Austin J. Kosier, M.D.; Decision and Order, 4941-4943 [2022-01834]

Download as PDF 4941 Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices denial. Careless or negligent handling of controlled substances creates the opportunity for diversion and [can] justify the revocation of an existing registration . . .’’ Bobby D. Reynolds, N.P., Tina L. Killebrew, N.P., & David R. Stout, N.P., 80 FR 28643, 28662 (2015) (quoting Paul J. Caragine, Jr. 63 FR 51592, 51601 (1998). In fact, the Agency has found in favor of revocation in cases where registrants have failed to document their prescribing decisions— a violation which has been clearly established in this case. The Agency has repeatedly emphasized that ‘‘[c]onscientious documentation is . . . not just a ministerial act, but a key treatment tool and vital indicator to evaluate whether the physician’s prescribing practices are within the usual course of professional practice.’’ Cynthia M. Cadet, M.D., 76 FR 19,450, 19,464 (2011) (internal citation and quotation omitted); see also Kaniz F. Khan-Jaffery, M.D., 85 FR 45,667, 45,686 (2020) (‘‘DEA’s ability to assess whether controlled substances registrations are consistent with the public interest is predicated upon the ability to consider the evidence and rationale of the practitioner at the time that she prescribed a controlled substance— adequate documentation is critical to that assessment.’’). The case at hand demonstrates prescribing beneath the applicable standard of care and outside the usual course of professional practice in California to multiple patients over the course of many years. I agree with the Chief ALJ that this conduct was egregious and I agree with his rationale for sanction. As stated above, for many reasons, I cannot find that I can entrust Respondent with a registration. Accordingly, I reject Respondent’s Exceptions and affirm the RD’s conclusion that Respondent’s registration should be revoked. in California. This Order is effective March 2, 2022. Anne Milgram, Administrator. [FR Doc. 2022–01838 Filed 1–28–22; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–947] Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Jkt 256001 9333 9630 9652 9780 Schedule II II II II The company plans to manufacture the above-listed controlled substance in bulk for development of a new active pharmaceutical ingredient (API) and validation for a Drug Master File submission to the Food and Drug Administration. No other activity for this drug code is authorized for this registration. Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2022–01816 Filed 1–28–22; 8:45 am] BILLING CODE P Siegfried USA, LLC. has applied to be registered as a bulk manufacturer 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 April 1, 2022 Such persons may also file a written request for a hearing on the application on or before April 1, 2022. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUMMARY: In accordance with 21 CFR 1301.33(a), this is notice that on December 8, 2021, Siegfried USA, LLC., 33 Industrial Park Road, Pennsville, New Jersey 08070– 3244, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code Controlled substance 17:38 Jan 28, 2022 Thebaine ................................. Opium tincture ........................ Oxymorphone ......................... Tapentadol .............................. Drug code BILLING CODE 4410–09–P Order Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a)(4) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate of Registration No. BC1317165 issued to Bradley H. Chesler, M.D. Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 21 U.S.C. 823(f), I further hereby deny any pending application of Bradley H. Chesler, M.D., to renew or modify this registration, as well as any other pending application of Bradley H. Chesler, M.D. for registration Controlled substance Gamma Hydroxybutyric Acid .. Dihydromorphine ..................... Hydromorphinol ....................... Amphetamine .......................... Lisdexamfetamine ................... Methylphenidate ...................... Amobarbital ............................. Pentobarbital ........................... Secobarbital ............................ Phenylacetone ........................ Codeine ................................... Oxycodone .............................. Hydromorphone ...................... Hydrocodone ........................... Methadone .............................. Methadone intermediate ......... Morphine ................................. Oripavine ................................. PO 00000 Frm 00110 Fmt 4703 Schedule 2010 9145 9301 1100 1205 1724 2125 2270 2315 8501 9050 9143 9150 9193 9250 9254 9300 9330 Sfmt 4703 I I I II II II II II II II II II II II II II II II DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 22–4] Austin J. Kosier, M.D.; Decision and Order On September 30, 2021, the Acting Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Austin J. Kosier, M.D. (hereinafter, Respondent) of Zanesville, Ohio. OSC, at 1 and 3. The OSC proposed the revocation of Respondent’s Certificate of Registration No. FK6714504. It alleged that Respondent ‘‘[does] not have authority to dispense or prescribe controlled substances in the [s]tate of Ohio, the state in which [Respondent is] registered with DEA.’’ Id. at 1 (citing 21 U.S.C. 824(a)(3)). Specifically, the OSC alleged that on or about May 12, 2021, the State Medical Board of Ohio issued an Order suspending Respondent’s state license to practice medicine and surgery. Id. at 2. The Order was effective immediately and ordered that Respondent ‘‘immediately cease the practice of medicine and surgery in Ohio.’’ Id. 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 (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)). E:\FR\FM\31JAN1.SGM 31JAN1 4942 Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices khammond on DSKJM1Z7X2PROD with NOTICES On October 25, 2021, Respondent timely requested a hearing by email.1 Administrative Law Judge Exhibit (hereinafter, ALJX) 4 (Request for Hearing). Respondent’s Request for Hearing also indicated that Respondent was ‘‘considering the submission of a corrective action plan.’’ Id. The Office of Administrative Law Judges put the matter on the docket and assigned it to Administrative Law Judge Teresa A. Wallbaum (hereinafter, the ALJ). On October 25, 2021, the ALJ issued a Briefing Schedule. See ALJX 5. The Government timely complied with the Briefing Schedule by filing a Notice of Filing of Evidence and Motion for Summary Disposition (hereinafter, Motion for Summary Disposition) on November 10, 2021. Order Granting the Government’s Motion for Summary Disposition, and Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (hereinafter, Recommended Decision or RD), at 2; see also ALJX 6. In its Motion for Summary Disposition, the Government requested summary disposition and recommended that Respondent’s DEA registration be revoked based on Respondent’s lack of authority to handle controlled substances in Ohio, the state in which he is registered with the DEA. Motion for Summary Disposition, at 5. On November 30, 2021, Respondent untimely filed a Memorandum in Opposition of Respondent [sic] to Government’s Motion for Summary Disposition (hereinafter, Respondent’s Opposition). RD, at 2; see also ALJX 7.2 Respondent’s Opposition argued that there ‘‘does not exist and [sic] mandate under the [Controlled Substances Act] whereas [the] tribunal shall or must revoke or suspend the [DEA registration] of a physician under a state summary suspension.’’ Respondent’s Opposition, at 1. Respondent’s Opposition also noted that Respondent’s state medical license, though suspended, was still 1 Though the Request for Hearing itself is undated, the record indicates that the Request for Hearing was filed on October 25, 2021. See Order Directing the Government to File Evidence Regarding its Lack of State Authority Allegation and Briefing Schedule (hereinafter, Briefing Schedule), at 1. I find that the Government’s service of the OSC was adequate and that the Request for Hearing was timely filed on October 25, 2021. 2 As a result of Respondent’s untimely filing, on November 30, 2021, the ALJ issued an Order to Show Good Cause Regarding Respondent’s Late Filing (hereinafter, Order to Show Good Cause). See ALJX 8. On November 30, 2021, Respondent timely filed a Response to Order to Show Good Cause stating that the untimely filing was due to a death in Respondent’s counsel’s family. RD, at 2; see also ALJX 9. The ALJ found that ‘‘the delay was minimal and caused no prejudice to the Government’’ and thus accepted Respondent’s Opposition. RD, at 2. VerDate Sep<11>2014 17:38 Jan 28, 2022 Jkt 256001 intact; 3 that ‘‘[t]he issue that led to his current case [was] unrelated to the practice of medicine and was in no way arose [sic] in the course and scope of practice’’; 4 and that ‘‘[Respondent] has had no previous issues in any way with his medical license in the past.’’ Id. Moreover, Respondent’s Opposition highlighted ‘‘the unbelievable work [Respondent] has done and is continuing to do within the medical community and specifically an online training and tutorial platform for health care practitioners and medical students around the world.’’ Id. at 2–3. Finally, Respondent’s Opposition highlighted that Respondent ‘‘has also taken [the] opportunity to maintain and enhance his own medical education’’ with CME courses. Id. at 3. Respondent’s Opposition sought the denial of the Government’s Motion for Summary Disposition and for the Tribunal to either grant Respondent’s request for a hearing or to stay the matter pending the outcome of the Ohio Medical Board hearing. Id. On December 2, 2021, the ALJ granted the Government’s Motion for Summary Disposition, finding that ‘‘[t]here is no genuine issue of material fact in this case’’ because ‘‘[t]he Government has established that Respondent currently lacks a medical license.’’ RD, at 7–8. The ALJ recommended that Respondent’s DEA registration be revoked and that any application to renew or modify his DEA registration be denied ‘‘because Respondent lacks state authority to handle controlled substances in Ohio.’’ Id. at 8. By letter dated December 27, 2021, the ALJ certified and transmitted the record to me for final Agency action. Transmittal Letter, at 1. The ALJ also advised that neither party filed exceptions. Id. 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 According to Agency records, Respondent is the holder of DEA Certificate of Registration No. FK6714504 at the registered address of 3 According to Respondent’s Opposition, the Ohio Medical Board ‘‘issued a summary suspension pending the outcome of a Medical Board Hearing in January of 2022.’’ Id. at 2. Further, according to Respondent’s Opposition, the suspension ‘‘was based on a provision in the Ohio Administrative Code that allows the Ohio Medical Board to summarily suspend a license of a physician based on [the] physician’s entry into an intervention program to address a mental health matter’’ and ‘‘[t]he matter at hand with [Respondent] is his ongoing struggle with his homosexuality.’’ Id. 4 See supra n.3. PO 00000 Frm 00111 Fmt 4703 Sfmt 4703 2916 Vangader Dr., Zanesville, OH 43701. Pursuant to this registration, Respondent is authorized to dispense controlled substances in Schedules II through V as a practitioner. Respondent’s registration expires on December 31, 2022. The Status of Respondent’s State License On May 12, 2021, the State Medical Board of Ohio (hereinafter, the Board) issued a Notice of Summary Suspension and Opportunity for Hearing (hereinafter, Summary Suspension) and an Entry of Order. Government Exhibit (hereinafter, GX) A, at 3 and 5. According to the Summary Suspension, on or about December 16, 2019, ‘‘the Franklin County Court of Common Pleas filed an indictment alleging [Respondent] had committed attempted unlawful sexual contact with a minor’’ on or about September 10, 2019. Id. Further, according to the Summary Suspension, ‘‘[o]n or about November 13, 2020, [Respondent] appeared before the Court for a hearing on [his] application for intervention in lieu of conviction for these offenses’’ and ‘‘[t]he Court granted [Respondent’s] application.’’ Id. The Summary Suspension states that ‘‘[Respondent] pleaded guilty to [the] felony offenses at a subsequent hearing held on or about December 9, 2020’’ and ‘‘[t]he Court ordered further proceedings be stayed while [Respondent was] under community control.’’ Id. In its Entry of Order on May 12, 2021, the Board found that ‘‘[Respondent’s] continued practice presents a danger of immediate and serious harm to the public’’ and ordered, effective immediately, that Respondent’s license to practice medicine and surgery in the state of Ohio be summarily suspended, that Respondent ‘‘immediately cease the practice of medicine and surgery in Ohio,’’ and that Respondent ‘‘immediately refer all active patients to other appropriate physicians.’’ Id. at 3. According to Ohio’s online records, of which I take official notice, Respondent’s medical license is still suspended and inactive.5 Ohio License 5 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, Respondent may dispute my finding by filing a properly supported motion for reconsideration of findings of fact within fifteen calendar days of the E:\FR\FM\31JAN1.SGM 31JAN1 Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices khammond on DSKJM1Z7X2PROD with NOTICES 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 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. VerDate Sep<11>2014 17:38 Jan 28, 2022 Jkt 256001 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 6 Other PO 00000 irrelevant exceptions omitted. Frm 00112 Fmt 4703 Sfmt 4703 4943 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. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: 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, SUMMARY: E:\FR\FM\31JAN1.SGM 31JAN1

Agencies

[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4941-4943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01834]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 22-4]


Austin J. Kosier, M.D.; Decision and Order

    On September 30, 2021, the Acting Assistant Administrator, 
Diversion Control Division, Drug Enforcement Administration 
(hereinafter, DEA or Government), issued an Order to Show Cause 
(hereinafter, OSC) to Austin J. Kosier, M.D. (hereinafter, Respondent) 
of Zanesville, Ohio. OSC, at 1 and 3. The OSC proposed the revocation 
of Respondent's Certificate of Registration No. FK6714504. It alleged 
that Respondent ``[does] not have authority to dispense or prescribe 
controlled substances in the [s]tate of Ohio, the state in which 
[Respondent is] registered with DEA.'' Id. at 1 (citing 21 U.S.C. 
824(a)(3)).
    Specifically, the OSC alleged that on or about May 12, 2021, the 
State Medical Board of Ohio issued an Order suspending Respondent's 
state license to practice medicine and surgery. Id. at 2. The Order was 
effective immediately and ordered that Respondent ``immediately cease 
the practice of medicine and surgery in Ohio.'' Id.
    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 (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)).

[[Page 4942]]

    On October 25, 2021, Respondent timely requested a hearing by 
email.\1\ Administrative Law Judge Exhibit (hereinafter, ALJX) 4 
(Request for Hearing). Respondent's Request for Hearing also indicated 
that Respondent was ``considering the submission of a corrective action 
plan.'' Id.
---------------------------------------------------------------------------

    \1\ Though the Request for Hearing itself is undated, the record 
indicates that the Request for Hearing was filed on October 25, 
2021. See Order Directing the Government to File Evidence Regarding 
its Lack of State Authority Allegation and Briefing Schedule 
(hereinafter, Briefing Schedule), at 1. I find that the Government's 
service of the OSC was adequate and that the Request for Hearing was 
timely filed on October 25, 2021.
---------------------------------------------------------------------------

    The Office of Administrative Law Judges put the matter on the 
docket and assigned it to Administrative Law Judge Teresa A. Wallbaum 
(hereinafter, the ALJ). On October 25, 2021, the ALJ issued a Briefing 
Schedule. See ALJX 5. The Government timely complied with the Briefing 
Schedule by filing a Notice of Filing of Evidence and Motion for 
Summary Disposition (hereinafter, Motion for Summary Disposition) on 
November 10, 2021. Order Granting the Government's Motion for Summary 
Disposition, and Recommended Rulings, Findings of Fact, Conclusions of 
Law, and Decision of the Administrative Law Judge (hereinafter, 
Recommended Decision or RD), at 2; see also ALJX 6. In its Motion for 
Summary Disposition, the Government requested summary disposition and 
recommended that Respondent's DEA registration be revoked based on 
Respondent's lack of authority to handle controlled substances in Ohio, 
the state in which he is registered with the DEA. Motion for Summary 
Disposition, at 5. On November 30, 2021, Respondent untimely filed a 
Memorandum in Opposition of Respondent [sic] to Government's Motion for 
Summary Disposition (hereinafter, Respondent's Opposition). RD, at 2; 
see also ALJX 7.\2\ Respondent's Opposition argued that there ``does 
not exist and [sic] mandate under the [Controlled Substances Act] 
whereas [the] tribunal shall or must revoke or suspend the [DEA 
registration] of a physician under a state summary suspension.'' 
Respondent's Opposition, at 1. Respondent's Opposition also noted that 
Respondent's state medical license, though suspended, was still intact; 
\3\ that ``[t]he issue that led to his current case [was] unrelated to 
the practice of medicine and was in no way arose [sic] in the course 
and scope of practice''; \4\ and that ``[Respondent] has had no 
previous issues in any way with his medical license in the past.'' Id. 
Moreover, Respondent's Opposition highlighted ``the unbelievable work 
[Respondent] has done and is continuing to do within the medical 
community and specifically an online training and tutorial platform for 
health care practitioners and medical students around the world.'' Id. 
at 2-3. Finally, Respondent's Opposition highlighted that Respondent 
``has also taken [the] opportunity to maintain and enhance his own 
medical education'' with CME courses. Id. at 3. Respondent's Opposition 
sought the denial of the Government's Motion for Summary Disposition 
and for the Tribunal to either grant Respondent's request for a hearing 
or to stay the matter pending the outcome of the Ohio Medical Board 
hearing. Id.
---------------------------------------------------------------------------

    \2\ As a result of Respondent's untimely filing, on November 30, 
2021, the ALJ issued an Order to Show Good Cause Regarding 
Respondent's Late Filing (hereinafter, Order to Show Good Cause). 
See ALJX 8. On November 30, 2021, Respondent timely filed a Response 
to Order to Show Good Cause stating that the untimely filing was due 
to a death in Respondent's counsel's family. RD, at 2; see also ALJX 
9. The ALJ found that ``the delay was minimal and caused no 
prejudice to the Government'' and thus accepted Respondent's 
Opposition. RD, at 2.
    \3\ According to Respondent's Opposition, the Ohio Medical Board 
``issued a summary suspension pending the outcome of a Medical Board 
Hearing in January of 2022.'' Id. at 2. Further, according to 
Respondent's Opposition, the suspension ``was based on a provision 
in the Ohio Administrative Code that allows the Ohio Medical Board 
to summarily suspend a license of a physician based on [the] 
physician's entry into an intervention program to address a mental 
health matter'' and ``[t]he matter at hand with [Respondent] is his 
ongoing struggle with his homosexuality.'' Id.
    \4\ See supra n.3.
---------------------------------------------------------------------------

    On December 2, 2021, the ALJ granted the Government's Motion for 
Summary Disposition, finding that ``[t]here is no genuine issue of 
material fact in this case'' because ``[t]he Government has established 
that Respondent currently lacks a medical license.'' RD, at 7-8. The 
ALJ recommended that Respondent's DEA registration be revoked and that 
any application to renew or modify his DEA registration be denied 
``because Respondent lacks state authority to handle controlled 
substances in Ohio.'' Id. at 8. By letter dated December 27, 2021, the 
ALJ certified and transmitted the record to me for final Agency action. 
Transmittal Letter, at 1. The ALJ also advised that neither party filed 
exceptions. Id.
    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

    According to Agency records, Respondent is the holder of DEA 
Certificate of Registration No. FK6714504 at the registered address of 
2916 Vangader Dr., Zanesville, OH 43701. Pursuant to this registration, 
Respondent is authorized to dispense controlled substances in Schedules 
II through V as a practitioner. Respondent's registration expires on 
December 31, 2022.

The Status of Respondent's State License

    On May 12, 2021, the State Medical Board of Ohio (hereinafter, the 
Board) issued a Notice of Summary Suspension and Opportunity for 
Hearing (hereinafter, Summary Suspension) and an Entry of Order. 
Government Exhibit (hereinafter, GX) A, at 3 and 5. According to the 
Summary Suspension, on or about December 16, 2019, ``the Franklin 
County Court of Common Pleas filed an indictment alleging [Respondent] 
had committed attempted unlawful sexual contact with a minor'' on or 
about September 10, 2019. Id. Further, according to the Summary 
Suspension, ``[o]n or about November 13, 2020, [Respondent] appeared 
before the Court for a hearing on [his] application for intervention in 
lieu of conviction for these offenses'' and ``[t]he Court granted 
[Respondent's] application.'' Id. The Summary Suspension states that 
``[Respondent] pleaded guilty to [the] felony offenses at a subsequent 
hearing held on or about December 9, 2020'' and ``[t]he Court ordered 
further proceedings be stayed while [Respondent was] under community 
control.'' Id. In its Entry of Order on May 12, 2021, the Board found 
that ``[Respondent's] continued practice presents a danger of immediate 
and serious harm to the public'' and ordered, effective immediately, 
that Respondent's license to practice medicine and surgery in the state 
of Ohio be summarily suspended, that Respondent ``immediately cease the 
practice of medicine and surgery in Ohio,'' and that Respondent 
``immediately refer all active patients to other appropriate 
physicians.'' Id. at 3.
    According to Ohio's online records, of which I take official 
notice, Respondent's medical license is still suspended and 
inactive.\5\ Ohio License

[[Page 4943]]

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

    \5\ 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, 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 and response shall be filed and served by email to the other 
party and to Office of the Administrator, Drug Enforcement 
Administration at [email protected].
---------------------------------------------------------------------------

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. Sec.  
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 Sec.  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 Sec.  
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 Sec.  3719.06(A)(1)(a)-(b).
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    \6\ Other irrelevant exceptions omitted.
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    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
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