Bulk Manufacturer of Controlled Substances Application: Irvine Labs, Inc., 84615-84616 [2024-24554]
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices
by an individual practitioner acting in
the usual course of his professional
practice.’’ 21 CFR 1306.04(a).
As for South Carolina state law,
grounds for disciplinary action against a
physician include when the physician
has: ‘‘engaged in dishonorable,
unethical, or unprofessional conduct
that is likely either to deceive, defraud,
or harm the public’’; ‘‘violated the code
of medical ethics adopted by the [State
Board of Medical Examiners] or has
been found by the [State Board of
Medical Examiners] to lack the ethical
or professional competence to practice’’;
‘‘failed to prepare or maintain an
adequate patient record of care
provided’’; ‘‘engaged in behavior that
exploits the physician-patient
relationship in a sexual way’’; and
‘‘improperly managed medical records,
including failure to maintain timely,
legible, accurate, and complete medical
records.’’ S.C. Code Ann. § 40–47–110.
Further, South Carolina regulations
require that prior to prescribing to a
patient, a physician must establish a
proper physician-patient relationship,
which entails that the physician ‘‘make
an informed medical judgment based on
the circumstances of the situation and
on the [physician’s] training and
experience’’; ‘‘personally perform and
document an appropriate history and
physical examination, make a diagnosis,
and formulate a therapeutic plan’’;
‘‘discuss with the patient the diagnosis
and the evidence for it, and the risks
and benefits of various treatment
options’’; and ‘‘ensure the availability of
the [physician] or coverage for the
patient for appropriate follow-up care.’’
Id. § 40–47–113(A).6
Here, consistent with Registrant’s
admissions, the Agency finds that
Registrant repeatedly issued
prescriptions for controlled substances
without conducting an appropriate
evaluation, without making a proper
diagnosis, without providing a
therapeutic plan, and without
discussing the risks, benefits and
treatment options with his patients.
RFAAX 1, at 3–5. Registrant has also
admitted and the Agency finds that
Registrant: engaged in sexual conduct
with a patient prior to issuing the
patient prescriptions for controlled
substances; issued a cocktail
prescription of opioids and a
benzodiazepine to multiple patients on
multiple occasions while failing to
document his reasoning for so doing;
and increased the dosages of controlled
6 South Carolina Code of Regulations § 81–60,
entitled Principles of Medical Ethics, states in
subsection A that ‘‘a physician shall be dedicated
to providing competent medical service with
compassion and respect for human dignity.’’
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18:48 Oct 22, 2024
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substance prescriptions for multiple
patients without medical justification
for so doing. Id. Based on Registrant’s
numerous deviations from the standard
of care, DEA’s medical expert
concluded, and the Agency finds, that
these prescriptions were not issued for
a legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice. Id. at 5. Registrant has further
admitted that he failed to provide
adequate patient records to one group of
state officials, then provided fraudulent
patient records to another group of state
officials. Id. As such, the Agency finds
that Registrant violated 21 CFR
1306.04(a) and South Carolina Code
§§ 40–47–110 and 40–47–113.
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 he can be entrusted with the
responsibility carried by a registration.
Garret Howard Smith, M.D., 83 FR
18882, 18910 (2018). To establish that
he can be entrusted with registration, a
registrant must both accept
responsibility and demonstrate that he
has undertaken corrective measures.
Holiday CVS, L.L.C., dba CVS Pharmacy
Nos 219 and 5195, 77 FR 62316, 62339
(2012); 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 factdependent determination based on
individual circumstances; therefore, the
Agency looks at factors such as the
acceptance of responsibility, the
credibility of that acceptance as it
relates to the probability of repeat
violations or behavior, the nature of the
misconduct that forms the basis for
sanction, and the Agency’s interest in
deterring similar acts. See, e.g., Robert
Wayne Locklear, M.D., 86 FR 33738,
33746 (2021).
Here, Registrant failed to answer the
allegations contained in the OSC and
did not otherwise avail himself of the
opportunity to refute the Government’s
case. As such, Registrant has made no
representations as to his future
compliance with the CSA nor made any
demonstration that he can be entrusted
with registration. Moreover, the
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Sfmt 4703
84615
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. BR6910803 issued to
David Carlos Rodriguez, M.D. 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 David Carlos Rodriguez,
M.D., to renew or modify this
registration, as well as any other
pending application of David Carlos
Rodriguez, M.D., for additional
registration in South Carolina. This
Order is effective November 22, 2024.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on October 15, 2024, by Administrator
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2024–24575 Filed 10–22–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1438]
Bulk Manufacturer of Controlled
Substances Application: Irvine Labs,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Irvine Labs, Inc. has applied
to be registered as a bulk manufacturer
of basic class(es) of controlled
substance(s). Refer to Supplementary
Information listed below for further
drug information.
SUMMARY:
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Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices
Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before December 23, 2024. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2024.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on August 26, 2024, Irvine
Labs, Inc., 7305 Murdy Circle,
Huntington Beach, California 92647–
3533, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
DATES:
Controlled substance
Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
I
Drug
code
Schedule
7350
7360
7370
I
I
I
I
The applicant plans to manufacture
bulk Active Pharmaceutical Ingredients
for product development and
distribution to DEA-registered
researchers. No other activities for these
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–24554 Filed 10–22–24; 8:45 am]
BILLING CODE 4410–09–P
khammond on DSKJM1Z7X2PROD with NOTICES
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
BRX Pharmacy; Decision and Order
On October 2, 2023, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause and Immediate Suspension of
Registration (OSC/ISO) to BRX
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18:48 Oct 22, 2024
Jkt 265001
Pharmacy of Stafford, Texas
(Registrant). Request for Final Agency
Action (RFAA), Exhibit (RFAAX) A, at
1. The OSC/ISO informed Registrant of
the immediate suspension of its DEA
Certificate of Registration, Control No.
FB7301497, pursuant to 21 U.S.C.
824(d), alleging that Registrant’s
continued registration constitutes ‘‘ ‘an
imminent danger to the public health or
safety.’ ’’ Id. (quoting 21 U.S.C. 824(d)).
The OSC/ISO also proposed the
revocation of Registrant’s registration,
alleging that Registrant’s continued
registration is inconsistent with the
public interest. Id. (citing 21
U.S.C.823(g)(1), 824(a)(4)).
The OSC/ISO notified Registrant of its
right to file with DEA a written request
for hearing. Id. at 10–11 (citing 21 CFR
1301.43). The OSC/ISO also notified
Registrant that if it requested a hearing
but failed to timely file an answer, it
would be deemed to have waived its
right to a hearing and be in default. Id.
(citing 21 CFR 1301.43(c)(2), (c)(3), (d)).
On October 30, 2023, Registrant timely
requested a hearing, however, Registrant
failed to answer the allegations of the
OSC/ISO. RFAA, at 1; RFAAX C, at 1.1
The matter was assigned to a DEA
Administrative Law Judge (ALJ) who
issued an Order for Prehearing
Statements that, among other things,
reminded Registrant to file a compliant
answer within 30 days of receipt of the
OSC/ISO.2 RFAA, at 1; RFAAX C, at 2.
On November 7, 2023, Registrant filed
an answer, but the ALJ found it
‘‘substantively non-compliant’’ and
ordered Registrant to refile. RFAA, at 2;
RFAAX B, at 4–8; RFAAX D, at 1.
Registrant ultimately failed to file a
compliant answer. RFAA, at 2; RFAAX
E, at 2. On November 13, 2023, the
Government filed a Motion to Terminate
Proceedings based on Registrant’s
failure to file an answer. RFAA, at 2.3
Registrant did not file a response. Id. On
November 27, 2023, the ALJ issued an
order finding Registrant in default and
terminating proceedings. Id.; RFAAX F,
at 4–5.
‘‘A default, unless excused, shall be
deemed to constitute a waiver of the
registrant’s . . . right to a hearing and
1 Based on the Government’s submissions in its
RFAA dated November 29, 2023, the Agency finds
that service of the OSC/ISO on Registrant was
adequate. Specifically, the Government’s exhibit
titled Notice of Service includes a copy of a Form
DEA–12 signed by Registrant’s Pharmacist-inCharge, indicating that Registrant was personally
served with the OSC/ISO on October 5, 2023.
RFAA, at 1; RFAAX B, at 1, 3.
2 Because the 30-day deadline for responding to
the OSC/ISO, November 4, 2023, fell on a Saturday,
the deadline for responding was November 6, 2023.
3 The Government refers to an ‘‘Exhibit G’’ that is
not included in the instant RFAA.
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Frm 00096
Fmt 4703
Sfmt 4703
an admission of the factual allegations
of the [OSC/ISO].’’ 21 CFR 1301.43(e).
Further, ‘‘[i]n the event that a registrant
. . . is deemed to be in default . . .
DEA may then file a request for final
agency action with the Administrator,
along with a record to support its
request. In such circumstances, the
Administrator may enter a default final
order pursuant to [21 CFR] 1316.67.’’ Id.
§ 1301.43(f)(1). Here, the Government
has requested final agency action based
on Registrant’s default pursuant to 21
CFR 1301.43(c), (f), 1301.46. RFAA, at 2;
see also 21 CFR 1316.67.
I. Findings of Fact
The Agency finds that, in light of
Registrant’s default, the factual
allegations in the OSC/ISO are
admitted.4 Registrant is deemed to have
admitted and the Agency finds that it
repeatedly dispensed prescriptions in
violation of the minimum practice
standards that govern pharmacy practice
in Texas. RFAAX A, at 4. Specifically,
from at least January 2022 through June
2023, Registrant repeatedly filled
controlled substance prescriptions that
contained multiple red flags of abuse
and/or diversion without addressing or
resolving the red flags, in violation of
both federal and state law. Id. at 4–5.
A. Pattern Prescribing, Substances of
Abuse, and Strength and Quantity
Texas regulations identify the
following prescribing patterns as red
flag factors: ‘‘[T]he pharmacy dispenses
a reasonably discernible pattern of
substantially identical prescriptions for
the same controlled substances . . . .’’;
‘‘[P]rescriptions . . . are routinely for
controlled substances commonly known
to be abused drugs . . . .’’; and
‘‘[P]rescriptions for controlled
substances are commonly for the highest
strength of the drug and/or for large
quantities . . . .’’ 22 Tex. Admin. Code
§§ 291.29(f)(1), (3), (5); RFAAX A, at 5.
Registrant is deemed to have admitted
that it failed to identify and resolve the
red flag of pattern prescribing,
substances of abuse, and strength and
quantity. RFAAX A, at 5. Specifically,
between January 2022 and May 2023,
Registrant filled prescriptions for
oxycodone (a Schedule II opioid) issued
by Dr. V.M. to C.B., E.B., K.B., T.H., and
O.B. Id. Each prescription was for the
highest strength of oxycodone, 30 mg,
which is known to be frequently abused,
and each prescription ranged from 70 to
105 dosage units, approximately 3 or 4
daily doses. Id.
4 The Agency need not adjudicate the criminal
violations alleged in the instant OSC/ISO. Ruan v.
United States, 142 S. Ct. 2,370 (2022) (decided in
the context of criminal proceedings).
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]]>Agencies
[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84615-84616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24554]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1438]
Bulk Manufacturer of Controlled Substances Application: Irvine
Labs, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Irvine Labs, Inc. has applied to be registered as a bulk
manufacturer of basic class(es) of controlled substance(s). Refer to
Supplementary Information listed below for further drug information.
[[Page 84616]]
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants, therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
December 23, 2024. Such persons may also file a written request for a
hearing on the application on or before December 23, 2024.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on August 26, 2024, Irvine Labs, Inc., 7305 Murdy
Circle, Huntington Beach, California 92647-3533, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract...................... 7350 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
------------------------------------------------------------------------
The applicant plans to manufacture bulk Active Pharmaceutical
Ingredients for product development and distribution to DEA-registered
researchers. No other activities for these drug codes are authorized
for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-24554 Filed 10-22-24; 8:45 am]
BILLING CODE 4410-09-P
