Anindita Nandi, M.D.; Decision and Order, 80157-80159 [2020-27235]

Download as PDF Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES 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 VerDate Sep<11>2014 23:25 Dec 10, 2020 Jkt 253001 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] PO 00000 Frm 00168 Fmt 4703 Sfmt 4703 80157 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 E:\FR\FM\11DEN1.SGM 11DEN1 80158 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices . . . [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. jbell on DSKJLSW7X2PROD with NOTICES 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 1 The RFAA includes Registrant’s proposed CAP/ hearing waiver. 2 The 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). VerDate Sep<11>2014 00:32 Dec 11, 2020 Jkt 253001 ‘‘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 3 Under 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. PO 00000 Frm 00169 Fmt 4703 Sfmt 4703 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 E:\FR\FM\11DEN1.SGM 11DEN1 80159 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 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. 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): SUPPLEMENTARY INFORMATION: Controlled substance Tetrahydrocannabinols .. Drug code 7370 Schedule 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 Timothy J. Shea, Acting Administrator. Drug Enforcement Administration [FR Doc. 2020–27235 Filed 12–10–20; 8:45 am] BILLING CODE 4410–09–P [Docket No. DEA–752] Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc. [Docket No. DEA–748] AGENCY: DEPARTMENT OF JUSTICE Drug Enforcement Administration, Justice. ACTION: Notice of application. Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA, LLC 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 SUMMARY: VerDate Sep<11>2014 00:32 Dec 11, 2020 Jkt 253001 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 SUMMARY: Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: jbell on DSKJLSW7X2PROD with NOTICES 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. PO 00000 Frm 00170 Fmt 4703 Sfmt 4703 for a hearing on the application on or before February 9, 2021. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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): SUPPLEMENTARY INFORMATION: Controlled substance Gamma Hydroxybutyric Acid. Marihuana ...................... Tetrahydrocannabinols .. Dihyromorphine ............. Difenoxin ........................ Amphetamine ................ Methamphetamine ......... Lisdexamfetamine ......... Methylphenidate ............ Nabilone ........................ Norfentanyl .................... Cocaine ......................... Codeine ......................... Dihydrocodeine .............. Oxycodone .................... Hydromorphone ............. Diphenoxylate ................ Ecgonine ........................ Hydrocodone ................. Levorphanol ................... Meperidine ..................... Methadone ..................... Methadone intermediate Morphine ........................ Thebaine ........................ Opium tincture ............... Oxymorphone ................ Noroxymorphone ........... Alfentanil ........................ Remifentanil ................... Sufentanil ....................... Tapentadol ..................... Fentanyl ......................... Drug code Schedule 2010 I 7360 7370 9145 9168 1100 1105 1205 1724 7379 8366 9041 9050 9120 9143 9150 9170 9180 9193 9220 9230 9250 9254 9300 9333 9630 9652 9668 9737 9739 9740 9780 9801 I I I I II II II II II II II II II II II II II II II II II II II II II II II II II II II 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 E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80157-80159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27235]


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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

[[Page 80158]]

. . . [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).
---------------------------------------------------------------------------

    \1\ The RFAA includes Registrant's proposed CAP/hearing waiver.
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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.
---------------------------------------------------------------------------

    \2\ The 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).
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \3\ Under 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 [email protected].
---------------------------------------------------------------------------

    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. Sec.  24:21-11(c) (West, current with laws 
through L. 2020, c. 109 and J.R. No. 2); see also N.J. Stat. Ann. Sec.  
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

[[Page 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. Sec.  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. Sec.  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
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