[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]


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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\
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    \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).
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    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.
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    \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.
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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\
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    \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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    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.
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    \9\ 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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    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.
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    \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.
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    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\
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    \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.
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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\
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    \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.
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    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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    \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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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.
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    \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.
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    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.
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    \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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    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\
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    \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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    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\
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    \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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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\
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    \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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    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.
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    \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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    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