80160 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

1The Hearing Request was deemed filed on July 

17, 2019. Order for Prehearing Statements, at 1. I 

find that the Government’s service of the OSC was 

adequate and that the Hearing Request was timely 

filed on July 17, 2019. 

2Respondent filed a Prehearing Statement on the 

same day. 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 19–29] 

Lisa Hofschulz, N.P.; Decision and 

Order 

On June 21, 2019, the Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause (hereinafter, OSC) to Lisa 

Hofschulz, N.P. (hereinafter, 

Respondent) of Wauwatosa, Wisconsin. 

OSC, at 1. The OSC proposed the 

revocation of Respondent’s Certificate of 

Registration No. MH1088182. Id. It 

alleged that Respondent is without 

‘‘authority to handle controlled 

substances in Wisconsin, the state in 

which [Respondent is] registered with 

DEA.’’ Id. 

Specifically, the OSC alleged that 

Respondent’s Wisconsin ‘‘Advance 

Practice Nursing Prescriber [hereinafter, 

APNP] license expired on September 30, 

2018, and has not been renewed. As a 

result of the expiration of [her] APNP 

license, [Respondent] currently lack[s] 

the authority to handle controlled 

substances in Wisconsin.’’ Id. at 1–2 

(citing 21 U.S.C 802(21), 823(f), and 

824(a)(3)). 

The OSC notified Respondent 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. at 2–3 (citing 

21 CFR 1301.43). The OSC also notified 

Respondent of the opportunity to 

submit a corrective action plan. Id. at 3 

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

By letter dated July 17, 2019, 

Respondent timely requested a hearing.1

Hearing Request, at 1. In the Hearing 

Request, Respondent stated that ‘‘[o]n 

May 17, 2019, Respondent applied to 

transfer her DEA registration from the 

State of Wisconsin to the State of 

Florida’’ and that ‘‘Respondent has a 

current and active Nurse Practitioner 

license . . . in the State of Florida.’’ Id. 

The Office of Administrative Law 

Judges put the matter on the docket and 

assigned it to Administrative Law Judge 

Mark M. Dowd (hereinafter, ALJ). The 

ALJ issued an Order for Prehearing 

Statements, dated July 18, 2019. The 

Government timely complied with the 

Briefing Schedule by filing a Motion for 

Summary Disposition on July 25, 2019 

(hereinafter, Government Motion or 

Govt Motion). In its Motion, the 

Government submitted evidence that 

the Wisconsin Board of Nursing 

(hereinafter, Board) entered a Final 

Decision and Order with an attached 

Stipulation on April 12, 2018, which 

suspended Respondent’s APNP 

following an investigation into unlawful 

prescribing practices, and Respondent 

therefore lacked authority to handle 

controlled substances in Wisconsin, the 

state in which she is registered with 

DEA. Govt Motion, at 1. The 

Government acknowledged that 

Respondent had requested a 

modification of her registration to 

Florida, but stated that the 

‘‘Government’s allegations in support of 

revocation of Respondent’s [registration] 

pertain solely to Respondent’s current 

authorization to handle controlled 

substances in Wisconsin [] and . . . do 

not address any denial of Respondent’s 

pending application for modification of 

that [registration.]’’ Id. at 4. In light of 

these facts, the Government argued that 

DEA must revoke her registration. Govt 

Motion, at 6. 

On July 31, 2019, Respondent 

requested an extension of time to file 

her Prehearing Statement and Response 

to Government’s Motion for Summary 

Disposition, which the ALJ granted that 

same day. See Respondent’s Unopposed 

Motion for Extension and ALJ’s Order 

Granting Respondent’s Unopposed 

Motion for Extension. On August 5, 

2019,2 Respondent filed a Response in 

Opposition to Government’s Motion for 

Summary Disposition (hereinafter, Resp 

Opposition). Respondent argued that 

‘‘Under the Administrative Procedure[ ] 

Act (‘‘APA’’), ‘[w]hen the licensee has 

made timely and sufficient application 

for a renewal or a new license in 

accordance with agency rules, a license 

with reference to an activity of a 

continuing nature does not expire until 

the application has been finally 

determined by the agency.’ ’’ Resp 

Opposition, at 1 (quoting 5 U.S.C. 558). 

Respondent, therefore, argued that the 

Agency is obligated to act on 

Respondent’s application for a 

registration in Florida. In the 

alternative, Respondent argued that 

even if the Agency decided that it must 

revoke Respondent’s application, then it 

‘‘should determine that the application 

for modification is not affected.’’ Id. at 

4. 

On August 8, 2019, the ALJ issued an 

Order Granting the Government’s 

Motion for Summary Disposition, and 

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and 

Recommended Decision of the 

Administrative Law Judge (hereinafter, 

Summary Disposition or SD). The ALJ 

granted the Government Motion for 

Summary Disposition—finding that the 

only subject of the underlying action 

was Respondent’s Wisconsin 

registration, Respondent had conceded 

that she had no authority in Wisconsin, 

and therefore, ‘‘summary disposition of 

an administrative case is warranted 

where, as here, ‘there is no factual 

dispute of substance.’ ’’ SD, at 7 (citing 

Veg-Mix, Inc. v. U.S. Dep’t of Agric., 832 

F.2d 601, 607 (D.C. Cir. 1987) (‘‘[A]n 

agency may ordinarily dispense with a 

hearing when no genuine dispute 

exists.’’ (citations omitted))). By letter 

dated September 4, 2019, the ALJ 

certified and transmitted the record to 

me for final Agency action. In that letter, 

the ALJ advised that neither party filed 

exceptions. I find that the time period 

to file exceptions has expired. See 21 

CFR 1316.66. 

I issue this Decision and Order based 

on the entire record before me. 21 CFR 

1301.43(e). I make the following 

findings of fact. 

Findings of Fact 

Respondent’s DEA Registration 

Respondent is the holder of DEA 

Certificate of Registration No. 

MH1088182 at the registered address of 

6163 Washington Circle, Wauwatosa, 

Wisconsin 53213. Govt Motion Exhibit 

(hereinafter, GX) 2, at 1. Pursuant to this 

registration, Respondent is authorized to 

dispense controlled substances in 

schedules II through V as a 

‘‘practitioner.’’ Id. Respondent’s 

registration expires on October 31, 2021, 

and is currently in ‘‘active pending 

status.’’ Id. 

The Status of Respondent’s State 

License 

On April 12, 2018, the Wisconsin 

Board of Nursing issued a Final 

Decision and Order (hereinafter, Board 

Order), in which Respondent stipulated 

to facts and conclusions of law related 

to her prescribing practices. Respondent 

Exhibit (hereinafter, RX) C (Board 

Order). The Board Order was ‘‘effective 

on the date of its signing.’’ Id. at 29. 

According to the Board Order, 

Respondent ‘‘engaged in unprofessional 

conduct . . . by departing from or 

failing to conform to the minimal 

standards of acceptable nursing practice 

that may create unnecessary risk or 

danger to a patient’s life, health, or 

safety.’’ Id. at 27. The Board suspended 

Respondent’s professional nursing 


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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80161 

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, 

Respondent may dispute my finding by filing a 

properly supported motion for reconsideration of 

findings 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 

Respondent files a motion, the Government shall 

have fifteen calendar days to file a response. Any 

motion and response shall be filed and served by 

email to the other party and to the Office of the 

Administrator at dea.addo.attorneys@dea.usdoj.gov. 

4 ‘‘[D]ispense[ ] means to deliver a controlled 

substance to an ultimate user . . . by, or pursuant 

to the lawful order of, a practitioner, including the 

prescribing and administering of a controlled 

substance . . . .’’ 21 CFR 802(10). 

5An advanced practice nurse (hereinafter, APN) 

who meets the requisite education, training and 

examination requirements, and who pays the 

required fee, ‘‘shall [be] grant[ed] a certificate to 

issue prescription orders.’’ Wis. Stat. § 441.16(2) 

(West, Current through 2019 Act 186, published 

April 18, 2020). 

6Under Wisconsin law, ‘‘dispensing’’ a controlled 

substance includes ‘‘prescribing’’ a controlled 

substance. Wis. Stat. § 961.01(7) (West, Current 

through 2019 Act 186, published April 18, 2020). 

license and advanced practice nurse 

prescriber certificate in Wisconsin for 

twenty-one (21) days, and further 

limited her license requiring that she 

‘‘not practice pain management’’ and 

‘‘not return to practice in the State of 

Wisconsin unless she provides written 

notification to the Board, or its designee, 

of intent to return to Wisconsin at least 

fifteen (15) days prior to return’’ at 

which time the Board ‘‘may impose 

additional limitations upon 

Respondent’s license.’’ Id. at 27–28. 

According to Wisconsin’s online 

records, of which I take official notice, 

Respondent’s Advance Practice Nurse 

Prescriber license status is listed as 

‘‘license is not current (Expired)’’ and 

further states ‘‘Not Eligible to Practice 

(See board order).’’ 3 Wisconsin 

Department of Safety and Professional 

Services Credential/Licensing Search, 

https://licensesearch.wi.gov (last visited 

on date of this Order). 

Based on the entire record before me, 

I find that Respondent currently is not 

licensed as an Advance Practice Nurse 

Prescriber in Wisconsin, the state in 

which Respondent is registered with 

DEA. 

I further find, as recommended by the 

ALJ, that Respondent’s application for 

modification is not the subject of this 

proceeding, and agree that the 

Government did not challenge that 

application modification in its OSC. See 

OSC, at 1; see also SD, at 7–8. 

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 Controlled 

Substances Act (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[4] 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 in that state. 

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

71371 (2011), pet. for rev. denied, 481 

F. App’x 826 (4th Cir. 2012); Frederick 

Marsh Blanton, M.D., 43 FR 27616, 

27617 (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. 

In Wisconsin, an ‘‘advanced practice 

nurse’’ is a registered nurse who ‘‘has a 

current license to practice professional 

nursing’’ in Wisconsin. Wis. Admin. 

Code N § 8.02(1) (West, Current through 

Wisconsin Register 776B, published 

August 31, 2020). An ‘‘advanced 

practice nurse prescriber’’ is ‘‘an 

advanced practice nurse who has been 

granted a certificate to issue 

prescription orders’’ under Wis. Stat. 

§ 441.16(2). Id. § 8.02(2).5

Under the Wisconsin Uniform 

Controlled Substances Act (hereinafter, 

Act), a person must have a federal 

controlled substances registration in 

order to lawfully dispense controlled 

substances in Wisconsin.6 Wis. Stat. 

§ 961.32(1m)(a) (West, Current through 

2019 Act 186, published April 18, 

2020). The Act further provides that a 

‘‘practitioner’’ includes an ‘‘advanced 

practice nurse . . . licensed, registered, 

certified or otherwise permitted to . . . 

dispense . . . a controlled substance in 

the course of professional practice.’’ Id. 

§ 961.01(19)(a). 

Here, the undisputed evidence in the 

record is that Respondent is not 

currently licensed as an APNP in 

Wisconsin. As such, she is not 

authorized to dispense controlled 

substances in Wisconsin, the state in 

which she is registered with the DEA. 

Because Respondent lacks authority to 

dispense controlled substances in 

Wisconsin, she is not eligible to hold a 

DEA registration in Wisconsin. 21 

U.S.C. 823(f). 

I agree with the ALJ’s finding that 

‘‘[t]he subject of the instant litigation is 

not whether the Respondent has 

requested to modify her [registration] to 

reflect an address in Florida, but 

whether she has state authority to 

dispense controlled substances in the 

state in which her [registration] is 

currently registered, Wisconsin, which 

she concedes, she does not.’’ SD, at 7. 

The current issue before me is whether 

Respondent has state authority in 

Wisconsin, and I find that she does not. 

See Parth S. Bharill, 84 FR 39014 

(2019). 

Although she admitted that her 

Wisconsin APRN license expired about 

forty days before she asked DEA to 

change the address of her registration 

from Wisconsin to Florida, Respondent 

opposed the Government’s Motion for 

Summary Disposition and argued for my 

focus first to be on her request for a 

change of address. Resp Opposition, at 

1. In doing so, as already discussed, 

Respondent suggested that I ignore the 

fact that the Show Cause Order I am 

adjudicating is based on Respondent’s 

lack of authority to dispense controlled 

substances in Wisconsin. 21 U.S.C. 

823(f) (stating that a prerequisite to 

receiving a registration is having 

authorization to dispense controlled 

substances in the state of requested 


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80162 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

registration). Respondent made no 

argument that convinces me to ignore 

the statutorily mandated show cause 

order process or to limit the Agency’s 

enforcement discretion and prerogatives 

by addressing her modification request 

based merely on a chronological 

sequence of events. 21 U.S.C. 823(c). 

The Wedgewood Village Pharmacy case 

Respondent cited explicitly articulates 

this process and DEA’s enforcement 

discretion and prerogatives when it 

states that, ‘‘[w]hen an application for 

modification of an existing 

practitioner’s registration is received by 

DEA, and before an approval may be 

given, DEA must determine whether 

there is any need to conduct a further 

investigative inquiry.’’ Wedgewood 

Village Pharmacy, Inc. v. Ashcroft, 293 

F. Supp. 2d, 462, 467 (D.N.J. 2003). 

Here, Respondent’s loss of APRN 

authority in Wisconsin was reason ‘‘to 

conduct a further investigative inquiry.’’ 

Id. Similarly, I reject Respondent’s 

alternative argument that, even if I 

revoke her registration, ‘‘then the 

application for modification should 

continue and be granted.’’ Resp 

Opposition, at 4. 

Respondent suggested that, even if I 

revoke her registration, her requested 

modification should continue and either 

be granted or be the subject of an order 

to show cause and a demonstration that 

‘‘granting the application is not in the 

public interest.’’ Id. She did not, 

however, address how to implement the 

regulatory requirement of maintaining 

the modification with the ‘‘old 

certificate’’ until its expiration when the 

old certificate already expired due to 

revocation. 21 CFR 1301.51(c). 

Respondent argued that the statement 

in 21 CFR 1301.51(c), that a ‘‘request for 

modification shall be handled in the 

same manner as an application for 

registration,’’ means that the Agency is 

‘‘required to register an applicant, 

unless it determines that the applicant’s 

registration would be inconsistent with 

the public interest.’’ Resp Opposition, at 

2 (citing 21 U.S.C. 823). The further 

support Respondent provided for her 

argument is the Wedgewood Village 

Pharmacy federal district court 

decision. Id. (citing Wedgewood Village 

Pharmacy, Inc. v. Ashcroft, 293 F. Supp. 

2d at 469). 

Respondent’s arguments ignore the 

entirety of 21 U.S.C. 823. That statutory 

provision premises a public interest 

analysis, in the first instance, on an 

applicant’s existing authorization ‘‘to 

dispense . . . controlled substances 

under the laws of the State in which he 

practices.’’ 21 U.S.C. 823(f). Respondent 

admitted that she lacks authority to 

dispense controlled substances in 

Wisconsin. Accordingly, if she were to 

apply for a registration in Wisconsin, 

the public interest portion of section 

823 would not be reached due to her 

failure to meet the threshold eligibility 

requirements for a registration. Thus, 

Respondent’s reliance on the district 

court’s decision in Wedgewood Village 

Pharmacy is unavailing. Although 

Wedgewood Village Pharmacy retained 

its state authorization to dispense 

controlled substances during its 

litigation and, as such, its eligibility for 

a registration, Respondent has not. 

Respondent did not address past 

Agency decisions concerning the 

precise portion of 21 CFR 1301.51(c) 

that she cited. Those decisions starkly 

show the weakness of Respondent’s 

position. Most recently, my predecessor 

noted that this portion of the regulation 

‘‘does not mean that a modification 

request is the same as an application for 

a new registration in every respect.’’ 

Parth S. Bharill, M.D., 84 FR 39014 n.2 

(2019) (citing Craig S. Morris, D.D.S., 83 

FR 36966, 36967 (2018)). In Craig S. 

Morris, D.D.S., my predecessor had 

noted that ‘‘[u]nlike a timely renewal 

application, a request to modify the 

registration address of an existing 

registration . . . does not remain 

pending after the registration expires, 

nor does it operate to extend when that 

registration expires.’’ 83 FR at 36967. 

Respondent also cited the 

Administrative Procedure Act 

(hereinafter, APA) as ‘‘clearly 

indicat[ing] a governmental policy, by 

which agencies must consider a timely 

application before terminating a current 

registration,’’ and 21 CFR 1301.36(i) for 

the proposition that ‘‘as long as a 

current DEA registrant submits his 

renewal application in a timely manner, 

an Order to Show Cause in 

administrative revocation proceedings 

will not void the registration.’’ Resp 

Opposition, at 2 (citing 5 U.S.C. 558 and 

Wedgewood Village Pharmacy, 293 F. 

Supp. 2d at 467). Both of these 

arguments fail because both section 558 

of the APA and section 1301.36(i) of 

DEA’s regulations concern applications 

for reregistration (renewal) or for a new 

registration. 5 U.S.C. 558 (‘‘When the 

licensee has made timely and sufficient 

application for a renewal or a new 

license . . .’’); 21 CFR 1301.36(i) (‘‘In 

the event that an applicant for 

reregistration (who is doing business 

under a registration previously granted 

and not revoked or suspended) has 

applied for reregistration . . .’’). 

Respondent’s request under 21 CFR 

1301.51(c) was not to renew or obtain a 

new registration. Her request was ‘‘for 

modification of her DEA registration, to 

change the address of her registration’’ 

from Wisconsin to Florida. Resp 

Opposition, at 1. As discussed above, 

the regulations are clear that the request 

to modify is not an extension of an 

existing registration, but shall be 

handled in the same manner as an 

application. See Cleveland J. Enmon, Jr. 

M.D., 77 FR 57,116, 57,125 (2012) 

(‘‘[W]hile the address change request is 

pending with the DEA, the registrant is 

not authorized to handle controlled 

substances at the new location until the 

DEA approves the modification.’’). 

Accordingly, I will order that 

Respondent’s DEA registration in 

Wisconsin 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. MH1088182 issued 

to Lisa Hofschulz, N.P. This Order is 

effective January 11, 2021. 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–27239 Filed 12–10–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 18–13] 

George Pursley, M.D.; Denial of 

Application 

I. Introduction 

On December 1, 2017, a former Acting 

Assistant Administrator, Diversion 

Control Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause to George Pursley, M.D. 

(hereinafter, Applicant), of Augusta, 

Georgia. Administrative Law Judge 

Exhibit (hereinafter, ALJX) 1 (Order to 

Show Cause (hereinafter, OSC)), at 1. 

The OSC proposed the denial of 

Applicant’s application for a DEA 

certificate of registration on the ground 

that his registration ‘‘would be 

inconsistent with the public interest,’’ 

citing 21 U.S.C. 823(f). Id. 

The substantive grounds for the 

proceeding, as more specifically alleged 

in the OSC, are that Applicant 

unlawfully pre-signed and pre-printed 

prescriptions, committed violations of 

applicable federal and state 

recordkeeping requirements, unlawfully 

prescribed controlled substances, and, 

citing 21 U.S.C. 823(f)(5), did not 

exhibit candor during DEA’s 

investigation. Id. at 2–8. 

The OSC notified Applicant of his 

right to request a hearing on the 


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