Coconut Grove Pharmacy; Decision and Order, 50372-50377 [2024-12972]
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The Commission vote for this
determination took place on June 7,
2024.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in part
210 of the Commission’s Rules of
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Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: June 7, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024–12885 Filed 6–12–24; 8:45 am]
BILLING CODE 7020–02–P
Having reviewed the entire record, the
Agency adopts and hereby incorporates
by reference the entirety of the ALJ’s
rulings, credibility findings,4 findings of
fact, conclusions of law, sanctions
analysis, and recommended sanction as
found in the RD and summarizes and
expands upon portions thereof herein.
I. Findings of Fact
Florida Standard of Care
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22–52]
Coconut Grove Pharmacy; Decision
and Order
On September 8, 2022, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause and Immediate Suspension of
Registration (OSC/ISO) to Coconut
Grove Pharmacy (Respondent) of
Florida. Administrative Law Judge
Exhibit (ALJX) 1 (OSC/ISO), at 1. The
OSC/ISO informed Respondent of the
immediate suspension of its DEA
Certificate of Registration (registration),
Control No. FC1162382, pursuant to 21
U.S.C. 824(d), alleging that
Respondent’s continued registration
constitutes ‘‘ ‘an imminent danger to the
public health or safety.’ ’’ Id. (quoting 21
U.S.C. 824(d)). The OSC/ISO also
proposed the revocation of
Respondent’s registration, alleging that
Respondent’s continued registration is
inconsistent with the public interest. Id.
(citing 21 U.S.C. 823(g)(1),1 824(a)(4)).2
A hearing was held before DEA
Administrative Law Judge Paul E.
Soeffing (the ALJ), who, on March 2,
2023, issued his Recommended Rulings,
Findings of Fact, Conclusions of Law,
and Decision (RD or Recommended
Decision). The RD recommended that
Respondent’s revocation be revoked.
RD, at 86. Following the issuance of the
RD, Respondent filed exceptions.3
1 Effective December 2, 2022, the Medical
Marijuana and Cannabidiol Research Expansion
Act, Public Law 117–215, 136 Stat. 2257 (2022)
(Marijuana Research Amendments or MRA),
amended the Controlled Substances Act (CSA) and
other statutes. Relevant to this matter, the MRA
redesignated 21 U.S.C. 823(f), cited in the OSC/ISO,
as 21 U.S.C. 823(g)(1). Accordingly, this Decision
cites to the current designation, 21 U.S.C. 823(g)(1),
and to the MRA-amended CSA throughout.
2 According to Agency records, Respondent’s
registration expired on August 31, 2023. The fact
that a registrant allows its registration to expire
during the pendency of an OSC/ISO does not
impact the Agency’s jurisdiction or prerogative
under CSA to adjudicate the OSC/ISO to finality.
Jeffrey D. Olsen, M.D., 84 FR 68474, 68,76–79
(2019).
3 The Agency has reviewed and considered the
Respondent’s exceptions and addresses them
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Thomas E. Hamilton, Pharm.D.,
testified as the Government’s expert
regarding pharmacy practice and
standards in the state of Florida. RD, at
12–13; Tr. 182–83. Dr. Hamilton
testified that he has over twenty years
of experience as a Florida pharmacist
and is currently employed as a
pharmacist in Northern Miami. RD, at
12; Tr. 176–78, 181.5 As for Respondent,
Mr. Robert M. Parrado, R.Ph., testified
as Respondent’s expert. RD, at 36; Tr.
497–98. Mr. Parrado testified that he has
been a licensed pharmacist in Florida
for over fifty years and has served on the
Florida Board of Pharmacy in various
roles, including as Chairman and as a
member of the rules committee. RD, at
37; Tr. 493–96.6 Regarding Mr. Parrado’s
testimony, the Agency agrees with the
ALJ that Mr. Parrado’s testimony was
not consistent nor logical (particularly
when compared to his prior testimony
in other matters) as Mr. Parrado at times
contradicted the language of Florida’s
regulations and used the term ‘‘red flag’’
inconsistently in a way that created
confusion; as such, his testimony
warrants only minimal weight. RD, at
48–49.7 Where Mr. Parrado’s testimony
diverges from that of Dr. Hamilton, the
Agency, like the ALJ, will credit Dr.
Hamilton. RD, at 49.8
Dr. Hamilton testified that the
standard of care for pharmacists in
Florida is informed by the regulations
herein, but ultimately agrees with the ALJ’s
recommendation.
4 The Agency adopts the ALJ’s summary of each
of the witnesses’ testimonies as well as the ALJ’s
assessment of each of the witnesses’ credibility. See
RD, at 8–49.
5 For Dr. Hamilton’s full qualifications, see RD, at
12–13, Government Exhibit (GX) 9.
6 For Mr. Parrado’s full qualifications, see RD, at
36–37, Respondent Exhibit (RX) 27.
7 The Agency incorporates herein the entire
summary of Mr. Parrado’s testimony as well as the
ALJ’s credibility assessment of Mr. Parrado as set
forth in the Recommended Decision, at 36–49.
8 The ALJ found, and the Agency agrees, that Dr.
Hamilton’s testimony was credible, internally
consistent, and generally logically persuasive. RD,
at 26. As noted by the ALJ, ‘‘[a]lthough at times [Dr.
Hamilton’s] explanation of the factual support and
basis for some of his opinions and conclusions was
brief, overall he presented an objective analysis.’’
Id. As such, the Agency finds Dr. Hamilton’s
testimony to be credible and reliable and affords it
significant weight. Id.
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promulgated by the Florida Board of
Pharmacy (the Board), including Florida
Administrative Code sections 64B16–
27.800, 64B16–27.810, and 64B16–
27.831. RD, at 13; Tr. 183–84. Florida
Administrative Code section 64B16–
27.800 states that pharmacies ‘‘shall’’
maintain a ‘‘patient record system,’’ that
‘‘provide[s] for the immediate retrieval
of information necessary for the
dispensing pharmacist to identify
previously dispensed drugs,’’ and ‘‘shall
record any known allergies, drug
reactions, idiosyncrasies, and chronic
conditions or disease states of the
patient and the identity of any other
drugs, including over-the-counter drugs,
or devices currently being used by the
patient which may relate to prospective
drug review.’’ Fla. Admin. Code section
64B16–27.800(1)–(2).9 It also states that
‘‘[t]he pharmacist shall record any
related information indicated by a
licensed health care practitioner.’’ Id.
Dr. Hamilton testified that this
regulation requires pharmacists to
document in the patient profile known
information that is specific to a patient,
especially information about a specific
drug or reasons that a patient is
prescribed a specific drug, to guide
future decision making and justify
dispensing. RD, at 13; Tr. 185, 194.
Florida Administrative Code section
64B16–27.810 requires that, prior to
dispensing, a pharmacist ‘‘review the
patient record and each new and refill
prescription . . . to promote therapeutic
appropriateness by identifying: (a) Overutilization or under-utilization; (b)
Therapeutic duplication; (c) Drugdisease contraindications; (d) Drug-drug
interactions; (e) Incorrect drug dosage or
duration of drug treatment; (f) Drugallergy interactions; [and] (g) Clinical
abuse/misuse.’’ Fla. Admin. Code
section 64B16–27.810. The regulation
further states that ‘‘[u]pon recognizing
any of the above, the pharmacist shall
take appropriate steps to avoid or
resolve the potential problems which
shall, if necessary, include consultation
with the prescriber.’’ Id. section 64B16–
27.810(2). Regarding this regulation, Dr.
Hamilton testified that in the practice of
pharmacy, the ‘‘things to look for’’ when
verifying or assessing a prescription are
termed ‘‘red flags’’ and the term ‘‘red
flag’’ means ‘‘caution’’ or ‘‘something to
bring your heightened awareness to.’’
RD, at 14; Tr. 185–86, 188.10 Dr.
9 This regulation requires that pharmacists
‘‘ensure that a reasonable effort is made to obtain’’
this information. Id. section 64B16–27.800(2).
10 Although the term ‘‘red flag’’ itself is not used
in the Florida regulation, Dr. Hamilton testified that
pharmacists know the term to mean ‘‘caution’’ and
the term is regularly used in the education and
practice of pharmacists in Florida. RD, at 14 n.21;
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Hamilton further testified that the
practice of pharmacy in Florida requires
that when a pharmacist recognizes any
of the ‘‘things to look for’’ or ‘‘red flags’’
in a prescription, ‘‘those things must be
resolved, and that resolution must be
documented before dispensing
medication.’’ 11 RD, at 14; Tr. 192, 273,
275–76, 353.
Lastly, Florida Administrative Code
section 64B16–27.831 states that ‘‘in
filling valid prescriptions for controlled
substances,’’ pharmacists should
‘‘exercise[e] sound professional
judgment,’’ and ‘‘dispens[e] controlled
substances for a legitimate medical
purpose in the usual course of
professional practice’’ considering
‘‘each patient’s unique situation.’’ Fla.
Admin. Code section 64B16–27.831. Dr.
Hamilton testified that this regulation
sets forth the standards for validating
prescriptions for controlled substances
as well as addresses how Florida
pharmacists are to assess whether a
prescription is written for a ‘‘legitimate
medical purpose,’’ which Dr. Hamilton
defines as the pharmacist’s
‘‘corresponding responsibility.’’ RD, at
15; Tr. 185.12 Dr. Hamilton further
testified that the ‘‘corresponding
responsibility’’ of pharmacists is to
work with physicians to take care of
patients, to make sure that prescriptions
written by physicians are not filled
blindly, and to make sure that a
prescription is correct for and used
correctly by the patient. RD, at 15; Tr.
188. Dr. Hamilton noted that if red flags
Tr. 186–188, 283, 344–345. Dr. Hamilton also
testified that there are not a finite number of red
flags and red flags could be ‘‘almost anything’’ that
causes concern. RD, at 14; Tr. 208.
11 Mr. Parrado disagreed with Dr. Hamilton
regarding the documentation of red flags and their
resolution; he testified that if there is a concern
with a prescription, a pharmacist can resolve the
concern and fill the prescription, but
documentation of the concern and its resolution is
strictly discretionary by the language of Florida law.
RD, at 38–39; Tr. 509–10, 520–21. However, when
testifying previously on behalf of the Government
in Superior Pharmacy I & II, Mr. Parrado stated that
(1) a pharmacist would ‘‘absolutely’’ document
resolution of a red flag; (2) anytime a pharmacist
has a concern with a prescription, the pharmacist
‘‘ ‘always [does] what [he/she has] to do to resolve
it and then [documents] it on the prescription’ ’’;
and (3) ‘‘ ‘the standard of practice has always been
[that] [a pharmacist documents] it on the
prescription.’ ’’ RD, at 43 (citing Superior Pharmacy
I & II, 81 FR 31310, 31321 (2016)); Tr. 532–34. Here,
like the ALJ, the Agency credits the testimony of Dr.
Hamilton and finds that the Florida standard of care
requires that any red flags present in a prescription
must be resolved before dispensing and such
resolution must be documented. RD, at 81; Tr. 192–
93, 228–29. The Agency also agrees with the ALJ
that from a plain reading of the laws at issue,
documentation of red flags and their resolution is
not discretionary, as argued by Mr. Parrado above,
but required. RD, at 81.
12 Dr. Hamilton testified that a valid prescription
is a prescription written for a legitimate medical
purpose. RD, at 15–16; Tr. 276.
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in a prescription have not been
resolved, the prescription is not valid
under the above regulation and should
not be filled. RD, at 15; Tr. 275–76.13
Respondent’s Improper Dispensing
Failure To Maintain Records
As mentioned above, Dr. Hamilton
testified that any red flags present in a
controlled substance prescription must
be resolved before dispensing the
prescription and such resolution must
be documented. RD, at 25; Tr. 192. Dr.
Hamilton testified that red flag
resolution should appear on a
prescription or in an electronic patient
profile as ‘‘some kind of note’’ or
documentation that references
resolution of the red flag. RD, at 14; Tr.
228. Further, Dr. Hamilton testified that
the need to document red flag resolution
is for patient safety purposes so that
information relating to the red flag
resolution is ‘‘readily retrievable.’’ RD,
at 14, 25; Tr. 192–93, 228. Ultimately,
Dr. Hamilton asserted that ‘‘if there [is]
no documentation, nothing happened.’’
RD, at 14, 25; Tr. 193.
Upon reviewing the documentation
for the seven patients at issue in the
current matter who filled their
prescriptions at Respondent over a span
of nearly two years, Dr. Hamilton found
that there were no notations resolving
the red flags present in the
prescriptions. RD, at 25; Tr. 197–276;
see GX 2–8. Because he did not find any
documentation of the identification or
resolution of the red flags present in
these prescriptions, Dr. Hamilton found,
in his expert opinion, that Respondent’s
dispensing fell below the Florida
standard of care and that Respondent
failed to meet its corresponding
responsibility. RD, at 25–26; Tr. 214–15,
227–29, 242–43, 251–52, 255–57, 261–
64, 265–276.
As for Respondent’s argument, Mr.
Parrado opined—based almost
exclusively on the representations of
Respondent’s Pharmacist-in-Charge
(PIC) about Respondent’s process for
13 There is some confusion in the record about the
term ‘‘red flag.’’ Mr. Parrado seems to believe that
when a prescription has characteristics of one or
more red flags, but those red flags are resolved, then
there is no red flag. See Tr. 571 (‘‘just because there
is [a] characteristic of a red flag [does not] mean that
there is one’’). This definition is debilitatingly
circular, and it would seem that Mr. Parrado
believes that there is a red flag only when a
pharmacist determines that a prescription cannot be
filled. When the Government, Dr. Hamilton, the
ALJ, and the Agency use the phrase ‘‘red flag,’’ they
are referring to the ‘‘things to look for’’ identified
in Fla. Admin. Code section 64B16–27.810 (what
Mr. Parrado would call a ‘‘potential red flag,’’ Tr.
571). Under this definition, prescriptions with red
flags that were properly resolved can be filled, and
prescriptions with unresolvable red flags cannot be
filled.
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validating prescriptions—that writing
‘‘verified’’ on the prescriptions and/or
patient profiles at issue was sufficient to
indicate that the prescriptions were
validated according to Florida laws,
regulations, and standards, and that
Respondent met its corresponding
responsibility. RD, at 41–42; Tr. 547,
608–09.14
The Agency credits Dr. Hamilton’s
testimony and finds that the Florida
standard of care requires that any red
flags present in a prescription must be
resolved before dispensing and such
resolution must be documented. See
supra n.11. The Agency also finds that
writing only ‘‘verified’’ on a
prescription or patient profile is not
sufficient to identify and resolve any red
flags that may be present.
The ALJ found, and the Agency
agrees, that the standard of care in
Florida requires that any red flags
present for a prescription or patient
must be resolved before dispensing and
that resolution must be documented.
RD, at 81 (citing Tr. 192–93, 228–29).
The ALJ found, and the Agency agrees,
that Respondent failed to do this,
rendering Respondent’s dispensing
practices outside the usual course of
professional practice and in violation of
the Florida standard of care. Id.15
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Prescription Drug Cocktails
According to Dr. Hamilton, a
combined prescription of drugs in
different classes or drugs that have
synergistic effects is a drug-drug
interaction red flag that must be
resolved before dispensing the
prescription. RD, at 16; Tr. 203, 238.
Regarding combinations of opioids and
benzodiazepines, Dr. Hamilton testified
14 Previously, in Hills Pharmacy, Mr. Parrado
testified that writing ‘‘verified’’ (paired with a
name) on a prescription does not tell you anything,
that ‘‘it was nothing,’’ and ‘‘that it was unclear what
the pharmacist verified.’’ RD, at 45–46 (citing Hills
Pharmacy, LLC, 81 FR 49816, 49825 (2016)); Tr.
547; GX 12.
15 In its Exceptions, Respondent argues that the
prescriptions at issue were legitimate prescriptions
written for a legitimate medical purpose.
Respondent’s Exceptions to Recommended
Decision (Exceptions), at 1–13. The Agency
reiterates that even assuming arguendo that the
prescriptions at issue were fully legitimate, it was
nonetheless Respondent’s corresponding
responsibility under the Florida standard of care, as
discussed above and throughout this Decision, to
recognize the red flags present in the prescriptions,
resolve the red flags, and document such resolution
appropriately, which Respondent undeniably failed
to do. Respondent also argues in its Exceptions that
the Government failed to prove that Respondent did
not take proper steps to validate the prescriptions
at issue. Exceptions, at 13–20, 25–28. Again, and as
discussed throughout this Decision, even assuming
arguendo that Respondent validated the
prescriptions at issue, Respondent was required to
document such steps and writing only ‘‘verified’’
was insufficient.
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that the Food and Drug Administration
(FDA) has issued a Black Box
Warning—FDA’s highest warning—
advising prescribers and pharmacists to
avoid the combination because both
drugs classes affect the central nervous
system, cause respiratory depression,
increase the risk of overdose, and when
taken together, have an ‘‘exponentially
higher effect on the body.’’ RD, at 16, 59;
Tr. 203–05, 238, 294. Dr. Hamilton
testified that an additional red flag
combination is the combination of drugs
that have opposite effects on the brain,
such as a stimulant (an ‘‘upper’’)
combined with a depressant (a
‘‘downer’’). RD, at 16; Tr. 238, 240.
Regarding combinations of opioids
and benzodiazepines, Dr. Hamilton
found that Patient A.R. was
simultaneously filling prescriptions for
immediate-release opioids (oxycodoneacetaminophen 10–325 and tramadol)
and a benzodiazepine (alprazolam). RD,
at 3–4 (Stip. 6), 17, 61; Tr. 205; GX 2a,
at 1–2; GX 2d. Dr. Hamilton also found
that Patient J.C. was filling prescriptions
for a benzodiazepine (temazepam) at
Respondent while PDMP data showed
that Patient J.C. was filling prescriptions
for an opioid (oxycodone) at a different
pharmacy; similarly, Patient M.W. was
filling prescriptions for an opioid
(oxycodone) at Respondent while PDMP
data show that Patient M.W. was filling
prescriptions for a benzodiazepine
(alprazolam) at a different pharmacy.
RD, at 4–5 (Stip. 8), 7 (Stip. 12), 17, 61–
62; Tr. 235–38, 268–69; GX 4a, at 2–3;
GX 8a, at 1–2. Dr. Hamilton opined that
Respondent should have recognized that
the prescriptions for these three patients
presented red flags and these red flags
needed to be properly resolved before
dispensing. RD, at 17, 61–62; Tr. 203,
208, 237–38, 268–69.
Regarding other dangerous
combinations, Dr. Hamilton found that
Patient J.C. was simultaneously filling
prescriptions for a stimulant
(methylphenidate) and a depressant
benzodiazepine (temazepam). RD, at 4–
5 (Stip. 8); Tr. 240; GX 4a; GX 4d. Again,
Dr. Hamilton opined that these
prescriptions presented red flags and
Respondent needed to properly resolve
these red flags before dispensing. RD, at
18; Tr. 240.
As for Respondent’s argument, Mr.
Parrado testified that after he reviewed
prescriber and patient affidavits, he was
of the opinion that the drug
combinations presented in this case did
not raise a red flag because the red flag
was resolved ‘‘originally and over time
in [the PIC’s] continuing conversations
with the patients and the doctors.’’ RD,
at 41; Tr. 574–75. As discussed supra,
even assuming arguendo that
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Respondent recognized the drug
combination red flags and attempted to
resolve them, writing only ‘‘verified’’ on
a prescription or patient profile is not
sufficient to actually resolve a red flag.
Accordingly, the Agency credits the
testimony of Dr. Hamilton that the drug
combination red flags present in the
prescriptions at issue were not properly
resolved prior to Respondent’s
dispensing.
The ALJ found, and the Agency
agrees, that the standard of care in
Florida requires that prior to dispensing,
a pharmacist document resolution of the
drug cocktail or drug-drug interaction
red flags that were present here due to
simultaneous dispensing of opioids
with benzodiazepines and
benzodiazepines with stimulants. RD, at
64 (citing Tr. 185–86, 192, 203, 238,
273, 275–76). The ALJ found, and the
Agency agrees, that Respondent failed to
do this, rendering Respondent’s
dispensing practices outside the usual
course of professional practice and in
violation of the Florida standard of care.
Id.
Immediate-Release and High Dosage
Opioids
According to Dr. Hamilton,
prescriptions of opiates alone can create
red flags that have to be resolved before
dispensing when: two separate
immediate-release opioids are
prescribed (‘‘therapeutic duplication’’);
when opioids are prescribed in their
highest strength version; or when
immediate-release opioids intended to
treat acute pain (as opposed to those
intended to treat chronic pain) are
prescribed for extended periods of time
(‘‘incorrect drug dosage or duration of
drug treatment’’). RD, at 18, 66; Tr. 198–
200, 206, 216, 243; Fla. Admin. Code
section 64B16–27.810(b), (e). Regarding
high dosages of opioids, Dr. Hamilton
testified that a dosage of 90 MMEs 16 per
day or greater warrants caution when
determining whether to fill the
prescription. RD, at 18–19; Tr. 208–
210.17 Regarding immediate-release
opioids prescribed for extended
durations, Dr. Hamilton opined that
filling immediate-release opioid
prescriptions month-over-month for an
extended time 18 is concerning and
16 MME is a measurement of opioid strength
based on milligram units of morphine per day and
MMEs for all opioids prescribed concurrently are
added together to determine the total MME per day.
RD, at 18 n.26; Tr. 209–212.
17 Dr. Hamilton testified that the red flag of a high
dosage of opioids can be justified if a patient is not
opioid naı̈ve, has been using opioids for an
extended time, or has a ‘‘certain disease state’’ such
as cancer. RD, at 19, 66; Tr. 210, 341.
18 Dr. Hamilton did not testify as to a specific
time period that would cause concern, but made
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constitutes a red flag that needs to be
resolved before dispensing. RD, at 20–
21, 69; Tr. 206, 244, 253.
In reviewing Respondent’s
dispensing, Dr. Hamilton found that
Patients A.R. and J.K. were both filling
prescriptions for a combination of two
immediate-release opioids (oxycodoneacetaminophen 10–325 with tramadol
and oxycodone-acetaminophen 10–325
with oxycodone, respectively). RD, at 3–
4 (Stip. 6), 6–7 (Stip. 10), 19–20, 68; Tr.
199–200, 243–45; GX 2a, 2d. Dr.
Hamilton opined that these instances of
therapeutic duplication constituted red
flags that had to be resolved before
dispensing. RD, at 19–20, 68; Tr. 200,
208, 243, 245. Mr. Parrado testified that
for at least one of the patients prescribed
two simultaneous immediate-release
opioids, Respondent originally had a
therapeutic duplication concern and
‘‘spoke with a doctor’’ who resolved the
concern, so there was ‘‘no longer a
concern’’ and there was ‘‘no reason [for
the Respondent] to continue doing
anything else.’’ RD, at 41; Tr. 571.
However, when testifying on behalf of
the Government in Superior Pharmacy I
& II, Mr. Parrado stated that a pharmacy
‘‘is never to dispense two immediate use
opioids at once, at the same time for the
same patient.’’ RD, at 43 (citing Superior
Pharmacy I & II, 81 FR 31327); Tr. 531.
As for immediate-release opioids
prescribed for extended durations, Dr.
Hamilton found the following: Patient
A.R was filling prescriptions for
immediate-release opioids (oxycodoneacetaminophen and tramadol) over a
span of approximately two years;
Patient J.K. was filling prescriptions for
immediate-release opioids (oxycodone
and oxycodone-acetaminophen 10–325)
over a span of approximately one-anda-half-years; Patient C.S. was filling
prescriptions for an immediate-release
opioid (hydromorphone, at the highest
strength,19 while an extended-release
version is available) over a span of
approximately one-and-a-half years; and
Patients J.L. and M.W. were both filling
prescriptions for a high-strength,
immediate-release opioid (oxycodone 30
mg) month-over-month for
approximately one-and-a-half years and
approximately one year, respectively.
RD, at 3–4 (Stips. 6–7), 5–7 (Stips. 9–10,
12), 20–21; Tr. 205–06, 218, 243–44,
253, 265; GX 2a; GX 2d; GX 3a; GX 3c;
GX 5a; GX 5d; GX 6a; GX 6c; GX 8a; GX
8d. Dr. Hamilton opined that these
clear that taking immediate-release opioids for ‘‘30,
60 days maximum’’ would be acceptable and that
over two years would be ‘‘very concerning.’’ RD, at
20; Tr. 205–206.
19 Dr. Hamilton opined that ‘‘having the highest
possible strength of an immediate-release opiate is
definitely a red flag.’’ RD, at 20; Tr. 218.
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prescriptions presented red flags and
Respondent needed to properly resolve
these red flags before dispensing. RD, at
20–21, 69; Tr. 206, 218. 244, 253, 265.
Concerning high dosage opioid
prescriptions, Dr. Hamilton found the
following: Patient A.R. was filling
prescriptions for oxycodoneacetaminophen 10–325 and tramadol
that together totaled 120 MMEs per day;
Patient C.S. was filling prescriptions for
hydromorphone at the highest strength
(8 mg) totaling as much as 260 MMEs
per day; Patient J.L. was filling
prescriptions for oxycodone at the
highest strength (30 mg) totaling
approximately 135 MMEs per day;
Patient M.G. was filling prescriptions
for oxycodone at the highest strength
(30 mg) totaling between 135 and 270
MMES per day; and Patient M.W. was
filling prescriptions for oxycodone at
dosages of either 15 mg or 30 mg
totaling between 90 and 265 MMEs per
day. RD, at 3–4 (Stips. 6–7), 5–6 (Stip.
9), 7 (Stips. 11–12), 21–22; Tr. 210–12,
218, 253–55, 258, 260, 265, 267; GX 2a;
GX 2d; GX 3a; GX 3c; GX 6a; GX 6c; GX
7a; GX 7d; GX 8a; GX 8d. Once more,
Dr. Hamilton opined that these
prescriptions presented red flags that
Respondent needed to properly resolve
before dispensing. RD, at 21–22, 70–71;
Tr. 210–12, 218, 253–55, 258, 267.
As for Respondent’s argument, Mr.
Parrado testified generally that based on
his review of the records and
conversations with Respondent’s PIC,
there were no incorrect drug dose or
duration of treatment red flags because
the patients had long-term pain and had
developed opioid tolerance as
established through the PIC’s purported
conversations with the patients and
prescribers. RD, at 41; Tr. 575–76. As
discussed supra, even assuming
arguendo that Respondent recognized
these red flags and attempted to resolve
them, writing only ‘‘verified’’ on a
prescription or patient profile is not
sufficient to actually resolve a red flag.
Accordingly, the Agency credits the
testimony of Dr. Hamilton that the
therapeutic duplication and incorrect
drug dosage or duration of drug
treatment red flags were not properly
resolved prior to Respondent’s
dispensing.
The ALJ found, and the Agency
agrees, that the standard of care in
Florida requires that prior to dispensing,
a pharmacist document resolution of the
therapeutic duplication red flags
(prescribing of two immediate-release
opioids) and incorrect drug dosage or
duration of treatment red flags
(immediate-release opioids prescribed
for extended durations and opioids
prescribed in their highest strength) that
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50375
were present here. RD, at 73 (citing Tr.
185–86, 192, 273, 275–76). The ALJ
found, and the Agency agrees, that
Respondent failed to do this, rendering
Respondent’s dispensing practices
outside the usual course of professional
practice and in violation of the Florida
standard of care. Id.
Alternating Between Cash and
Insurance 20
According to Dr. Hamilton, a patient
paying for some prescriptions with
insurance while paying for others with
cash is a red flag, but only for the
prescriptions paid for in cash. RD, at 23;
Tr. 231. Concerning this issue, Dr.
Hamilton found that Patient J.C. was
paying for some medications with
insurance while paying for other,
controlled medications with cash,
which was a red flag that needed to be
resolved before dispensing. RD, at 24;
Tr. 240–41; GX 4d. Further, Dr.
Hamilton found that Patient M.W. was
using cash to pay for oxycodone at
Respondent while using insurance to
pay for alprazolam at a different
pharmacy. RD, at 24–25; Tr. 270; GX 8a.
Again, Dr. Hamilton opined that this
was a red flag that needed to be resolved
before dispensing. RD, at 25; Tr. 270–71.
Regarding Patient J.C. paying for his
methylphenidate prescription with
cash, the PIC testified that he spoke
with Dr. R., Patient J.C.’s physician,
about Patient J.C.’s prescription and Dr.
R. told the PIC that Patient J.C. had
limited insurance. RD, at 29 n.37; Tr.
461–62.
Again, as discussed supra, even
assuming arguendo that Respondent
recognized these red flags and
attempted to resolve them, writing only
‘‘verified’’ on a prescription or patient
profile is not sufficient to actually
resolve a red flag. Accordingly, the
Agency credits the testimony of Dr.
Hamilton that the red flag of alternating
between cash and insurance was not
properly resolved prior to Respondent’s
dispensing.
The ALJ found, and the Agency
agrees, that the standard of care in
Florida requires that prior to dispensing,
a pharmacist document resolution of the
red flag of alternating between cash and
insurance that was present here. RD, at
77 (citing Tr. 185–86, 192, 273, 275–76).
The ALJ found, and the Agency agrees,
that Respondent failed to do this,
rendering Respondent’s dispensing
practices outside the usual course of
20 This Decision and Order does not address
allegations concerning the high cash payment/high
pricing red flag due to the number and
egregiousness of the rest of the allegations.
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professional practice and in violation of
the Florida standard of care. Id.21
II. Discussion
A. The Five Public Interest Factors
Under the 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 [its]
registration under section 823 of this
title inconsistent with the public
interest as determined under such
section.’’ 21 U.S.C. 824(a). In making the
public interest determination, the CSA
requires consideration of the following
factors:
(A) The recommendation of the
appropriate State licensing board or
professional disciplinary authority.
(B) The [registrant’s] experience in
dispensing, or conducting research with
respect to controlled substances.
(C) The [registrant’s] conviction record
under Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(E) Such other conduct which may threaten
the public health and safety.
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21 U.S.C. 823(g)(1).
The Agency considers these public
interest factors in the disjunctive. Robert
A. Leslie, M.D., 68 FR 15227, 15230
(2003). Each factor is weighed on a caseby-case basis. Morall v. Drug Enf’t
Admin., 412 F.3d 165, 173–74 (D.C. Cir.
2005). Any one factor, or combination of
factors, may be decisive. David H. Gillis,
M.D., 58 FR 37507, 37508 (1993).
The Government has the burden of
proof in this proceeding. 21 CFR
1301.44. While the Agency has
considered all of the public interest
factors in 21 U.S.C. 823(g)(1), the
Government’s evidence in support of its
prima facie case for revocation of
Respondent’s registration is confined to
Factors B and D. RD, at 52–53; see also
id. at 52 n.58 (finding that Factors A, C,
and E do not weigh for or against
revocation).
Having reviewed the record and the
RD, the Agency agrees with the ALJ,
adopts the ALJ’s analysis, and finds that
the Government’s evidence satisfies its
prima facie burden of showing that
21 Respondent argues in its Exceptions that none
of the prescriptions at issue were actually abused
or diverted. Exceptions, at 20–23. Nonetheless,
Agency precedent is clear that proof of actual,
subsequent harm is not required when a registrant
has acted inconsistently with the public interest.
Melanie Baker, N.P., 86 FR 23998, 24009 (2021);
Larry C. Daniels, M.D., 86 FR 61630, 61660–61
(2021); Jeanne E. Germeil, M.D., 85 FR 73786, 73799
n.32 (2020).
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Respondent’s continued registration
would be ‘‘inconsistent with the public
interest.’’ 21 U.S.C. 824(a)(4); RD, at 51–
82.
B. Factors B and D
Evidence is considered under Public
Interest Factors B and D when it reflects
compliance (or non-compliance) with
laws related to controlled substances
and experience dispensing controlled
substances. See Sualeh Ashraf, M.D., 88
FR 1095, 1097 (2023); Kareem Hubbard,
M.D., 87 FR 21156, 21162 (2022). In the
current matter, the Government has
alleged that Respondent violated
numerous federal and state laws
regulating controlled substances. OSC/
ISO, at 2–7.22 Specifically, federal law
requires that ‘‘[a] prescription for a
controlled substance may only be filled
by a pharmacist, acting in the usual
course of his professional practice,’’ and
that ‘‘[a] prescription for a controlled
substance to be effective must be issued
for a legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice.’’ 21 CFR 1306.04(a), 1306.06;
see also 21 U.S.C. 829. Federal law also
emphasizes that although ‘‘[t]he
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.’’ 21 CFR 1306.04(a).23
As for state law, Florida
Administrative Code section 64B16–
27.810 requires that, prior to dispensing,
a pharmacist ‘‘review the patient record
and each new and refill prescription
. . . to promote therapeutic
appropriateness by identifying: (a) Overutilization or under-utilization; (b)
Therapeutic duplication; (c) Drugdisease contraindications; (d) Drug-drug
interactions; (e) Incorrect drug dosage or
duration of drug treatment; (f) Drugallergy interactions; [and] (g) Clinical
abuse/misuse.’’ Fla. Admin. Code
section 64B16–27.810. The regulation
further states that ‘‘[u]pon recognizing
any of the above, the pharmacist shall
take appropriate steps to avoid or
resolve the potential problems which
shall, if necessary, include consultation
with the prescriber.’’ Id. section 64B16–
27.810(2).
22 The Agency need not adjudicate the criminal
violations alleged in the instant OSC/ISO. Ruan v.
United States, 142 S. Ct. 2370 (2022) (decided in
the context of criminal proceedings).
23 Further, federal law ‘‘prohibit[s] a pharmacist
from filling a prescription for a controlled substance
when he either knows or has reason to know that
the prescription was not written for a legitimate
medical purpose.’’ Id.
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Sfmt 4703
In addition, Florida Administrative
Code section 64B16–27.800 states that
pharmacies ‘‘shall’’ maintain a ‘‘patient
record system,’’ that ‘‘provide[s] for the
immediate retrieval of information
necessary for the dispensing pharmacist
to identify previously dispensed drugs,’’
and ‘‘shall record any known allergies,
drug reactions, idiosyncrasies, and
chronic conditions or disease states of
the patient and the identity of any other
drugs, including over-the-counter drugs,
or devices currently being used by the
patient which may relate to prospective
drug review.’’ Fla. Admin. Code section
64B16–27.800(1)–(2).24 It also states that
‘‘[t]he pharmacist shall record any
related information indicated by a
licensed health care practitioner.’’ Id.
Lastly, Florida Administrative Code
section 64B16–27.831 states that ‘‘in
filling valid prescriptions for controlled
substances,’’ pharmacists should
‘‘exercise[e] sound professional
judgment,’’ and ‘‘dispens[e] controlled
substances for a legitimate medical
purpose in the usual course of
professional practice’’ considering
‘‘each patient’s unique situation.’’ Fla.
Admin. Code section 64B16–27.831.
In the current matter, the Agency
agrees with the ALJ’s analysis that
Respondent’s dispensing fell below the
Florida standard of care—and thus was
outside the usual course of professional
practice—because, as detailed above,
Respondent dispensed numerous
controlled substance prescriptions to
seven patients without properly
addressing and resolving clear red flags
of abuse and/or diversion including
drug cocktails, immediate-release and
high dosage opioids, and patients
alternating between paying for
prescriptions with cash and insurance.
See RD, at 51–82. As Respondent’s
conduct displays clear violations of the
federal and state regulations described
above, the Agency agrees with the ALJ
and hereby finds that Respondent
repeatedly violated federal and state law
relating to controlled substances. RD, at
81–82. Accordingly, the Agency agrees
with the ALJ and finds that Factors B
and D weigh in favor of revocation of
Respondent’s registration and thus finds
Respondent’s continued registration to
be inconsistent with the public interest
in balancing the factors of 21 U.S.C.
823(g)(1). Id.
III. Sanction
Where, as here, the Government has
established sufficient grounds to revoke
Respondent’s registration, the burden
24 This regulation requires that pharmacists
‘‘ensure that a reasonable effort is made to obtain’’
this information. Id. section 64B16–27.800(2).
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shifts to the registrant to show why it
can be entrusted with the responsibility
carried by a registration. Garret Howard
Smith, M.D., 83 FR 18882, 18910 (2018).
When a registrant has committed acts
inconsistent with the public interest, it
must both accept responsibility and
demonstrate that it has undertaken
corrective measures. Holiday CVS,
L.L.C., dba CVS Pharmacy Nos 219 and
5195, 77 FR 62316, 62339 (2012)
(internal quotations omitted). Trust is
necessarily a fact-dependent
determination based on individual
circumstances; therefore, the Agency
looks at factors such as the acceptance
of responsibility, the credibility of that
acceptance as it relates to the
probability of repeat violations or
behavior, the nature of the misconduct
that forms the basis for sanction, and the
Agency’s interest in deterring similar
acts. See, e.g., Robert Wayne Locklear,
M.D., 86 FR 33738, 33746 (2021).
Here, and as noted by the ALJ, the
PIC, as Respondent’s pharmacy
manager, did not admit any fault or
accept any responsibility for his
conduct in filling the prescriptions at
issue. RD, at 83.25 As such, the ALJ
concluded, and the Agency agrees, that
Respondent has not demonstrated
unequivocal acceptance of
responsibility for its actions. Id. at 84
(citing Jones Total Health Care
Pharmacy, L.L.C. & SND Health Care,
L.L.C., 81 FR 79188, 79201–202
(2016)).26
In addition to acceptance of
responsibility, the Agency considers
both specific and general deterrence
when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR
74810. In this case, the Agency agrees
with the ALJ that given that the PIC
filled many of the prescriptions at issue,
yet failed to acknowledge that any red
flags existed or required resolution, ‘‘the
interests of specific deterrence, even
standing alone, motivate powerfully in
favor of revocation.’’ RD, at 85; Tr. 361,
363–76. Further, the Agency agrees with
the ALJ that the interests of general
deterrence also support revocation, as a
lack of sanction in the current matter
would send a message to the registrant
community that the failure to properly
25 Nor did Respondent’s owner, A.V.,
acknowledge any fault or accept any responsibility
for Respondent’s improper dispensing practices. Id.
at 83–84.
26 When a registrant fails to make the threshold
showing of acceptance of responsibility, the Agency
need not address the registrant’s remedial measures.
Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019)
(citing Jones Total Health Care Pharmacy, 81 FR
79202–303); Daniel A. Glick, D.D.S., 80 FR 74800,
74801, 74,810 (2015). Even so, in the current matter,
neither the PIC nor A.V. outlined any remedial
measures taken by Respondent. RD, at 83–84.
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address and document resolution of red
flags can be excused. RD, at 85–86.
Moreover, the Agency agrees with the
ALJ that Respondent’s actions were
egregious. Id. at 84. As stated by the
ALJ, ‘‘Respondent dispensed many
controlled substances over a two-year
period without any regard for its
obligations to identify, resolve, or
document any red flags of potential
abuse or diversion’’ and with awareness
of both its obligations and the existence
of numerous red flags in the
prescriptions that it was filling and
dispensing. Id. at 84–85.
In sum, Respondent has not offered
any credible evidence on the record that
rebuts the Government’s case for
revocation of its registration and
Respondent has not demonstrated that it
can be entrusted with the responsibility
of registration. Id. at 86. Accordingly,
the Agency will order that Respondent’s
registration be revoked.27
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. FC1162382 issued to
Coconut Grove Pharmacy. Further,
pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(g)(1), I hereby deny any pending
applications of Coconut Grove
Pharmacy to renew or modify this
registration, as well as any other
pending application of Coconut Grove
Pharmacy for additional registration in
Florida. This Order is effective July 15,
2024.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on June 6, 2024, by Administrator Anne
Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
27 Regarding Respondent’s additional assertions
in its Exceptions that the pharmacy being served
with an OSC/ISO did not allow it an opportunity
to submit a corrective action plan (Exceptions, at
30), the Agency notes that Respondent had ample
opportunity in presenting its case-in-chief to fully
accept responsibility for its improper practices and
to offer remedial measures, but Respondent failed
to do so, see supra. Further, regarding Respondent’s
noting that the PIC has never previously faced
disciplinary measures for his dispensing
(Exceptions, at 29), this point was addressed by the
ALJ in considering Public Interest Factors A, C, and
E (see supra II.A.) and has been considered by the
Agency.
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50377
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2024–12972 Filed 6–12–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Office of the Attorney General
[A.G. Order No. 5945–2024]
Attorney General Designation of
Switzerland as a ‘‘Qualifying State’’
Department of Justice.
Notice.
AGENCY:
ACTION:
In accordance with an
Executive order, the Attorney General
has designated Switzerland as a
‘‘qualifying state.’’
DATES: June 13, 2024. The designation is
to become effective on the date of entry
into force of an amendment to Annex 1
to the Swiss Data Protection Ordinance
listing the United States for data
transferred in reliance on the Swiss–
U.S. Data Privacy Framework.
FOR FURTHER INFORMATION CONTACT:
Susan Hennessey, Chief Counsel
Performing the Duties of the Deputy
Assistant Attorney General, National
Security Division, United States
Department of Justice, Washington, DC
20530; telephone: (202) 514–1057. This
is not a toll-free number.
SUPPLEMENTARY INFORMATION: Executive
Order 14086 of October 7, 2022
(Enhancing Safeguards for United States
Signals Intelligence Activities),
establishes a two-level redress
mechanism for the review of qualifying
complaints by individuals filed through
an appropriate public authority in a
‘‘qualifying state’’ and alleging certain
violations of U.S. law concerning
signals intelligence activities. A country
or regional economic integration
organization may be designated as a
qualifying state by the Attorney General
if he determines, in consultation with
the Secretary of State, the Secretary of
Commerce, and the Director of National
Intelligence, that it meets the
requirements set forth in section 3(f) of
Executive Order 14086. The Attorney
General has made those determinations
on the basis of the information
contained in the ‘‘Memorandum in
Support of Designation of Switzerland
as a Qualifying State Under Executive
Order 14086’’ prepared by the National
Security Division of the Department of
SUMMARY:
E:\FR\FM\13JNN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 115 (Thursday, June 13, 2024)]
[Notices]
[Pages 50372-50377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12972]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22-52]
Coconut Grove Pharmacy; Decision and Order
On September 8, 2022, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Coconut Grove Pharmacy (Respondent) of
Florida. Administrative Law Judge Exhibit (ALJX) 1 (OSC/ISO), at 1. The
OSC/ISO informed Respondent of the immediate suspension of its DEA
Certificate of Registration (registration), Control No. FC1162382,
pursuant to 21 U.S.C. 824(d), alleging that Respondent's continued
registration constitutes `` `an imminent danger to the public health or
safety.' '' Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also proposed
the revocation of Respondent's registration, alleging that Respondent's
continued registration is inconsistent with the public interest. Id.
(citing 21 U.S.C. 823(g)(1),\1\ 824(a)(4)).\2\
---------------------------------------------------------------------------
\1\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat.
2257 (2022) (Marijuana Research Amendments or MRA), amended the
Controlled Substances Act (CSA) and other statutes. Relevant to this
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC/ISO,
as 21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the
current designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA
throughout.
\2\ According to Agency records, Respondent's registration
expired on August 31, 2023. The fact that a registrant allows its
registration to expire during the pendency of an OSC/ISO does not
impact the Agency's jurisdiction or prerogative under CSA to
adjudicate the OSC/ISO to finality. Jeffrey D. Olsen, M.D., 84 FR
68474, 68,76-79 (2019).
---------------------------------------------------------------------------
A hearing was held before DEA Administrative Law Judge Paul E.
Soeffing (the ALJ), who, on March 2, 2023, issued his Recommended
Rulings, Findings of Fact, Conclusions of Law, and Decision (RD or
Recommended Decision). The RD recommended that Respondent's revocation
be revoked. RD, at 86. Following the issuance of the RD, Respondent
filed exceptions.\3\ Having reviewed the entire record, the Agency
adopts and hereby incorporates by reference the entirety of the ALJ's
rulings, credibility findings,\4\ findings of fact, conclusions of law,
sanctions analysis, and recommended sanction as found in the RD and
summarizes and expands upon portions thereof herein.
---------------------------------------------------------------------------
\3\ The Agency has reviewed and considered the Respondent's
exceptions and addresses them herein, but ultimately agrees with the
ALJ's recommendation.
\4\ The Agency adopts the ALJ's summary of each of the
witnesses' testimonies as well as the ALJ's assessment of each of
the witnesses' credibility. See RD, at 8-49.
---------------------------------------------------------------------------
I. Findings of Fact
Florida Standard of Care
Thomas E. Hamilton, Pharm.D., testified as the Government's expert
regarding pharmacy practice and standards in the state of Florida. RD,
at 12-13; Tr. 182-83. Dr. Hamilton testified that he has over twenty
years of experience as a Florida pharmacist and is currently employed
as a pharmacist in Northern Miami. RD, at 12; Tr. 176-78, 181.\5\ As
for Respondent, Mr. Robert M. Parrado, R.Ph., testified as Respondent's
expert. RD, at 36; Tr. 497-98. Mr. Parrado testified that he has been a
licensed pharmacist in Florida for over fifty years and has served on
the Florida Board of Pharmacy in various roles, including as Chairman
and as a member of the rules committee. RD, at 37; Tr. 493-96.\6\
Regarding Mr. Parrado's testimony, the Agency agrees with the ALJ that
Mr. Parrado's testimony was not consistent nor logical (particularly
when compared to his prior testimony in other matters) as Mr. Parrado
at times contradicted the language of Florida's regulations and used
the term ``red flag'' inconsistently in a way that created confusion;
as such, his testimony warrants only minimal weight. RD, at 48-49.\7\
Where Mr. Parrado's testimony diverges from that of Dr. Hamilton, the
Agency, like the ALJ, will credit Dr. Hamilton. RD, at 49.\8\
---------------------------------------------------------------------------
\5\ For Dr. Hamilton's full qualifications, see RD, at 12-13,
Government Exhibit (GX) 9.
\6\ For Mr. Parrado's full qualifications, see RD, at 36-37,
Respondent Exhibit (RX) 27.
\7\ The Agency incorporates herein the entire summary of Mr.
Parrado's testimony as well as the ALJ's credibility assessment of
Mr. Parrado as set forth in the Recommended Decision, at 36-49.
\8\ The ALJ found, and the Agency agrees, that Dr. Hamilton's
testimony was credible, internally consistent, and generally
logically persuasive. RD, at 26. As noted by the ALJ, ``[a]lthough
at times [Dr. Hamilton's] explanation of the factual support and
basis for some of his opinions and conclusions was brief, overall he
presented an objective analysis.'' Id. As such, the Agency finds Dr.
Hamilton's testimony to be credible and reliable and affords it
significant weight. Id.
---------------------------------------------------------------------------
Dr. Hamilton testified that the standard of care for pharmacists in
Florida is informed by the regulations
[[Page 50373]]
promulgated by the Florida Board of Pharmacy (the Board), including
Florida Administrative Code sections 64B16-27.800, 64B16-27.810, and
64B16-27.831. RD, at 13; Tr. 183-84. Florida Administrative Code
section 64B16-27.800 states that pharmacies ``shall'' maintain a
``patient record system,'' that ``provide[s] for the immediate
retrieval of information necessary for the dispensing pharmacist to
identify previously dispensed drugs,'' and ``shall record any known
allergies, drug reactions, idiosyncrasies, and chronic conditions or
disease states of the patient and the identity of any other drugs,
including over-the-counter drugs, or devices currently being used by
the patient which may relate to prospective drug review.'' Fla. Admin.
Code section 64B16-27.800(1)-(2).\9\ It also states that ``[t]he
pharmacist shall record any related information indicated by a licensed
health care practitioner.'' Id. Dr. Hamilton testified that this
regulation requires pharmacists to document in the patient profile
known information that is specific to a patient, especially information
about a specific drug or reasons that a patient is prescribed a
specific drug, to guide future decision making and justify dispensing.
RD, at 13; Tr. 185, 194.
---------------------------------------------------------------------------
\9\ This regulation requires that pharmacists ``ensure that a
reasonable effort is made to obtain'' this information. Id. section
64B16-27.800(2).
---------------------------------------------------------------------------
Florida Administrative Code section 64B16-27.810 requires that,
prior to dispensing, a pharmacist ``review the patient record and each
new and refill prescription . . . to promote therapeutic
appropriateness by identifying: (a) Over-utilization or under-
utilization; (b) Therapeutic duplication; (c) Drug-disease
contraindications; (d) Drug-drug interactions; (e) Incorrect drug
dosage or duration of drug treatment; (f) Drug-allergy interactions;
[and] (g) Clinical abuse/misuse.'' Fla. Admin. Code section 64B16-
27.810. The regulation further states that ``[u]pon recognizing any of
the above, the pharmacist shall take appropriate steps to avoid or
resolve the potential problems which shall, if necessary, include
consultation with the prescriber.'' Id. section 64B16-27.810(2).
Regarding this regulation, Dr. Hamilton testified that in the practice
of pharmacy, the ``things to look for'' when verifying or assessing a
prescription are termed ``red flags'' and the term ``red flag'' means
``caution'' or ``something to bring your heightened awareness to.'' RD,
at 14; Tr. 185-86, 188.\10\ Dr. Hamilton further testified that the
practice of pharmacy in Florida requires that when a pharmacist
recognizes any of the ``things to look for'' or ``red flags'' in a
prescription, ``those things must be resolved, and that resolution must
be documented before dispensing medication.'' \11\ RD, at 14; Tr. 192,
273, 275-76, 353.
---------------------------------------------------------------------------
\10\ Although the term ``red flag'' itself is not used in the
Florida regulation, Dr. Hamilton testified that pharmacists know the
term to mean ``caution'' and the term is regularly used in the
education and practice of pharmacists in Florida. RD, at 14 n.21;
Tr. 186-188, 283, 344-345. Dr. Hamilton also testified that there
are not a finite number of red flags and red flags could be ``almost
anything'' that causes concern. RD, at 14; Tr. 208.
\11\ Mr. Parrado disagreed with Dr. Hamilton regarding the
documentation of red flags and their resolution; he testified that
if there is a concern with a prescription, a pharmacist can resolve
the concern and fill the prescription, but documentation of the
concern and its resolution is strictly discretionary by the language
of Florida law. RD, at 38-39; Tr. 509-10, 520-21. However, when
testifying previously on behalf of the Government in Superior
Pharmacy I & II, Mr. Parrado stated that (1) a pharmacist would
``absolutely'' document resolution of a red flag; (2) anytime a
pharmacist has a concern with a prescription, the pharmacist ``
`always [does] what [he/she has] to do to resolve it and then
[documents] it on the prescription' ''; and (3) `` `the standard of
practice has always been [that] [a pharmacist documents] it on the
prescription.' '' RD, at 43 (citing Superior Pharmacy I & II, 81 FR
31310, 31321 (2016)); Tr. 532-34. Here, like the ALJ, the Agency
credits the testimony of Dr. Hamilton and finds that the Florida
standard of care requires that any red flags present in a
prescription must be resolved before dispensing and such resolution
must be documented. RD, at 81; Tr. 192-93, 228-29. The Agency also
agrees with the ALJ that from a plain reading of the laws at issue,
documentation of red flags and their resolution is not
discretionary, as argued by Mr. Parrado above, but required. RD, at
81.
---------------------------------------------------------------------------
Lastly, Florida Administrative Code section 64B16-27.831 states
that ``in filling valid prescriptions for controlled substances,''
pharmacists should ``exercise[e] sound professional judgment,'' and
``dispens[e] controlled substances for a legitimate medical purpose in
the usual course of professional practice'' considering ``each
patient's unique situation.'' Fla. Admin. Code section 64B16-27.831.
Dr. Hamilton testified that this regulation sets forth the standards
for validating prescriptions for controlled substances as well as
addresses how Florida pharmacists are to assess whether a prescription
is written for a ``legitimate medical purpose,'' which Dr. Hamilton
defines as the pharmacist's ``corresponding responsibility.'' RD, at
15; Tr. 185.\12\ Dr. Hamilton further testified that the
``corresponding responsibility'' of pharmacists is to work with
physicians to take care of patients, to make sure that prescriptions
written by physicians are not filled blindly, and to make sure that a
prescription is correct for and used correctly by the patient. RD, at
15; Tr. 188. Dr. Hamilton noted that if red flags in a prescription
have not been resolved, the prescription is not valid under the above
regulation and should not be filled. RD, at 15; Tr. 275-76.\13\
---------------------------------------------------------------------------
\12\ Dr. Hamilton testified that a valid prescription is a
prescription written for a legitimate medical purpose. RD, at 15-16;
Tr. 276.
\13\ There is some confusion in the record about the term ``red
flag.'' Mr. Parrado seems to believe that when a prescription has
characteristics of one or more red flags, but those red flags are
resolved, then there is no red flag. See Tr. 571 (``just because
there is [a] characteristic of a red flag [does not] mean that there
is one''). This definition is debilitatingly circular, and it would
seem that Mr. Parrado believes that there is a red flag only when a
pharmacist determines that a prescription cannot be filled. When the
Government, Dr. Hamilton, the ALJ, and the Agency use the phrase
``red flag,'' they are referring to the ``things to look for''
identified in Fla. Admin. Code section 64B16-27.810 (what Mr.
Parrado would call a ``potential red flag,'' Tr. 571). Under this
definition, prescriptions with red flags that were properly resolved
can be filled, and prescriptions with unresolvable red flags cannot
be filled.
---------------------------------------------------------------------------
Respondent's Improper Dispensing
Failure To Maintain Records
As mentioned above, Dr. Hamilton testified that any red flags
present in a controlled substance prescription must be resolved before
dispensing the prescription and such resolution must be documented. RD,
at 25; Tr. 192. Dr. Hamilton testified that red flag resolution should
appear on a prescription or in an electronic patient profile as ``some
kind of note'' or documentation that references resolution of the red
flag. RD, at 14; Tr. 228. Further, Dr. Hamilton testified that the need
to document red flag resolution is for patient safety purposes so that
information relating to the red flag resolution is ``readily
retrievable.'' RD, at 14, 25; Tr. 192-93, 228. Ultimately, Dr. Hamilton
asserted that ``if there [is] no documentation, nothing happened.'' RD,
at 14, 25; Tr. 193.
Upon reviewing the documentation for the seven patients at issue in
the current matter who filled their prescriptions at Respondent over a
span of nearly two years, Dr. Hamilton found that there were no
notations resolving the red flags present in the prescriptions. RD, at
25; Tr. 197-276; see GX 2-8. Because he did not find any documentation
of the identification or resolution of the red flags present in these
prescriptions, Dr. Hamilton found, in his expert opinion, that
Respondent's dispensing fell below the Florida standard of care and
that Respondent failed to meet its corresponding responsibility. RD, at
25-26; Tr. 214-15, 227-29, 242-43, 251-52, 255-57, 261-64, 265-276.
As for Respondent's argument, Mr. Parrado opined--based almost
exclusively on the representations of Respondent's Pharmacist-in-Charge
(PIC) about Respondent's process for
[[Page 50374]]
validating prescriptions--that writing ``verified'' on the
prescriptions and/or patient profiles at issue was sufficient to
indicate that the prescriptions were validated according to Florida
laws, regulations, and standards, and that Respondent met its
corresponding responsibility. RD, at 41-42; Tr. 547, 608-09.\14\
---------------------------------------------------------------------------
\14\ Previously, in Hills Pharmacy, Mr. Parrado testified that
writing ``verified'' (paired with a name) on a prescription does not
tell you anything, that ``it was nothing,'' and ``that it was
unclear what the pharmacist verified.'' RD, at 45-46 (citing Hills
Pharmacy, LLC, 81 FR 49816, 49825 (2016)); Tr. 547; GX 12.
---------------------------------------------------------------------------
The Agency credits Dr. Hamilton's testimony and finds that the
Florida standard of care requires that any red flags present in a
prescription must be resolved before dispensing and such resolution
must be documented. See supra n.11. The Agency also finds that writing
only ``verified'' on a prescription or patient profile is not
sufficient to identify and resolve any red flags that may be present.
The ALJ found, and the Agency agrees, that the standard of care in
Florida requires that any red flags present for a prescription or
patient must be resolved before dispensing and that resolution must be
documented. RD, at 81 (citing Tr. 192-93, 228-29). The ALJ found, and
the Agency agrees, that Respondent failed to do this, rendering
Respondent's dispensing practices outside the usual course of
professional practice and in violation of the Florida standard of care.
Id.\15\
---------------------------------------------------------------------------
\15\ In its Exceptions, Respondent argues that the prescriptions
at issue were legitimate prescriptions written for a legitimate
medical purpose. Respondent's Exceptions to Recommended Decision
(Exceptions), at 1-13. The Agency reiterates that even assuming
arguendo that the prescriptions at issue were fully legitimate, it
was nonetheless Respondent's corresponding responsibility under the
Florida standard of care, as discussed above and throughout this
Decision, to recognize the red flags present in the prescriptions,
resolve the red flags, and document such resolution appropriately,
which Respondent undeniably failed to do. Respondent also argues in
its Exceptions that the Government failed to prove that Respondent
did not take proper steps to validate the prescriptions at issue.
Exceptions, at 13-20, 25-28. Again, and as discussed throughout this
Decision, even assuming arguendo that Respondent validated the
prescriptions at issue, Respondent was required to document such
steps and writing only ``verified'' was insufficient.
---------------------------------------------------------------------------
Prescription Drug Cocktails
According to Dr. Hamilton, a combined prescription of drugs in
different classes or drugs that have synergistic effects is a drug-drug
interaction red flag that must be resolved before dispensing the
prescription. RD, at 16; Tr. 203, 238. Regarding combinations of
opioids and benzodiazepines, Dr. Hamilton testified that the Food and
Drug Administration (FDA) has issued a Black Box Warning--FDA's highest
warning--advising prescribers and pharmacists to avoid the combination
because both drugs classes affect the central nervous system, cause
respiratory depression, increase the risk of overdose, and when taken
together, have an ``exponentially higher effect on the body.'' RD, at
16, 59; Tr. 203-05, 238, 294. Dr. Hamilton testified that an additional
red flag combination is the combination of drugs that have opposite
effects on the brain, such as a stimulant (an ``upper'') combined with
a depressant (a ``downer''). RD, at 16; Tr. 238, 240.
Regarding combinations of opioids and benzodiazepines, Dr. Hamilton
found that Patient A.R. was simultaneously filling prescriptions for
immediate-release opioids (oxycodone-acetaminophen 10-325 and tramadol)
and a benzodiazepine (alprazolam). RD, at 3-4 (Stip. 6), 17, 61; Tr.
205; GX 2a, at 1-2; GX 2d. Dr. Hamilton also found that Patient J.C.
was filling prescriptions for a benzodiazepine (temazepam) at
Respondent while PDMP data showed that Patient J.C. was filling
prescriptions for an opioid (oxycodone) at a different pharmacy;
similarly, Patient M.W. was filling prescriptions for an opioid
(oxycodone) at Respondent while PDMP data show that Patient M.W. was
filling prescriptions for a benzodiazepine (alprazolam) at a different
pharmacy. RD, at 4-5 (Stip. 8), 7 (Stip. 12), 17, 61-62; Tr. 235-38,
268-69; GX 4a, at 2-3; GX 8a, at 1-2. Dr. Hamilton opined that
Respondent should have recognized that the prescriptions for these
three patients presented red flags and these red flags needed to be
properly resolved before dispensing. RD, at 17, 61-62; Tr. 203, 208,
237-38, 268-69.
Regarding other dangerous combinations, Dr. Hamilton found that
Patient J.C. was simultaneously filling prescriptions for a stimulant
(methylphenidate) and a depressant benzodiazepine (temazepam). RD, at
4-5 (Stip. 8); Tr. 240; GX 4a; GX 4d. Again, Dr. Hamilton opined that
these prescriptions presented red flags and Respondent needed to
properly resolve these red flags before dispensing. RD, at 18; Tr. 240.
As for Respondent's argument, Mr. Parrado testified that after he
reviewed prescriber and patient affidavits, he was of the opinion that
the drug combinations presented in this case did not raise a red flag
because the red flag was resolved ``originally and over time in [the
PIC's] continuing conversations with the patients and the doctors.''
RD, at 41; Tr. 574-75. As discussed supra, even assuming arguendo that
Respondent recognized the drug combination red flags and attempted to
resolve them, writing only ``verified'' on a prescription or patient
profile is not sufficient to actually resolve a red flag. Accordingly,
the Agency credits the testimony of Dr. Hamilton that the drug
combination red flags present in the prescriptions at issue were not
properly resolved prior to Respondent's dispensing.
The ALJ found, and the Agency agrees, that the standard of care in
Florida requires that prior to dispensing, a pharmacist document
resolution of the drug cocktail or drug-drug interaction red flags that
were present here due to simultaneous dispensing of opioids with
benzodiazepines and benzodiazepines with stimulants. RD, at 64 (citing
Tr. 185-86, 192, 203, 238, 273, 275-76). The ALJ found, and the Agency
agrees, that Respondent failed to do this, rendering Respondent's
dispensing practices outside the usual course of professional practice
and in violation of the Florida standard of care. Id.
Immediate-Release and High Dosage Opioids
According to Dr. Hamilton, prescriptions of opiates alone can
create red flags that have to be resolved before dispensing when: two
separate immediate-release opioids are prescribed (``therapeutic
duplication''); when opioids are prescribed in their highest strength
version; or when immediate-release opioids intended to treat acute pain
(as opposed to those intended to treat chronic pain) are prescribed for
extended periods of time (``incorrect drug dosage or duration of drug
treatment''). RD, at 18, 66; Tr. 198-200, 206, 216, 243; Fla. Admin.
Code section 64B16-27.810(b), (e). Regarding high dosages of opioids,
Dr. Hamilton testified that a dosage of 90 MMEs \16\ per day or greater
warrants caution when determining whether to fill the prescription. RD,
at 18-19; Tr. 208-210.\17\ Regarding immediate-release opioids
prescribed for extended durations, Dr. Hamilton opined that filling
immediate-release opioid prescriptions month-over-month for an extended
time \18\ is concerning and
[[Page 50375]]
constitutes a red flag that needs to be resolved before dispensing. RD,
at 20-21, 69; Tr. 206, 244, 253.
---------------------------------------------------------------------------
\16\ MME is a measurement of opioid strength based on milligram
units of morphine per day and MMEs for all opioids prescribed
concurrently are added together to determine the total MME per day.
RD, at 18 n.26; Tr. 209-212.
\17\ Dr. Hamilton testified that the red flag of a high dosage
of opioids can be justified if a patient is not opioid na[iuml]ve,
has been using opioids for an extended time, or has a ``certain
disease state'' such as cancer. RD, at 19, 66; Tr. 210, 341.
\18\ Dr. Hamilton did not testify as to a specific time period
that would cause concern, but made clear that taking immediate-
release opioids for ``30, 60 days maximum'' would be acceptable and
that over two years would be ``very concerning.'' RD, at 20; Tr.
205-206.
---------------------------------------------------------------------------
In reviewing Respondent's dispensing, Dr. Hamilton found that
Patients A.R. and J.K. were both filling prescriptions for a
combination of two immediate-release opioids (oxycodone-acetaminophen
10-325 with tramadol and oxycodone-acetaminophen 10-325 with oxycodone,
respectively). RD, at 3-4 (Stip. 6), 6-7 (Stip. 10), 19-20, 68; Tr.
199-200, 243-45; GX 2a, 2d. Dr. Hamilton opined that these instances of
therapeutic duplication constituted red flags that had to be resolved
before dispensing. RD, at 19-20, 68; Tr. 200, 208, 243, 245. Mr.
Parrado testified that for at least one of the patients prescribed two
simultaneous immediate-release opioids, Respondent originally had a
therapeutic duplication concern and ``spoke with a doctor'' who
resolved the concern, so there was ``no longer a concern'' and there
was ``no reason [for the Respondent] to continue doing anything else.''
RD, at 41; Tr. 571. However, when testifying on behalf of the
Government in Superior Pharmacy I & II, Mr. Parrado stated that a
pharmacy ``is never to dispense two immediate use opioids at once, at
the same time for the same patient.'' RD, at 43 (citing Superior
Pharmacy I & II, 81 FR 31327); Tr. 531.
As for immediate-release opioids prescribed for extended durations,
Dr. Hamilton found the following: Patient A.R was filling prescriptions
for immediate-release opioids (oxycodone-acetaminophen and tramadol)
over a span of approximately two years; Patient J.K. was filling
prescriptions for immediate-release opioids (oxycodone and oxycodone-
acetaminophen 10-325) over a span of approximately one-and-a-half-
years; Patient C.S. was filling prescriptions for an immediate-release
opioid (hydromorphone, at the highest strength,\19\ while an extended-
release version is available) over a span of approximately one-and-a-
half years; and Patients J.L. and M.W. were both filling prescriptions
for a high-strength, immediate-release opioid (oxycodone 30 mg) month-
over-month for approximately one-and-a-half years and approximately one
year, respectively. RD, at 3-4 (Stips. 6-7), 5-7 (Stips. 9-10, 12), 20-
21; Tr. 205-06, 218, 243-44, 253, 265; GX 2a; GX 2d; GX 3a; GX 3c; GX
5a; GX 5d; GX 6a; GX 6c; GX 8a; GX 8d. Dr. Hamilton opined that these
prescriptions presented red flags and Respondent needed to properly
resolve these red flags before dispensing. RD, at 20-21, 69; Tr. 206,
218. 244, 253, 265.
---------------------------------------------------------------------------
\19\ Dr. Hamilton opined that ``having the highest possible
strength of an immediate-release opiate is definitely a red flag.''
RD, at 20; Tr. 218.
---------------------------------------------------------------------------
Concerning high dosage opioid prescriptions, Dr. Hamilton found the
following: Patient A.R. was filling prescriptions for oxycodone-
acetaminophen 10-325 and tramadol that together totaled 120 MMEs per
day; Patient C.S. was filling prescriptions for hydromorphone at the
highest strength (8 mg) totaling as much as 260 MMEs per day; Patient
J.L. was filling prescriptions for oxycodone at the highest strength
(30 mg) totaling approximately 135 MMEs per day; Patient M.G. was
filling prescriptions for oxycodone at the highest strength (30 mg)
totaling between 135 and 270 MMES per day; and Patient M.W. was filling
prescriptions for oxycodone at dosages of either 15 mg or 30 mg
totaling between 90 and 265 MMEs per day. RD, at 3-4 (Stips. 6-7), 5-6
(Stip. 9), 7 (Stips. 11-12), 21-22; Tr. 210-12, 218, 253-55, 258, 260,
265, 267; GX 2a; GX 2d; GX 3a; GX 3c; GX 6a; GX 6c; GX 7a; GX 7d; GX
8a; GX 8d. Once more, Dr. Hamilton opined that these prescriptions
presented red flags that Respondent needed to properly resolve before
dispensing. RD, at 21-22, 70-71; Tr. 210-12, 218, 253-55, 258, 267.
As for Respondent's argument, Mr. Parrado testified generally that
based on his review of the records and conversations with Respondent's
PIC, there were no incorrect drug dose or duration of treatment red
flags because the patients had long-term pain and had developed opioid
tolerance as established through the PIC's purported conversations with
the patients and prescribers. RD, at 41; Tr. 575-76. As discussed
supra, even assuming arguendo that Respondent recognized these red
flags and attempted to resolve them, writing only ``verified'' on a
prescription or patient profile is not sufficient to actually resolve a
red flag. Accordingly, the Agency credits the testimony of Dr. Hamilton
that the therapeutic duplication and incorrect drug dosage or duration
of drug treatment red flags were not properly resolved prior to
Respondent's dispensing.
The ALJ found, and the Agency agrees, that the standard of care in
Florida requires that prior to dispensing, a pharmacist document
resolution of the therapeutic duplication red flags (prescribing of two
immediate-release opioids) and incorrect drug dosage or duration of
treatment red flags (immediate-release opioids prescribed for extended
durations and opioids prescribed in their highest strength) that were
present here. RD, at 73 (citing Tr. 185-86, 192, 273, 275-76). The ALJ
found, and the Agency agrees, that Respondent failed to do this,
rendering Respondent's dispensing practices outside the usual course of
professional practice and in violation of the Florida standard of care.
Id.
Alternating Between Cash and Insurance \20\
---------------------------------------------------------------------------
\20\ This Decision and Order does not address allegations
concerning the high cash payment/high pricing red flag due to the
number and egregiousness of the rest of the allegations.
---------------------------------------------------------------------------
According to Dr. Hamilton, a patient paying for some prescriptions
with insurance while paying for others with cash is a red flag, but
only for the prescriptions paid for in cash. RD, at 23; Tr. 231.
Concerning this issue, Dr. Hamilton found that Patient J.C. was paying
for some medications with insurance while paying for other, controlled
medications with cash, which was a red flag that needed to be resolved
before dispensing. RD, at 24; Tr. 240-41; GX 4d. Further, Dr. Hamilton
found that Patient M.W. was using cash to pay for oxycodone at
Respondent while using insurance to pay for alprazolam at a different
pharmacy. RD, at 24-25; Tr. 270; GX 8a. Again, Dr. Hamilton opined that
this was a red flag that needed to be resolved before dispensing. RD,
at 25; Tr. 270-71. Regarding Patient J.C. paying for his
methylphenidate prescription with cash, the PIC testified that he spoke
with Dr. R., Patient J.C.'s physician, about Patient J.C.'s
prescription and Dr. R. told the PIC that Patient J.C. had limited
insurance. RD, at 29 n.37; Tr. 461-62.
Again, as discussed supra, even assuming arguendo that Respondent
recognized these red flags and attempted to resolve them, writing only
``verified'' on a prescription or patient profile is not sufficient to
actually resolve a red flag. Accordingly, the Agency credits the
testimony of Dr. Hamilton that the red flag of alternating between cash
and insurance was not properly resolved prior to Respondent's
dispensing.
The ALJ found, and the Agency agrees, that the standard of care in
Florida requires that prior to dispensing, a pharmacist document
resolution of the red flag of alternating between cash and insurance
that was present here. RD, at 77 (citing Tr. 185-86, 192, 273, 275-76).
The ALJ found, and the Agency agrees, that Respondent failed to do
this, rendering Respondent's dispensing practices outside the usual
course of
[[Page 50376]]
professional practice and in violation of the Florida standard of care.
Id.\21\
---------------------------------------------------------------------------
\21\ Respondent argues in its Exceptions that none of the
prescriptions at issue were actually abused or diverted. Exceptions,
at 20-23. Nonetheless, Agency precedent is clear that proof of
actual, subsequent harm is not required when a registrant has acted
inconsistently with the public interest. Melanie Baker, N.P., 86 FR
23998, 24009 (2021); Larry C. Daniels, M.D., 86 FR 61630, 61660-61
(2021); Jeanne E. Germeil, M.D., 85 FR 73786, 73799 n.32 (2020).
---------------------------------------------------------------------------
II. Discussion
A. The Five Public Interest Factors
Under the 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 [its] registration under section 823 of this title
inconsistent with the public interest as determined under such
section.'' 21 U.S.C. 824(a). In making the public interest
determination, the CSA requires consideration of the following factors:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1).
The Agency considers these public interest factors in the
disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each
factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin.,
412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination
of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508
(1993).
The Government has the burden of proof in this proceeding. 21 CFR
1301.44. While the Agency has considered all of the public interest
factors in 21 U.S.C. 823(g)(1), the Government's evidence in support of
its prima facie case for revocation of Respondent's registration is
confined to Factors B and D. RD, at 52-53; see also id. at 52 n.58
(finding that Factors A, C, and E do not weigh for or against
revocation).
Having reviewed the record and the RD, the Agency agrees with the
ALJ, adopts the ALJ's analysis, and finds that the Government's
evidence satisfies its prima facie burden of showing that Respondent's
continued registration would be ``inconsistent with the public
interest.'' 21 U.S.C. 824(a)(4); RD, at 51-82.
B. Factors B and D
Evidence is considered under Public Interest Factors B and D when
it reflects compliance (or non-compliance) with laws related to
controlled substances and experience dispensing controlled substances.
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D.,
87 FR 21156, 21162 (2022). In the current matter, the Government has
alleged that Respondent violated numerous federal and state laws
regulating controlled substances. OSC/ISO, at 2-7.\22\ Specifically,
federal law requires that ``[a] prescription for a controlled substance
may only be filled by a pharmacist, acting in the usual course of his
professional practice,'' and that ``[a] prescription for a controlled
substance to be effective must be issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice.'' 21 CFR 1306.04(a), 1306.06; see also 21 U.S.C.
829. Federal law also emphasizes that although ``[t]he 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.'' 21 CFR
1306.04(a).\23\
---------------------------------------------------------------------------
\22\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC/ISO. Ruan v. United States, 142 S. Ct.
2370 (2022) (decided in the context of criminal proceedings).
\23\ Further, federal law ``prohibit[s] a pharmacist from
filling a prescription for a controlled substance when he either
knows or has reason to know that the prescription was not written
for a legitimate medical purpose.'' Id.
---------------------------------------------------------------------------
As for state law, Florida Administrative Code section 64B16-27.810
requires that, prior to dispensing, a pharmacist ``review the patient
record and each new and refill prescription . . . to promote
therapeutic appropriateness by identifying: (a) Over-utilization or
under-utilization; (b) Therapeutic duplication; (c) Drug-disease
contraindications; (d) Drug-drug interactions; (e) Incorrect drug
dosage or duration of drug treatment; (f) Drug-allergy interactions;
[and] (g) Clinical abuse/misuse.'' Fla. Admin. Code section 64B16-
27.810. The regulation further states that ``[u]pon recognizing any of
the above, the pharmacist shall take appropriate steps to avoid or
resolve the potential problems which shall, if necessary, include
consultation with the prescriber.'' Id. section 64B16-27.810(2).
In addition, Florida Administrative Code section 64B16-27.800
states that pharmacies ``shall'' maintain a ``patient record system,''
that ``provide[s] for the immediate retrieval of information necessary
for the dispensing pharmacist to identify previously dispensed drugs,''
and ``shall record any known allergies, drug reactions, idiosyncrasies,
and chronic conditions or disease states of the patient and the
identity of any other drugs, including over-the-counter drugs, or
devices currently being used by the patient which may relate to
prospective drug review.'' Fla. Admin. Code section 64B16-27.800(1)-
(2).\24\ It also states that ``[t]he pharmacist shall record any
related information indicated by a licensed health care practitioner.''
Id.
---------------------------------------------------------------------------
\24\ This regulation requires that pharmacists ``ensure that a
reasonable effort is made to obtain'' this information. Id. section
64B16-27.800(2).
---------------------------------------------------------------------------
Lastly, Florida Administrative Code section 64B16-27.831 states
that ``in filling valid prescriptions for controlled substances,''
pharmacists should ``exercise[e] sound professional judgment,'' and
``dispens[e] controlled substances for a legitimate medical purpose in
the usual course of professional practice'' considering ``each
patient's unique situation.'' Fla. Admin. Code section 64B16-27.831.
In the current matter, the Agency agrees with the ALJ's analysis
that Respondent's dispensing fell below the Florida standard of care--
and thus was outside the usual course of professional practice--
because, as detailed above, Respondent dispensed numerous controlled
substance prescriptions to seven patients without properly addressing
and resolving clear red flags of abuse and/or diversion including drug
cocktails, immediate-release and high dosage opioids, and patients
alternating between paying for prescriptions with cash and insurance.
See RD, at 51-82. As Respondent's conduct displays clear violations of
the federal and state regulations described above, the Agency agrees
with the ALJ and hereby finds that Respondent repeatedly violated
federal and state law relating to controlled substances. RD, at 81-82.
Accordingly, the Agency agrees with the ALJ and finds that Factors B
and D weigh in favor of revocation of Respondent's registration and
thus finds Respondent's continued registration to be inconsistent with
the public interest in balancing the factors of 21 U.S.C. 823(g)(1).
Id.
III. Sanction
Where, as here, the Government has established sufficient grounds
to revoke Respondent's registration, the burden
[[Page 50377]]
shifts to the registrant to show why it can be entrusted with the
responsibility carried by a registration. Garret Howard Smith, M.D., 83
FR 18882, 18910 (2018). When a registrant has committed acts
inconsistent with the public interest, it must both accept
responsibility and demonstrate that it has undertaken corrective
measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and 5195, 77 FR
62316, 62339 (2012) (internal quotations omitted). Trust is necessarily
a fact-dependent determination based on individual circumstances;
therefore, the Agency looks at factors such as the acceptance of
responsibility, the credibility of that acceptance as it relates to the
probability of repeat violations or behavior, the nature of the
misconduct that forms the basis for sanction, and the Agency's interest
in deterring similar acts. See, e.g., Robert Wayne Locklear, M.D., 86
FR 33738, 33746 (2021).
Here, and as noted by the ALJ, the PIC, as Respondent's pharmacy
manager, did not admit any fault or accept any responsibility for his
conduct in filling the prescriptions at issue. RD, at 83.\25\ As such,
the ALJ concluded, and the Agency agrees, that Respondent has not
demonstrated unequivocal acceptance of responsibility for its actions.
Id. at 84 (citing Jones Total Health Care Pharmacy, L.L.C. & SND Health
Care, L.L.C., 81 FR 79188, 79201-202 (2016)).\26\
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\25\ Nor did Respondent's owner, A.V., acknowledge any fault or
accept any responsibility for Respondent's improper dispensing
practices. Id. at 83-84.
\26\ When a registrant fails to make the threshold showing of
acceptance of responsibility, the Agency need not address the
registrant's remedial measures. Ajay S. Ahuja, M.D., 84 FR 5479,
5498 n.33 (2019) (citing Jones Total Health Care Pharmacy, 81 FR
79202-303); Daniel A. Glick, D.D.S., 80 FR 74800, 74801, 74,810
(2015). Even so, in the current matter, neither the PIC nor A.V.
outlined any remedial measures taken by Respondent. RD, at 83-84.
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In addition to acceptance of responsibility, the Agency considers
both specific and general deterrence when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR 74810. In this case, the
Agency agrees with the ALJ that given that the PIC filled many of the
prescriptions at issue, yet failed to acknowledge that any red flags
existed or required resolution, ``the interests of specific deterrence,
even standing alone, motivate powerfully in favor of revocation.'' RD,
at 85; Tr. 361, 363-76. Further, the Agency agrees with the ALJ that
the interests of general deterrence also support revocation, as a lack
of sanction in the current matter would send a message to the
registrant community that the failure to properly address and document
resolution of red flags can be excused. RD, at 85-86.
Moreover, the Agency agrees with the ALJ that Respondent's actions
were egregious. Id. at 84. As stated by the ALJ, ``Respondent dispensed
many controlled substances over a two-year period without any regard
for its obligations to identify, resolve, or document any red flags of
potential abuse or diversion'' and with awareness of both its
obligations and the existence of numerous red flags in the
prescriptions that it was filling and dispensing. Id. at 84-85.
In sum, Respondent has not offered any credible evidence on the
record that rebuts the Government's case for revocation of its
registration and Respondent has not demonstrated that it can be
entrusted with the responsibility of registration. Id. at 86.
Accordingly, the Agency will order that Respondent's registration be
revoked.\27\
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\27\ Regarding Respondent's additional assertions in its
Exceptions that the pharmacy being served with an OSC/ISO did not
allow it an opportunity to submit a corrective action plan
(Exceptions, at 30), the Agency notes that Respondent had ample
opportunity in presenting its case-in-chief to fully accept
responsibility for its improper practices and to offer remedial
measures, but Respondent failed to do so, see supra. Further,
regarding Respondent's noting that the PIC has never previously
faced disciplinary measures for his dispensing (Exceptions, at 29),
this point was addressed by the ALJ in considering Public Interest
Factors A, C, and E (see supra II.A.) and has been considered by the
Agency.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
FC1162382 issued to Coconut Grove Pharmacy. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Coconut Grove Pharmacy to renew
or modify this registration, as well as any other pending application
of Coconut Grove Pharmacy for additional registration in Florida. This
Order is effective July 15, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 6, 2024, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-12972 Filed 6-12-24; 8:45 am]
BILLING CODE 4410-09-P
