[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84616-84620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24564]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


BRX Pharmacy; Decision and Order

    On October 2, 2023, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO) to BRX Pharmacy of Stafford, Texas (Registrant). 
Request for Final Agency Action (RFAA), Exhibit (RFAAX) A, at 1. The 
OSC/ISO informed Registrant of the immediate suspension of its DEA 
Certificate of Registration, Control No. FB7301497, pursuant to 21 
U.S.C. 824(d), alleging that Registrant'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 Registrant's registration, alleging that Registrant's 
continued registration is inconsistent with the public interest. Id. 
(citing 21 U.S.C.823(g)(1), 824(a)(4)).
    The OSC/ISO notified Registrant of its right to file with DEA a 
written request for hearing. Id. at 10-11 (citing 21 CFR 1301.43). The 
OSC/ISO also notified Registrant that if it requested a hearing but 
failed to timely file an answer, it would be deemed to have waived its 
right to a hearing and be in default. Id. (citing 21 CFR 1301.43(c)(2), 
(c)(3), (d)). On October 30, 2023, Registrant timely requested a 
hearing, however, Registrant failed to answer the allegations of the 
OSC/ISO. RFAA, at 1; RFAAX C, at 1.\1\ The matter was assigned to a DEA 
Administrative Law Judge (ALJ) who issued an Order for Prehearing 
Statements that, among other things, reminded Registrant to file a 
compliant answer within 30 days of receipt of the OSC/ISO.\2\ RFAA, at 
1; RFAAX C, at 2. On November 7, 2023, Registrant filed an answer, but 
the ALJ found it ``substantively non-compliant'' and ordered Registrant 
to refile. RFAA, at 2; RFAAX B, at 4-8; RFAAX D, at 1. Registrant 
ultimately failed to file a compliant answer. RFAA, at 2; RFAAX E, at 
2. On November 13, 2023, the Government filed a Motion to Terminate 
Proceedings based on Registrant's failure to file an answer. RFAA, at 
2.\3\ Registrant did not file a response. Id. On November 27, 2023, the 
ALJ issued an order finding Registrant in default and terminating 
proceedings. Id.; RFAAX F, at 4-5.
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    \1\ Based on the Government's submissions in its RFAA dated 
November 29, 2023, the Agency finds that service of the OSC/ISO on 
Registrant was adequate. Specifically, the Government's exhibit 
titled Notice of Service includes a copy of a Form DEA-12 signed by 
Registrant's Pharmacist-in-Charge, indicating that Registrant was 
personally served with the OSC/ISO on October 5, 2023. RFAA, at 1; 
RFAAX B, at 1, 3.
    \2\ Because the 30-day deadline for responding to the OSC/ISO, 
November 4, 2023, fell on a Saturday, the deadline for responding 
was November 6, 2023.
    \3\ The Government refers to an ``Exhibit G'' that is not 
included in the instant RFAA.
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    ``A default, unless excused, shall be deemed to constitute a waiver 
of the registrant's . . . right to a hearing and an admission of the 
factual allegations of the [OSC/ISO].'' 21 CFR 1301.43(e). Further, 
``[i]n the event that a registrant . . . is deemed to be in default . . 
. DEA may then file a request for final agency action with the 
Administrator, along with a record to support its request. In such 
circumstances, the Administrator may enter a default final order 
pursuant to [21 CFR] 1316.67.'' Id. Sec.  1301.43(f)(1). Here, the 
Government has requested final agency action based on Registrant's 
default pursuant to 21 CFR 1301.43(c), (f), 1301.46. RFAA, at 2; see 
also 21 CFR 1316.67.

I. Findings of Fact

    The Agency finds that, in light of Registrant's default, the 
factual allegations in the OSC/ISO are admitted.\4\ Registrant is 
deemed to have admitted and the Agency finds that it repeatedly 
dispensed prescriptions in violation of the minimum practice standards 
that govern pharmacy practice in Texas. RFAAX A, at 4. Specifically, 
from at least January 2022 through June 2023, Registrant repeatedly 
filled controlled substance prescriptions that contained multiple red 
flags of abuse and/or diversion without addressing or resolving the red 
flags, in violation of both federal and state law. Id. at 4-5.
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    \4\ The Agency need not adjudicate the criminal violations 
alleged in the instant OSC/ISO. Ruan v. United States, 142 S. Ct. 
2,370 (2022) (decided in the context of criminal proceedings).
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A. Pattern Prescribing, Substances of Abuse, and Strength and Quantity

    Texas regulations identify the following prescribing patterns as 
red flag factors: ``[T]he pharmacy dispenses a reasonably discernible 
pattern of substantially identical prescriptions for the same 
controlled substances . . . .''; ``[P]rescriptions . . . are routinely 
for controlled substances commonly known to be abused drugs . . . .''; 
and ``[P]rescriptions for controlled substances are commonly for the 
highest strength of the drug and/or for large quantities . . . .'' 22 
Tex. Admin. Code Sec. Sec.  291.29(f)(1), (3), (5); RFAAX A, at 5.
    Registrant is deemed to have admitted that it failed to identify 
and resolve the red flag of pattern prescribing, substances of abuse, 
and strength and quantity. RFAAX A, at 5. Specifically, between January 
2022 and May 2023, Registrant filled prescriptions for oxycodone (a 
Schedule II opioid) issued by Dr. V.M. to C.B., E.B., K.B., T.H., and 
O.B. Id. Each prescription was for the highest strength of oxycodone, 
30 mg, which is known to be frequently abused, and each prescription 
ranged from 70 to 105 dosage units, approximately 3 or 4 daily doses. 
Id.

[[Page 84617]]

    Further, between January 2022 and June 2023, Registrant filled 
prescriptions for hydrocodone-acetaminophen (a Schedule II opioid) 
issued by Dr. V.M. to C.A., C.S., J.M., J.S., J.M2., and T.S. Id. Each 
prescription was for the highest strength of hydrocodone-acetaminophen, 
10/325 mg, which is known to be frequently abused, and the 
prescriptions ranged from 100 to 104 dosage units, approximately 4 
daily doses. Id.
    Accordingly, the Agency finds that Registrant filled all these 
prescriptions without first resolving the prescriptions' red flags of 
pattern prescribing, substances of abuse, and strength and quantity. 
Id.

B. Controlled Substances Prescribed With Non-Controlled Substances

    Texas regulations identify the following prescribing pattern as a 
red flag factor: ``[D]angerous drugs or over-the-counter products [OTC] 
. . . are consistently added by the prescriber to prescriptions for 
controlled substances presented to the pharmacy, indicating a lack of 
individual drug therapy . . . .'' 22 Tex. Admin. Code Sec.  
291.29(f)(6); RFAAX A, at 6.
    Registrant is deemed to have admitted that it failed to identify 
and resolve the red flag of similar prescriptions for controlled 
substances with OTC products issued by the same practitioner. RFAAX A, 
at 6. Specifically, between January 2022 and June 2023, Registrant 
filled prescriptions issued by Dr. V.M. to the eleven individuals 
listed above for opioids in combination with non-steroidal anti-
inflammatory drugs, muscle relaxers, laxatives, and multi-vitamins. Id.
    Accordingly, the Agency finds that Registrant filled all these 
prescriptions without first resolving the red flag of controlled 
substances being prescribed with non-controlled OTC products. Id.

C. Shared Addresses

    Texas regulations identify the following prescribing pattern as a 
red flag factor: ``[M]ultiple persons with the same address present 
substantially similar controlled substance prescriptions from the same 
practitioner.'' 22 Tex. Admin. Code Sec.  291.29(f)(11); RFAAX A, at 6.
    Registrant is deemed to have admitted that it failed to identify 
and resolve the red flag of patients with the same address presenting 
the same, or substantially similar, prescriptions from the same 
practitioner. RFAAX A, at 6. Specifically, between January 2022 and May 
2023, Registrant filled prescriptions for oxycodone 30 mg for E.B. and 
K.B., who both share the same address and received their prescriptions 
from the same practitioner, Dr. V.M. Id. Moreover, between January 2022 
and May 2023, Registrant filled prescriptions for hydrocodone-
acetaminophen 10/325 mg for J.M., J.M2., and T.S., who all share the 
same address and received their prescriptions from the same 
practitioner, Dr. V.M. Id.
    Accordingly, the Agency finds that Registrant filled all these 
prescriptions without first resolving the red flag of patients with the 
same address presenting the same, or substantially similar, 
prescriptions from the same practitioner. Id.

D. Cash Payments

    Texas regulations identify the following prescribing pattern as a 
red flag factor: ``[P]ersons consistently pay for controlled substance 
prescriptions with cash or cash equivalents more often than through 
insurance.'' 22 Tex. Admin. Code Sec.  291.29(f)(12); RFAAX A, at 6-7.
    Registrant is deemed to have admitted that it failed to identify 
and resolve the red flag of cash payments, which is a common red flag 
because it allows a patient to avoid the scrutiny associated with the 
use of insurance. RFAAX A, at 6-7. Specifically, between January 2022 
and June 2023, Registrant routinely accepted cash payments for 
controlled substance prescriptions, including all of the prescriptions 
for the eleven individuals described above. Id. at 7.\5\
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    \5\ 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. Coconut 
Grove Pharmacy, 89 FR 50,372, 50,375 n.20 (2024).
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    Accordingly, the Agency finds that Registrant filled all these 
prescriptions without first resolving the red flag of routinely 
accepting cash payments for controlled substance prescriptions. Id.

E. Prescriber Area of Practice

    Texas regulations identify the following prescribing pattern as a 
red flag factor: ``[T]he controlled substance(s) or the quantity of the 
controlled substance(s) prescribed are inconsistent with the 
practitioner's area of medical practice.'' 22 Tex. Admin. Code Sec.  
291.29(f)(9); RFAAX A, at 7. Registrant is deemed to have admitted that 
between January 2022 and June 2023, Registrant repeatedly filled 
prescriptions for oxycodone and hydrocodone-acetaminophen issued by Dr. 
V.M., despite Dr. V.M. prescribing outside her family and 
administrative medicine area of practice. RFAAX A, at 7.\6\ 
Accordingly, the Agency finds that Registrant filled all these 
prescriptions without first resolving the red flag arising from the 
prescriber's area of practice.
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    \6\ Texas regulations further identify as a red flag pattern, 
``[T]he practitioner's clinic is not registered as, and not exempted 
from registration as, a pain management clinic by the Texas Medical 
Board, despite prescriptions by the practitioner presented to the 
pharmacy indicating that the practitioner is mostly prescribing 
opioids, benzodiazepines, barbiturates, or carisoprodol, but not 
including suboxone, or any combination of these drugs.'' 22 Tex. 
Admin. Code Sec.  291.29(f)(8). The OSC alleges, and it is therefore 
deemed admitted, that ``Dr. [V.M.] is not Board Certified in the 
area of pain management.'' RFAAX A, at 6. However, there is not 
substantial evidence or an admission that the prescriptions issued 
by Dr. V.M. that were presented to the Registrant were mostly for 
opioids and the other listed controlled substances. Accordingly, the 
Agency cannot sustain this allegation or find that it presents an 
additional instance of the prescriber area of practice red flag.
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F. Long Distances

    Registrant is deemed to have admitted that it repeatedly filled 
prescriptions without identifying and resolving the red flag of 
patients traveling long distances to obtain or fill controlled 
substance prescriptions.\7\ RFAAX A, at 7-8. Specifically, Registrant 
is deemed to have admitted that it filled prescriptions for at least 
four individuals, E.B., K.B., C.B., and C.S., whose residences were in 
``completely opposite areas of the Houston Metropolitan area'' from 
their physician's office (Dr. V.M.) and from their pharmacy 
(Registrant). Id. Registrant further admits that there were several 
pharmacies closer to both Dr. V.M.;s office and the four individuals' 
residences. Id.
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    \7\ Though long distances are not specifically mentioned in the 
Texas regulations, see infra II.B., the OSC/ISO notes that the 
Agency has found that traveling long distances to obtain or fill 
controlled substance prescriptions is an additional, well-known red 
flag of abuse and/or diversion. Id.
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    Accordingly, the Agency finds that Registrant filled all these 
prescriptions without first resolving the red flag of patients 
traveling long distances to fill prescriptions for controlled 
substances. Id.

G. Other Red Flags 8
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    \8\ Although the OSC/ISO refers to the following alleged conduct 
as ``Other Red Flags,'' these forms of alleged conduct are not 
specifically listed in the Texas regulations as red flags under 22 
Tex. Admin. Code Sec.  291.29(f). See infra II.B. Instead, the 
following alleged conduct constitutes violations of 22 Tex. Admin. 
Code Sec.  291.29(a)-(b) See infra II.B.
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    Registrant is deemed to have admitted that it repeatedly filled 
controlled substance prescriptions when it had reason to doubt the 
accuracy or legitimacy of the prescriptions, and did so without 
identifying and resolving this red flag. Id. at 8-9. For example,

[[Page 84618]]

Registrant repeatedly filled prescriptions for individuals who, despite 
receiving controlled substances for supposedly chronic pain, were 
filling their prescriptions late. Id. at 8. On November 1, 2022, 
Registrant filled a prescription for oxycodone 30 mg for T.H. 
approximately seven days after the prescription was written. Id. On 
November 21, 2022, Registrant filled a prescription for oxycodone 30 mg 
for K.B. approximately eleven days after the prescription was written. 
Id. On February 16, 2023, Registrant filled a prescription for 
hydrocodone-acetaminophen 10/325 mg for J.S. nine days after the 
prescription was written. Id. Lastly, on March 23, 2023, and April 27, 
2023, Registrant filled prescriptions for oxycodone 30 mg for O.B. ten 
or more days after the prescriptions were written. Id.
    Moreover, Registrant repeatedly filled prescriptions for controlled 
substances when there were months when the prescriptions were neither 
prescribed nor filled. Id. Between November 16, 2022, and February 28, 
2023, C.A. failed to have a monthly controlled prescription filled, but 
filled other non-controlled prescriptions at Registrant. Id. Between 
October 18, 2022, and April 12, 2023, J.M2. failed to have a monthly 
controlled prescription filled. Id. at 9. Between November 23, 2022, 
and March 3, 2023, as well as between March 3, 2023, and June 5, 2023, 
C.S. failed to have a monthly controlled prescription filled, but 
filled other non-controlled prescriptions at Registrant. Id. Between 
November 17, 2022, and February 16, 2023, J.S. failed to have a monthly 
controlled prescription filled, but filled other non-controlled 
prescriptions at Registrant. Id. Between April 28, 2022, and October 
18, 2022, as well as between November 22, 2022, and May 4, 2023, J.M. 
failed to have a monthly controlled prescription filled, but filled 
other non-controlled prescriptions at Registrant. Id. Between February 
13, 2023, and May 2, 2023, K.B. failed to have a monthly controlled 
prescription filled, but filled other non-controlled prescriptions at 
Registrant. Id. Between November 1, 2022, and April 25, 2023, T.H. 
failed to have a monthly controlled prescription filled. Id. Finally, 
between September 15, 2022, and February 15, 2023, O.B. failed to have 
a monthly controlled prescription filled at Registrant, while on 
November 13, 2022, O.B. filled a controlled prescription at another 
pharmacy. Id.
    Registrant is also deemed to have admitted that it dispensed 
prescriptions for high dosages of controlled substances that, in 
combination with other substances, can cause respiratory depression and 
can lead to coma or death. Id. Specifically, Registrant dispensed 
oxycodone and cyclobenzaprine (a non-scheduled muscle relaxer) together 
to E.B. approximately eleven times. Id. Registrant also dispensed 
oxycodone and either gabapentin (a non-scheduled anticonvulsant) or 
tizanidine (a non-scheduled muscle relaxer) together to K.B. 
approximately seven times. Id.
    Accordingly, the Agency finds that Registrant filled all these 
prescriptions without first resolving the red flags of late fills, gaps 
in filling prescriptions, and high dosages of controlled substances in 
dangerous combinations. Id.

H. Expert Review

    DEA retained an independent pharmacy expert who concluded that the 
above prescription data presented multiple red flags that were highly 
indicative of abuse and diversion. Id. Registrant is deemed to have 
admitted and the Agency finds that these red flags were not resolved by 
a pharmacist acting in the usual course of professional practice prior 
to dispensing, and, therefore, that each prescription was filled 
outside the Texas standard of care. Id.

II. Discussion

A. The Five Public Interest Factors

    Under the Controlled Substances Act (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 [21 
U.S.C. 823] 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).
    While the Agency has considered all of the public interest factors 
in 21 U.S.C. 823(g)(1),\9\ the Government's evidence in support of its 
prima facie case for revocation of Registrant's registration is 
confined to Factors B and D. See RFAAX A, at 5. Moreover, the 
Government has the burden of proof in this proceeding. 21 CFR 1301.44.
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    \9\ As to Factor A, the record contains no evidence of a 
recommendation from any state licensing board or professional 
disciplinary authority. 21 U.S.C. 823(g)(1)(A). Nonetheless, an 
absence of such evidence ``does not weigh for or against a 
determination as to whether continuation of the [registrant's] DEA 
certification is consistent with the public interest.'' Roni 
Dreszer, M.D., 76 FR 19,434, 19,444 (2011). As to Factor C, there is 
no evidence in the record that Registrant has been convicted of an 
offense under either federal or state law ``relating to the 
manufacture, distribution, or dispensing of controlled substances.'' 
21 U.S.C. 823(g)(1)(C). However, as Agency cases have noted, ``the 
absence of such a conviction is of considerably less consequence in 
the public interest inquiry'' and is therefore not dispositive. 
Dewey C. MacKay, M.D., 75 FR 49,956, 49,973 (2010). Finally, as to 
Factor E, the Government's evidence fits squarely within the 
parameters of Factors B and D and does not raise ``other conduct 
which may threaten the public health and safety.'' 21 U.S.C. 
823(g)(1)(E). Accordingly, Factor E does not weigh for or against 
Registrant.
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    Here, the Agency finds that the Government's evidence satisfies its 
prima facie burden of showing that Registrant's continued registration 
would be ``inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4).

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 1,095, 1,097 (2023); Kareem Hubbard, 
M.D., 87 FR 21,156, 21,162 (2022). In the current matter, the 
Government has alleged that Registrant violated both federal and state 
law regulating controlled substances. RFAAX A, at 2-4.
    Specifically, a pharmacist may only fill a prescription that was 
``issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of his professional practice.'' Id. Sec.  
1306.04(a). 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

[[Page 84619]]

who fills the prescription.'' Id. Section 1306.04(a) prohibits ``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.'' Wheatland Pharmacy, 78 FR 
69,441, 69,445 (2013) (internal quotations and alterations omitted); 
RFAAX 2, at 2. DEA regulations require ``pharmacists to identify and 
resolve suspicions that a prescription is illegitimate.'' Trinity 
Pharmacy II, 83 FR 7,304, 7,331 (2018); RFAAX 2, at 2. Further, under 
federal regulations, a prescription for a controlled substance ``may 
only be filled by a pharmacist, acting in the usual course of his 
professional practice.'' 21 CFR 1306.06.
    As for state law, under Texas regulations, ``[a] pharmacist may not 
dispense . . . a controlled substance . . . except under a valid 
prescription and in the course of professional practice.'' Tex. Health 
& Safety Code Sec.  481.074(a). Regarding the specific standards for a 
pharmacist filing a new or refill prescription, ``[f]or the purpose of 
promoting therapeutic appropriateness, a pharmacist shall, prior to or 
at the time of dispensing a prescription drug order, review the 
patient's medication record. Such review shall at a minimum identify 
clinically significant: . . . (III) reasonable dose and route of 
administration; . . . (VI) drug-drug interactions; . . . [and] (X) 
proper utilization, including overutilization or underutilization.'' 22 
Tex. Admin. Code Sec.  291.33(c)(2)(A)(i). ``Upon identifying any 
clinically significant conditions [or] situations . . . the pharmacist 
shall take appropriate steps to avoid or resolve the problem including 
consultation with the prescribing practitioner.'' Id. Sec.  
291.33(c)(2)(A)(ii). ``Prior 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); see also id. Sec. Sec.  291.29(a)-(b), 
291.33(c)(2)(C) (describing the requirements for documentation).
    Regarding ``red flag factors'' that are ``relevant to preventing 
the non-therapeutic dispensing of controlled substances,'' Texas 
regulations identify the following relevant circumstances as red flags:
    (1) the pharmacy dispenses a reasonably discernible pattern of 
substantially identical prescriptions for the same controlled 
substances, potentially paired with other drugs, for numerous persons, 
indicating a lack of individual drug therapy in prescriptions issued by 
the practitioner; . . .
    (3) prescriptions by a prescriber presented to the pharmacy are 
routinely for controlled substances commonly known to be abused drugs, 
including opioids, benzodiazepines, muscle relaxants, psychostimulants, 
and/or cough syrups containing codeine, or any combination of these 
drugs;
    (4) prescriptions for controlled substances by a prescriber 
presented to the pharmacy contain nonspecific or no diagnoses, or lack 
the intended use of the drug;
    (5) 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; . . .
    (8) the practitioner's clinic is not registered as, and not 
exempted from registration as, a pain management clinic by the Texas 
Medical Board, despite prescriptions by the practitioner presented to 
the pharmacy indicating that the practitioner is mostly prescribing 
opioids . . . ;
    (9) the controlled substance(s) or the quantity of the controlled 
substance(s) prescribed are inconsistent with the practitioner's area 
of medical practice; . . .
    (11) multiple persons with the same address present substantially 
similar controlled substance prescriptions from the same practitioner; 
[and]
    (12) persons consistently pay for controlled substance 
prescriptions with cash or cash equivalents more often than through 
insurance.''

Id. Sec.  291.29(f). Further, under Texas regulations, ``[a] pharmacist 
shall not dispense a prescription drug if the pharmacist knows or 
should know the prescription drug order is fraudulent or forged.''Id.
    Here, as found above, Registrant is deemed to have admitted and the 
Agency finds that Registrant repeatedly filled prescriptions for 
controlled substances that contained multiple red flags of abuse and/or 
diversion without addressing or resolving those red flags. RFAAX A, at 
5-9. DEA's pharmacy expert concluded that these red flags were highly 
indicative of abuse and diversion. Id. at 9. Registrant has further 
admitted that none of the above-referenced controlled substance 
prescriptions were filled for a legitimate medical purpose in the usual 
course of professional practice. Id. As such, the Agency finds that 
Registrant violated 21 CFR 1306.04, 1306.06; Texas Health & Safety Code 
Sec.  481.074; and 22 Texas Administrative Code Sec. Sec.  291.29, 
291.33.
    Accordingly, the Agency finds that Factors B and D weigh in favor 
of revocation of Registrant's registration and thus finds Registrant's 
continued registration to be inconsistent with the public interest in 
balancing the factors of 21 U.S.C. 823(g)(1). The Agency further finds 
that Registrant failed to provide any evidence to rebut the 
Government's prima facie case.

III. Sanction

    Where, as here, the Government has established grounds for 
revocation, 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). To establish that it 
can be entrusted with registration, a registrant 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); see also Michele 
L. Martinho, M.D., 86 FR 24,012, 24,019 (2021); George D. Gowder, III, 
M.D., 89 FR 76,152, 76,154 (2024). 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, Registrant failed to answer the allegations contained in the 
OSC/ISO and did not otherwise avail itself of the opportunity to refute 
the Government's case. As such, Registrant has made no representations 
as to its future compliance with the CSA nor made any demonstration 
that it can be entrusted with registration. Moreover, the evidence 
presented by the Government shows that Registrant violated the CSA, 
further indicating that Registrant cannot be entrusted.
    Accordingly, the Agency will order the revocation of Registrant's 
registration.

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. 
FB7301497 issued to BRX 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 BRX Pharmacy to renew or modify this

[[Page 84620]]

registration, as well as any other pending application of BRX Pharmacy 
for additional registration in Texas. This Order is effective November 
22, 2024.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 15, 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. 2024-24564 Filed 10-22-24; 8:45 am]
BILLING CODE 4410-09-P