BRX Pharmacy; Decision and Order, 84616-84620 [2024-24564]
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84616
Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices
Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before December 23, 2024. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2024.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on August 26, 2024, Irvine
Labs, Inc., 7305 Murdy Circle,
Huntington Beach, California 92647–
3533, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
DATES:
Controlled substance
Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
I
Drug
code
Schedule
7350
7360
7370
I
I
I
I
The applicant plans to manufacture
bulk Active Pharmaceutical Ingredients
for product development and
distribution to DEA-registered
researchers. No other activities for these
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–24554 Filed 10–22–24; 8:45 am]
BILLING CODE 4410–09–P
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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
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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.
‘‘A default, unless excused, shall be
deemed to constitute a waiver of the
registrant’s . . . right to a hearing and
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-inCharge, 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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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.
§ 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.
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
§§ 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.
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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Further, between January 2022 and
June 2023, Registrant filled
prescriptions for hydrocodoneacetaminophen (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.
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B. Controlled Substances Prescribed
With Non-Controlled Substances
Texas regulations identify the
following prescribing pattern as a red
flag factor: ‘‘[D]angerous drugs or overthe-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 § 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 nonsteroidal anti-inflammatory drugs,
muscle relaxers, laxatives, and multivitamins. 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
§ 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
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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 hydrocodoneacetaminophen 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 § 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
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 § 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
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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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.
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.
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
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,
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 § 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.
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, wellknown red flag of abuse and/or diversion. Id.
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 § 291.29(f). See infra II.B. Instead, the
following alleged conduct constitutes violations of
22 Tex. Admin. Code § 291.29(a)–(b) See infra II.B.
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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 hydrocodoneacetaminophen 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 noncontrolled 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
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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 nonscheduled 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
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A. Leslie, M.D., 68 FR 15,227, 15,230
(2003). Each factor is weighed on a caseby-case basis. Morall v. Drug Enf’t
Admin., 412 F.3d 165, 173–74 (D.C. Cir.
2005). Any one factor, or combination of
factors, may be decisive. David H. Gillis,
M.D., 58 FR 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.
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. § 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
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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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
§ 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
§ 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.
§ 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.
§ 291.33(c)(2)(A)(iv); see also id.
§§ 291.29(a)–(b), 291.33(c)(2)(C)
(describing the requirements for
documentation).
Regarding ‘‘red flag factors’’ that are
‘‘relevant to preventing the nontherapeutic 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
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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. § 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 abovereferenced 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 § 481.074; and 22 Texas
Administrative Code §§ 291.29, 291.33.
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
84619
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 factdependent 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
E:\FR\FM\23OCN1.SGM
23OCN1
84620
Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
khammond on DSKJM1Z7X2PROD with NOTICES
Itani Family Pharmacy, PLC; 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 Itani Family
Pharmacy, PLC, of Titusville, Florida
(Registrant). Request for Final Agency
Action (RFAA), Exhibit (RFAAX) 1,
Attachment (Attach.) A (hereinafter,
OSC/ISO), at 1, 6. The OSC/ISO
informed Registrant of the immediate
suspension of its DEA registration, No.
FI2917702,1 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. at 1 (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
1 The record represents that this registration
expired on November 30, 2023. RFAAX 1, at 1. The
fact that a registrant allows its registration to expire
during the pendency of an administrative
enforcement proceeding does not impact the
Agency’s jurisdiction or prerogative to adjudicate
the OSC/ISO to finality. Jeffrey D. Olsen, M.D., 84
FR 68474, 68479 (2019).
VerDate Sep<11>2014
18:48 Oct 22, 2024
Jkt 265001
for hearing within 30 days after the date
of receipt of the OSC/ISO. OSC/ISO, at
5–6 (citing 21 CFR 1301.43(a)). The
OSC/ISO also notified Registrant that if
it failed to file such a request, it would
be deemed to have waived its right to
a hearing and be in default. Id. (citing
21 CFR 1301.43(c)). The OSC/ISO
further notified Registrant that
‘‘[d]efault constitutes a waiver of
[Registrant’s] right to a hearing and an
admission of the factual allegations of
this [OSC/ISO].’’ Id. (citing 21 CFR
1301.43(e)).
On June 19, 2023, the OSC/ISO was
personally served on Registrant’s owner
and pharmacist-in-charge (PIC), Mr.
Basil Itani. RFAAX 1, at 1. On June 30,
2023, a purported request for hearing
was filed with the DEA Office of
Administrative Law Judges (OALJ) and
assigned to the Chief Administrative
Law Judge (Chief ALJ). RFAA, at 2. A
prehearing conference was then held on
July 27, 2023. RFAA, at 2; RFAAX 2, at
2; RFAAX 4, at 1–2.
On September 22, 2023, the
Government filed a motion to terminate
the proceedings. RFAAX 2, at 4–5. In
the motion, the Government represented
that after the July 27 prehearing
conference, ‘‘it came to DEA’s attention
that Mr. Basil Itani was unaware of any
administrative proceedings that had
taken place’’ and that he had ‘‘no
interest in proceeding forward with the
administrative hearing.’’ Id. at 2. The
Government further represented that
Mr. Itani had informed DEA that he did
not have interest in proceeding with a
hearing, and ‘‘only his father . . . would
possess any interest in moving forward
with the DEA administrative hearing.’’
Id. After learning this information,
Government counsel notified the
attorney who filed the hearing request
(hereinafter, Counsel) that the
Government would file a motion to
terminate the proceedings unless
Counsel provided the Government with
evidence ‘‘that [Counsel] represented
[Mr. Itani] and his interests in this
administrative hearing.’’ Id. The
Government never received any
response to this request and filed a
motion to terminate, arguing that
Registrant’s hearing request ‘‘was made
without authority’’ because Mr. Itani—
the only individual who had authority
to request a hearing 2—did not ‘‘provide
2 The Agency agrees with the Government and the
Chief ALJ that the only individual with authority
to request a hearing on Registrant’s behalf was its
owner and PIC, Mr. Itani, as he has been
Registrant’s only managing member and is the sole
signatory and contact on Registrant’s registration.
RFAAX 2, at 2–4; RFAAX 4, at 3–4; see also infra
note 3.
PO 00000
Frm 00100
Fmt 4703
Sfmt 4703
express authority to request a hearing on
behalf of the pharmacy.’’ Id. at 3–5.
On September 28, 2023, the Chief ALJ
ordered Counsel to ‘‘provide . . . a
notarized power of attorney showing the
requisite authority to act as a
representative [of Registrant] in these
administrative enforcement
proceedings.’’ RFAAX 3 (citing 21 CFR
1316.50). Counsel never responded to
the Government’s motion to terminate
or the Chief ALJ’s directive, and never
produced any evidence demonstrating
that he had authority to represent
Registrant. RFAAX 4, at 1, 3. Based on
Registrant’s failure to respond, on
October 5, 2023, the Chief ALJ granted
the Government’s unopposed motion
and terminated proceedings, finding
that ‘‘there is simply no basis upon
which to conclude that [Counsel] has
authority to act on behalf of [Registrant],
or that the [request for hearing] in this
case is valid.’’ Id. at 4.
The Agency agrees with the Chief
ALJ. Counsel was given three
opportunities to demonstrate that he
was authorized to request a hearing for
Registrant after the Government learned
that Mr. Itani was unaware of the
proceedings and had no interest in
participating. In response to these
opportunities, Counsel remained silent.
Indeed, by the time the Chief ALJ
terminated the case, it had been over
two months since Counsel had
communicated with OALJ or made any
filings in the matter. RFAAX 4, at 2
nn.3–4. Despite multiple requests,
Counsel remained silent and, as the
Chief ALJ found, failed to demonstrate
that he had the authority to act for
Registrant.3 RFAAX 4, at 3–4.
Accordingly, the Agency finds that a
valid hearing request was never filed in
this matter and, consequently, that
Registrant is deemed to be in default.4
21 CFR 1301.43(c)(1). ‘‘A default, unless
3 See supra note 2. Given the Government’s
unrefuted representations that Mr. Itani was
unaware that a hearing had been requested and that
he had no interest in a hearing, the Agency views
Counsel’s extended silence in the face of multiple
requests as sufficient evidence that the hearing
request was not filed upon the direction of Mr.
Itani, the only person entitled to request a hearing
for Registrant.
4 Even if the hearing request had been valid,
Registrant would be deemed to be in default based
on its ‘‘fail[ure] to plead . . . or otherwise defend’’
itself. See 21 CFR 1301.43(c)(3) (‘‘In the event . . .
a person who has requested a hearing fails to plead
. . . or otherwise defend, said party shall be
deemed to be in default and the opposing party may
move to terminate the proceeding.’’). Here, as the
Chief ALJ found, Registrant waived its right to a
hearing by failing to respond to the Government’s
motion to terminate, failing to respond to chambers
staff at the Chief ALJ’s direction, failing to file
exhibits, and failing to file a notarized power of
attorney as ordered by the Chief ALJ. RFAAX 4, at
4.
E:\FR\FM\23OCN1.SGM
23OCN1
Agencies
[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]
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
``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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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