[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Notices]
[Pages 75573-75579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20937]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 23-48]


Awesome Care Pharmacy, Inc.; Decision and Order

    On June 1, 2023, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO) to Awesome Care Pharmacy, Inc., (Respondent) of 
Houston, Texas. OSC/ISO, at 1. The OSC/ISO informed Respondent of the 
immediate suspension of its DEA Certificate of Registration Number 
FA2332346 (registration), 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. at 1 (quoting 21 U.S.C. 824(d)).\1\ 
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. 824(a)(4)).
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    \1\ Respondent argues in its Exceptions to the Recommended 
Decision (Exceptions) that the ISO ``led to the `wrongful takings' 
of its DEA license'' because the hearing established that no 
diversion occurred and there was ``no imminent harm, no harm, and no 
damage, threat or harm to the `public interest.' '' Exceptions, at 1 
(citing Tr. 8, 14, 52-53, 55, 69, 179-81, 192). However in this 
case, the evidence showed that Respondent repeatedly dispensed 
dangerous combinations of controlled substances that posed serious 
risks to patients without first resolving blatant red flags of drug 
abuse and diversion. Respondent's repeated dispensing of controlled 
substances outside the usual course of the professional practice and 
in violation of federal and state law established ``a substantial 
likelihood of an immediate threat that death, serious bodily harm, 
or abuse of a controlled substance . . . [would] occur in the 
absence of the immediate suspension'' of Respondent's registration. 
21 U.S.C. 824(d). Thus, the Agency finds that at the time the 
Government issued the OSC/ISO, there was clear evidence of imminent 
danger. Moreover, the immediate suspension aspect of the 
Government's case was final as of the date the OSC/ISO was issued by 
the Administrator, and is not the subject of these proceedings. 21 
U.S.C. 824(d)(1) (``A[n immediate] suspension . . . shall continue 
in effect until the conclusion of [administrative enforcement] 
proceedings, including judicial review thereof, unless sooner 
withdrawn by the Attorney General or dissolved by a court of 
competent jurisdiction.''); 21 CFR 1301.36(h) (``Any suspension 
shall continue in effect until the conclusion of all proceedings 
upon the revocation or suspension, including any judicial review 
thereof, unless sooner withdrawn by the Administrator or dissolved 
by a court of competent jurisdiction.'').
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    A hearing was held before DEA Administrative Law Judge Paul E. 
Soeffing (the ALJ), who, on February 6, 2024, issued his Recommended 
Rulings, Findings of Fact, Conclusions of Law, and Decision 
(Recommended Decision or RD), which recommended revocation of 
Respondent's registration. RD, at 59. Following the issuance of the RD, 
Respondent filed exceptions.\2\ Having reviewed the entire record, the 
Agency adopts and hereby incorporates by reference the entirety of the 
ALJ's rulings, credibility findings,\3\ findings of fact, conclusions 
of law, sanctions analysis, and recommended sanction as found in the RD 
and summarizes and clarifies portions thereof herein.\4\
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    \2\ The Agency has reviewed and considered the Respondent's 
exceptions and addresses them herein, but ultimately agrees with the 
ALJ's recommendation.
    \3\ The Agency adopts the ALJ's summary of each witness' 
testimony, as well as the ALJ's assessment of each witness' 
credibility, except as clarified herein. See RD, at 4-53.
    \4\ Respondent argues in its Exceptions that the ALJ was biased 
towards the Government. Respondent's only record support for this 
assertion is a citation to the transcript where the ALJ thanks the 
Government for printing certain documents in large enough font for 
him to read. Exceptions, at 3 (citing Tr. 46-47). Respondent cites 
no authority suggesting that the ALJ's expression of appreciation 
for a chosen font size reflects bias especially where, as here, the 
ALJ thanked both parties at the end of the hearing for their zealous 
advocacy. Tr. 522.
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 I. Findings of Fact

Texas Standard of Care

    Katherine Salinas testified as the Government's expert regarding 
the standard of care for pharmacy practice in the State of Texas. RD, 
at 6; Tr. 96-97. Ms. Salinas has been licensed as a pharmacist in Texas 
for over thirty years and has dispensed medications in retail 
pharmacies since 1992. RD, at 6; Tr. 89-91, 167. Ms. Salinas served as 
a Compliance Officer with the Texas Board for approximately nine years, 
where she inspected approximately 2,700 pharmacies, and she currently 
works as the Medication Safety and Drug Diversion Supervisor for the 
University of Texas Medical Branch. RD, at 6-7; Tr. 93-95.\5\
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    \5\ For Ms. Salinas's full qualifications, see RD, at 6-7, 
Government Exhibit (GX) 10.
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    Dr. Okpala, Respondent's owner and Pharmacist-in-Charge (PIC), 
testified on Respondent's behalf. Dr. Okpala testified that he has been 
licensed as a pharmacist in Texas since 1993. RD, at 20; Tr. 373, 376-
77; RX 2, at 2.\6\ The Agency agrees with the ALJ that Dr. Okpala has a 
significant personal interest in the outcome of these proceedings. RD, 
at 24. Additionally, the Agency finds that Dr. Okpala's testimony at 
times contradicted the language of Texas's regulations. Therefore, to 
the extent that Dr. Okpala's testimony diverges from the Texas 
regulations and the testimony of Ms. Salinas, the Agency will credit 
Ms. Salinas's testimony.\7\
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    \6\ The Agency incorporates herein the entire summary of Dr. 
Okpala's testimony. RD, at 19-24.
    \7\ The ALJ found Dr. Okpala's testimony to be ``generally 
credible,'' while noting that Dr. Okpala failed to lay an adequate 
foundation for his testimony that the patients in this case suffered 
from chronic pain. RD, at 24. The ALJ determined that ``[t]o the 
extent that [Dr. Okpala's] testimony differs from the testimony of 
other testifying witnesses, I will consider his personal interest in 
this case, and I will give his testimony the weight it deserves in 
light of other evidence and testimony presenting during the 
hearing.'' Id. The Agency agrees with the amount of weight that the 
ALJ afforded Dr. Okpala's testimony, except as clarified herein.
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    Ms. Salinas testified that the standard of care in Texas is 
informed by DEA regulations and Texas laws and regulations, including 
Texas Administrative Code Sec.  291.29(b), which requires pharmacists 
to ``make every reasonable effort to ensure that any prescription drug 
order . . . has been issued for a legitimate medical purpose by a 
practitioner in the course of medical practice.'' 22 Tex. Admin. Code 
Sec.  291.29(b); RD, at 7-8; Tr. 98-100. Ms.

[[Page 75574]]

Salinas testified that this obligation is known as the pharmacist's 
``corresponding responsibility,'' and it is the ``foundation . . . of 
good pharmacy practice.'' RD, at 7; Tr. 98, 327.
    Ms. Salinas testified that the Texas Administrative Code ``lists 
out several patterns that the pharmacist needs to be aware of to assess 
[a] prescription and determine if [it] was indeed issued for a 
legitimate medical purpose.'' RD, at 7; Tr. 98. Consistent with Ms. 
Salinas's testimony, Texas Administrative Code Sec.  291.29(f) states 
that ``[a] pharmacist shall make every reasonable effort to prevent 
inappropriate dispensing due to fraudulent, forged, invalid, or 
medically inappropriate prescriptions in violation of a pharmacist's 
corresponding responsibility,'' and provides a list of nineteen 
``patterns (i.e., red flag factors) [that] are relevant to preventing 
the non-therapeutic dispensing of controlled substances.'' 22 Tex. 
Admin. Code Sec.  291.29(f). The statute further states that these red 
flags ``shall be considered by evaluating the totality of the 
circumstances rather than any single factor.'' Id. Ms. Salinas 
testified that the statute's list of red flags is not exhaustive. RD, 
at 8; Tr. 98, 104-06. A red flag is ``anything that should make the 
pharmacist question [a] prescription and whether or not [it] is safe 
and appropriate.'' Tr. 106. Ms. Salinas identified some examples of red 
flags, including that multiple patients are receiving essentially the 
same pattern of prescriptions from a small number of prescribers, or 
that prescriptions are for commonly abused drugs, such as opioids, 
benzodiazepines, and cough syrups. Tr. 105.
    Ms. Salinas testified that a pharmacist should evaluate a 
prescription for red flags by looking at all of the details on the face 
of the prescription (e.g., name, address, date of birth, quantity of 
drug prescribed), checking the Prescription Monitoring Program (PMP), 
running a public search for the provider to see if there are any 
disciplinary orders, talking to the patient, and calling the 
prescribing doctor to discuss any potential red flags. RD, at 8; Tr. 
106-08. If the pharmacist identifies any red flags that indicate that 
the prescription might not be legitimate, then the pharmacist must 
attempt to resolve those red flags by ``taking into account [the] 
bigger picture,'' including conversations with the patient and 
prescriber, relevant statutes and laws, discussions with colleagues, 
and PMP data. RD, at 8, 10; Tr. 106-08, 209-10, 304-05, 307-08, 313, 
317-18, 327. Ms. Salinas testified that if the pharmacist determines 
that the red flag cannot be resolved, then the pharmacist should not 
fill the prescription. RD, at 8; Tr. 107. If, on the other hand, the 
pharmacist determines that the red flag can be resolved, Ms. Salinas 
testified that the pharmacist must document the resolution of the red 
flag, the rationale behind the decision to dispense the medication, and 
the pharmacist's discussions with the prescriber. RD, at 8-10; Tr. 107-
12, 142, 327.
    Consistent with Ms. Salinas's testimony, the Texas Administrative 
Code states that ``[p]rior to dispensing, any questions regarding a 
prescription drug order must be resolved with the prescriber and 
written documentation of these discussions made and maintained as 
specified in subparagraph (C) of this paragraph.'' 22 Tex. Admin. Code 
Sec.  291.33(c)(2)(A)(iv). Subparagraph C specifies that the following 
information about the pharmacist's consultation with the prescriber 
shall be documented ``on the prescription or in the pharmacy's data 
processing system associated with the prescription'': ``(i) date the 
prescriber was consulted; (ii) name of the person communicating the 
prescriber's instructions; (iii) any applicable information pertaining 
to the consultation; and (iv) initials or identification code of the 
pharmacist performing the consultation clearly recorded for the purpose 
of identifying the pharmacist who performed the consultation.'' Id. at 
Sec.  291.33(c)(2)(C); RD, at 9; Tr. 112. Ms. Salinas testified that 
the purpose of documentation is to show that the pharmacist saw the red 
flags and resolved them. RD, at 9; Tr. 112.
    Finally, the Texas Administrative Code requires pharmacists to 
``exercise sound professional judgment with respect to the accuracy and 
authenticity of any prescription drug order they dispense, which 
requires ``verify[ing] the order with the practitioner prior to 
dispensing'' ``[i]f the pharmacist questions the accuracy or 
authenticity of a prescription drug order.'' 22 Tex. Admin. Code Sec.  
291.34(b)(1)(A).

Respondent's Improper Dispensing

    Ms. Salinas testified that she reviewed Respondent's PMP history, 
dispensing history, and a subset of patient profiles, Tr. 115, and she 
testified about the red flags that she observed with the prescriptions 
for these patients, including drug cocktails, pattern prescribing, 
prescriptions lacking diagnosis codes, patients receiving controlled 
substances from multiple prescribers, and gaps in prescriptions 
exceeding one month. RD, at 11-19.
Drug Cocktails
    One of the potential red flags identified by the Texas 
Administrative Code is when ``prescriptions by a prescriber . . . are 
routinely for controlled substances commonly known to be abused drugs, 
including opioids, benzodiazepines, muscle relaxants, . . . or any 
combination of these drugs.'' 22 Tex. Admin. Code Sec.  291.29(f)(3). 
Ms. Salinas testified that a combination of drugs is referred to as a 
``drug cocktail.'' RD, at 11; Tr. 122, 328-29. For example, when 
combined, hydrocodone (an opioid) and carisoprodol (a muscle 
relaxant)--which are both highly abusable on their own--can create a 
potentially dangerous drug cocktail that increases the risk of 
respiratory depression, overdose, or death. RD, at 11; Tr. 118-22, 136, 
143, 147, 153, 290, 328-29.\8\ Ms. Salinas testified that the risks to 
patients from taking these drugs together continue for as long as they 
are taking them, not just the first time they are prescribed. RD, at 
11; Tr. 329. In this case, Ms. Salinas testified that A.T., T.B., K.B., 
and S.D. were all receiving a dangerous cocktail of hydrocodone and 
carisoprodol. RD, at 11; Tr. 118-22, 136, 143, 147, 153, 328-29.
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    \8\ DI Fernandez similarly testified that hydrocodone-
acetaminophen and carisoprodol are ``very popular in Houston and are 
highly diverted,'' and they are considered ``a dangerous 
combination.'' RD, at 34; Tr. 24-25.
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    As for Respondent, Dr. Okpala testified that the combination of 
hydrocodone-acetaminophen and carisoprodol did not present a red flag 
because these medications are combined to produce a ``synergistic 
effect'' that is more effective for treating chronic pain. RD, at 34-
35; Tr. 419-20, 457. However, Dr. Okpala did not produce adequate 
evidence that these patients actually suffered from chronic pain or 
that these drugs were prescribed together to produce a synergistic 
effect. Nor did Dr. Okpala acknowledge that these drugs can be very 
dangerous when combined. Thus, the ALJ found, and the Agency agrees, 
that the frequent prescribing of the drug cocktail of hydrocodone and 
carisoprodol was a red flag that Respondent should have identified, 
resolved, and documented prior to dispensing. RD, at 36.
Pattern Prescribing
    The Texas Administrative Code identifies several red flags that Ms. 
Salinas referred to as ``pattern prescribing,'' including that: (1) the 
pharmacy ``dispenses a reasonably discernible pattern of substantially 
identical prescriptions for the same controlled substances, potentially

[[Page 75575]]

paired with other drugs, for numerous persons, indicating a lack of 
individual drug therapy in prescriptions issued by the practitioner,'' 
22 Tex. Admin. Code Sec.  291.29(f)(1); (2) ``the pharmacy operates 
with a reasonably discernible pattern of overall low prescription 
dispensing volume, maintaining relatively consistent [one-to-one] ratio 
of controlled substances to dangerous drugs and/or over-the-counter 
products dispensed as prescriptions,'' id. at Sec.  291.29(f)(2); and/
or (3) ``prescriptions for controlled substances are commonly for the 
highest strength of the drug and/or for large quantities (e.g., monthly 
supply), indicating a lack of individual drug therapy in prescriptions 
issued by the practitioner,'' id. at Sec.  291.29(f)(5). RD, at 11-12; 
Tr. 129, 339.
    In this case, Ms. Salinas testified that Respondent's dispensing to 
A.T., T.B., K.B., and S.D. reflected a repeated pattern of large 
quantities of carisoprodol and hydrocodone in the highest strength 
available. RD, at 12, 37; Tr. 118-19, 132-33, 136, 143, 147, 339. The 
highest strength of carisoprodol is 350 mg, and Respondent frequently 
dispensed 60 to 80 tablets per month to patients. RD, at 12; Tr. 121. 
The highest strength of hydrocodone-acetaminophen is 10/325 mg, and 
Respondent frequently dispensed quantities exceeding 100 tablets per 
month to patients, which Ms. Salinas testified is a red flag. RD, at 
12, 37; Tr. 120-21, 143. Ms. Salinas testified that hydrocodone-
acetaminophen is highly addictive and is ``one of the pattern drugs 
that [she sees] most often . . . with patterns of . . . abuse.'' RD, at 
12-13; Tr. 120-21, 149. Ms. Salinas testified that hydrocodone is best 
when limited to short-term use, so it is a red flag to see hydrocodone 
prescribed month after month. RD, at 12-13, 37; Tr. 122, 143, 148-51, 
339-40. Ms. Salinas testified that hydrocodone may be prescribed for 
over three months to patients suffering from chronic pain,\9\ but the 
pharmacist must still exercise the ``corresponding responsibility to 
determine if that [is] appropriate.'' Tr. 150. Ms. Salinas also 
testified that Respondent often dispensed hydrocodone and carisoprodol 
along with non-controlled drugs, such as ibuprofen, naproxen, or 
multivitamins, reflecting the one-to-one ratio identified in the Texas 
Administrative Code. RD, at 11; Tr. 121-22, 129, 153.
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    \9\ Ms. Salinas testified that chronic pain is pain that ``lasts 
greater than three months.'' RD, at 14 n.51; Tr. 150.
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    As for Respondent, Dr. Okpala testified that the repeated 
prescriptions for maximum-strength controlled substances in large 
quantities over multiple months did not present a red flag because 
these patients all had chronic pain. RD, at 39; Tr. 406-08, 490, 497, 
510. However, the ALJ found, and the Agency agrees, that Dr. Okpala did 
not present sufficient evidence to establish that these patients had 
chronic pain. RD, at 39. Dr. Okpala testified that he concluded that 
they had chronic pain based on the frequency they saw their prescribing 
doctors,\10\ the conversations and interactions he had with the 
patients and prescribers, and the types of medications prescribed. RD, 
at 39; Tr. 406-08, 490, 497, 510. Dr. Okpala testified that it was 
``common sense'' for a pharmacist to conclude that a patient suffers 
from chronic pain when the patient is receiving monthly prescriptions 
for hydrocodone-acetaminophen. RD, at 39; Tr. 342, 497. He further 
testified that knowing the cause of the patients' pain would not impact 
his decision to dispense the prescriptions presented in this case. RD, 
at 52; Tr. 501
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    \10\ The ALJ found, and the Agency agrees, that Dr. Okpala's 
testimony that he knew the patients had chronic pain based on the 
frequency of their visits was concerning. RD, at 39. As the ALJ 
noted, the fact ``[t]hat these patients frequently visited 
prescribers and received repeated prescriptions for high quantities 
and similar dosage units of controlled substances on a monthly basis 
is the very red flag indicative of a lack of personalized care 
identified by Ms. Salinas and the Texas Administrative Code.'' Id.
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    However, Ms. Salinas testified that the nature of the drug 
prescribed does not communicate a diagnosis to the pharmacist, and the 
pharmacist should not assume why the drug was prescribed. RD, at 16; 
Tr. 306, 329-30. Moreover, Ms. Salinas testified that there was no 
documentation on the prescriptions suggesting that the repeated 
hydrocodone prescriptions were for chronic pain. RD, at 15, 41-42; Tr. 
150-51, 251-55. Finally, even assuming that Respondent did discuss the 
diagnoses with the patients or prescribers, the lack of any 
documentation of those conversations renders Respondent's dispensing 
outside of the standard of care. RD, at 14, 38; Tr. 150-51; 22 Tex. 
Admin. Code Sec.  291.33(c)(2)(A)(iv).
    Thus, the ALJ found, and the Agency agrees, that repeated 
prescriptions for high quantities and high strengths of commonly-abused 
drugs, sometimes in combination with non-controlled substances in a 
one-to-one ratio, was a red flag that Respondent should have 
identified, resolved, and documented prior to dispensing. RD, at 39-40.
Prescriptions Lacking Specific Diagnoses
    Another potential red flag identified by the Texas Administrative 
Code is when prescriptions for controlled substances ``contain 
nonspecific or no diagnoses, or lack the intended use of the drug.'' 22 
Tex. Admin. Code Sec.  291.29(f)(4); RD, at 14; Tr. 128. Ms. Salinas 
testified that the diagnosis code is especially important when 
hydrocodone or carisoprodol is prescribed, because those medications 
are a red flag. RD, at 14; Tr. 127. Ms. Salinas testified that in this 
case, there was generally no documentation on the face of a 
prescription related to a patient's diagnosis, so she could not 
determine whether a patient was being prescribed hydrocodone for 
chronic or acute pain, which may impact the length of time a patient is 
prescribed hydrocodone. RD, at 15; Tr. 150-51. Ms. Salinas testified 
that diagnoses of ``pain'' or ``chronic pain syndrome'' are not 
specific enough under the Texas Administrative Code, and should trigger 
a red flag analysis. RD, at 15; Tr. 331-32. Ms. Salinas testified that 
she was unable to determine the purpose of the prescriptions or the 
type of pain that the medications were intended to treat. RD, at 15-16; 
Tr. 252-53, 329.
    As for Respondent, Dr. Okpala presented conflicting testimony 
regarding whether ``pain'' was a diagnosis, but ultimately testified 
that pain may be used as a diagnosis. RD, at 42; Tr. 484-85. Dr. Okpala 
also testified that neither DEA nor Texas regulations requires the 
inclusion of diagnosis codes on the face of a prescription. RD, at 42; 
Tr. 448, 507. Finally, Dr. Okpala testified that he knew that the 
patients in this case had chronic pain, although the Agency found above 
that this conclusion was not adequately supported.
    The ALJ found, and the Agency agrees, that Ms. Salinas's testimony 
was more credible on this issue because it was supported by the 
relevant provisions of the Texas Administrative Code, which identify 
nonspecific diagnosis codes as a relevant red flag factor. RD, at 42; 
22 Tex. Admin. Code Sec.  291.29(f)(4). Thus, the ALJ found, and the 
Agency agrees, that the lack of specific diagnoses to justify the 
controlled substance prescriptions was a red flag that Respondent 
should have identified, resolved, and documented prior to dispensing. 
RD, at 42-43.
Gaps in Prescriptions
    Ms. Salinas testified that another potential red flag is when gaps 
between usually-consistent monthly

[[Page 75576]]

prescriptions exceed a month, because this indicates that the patient 
is not taking the controlled substance as prescribed. RD, at 18, 48-49; 
Tr. 140. Ms. Salinas testified that if a pharmacist observes a gap, the 
pharmacist should have a discussion with the patient to ensure that the 
patient is taking the medication correctly and document that 
discussion. RD, at 18-19; Tr. 140, 142. The pharmacist should also 
contact the prescribing physician to determine the purpose of the gap, 
and document that conversation if the red flag is resolved. RD, at 19; 
Tr. 341-42. The ALJ found, and the Agency agrees, that gaps between 
prescriptions exceeding one month was a red flag that Respondent should 
have identified, resolved, and documented prior to dispensing. RD, at 
49-50.\11\
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    \11\ Respondent, through counsel, argued in its closing argument 
that the Government is improperly tasking Respondent with 
communicating with prescribers during time periods where 
prescriptions are not presented to the pharmacy. RD, at 49; Tr. 520. 
Respondent argued that ``[t]he societal interest, including that of 
pharmacies, is to minimize the use and abuse of opioids,'' and thus 
Respondent should not be responsible for communicating with 
physicians when a patient is not prescribed controlled substances 
after previous, repeated monthly prescriptions. RD, at 49; Tr. 521. 
The ALJ found, and the Agency agrees, that this argument 
misconstrues Ms. Salinas's testimony. RD, at 49. According to Ms. 
Salinas, lengthy gaps in habitual prescriptions provides evidence of 
potential abuse and diversion. RD, at 49; Tr. 140. Ms. Salinas is 
not testifying that Respondent must attempt to dispense more 
medication to a patient when that patient is not issued the typical 
monthly prescription. RD, at 49. Rather, Respondent must contact the 
prescribing physician and document that communication when a patient 
returns to the pharmacy to receive the previously regular medication 
after a significant gap in treatment. Id.; Tr. 140-42, 154, 341-42. 
Aside from the argument presented in its closing statement, the 
Respondent presented no evidence to rebut Ms. Salinas's expert 
testimony that gaps between prescriptions presented a red flag that 
required documented resolution prior to dispensing. RD, at 49. 
Therefore, the Agency agrees with the ALJ and credits Ms. Salinas's 
unrebutted expert testimony about this red flag. Id. at 49-50.
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Respondent's Dispensing to A.T., T.B., K.B., and S.D.

    Ms. Salinas testified in more detail about the prescriptions that 
she reviewed for A.T., T.B., K.B., and S.D. Ms. Salinas testified that 
she identified the following red flags with the prescriptions that 
Respondent dispensed to A.T.: (1) A.T. was receiving pattern 
prescriptions for a dangerous cocktail of hydrocodone and carisoprodol, 
RD, at 12; Tr. 118-19, 120-21; (2) A.T. was receiving the same 
controlled substances from at least six prescribers,\12\ RD, at 17; Tr. 
118-19, 136-38; (3) A.T. was also receiving non-controlled substances, 
such as ibuprofen and biofreeze, which implicates the one-to-one 
controlled to non-controlled substances pattern identified in the Texas 
Administrative Code, RD, at 17; Tr. 132, 137-38; (4) A.T. repeatedly 
received a high quantity of carisoprodol along with a high quantity of 
hydrocodone, which is a strong opioid that is best when limited to 
short-term use, RD, at 12; Tr. 119, 122-23; (5) many of A.T.'s 
prescriptions lacked a diagnosis code or any language indicating the 
purpose of the prescription, and others contained a non-specific 
diagnosis code of ``chronic pain syndrome,'' RD, at 15; Tr. 136-37, 
331-32; GX 2, at 10-11, 84; and (6) there was a gap in A.T.'s 
prescriptions of over a month that indicated that she was not taking 
the medications as prescribed, RD, at 18-19; Tr. 139-41. Ms. Salinas 
testified that there was no documentation indicating that Respondent 
identified or resolved any of these red flags, and that Respondent 
therefore failed to exercise its corresponding responsibility and abide 
by the standard of care in its dispensing to A.T. RD, at 9; Tr. 
139.\13\
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    \12\ The Texas Administrative Code identifies patients 
``obtaining similar drugs from multiple practitioners'' as a 
potential red flag factor, and Ms. Salinas testified that this is a 
common red flag that must be identified, resolved, and documented 
prior to dispensing. 22 Tex. Admin. Code Sec.  291.29(f)(10); RD, at 
16; Tr. 123-34; 340. The ALJ found that the Government had not 
proven that multiple prescribers was a red flag in this case because 
Dr. Okpala testified that several of the prescribers worked together 
in a group practice, that he visited the group practice frequently 
to ensure that the patients were being treated appropriately, and 
that he maintained professional relationships with all of the 
prescribers. RD, at 23, 43-47; Tr. 386-89, 391, 394, 398-99, 406, 
467, 490, 502. However, Dr. Okpala's testimony on this issue is more 
relevant to whether the red flag of multiple prescribers can be 
resolved in this case, not whether multiple prescribers is a red 
flag that warrants follow up. Dr. Okpala's testimony actually 
supports the conclusion that multiple prescribers was a red flag. He 
testified that he visited the group practice on at least twenty 
occasions to ``make sure [the prescribers] [did] what [they were] 
supposed to do for patients,'' RD, at 23, 44; Tr. 387-89, 391, 394, 
which suggests that he felt the need to surveil the clinic, and he 
even testified that the doctors told him, ``okay, if you're doubting 
me, stay there and watch.'' Tr. 393. Thus, the Agency credits Ms. 
Salinas's credible expert testimony, as supported by Texas law, that 
multiple prescribers was a red flag that should have been 
identified, resolved, and documented. Dr. Okpala did not document 
any of his discussions with the prescribers or any other steps that 
he took to resolve this red flag, which is required by Texas law and 
the standard of care. 22 Tex. Admin. Code Sec.  291.33(c)(2)(A)(iv); 
RD, at 8-10; Tr. 107-12, 142, 327. Even without this finding, the 
combination of other red flags is ``so suspicious as to support a 
finding that the pharmacists who filled them violated their 
corresponding responsibility due to actual knowledge of, or willful 
blindness to, the prescriptions' illegitimacy.'' Lewisville Medical 
Pharmacy, 87 FR at 59,459 (citing The Pharmacy Place, 86 FR 21,008, 
21,013 (collecting Agency decisions)).
    \13\ For more details about the prescriptions that Respondent 
filled for A.T. without identifying and resolving these red flags, 
see RD, at 30-50; GX 2-3.
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    Ms. Salinas testified that she identified the following red flags 
with the prescriptions that Respondent dispensed to T.B.: (1) T.B. was 
receiving pattern prescriptions for a dangerous cocktail of hydrocodone 
and carisoprodol, RD, at 11, Tr. 132-22; GX 5; (2) T.B. was also 
receiving non-controlled substances, such as ibuprofen and lisinopril, 
which implicates the one-to-one controlled to non-controlled substances 
pattern identified in the Texas Administrative Code, RD, at 12-13; Tr. 
129-30, 131-32; GX 5; (3) T.B. was receiving these medications from 
multiple prescribers, RD, at 13, 17; Tr. 130-33; (4) T.B. repeatedly 
received a high quantity of carisoprodol along with a high quantity of 
hydrocodone (always over 100 tablets), which is a strong opioid that is 
best when limited to short-term use, RD, at 12-13; Tr. 122-23, 129-33; 
and (5) none of T.B.'s prescriptions for a fifteen-month period 
contained diagnosis codes. RD, at 15; Tr. 125-126, 333-34. Ms. Salinas 
testified that there was no documentation indicating that Respondent 
identified or resolved any of these red flags, and that Respondent 
therefore failed to exercise its corresponding responsibility and abide 
by the standard of care in its dispensing to A.T. RD, at 9; Tr. 134-
35.\14\
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    \14\ For more details about the prescriptions that Respondent 
filled for T.B. without identifying and resolving these red flags, 
see RD, at 30-50; GX 4-5.
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    Ms. Salinas testified that she identified the following red flags 
with the prescriptions that Respondent dispensed to K.B.: (1) K.B. was 
receiving pattern prescriptions for a dangerous cocktail of hydrocodone 
and carisoprodol in the same quantity each month, RD, at 11, 13; Tr. 
143; GX 7; (2) K.B. was also receiving non-controlled substances, such 
as ibuprofen and biofreeze, which implicates the one-to-one controlled 
to non-controlled substances pattern identified in the Texas 
Administrative Code, RD, at 17; Tr. 129-32, 144-45; GX 6, at 1-2; (3) 
K.B. was receiving these medications from multiple prescribers, RD, at 
17; Tr. 143-45; GX 6 at 1-2; (4) K.B. repeatedly received a high 
quantity of hydrocodone (over 100 tablets), which is a strong opioid 
that is best when limited to short-term use, RD, at 13; Tr. 122-23, 
143; and (5) the vast majority of K.B.'s prescriptions lacked a 
diagnosis code. RD, at 15; Tr. 143-44; GX 6, at 24-25. Ms. Salinas 
testified that there was no documentation indicating that Respondent 
identified or resolved any of these red flags, and that Respondent

[[Page 75577]]

therefore failed to exercise its corresponding responsibility and abide 
by the standard of care in its dispensing to K.B. RD, at 9; Tr. 146, 
155; GX 6, 7.\15\
---------------------------------------------------------------------------

    \15\ For more details about the prescriptions that Respondent 
filled for K.B. without identifying and resolving these red flags, 
see RD, at 30-50; GX 6-7.
---------------------------------------------------------------------------

    Ms. Salinas testified that she identified the following red flags 
with the prescriptions that Respondent dispensed to S.D: (1) S.D was 
receiving pattern prescriptions for a dangerous cocktail of hydrocodone 
and carisoprodol in the same quantity each month, RD, at 11, 13; Tr. 
147; GX 9; (2) S.D. was also receiving non-controlled substances, such 
as gabapentin and naproxen, which implicates the one-to-one controlled 
to non-controlled substances pattern identified in the Texas 
Administrative Code, RD, at 13; Tr. 153; (3) S.D. was receiving these 
medications from multiple prescribers, RD, at 17; Tr. 132, 147, 151-52; 
GX 8 at 1-2; (4) S.D. repeatedly received a high quantity of 
hydrocodone, which is a strong opioid that is best limited to short-
term use, RD, at 13; Tr. 122-23, 147; (5) none of S.D.'s prescriptions 
contain diagnosis codes, RD, at 15; Tr. 151; GX 8, at 9-10; and (6) 
there were gaps in S.D's prescriptions that indicated that S.D. was not 
taking the medications as prescribed. RD, at 19; Tr. 154. Ms. Salinas 
testified that there was no documentation indicating that Respondent 
identified or resolved any of these red flags, and that Respondent 
therefore failed to exercise its corresponding responsibility and abide 
by the standard of care in its dispensing to S.D. RD, at 9; Tr. 153-54; 
GX 8, 9.\16\
---------------------------------------------------------------------------

    \16\ For more details about the prescriptions that Respondent 
filled for S.D. without identifying and resolving these red flags, 
see RD, at 30-50; GX 8-9.
---------------------------------------------------------------------------

    As for Respondent, Dr. Okpala testified that he did not observe any 
red flags with any of the prescriptions in this case, so there was 
``[n]othing to resolve'' and nothing to document. Tr. 402. Respondent's 
counsel asked Dr. Okpala what he did if he encountered 
``[prescriptions] that looked like red flags,'' and Dr. Okpala 
testified that he would follow up, call physicians, and speak to 
patients. RD, at 21; Tr. 402, 467, 479-80. Dr. Okpala testified that he 
``did that on all these prescriptions.'' Tr. 467. When Government 
counsel asked Dr. Okpala why there were no notes on the prescriptions 
or in the patient file, Dr. Okpala replied, ``I mean, I know the 
patients; I know the doctors. I did my job professionally as a 
pharmacist, and I used my professional judgment, and that's what I 
did.'' Tr. 480.
    Dr. Okpala's testimony that the prescriptions in this case did not 
present any red flags is simply not credible. The patterns presented by 
these prescriptions are specifically identified in the Texas 
Administrative Code as potential red flag factors, and Ms. Salinas 
offered credible expert testimony with respect to each red flag. Dr. 
Okpala testified that he took steps to verify the legitimacy of these 
prescriptions, despite his belief that there were no red flags. 
However, even assuming arguendo that Dr. Okpala did take these steps 
for the relevant prescriptions, he did not document his actions as 
required by the Texas standard of care. Moreover, it is unclear what 
Dr. Okpala would have discussed with the patients and physicians if he 
did not believe that any red flags existed. RD, at 51. Therefore, the 
Agency does not credit Dr. Okpala's testimony that these prescriptions 
did not present red flags, or that Dr. Okpala satisfied his obligation 
to ensure that there were no red flags. RD, at 51.
    Thus, the ALJ found, and the Agency agrees, that the standard of 
care in Texas requires that any red flags present for a prescription 
must be resolved before dispensing and that the resolution must be 
documented. RD, at 27-53. The ALJ also found, and the Agency agrees, 
that Respondent failed to do this, rendering Respondent's dispensing to 
A.T., T.B., K.B., and S.D. outside the usual course of professional 
practice and in violation of the Texas standard of care. Id. The Agency 
further finds that Respondent failed to exercise sound professional 
judgment in filling the prescriptions in this case. RD, at 9; Tr. 328.

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 15,227, 15,230 (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 37,507, 
37,508 (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 27-33; see also id. at 27 n.78 
(finding that Factors A, C, and E do not weigh for or against 
revocation \17\).
---------------------------------------------------------------------------

    \17\ Regarding Respondent's argument that the lack of 
disciplinary action against Respondent or Dr. Okpala was not given 
appropriate weight in the public interest analysis (Exceptions, at 
2-3), this point was addressed by the ALJ in considering Public 
Interest Factors A, C, and E and the Agency agrees with the ALJ's 
analysis.
---------------------------------------------------------------------------

    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 27-54.

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 21,156, 21,162 (2022). In the current matter, the Government has 
alleged that Respondent violated numerous federal and state laws 
regulating controlled substances. OSC/ISO, at 2-9. 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

[[Page 75578]]

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). 
DEA has consistently interpreted this provision as prohibiting 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.'' Medicine Shoppe-
Jonesborough, 73 FR 364, 381 (2008) (citing Medic-Aid Pharmacy, 55 FR 
30,043, 30,044 (1990)). DEA has further held that ``[w]hen 
prescriptions are clearly not issued for legitimate medical purposes, a 
pharmacist may not intentionally close his eyes and thereby avoid 
[actual] knowledge of the real purpose of the prescription.'' Ralph J. 
Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730 (1990).
    As for state law, Texas Administrative Code Sec.  291.29(b) 
requires pharmacists to ``make every reasonable effort to ensure that 
any prescription drug order . . . has been issued for a legitimate 
medical purpose by a practitioner in the course of medical practice.'' 
22 Tex. Admin. Code Sec.  291.29(b). The statute further requires 
pharmacists to ``make every reasonable effort to prevent inappropriate 
dispensing due to fraudulent, forged, invalid, or medically 
inappropriate prescriptions in violation of a pharmacist's 
corresponding responsibility,'' by considering a list of nineteen 
``patterns (i.e., red flag factors) [that] are relevant to preventing 
the non-therapeutic dispensing of controlled substances.'' Id. Sec.  
291.29(f). These red flag factors ``shall be considered by evaluating 
the totality of the circumstances rather than any single factor.'' Id.
    In addition, Texas law requires pharmacists to ``exercise sound 
professional judgment with respect to the accuracy and authenticity of 
any prescription drug order they dispense,'' which requires 
``verify[ing] the order with the practitioner prior to dispensing'' 
``[i]f the pharmacist questions the accuracy or authenticity of a 
prescription drug order.'' Id. 291.34(b)(1)(A). Finally, Texas law 
requires that ``[p]rior to dispensing, any questions regarding a 
prescription drug order must be resolved with the prescriber and 
written documentation of these discussions made and maintained . . . 
.'' Id. Sec.  291.33(c)(2)(A)(iv).
    In the current matter, the Agency agrees with the ALJ's analysis 
that Respondent's dispensing fell below the Texas standard of care, and 
thus was outside the usual course of professional practice, because, as 
detailed above, Respondent dispensed numerous controlled substance 
prescriptions to four patients without properly addressing and 
resolving clear red flags of abuse and diversion including dangerous 
drug cocktails, pattern prescriptions for high doses and quantities of 
commonly abused controlled substances, and patients receiving 
controlled substances from multiple prescribers. See RD, at 27-53.
    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 27-53. Accordingly, the 
Agency 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.
Respondent's Exceptions
    Respondent argues in its Exceptions that the determination of 
whether a red flag exists is subjective and it is made by the 
pharmacist based on the totality of circumstances at the time of 
dispensing. Exceptions, at 3, 8-11. Respondent argues that the ALJ 
erred by giving more weight to Ms. Salinas's testimony about the 
existence of red flags than to Dr. Okpala's, because ``an expert 
witness's testimony cannot replace the subjective thoughts of a 
pharmacist when they are filling a prescription.'' Id. Respondent 
further argues that the duty to resolve and document the resolution of 
a red flag only arises if the pharmacist subjectively determines that a 
red flag exists. Id.
    The Agency has repeatedly rejected these arguments. In a recent 
case in Texas, the respondent's owner and PIC testified, like Dr. 
Okpala, that red flags explicitly listed in Texas law were not actually 
red flags, and that there is no duty to document if the pharmacist does 
not identify any red flags. Lewisville Medical Pharmacy, 87 FR 59,456, 
59,459 (2022). The Agency found that this testimony was ``evidence that 
Respondent was willfully blind to red flags on the prescriptions it 
filled,'' and that it ``evidences, at best, a deep and endemic 
understanding of Texas and federal law.'' Id. at 59,459-60. Here, the 
Agency likewise finds that Dr. Okpala's testimony reflects a troubling 
indifference towards Texas law and supports a finding that he was 
willfully blind to the numerous red flags presented by the 
prescriptions in this case.
    Respondent also argues in its Exceptions that Dr. Okpala knew that 
the prescriptions were issued for a legitimate medical purpose because 
he had spoken to the doctors and he knew that they had valid doctor-
patient relationships with the patients at issue. Exceptions, at 7-10. 
This argument again reflects a deep misunderstanding of a pharmacist's 
professional obligations under federal and Texas law. A pharmacist must 
always exercise his corresponding responsibility to identify, resolve, 
and document red flags, even where the prescriptions are ultimately 
determined to be legitimate, and even where there ultimately is a valid 
doctor-patient relationship. Respondent undeniably failed to fulfill 
this obligation. Respondent's Exception also implies that every 
prescription that is issued in a valid doctor-patient relationship is 
legitimate, but Respondent offers no support for this assertion. And 
regardless of whether Respondent believed that the prescribers in this 
case had valid doctor-patient relationships with their patients, the 
evidence overwhelmingly suggests that the prescriptions that they 
issued were not legitimate. Prior Agency decisions have consistently 
found that prescriptions with a similar list of red flags were ``so 
suspicious as to support a finding that the pharmacists who filled them 
violated their corresponding responsibility due to actual knowledge of, 
or willful blindness to, the prescriptions' illegitimacy,'' \18\ and 
Ms. Salinas credibly testified that there were numerous red flags that 
created doubt as to whether the prescriptions in this case were 
legitimate. RD, at 9; Tr. 336. Ms. Salinas's testimony that the 
prescriptions raised numerous suspicions--such as repeated pattern 
prescriptions for high-dose opioids and dangerous combinations of 
controlled substances--stands in stark contrast to Dr. Okpala's 
testimony that it was ``common sense'' to assume that hydrocodone was 
permissibly being prescribed for chronic pain. RD, at 39; Tr. 342, 497. 
This testimony reflects a troubling indifference towards the dangers 
posed by repeated prescriptions for a Schedule II controlled substance, 
and it further reinforces that Dr. Okpala does not understand his 
corresponding responsibility.
---------------------------------------------------------------------------

    \18\ Lewisville Medical Pharmacy, 87 FR at 59,459 (citing The 
Pharmacy Place, 86 FR 21,008, 21,013 (collecting Agency decisions)).
---------------------------------------------------------------------------

    Finally, Respondent argues in its Exceptions that the Government 
failed to prove that the prescriptions were

[[Page 75579]]

invalid, that they were issued for non-therapeutic purposes, or that 
Respondent dispensed them inaccurately. Exceptions, at 2, 7-8. Again, 
Respondent's Exception misconstrues the applicable legal standard. The 
Government need not demonstrate that a prescription was invalid, non-
therapeutic, or illegitimate in order to prove that a pharmacist 
violated his corresponding responsibility. The Government need only 
prove that the pharmacist failed to identify, resolve, and document red 
flags presented by a prescription, which, here, Respondent repeatedly 
failed to do.

III. Sanction

    Where, as here, the Government has established sufficient grounds 
to revoke Respondent's registration, the burden 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 18,882, 
18,910 (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 62,316, 62,339 (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 33,738, 33,746 
(2021).
    Here, and as noted by the ALJ, Respondent's PIC explicitly denied 
any responsibility for repeatedly filling prescriptions in violation of 
state and federal law. RD, at 55. Dr. Okpala repeatedly testified that 
he did not observe any red flags with any of the prescriptions in this 
case and that he strictly follows the relevant law and regulations. RD, 
at 55; Tr. 402, 414-15, 452, 460, 467, 474-75, 503. As such, the ALJ 
concluded, and the Agency agrees, that Respondent has not demonstrated 
unequivocal acceptance of responsibility for its actions. RD, at 56-57 
(citing Jones Total Health Care Pharmacy, L.L.C. & SND Health Care, 
L.L.C., 81 FR 79,188, 79,201-202 (2016)).\19\
---------------------------------------------------------------------------

    \19\ 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 5,479, 
5,498 n.33 (2019) (citing Jones Total Health Care Pharmacy, 81 FR at 
79,202-303); Daniel A. Glick, D.D.S., 80 FR 74,800, 74,801, 74,810 
(2015). Even so, in the current matter, Respondent did not identify 
any relevant remedial measures.
---------------------------------------------------------------------------

    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 74,800, 74,810 (2015). In this 
case, the Agency agrees with the ALJ that the interests of specific 
deterrence motivate in favor of revocation given that Respondent's PIC 
filled many of the prescriptions at issue, yet failed to acknowledge 
that any red flags existed or required resolution. RD, at 58-59. As the 
ALJ noted, Respondent continues to reject the notion that pharmacists 
have a duty to identify and resolve red flags prior to dispensing, 
which indicates that Respondent has not been rehabilitated. Id. at 55-
56. Respondent argues in its Post-Hearing Brief (PHB) that ``there is 
no cause of action in Texas for `red flags' or failing to meet 
`corresponding duty,' '' despite having been confronted in this 
proceeding with numerous federal and state laws that explicitly 
articulate this obligation. Id. (citing Respondent's PHB, at 5). 
Portions of Dr. Okpala's testimony indicate that Dr. Okpala is more 
focused on avoiding further government scrutiny than complying with 
federal and state law. RD, at 56. Dr. Okpala testified that he has 
never had a problem in his thirty years of practicing pharmacy, but 
that he will maintain better documentation in the future because 
``having this court order [ ] told [him] that.'' RD, at 56; Tr. 402-03, 
468. Further, Dr. Okpala's failure to acknowledge the dangers of 
concurrent prescriptions for opioids and benzodiazepines is troubling 
and indicates that Respondent cannot be trusted to safely dispense 
controlled substances. The Agency also agrees with the ALJ that the 
interests of general deterrence 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. Id. at 59.
    Moreover, the Agency agrees with the ALJ that Respondent's actions 
were egregious. Id. at 57-58. As the ALJ noted, Respondent dispensed 
dangerous combinations of controlled substances to four patients over a 
two-year period without resolving multiple red flags indicative of 
abuse and diversion. Id. at 57-58. Ms. Salinas testified that the 
nature of the controlled substances issued by the Respondent ``put 
people in danger.'' \20\ Id. at 58; Tr. 288. 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. RD, at 58-59. Accordingly, the Agency will order that 
Respondent's registration be revoked.
---------------------------------------------------------------------------

    \20\ Respondent noted in its Exceptions that none of the 
medications it dispensed caused adverse reactions, which Respondent 
argues supports a conclusion that ``Respondent did not fill any 
`unlawful' prescription [sic].'' Exceptions, at 7. However, it is 
not necessary for the Agency to find patient harm to revoke a 
registration. Melanie Baker, N.P., 86 FR 23,998, 24,009 (2021); 
Larry C. Daniels, M.D., 86 FR 61,630, 61,660-61 (2021); Jeanne E. 
Germeil, M.D., 85 FR 73,786, 73,799 n.32 (2020). Moreover, Ms. 
Salinas testified that a pharmacist's corresponding responsibility 
to address red flags remains in place even if a patient does not 
physically suffer any adverse effects from a medication or drug 
cocktail. RD, at 9; Tr. 329.
---------------------------------------------------------------------------

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. 
FA2332346 issued to Awesome Care 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 Awesome Care Pharmacy, to renew 
or modify this registration, as well as any other pending application 
of Awesome Care Pharmacy, for additional registration in Texas. This 
Order is effective October 16, 2024.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
September 10, 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. 2024-20937 Filed 9-13-24; 8:45 am]
BILLING CODE 4410-09-P