Notice2024-23495
Halowells Pharmacy; Decision and Order
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Published
October 10, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 89 Issue 197 (Thursday, October 10, 2024)</title>
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[Federal Register Volume 89, Number 197 (Thursday, October 10, 2024)]
[Notices]
[Pages 82267-82271]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-23495]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Halowells Pharmacy; Decision and Order
On November 8, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Halowells Pharmacy (Registrant) of Pearland,
Texas. 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.
[[Page 82268]]
FH9037830, 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, and 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. at 9 (citing 21 CFR 1301.43). Here, Registrant did
not request a hearing. RFAA, at 2.\1\ ``A default, unless excused,
shall be deemed to constitute a waiver of the registrant's/applicant's
right to a hearing and an admission of the factual allegations of the
[OSC/ISO].'' 21 CFR 1301.43(e).
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\1\ Based on the Government's submissions in its RFAA dated
January 4, 2024, the Agency finds that service of the OSC/ISO on
Registrant was adequate and rendered on November 16, 2023.
Specifically, the Government included as an attachment to its RFAA a
Form DEA-12 signed by a representative of Registrant, indicating
that Registrant was personally served with the OSC/ISO on November
16, 2023. RFAA, at 1-2; RFAAX B.
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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. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC/ISO are admitted.\2\ Registrant is
deemed to have admitted 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 July 2023, Registrant repeatedly filled controlled
substance prescriptions that contained multiple red flags of abuse and/
or diversion without addressing or resolving the red flags, in
violation of both Federal and State law. Id. at 4-5.
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\2\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC/ISO. Ruan v. United States, 142 S. Ct.
2,370 (2022) (decided in the context of criminal proceedings).
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A. Pattern Prescribing
Texas regulations identify the following prescribing patterns as
red flag factors: Dispensing to numerous persons substantially
identical prescriptions by the same prescriber for the same controlled
substances; a prescriber's prescriptions are routinely for controlled
substances commonly known to be abused drugs, including opioids; and a
prescriber's prescriptions for controlled substances are commonly for
the highest strength of the drug and/or for large quantities (e.g.,
monthly supply). 22 Tex. Admin. Code section 291.29(f)(1), (3), (5);
RFAAX A, at 3-4.
Registrant is deemed to have admitted that it failed to identify
and resolve the red flag that occurs when a practitioner prescribes the
same controlled substance in identical or substantially similar
quantities to multiple patients. RFAAX A, at 5. Specifically, between
January 2022 and June 2023, Registrant filled over 90 prescriptions for
oxycodone issued by Dr. V.M. to C.W., D.S.T., D.W., E.W., J.L., J.R.,
and L.T. Id. Each prescription was for the highest strength of
oxycodone, 30 mg, which is known to be frequently abused, and each
prescription ranged from 98 to 105 dosage units. Id.
Further, between January 2022 and June 2023, Registrant filled over
30 prescriptions for hydrocodone-acetaminophen issued by Dr. V.M. to
D.S.E., D.S.M., and J.J. 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 90 to 105 dosage
units. Id.
Accordingly, the Agency finds that Registrant filled over 120
controlled substance prescriptions without first resolving the pattern
prescribing red flags.
B. Prescriptions Lacking Specific Diagnosis
Texas regulations identify the following prescribing pattern as a
red flag factor: ``[P]rescriptions for controlled substances by a
prescriber presented to the pharmacy contain nonspecific or no
diagnoses, or lack the intended use of the drug.'' 22 Tex. Admin. Code
section 291.29(f)(4); RFAAX A, at 3.
Registrant is deemed to have admitted that it failed to identify
and resolve the red flag of prescriptions lacking a specific diagnosis.
RFAAX A, at 5. Specifically, between January 2022 and June 2023,
Registrant filled prescriptions lacking specific diagnoses for all ten
individuals \3\ for oxycodone 30 mg and hydrocodone-acetaminophen 10/
325 mg. Id. Accordingly, the Agency finds that Registrant filled
controlled substance prescriptions without first resolving the red flag
of prescriptions lacking a specific diagnosis.
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\3\ C.W., D.S.E., D.S.M., D.S.T., D.W., E.W., J.J., J.L., J.R.,
and L.T., the relevant individuals to whom prescriptions were
improperly filled in this case, are referred to collectively as the
ten individuals.
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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 section 291.29(f)(11); RFAAX A, at
4.
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, or substantially similar, prescriptions from the
same practitioner. RFAAX A, at 6. Specifically, between January 2022
and June 2023, Registrant filled prescriptions for oxycodone 30 mg for
C.W. and D.W., who both share the same address and received their
prescriptions from the same practitioner, Dr. V.M. Id. Between January
2022 and April 2023, Registrant filled prescriptions for hydrocodone-
acetaminophen 10/325 mg for D.S.M. and J.J., who both share the same
address and received their prescriptions from the same practitioner,
Dr. V.M. Id. Between February 2022 and June 2023, Registrant filled
prescriptions for oxycodone 30 mg for J.R. and L.T., who both share the
same address and received their prescriptions from the same
practitioner, Dr. V.M. Id. Finally, between January 2022 and May 2023,
Registrant filled prescriptions for hydrocodone-acetaminophen 10/325 mg
for D.S.E. and J.L.,\4\ who both share the same address and received
their prescriptions from the same practitioner, Dr. V.M. Id.
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\4\ The OSC also alleges, and it is therefore admitted, that
Registrant filled oxycodone 30 mg for D.S.T. who shared an address
with D.S.E. and J.L. and saw the same practitioner. Id. This
allegation is not sustained because there is not substantial
evidence or an admission that clearly establishes that hydrocodone-
acetaminophen 10/325 is a ``substantially similar controlled
substance prescription'' to oxycodone 30 mg such that the
prescription presents an additional instance of the shared address
red flag. Id.
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Accordingly, the Agency finds that Registrant filled controlled
substance prescriptions without first resolving the red flag of shared
addresses.
[[Page 82269]]
D. 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 section
291.29(f)(9); RFAAX A, at 6. 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 of her family and
administrative medicine area of practice. RFAAX A, at 6.\5\
Accordingly, the Agency finds that Registrant filled controlled
substance prescriptions without first resolving the red flag arising
from the prescriber's area of practice.
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\5\ 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 section 291.29(f)(8). The OSC alleges, and it is
therefore deemed admitted, that ``Dr. [V.M.] is not Board Certified
in the area of pain management.'' RFAAX A, at 6. However, there is
not substantial evidence or an admission that the prescriptions
issued by Dr. V.M. that were presented to the Registrant were mostly
for opioids and the other listed controlled substances. Accordingly,
the Agency cannot sustain this allegation or find that it presents
an additional instance of the prescriber area of practice red flag.
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E. Long Distances
Registrant is deemed to have admitted that individuals traveling
long distances to obtain or fill controlled substance prescriptions is
a well-known red flag of abuse or diversion. Registrant further admits
that it repeatedly filled prescriptions without identifying and
resolving the red flag of patients traveling long distances to obtain
or fill controlled substance prescriptions. Id. at 7. Specifically,
Registrant is deemed to have admitted that it filled prescriptions for
seven individuals, C.W., D.W., D.S.M., J.J., E.W., J.R., and L.T.,
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 seven
individuals' residences. Id.
Accordingly, the Agency finds that Registrant filled controlled
substance prescriptions without first resolving the red flag arising
from long distances traveled.
F. 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 A, at 7-
8.
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. Id. at 7-8. Specifically, between January 2022 and
July 2023, Registrant routinely accepted cash payments for controlled
substance prescriptions, including for each of the prescriptions filled
for each of the ten individuals as described above. Id. at 8.
Registrant is also deemed to have admitted that for L.T., Registrant
routinely accepted cash payment for L.T.'s prescriptions between
February 2022 and July 2023, despite the Texas Prescription Drug
Monitoring Program Report indicating that L.T. used insurance at other
pharmacies on three occasions.\6\ Id.
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\6\ The OSC additionally alleged, and it is therefore deemed
admitted, that ``between January 2022 and July 2023, [Registrant]
routinely dispensed a quantity less than the amount prescribed by
the physician and provided no documentation regarding approval from
the physician.'' Id. The OSC implies that this conduct violates 22
Texas Administrative Code section 291.33(c)(2)(A)(iv), which states:
``[P]rior 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. It is not
clear from substantial record evidence or an admission that the
Registrant filling a quantity less than what was prescribed means
that Registrant must have had unresolved questions regarding the
prescription drug order. Accordingly, this allegation regarding the
red flag of dispensing less than prescribed is not sustained. The
Agency finds that the founded allegations discussed above are more
than sufficient to support the Government's requested sanction of
revocation under these circumstances.
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Accordingly, the Agency finds that Registrant filled controlled
substance prescriptions without first resolving the red flag arising
from cash payments.
G. 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 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
CFR 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 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. David H. Gillis, M.D., 58 FR 37507, 37508
(1993).
While the Agency has considered all of the public interest factors
in 21 U.S.C. 823(g)(1),\7\ 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
[[Page 82270]]
RFAAX A, at 4-5. Moreover, the Government has the burden of proof in
this proceeding. 21 CFR 1301.44.
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\7\ 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 19434, 19444 (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). Agency cases have found that ``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 49956, 49973 (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 1095, 1097 (2023); Kareem Hubbard, M.D.,
87 FR 21156, 21162 (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 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 69441, 69445 (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 7304,
7331 (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 section 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 section 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. section
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.
section 291.33(c)(2)(A)(iv); see also id. sections 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. section 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, Registrant has admitted that it 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 5-8. DEA's pharmacy expert concluded that these
red flags were highly indicative of abuse and diversion. Id. at 8.
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 section 481.074, and 22 Texas Administrative Code
sections 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 18882, 18910 (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., d/b/a CVS/Pharmacy Nos. 219 and 5195, 77
FR 62316, 62339 (2012) (internal quotations omitted); see also Michele
L. Martinho, M.D., 86 FR 24012, 24019 (2021); George D. Gowder, III,
M.D., 89 FR 76152, 76154 (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 33738, 33746
(2021).
Here, Registrant failed to answer the allegations contained in the
OSC/ISO
[[Page 82271]]
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.
FH9037830 issued to Halowells 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 Halowells Pharmacy to renew or
modify this registration, as well as any other pending application of
Halowells Pharmacy for additional registration in Texas. This Order is
effective November 12, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 4, 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. 2024-23495 Filed 10-9-24; 8:45 am]
BILLING CODE 4410-09-P
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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.