Federal Register / Vol. 89, No. 203 / Monday, October 21, 2024 / Notices 84195 

1The Agency adopts the ALJ’s summary of the 

witnesses’ testimonies as well as the ALJ’s 

assessment of the witnesses’ credibility. RD, at 3– 

21. 

2On May 30, 2024, Respondent signed a DEA 

Form 104, Surrender for Cause of DEA Certificate 

of Registration. See 21 CFR 1301.52(a). Even when 

a registration is terminated, the Agency has 

discretion to adjudicate the OSC to finality. See 

Jeffrey D. Olsen, M.D., 84 FR 68,474, 68,479 (2019) 

(declining to dismiss an immediate suspension 

order when the registrant allowed the registration 

to expire before final adjudication); Steven M. 

Kotsonis, M.D., 85 FR 85667, 85668–69 (2020) 

(concluding that termination of a registration under 

21 CFR 1301.52 does not preclude DEA from 

issuing a final decision and that the Agency would 

assess such matters on a case-by-case basis to 

determine if a final adjudication is warranted); The 

Pharmacy Place, 86 FR 21008, 21008–09 (2021) 

(‘‘Adjudicating this matter to finality will create a 

public record to educate current and prospective 

registrants about the Agency’s expectations 

regarding the responsibilities of registrant[s] . . . 

under the CSA and allow stakeholders to provide 

feedback regarding the Agency’s enforcement 

priorities and practices.’’); Creekbend Community 

Pharmacy, 86 FR 40627, 40628 n.4 (2021) 

(‘‘Adjudicating this matter to finality will create an 

official record the Agency can use in any future 

interactions with Respondent . . . or other persons 

who were associated with Respondent.’’). As in 

these cases, the Agency has evaluated the 

circumstances of this matter and determined that 

the matter should be adjudicated to finality for the 

purpose of creating an official record of the 

allegations and evidence, and educating the 

registrant community, the public, and stakeholders 

about the responsibilities associated with holding a 

DEA registration and the Agency’s enforcement 

priorities. 

3The ALJ found that ‘‘to the extent 

[Respondent’s] testimony contradicts with that 

offered by [the Diversion Investigator], [she] gives 

full credit to the [Diversion Investigator]’s 

testimony.’’ RD, at 21. The Agency agrees with the 

amount of weight that the ALJ afforded 

Respondent’s testimony. 

4CES’s staff did not hold DEA registrations. RD, 

at 5, 16; Tr. 50, 225–26. 

5A hard token is a physical device similar to a 

key fob that may be used to authenticate an 

electronic prescription. Tr. 45; 21 CFR 

1311.115(a)(3), 1311.140(a)(5). The hard token 

which Respondent used was not offered into 

evidence. Tr. 47. Instead, a picture of a hard token 

similar to one used by Respondent was admitted 

into evidence. Tr. 45–48; GX 22. The picture shows 

a small device, roughly two inches in length, with 

a small screen on which a PIN number would be 

displayed. Id. When a hard token is used to sign 

a prescription, the token generates a unique 

identification PIN number which serves as the 

signature on the prescription. RD, at 5; Tr. 46. The 

PIN is unique to each prescription and can be 

traced to the prescriber. Id. 

6The Agency agrees with the ALJ’s assessment 

that the DI was ‘‘a credible, reliable’’ witness and 

that her testimony was clear, objective, consistent, 

precise, and ‘‘corroborated by the documentary 

evidence.’’ RD, at 9. The ALJ found that ‘‘[t]o the 

extent her testimony conflicts with Respondent’s 

testimony, . . . [she] credits [the DI].’’ Id. The 

Agency agrees with the amount of weight that the 

ALJ afforded Respondent’s testimony. 

submitting responses to the complaint 

and the notice of investigation will not 

be granted unless good cause therefor is 

shown. 

Failure of a respondent to file a timely 

response to each allegation in the 

complaint and in this notice may be 

deemed to constitute a waiver of the 

right to appear and contest the 

allegations of the complaint and this 

notice, and to authorize the 

administrative law judge and the 

Commission, without further notice to 

the respondent, to find the facts to be as 

alleged in the complaint and this notice 

and to enter an initial determination 

and a final determination containing 

such findings, and may result in the 

issuance of an exclusion order or a cease 

and desist order or both directed against 

the respondent. 

By order of the Commission. 

Issued: October 16, 2024. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2024–24285 Filed 10–18–24; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 23–65] 

Neeraj B. Shah, M.D.; Decision and 

Order 

On August 30, 2023, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause (OSC) to Neeraj B. Shah, M.D., 

(Respondent) of Austin, Texas. 

Administrative Law Judge Exhibit 

(ALJX) 1 (OSC), at 1. The OSC proposed 

the revocation of Respondent’s DEA 

Certificate of Registration (registration), 

No. FS2968444, and alleged that 

Respondent’s continued registration is 

inconsistent with the public interest. Id. 

(citing 21 U.S.C. 823(g)(1), 824(a)(4)). 

A hearing was held before DEA 

Administrative Law Judge (ALJ) Teresa 

A. Wallbaum who, on March 8, 2024, 

issued her Recommended Rulings, 

Findings of Fact, Conclusions of Law, 

and Decision of the Administrative Law 

Judge (RD). The RD recommended that 

Respondent’s registration be revoked. 

RD, at 33. Neither party filed exceptions 

to the RD. Having reviewed the entire 

record, the Agency adopts and hereby 

incorporates by reference the entirety of 

the ALJ’s rulings, credibility findings,1

findings of fact, conclusions of law, 

sanctions analysis, and recommended 

sanction in the RD and summarizes and 

expands upon portions thereof herein.2

I. Findings of Fact 

The Agency finds from clear, 

unequivocal, and convincing evidence 

that Respondent failed to maintain sole 

possession of his hard token for issuing 

electronic controlled substance 

prescriptions, that he allowed 

unauthorized individuals to issue 

electronic controlled substance 

prescriptions using his DEA credentials, 

and that in doing so, he allowed 

controlled substances to be prescribed 

outside the usual course of professional 

practice and without a legitimate 

medical purpose. RD, at 24–27. 

Respondent’s Hard Token, Credentials, 

and Electronic Prescribing 

In July 2019, Respondent 3 received 

an unsolicited fax offering employment 

as a prescribing practitioner with a 

telemedicine platform called Church 

Ekklasia Sozo (CES).4 RD, at 11–12; Tr. 

184–86, 327; Respondent’s Exhibit (RX) 

1. The company was based out of North 

Carolina and Respondent lived and 

worked in Texas. RD, at 4, 10, 12; ALJX 

8, at 2, Stips. 1–3. Respondent joined 

CES in September 2019 and had his first 

patient intake and clinical encounter in 

May 2020. RD, at 12; Tr. 197–98. 

Respondent worked as a contractor 

physician for CES from September 9, 

2019, to December 13, 2021. RD, at 4, 

11–12; Tr. 40, 192–94; ALJX 8, at 2, 

Stip. 2. As a condition of employment 

at CES, Respondent was required to 

obtain a hard token 5 for the purpose of 

issuing electronic controlled substance 

prescriptions and to give the hard token 

to CES staff in North Carolina. RD, at 4, 

6–7, 13; Tr. 44–45, 58–59, 227–29, 231, 

280, 284. Respondent admitted to giving 

his hard token to CES and allowing the 

company to keep his electronic 

signature on file to issue controlled 

substance prescriptions under his DEA 

registration. Id. 

On December 1, 2021, a DEA 

Diversion Investigator (DI) 6 conducted a 

regulatory inspection of Respondent’s 

registered premises. RD, at 3–4; Tr. 28, 

31–38, 138, 141–42, 156; Government’s 

Exhibit (GX) 2. At the inspection, the DI 

informed Respondent that over 1,900 

prescriptions for buprenorphine 

products (a schedule III controlled 

substance) had been issued under his 

registration in the past two years. RD, at 

4; Tr. 41–43. Respondent stated that this 

number was ‘‘too high’’ because he only 

saw ‘‘about 20 to 25 patients.’’ Id. The 

DI asked Respondent to show her a 

prescription that he had issued, and 

Respondent pulled up a recently issued 

controlled substance prescription for 

patient J.O. RD, at 5–6; Tr. 50–53; GX 

20, at 29. The prescription bore a time 

stamp indicating that it had been signed 

by Respondent while the DI was 

conducting the inspection. Id. Although 

the prescription for J.O. purported to be 

signed by Respondent, Respondent told 

the DI that he did not know this patient, 


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7The DI informed Respondent and CES’s owner 

that CES must cease using Respondent’s registration 

for prescribing controlled substances and that the 

hard token must be returned to Respondent. RD, at 

6; Tr. 58, 157, 163. After the inspection ended, 

Respondent sent an email to CES’s owner directing 

CES to stop using his registration for issuing 

prescriptions and to overnight return his hard token 

to his home. RD, at 7, 17; Tr. 62, 66–69, 159, 237; 

GX 14. 

8 It is important to emphasize the clarity with 

which this requirement is stated in the regulation. 

The requirement to ‘‘retain sole possession’’ is 

stated simply, clearly, and unambiguously in plain 

language. See Electronic Prescriptions for 

Controlled Substances, 75 FR 16236, 16277 (Mar. 

31, 2010). To further emphasize this point, the RD 

put it well: the requirement to retain sole 

possession of the hard token is set forth ‘‘in plain, 

simple English, and is consistent with basic 

common sense.’’ RD, at 32. 

had never conducted a telemedicine 

appointment for this patient, and had 

never established a doctor-patient 

relationship with this patient. RD, at 8– 

9, 18; Tr. 107–09, 148–56, 161–63, 234, 

236, 286–87, 296–97, 332; GX 24. 

The DI asked how Respondent could 

have signed and issued this prescription 

during the inspection when Respondent 

had not conducted any telemedicine 

visits during that time. RD, at 5–6; Tr. 

53. Respondent explained that CES had 

his signature on file, which allowed the 

company’s unregistered staff to issue 

electronic prescriptions on his behalf. 

RD, at 4; Tr. 44–45. Respondent also 

stated that he had given his hard token 

to CES in North Carolina as a condition 

of his employment with CES.7 RD, at 6– 

7, 13; Tr. 58–59, 227–29, 231, 280, 284– 

85. Further, CES’s owner telephonically 

explained that it was CES’s standard 

procedure for nurses to sign the 

prescriptions, ‘‘because the [ nurses] 

were [ ] agent[s] of the doctor.’’ RD, at 

4–6; Tr. 53–54. 

II. Discussion 

A. The Five Public Interest Factors 

Under the 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 his 

registration under [21 U.S.C. 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 caseby-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). The 

inquiry is ‘‘focuse[d] on protecting the 

public interest.’’ Jayam Krishna-Iyer, 

M.D., 74 FR 459, 462 (2009). 

The Government has the burden of 

proof in this proceeding. 21 CFR 

1301.44. While the Agency has 

considered all the public interest factors 

in 21 U.S.C. 823(g)(1), the Government’s 

evidence in support of its prima facie 

case for revoking Respondent’s 

registration is confined to Factors B and 

D. RD, at 24 n.24 (finding that Factors 

A, C, and E do not weigh for or against 

the sanction sought by the Government). 

Having reviewed the record and the RD, 

the Agency adopts the ALJ’s analysis, 

and agrees that the Government’s 

evidence satisfies its prima facie burden 

of showing that Respondent’s continued 

registration would be inconsistent with 

the public interest. RD, at 27, 33; 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 1,095, 1,097 (2023); Kareem 

Hubbard, M.D., 87 FR 21,156, 21,162 

(2022). 

DEA regulations allow registrants to 

issue electronic prescriptions for 

controlled substances in schedules II–V. 

21 CFR 1311.100(b); RD, at 23. To issue 

an electronic prescription for a 

controlled substance, the prescriber 

must authenticate the prescription using 

at least two of the following factors: (1) 

‘‘Something only the practitioner 

knows, such as a password or response 

to a challenge question’’; (2) ‘‘Something 

the practitioner is, biometric data such 

as a fingerprint or iris scan’’; and/or (3) 

‘‘Something the practitioner has, a 

device (hard token) separate from the 

computer to which the practitioner is 

gaining access.’’ 21 CFR 1311.115(a), 

1311.120(b)(5), (11); RD, at 23; Tr. 45. 

This two-factor authentication process 

‘‘constitute[s] the signing of the 

prescription by the practitioner.’’ 21 

CFR 1311.140(a)(5). ‘‘[O]nly the 

registrant may sign the prescription,’’ 

and when signing the prescription, the 

registrant must comply with the twofactor authentication requirement. 21 

CFR 1311.135(a); RD, at 23. Although 

DEA regulations permit a non-registered 

agent to enter data on the prescription, 

the registrant must sign the prescription 

himself. Id. 

DEA regulations make clear that 

‘‘[t]he practitioner must retain sole 

possession of the hard token’’ and 

‘‘must not allow any other person to use 

the token.’’ 8 21 CFR 1311.102(a); RD, at 

23. The regulation further states that the 

practitioner ‘‘must not share the 

password or other knowledge factor, or 

biometric information, with any other 

person’’ and ‘‘[t]he practitioner must not 

allow any other person to use the token 

or enter the knowledge factor or other 

identification means to sign 

prescriptions for controlled substances.’’ 

Id. ‘‘Failure by the practitioner to secure 

the hard token, knowledge factor, or 

biometric information may provide a 

basis for revocation or suspension of 

registration.’’ Id. 

Regarding the hard token, substantial 

record evidence, including 

Respondent’s admission, establishes 

that Respondent gave his hard token to 

CES staff in North Carolina and allowed 

them to maintain physical possession of 

it. RD, at 25–26; Tr. 53–59, 66–67, 227– 

31, 237, 285. Accordingly, substantial 

record evidence establishes that 

Respondent failed to ‘‘retain sole 

possession of the hard token,’’ in 

violation of 21 CFR 1311.102(a). RD, at 

25–26; see also Allan Alexander 

Rashford, M.D., 87 FR 77637, 77637–38 

(2022) (revoking respondent’s 

registration, in part, for violating 21 CFR 

1311.102(a) due to ‘‘entrusting his 

secure credentials to his wife and son 

and allowing them to access and 

provide his PIN’’ to prescribe controlled 

substances). 

Regarding credentials, substantial 

record evidence, including 

Respondent’s admission, establishes 

that Respondent allowed CES to keep 

his signature on file to use in 

conjunction with the hard token in 

order to complete the two-factor 

authentication process for signing and 

issuing electronic controlled substance 

prescriptions on his behalf. RD, at 26; 

Tr. 44–45, 53–59, 157, 163, 222, 225–27, 

229, 231, 280, 284; GX 14; GX 20–21 

(prescriptions issued by CES staff to J.O. 

and three other patients). In so doing, 

Respondent violated federal and state 

regulations that prohibit any person 

other than the registrant from signing 


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9The Agency finds that it is not necessary to 

determine the precise number of prescriptions that 

were issued by CES with Respondent’s hard token 

and credentials. RD, at 26. The record clearly 

establishes and Respondent admitted that 

prescriptions were being issued under Respondent’s 

registration for at least one patient he never saw 

(J.O.) and at quantities that exceeded the patients 

he did see. See RD, at 4, 20, 26; GX 20, at 17–29; 

Tr. 41–43 (when the DI informed Respondent that 

the PMP showed 1,900 prescriptions had been 

issued under his registration, he responded that this 

number was ‘‘too high’’ because he only saw ‘‘about 

20 to 25 patients’’); Tr. 234, 236, 286–87, 297, 332. 

10The allegation that Respondent failed to 

establish a doctor-patient relationship in this case 

pertains only to J.O. Tr. 92. Although the 

Government admitted additional prescriptions into 

evidence that CES staff issued using Respondent’s 

hard token—all of which were issued in violation 

of 21 CFR 1311.135(a)—the Government has not 

alleged that Respondent failed to establish a doctorpatient relationship with these patients. Tr. 81–82, 

92. 

11 It is a long-standing principle of diversion law 

that DEA registrants are ‘‘strictly liable for all 

activities which occur under the authority of their 

registrations.’’ Sigrid Sanchez, M.D., 78 FR 39331, 

39336 (2013). In line with this well-established 

principle, it is reasonable to find that a registrant 

can be held liable for controlled substances being 

prescribed outside the usual course of professional 

practice even when issued by someone else under 

his registration. For instance, where a registrant’s 

actions allow an unregistered person to prescribe 

controlled substances, as Respondent did here, the 

registrant can be found in violation of 21 CFR 

1306.04(a). Robert G. Hallermeier, M.D., 62 FR 

26818, 26820 (1997). This is because the purpose 

of § 1306.04(a)—to ensure that ‘‘patients use 

controlled substances under the supervision of a 

doctor so as to prevent’’ diversion—is thwarted 

when a registrant allows an unregistered person to 

prescribe controlled substances under the 

registrant’s registration to patients the registrant has 

never seen, which occurred in this case. Gonzales 

v. Oregon, 546 U.S. 243, 274 (2006). When a 

registrant allows an unauthorized person to 

prescribe controlled substances, such as when 

Respondent allowed CES’s unregistered staff to 

prescribe controlled substances to patients 

Respondent had never seen, the registrant creates a 

‘‘substantial risk that the drugs would be diverted 

and abused,’’ which undermines the purpose of 

§ 1306.04(a)’s prescription requirement. Arvinder 

Singh, M.D., 81 FR 8247, 8249 (2016). 

Holding a registrant liable for violating 

§ 1306.04(a) where prescriptions are issued by 

someone else under his registration is an extension 

of the Agency’s precedent and the principle that 

registrants are ‘‘strictly liable for all activities which 

occur under the authority of their registrations.’’ 

Sigrid Sanchez, M.D., 78 FR at 39336. For example, 

in the context of electronic prescriptions, the 

Agency has revoked a registration, in part, due to 

the registrant ‘‘improperly issu[ing] electronic 

controlled substance prescriptions by entrusting his 

secure credentials to his wife and son and allowing 

them to access and provide his PIN in the issuance 

of those prescriptions.’’ Allen Alexander Rashford, 

M.D., 87 FR at 77638. Similarly, DEA has long held 

that when a registrant allows other individuals to 

use their registration, a serious violation is 

committed. See Brian Thomas Nichol, M.D., 83 FR 

47352, 47367 (2018) (concluding respondent 

committed a ‘‘serious violation of the CSA’’ when 

he pre-signed prescriptions and gave them to 

unregistered staff, creating a ‘‘substantial risk’’ of 

diversion and abuse); Rose Mary Jacinta Lewis, 

M.D., 72 FR 4035, 4041–42 (2007) (affirming an 

immediate suspension order where a registrant 

allowed another person to use her DEA credentials 

to obtain controlled substances and where such 

misconduct demonstrated ‘‘indifference to her 

obligations’’ and created a danger to public safety); 

Anthony L. Cappelli, M.D., 59 FR 42288, 42288 

(1994) (‘‘By allowing an unregistered and 

unauthorized person to use his DEA number, 

Respondent was responsible for any use and misuse 

of that number. Moreover, such a violation is 

aggravated by the fact that Respondent allowed a 

non-practitioner to use his DEA number at an 

unregistered location.’’). 

and authenticating an electronic 

controlled substance prescription. RD, 

at 26; Tr. 57–58; 21 CFR 1311.135(a); 22 

Tex. Admin. Code § 315.3(c)(1) 

(requiring Texas practitioners to comply 

with the requirements set forth in 21 

CFR 1311). 

Respondent allowed illegal electronic 

controlled substance prescriptions to be 

issued under his registration by giving 

away his hard token and two-factor 

authentication credentials.9 RD, at 4–5, 

16, 26, 32; Tr. 42–43, 226. The 

regulations governing the issuance of 

electronic controlled substance 

prescriptions do not ‘‘relieve[] a 

practitioner of his responsibility to 

dispense controlled substances only for 

a legitimate medical purpose while 

acting in the usual course of his 

professional practice.’’ 21 CFR 

1311.102(k); RD, at 23; see also 21 CFR 

1311.100(f). ‘‘The practitioner has the 

same responsibilities when issuing [an 

electronic prescription] as when issuing 

a paper or oral prescription,’’ including 

the requirement ‘‘to ensure the validity 

of [that] prescription.’’ 21 CFR 

1311.102(k); RD, at 23. 

Under DEA regulations, a controlled 

substance prescription may only ‘‘be 

issued for a legitimate medical purpose 

by an individual practitioner acting in 

the usual course of his professional 

practice.’’ 21 CFR 1306.04(a). Similarly, 

under Texas law, a controlled substance 

prescription may only be issued ‘‘for a 

valid medical purpose and in the course 

of medical practice.’’ Tex. Health & 

Safety Code § 481.071(a). Texas law 

states that prescribing a controlled 

substance ‘‘without first establishing a 

valid practitioner-patient relationship’’ 

falls outside the scope of professional 

medical practice. 22 Tex. Admin. Code 

§ 190.8(1)(L). 

Respondent admitted that he never 

established a doctor-patient relationship 

with J.O., yet thirteen prescriptions 

were written for J.O. using Respondent’s 

hard token and electronic signature.10

RD, at 8–9, 18, 26; Tr. 107–09, 148–56, 

161–63, 234, 286–87, 296–97, 332; GX 

20, 24. Accordingly, these prescriptions 

were issued without a legitimate 

medical purpose and outside the usual 

course of professional practice, in 

violation of federal and state law.11 RD, 

at 26; 21 CFR 1306.04(a); Tex. Health & 

Safety Code § 481.071(a); 22 Tex. 

Admin. Code § 190.8(1)(L). 

In sum, and in agreement with the 

RD, the Agency finds that the record 

contains substantial evidence that 

Respondent acted in violation of both 

federal and state law. RD, at 24–27; 21 

U.S.C. 823(g)(1), 824(a)(4); 21 CFR 

1306.04(a), 1311.100(f), 1311.102(a), (k), 

1311.115(a), 1311.120(b)(5), (b)(11), 

1311.125(c), 1311.135(a), 1311.140(a)(5); 

22 Tex. Admin. Code § 315.3(c)(1); Tex. 

Health & Safety Code § 481.071(a). In 

weighing factors B and D, the Agency 

finds that the Government has 

established a prima facie case that 

Respondent committed acts that render 

his registration inconsistent with the 

public interest and support revocation 

of his registration. 21 U.S.C. 823(g)(1); 

RD, at 27. 

III. Sanction 

Where, as here, the Government has 

established sufficient grounds to issue a 

sanction against Respondent’s 

registration, 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). 

‘‘[T]rust is necessarily a fact-dependent 

determination based’’ on individual 

circumstances; therefore, the Agency 

looks at factors such as ‘‘the acceptance 

of responsibility and 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.’’ Robert Wayne 

Locklear, M.D., 86 FR 33738, 33746 

(2021). To be effective, acceptance of 

responsibility must be unequivocal. 

Mohammed Asgar, M.D., 83 FR 29569, 

29573 (2018). When a registrant has 

committed acts inconsistent with the 

public interest, he must both accept 

responsibility and demonstrate that he 

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). 

Here, Respondent has failed to fully 

and credibly accept responsibility for 

the proven misconduct. RD, at 27–29. 

When asked about his decision to 

surrender physical possession of the 

hard token to CES, Respondent 

expressed regret and remorse. RD, at 28; 

Tr. 229, 316. Respondent testified that 

turning over the hard token was ‘‘a 

decision that [he] now regret[s] and [is] 

extremely remorseful about.’’ RD, at 28; 

Tr. 229, 316. Regret and remorse, 

however, are not the same as taking 


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12See Nicholas P. Roussis, M.D., 86 FR 59190, 

59194 (2021) (explaining ‘‘remorse and acceptance 

of responsibility are not the same thing’’ in that a 

respondent’s remorse is primarily concerned with 

his unpleasant feelings whereas a full acceptance of 

responsibility acknowledges the harm his actions 

posed to the public); Ibrahim Al-Qawaqneh, D.D.S., 

86 FR 10354, 10357 (2021) (finding that regret did 

not amount to acceptance of responsibility). 

13Respondent testified that he read 21 CFR 

1311.102(a) as part of his due diligence before 

joining CES; however, when the Government asked 

whether he was aware of a regulation prohibiting 

the surrender of a hard token to someone else, 

Respondent stated: ‘‘No. Not before I joined CES. I 

was not aware of this.’’ Tr. 316. The first words of 

21 CFR 1311.102(a) are ‘‘[t]he practitioner must 

retain sole possession of the hard token.’’ 

Respondent’s testimony that he read this regulation, 

given his claim that he was not aware that he had 

to keep the hard token, causes the Agency to 

question Respondent’s credibility. RD, at 31; see 

also Daniel A. Glick, D.D.S., 80 FR 74,800, 74809 

(2015) (holding ignorance of the CSA or DEA’s 

regulations are no defense to proven violations). 

14He acknowledged that nowhere in the 

company’s protocols or manuals was there an 

assurance from the company that surrendering his 

hard token complied with DEA regulations. RD, at 

18; Tr. 318–19. 

15He testified that he ‘‘understand[s] the gravity 

of my—the mistakes that have occurred.’’ RD, at 28; 

Tr. 244. Rather than take ownership by calling them 

‘‘my mistakes,’’ he referred to mistakes in a passive 

and general sense. See also Tr. 335 (referring 

broadly to ‘‘mistakes that occurred’’). Indeed, the 

majority of his testimony reveals that Respondent 

understands the ‘‘mistakes’’ to mean the mistakes 

that CES made and the mistake that he made in 

trusting CES. RD, at 28; see Sualeh Ashraf, M.D., 

88 FR at 1098 (discrediting respondent’s acceptance 

of responsibility due to him blaming someone else 

for being the ‘‘criminal mind’’ behind the 

misconduct); Michael A. White, M.D., 79 FR 62957, 

62967–68 (2014) (finding that the standard for 

accepting responsibility was not met where 

respondent blamed others for his misconduct); 

Robert Raymond Reppy, D.O., 76 FR 61,154, 61,180 

(2011) (finding that respondent failed to fully and 

credibly accept responsibility where most of his 

testimony shifted blame to others and focused on 

how he was ‘‘duped’’ into violating the CSA). 

Furthermore, although Respondent acknowledged 

at the hearing that protecting his registration is 

‘‘solely’’ his responsibility, this after-the-fact 

realization conflicts with other parts of his 

testimony where he blamed CES for his failure to 

protect his DEA registration. Tr. 335. 

16Respondent’s proposed remedial measures 

included deactivating all tokens that he was no 

longer using; hiring a third-party to conduct a 

regulatory compliance audit of his practice; 

searching the PMP for prescriptions issued under 

his COR; and writing a controlled substances 

protocol for other practitioners. Tr. 238–43. 

Although these measures are not without merit, the 

proposed remediation fails to convince the Agency 

that he can be trusted with a registration. John Qian, 

M.D., 89 FR 59934, 59937–38 (2024). In this regard, 

even if these measures were enacted, Respondent’s 

insufficient acceptance of responsibility 

demonstrated that he believes it was CES, not 

himself, who bore ultimate responsibility for the 

proven misconduct. RD, at 27–28. In this sense, 

Respondent’s proposed measures are not backed up 

by his willingness to take personal responsibility 

for his actions, and therefore, their remedial 

efficacy rings hollow. Jeffrey Pollock, P.A., 89 FR 

54052, 54058 n.38 (2024). Additionally, the 

proposed measures are misplaced. Deactivating 

unused tokens and auditing his practice have no 

relevance to the proven violation of failing to 

maintain sole possession of his hard token and not 

sharing his authentication credentials. Likewise, 

checking the PMP and instructing other 

practitioners on their responsibilities have no 

bearing on the misconduct, especially given the fact 

that he believes the misconduct was primarily 

CES’s fault for misleading him. RD, at 27–28. 

Furthermore, in light of the egregiousness of the 

misconduct and the need for deterrence, his 

proposed remedial measures are insufficient. Id. at 

29. 

17 In a Notice of Proposed Rulemaking, the 

Agency explained that by requiring registrants to 

retain sole possession of the hard token, ‘‘the 

practitioner can eliminate the risk of fraudulent 

prescriptions and, if the token is lost, stolen, or 

compromised, he will be immediately alerted to the 

threat and have the authentication protocol 

revoked.’’ See Electronic Prescriptions for 

Controlled Substances, 73 FR 36722, 36737 (June 

27, 2008). The Agency further explained that the 

requirement for the practitioner to retain sole 

possession of the hard token serves to protect the 

practitioner as well as the pharmacy from forged or 

fraudulent prescriptions, and to provide ‘‘assurance 

ownership of the misconduct, its 

gravity, and its threat to public safety.12

When specifically asked whether he 

accepted responsibility, he testified that 

he ‘‘accept[s] full responsibility for the 

mistakes that occurred.’’ RD, at 28; Tr. 

335. However, that acceptance of 

responsibility was far from unequivocal 

as Respondent repeatedly blamed his 

decision to give up possession of the 

token on CES. RD, at 28. Respondent 

testified that in trusting CES with his 

hard token, he had ‘‘the wool pulled 

over [his] eyes.’’ Id.; Tr. 238. He testified 

that CES created an impression of being 

compliant with state and federal law. 

RD, at 13–17. Specifically, he testified 

about receiving a memorandum from 

the company’s CEO detailing the effects 

of the Drug Addiction Treatment Act 

(DATA) of 2000 on the company’s 

prescribing practices, RD, at 16; Tr. 199– 

204; RX 4, and how this memorandum 

gave him assurance that CES was taking 

regulatory compliance seriously. RD, at 

16; Tr. 209–10. He also testified about 

a July 2021 audit report written by the 

company’s compliance officer, a former 

DEA DI, which memorialized the policy 

that the company and its agents were 

authorized to issue controlled substance 

prescriptions on behalf of the provider. 

RD, at 13–16; Tr. 219–27, 314; RX 2, at 

18. Respondent testified that he was 

‘‘impressed that [CES] took the trouble 

and had retained a retired DEA 

investigator as their chief compliance 

officer to ensure that the company was 

following rules and regulations.’’ RD, at 

12; Tr. 189–93, 334. He testified that all 

these assurances led him to believe that 

CES had more expertise than he did 

regarding regulatory compliance. RD, at 

13, 31–32; Tr. 230, 283–84, 321. 

Respondent also testified that he read 

the requirement to retain sole 

possession of the hard token prior to 

joining CES,13 but blamed the company 

for misinterpreting the regulation.14 RD, 

at 28, 31–32; Tr. 315–16. Shifting the 

blame onto the company further 

undermines his attempt to accept 

responsibility.15 Id. 

Furthermore, Respondent testified 

that when he gave up physical 

possession of his hard token, he 

believed CES would only use the token 

and his credentials to issue controlled 

substance prescriptions for patients 

with whom Respondent had established 

a doctor-patient relationship. RD, at 16, 

32; Tr. 222–23, 230, 284. Even if this 

was his intention, relinquishing control 

of the token in-and-of-itself was a clear 

violation of 21 CFR 1311.102(a) that 

allowed diversion to occur. 

Respondent’s attempt to downplay his 

misconduct further undermines his 

acceptance of responsibility and calls 

into question whether he truly 

understands the gravity of his 

misconduct. RD, at 30–32. In sum, the 

Agency agrees with the RD that 

Respondent failed to unequivocally 

accept responsibility for the proven 

violations. RD, at 27–29. 

The Agency is only required to 

consider remedial measures where a 

respondent has tendered a full and 

credible acceptance of responsibility. 

Ajay S. Ahuja, M.D., 84 FR 5479, 5498 

n.33 (2019); Daniel A. Glick, D.D.S., 80 

FR at 74810. Here, the Agency need not 

consider remedial measures given the 

lack of acceptance of responsibility. RD, 

at 29. Nevertheless, even if Respondent 

had accepted responsibility, his 

proposed remedial measures would not 

change the outcome of this case.16 Id. 

In addition to acceptance of 

responsibility, the Agency looks to the 

egregiousness and extent of the 

misconduct. Garrett Howard Smith, 

M.D., 83 FR at 18910 (collecting cases), 

and considers both specific and general 

deterrence when determining an 

appropriate sanction. Daniel A. Glick, 

D.D.S., 80 FR at 74810. 

Here, the Agency agrees with the ALJ 

that Respondent’s misconduct was 

egregious. RD, at 29–30. The CSA 

establishes a ‘‘closed system for 

regulating the distribution’’ of 

controlled substances ‘‘to prevent the 

diversion of these substances to those 

who would either abuse them or sell 

them to those who do.’’ Holiday CVS, 

L.L.C., d/b/a CVS/Pharmacy Nos. 219 

and 5195, 77 FR at 62317 (citing 

Gonzales, 546 U.S. at 250). DEA 

regulations contain a clear mandate to 

‘‘retain sole possession of the hard 

token’’ for a reason: to keep the closed 

system of distribution 

closed.17 Gonzales, 546 U.S. at 250–51. 


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Federal Register / Vol. 89, No. 203 / Monday, October 21, 2024 / Notices 84199 

that only a legitimate practitioner issued the 

prescription.’’ Id. 

In this case, Respondent enabled 

unregistered individuals at an 

unregistered location to issue multiple 

controlled substance prescriptions, 

including at least a year’s worth of 

controlled substance prescriptions for 

patient J.O. whom Respondent had 

never evaluated. RD, at 4–5, 16, 18, 26, 

29–30; Tr. 42–43, 50, 225–26. Therefore, 

by giving away his hard token and twofactor authentication data to 

unauthorized persons, Respondent 

committed egregious violations of DEA’s 

regulations that created a risk of 

diversion and threatened public safety. 

RD, at 29–31. 

The Agency also concludes that 

revocation of Respondent’s registration 

is necessary to deter the registrant 

community from engaging in similar 

misconduct. RD, at 30–31. There is 

simply no conceivable world in which 

it is acceptable for a practitioner to give 

away his or her prescribing credentials 

to anyone else, including a telemedicine 

platform. When a practitioner is 

awarded the privilege of prescribing 

controlled substances in the form of a 

registration, that privilege belongs to the 

registrant and the registrant alone—it 

cannot be given away. The Agency 

agrees with the ALJ that the interests of 

general deterrence support revocation, 

as a lack of sanction in the current 

matter would send a message to the 

registrant community that giving away a 

hard token and two-factor 

authentication credentials can be 

overlooked and excused. RD, at 30; see 

also Jeffrey Pollock, P.A., 89 FR at 

54058. Revocation is also necessary to 

impress upon Respondent the 

seriousness of his misconduct and to 

deter him from committing the same 

misconduct in the future. Id. 

In sum, Respondent has not offered 

sufficient mitigating evidence to 

establish that he can be trusted with the 

responsibility of maintaining a DEA 

registration. RD, at 27–33. Accordingly, 

the Agency will order that Respondent’s 

registration be revoked. RD, at 33. 

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. FS2968444 issued to 

Neeraj B. Shah, 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 Neeraj B. Shah, M.D., to renew or 

modify this registration, as well as any 

other pending application of Neeraj B. 

Shah, M.D., for additional registration in 

Texas. This Order is effective November 

20, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 10, 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. 2024–24189 Filed 10–18–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

[CPCLO Order No. 05–2024] 

Privacy Act of 1974; Systems of 

Records 

AGENCY: Office of Justice Programs, 

United States Department of Justice. 

ACTION: Notice of a new system of 

records. 

SUMMARY: Pursuant to the Privacy Act of 

1974 and Office of Management and 

Budget (OMB) Circular No. A–108, 

notice is hereby given that the Office of 

Justice Programs (hereinafter OJP), a 

component within the United States 

Department of Justice (DOJ or 

Department), proposes to develop a new 

system of records notice titled Training 

and Technical Assistance Center 

Records, JUSTICE/OJP—018. The OJP 

proposes to establish this system of 

records to manage data from individuals 

and organizations that may be providing 

or requesting training and technical 

assistance, as well as associated events 

and deliverables. 

DATES: In accordance with 5 U.S.C. 

552a(e)(4) and (11), this notice is 

applicable upon publication, subject to 

a 30-day period in which to comment 

on the routine uses, described below. 

Please submit any comments by 

November 20, 2024. 

ADDRESSES: The public, OMB, and 

Congress are invited to submit any 

comments by mail to the United States 

Department of Justice, Office of Privacy 

and Civil Liberties, ATTN: Privacy 

Analyst, National Place Building, 1331 

Pennsylvania Avenue NW, Suite 1000, 

Washington, DC 20530; by facsimile at 

202–307–0693; or by email at 

privacy.compliance@usdoj.gov. To 

ensure proper handling, please 

reference the above CPCLO Order No. 

on your correspondence. 

FOR FURTHER INFORMATION CONTACT: 

Nathanial Kenser, Assistant General 

Counsel, Office of Justice Programs, 

Nathanial.T.Kenser@usdoj.gov, 202– 

307–0790. 

SUPPLEMENTARY INFORMATION: The Office 

of Justice Programs’ Training and 

Technical Assistance Centers offer 

rapid, expert, coordinated, researchdriven or evidence-based justice-related 

training and technical assistance (TTA) 

on a wide range of topics relevant to 

state and local practitioners, victim 

service providers, and allied 

professionals. All TTA is designed to 

address the needs of practitioners and 

help improve state and local justice 

system responses, respond to juvenile 

delinquency, build capacity, enhance 

strategic planning, expand the use of 

evidence-based practices, and improve 

the quality of services offered to victims 

of crime. 

Pursuant to 5 U.S.C. 552a(b)(12), 

records maintained in this system of 

records may be disclosed to a consumer 

reporting agency without the prior 

written consent of the individual to 

whom the record pertains. Such 

disclosures will only be made in 

accordance with 31 U.S.C. 3711(e). 

In accordance with 5 U.S.C. 552a(r), 

the Department has provided a report to 

OMB and Congress on this new system 

of records. 

Dated: October 2, 2024. 

Peter A. Winn, 

Chief Privacy and Civil Liberties Officer, 

United States Department of Justice. 

SYSTEM NAME AND NUMBER: 

Training and Technical Assistance 

Center Records (TTAC), JUSTICE/OJP— 

018. 

SECURITY CLASSIFICATION: 

The system is unclassified. 

SYSTEM LOCATION: 

Records are maintained at the 

following locations: Office of Justice 

Programs (OJP), 810 7th Street NW, 

Washington, DC 20531; NTT Global, 

1625 West National Drive, Sacramento, 

CA 95834; and Amazon Web Services 

GovCloud, 13200 Woodland Park Road, 

Herndon, VA 20171. The cloud 

computing service provider and its 

location may change, so this document 

may not reflect the most current 


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