[Federal Register Volume 90, Number 61 (Tuesday, April 1, 2025)]
[Notices]
[Pages 14386-14390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-05527]
[[Page 14386]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Baijes Bissonnet Pharmacy; Decision and Order
On December 15, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Baijes Bissonnet
Pharmacy of Stafford, Texas (Applicant). Request for Final Agency
Action (RFAA), Exhibit (RFAAX) 1, at 1, 9. The OSC proposed the denial
of Applicant's application for DEA registration, Control No.
W22147152A, alleging that Applicant's registration is inconsistent with
the public interest. Id. at 1 (citing 21 U.S.C. 823(g)(1)).
Specifically, the OSC/ISO alleges that ``[Applicant] repeatedly
filled prescriptions for Schedule II through V controlled substances
that contained multiple red flags indicative of diversion and/or abuse
without addressing or resolving those red flags, and [Applicant's
decision] to fill those prescriptions despite unresolved red flags, . .
. [violated] federal and Texas law, including 21 CFR 1306.04(a),
1306.06; Tex. Health & Safety Code sections 481.074(a), 481.128; 22
Tex. Admin. Code sections 291.33(c)(2)(A)(ii), (iv), 291.29(f).'' RFAAX
1, at 4.
The OSC notified Applicant of its right to file with DEA a written
request for hearing within 30 days after the date of receipt of the
OSC. Id. at 8 (citing 21 CFR 1301.43(a)). The OSC also notified
Applicant 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) through (e)). The OSC further instructed Applicant that
a hearing request should be submitted to the DEA Office of
Administrative Law Judges (OALJ) email inbox.\1\ Id.
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\1\ Alternatively, the OSC instructed that a hearing request
could be mailed to the OALJ Hearing Clerk. RFAAX 1, at 8-9; see also
21 CFR 1316.47, 1321.01. The OSC also informed Applicant that a
hearing request is filed once it is received by the OALJ Hearing
Clerk. Id. at 9 (citing 21 CFR 1316.45).
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On December 19, 2023, a DEA Diversion Investigator personally
served the OSC on Applicant's owner and pharmacist-in-charge (PIC).\2\
RFAAX 2, at 2. Based on this date of service, the deadline for filing a
hearing request was January 18, 2024. RFAAX 1, at 8; see also 21 CFR
1301.37(d)(1), 1301.43(a). The day before the filing deadline, January
17, 2024, Applicant mailed a hearing request letter through the U.S.
Postal Service (USPS). RFAAX 3, at 5.\3\ Contrary to the OSC's clear
instructions to send mail to the OALJ Hearing Clerk at the specific
address listed in the OSC, Applicant addressed the letter to the DEA
Hearing Facility in Arlington, Virginia, a building that does not
accept mail. RFAA, at 4; RFAAX 3, at 5. Because Applicant sent the
hearing request to the wrong address, it was returned to Applicant
without ever being received by the OALJ Hearing Clerk. RFAA, at 4;
RFAAX 3, at 6.
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\2\ Applicant's owner/PIC signed a Form DEA-12 acknowledging
receipt of the OSC on December 19, 2023. RFAAX 2, Attachment 1, at
1.
\3\ The USPS receipt indicates that the expected delivery date
was January 22, 2024, four days after the 30-day deadline for
requesting a hearing. Id.
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On February 29, 2024, Applicant sent a second hearing request
letter through USPS, which was delivered on March 4, 2024, nearly two
months after the deadline for filing a hearing request had passed.
RFAA, at 3; RFAAX 3, at 1; RFAAX 4, at 1. Although Applicant mailed its
second hearing request letter to the correct mailing address, Applicant
addressed the letter to the wrong DEA office, specifically the Office
of Chief Counsel (CC). RFAA, at 3, 5; RFAAX 3, at 1. The second hearing
request was also never received by the OALJ Hearing Clerk. Id.
To summarize, the OSC, which was personally served on Applicant's
owner/PIC, contained clear instructions detailing how to file a hearing
request, where to send the hearing request, and the deadline for doing
so. Nonetheless, Applicant mailed its first hearing request letter to
the wrong mailing address and wrong recipient. Even if Applicant's
first hearing request letter had been sent to the correct mailing
address, it likely would have been received, and therefore filed,
several days after the filing deadline. Further, although Applicant
mailed a second hearing request letter to the DEA mailing address,
Applicant again failed to address it to the OALJ Hearing Clerk as
instructed by the OSC. The second hearing request letter was sent
nearly a month and a half after the filing deadline.
To date, Applicant has not filed a hearing request with the OALJ
Hearing Clerk, has not provided good cause for its failure to timely
request a hearing,\4\ and has not filed a motion to excuse the default
with the Office of the Administrator.\5\ 21 CFR 1301.43(c)(1).
Accordingly, the Agency finds that Applicant is in default.
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\4\ In its second letter, Applicant acknowledged that the first
letter was returned by USPS because it used the incorrect mailing
address. RFAAX 3, at 4. Under these facts, using the incorrect
address does not constitute good cause for failing to timely file a
hearing request, especially when the OSC clearly informed Applicant
to send hearing requests to the OALJ email inbox or the ``Hearing
Clerk, [OALJ, DEA], 8701 Morrissette Drive, Springfield, VA 22152'';
moreover, the hearing request was projected to be untimely even had
it been addressed correctly. RFAAX 1, at 8-9; RFAAX 3, at 5; 21 CFR
1316.45; see also Keith Ky Ly, D.O., 80 FR 29025, 29028 (2015)
(finding good cause was not shown where a registrant mailed a
hearing request to the incorrect address).
\5\ A party found in default may file a motion showing good
cause to set aside the default no later than 30 days from the date
of issuance of a final order. 21 CFR 1301.43(f)(3). Such motion must
be filed with the Office of the Administrator, Drug Enforcement
Administration, at [email protected].
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``A default, unless excused, shall be deemed to constitute a waiver
of the [applicant's] right to a hearing and an admission of the factual
allegations of the [OSC].'' 21 CFR 1301.43(e). Further, ``[i]n the
event that [an applicant] . . . 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]
Sec. 1316.67.'' 21 CFR 1301.43(f)(1). Here, the Government has
requested final agency action based on Applicant's default pursuant to
21 CFR 1301.43(d), (e), (f)(1), 1301.46. RFAA, at 1; see also 21 CFR
1316.67.
I. Applicable Law
As already discussed, the OSC/ISO alleges that Applicant violated
multiple provisions of the Controlled Substances Act (CSA) and its
implementing regulations. As the Supreme Court stated in Gonzales v.
Raich, ``the main objectives of the CSA were to conquer drug abuse and
to control the legitimate and illegitimate traffic in controlled
substances. . . . To effectuate these goals, Congress devised a closed
regulatory system making it unlawful to . . . dispense[ ] or possess
any controlled substance except in a manner authorized by the CSA.''
545 U.S. 1, at 12-13 (2005). In maintaining this closed regulatory
system, ``[t]he CSA and its implementing regulations set forth strict
requirements regarding registration, . . . drug security, and
recordkeeping.'' Id. at 14.
The OSC/ISO's allegations concern the CSA's ``statutory and
regulatory provisions . . . mandating . . . compliance with . . .
prescription requirements'' and, therefore, go to the heart of the
CSA's ``closed regulatory system'' specifically designed ``to conquer
drug abuse and to control the legitimate and illegitimate traffic in
controlled substances,'' and ``to prevent the diversion of drugs from
legitimate to illicit channels.'' Id. at 12-14, 27.
[[Page 14387]]
The Allegation That Applicant Filled Prescriptions Without Addressing
or Resolving Red Flags of Abuse and/or Diversion
According to the CSA's implementing regulations, a lawful
prescription for controlled substances is one that is ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a); see
Gonzales v. Oregon, 546 U.S. 243, 274 (2006), United States v. Hayes,
595 F.2d 258 (5th Cir. 1979), rehearing den., 598 F.2d 620 (5th Cir.
1979), cert. denied, 444 U.S. 866 (1979); RFAAX 1, at 2. Although
``[t]he responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner . . . a
corresponding responsibility rests with the pharmacist who fills the
prescription.'' 21 CFR 1306.04(a); United States v. Moore, 423 U.S.
122, 136 n.12 (1975); United States v. Armstrong, 550 F.3d 382, 387 n.6
(5th Cir. 2008); RFAAX 1, at 2. The corresponding responsibility
requires ``pharmacists to identify and resolve suspicions that a
prescription is illegitimate . . . before `knowingly filling such a
purported prescription.' '' Trinity Pharmacy II, 83 FR 7304, 7331
(2018); RFAAX 1, at 2; see also Suntree Pharmacy and Suntree Medical
Equipment, LLC v. Drug Enf't Agency, 2022 WL 444,357, *6 (11th Cir.)
(upholding the Agency's revocation order, which was ``[b]ased on [the]
finding that Suntree violated its corresponding responsibility by
filling prescriptions for controlled substances without resolving
obvious red flags that the prescriptions lacked a legitimate medical
purpose''). A respondent pharmacy ``fail[s] to comply with its
corresponding responsibility not to fill prescriptions written for
illegitimate purposes'' when it fails to ``tak[e] and document[ ] steps
to resolve . . . red flags or refus[e] to fill prescriptions with
unresolvable red flags.'' Pharmacy Doctors Enterprises Inc., d.b.a.
Zion Clinic Pharmacy, 789 F. App'x 724, 731 (11th Cir. 2020). DEA
regulations further require that a ``prescription for a controlled
substance may only be filled by a pharmacist, acting in the usual
course of his [or her] professional practice.'' 21 CFR 1306.06; RFAAX
1, at 2.
As for state law, Texas regulations have a similar requirement that
pharmacists ensure that controlled substance prescriptions are ``issued
for a legitimate medical purpose by a practitioner in the course of
medical practice.'' 22 Tex. Admin. Code section 291.29(b); RFAAX 1, at
2, 4; see also Tex. Health & Safety Code sections 481.074(a),
481.128(a)(1). If the pharmacist observes any problem that raises
doubts about the legitimacy of a prescription, the pharmacist must
``verify the order with the practitioner prior to dispensing.'' Id.
section 291.29(a); RFAAX 1, at 4.
Texas regulations set forth various ``red flag factors'' that a
pharmacist must consider in preventing the non-therapeutic dispensing
of controlled substances. 22 Tex. Admin. Code section 291.29(f); RFAAX
1, at 3. Pharmacists should consider these red flags ``by evaluating
the totality of the circumstances rather than any single factor.'' 22
Tex. Admin. Code section 291.29(f). These red flags include instances
where:
(f)(1) ``the pharmacy dispenses a reasonably discernible pattern
of substantially identical prescriptions for the same controlled
substances . . . ,''
(f)(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,''
(f)(10) ``the Texas Prescription Monitoring Program indicates
the person presenting the prescriptions is obtaining similar drugs
from multiple practitioners, and/or that the persons [sic] is being
dispensed similar drugs at multiple pharmacies,'' and
(f)(12) ``persons consistently pay for controlled substance
prescriptions with cash or cash equivalents more often than through
insurance.''
RFAAX 1, at 2-3, 5-7. In addition to evaluating these red flag
factors, a Texas pharmacist may not fill a prescription when a
pharmacist has reason to believe that a prescription is inaccurate,
inauthentic, or not issued for a legitimate medical purpose. See 22
Tex. Admin. Code section 291.29(a), (b).
Texas regulations further require pharmacists to ``review the
patient's medication record'' to ensure the ``therapeutic
appropriateness'' of the prescription, and if a problem is observed,
the pharmacist must ``avoid or resolve the problem including
consultation with the prescribing practitioner.'' 22 Tex. Admin. Code
sections 291.33(c)(2)(A)(i)-(ii); RFAAX 1, at 2-3. A pharmacist must
resolve all problems raised by a prescription before dispensing it and
must document how the problem was resolved. Id. section
291.33(c)(2)(A)(iv); RFAAX 1, at 3; see also section 291.33(c)(2)(C)
(outlining the information that such documentation must include).
II. Findings of Fact
The Allegation That Applicant Filled Prescriptions Without Addressing
or Resolving Red Flags of Abuse and/or Diversion
The Agency finds that, in light of Applicant's default, the factual
allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Applicant is deemed to have admitted and the Agency finds
that Applicant repeatedly dispensed prescriptions in violation of the
minimum practice standards that govern pharmacy practice in Texas.
RFAAX 1, at 4-8. Specifically, from at least March 2021 through August
2022, Applicant repeatedly filled prescriptions for controlled
substances that raised multiple red flags of abuse and/or diversion
without addressing or resolving the red flags.\6\ Id.
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\6\ Applicant's misconduct which forms the basis of the OSC, and
which Applicant is deemed to have admitted, occurred under
Applicant's prior DEA registration, which Applicant surrendered for
cause on August 25, 2022. Id.
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A. Pattern Prescribing
As discussed above, see supra Section I, Texas regulations identify
the following prescribing patterns as red flag factors: ``the pharmacy
dispenses a reasonably discernible pattern of substantially identical
prescriptions for the same controlled substances . . . ,'', and ``the
Texas Prescription Monitoring Program indicates the person presenting
the prescriptions is obtaining similar drugs from multiple
practitioners, and/or that the persons [sic] is being dispensed similar
drugs at multiple pharmacies.'' 22 Tex. Admin. Code sections
291.29(f)(1), (f)(10). RFAAX 1, at 5.
Applicant is deemed to have admitted that Applicant failed to
identify and resolve the red flag of pattern prescribing which is
indicative of a lack of individualized care for patients. RFAAX 1, at
3, 5. Applicant admits that ``prescriptions dispensed for seven
patients were essentially identical prescriptions issued by the same
prescriber and/or similar drugs from multiple practitioners.'' Id. at
5. Specifically, Applicant admits that he dispensed the following: six
essentially identical prescriptions to J.F. for hydrocodone-
acetaminophen 10/325 mg (a Schedule II opioid) and carisoprodol 350 mg
(a Schedule IV muscle relaxant) issued by Drs. B.N. and A.N.; three
essentially identical prescriptions to P.R. for oxycodone 30 mg (a
Schedule II opioid) issued by Drs. B.N. and A.N.; five essentially
identical prescriptions to M.R.S. for oxycodone 30 mg issued
[[Page 14388]]
by Drs. B.N., A.P., and D.F.; seven essentially identical prescriptions
for hydrocodone-acetaminophen 10/325 mg and five essentially identical
prescriptions for carisoprodol 350 mg to M.S. issued by Drs. A.P.,
J.A., M.A., and E.P.; seven essentially identical prescriptions to J.V.
for oxycodone 30 mg issued by Drs. A.N., B.N., A.P., and D.F.; and nine
essentially identical prescriptions to C.W. for oxycodone 30 mg issued
by Drs. A.N., B.N., A.P., and D.F. Id.
Accordingly, the Agency finds substantial record evidence that
Applicant filled 42 prescriptions to six individuals without first
resolving the prescriptions' red flag of pattern prescribing. Id.
B. 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 section 291.29(f)(12); RFAAX 1, at 5-
6.
Applicant is deemed to have admitted that it failed to identify and
resolve the red flag of cash payments for controlled substances, which
is a common red flag because it allows a patient to avoid the scrutiny
associated with the use of insurance. RFAAX 1, at 5-6. Specifically,
from at least March 9, 2021, to June 22, 2022, Applicant accepted cash
payments for 492 out of 575 total controlled substance prescriptions
(85% of controlled substance prescriptions). Id. at 6.
Accordingly, the Agency finds substantial record evidence that
Applicant filled 492 prescriptions without resolving the red flag of
cash payments for controlled substance prescriptions. Id.
C. Long Distances
Applicant is deemed to have admitted that it repeatedly filled
controlled substance prescriptions without identifying and resolving
the red flag of patients traveling long distances to obtain or fill the
prescriptions.\7\ Id. at 6-7. Specifically, Applicant is deemed to have
admitted that it filled prescriptions for at least four individuals,
B.H. (two prescriptions), B.M. (two prescriptions), P.R. (three
prescriptions), and C.Y. (three prescriptions), who each traveled over
100 miles one way from their listed address to Applicant's location to
purchase controlled substances prescriptions with cash. Id. at 7.
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\7\ Though long distances are not specifically mentioned in the
Texas regulations as a red flag factor, the OSC notes that ``DEA has
found that traveling long distances to obtain or fill controlled
substance prescriptions is a well-known red flag of abuse or
diversion.'' RFAAX 1, at 6 (citing, e.g., E. Main St. Pharmacy, 75
FR 66149, 66164 (2010) (finding that ``the fact that the patients
were driving so far to get their prescriptions filled `would be a
major red flag to any pharmacist' '').
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Accordingly, the Agency finds substantial record evidence that
Applicant filled these ten controlled substance prescriptions without
first resolving the red flag of patients traveling long distance to
obtain their prescriptions. Id. Additionally, Applicant is deemed to
have admitted, and the Agency finds substantial record evidence, that
Applicant filled these prescriptions outside the usual course of
professional practice. Id.
D. Drug Cocktails
Texas regulations identify the following prescribing pattern as a
red flag factor: ``[P]rescriptions 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.'' 22 Tex. Admin. Code section 291.29(f)(3);
RFAAX 1, at 7.
Applicant is deemed to have admitted that it repeatedly filled
controlled substance prescriptions without identifying and resolving
the red flag of drug cocktails. RFAAX 1, at 7. Specifically, Applicant
is deemed to have admitted that on approximately nine occasions,
Applicant dispensed a drug cocktail containing an opioid (hydrocodone-
acetaminophen) and a muscle relaxant (carisoprodol) to seven patients:
J.F., B.H., B.M., P.R., L.S., M.S., and C.Y. Id.
Accordingly, the Agency finds substantial record evidence that
Applicant filled these nine prescriptions without first resolving the
red flag of drug cocktails. Id.
E. Other Red Flags \8\
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\8\ Although the OSC 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
Texas Administrative Code section 291.29(f). Instead, the following
alleged conduct constitutes violations of 22 Texas Administrative
Code section 291.29(a)-(b).
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A Texas pharmacist may not fill a prescription when the pharmacist
has reason to believe that a prescription is inaccurate, inauthentic,
or not issued for a legitimate medical purpose. See 22 Tex. Admin. Code
section 291.29(a), (b); RFAAX 1, at 7-8. Applicant is deemed to have
admitted that it repeatedly filled controlled substance prescriptions
when it had reason to doubt the accuracy or legitimacy of multiple
prescriptions. RFAAX 1, at 7.
Specifically, Applicant admits that it ``had reason to doubt the
accuracy or legitimacy of several prescriptions when the patients who
were receiving controlled substances for chronic pain had several late
fills.'' Id. On six occasions from September 23, 2021, to January 25,
2022, Applicant filled for J.F. multiple controlled substances
prescriptions 35 or more days after the prescriptions were written. Id.
at 8. On multiple occasions from May 12, 2021, to May 5, 2022,
Applicant filled for L.S. multiple controlled substances prescriptions
30 or more days after the prescriptions were written. Id. Finally, on
multiple occasions from October 15, 2021, to August 4, 2022, Applicant
filled for J.V. multiple controlled substances prescriptions 30 or more
days after the prescriptions were written. Id.
Accordingly, the Agency finds substantial record evidence that
Applicant filled multiple prescriptions for three patients even though
it had reason to doubt their accuracy or legitimacy. Id. at 7-8.
F. 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. at 8. Applicant is deemed to
have admitted 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 standard of care of pharmacy practice in Texas.'' Id.
Accordingly the Agency finds substantial record evidence that
Applicant dispensed the above-referenced prescriptions without first
resolving the red flags of pattern prescribing, cash payments, long
distances, and/or drug cocktails, or when it had reason to doubt the
accuracy or legitimacy of the prescriptions. The Agency further finds
substantial record evidence that Applicant's dispensing of these
prescriptions was outside the usual course of professional practice.
III. Discussion
A. The Five Public Interest Factors
Under Section 304 of the CSA, ``[a] registration . . . to . . .
distribute[ ] or dispense a controlled substance . . . may be suspended
or revoked by the Attorney General upon a finding that the registrant .
. . has committed such
[[Page 14389]]
acts as would render his registration under . . . [21 U.S.C. 823]
inconsistent with the public interest as determined by such section.''
21 U.S.C. 824(a)(4). In the case of a ``practitioner,'' which is
defined in 21 U.S.C. 802(21) to include a ``pharmacy,'' Congress
directed the Attorney General to consider five factors in making the
public interest determination. 21 U.S.C. 823(g)(1)(A-E).\9\ The five
factors are considered in the disjunctive. Gonzales v. Oregon, 546 U.S.
at 292-93 (2006) (Scalia, J., dissenting) (``It is well established
that these factors are to be considered in the disjunctive,'' citing In
re Arora, 60 FR 4447, 4448 (1995)); Robert A. Leslie, M.D., 68 FR
15227, 15230 (2003). Each factor is weighed on a case-by-case basis.
Morall v. Drug Enf't Admin., 412 F.3d 165, 173-74 (D.C. Cir. 2005). Any
one factor, or combination of factors, may be decisive. Penick Corp. v.
Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007); Morall, 412
F.3d. at n.2; David H. Gillis, M.D., 58 FR 37507, 37508 (1993).
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\9\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are: (A) The
recommendation of the appropriate State licensing board or
professional disciplinary authority. (B) The applicant's experience
in dispensing, or conducting research with respect to controlled
substances. (C) The applicant'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.
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In this matter, while all of the 21 U.S.C. 823(g)(1) factors have
been considered, the Agency finds that the Government's evidence in
support of its prima facie case is confined to Factors B and D.\10\ See
RFAAX 1, at 4. Moreover, the Government has the burden of proof in this
proceeding. 21 CFR 1301.44.
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\10\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC. Ruan v. United States, 597 U.S. 450
(2022) (decided in the context of criminal proceedings).
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Here, the Agency finds that the Government's evidence satisfies its
prima facie burden of showing that Applicant's registration would be
``inconsistent with the public interest.'' 21 U.S.C. 823(g)(1).
B. Allegation That Applicant's Registration Is Inconsistent With the
Public Interest
Factors B and/or D--Applicant's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
Evidence is considered under Public Interest Factors B and D when
it reflects compliance or non-compliance with federal and local laws
related to controlled substances and experience dispensing controlled
substances. 21 U.S.C. 823(g)(1)(B) and (D); see also Kareem Hubbard,
M.D., 87 FR 21156, 21162 (2022). Here, as found above, Applicant is
deemed to have admitted and the Agency finds that Applicant repeatedly
filled prescriptions for controlled substances that contained red flags
of abuse and/or diversion without addressing or resolving those red
flags. RFAAX 1, at 4-8. DEA's independent pharmacy expert concluded
that these red flags were highly indicative of abuse and diversion. Id.
at 8. Applicant 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 substantial record evidence that the
Government established a prima facie case that Applicant violated 21
CFR 1306.04, 1306.06; 22 Texas Administrative Code sections 291.29,
291.33; and Texas Health & Safety Code sections 481.074, 481.128. The
Agency further finds that Factors B and D weigh in favor of denial of
Applicant's application and that Applicant's registration would be
inconsistent with the public interest in balancing the factors of 21
U.S.C. 823(g)(1). Accordingly, the Agency finds that the Government
established a prima facie case, that Applicant did not rebut that prima
facie case, and that there is substantial record evidence supporting
the denial of Applicant's application. 21 U.S.C. 823(g)(1).
IV. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Applicant's registration is inconsistent with the public
interest due to its numerous violations pertaining to controlled
substances, the burden shifts to Applicant to show why it can be
entrusted with a registration. Morall, 412 F.3d. at 174; Jones Total
Health Care Pharmacy, 881 F.3d 823, 830 (11th Cir. 2018); Garrett
Howard Smith, M.D., 83 FR 18882 (2018). The issue of trust is
necessarily a fact-dependent determination based on the circumstances
presented by the individual resgistrant. Jeffrey Stein, M.D., 84 FR
46968, 46972 (2019); see also Jones Total Health Care Pharmacy, 881
F.3d at 833. Moreover, as past performance is the best predictor of
future performance, DEA Administrators have required that a registrant
who has committed acts inconsistent with the public interest must
accept responsibility for those acts and demonstrate that it will not
engage in future misconduct. Jones Total Health Care Pharmacy, 881 F.3d
at 833. A registrant's acceptance of responsibility must be
unequivocal. Id. at 830-31. In addition, a registrant's candor during
the investigation and hearing has been an important factor in
determining acceptance of responsibility and the appropriate sanction.
Id. Further, DEA Administrators have found that the egregiousness and
extent of the misconduct are significant factors in determining the
appropriate sanction. Id. at 834 and n.4. DEA Administrators have also
considered the need to deter similar acts by the specific registrant
and by the community of registrants. Jeffrey Stein, M.D., 84 FR 46972-
73.
Here, Applicant did not timely or properly request a hearing and
was deemed to be in default. 21 CFR 1301.43(c)(1), (e), (f)(1); RFAA,
at 1-9. To date, Applicant has not filed a motion with the Office of
the Administrator to excuse the default. 21 CFR 1301.43(c)(1).
Applicant has thus failed to answer the allegations contained in the
OSC and has not otherwise availed itself of the opportunity to refute
the Government's case. As such, Applicant 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 Applicant violated the CSA,
further indicating that Applicant cannot be entrusted.
Accordingly, the Agency will order the denial of Applicant's
application.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(g)(1), I hereby deny the pending application for a DEA
Certificate of Registration, Control No. W22147152A, submitted by
Baijes Bissonnet Pharmacy, as well as any other pending application of
Baijes Bissonnet Pharmacy for additional registration in Texas. This
Order is effective May 1, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
March 25, 2025, by Acting Administrator Derek Maltz. 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
[[Page 14390]]
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. 2025-05527 Filed 3-31-25; 8:45 am]
BILLING CODE 4410-09-P