Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80157 

who have the greatest access to 

controlled substances and therefore the 

greatest opportunity for diversion, were 

responsible for a large part of the illegal 

drug traffic.’’). The Agency has 

previously found that proof of a single 

act of intentional or knowing diversion 

is sufficient to satisfy the Government’s 

prima facie burden of showing that a 

practitioner’s continued registration is 

inconsistent with the public interest. 

McNichol, 77 FR at 57,145–46 (2012); 

see also, Alan H. Olefsky, 57 FR 928, 

928–29 (1992) (revoking registration 

based on physician’s presentation of 

two fraudulent prescriptions to 

pharmacist in single act where 

physician failed to acknowledge his 

misconduct). Accordingly, I find that 

the evidence in this matter establishes 

Registrant ‘‘has committed such acts as 

would render his registration . . . 

inconsistent with the public interest.’’ 

See 21 U.S.C. 824(a)(4). 

For purposes of the imminent danger 

inquiry, my findings also lead to the 

conclusion that Registrant ‘‘fail[ed] . . . 

to maintain effective controls against 

diversion or otherwise comply with the 

obligations of a registrant’’ under the 

CSA. 21 U.S.C. 824(d)(2). The 

substantial evidence that Registrant was 

issuing prescriptions for controlled 

substances without a legitimate medical 

purpose and outside the usual course of 

professional practice also establishes 

that there was ‘‘a substantial likelihood 

[that an] . . . abuse of a controlled 

substance . . . [would] occur in the 

absence of the immediate suspension’’ 

of Registrant’s registration. Id. As I 

found above, the recording of the 

February 16, 2018 visit between 

Registrant and the undercover officers 

and the undercover officers’ accountings 

of their other visits establish that 

Registrant unlawfully prescribed 

controlled substances to the officers 

without conducting physical 

examinations and wrote controlled 

substance prescriptions in TFO Two’s 

name for her to give to TFO One. Thus, 

at the time the Government issued the 

OSC, the Government had clear 

evidence of Registrant’s violations of 

law. 

III. Sanction 

Where, as here, the Government has 

met its prima facie burden of showing 

that a Registrant’s continued registration 

is inconsistent with the public interest, 

the burden shifts to the Registrant to 

show why he can be entrusted with a 

registration. Garrett Howard Smith, 

M.D., 83 FR 18,882, 18,910 (2018) 

(collecting cases). Registrant did not 

present any evidence of remorse for his 

past misconduct or evidence of 

rehabilitative actions taken to correct 

his past unlawful behavior. Further, he 

provided no assurances that he would 

not engage in such conduct in the 

future. Absent such evidence and such 

assurances in this matter, I find that 

continued registration of Registrant is 

inconsistent with the public interest. 

Registrant’s silence weighs against his 

continued registration. Zvi H. Perper, 

M.D., 77 FR 64,131, 64,142 (2012 (citing 

Med. Shoppe-Jonesborough, 73 FR at 

387); see also Samuel S. Jackson, 72 FR 

23,848, 23,853 (2007). Accordingly, I 

find that the factors weigh in favor of 

sanction, and I shall order the sanctions 

the Government requested, as contained 

in the Order below. 

IV. 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 FS3042885 issued to 

Zelijko Stjepanovic, M.D. Further, 

pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

823(f), I hereby deny any pending 

application of Zelijko Stjepanovic, M.D. 

to renew or modify this registration. 

This Order is effective January 11, 2021. 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–27231 Filed 12–10–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Anindita Nandi, M.D.; Decision and 

Order 

On January 31, 2020, the Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause (hereinafter, OSC) to Anindita 

Nandi, M.D. (hereinafter, Registrant) of 

Jersey City, New Jersey. OSC, at 1. The 

OSC proposed the revocation of 

Registrant’s Certificate of Registration 

No. FN5040136. Id. It alleged that 

Registrant has ‘‘no state authority to 

handle controlled substances.’’ Id. 

(citing 21 U.S.C. 824(a)(3)). 

Specifically, the OSC alleged that, 

‘‘[o]n September 25, 2018, the New 

Jersey State Board of Medical Examiners 

(hereinafter, BME) issued an Order of 

Temporary Suspension of License, 

suspending . . . [Registrant’s] license to 

practice medicine and surgery in the 

State of New Jersey, effective September 

12, 2018.’’ OSC, at 2. The OSC further 

alleged that Registrant’s ‘‘State of New 

Jersey C[ontrolled] D[angerous] 

S[ubstance] (hereinafter, CDS) license is 

in an ‘Inactive’ status, having expired on 

October 31, 2018.’’ Id. The OSC 

concluded that ‘‘[c]onsequently, the 

DEA must revoke . . . [her] DEA 

registration based on . . . [her] lack of 

authority to handle controlled 

substances in the State of New Jersey.’’ 

Id. 

The OSC notified Registrant of the 

right to request a hearing on the 

allegations or to submit a written 

statement, while waiving the right to a 

hearing, the procedures for electing each 

option, and the consequences for failing 

to elect either option. Id. (citing 21 CFR 

1301.43). The OSC also notified 

Registrant of the opportunity to submit 

a corrective action plan. OSC, at 3 

(citing 21 U.S.C. 824(c)(2)(C)). 

Adequacy of Service 

In a sworn Declaration, dated May 21, 

2020, a DEA Diversion Investigator 

assigned to the Newark Division Office 

(hereinafter, DI) stated that he attempted 

personal service of the OSC on 

Registrant at the Hudson County 

Correctional Facility. Request for Final 

Agency Action (hereinafter, RFAA), EX 

5 (DI Declaration), at 1. Registrant, 

however, refused to meet with DI. Id. 

DI, therefore, sent the OSC to 

Registrant certified mail, return receipt 

requested. Id. He attached the executed 

return receipt card, dated February 26, 

to his Declaration. Id. at Attachment C. 

Further evidence of the adequacy of the 

Government’s service is Registrant’s 

proposed Corrective Action Plan 

(hereinafter, CAP) and waiver of hearing 

dated March 4, 2020. RFAA EX 6 (CAP), 

at 1. Accordingly, I find that the 

Government’s service of the OSC was 

adequate. 

Registrant’s Proposed CAP 

As already discussed, Registrant 

timely submitted a proposed CAP and 

waiver of hearing. Id. In her CAP, 

Registrant asked that this proceeding be 

discontinued or postponed. Id. She 

alleged that she received notification of 

the reactivation of her medical license 

in July 2019. Id. at 2. Further, she 

alleged that she timely renewed her 

‘‘second State of NJ CDS Account.’’ Id. 

I find that Registrant waived her right 

to a hearing and proposed a CAP. I find 

that the Assistant Administrator, 

Diversion Control Division, denied 

Registrant’s CAP request that the 

administrative proceeding be 

discontinued or deferred. RFAA EX 7 

(Letter Denying Proposed CAP), at 1. I 

also find that the Assistant 

Administrator concluded that ‘‘there is 

no potential modification of . . . [her 

proposedCAP] that could or would alter 


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80158 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

1The RFAA includes Registrant’s proposed CAP/ 

hearing waiver. 

2The fact that a Registrant’s registration expires 

during the pendency of an OSC does not impact my 

jurisdiction or prerogative under the Controlled 

Substances Act (hereinafter, CSA) to adjudicate the 

OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 68,474 

(2019). 

3Under the Administrative Procedure Act, an 

agency ‘‘may take official notice of facts at any stage 

in a proceeding—even in the final decision.’’ 

United States Department of Justice, Attorney 

General’s Manual on the Administrative Procedure 

Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 

1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an 

agency decision rests on official notice of a material 

fact not appearing in the evidence in the record, a 

party is entitled, on timely request, to an 

opportunity to show the contrary.’’ Accordingly, 

Applicant may dispute my finding by filing a 

properly supported motion for reconsideration of 

finding of fact within fifteen calendar days of the 

date of this Order. Any such motion shall be filed 

with the Office of the Administrator and a copy 

shall be served on the Government. In the event 

Applicant files a motion, the Government shall 

have fifteen calendar days to file a response. Any 

such motion and response shall be filed and served 

by email on the other party at the email address the 

party submitted for receipt of communications 

related to this administrative proceeding, and on 

the Office of the Administrator, Drug Enforcement 

Administration at dea.addo.attorneys@

dea.usdoj.gov. 

. . . [his] decision in this regard.’’ Id. I 

agree. 

The Government forwarded its RFAA, 

along with the evidentiary record, to my 

office on May 26, 2020. In its RFAA, the 

Government represented that 

‘‘Registrant has no valid medical license 

or CDS registration in New Jersey.’’ 

RFAA, at 3. The Government requested 

that Registrant’s registration be revoked. 

Id. at 4. 

I issue this Decision and Order based 

on the record submitted by the 

Government in its RFAA, which 

constitutes the entire record before me.1

21 CFR 1301.43(e). 

Findings of Fact 

Registrant’s DEA Registration 

Registrant is the holder of DEA 

Certificate of Registration No. 

FN5040136 at the registered address of 

610 Washington Boulevard, Jersey City, 

NJ 07310. RFAA, EX 1 (Certification of 

Registration History), at 1. Pursuant to 

this registration, Registrant is authorized 

to dispense controlled substances in 

schedules II through V as a practitioner. 

Id. Registrant’s registration expired on 

October 31, 2020.2 Id. 

The Status of Registrant’s State License 

and Registration 

The Government submitted a certified 

copy of the ‘‘Order of Temporary 

Suspension of License’’ concerning 

Registrant that the BME issued on 

September 25, 2018. RFAA, EX 3 

(hereinafter, Temporary Suspension 

Order). The Temporary Suspension 

Order ‘‘temporarily suspended 

(Registrant’s New Jersey medical 

license) pending final adjudication of 

the allegations of the Verified 

Complaint.’’ Id. at 12. It ordered 

Registrant immediately to cease and 

desist practicing medicine in New 

Jersey and it set out the steps required 

for Registrant’s reinstatement. Id. at 12– 

13. 

The Government also submitted a 

Certification from the New Jersey Drug 

Control Unit stating that Registrant’s 

‘‘CDS registration became inactive on 

September 25, 2018, when a suspension 

was imposed on her medical license. 

Her CDS registration remains inactive.’’ 

RFAA, EX 4 (New Jersey Attorney 

General, Division of Consumer Affairs, 

Drug Control Unit, Certification that 

Registrant’s CDS registration is 

‘‘Inactive’’), at 1. The Certification is 

dated January 17, 2020. Id. 

As already discussed, Registrant’s 

proposed CAP alleged that her New 

Jersey medical license was ‘‘reactivated’’ 

in July 2019 and that her controlled 

dangerous substance registration was 

‘‘timely . . . renewed.’’ RFAA, EX 6, at 

2. Her proposed CAP, however, did not 

include evidence documenting or 

supporting her allegations. 

According to New Jersey’s online 

records, Registrant’s medical license is 

still suspended today.3 New Jersey 

Division of Consumer Affairs License 

Information, https://

www.njconsumeraffairs.gov (last visited 

date of signature of this Order). The 

evidence that the Government 

submitted with its RFAA, EX 3 and EX 

8, and the evidence from today’s New 

Jersey online records outweigh 

Registrant’s unsupported allegation 

about her ‘‘reactivated’’ medical license. 

Accordingly, I find that Registrant’s 

New Jersey medical license is currently 

suspended. 

The Government’s RFAA includes 

evidence that Registrant’s New Jersey 

controlled dangerous substance 

registration is inactive. RFAA, EX 4, at 

1. Registrant’s CAP did not include 

evidence supporting her allegation that 

she ‘‘timely . . . renewed’’ her New 

Jersey controlled dangerous substance 

registration. RFAA, EX 6, at 2. The 

Government’s evidence outweighs 

Registrant’s unsupported allegation. 

Accordingly, I find that Registrant is not 

authorized in New Jersey to dispense 

controlled substances. See also infra 

Discussion section. 

Discussion 

Pursuant to 21 U.S.C. 824(a)(3), the 

Attorney General is authorized to 

suspend or revoke a registration issued 

under section 823 of the CSA ‘‘upon a 

finding that the registrant . . . has had 

his State license or registration 

suspended . . . [or] revoked . . . by 

competent State authority and is no 

longer authorized by State law to engage 

in the . . . dispensing of controlled 

substances.’’ With respect to a 

practitioner, the Agency has long stated 

that the possession of authority to 

dispense controlled substances under 

the laws of the state in which the 

practitioner engages in professional 

practice is a fundamental condition for 

obtaining and maintaining a 

practitioner’s registration. See, e.g., 

James L. Hooper, M.D., 76 FR 71,371 

(2011), pet. for rev. denied, 481 F. App’x 

826 (4th Cir. 2012); Frederick Marsh 

Blanton, M.D., 43 FR 27,616, 27,617 

(1978). 

This rule derives from the text of two 

provisions of the CSA. First, Congress 

defined the term ‘‘practitioner’’ to mean 

‘‘a physician . . . or other person 

licensed, registered, or otherwise 

permitted, by . . . the jurisdiction in 

which he practices . . . , to distribute, 

dispense, . . . [or] administer . . . a 

controlled substance in the course of 

professional practice.’’ 21 U.S.C. 

802(21). Second, in setting the 

requirements for obtaining a 

practitioner’s registration, Congress 

directed that ‘‘[t]he Attorney General 

shall register practitioners . . . if the 

applicant is authorized to dispense . . . 

controlled substances under the laws of 

the State in which he practices.’’ 21 

U.S.C. 823(f). Because Congress has 

clearly mandated that a practitioner 

possess state authority in order to be 

deemed a practitioner under the CSA, 

the Agency has repeatedly stated that 

revocation of a practitioner’s registration 

is the appropriate sanction whenever 

she is no longer authorized to dispense 

controlled substances under the laws of 

the state in which she practices. See, 

e.g., James L. Hooper, M.D., 76 FR at 

71,371–72; Sheran Arden Yeates, M.D., 

71 FR 39,130, 39,131 (2006); Dominick 

A. Ricci, M.D., 58 FR 51,104, 51,105 

(1993); Bobby Watts, M.D., 53 FR 

11,919, 11,920 (1988); Frederick Marsh 

Blanton, M.D., 43 FR at 27,617. 

According to New Jersey statute, 

‘‘Practitioners shall be registered to 

dispense substances in Schedules II 

through IV if they are authorized to 

dispense or conduct research under the 

law of this State.’’ N.J. Stat. Ann. 

§ 24:21–11(c) (West, current with laws 

through L. 2020, c. 109 and J.R. No. 2); 

see also N.J. Stat. Ann. § 24:21–10(a) 

(West, current with laws through L. 

2020, c. 109 and J.R. No. 2) (‘‘Every 

person who manufactures, distributes, 

or dispenses any controlled dangerous 


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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80159 

substance within this State . . . shall 

obtain a registration issued by the 

division in accordance with rules and 

regulations promulgated by it.’’). 

New Jersey statute defines 

‘‘practitioner’’ as a ‘‘physician.’’ N.J. 

Stat. Ann. § 24:21–2 (West, current with 

laws through L. 2020, c. 109 and J.R. No. 

2). It defines ‘‘physician’’ as ‘‘a 

physician authorized by law to practice 

medicine in this or any other state.’’ Id. 

Here, the weight of the evidence in 

the record is that Registrant’s license to 

practice medicine is currently 

suspended and that her CDS registration 

is inactive. In New Jersey, as already 

discussed, a ‘‘practitioner’’ must be a 

physician authorized by law to practice 

medicine. Id. As such, she is not a 

‘‘physician’’ or a ‘‘practitioner’’ as New 

Jersey statute defines those terms. Id. 

Thus, since Registrant lacks authority to 

practice medicine in New Jersey and 

does not have an active New Jersey CDS 

registration, she is not eligible to 

dispense controlled substances in that 

state. N.J. Stat. Ann. § 24:21–11(c). As 

such, based on the overwhelming record 

evidence and the law in New Jersey, I 

find that Registrant is not authorized to 

dispense controlled substances in New 

Jersey. 21 U.S.C. 824(a)(3). Accordingly, 

I will order that Registrant’s DEA 

registration be revoked. 

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. FN5040136 issued to 

Anindita Nandi, M.D. This Order is 

effective January 11, 2021. 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–27235 Filed 12–10–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–748] 

Bulk Manufacturer of Controlled 

Substances Application: Sterling 

Pharma USA, LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Sterling Pharma USA, LLC 

has applied to be registered as a bulk 

manufacturer of basic class(es) of 

controlled substance(s). Refer to 

Supplemental Information listed below 

for further drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before February 9, 2021. Such 

persons may also file a written request 

for a hearing on the application on or 

before February 9, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on August 24, 2020, 

Sterling Pharma USA, LLC, 1001 

Sheldon Drive, Suite 101, Cary, North 

Carolina 27513–2079, applied to be 

registered as a bulk manufacturer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

Tetrahydrocannabinols .. 7370 I 

The company plans to manufacture in 

bulk drug code 7370 

(Tetrahydrocannabinols) exclusively 

from hemp extract, for distribution and 

sale to its customers. No other activities 

for this drug code is authorized for this 

registration. 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2020–27240 Filed 12–10–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–752] 

Bulk Manufacturer of Controlled 

Substances Application: Johnson 

Matthey, Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Johnson Matthey, Inc., has 

applied to be registered as a bulk 

manufacturer of basic class(es) of 

controlled substance(s). Refer to 

Supplemental Information listed below 

for further drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before February 9, 2021. Such 

persons may also file a written request 

for a hearing on the application on or 

before February 9, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on November 2, 2020, 

Johnson Matthey, Inc., 2003 Nolte Drive 

West Deptford, New Jersey 08066–1742, 

applied to be registered as an bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Gamma Hydroxybutyric 

Acid.

2010 I 

Marihuana ...................... 7360 I 

Tetrahydrocannabinols .. 7370 I 

Dihyromorphine ............. 9145 I 

Difenoxin ........................ 9168 I 

Amphetamine ................ 1100 II 

Methamphetamine ......... 1105 II 

Lisdexamfetamine ......... 1205 II 

Methylphenidate ............ 1724 II 

Nabilone ........................ 7379 II 

Norfentanyl .................... 8366 II 

Cocaine ......................... 9041 II 

Codeine ......................... 9050 II 

Dihydrocodeine .............. 9120 II 

Oxycodone .................... 9143 II 

Hydromorphone ............. 9150 II 

Diphenoxylate ................ 9170 II 

Ecgonine ........................ 9180 II 

Hydrocodone ................. 9193 II 

Levorphanol ................... 9220 II 

Meperidine ..................... 9230 II 

Methadone ..................... 9250 II 

Methadone intermediate 9254 II 

Morphine ........................ 9300 II 

Thebaine ........................ 9333 II 

Opium tincture ............... 9630 II 

Oxymorphone ................ 9652 II 

Noroxymorphone ........... 9668 II 

Alfentanil ........................ 9737 II 

Remifentanil ................... 9739 II 

Sufentanil ....................... 9740 II 

Tapentadol ..................... 9780 II 

Fentanyl ......................... 9801 II 

The company plans to bulk 

manufacture the listed controlled 

substances for the internal use 

intermediates or for sale to its 

customers. In reference to drug codes 

7360 (Marihuana), and 7370 

(Tetrahydrocannabinols), the company 

plans to bulk manufacture these drugs 

as synthetic. No other activities for these 

drug codes are authorized for this 

registration. 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2020–27241 Filed 12–10–20; 8:45 am] 

BILLING CODE 4410–09–P 


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