William Mikaitis, M.D.; Decision and Order, 73833-73834 [2015-29935]

Download as PDF 73833 Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices Controlled substance Schedule Nabilone (7379) ........................................................................................................................................................................................... 1-Phenylcyclohexylamine (7460) ................................................................................................................................................................. Phencyclidine (7471) ................................................................................................................................................................................... Phenylacetone (8501) ................................................................................................................................................................................. 1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................ Alphaprodine (9010) .................................................................................................................................................................................... Anileridine (9020) ........................................................................................................................................................................................ Etorphine HCI (9059) .................................................................................................................................................................................. Dihydrocodeine (9120) ................................................................................................................................................................................ Diphenoxylate (9170) .................................................................................................................................................................................. Ecgonine (9180) .......................................................................................................................................................................................... Ethylmorphine (9190) .................................................................................................................................................................................. Levomethorphan (9210) .............................................................................................................................................................................. Levorphanol (9220) ..................................................................................................................................................................................... Isomethadone (9226) .................................................................................................................................................................................. Meperidine (9230) ....................................................................................................................................................................................... Meperidine intermediate-A (9232) ............................................................................................................................................................... Meperidine intermediate-B (9233) ............................................................................................................................................................... Meperidine intermediate-C (9234) ............................................................................................................................................................... Metazocine (9240) ....................................................................................................................................................................................... Metopon (9260) ........................................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) (9273) .............................................................................................................................. Dihydroetorphine (9334) .............................................................................................................................................................................. Levo-alphacetylmethadol (9648) ................................................................................................................................................................. Noroxymorphone (9668) .............................................................................................................................................................................. Phenazocine (9715) .................................................................................................................................................................................... Piminodine (9730) ....................................................................................................................................................................................... Racemethorphan (9732) .............................................................................................................................................................................. Racemorphan (9733) ................................................................................................................................................................................... Alfentanil (9737) .......................................................................................................................................................................................... Remifentanil (9739) ..................................................................................................................................................................................... Sufentanil (9740) ......................................................................................................................................................................................... Carfentanil (9743) ........................................................................................................................................................................................ Tapentadol (9780) ....................................................................................................................................................................................... Bezitramide (9800) ...................................................................................................................................................................................... Moramide-intermediate (9802) .................................................................................................................................................................... The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. Placement of these drug codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. 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). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Dated: November 19, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–29934 Filed 11–24–15; 8:45 am] tkelley on DSK3SPTVN1PROD with NOTICES BILLING CODE 4410–09–P VerDate Sep<11>2014 19:15 Nov 24, 2015 Jkt 238001 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, PO 00000 Frm 00136 Fmt 4703 Sfmt 4703 II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II 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 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, 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. § 1301.43(e). I make the following findings. tkelley on DSK3SPTVN1PROD with NOTICES 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. 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 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). VerDate Sep<11>2014 19:15 Nov 24, 2015 Jkt 238001 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. PO 00000 Frm 00137 Fmt 4703 Sfmt 4703 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 Dated: November 17, 2015 Chuck Rosenberg, Acting Administrator. [FR Doc. 2015–29935 Filed 11–24–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1117–0034] Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Collection of Laboratory Analysis Data on Drug Samples Tested by Non-Federal (State and Local Government) Crime Laboratories Drug Enforcement Administration, Department of Justice. ACTION: 60-day Notice. AGENCY: The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. DATES: Comments are encouraged and will be accepted for 60 days until January 25, 2016. FOR FURTHER INFORMATION CONTACT: If you have comments on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection SUMMARY: 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. E:\FR\FM\25NON1.SGM 25NON1

Agencies

[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Notices]
[Pages 73833-73834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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
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