Steven A. Holper, M.D.; Decision and Order, 64165-64166 [2020-22390]

Download as PDF Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Notices collection: The estimated annual public burden associated with this collection is 540 hours, which is equal to 300 (# of respondents) * 1 (# of responses per respondents) * 1.8 (1 hour and 48 minutes). If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530. Dated: October 6, 2020. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice. Controlled substance Drug code 5-Methoxy-N-Ndimethyltryptamine. Norlevorphanol Schedule 7431 I 9634 I The company plans to manufacture the above-listed controlled substances as clinical trial and starting materials to make compounds for distribution to its customers. No other activity for these drug codes is authorized for this registration. William T. McDermott, Assistant Administrator. [FR Doc. 2020–22442 Filed 10–8–20; 8:45 am] BILLING CODE P [FR Doc. 2020–22453 Filed 10–8–20; 8:45 am] BILLING CODE 4410–30–P DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Steven A. Holper, M.D.; Decision and Order [Docket No. DEA–720] Bulk Manufacturer of Controlled Substances Application: Purisys, LLC Drug Enforcement Administration, Justice. AGENCY: ACTION: Notice of application. Purisys, 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. SUMMARY: 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 December 8, 2020. Such persons may also file a written request for a hearing on the application on or before December 8, 2020 DATES: 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 August 27, 2020, Purisys, LLC, 1550 Olympic Drive, Athens, Georgia 30601–1602, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substances: SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:26 Oct 08, 2020 Jkt 253001 On October 22, 2019, the Acting Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, Government or DEA), issued an Order to Show Cause (hereinafter, OSC) to Steven A. Holper, M.D., (hereinafter, Registrant), of Las Vegas, Nevada. Government’s Request for Final Agency Action Exhibit (hereinafter, RFAAX) 5 (OSC), at 1. The OSC proposed the revocation of Registrant’s Certificate of Registration No. BH2498106. It alleged that Registrant is without ‘‘authority to handle controlled substances in Nevada, the state in which [Registrant is] registered with the DEA.’’ Id. (citing 21 U.S.C. 823(f) and 824(a)(3)). Specifically, the OSC alleged that Registrant’s state controlled substance license expired on October 21, 2018. Id. at 1–2. The OSC also alleged that Registrant’s state medical license was revoked by the Board of Medical Examiners of the State of Nevada on September 6, 2019. Id. at 2. The OSC further alleged that Registrant is not eligible to obtain or retain a DEA registration because he lacks state authority to handle controlled substances in the state of Nevada. Id. The OSC notified Registrant of the right to either request a hearing on the allegations or submit a written statement in lieu of exercising 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 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 64165 a corrective action plan. Id. at 3 (citing 21 U.S.C. 824(c)(2)(C)). A DEA Diversion Investigator personally served Registrant with the OSC on December 16, 2019. RFAAX 12, at 2–3 (Declaration of Diversion Investigator One). I find that more than thirty days have now passed since the Government accomplished service of the OSC. Further, based on the Government’s written representations, I find that neither Registrant, nor anyone purporting to represent Registrant, requested a hearing, submitted a written statement while waiving Registrant’s right to a hearing, or submitted a corrective action plan. RFAAX 11, at 3– 4 (Declaration of Diversion Investigator Two). Accordingly, I find that Registrant has waived the right to a hearing and the right to submit a written statement and corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this Decision and Order based on the record submitted by the Government, which constitutes the entire record before me. 21 CFR 1301.46. Findings of Fact Registrant’s DEA Registration Registrant is the holder of DEA Certificate of Registration No. BH2498106 at the registered address of 3233 W. Charleston Blvd. 202, Las Vegas, NV 89102. RFAAX 1 (Registrant’s DEA Certificate of Registration). Pursuant to this registration, Registrant is authorized to dispense controlled substances in schedules II through V as a practitioner. Id. Registrant’s registration will expire on its own terms on October 31, 2020. Id. DEA Investigation and the Status of Registrant’s State Licenses On July 22, 2019, Registrant was sentenced in the United States District Court for the District of Nevada on a matter related to his conviction on one count of unlawful distribution of a controlled substance. RFAAX 11, at 2. On August 12, 2019, a DEA Diversion Investigator (hereinafter, DI Two) asked Registrant, through his legal counsel, to voluntarily surrender his DEA registration. Id. Registrant declined. Id. The General Counsel for the Nevada State Board of Pharmacy (hereinafter, Pharmacy Board) sent DI Two a letter dated September 17, 2019, stating that Registrant did not renew his Nevada controlled substance license and did not hold an active controlled substance license with the Pharmacy Board. RFAAX 4. According to the online records of the Pharmacy Board, Registrant’s controlled substance E:\FR\FM\09OCN1.SGM 09OCN1 64166 Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Notices license, license no. CS057748, expired on October 31, 2018, id.; RFAAX 9 (Printout of Pharmacy Board website dated March 25, 2020), and remains closed,1 https://online.nvbop.org/#/ verifylicense (last visited September 24, 2020). On September 6, 2019, the Nevada State Board of Medical Examiners (hereinafter, Medical Board) revoked Registrant’s medical license, license no. 6061, pursuant to a settlement agreement between Registrant and the Investigative Committee of the Medical Board. RFAAX 3 (Settlement Agreement). The Investigative Committee of the Medical Board had filed a Complaint on April 3, 2019, charging Registrant with ‘‘violating the Medical Practice Act.’’ Id. at 1. Specifically, the Complaint alleged ‘‘one (1) violation of NRS 640.306(1)(c), Illegal Dispensing of Controlled Substances (Count 1), one (1) violation of NRS 630.306(1)(p), Unsafe or Unprofessional Conduct (Count II), and one (1) violation of NRS 630.301(9), Disreputable Conduct (Count III).’’ Id. at 1–2. Pursuant to the Settlement Agreement, Registrant admitted to Count 1 of the Complaint and agreed that the Medical Board could issue an order finding that Registrant ‘‘engaged in conduct that is grounds for discipline pursuant to the Medical Practice Act.’’ Id. at 4. The Settlement Agreement stated that, upon adoption of the Agreement by the Medical Board, Registrant’s medical license would be immediately revoked and Registrant would be ineligible to apply for reinstatement for a period of three years. Id. The Medical Board adopted the Settlement Agreement on September 6, 2019. Id. at 8. Accordingly, I find that Registrant currently is neither licensed to engage in the practice of medicine nor licensed to dispense controlled substances in 1 I take official notice of the online records of the Nevada State Board of Pharmacy. 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, Registrant may dispute my finding by filing a properly supported motion for reconsideration 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 Registrant files a motion, the Government shall have fifteen calendar days to file a response. Any such motion and response may be filed and served by email (dea.addo.attorneys@ dea.usdoj.gov). VerDate Sep<11>2014 17:26 Oct 08, 2020 Jkt 253001 Nevada, the state in which Registrant is registered with the DEA. 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 DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a 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 Fed. Appx. 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 DEA has held repeatedly that revocation of a practitioner’s registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the state in which he practices. See, e.g., James L. Hooper, 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, 43 FR at 27,617. Nevada law gives authority to ‘‘practitioners’’ to dispense controlled substances, Nev. Rev. Stat. § 453.337 (West 2020), and requires that ‘‘[e]very practitioner . . . who dispenses any controlled substance within this State PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 . . . shall obtain biennially a registration issued by the [Pharmacy] Board,’’ Nev. Rev. Stat. § 453.226(1) (West 2020). Nevada law further defines ‘‘practitioner’’ to mean ‘‘a physician . . . who holds a license to practice his or her profession in this State and is registered pursuant to [the Uniform Controlled Substances Act].’’ Nev. Rev. Stat. § 453.126(1) (West 2020). Here, the undisputed evidence in the record is that Registrant’s license to practice medicine is revoked. As such, he is not a ‘‘practitioner,’’ a physician licensed to practice his profession in Nevada and registered to dispense controlled substances, according to Nevada law. Further, under Nevada law, a practitioner who dispenses a controlled substance in Nevada must be registered. The undisputed record evidence is that Registrant’s Nevada controlled substance license is expired. Thus, because Registrant lacks authority to dispense controlled substances in Nevada, Registrant is not eligible to maintain a DEA registration. 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. BH2498106 issued to Steven A. Holper, 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 Steven A. Holper, M.D. to renew or modify this registration, as well as any pending application of Steven A. Holper, M.D. for registration in Nevada. This Order is effective November 9, 2020. Timothy J. Shea, Acting Administrator. [FR Doc. 2020–22390 Filed 10–8–20; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Notice of Lodging Proposed Consent Decree In accordance with Departmental Policy, 28 CFR 50.7, notice is hereby given that a proposed Consent Decree in United States v. D.R. Horton, Inc., Case No. 8:20–cv–02271–CEH–CPT, was lodged with the United States District Court for the Middle District of Florida, Tampa Division, on October 1, 2020. This proposed Consent Decree concerns a complaint filed by the United States, pursuant to Sections 309 and 404 of the Clean Water Act E:\FR\FM\09OCN1.SGM 09OCN1

Agencies

[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Notices]
[Pages 64165-64166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22390]


-----------------------------------------------------------------------

 DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Steven A. Holper, M.D.; Decision and Order

    On October 22, 2019, the Acting Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (hereinafter, 
Government or DEA), issued an Order to Show Cause (hereinafter, OSC) to 
Steven A. Holper, M.D., (hereinafter, Registrant), of Las Vegas, 
Nevada. Government's Request for Final Agency Action Exhibit 
(hereinafter, RFAAX) 5 (OSC), at 1. The OSC proposed the revocation of 
Registrant's Certificate of Registration No. BH2498106. It alleged that 
Registrant is without ``authority to handle controlled substances in 
Nevada, the state in which [Registrant is] registered with the DEA.'' 
Id. (citing 21 U.S.C. 823(f) and 824(a)(3)).
    Specifically, the OSC alleged that Registrant's state controlled 
substance license expired on October 21, 2018. Id. at 1-2. The OSC also 
alleged that Registrant's state medical license was revoked by the 
Board of Medical Examiners of the State of Nevada on September 6, 2019. 
Id. at 2. The OSC further alleged that Registrant is not eligible to 
obtain or retain a DEA registration because he lacks state authority to 
handle controlled substances in the state of Nevada. Id.
    The OSC notified Registrant of the right to either request a 
hearing on the allegations or submit a written statement in lieu of 
exercising 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. Id. at 3 (citing 21 
U.S.C. 824(c)(2)(C)).
    A DEA Diversion Investigator personally served Registrant with the 
OSC on December 16, 2019. RFAAX 12, at 2-3 (Declaration of Diversion 
Investigator One). I find that more than thirty days have now passed 
since the Government accomplished service of the OSC. Further, based on 
the Government's written representations, I find that neither 
Registrant, nor anyone purporting to represent Registrant, requested a 
hearing, submitted a written statement while waiving Registrant's right 
to a hearing, or submitted a corrective action plan. RFAAX 11, at 3-4 
(Declaration of Diversion Investigator Two). Accordingly, I find that 
Registrant has waived the right to a hearing and the right to submit a 
written statement and corrective action plan. 21 CFR 1301.43(d) and 21 
U.S.C. 824(c)(2)(C). I, therefore, issue this Decision and Order based 
on the record submitted by the Government, which constitutes the entire 
record before me. 21 CFR 1301.46.

Findings of Fact

Registrant's DEA Registration

    Registrant is the holder of DEA Certificate of Registration No. 
BH2498106 at the registered address of 3233 W. Charleston Blvd. 202, 
Las Vegas, NV 89102. RFAAX 1 (Registrant's DEA Certificate of 
Registration). Pursuant to this registration, Registrant is authorized 
to dispense controlled substances in schedules II through V as a 
practitioner. Id. Registrant's registration will expire on its own 
terms on October 31, 2020. Id.

DEA Investigation and the Status of Registrant's State Licenses

    On July 22, 2019, Registrant was sentenced in the United States 
District Court for the District of Nevada on a matter related to his 
conviction on one count of unlawful distribution of a controlled 
substance. RFAAX 11, at 2. On August 12, 2019, a DEA Diversion 
Investigator (hereinafter, DI Two) asked Registrant, through his legal 
counsel, to voluntarily surrender his DEA registration. Id. Registrant 
declined. Id.
    The General Counsel for the Nevada State Board of Pharmacy 
(hereinafter, Pharmacy Board) sent DI Two a letter dated September 17, 
2019, stating that Registrant did not renew his Nevada controlled 
substance license and did not hold an active controlled substance 
license with the Pharmacy Board. RFAAX 4. According to the online 
records of the Pharmacy Board, Registrant's controlled substance

[[Page 64166]]

license, license no. CS057748, expired on October 31, 2018, id.; RFAAX 
9 (Printout of Pharmacy Board website dated March 25, 2020), and 
remains closed,\1\ https://online.nvbop.org/#/verifylicense (last 
visited September 24, 2020).
---------------------------------------------------------------------------

    \1\ I take official notice of the online records of the Nevada 
State Board of Pharmacy. 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, Registrant may 
dispute my finding by filing a properly supported motion for 
reconsideration 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 Registrant files a motion, the Government shall have fifteen 
calendar days to file a response. Any such motion and response may 
be filed and served by email ([email protected]).
---------------------------------------------------------------------------

    On September 6, 2019, the Nevada State Board of Medical Examiners 
(hereinafter, Medical Board) revoked Registrant's medical license, 
license no. 6061, pursuant to a settlement agreement between Registrant 
and the Investigative Committee of the Medical Board. RFAAX 3 
(Settlement Agreement). The Investigative Committee of the Medical 
Board had filed a Complaint on April 3, 2019, charging Registrant with 
``violating the Medical Practice Act.'' Id. at 1. Specifically, the 
Complaint alleged ``one (1) violation of NRS 640.306(1)(c), Illegal 
Dispensing of Controlled Substances (Count 1), one (1) violation of NRS 
630.306(1)(p), Unsafe or Unprofessional Conduct (Count II), and one (1) 
violation of NRS 630.301(9), Disreputable Conduct (Count III).'' Id. at 
1-2. Pursuant to the Settlement Agreement, Registrant admitted to Count 
1 of the Complaint and agreed that the Medical Board could issue an 
order finding that Registrant ``engaged in conduct that is grounds for 
discipline pursuant to the Medical Practice Act.'' Id. at 4. The 
Settlement Agreement stated that, upon adoption of the Agreement by the 
Medical Board, Registrant's medical license would be immediately 
revoked and Registrant would be ineligible to apply for reinstatement 
for a period of three years. Id. The Medical Board adopted the 
Settlement Agreement on September 6, 2019. Id. at 8.
    Accordingly, I find that Registrant currently is neither licensed 
to engage in the practice of medicine nor licensed to dispense 
controlled substances in Nevada, the state in which Registrant is 
registered with the DEA.

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 DEA has also long held that the possession of 
authority to dispense controlled substances under the laws of the state 
in which a 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 Fed. Appx. 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 DEA has held repeatedly that revocation 
of a practitioner's registration is the appropriate sanction whenever 
he is no longer authorized to dispense controlled substances under the 
laws of the state in which he practices. See, e.g., James L. Hooper, 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, 43 
FR at 27,617.
    Nevada law gives authority to ``practitioners'' to dispense 
controlled substances, Nev. Rev. Stat. Sec.  453.337 (West 2020), and 
requires that ``[e]very practitioner . . . who dispenses any controlled 
substance within this State . . . shall obtain biennially a 
registration issued by the [Pharmacy] Board,'' Nev. Rev. Stat. Sec.  
453.226(1) (West 2020). Nevada law further defines ``practitioner'' to 
mean ``a physician . . . who holds a license to practice his or her 
profession in this State and is registered pursuant to [the Uniform 
Controlled Substances Act].'' Nev. Rev. Stat. Sec.  453.126(1) (West 
2020).
    Here, the undisputed evidence in the record is that Registrant's 
license to practice medicine is revoked. As such, he is not a 
``practitioner,'' a physician licensed to practice his profession in 
Nevada and registered to dispense controlled substances, according to 
Nevada law. Further, under Nevada law, a practitioner who dispenses a 
controlled substance in Nevada must be registered. The undisputed 
record evidence is that Registrant's Nevada controlled substance 
license is expired. Thus, because Registrant lacks authority to 
dispense controlled substances in Nevada, Registrant is not eligible to 
maintain a DEA registration. 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. 
BH2498106 issued to Steven A. Holper, 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 Steven A. Holper, M.D. to renew or 
modify this registration, as well as any pending application of Steven 
A. Holper, M.D. for registration in Nevada. This Order is effective 
November 9, 2020.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-22390 Filed 10-8-20; 8:45 am]
BILLING CODE 4410-09-P


This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.