Notice2025-06312
Mariste Pharmacy; Decision and Order
Primary source
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Published
April 14, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 90 Issue 70 (Monday, April 14, 2025)</title>
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[Federal Register Volume 90, Number 70 (Monday, April 14, 2025)]
[Notices]
[Pages 15583-15587]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06312]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Mariste Pharmacy; Decision and Order
On May 20, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Mariste Pharmacy (Registrant) of Richmond,
Texas. Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1.
The OSC/ISO informed Registrant of the immediate suspension of its DEA
Certificate of Registration, Control No. FM2279431, 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)).
Specifically, the OSC/ISO alleged that Registrant ``repeatedly
filled Schedule II-V controlled substance prescriptions that contained
red flags indicative of diversion and/or abuse, without appropriately
addressing or resolving those red flags, . . . [in] violation of both
federal and Texas law, including 21 CFR 1306.04(a) and 1306.06; and
Texas Health & Safety Code Ann. Sec. 481.074(a).'' RFAAX 1, at 5. The
OSC/ISO also alleged that Registrant ``had numerous record keeping
violations and improperly stored controlled substances at a non-
registered location,'' in violation of 21 CFR 1304.11(a)-(c) and
1304.21(a), (d). Id. at 5-6.
The OSC/ISO notified Registrant of its right to file with DEA a
written request for hearing within 30 days after the date of receipt of
the OSC/ISO. Id. at 10-11 (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), (d), (e)).
[[Page 15584]]
To date, Registrant has not filed a hearing request with the OALJ
Hearing Clerk,\1\ has not provided good cause for its failure to timely
request a hearing, and has not filed a motion to excuse the default
with the Office of the Administrator.\2\ 21 CFR 1301.43(c)(1).
Accordingly, the Agency finds that Registrant is in default.
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\1\ According to the Government's representations in the RFAA,
Registrant filed a letter on June 19, 2024, in which it ``admitted,
denied and/or further expounded on the allegations charged in the
[OSC/ISO].'' RFAA, at 2. The Government represented that ``absent in
this letter was a request for hearing'' and that ``DEA has not
received any other correspondence from Registrant, or any attorney
acting on her behalf, concerning the [OSC/ISO].'' Id.
\2\ 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 <a href="/cdn-cgi/l/email-protection#5c38393d723d383833723d2828332e3239252f1c38393d723b332a"><span class="__cf_email__" data-cfemail="fa9e9f9bd49b9e9e95d49b8e8e9588949f8389ba9e9f9bd49d958c">[email protected]</span></a>.
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``A default, unless excused, shall be deemed to constitute a waiver
of the [registrant's] right to a hearing and an admission of the
factual allegations of the [OSC/ISO].'' 21 CFR 1301.43(e). Further,
``[i]n the event that a registrant . . . is deemed to be in default . .
. DEA may then file a request for final agency action with the
Administrator, along with a record to support its request. In such
circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] Sec. 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 3; see
also 21 CFR 1316.67.
I. Applicable Law
As already discussed, the OSC/ISO alleges that Registrant 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 . . .
security controls to guard against diversion, recordkeeping and
reporting obligations, and 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.
The Allegation That Registrant 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); 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'');
RFAAX 1, at 2. 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); see also
Tex. Health & Safety Code sections 481.074(a), 481.128(a)(1); RFAAX 1,
at 3. Texas regulations also specify that ``[a] pharmacist may not
dispense . . . a controlled substance . . . except under a valid
prescription and in the course of professional practice.'' Tex. Health
& Safety Code section 481.074(a); RFAAX 1, at 3.
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 4. 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)(11) multiple persons with the same address present
substantially similar controlled substance prescriptions from the same
practitioner; and (f)(12) persons consistently pay for controlled
substance prescriptions with cash or cash equivalents more often than
through insurance. RFAAX 1, at 4. Texas regulations also identify ``the
geographical distance between the practitioner and the patient'' as a
``reason[ ] to suspect that a prescription may have been authorized in
the absence of a valid patient-practitioner relationship or in
violation of the practitioner's standard of practice.'' 22 Tex. Admin.
Code section 291.29(c)(4); RFAAX 1, at 8. 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.'' 22 Tex. Admin. Code section 291.29(f). 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 3. A pharmacist must resolve all
problems raised by a prescription before dispensing it and must
document how the problem was resolved. 22 Tex. Admin. Code section
291.33(c)(2)(A)(iv);
[[Page 15585]]
see also id. section 291.33(c)(2)(C) (outlining the information that
such documentation must include); RFAAX 1, at 3-4.
The Allegation That Registrant Failed to Adequately Maintain Complete
and Accurate Records
Federal law also imposes recordkeeping and security requirements on
pharmacies. For example, the CSA requires pharmacies to keep accurate
and timely records of inventory and dispensing. 21 CFR 1304.11(a)-(c);
RFAAX 1, at 5. This includes conducting and maintaining an ``initial
inventory . . . of all stocks of controlled substances on hand on the
date [the pharmacy] first engages in the . . . dispensing of controlled
substances,'' as well as conducting and maintaining a ``biennial
inventory . . . of all stocks of controlled substances on hand.'' 21
CFR 1304.11(a)-(c); RFAAX 1, at 5. Pharmacies must retain these
inventories ``for at least 2 years from the date of such inventory or
records, for inspection and copying.'' 21 CFR 1304.04; RFAAX 1, at 3.
The CSA also requires pharmacies to ``maintain, on a current basis, a
complete and accurate record of each substance . . . received,'' and
the pharmacy must ``record[ ] . . . the date on which the controlled
substances are actually received.'' 21 CFR 1304.21(a); RFAAX 1, at 3.
II. Findings of Fact
The Allegation That Registrant Filled Prescriptions Without Addressing
or Resolving Red Flags of Abuse and/or Diversion
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC/ISO are deemed admitted.\3\ 21 CFR
1301.43(e). Accordingly, Registrant is deemed to have admitted and the
Agency finds that Registrant repeatedly dispensed prescriptions in
violation of the minimum practice standards that govern pharmacy
practice in Texas. RFAAX 1, at 6-9. Specifically, from at least
February 2021 through March 2024, Registrant repeatedly filled
controlled substance prescriptions that contained multiple red flags of
abuse and/or diversion without addressing or resolving the red flags.
Id.
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\3\ 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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Cash Payments
As discussed above, see supra Section I, 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 6. Registrant is deemed to have
admitted that it failed to identify and resolve the red flag of cash
payments. RFAAX 1, at 6. Specifically, between February 2021 and March
2024, Registrant filled 1,273 prescriptions for oxycodone 30 mg (a
Schedule II opioid), and approximately 1,272 of those prescriptions
were paid for in cash or cash equivalents. Id.
Accordingly, the Agency finds substantial record evidence that
Registrant filled approximately 1,272 controlled substance
prescriptions without first resolving the red flag arising from cash
payments.
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 section 291.29(f)(11); RFAAX 1, at
7. Registrant is deemed to have admitted that it failed to identify and
resolve the red flag of multiple persons with the same address
presenting the same prescriptions from the same practitioner. RFAAX 1,
at 7-8. Specifically, between February 2021 and August 2023, Registrant
filled controlled substance prescriptions for two groups of patients
who shared the same address \4\ and presented prescriptions for the
same controlled substance (oxycodone 30 mg) from the same practitioner
(Dr. V.M.). Id. at 8.\5\
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\4\ These patients included T.C., R.L.C., and T.G., who shared
the same address, and H.E., Z.J., and Di.P. who shared the same
address.
\5\ The OSC/ISO contains additional allegations of patients with
a shared address presenting prescriptions for the same controlled
substance from the same prescriber. RFAAX 1, at 7-8. However, each
of these allegations identifies multiple prescribers and multiple
patients, and it is unclear which prescribers issued prescriptions
to which patients. Thus, it is not clear from substantial record
evidence or an admission that patients sharing the same address were
receiving the same controlled substance from the same prescriber.
Accordingly, the remaining allegations regarding the red flag of
pattern prescribing are not sustained. The Agency finds that the
founded allegations in this decision are more than sufficient to
support the Government's requested sanction of revocation under
these circumstances.
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Accordingly, the Agency finds substantial record evidence that
Registrant filled numerous controlled substance prescriptions without
first resolving the red flag of shared addresses.
Long Distances
Texas regulations identify ``the geographical distance between the
practitioner and the patient'' as a ``reason[ ] to suspect that a
prescription may have been authorized in the absence of a valid
patient-practitioner relationship or in violation of the practitioner's
standard of practice.'' 22 Tex. Admin. Code section 291.29(c)(4); RFAAX
1, at 8. 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 controlled substance
prescriptions. RFAAX 1, at 8-9. Specifically, Registrant is deemed to
have admitted that between February 2021 and June 2022, it filled
numerous prescriptions for four individuals (A.S.W., De.D.G., J.G., and
C.R.) who traveled more than 45 miles one way to obtain their
controlled substance prescriptions, and for three individuals (D.A.,
F.G., and R.D.) who traveled more than 70 miles one way to obtain their
prescriptions. Id. at 9.
Accordingly, the Agency finds substantial record evidence that
Registrant filled numerous controlled substance prescriptions without
first resolving the red flag arising from long distances traveled.\6\
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\6\ The OSC/ISO additionally alleged that Registrant filled
numerous prescriptions for controlled substances for certain
patients that were issued by practitioners engaging in ``pattern
prescribing.'' RFAAX 1, 6-7. For example, the OSC/ISO alleges, and
it is therefore admitted, that ``Between February 1, 2021, and until
at least March 6, 2024, the Pharmacy filled prescriptions for
Patients V.R., B.A.C., R.B., V.S., R.J.H., B.R., L.K., K.K., C.D.G.,
R.F., H.W, and De.G. who presented prescriptions for oxycodone 30 mg
from multiple practitioners, in violation of Texas law.'' Id. at 7.
The OSC/ISO implies that this conduct violates 22 Texas
Administrative Code section 291.29(f)(10), which identifies as a
potential red flag factor that ``the Texas Prescription Monitoring
Program indicates the person presenting the prescriptions is
obtaining similar drugs from multiple practitioners.'' It is not
clear from substantial record evidence or an admission whether each
of the 12 patients listed was receiving prescriptions from multiple
practitioners, or if there were multiple prescribers who issued
prescriptions to this group of 12 patients. Accordingly, this
allegation is not sustained.
The OSC/ISO also alleged, and it is therefore admitted, that
``Between February 1, 2021, and until at least March 6, 2024, the
Pharmacy filled oxycodone 30 mg prescriptions for Patients B.A.C.,
D.Y., K.M.K., Z.J., S.D.W., R.B., V.R., and H.W. which were for only
the highest strength and in high quantities, in violation of Texas
law.'' RFAAX 1, at 6-7. The OSC/ISO implies that this conduct
violates 22 Texas Administrative Code section 291.29(f)(5), which
identifies as a potential red flag factor that ``prescriptions for
controlled substances are commonly for the highest strength of the
drug and/or for large quantities (e.g., monthly supply), indicating
a lack of individual drug therapy in prescriptions issued by the
practitioner.'' Id. at 7. It is not clear from substantial record
evidence or an admission that any of these patients shared the same
practitioner. Accordingly, this allegation is not sustained. The
Agency finds that the founded allegations in this decision are more
than sufficient to support the Government's requested sanction of
revocation under these circumstances.
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[[Page 15586]]
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. The expert further concluded,
and Registrant admits that, ``[t]hese red flags were not adequately
resolved by a pharmacist acting in the usual course of professional
practice prior to dispensing, and therefore, each prescription was
filled outside the standard of care of pharmacy practice in Texas.''
Id. Registrant further admitted that none of the above-referenced
controlled substance prescriptions was filled for a legitimate medical
purpose. Id.
Accordingly, the Agency finds substantial record evidence that
Registrant dispensed the above-referenced prescriptions without first
resolving the red flags of cash payments, long distances, and/or shared
addresses, and that Registrant's dispensing of these prescriptions was
outside the usual course of professional practice. Additionally, the
Agency finds substantial record evidence that none of the above-
referenced controlled substance prescriptions was filled for a
legitimate medical purpose.
The Allegation That Registrant Failed to Adequately Maintain Complete
and Accurate Records
Registrant is deemed to have admitted that it failed to adequately
maintain an initial inventory and a biennial inventory, which prevented
DEA from conducting an audit. RFAAX 1, at 5. Accordingly, the Agency
finds substantial evidence that Registrant failed to adequately
maintain an initial and biennial inventory.
Further, Registrant is deemed to have admitted that between
February 2021 and February 2023, it failed to adequately maintain
complete and accurate continuing records regarding its inventory of
controlled substances. Id. at 6. Specifically, Registrant admits that
it failed to adequately maintain a record of the receipt of controlled
substances, and that it was unable to provide DEA with even the most
basic required documentation concerning its on-hand controlled
substance inventory. Id.
Accordingly, the Agency finds substantial evidence that Registrant
failed to maintain a complete and accurate record of each substance
received.\7\
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\7\ The OSC/ISO additionally alleged, and it is therefore
admitted, that ``on or about February 14, 2023, [Registrant's] owner
was discovered to be storing large amounts of controlled substances
at a personal residence that is not a registered location,'' and
that ``DEA discovered that the controlled substances were being
transported back and forth between the registered pharmacy location
and the unregistered personal residence.'' RFAAX 1, at 6. The OSC/
ISO implies that this conduct violates 21 CFR 1301.75(b), which
states that ``Controlled substances listed in Schedules II, III, IV,
and V shall be stored in a securely locked, substantially
constructed cabinet.'' It is not clear from substantial record
evidence or an admission that Registrant's transporting of
controlled substances means that Registrant was not storing
controlled substances in a ``securely locked, substantially
constructed cabinet.'' Further, 21 CFR 1301.75(b) does not state
that controlled substances must be stored at a ``registered
location,'' and the OSC/ISO does not identify additional statutory
support for this requirement. Accordingly, this allegation regarding
the failure to adequately store controlled substances is not
sustained. The Agency finds that the founded allegations in this
decision are more than sufficient to support the Government's
requested sanction of revocation under these circumstances.
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I. 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 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).\8\ 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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\8\ 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. See
RFAAX 1, at 6. 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.
823(g)(1).
B. Allegation That Registrant's Registration Is Inconsistent With the
Public Interest
Factors B and/or D--Registrant'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, Registrant is deemed to have admitted and the
Agency finds that Registrant 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
5-9. Registrant has further admitted and the Agency finds 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 Registrant violated 21 CFR 1306.04, 1306.06, Texas Health & Safety
Code section 481.074, and 22 Texas Administrative Code sections 291.29,
291.33.
Additionally, as found above, Registrant is deemed to have admitted
and the Agency finds that Registrant failed to maintain an initial and
biennial inventory. As such, the Agency finds substantial record
evidence that Registrant violated 21 CFR 1304.11(a)-(c) and 1304.04.\9\
Finally, Registrant has
[[Page 15587]]
admitted and the Agency finds that it failed to maintain complete and
accurate records of each controlled substance received. As such, the
Agency finds substantial record evidence that Registrant violated 21
CFR 1304.21(a).
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\9\ The OSC/ISO alleges that Registrant's failure to maintain an
initial and biennial inventory and its failure to maintain records
of receipt of controlled substances also violated 22 Texas
Administrative Code section 291.75(a)(l), (c)(4)-(5). RFAAX 1, at 5.
However, the OSC/ISO does not contain sufficient factual or legal
analysis to enable to Agency to assess the relevance or
applicability of these statutes. Section (a)(1)(A) pertains to
institutional pharmacies, and the OSC/ISO does not allege that
Registrant is an institutional pharmacy. Section (c)(4) outlines
requirements for patient records of Schedule II controlled
substances to be maintained separately from patient records of
controlled substances in other schedules, and it outlines additional
requirements related to distribution records and institutional
pharmacies. Finally, Section (c)(5) pertains to floor stock records.
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The Agency further finds that Factors B and D weigh in favor of
denial of Registrant's application and that Registrant'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 Registrant did not
rebut that prima facie case, and that there is substantial record
evidence supporting the revocation of Registrant's registration. 21
U.S.C. 823(g)(1).
II. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Registrant's registration is inconsistent with the public
interest due to its numerous violations pertaining to controlled
substances, the burden shifts to Registrant 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 registrant. 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, Registrant 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, Registrant has not filed a motion with the Office of
the Administrator to excuse the default. 21 CFR 1301.43(c)(1).
Registrant 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, 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
application.
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.
FM2279431 issued to Mariste 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 Mariste Pharmacy to renew or
modify this registration, as well as any other pending application of
Mariste Pharmacy for additional registration in Texas. This Order is
effective May 14, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 8, 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 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. 2025-06312 Filed 4-11-25; 8:45 am]
BILLING CODE 4410-09-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on April 14, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.