Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 84615 

6South 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.’’ 

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 

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 

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. 

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. 


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84616 Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 

1Based 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. 

2Because 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. 

3The Government refers to an ‘‘Exhibit G’’ that is 

not included in the instant RFAA. 

4The 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). 

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): 

Controlled substance Drug 

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 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

BRX Pharmacy; Decision and Order 

On October 2, 2023, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO) to BRX 

Pharmacy of Stafford, Texas 

(Registrant). Request for Final Agency 

Action (RFAA), Exhibit (RFAAX) A, at 

1. The OSC/ISO informed Registrant of 

the immediate suspension of its DEA 

Certificate of Registration, Control No. 

FB7301497, pursuant to 21 U.S.C. 

824(d), alleging that Registrant’s 

continued registration constitutes ‘‘ ‘an 

imminent danger to the public health or 

safety.’ ’’ Id. (quoting 21 U.S.C. 824(d)). 

The OSC/ISO also proposed the 

revocation of Registrant’s registration, 

alleging that Registrant’s continued 

registration is inconsistent with the 

public interest. Id. (citing 21 

U.S.C.823(g)(1), 824(a)(4)). 

The OSC/ISO notified Registrant of its 

right to file with DEA a written request 

for hearing. Id. at 10–11 (citing 21 CFR 

1301.43). The OSC/ISO also notified 

Registrant that if it requested a hearing 

but failed to timely file an answer, it 

would be deemed to have waived its 

right to a hearing and be in default. Id. 

(citing 21 CFR 1301.43(c)(2), (c)(3), (d)). 

On October 30, 2023, Registrant timely 

requested a hearing, however, Registrant 

failed to answer the allegations of the 

OSC/ISO. RFAA, at 1; RFAAX C, at 1.1

The matter was assigned to a DEA 

Administrative Law Judge (ALJ) who 

issued an Order for Prehearing 

Statements that, among other things, 

reminded Registrant to file a compliant 

answer within 30 days of receipt of the 

OSC/ISO.2 RFAA, at 1; RFAAX C, at 2. 

On November 7, 2023, Registrant filed 

an answer, but the ALJ found it 

‘‘substantively non-compliant’’ and 

ordered Registrant to refile. RFAA, at 2; 

RFAAX B, at 4–8; RFAAX D, at 1. 

Registrant ultimately failed to file a 

compliant answer. RFAA, at 2; RFAAX 

E, at 2. On November 13, 2023, the 

Government filed a Motion to Terminate 

Proceedings based on Registrant’s 

failure to file an answer. RFAA, at 2.3

Registrant did not file a response. Id. On 

November 27, 2023, the ALJ issued an 

order finding Registrant in default and 

terminating proceedings. Id.; RFAAX F, 

at 4–5. 

‘‘A default, unless excused, shall be 

deemed to constitute a waiver of the 

registrant’s . . . right to a hearing and 

an admission of the factual allegations 

of the [OSC/ISO].’’ 21 CFR 1301.43(e). 

Further, ‘‘[i]n the event that a registrant 

. . . is deemed to be in default . . . 

DEA may then file a request for final 

agency action with the Administrator, 

along with a record to support its 

request. In such circumstances, the 

Administrator may enter a default final 

order pursuant to [21 CFR] 1316.67.’’ Id. 

§ 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. 


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