Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices 4943 

date of this Order. Any such motion and response 

shall be filed and served by email to the other party 

and to Office of the Administrator, Drug 

Enforcement Administration at 

dea.addo.attorneys@dea.usdoj.gov. 6Other irrelevant exceptions omitted. 

Look Up, https://elicense.ohio.gov/oh_

verifylicense (last visited date of 

signature of this Order). Accordingly, I 

find that Respondent is not currently 

licensed to practice medicine in Ohio, 

the state in which he 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 Controlled 

Substances Act (hereinafter, 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 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 71371–72; 

Sheran Arden Yeates, M.D., 71 FR 

39130, 39131 (2006); Dominick A. Ricci, 

M.D., 58 FR 51104, 51105 (1993); Bobby 

Watts, M.D., 53 FR 11919, 11920 (1988); 

Frederick Marsh Blanton, 43 FR 27617. 

Moreover, because ‘‘the controlling 

question’’ in a proceeding brought 

under 21 U.S.C. 824(a)(3) is whether the 

holder of a practitioner’s registration ‘‘is 

currently authorized to handle 

controlled substances in the [S]tate,’’ 

Hooper, 76 FR 71371 (quoting Anne 

Lazar Thorn, 62 FR 12847, 12848 

(1997)), the Agency has also long held 

that revocation is warranted even where 

a practitioner is still challenging the 

underlying action. Bourne Pharmacy, 72 

FR 18273, 18274 (2007); Wingfield 

Drugs, 52 FR 27070, 27071 (1987). Thus, 

it is of no consequence that the final 

outcome of the underlying action may 

still be pending. What is consequential 

is my finding that Respondent is not 

currently authorized to dispense 

controlled substances in Ohio, the state 

in which he is registered with the DEA. 

Under Ohio law, ‘‘[n]o person shall 

knowingly obtain, possess, or use a 

controlled substance or a controlled 

substance analog,’’ except 6 pursuant to 

a ‘‘prescription issued by a licensed 

health professional authorized to 

prescribe drugs if the prescription was 

issued for a legitimate medical 

purpose.’’ Ohio Rev. Code Ann. 

§ 2925.11(A), (B)(1)(d) (West 2021). 

Ohio law further states that a 

‘‘‘[l]icensed health professional 

authorized to prescribe drugs’ or 

‘prescriber’ means an individual who is 

authorized by law to prescribe drugs or 

dangerous drugs . . . in the course of 

the individual’s professional practice.’’ 

Id. at § 4729.01(I). The definition further 

provides a limited list of authorized 

prescribers, the relevant provision of 

which is ‘‘[a] physician authorized 

under Chapter 4731 of the Revised Code 

to practice medicine and surgery, 

osteopathic medicine and surgery, or 

podiatric medicine and surgery.’’ Id. at 

§ 4729.01(I)(5). In addition, the Ohio 

Uniform Controlled Substances Act 

permits ‘‘[a] licensed health professional 

authorized to prescribe drugs, if acting 

in the course of professional practice, in 

accordance with the laws regulating the 

professional’s practice’’ to prescribe or 

administer schedule II, III, IV, and V 

controlled substances to patients. Id. at 

§ 3719.06(A)(1)(a)–(b). 

Here, the undisputed evidence in the 

record is that Respondent currently 

lacks authority to practice medicine in 

Ohio. As already discussed, a physician 

is authorized by law to prescribe or 

administer drugs in Ohio only when 

authorized to practice medicine and 

surgery under Ohio law. Thus, because 

Respondent lacks authority to practice 

medicine in Ohio and, therefore, is not 

authorized to handle controlled 

substances in Ohio, Respondent is not 

eligible to maintain a DEA registration. 

Accordingly, I will order that 

Respondent’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. FK6714504 issued to 

Austin J. Kosier, 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 

Austin J. Kosier, M.D. to renew or 

modify this registration, as well as any 

other pending application of Austin J. 

Kosier, M.D., for additional registration 

in Ohio. This Order is effective March 

2, 2022. 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–01834 Filed 1–28–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–946] 

Importer of Controlled Substances 

Application: Mylan Pharmaceuticals 

Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Mylan Pharmaceuticals Inc. 

has applied to be registered as an 

importer of basic class(es) of controlled 

substance(s). Refer to Supplementary 

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 March 2, 2022. Such persons 

may also file a written request for a 

hearing on the application on or before 

March 2, 2022. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing must 

be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 


khammond on DSKJM1Z7X2PROD with NOTICES
4944 Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices 

*A I have made minor, nonsubstantive, 

grammatical changes to the RD and nonsubstantive 

conforming edits. Where I have made substantive 

changes, omitted language for brevity or relevance, 

or where I have added to or modified the Chief 

ALJ’s opinion, I have noted the edits in brackets, 

and I have included specific descriptions of the 

modifications in brackets or in footnotes marked 

with an asterisk and a letter. Within those brackets 

and footnotes, the use of the personal pronoun ‘‘I’’ 

refers to myself—the Administrator. 

*BI have omitted the RD’s discussion of the 

procedural history to avoid repetition with my 

introduction. 

Virginia 22152. All request for a hearing 

should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/OALJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DPW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on December 7, 2021, 

Mylan Pharmaceuticals Inc., 2898 

Manufacturers Road, Greensboro, North 

Carolina 27406–4600, applied to be 

registered as an importer of the 

following basic class(es) of controlled 

substance(s): 

Controlled 

substance 

Drug 

code 

Schedule 

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

The company plans to import the 

above controlled substance as a Federal 

Drug Administration-approved drug 

product in finished dosage form for 

commercial distribution to its 

customers. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Brian S. Besser, 

Acting Assistant Administrator. 

[FR Doc. 2022–01817 Filed 1–28–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 21–11] 

Michael E. Smith, D.V.M.; Decision and 

Order 

On December 3, 2020, a former 

Assistant Administrator, Diversion 

Control Division, of the Drug 

Enforcement Administration 

(hereinafter, DEA or Government), 

issued an Order to Show Cause 

(hereinafter, OSC) to Michael E. Smith, 

D.V.M. (hereinafter, Respondent) of 

Zanesville, Ohio. Administrative Law 

Judge Exhibit (hereinafter, ALJX) 1 

(OSC), at 1 and 5. The OSC proposed 

the denial of Respondent’s application 

for DEA Certificate of Registration No. 

W20010614C (hereinafter, COR or 

registration) and the denial of any 

applications for any other DEA 

registrations pursuant to 21 U.S.C. 

824(a)(2) and 824(a)(4) because 

Respondent was convicted of a felony 

related to controlled substances and 

because ‘‘[Respondent’s] registration 

would be inconsistent with the public 

interest, as that term is defined in 21 

U.S.C. 823(f).’’ Id. at 1. 

On January 1, 2021, the Respondent 

timely requested a hearing, which 

commenced (and ended) on April 19, 

2021, at the DEA Hearing Facility in 

Arlington, Virginia with the parties, 

counsel, and witnesses participating via 

video teleconference (VTC). On June 30, 

2021, Administrative Law Judge Paul E. 

Soeffing (hereinafter, the ALJ) issued his 

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge 

(hereinafter, Recommended Decision or 

RD). 

By letter dated August 5, 2021, the 

ALJ certified and transmitted the record 

to me for final Agency action. In the 

letter, the ALJ advised that the 

Respondent filed untimely exceptions to 

the Recommend Decision on July 26, 

2021. The ALJ stated that the 

Respondent had received an extension 

of time to file his exceptions by 2:00 

p.m. ET on July 26, but did not file them 

until 2:58 p.m. ET. The ALJ also advised 

that the Government filed its Response 

to the Respondent’s Exceptions on 

August 5, 2021. 

Having reviewed the entire record, I 

find Respondent’s Exceptions without 

merit and I adopt the ALJ’s rulings, 

findings of fact as modified, conclusions 

of law and recommended sanction with 

minor modifications, where noted 

herein.*A Although Respondent’s 

Exceptions were untimely, in this case, 

I decided to nonetheless consider and 

address each of Respondent’s 

Exceptions, and issue my final Order in 

this case following the Recommended 

Decision. 

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge 

Paul E. Soeffing 

U.S. Administrative Law Judge 

June 30, 2021 

*B The issue in this case is whether 

the record as a whole establishes by a 

preponderance of the evidence that the 

Respondent’s application for a DEA 

COR, Control No. W20010614C, should 

be denied, and any other pending 

applications for additional registrations 

should be denied, pursuant to 21 U.S.C. 

824(a)(2) and (a)(4), because the 

Respondent has been convicted of a 

felony relating to controlled substances, 

and because his registration would be 

inconsistent with the public interest, as 

that term is defined in 21 U.S.C. 823(f). 

After carefully considering the 

testimony elicited at the hearing, the 

admitted exhibits, the arguments of 

counsel, and the record as a whole, I 

have set forth my recommended 

findings of fact and conclusions of law 

below. 

I. Findings of Fact 

A. Allegations 

The Government alleges that the 

Respondent’s application for a DEA 

COR, Control No. W20010614C, should 

be denied and any applications by the 

Respondent for any other DEA 

registrations should be denied, pursuant 

to 21 U.S.C. 824, because (1) 

Respondent has been convicted of a 

felony relating to controlled substances; 

and (2) that registration would be 

inconsistent with the public interest, as 

that term is defined in 21 U.S.C. 823(f). 

B. Stipulations 

The Government and the Respondent 

agreed to fourteen stipulations, which I 

recommend be accepted as fact in these 

proceedings: 

1. Respondent was previously registered 

with the DEA to handle controlled 

substances in Schedules II through V under 

DEA COR No. FS1126146 at 100 Sally Road, 

Zanesville, Ohio 43701. 

2. Respondent surrendered DEA COR No. 

FS1126146 for cause on or about July 20, 

2015, pursuant to his plea agreement in Case 

CR2015–0052, State of Ohio v. Michael E. 

Smith. 

3. Respondent submitted an electronic 

application for a new DEA COR on or about 

February 3, 2020. 

4. Government Exhibit No. 1 is a true and 

correct copy of Respondent’s February 3, 

2020 application for a DEA COR. 

5. Government Exhibit No. 2 is a true and 

correct copy of the Certification of 

Registration History showing Respondent’s 

answers to the liability questions from his 

February 3, 2020 application for a DEA COR. 

6. Government Exhibit No. 3 is a true and 

correct copy of the docket sheet in Case 

CR2015–0052, State of Ohio v. Michael E. 

Smith. 

7. Government Exhibit No. 4 is a true and 

correct copy of Respondent’s signed plea 

agreement, dated July 20, 2015, in Case 

CR2015–0052, State of Ohio v. Michael E. 

Smith. 

8. Government Exhibit No. 5 is a true and 

correct copy of the court’s entry of 

Respondent’s plea agreement, dated July 23, 


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