless we do.'' 
Tr. 567; RD, at 99. Further, even after the Florida Board of Pharmacy 
had told Respondents' Owner and PIC that a practitioner could not 
prescribe to himself, Respondents maintained that the law permitted 
them to fill those prescriptions. See Resp Exceptions; Tr. 573, 809-10. 
Respondent Pharmacy did cease filling the prescriptions as a result of 
the Board of Pharmacy's instructions; however, the fact that Respondent 
Pharmacy

[[Page 73777]]

relied on an interpretation involving a legal loophole to fill the 
prescriptions in the first place, and then continued to argue that the 
behavior was lawful in spite of the state's assertions to the contrary, 
not only demonstrates no remorse, but also demonstrates a willingness 
to push the boundaries of the law to maximize business. Such a 
willingness does not inspire optimism about Respondents' future 
compliance with the CSA.
    I agree with the ALJ that the egregiousness of Respondent 
Pharmacy's conduct and the interests of specific and general deterrence 
support a sanction of revocation. RD, at 99. ``Specifically, 
pharmacists employed by the Pharmacy, as well as [Respondents' Owner 
and PIC], dispensed numerous prescriptions of controlled substances in 
violation of their corresponding responsibility.'' Id.
    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, 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.
    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. Further, the ALJ found, and I agree, 
that if I revoke Respondent Pharmacy's registration, Respondent LLC 
``could pick up where the Pharmacy left off without missing a beat. 
Accordingly, due to that commonality, it is appropriate to treat the 
Pharmacy and Suntree Medical as one integrated enterprise.'' RD, at 
101. Due to the commonality of ownership and procedures, I cannot 
entrust Respondent LLC with a registration any more than I can entrust 
Respondent Pharmacy with one.
    Therefore, I shall order the sanctions the Government requested, as 
contained in the Order below.

V. 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 Certificates of Registration Nos. 
BS7384174 and FS2194289 issued to Suntree Pharmacy and Suntree Medical 
Equipment LLC. Further, pursuant to 28 CFR 0.100(b) and the authority 
vested in me by 21 U.S.C. 823(f), I hereby deny any pending application 
of Suntree Pharmacy and Suntree Medical Equipment to renew or modify 
these registrations, as well as any other pending application of 
Suntree Pharmacy and Suntree Medical Equipment for registration in 
Florida. This order is effective December 21, 2020.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-25531 Filed 11-18-20; 8:45 am]
BILLING CODE 4410-09-P