80_FR_74060 80 FR 73833 - William Mikaitis, M.D.; Decision and Order

80 FR 73833 - William Mikaitis, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 227 (November 25, 2015)

Page Range73833-73834
FR Document2015-29935

Federal Register, Volume 80 Issue 227 (Wednesday, November 25, 2015) 
[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Notices]
[Pages 73833-73834]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29935]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


William Mikaitis, M.D.; Decision and Order

    On July 23, 2015, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to William Mikaitis, M.D. (Registrant), of 
Lockport, Illinois. The Show Cause Order proposed the revocation of 
Registrant's DEA Certificate of Registration AM1585770, and the denial 
of any applications to renew or modify the registration as well as any 
other applications for a DEA registration, on the ground that he 
``do[es] not have authority to practice medicine or handle controlled 
substances in Illinois, the [S]tate in which [he] is registered with 
the DEA.'' Show Cause Order at 1 (citing 21 U.S.C. 823(f) and 
824(a)(3)).
    The Show Cause Order alleged that Registrant is registered with the 
DEA as a practitioner authorized to handle controlled substances in 
Schedules II through V at the registered address of 1206 E. 9th St., 
Suite 210, Lockport, Illinois. Id. The Order alleged that Registrant's 
registration expires by its terms on January 31, 2018. Id.
    The Order further alleged that ``[e]ffective March 5, 2015, the 
State of Illinois, Department of Financial and Professional Regulation 
(IDFPR), Division of Professional Regulation, issued an Order in which 
the IDFPR temporarily suspended [his] Illinois [P]hysician and 
[S]urgeon [L]icense and [his] controlled substance licenses'' and that 
``[t]his Order remains in effect.'' Id. The Show Cause Order thus 
asserted that ``DEA must revoke [his] registration based upon [his] 
lack of authority to handle controlled substances in the State of 
Illinois.'' Id. (citing 21 U.S.C. 802(21), 823(f) and 824(a)(3)).
    The Show Cause Order also notified Registrant of his right to 
request a hearing on the allegations or to submit a written statement 
in lieu of a hearing, the procedure for electing either option, and the 
consequence for failing to elect either option. Id. at 2 (citing 21 CFR 
1301.43).
    On July 30, 2015, a Diversion Investigator met Registrant at the 
office of his attorney and personally served the Show Cause Order on 
him. See GX 5 (Affidavit of DI). The Government

[[Page 73834]]

represents that since the date of service, neither Registrant, nor any 
person purporting to represent him, has requested a hearing or 
submitted a written statement while waiving his right to a hearing. See 
Govt. Req. for Final Agency Action, at 3-4. Because more than thirty 
(30) days have now passed since the date of service of the Show Cause 
Order and Registrant has neither requested a hearing nor submitted a 
written statement in lieu of a hearing, I find that he has waived his 
right to either request a hearing or to submit a written statement. 21 
CFR 1301.43(d). I therefore issue this Decision and Final Order based 
on the record submitted by the Government. Id. Sec.  1301.43(e). I make 
the following findings.

Findings

    Registrant is the holder of DEA Certificate of Registration 
AM1585770, pursuant to which he is authorized to dispense controlled 
substances in schedules II-V as a practitioner, at the registered 
address of 1206 E. 9th St., Suite 210, Lockport, Illinois. GX 2. His 
registration does not expire until January 31, 2018. Id.
    On March 5, 2015, the Illinois Department of Financial and 
Professional Regulation, Division of Professional Regulation, ordered 
the suspension of Respondent's Illinois Physician and Surgeon License, 
as well as his state Controlled Substance Licenses, pending proceedings 
before the Department of Financial and Professional Regulation and the 
Medical Disciplinary Board of the State. GX 4 at 1. I take official 
notice that as of this date, the public Web site maintained by the 
Illinois Department of Financial and Professional Regulation shows that 
Registrant's Physician and Surgeon License as well as his Illinois 
Controlled Substance Licenses remain suspended based on the State's 
allegations that he engaged in ``unprofessional conduct, aid[ed] and 
abet[ed] [the] unlicensed practice of medicine and [committed] multiple 
violations of the Controlled Substance Act.'' \1\ See https://ilesonline.idfpr.illinois.gov/DPR/Lookup/LicenseLookup.aspx.
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    \1\ Under the Administrative Procedure Act (APA), an agency 
``may take official notice of facts at any stage in a proceeding--
even in the final decision.'' U.S. Dept. of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979).
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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, ``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.'' Moreover, DEA has repeatedly 
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 James L. Hooper, 76 FR 
71371 (2011), pet. for rev. denied, 481 Fed. App'x 826 (4th Cir. 2012).
    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 . . . to dispense . . . controlled substances . . . 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 Act, DEA has 
long held that the 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 
medicine. See, e.g., Calvin Ramsey, 76 FR 20034, 20036 (2011); Sheran 
Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 
51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988).
    This is so even where a state board has suspended a practitioner's 
authority prior to providing the practitioner with a hearing to contest 
the board's allegations. See Gary Alfred Shearer, 78 FR 19009 (2013) 
(holding that revocation is warranted even where a state order has 
summarily suspended a practitioner's controlled substances authority 
and the state agency's order remains subject to challenge in either 
administrative or judicial proceedings); see also Bourne Pharmacy, 
Inc., 72 FR 18273, 18274 (2007); Winfield Drugs, Inc., 52 FR 27070 
(1987). Accordingly, consistent with agency precedent, the revocation 
of Registrant's registration is warranted.
    Because Registrant currently lacks authority to dispense controlled 
substances in Illinois, the State in which he holds his DEA 
registration, I will order that his registration be revoked and that 
any pending applications be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 21 CFR 0.100(b), I order that DEA Certificate of 
Registration AM1585770, issued to William Mikaitis, M.D., be, and it 
hereby is, revoked. I further order that any pending application of 
William Mikaitis, M.D., to renew or modify his registration, as well as 
any other pending application of William Mikaitis, M.D., for a DEA 
Certificate of Registration, be, and it hereby is, denied. This Order 
is effective immediately.\2\
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    \2\ Based on the State's finding ``that Respondent's actions 
constitute an immediate danger to the public,'' I conclude that the 
public interest necessitates that this Order be effective 
immediately. 21 CFR 1316.67.

    Dated: November 17, 2015
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-29935 Filed 11-24-15; 8:45 am]
BILLING CODE 4410-09-P

Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices 73833 Controlled substance Schedule Nabilone (7379) ........................................................................................................................................................................................... II 1-Phenylcyclohexylamine (7460) ................................................................................................................................................................. II Phencyclidine (7471) ................................................................................................................................................................................... II Phenylacetone (8501) ................................................................................................................................................................................. II 1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................ II Alphaprodine (9010) .................................................................................................................................................................................... II Anileridine (9020) ........................................................................................................................................................................................ II Etorphine HCI (9059) .................................................................................................................................................................................. II Dihydrocodeine (9120) ................................................................................................................................................................................ II Diphenoxylate (9170) .................................................................................................................................................................................. II Ecgonine (9180) .......................................................................................................................................................................................... II Ethylmorphine (9190) .................................................................................................................................................................................. II Levomethorphan (9210) .............................................................................................................................................................................. II Levorphanol (9220) ..................................................................................................................................................................................... II Isomethadone (9226) .................................................................................................................................................................................. II Meperidine (9230) ....................................................................................................................................................................................... II Meperidine intermediate-A (9232) ............................................................................................................................................................... II Meperidine intermediate-B (9233) ............................................................................................................................................................... II Meperidine intermediate-C (9234) ............................................................................................................................................................... II Metazocine (9240) ....................................................................................................................................................................................... II Metopon (9260) ........................................................................................................................................................................................... II Dextropropoxyphene, bulk (non-dosage forms) (9273) .............................................................................................................................. II Dihydroetorphine (9334) .............................................................................................................................................................................. II Levo-alphacetylmethadol (9648) ................................................................................................................................................................. II Noroxymorphone (9668) .............................................................................................................................................................................. II Phenazocine (9715) .................................................................................................................................................................................... II Piminodine (9730) ....................................................................................................................................................................................... II Racemethorphan (9732) .............................................................................................................................................................................. II Racemorphan (9733) ................................................................................................................................................................................... II Alfentanil (9737) .......................................................................................................................................................................................... II Remifentanil (9739) ..................................................................................................................................................................................... II Sufentanil (9740) ......................................................................................................................................................................................... II Carfentanil (9743) ........................................................................................................................................................................................ II Tapentadol (9780) ....................................................................................................................................................................................... II Bezitramide (9800) ...................................................................................................................................................................................... II Moramide-intermediate (9802) .................................................................................................................................................................... II The company plans to import DEPARTMENT OF JUSTICE Illinois. Id. The Order alleged that analytical reference standards for Registrant’s registration expires by its distribution to its customers for research Drug Enforcement Administration terms on January 31, 2018. Id. and analytical purposes. Placement of The Order further alleged that William Mikaitis, M.D.; Decision and ‘‘[e]ffective March 5, 2015, the State of these drug codes onto the company’s Order Illinois, Department of Financial and registration does not translate into automatic approval of subsequent Professional Regulation (IDFPR), On July 23, 2015, the Deputy permit applications to import controlled Division of Professional Regulation, Assistant Administrator, Office of issued an Order in which the IDFPR substances. Diversion Control, Drug Enforcement temporarily suspended [his] Illinois Approval of permit applications will Administration (DEA), issued an Order [P]hysician and [S]urgeon [L]icense and occur only when the registrant’s to Show Cause to William Mikaitis, [his] controlled substance licenses’’ and business activity is consistent with what M.D. (Registrant), of Lockport, Illinois. that ‘‘[t]his Order remains in effect.’’ Id. is authorized under 21 U.S.C. 952(a)(2). The Show Cause Order proposed the The Show Cause Order thus asserted Authorization will not extend to the revocation of Registrant’s DEA that ‘‘DEA must revoke [his] registration Certificate of Registration AM1585770, based upon [his] lack of authority to import of FDA approved or non- and the denial of any applications to handle controlled substances in the approved finished dosage forms for renew or modify the registration as well State of Illinois.’’ Id. (citing 21 U.S.C. commercial sale. as any other applications for a DEA 802(21), 823(f) and 824(a)(3)). Dated: November 19, 2015. registration, on the ground that he The Show Cause Order also notified Louis J. Milione, ‘‘do[es] not have authority to practice Registrant of his right to request a Deputy Assistant Administrator. medicine or handle controlled hearing on the allegations or to submit [FR Doc. 2015–29934 Filed 11–24–15; 8:45 am] substances in Illinois, the [S]tate in a written statement in lieu of a hearing, which [he] is registered with the DEA.’’ the procedure for electing either option, BILLING CODE 4410–09–P Show Cause Order at 1 (citing 21 U.S.C. and the consequence for failing to elect tkelley on DSK3SPTVN1PROD with NOTICES 823(f) and 824(a)(3)). either option. Id. at 2 (citing 21 CFR The Show Cause Order alleged that 1301.43). Registrant is registered with the DEA as On July 30, 2015, a Diversion a practitioner authorized to handle Investigator met Registrant at the office controlled substances in Schedules II of his attorney and personally served through V at the registered address of the Show Cause Order on him. See GX 1206 E. 9th St., Suite 210, Lockport, 5 (Affidavit of DI). The Government VerDate Sep<11>2014 19:15 Nov 24, 2015 Jkt 238001 PO 00000 Frm 00136 Fmt 4703 Sfmt 4703 E:\FR\FM\25NON1.SGM 25NON1

73834 Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices represents that since the date of service, the registrant . . . has had his State Because Registrant currently lacks neither Registrant, nor any person license or registration suspended [or] authority to dispense controlled purporting to represent him, has revoked . . . by competent State substances in Illinois, the State in which requested a hearing or submitted a authority and is no longer authorized by he holds his DEA registration, I will written statement while waiving his State law to engage in the . . . order that his registration be revoked right to a hearing. See Govt. Req. for dispensing of controlled substances.’’ and that any pending applications be Final Agency Action, at 3–4. Because Moreover, DEA has repeatedly held that denied. more than thirty (30) days have now the possession of authority to dispense passed since the date of service of the controlled substances under the laws of Order Show Cause Order and Registrant has the State in which a practitioner engages Pursuant to the authority vested in me neither requested a hearing nor in professional practice is a by 21 U.S.C. 823(f) and 824(a), as well submitted a written statement in lieu of fundamental condition for obtaining as 21 CFR 0.100(b), I order that DEA a hearing, I find that he has waived his and maintaining a practitioner’s Certificate of Registration AM1585770, right to either request a hearing or to registration. See James L. Hooper, 76 FR issued to William Mikaitis, M.D., be, submit a written statement. 21 CFR 71371 (2011), pet. for rev. denied, 481 and it hereby is, revoked. I further order 1301.43(d). I therefore issue this Fed. App’x 826 (4th Cir. 2012). that any pending application of William Decision and Final Order based on the This rule derives from the text of two Mikaitis, M.D., to renew or modify his record submitted by the Government. Id. provisions of the CSA. First, Congress registration, as well as any other § 1301.43(e). I make the following defined ‘‘the term ‘practitioner’ [to] pending application of William findings. mean [ ] a . . . physician . . . or other Mikaitis, M.D., for a DEA Certificate of person licensed, registered or otherwise Registration, be, and it hereby is, Findings permitted, by . . . the jurisdiction in denied. This Order is effective Registrant is the holder of DEA which he practices . . . to distribute, immediately.2 Certificate of Registration AM1585770, dispense, [or] administer . . . a Dated: November 17, 2015 pursuant to which he is authorized to controlled substance in the course of dispense controlled substances in Chuck Rosenberg, professional practice.’’ 21 U.S.C. schedules II–V as a practitioner, at the 802(21). Second, in setting the Acting Administrator. registered address of 1206 E. 9th St., requirements for obtaining a [FR Doc. 2015–29935 Filed 11–24–15; 8:45 am] Suite 210, Lockport, Illinois. GX 2. His practitioner’s registration, Congress BILLING CODE 4410–09–P registration does not expire until directed that ‘‘[t]he Attorney General January 31, 2018. Id. shall register practitioners . . . to On March 5, 2015, the Illinois dispense . . . controlled substances DEPARTMENT OF JUSTICE Department of Financial and . . . if the applicant is authorized to [OMB Number 1117–0034] Professional Regulation, Division of dispense . . . controlled substances Professional Regulation, ordered the under the laws of the State in which he Agency Information Collection suspension of Respondent’s Illinois practices.’’ 21 U.S.C. 823(f). Because Activities; Proposed eCollection, Physician and Surgeon License, as well Congress has clearly mandated that a eComments Requested; Extension as his state Controlled Substance practitioner possess state authority in Without Change of a Previously Licenses, pending proceedings before order to be deemed a practitioner under Approved Collection; Collection of the Department of Financial and the Act, DEA has long held that the Laboratory Analysis Data on Drug Professional Regulation and the Medical revocation of a practitioner’s registration Samples Tested by Non-Federal (State Disciplinary Board of the State. GX 4 at is the appropriate sanction whenever he and Local Government) Crime 1. I take official notice that as of this is no longer authorized to dispense Laboratories date, the public Web site maintained by controlled substances under the laws of the Illinois Department of Financial and the State in which he practices AGENCY: Drug Enforcement Professional Regulation shows that medicine. See, e.g., Calvin Ramsey, 76 Administration, Department of Justice. Registrant’s Physician and Surgeon FR 20034, 20036 (2011); Sheran Arden ACTION: 60-day Notice. License as well as his Illinois Controlled Yeates, M.D., 71 FR 39130, 39131 SUMMARY: The Department of Justice Substance Licenses remain suspended (2006); Dominick A. Ricci, 58 FR 51104, (DOJ), Drug Enforcement based on the State’s allegations that he 51105 (1993); Bobby Watts, 53 FR Administration (DEA), will be engaged in ‘‘unprofessional conduct, 11919, 11920 (1988). submitting the following information aid[ed] and abet[ed] [the] unlicensed This is so even where a state board collection request to the Office of practice of medicine and [committed] has suspended a practitioner’s authority Management and Budget (OMB) for multiple violations of the Controlled prior to providing the practitioner with review and approval in accordance with Substance Act.’’ 1 See https:// a hearing to contest the board’s the Paperwork Reduction Act of 1995. ilesonline.idfpr.illinois.gov/DPR/ allegations. See Gary Alfred Shearer, 78 FR 19009 (2013) (holding that DATES: Comments are encouraged and Lookup/LicenseLookup.aspx. revocation is warranted even where a will be accepted for 60 days until Discussion state order has summarily suspended a January 25, 2016. Pursuant to 21 U.S.C. 824(a)(3), the practitioner’s controlled substances FOR FURTHER INFORMATION CONTACT: If Attorney General is authorized to authority and the state agency’s order you have comments on the estimated suspend or revoke a registration issued remains subject to challenge in either public burden or associated response tkelley on DSK3SPTVN1PROD with NOTICES under section 823, ‘‘upon a finding that administrative or judicial proceedings); time, suggestions, or need a copy of the see also Bourne Pharmacy, Inc., 72 FR proposed information collection 1 Under the Administrative Procedure Act (APA), 18273, 18274 (2007); Winfield Drugs, an agency ‘‘may take official notice of facts at any Inc., 52 FR 27070 (1987). Accordingly, 2 Based on the State’s finding ‘‘that Respondent’s stage in a proceeding—even in the final decision.’’ actions constitute an immediate danger to the U.S. Dept. of Justice, Attorney General’s Manual on consistent with agency precedent, the public,’’ I conclude that the public interest the Administrative Procedure Act 80 (1947) (Wm. revocation of Registrant’s registration is necessitates that this Order be effective W. Gaunt & Sons, Inc., Reprint 1979). warranted. immediately. 21 CFR 1316.67. VerDate Sep<11>2014 19:15 Nov 24, 2015 Jkt 238001 PO 00000 Frm 00137 Fmt 4703 Sfmt 4703 E:\FR\FM\25NON1.SGM 25NON1


Document Created: 2018-03-01 11:15:33
Document Modified: 2018-03-01 11:15:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation80 FR 73833 
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