Notice2024-24564
BRX Pharmacy; Decision and Order
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Published
October 23, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 89 Issue 205 (Wednesday, October 23, 2024)</title>
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[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84616-84620]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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</html>Indexed from Federal Register on October 23, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.