83_FR_7255 83 FR 7221 - James E. Ranochak, M.D.; Decision and Order

83 FR 7221 - James E. Ranochak, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 34 (February 20, 2018)

Page Range7221-7223
FR Document2018-03301

Federal Register, Volume 83 Issue 34 (Tuesday, February 20, 2018)
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7221-7223]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03301]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


James E. Ranochak, M.D.; Decision and Order

    On September 11, 2017, the Acting Assistant Administrator, 
Diversion Control Division, Drug Enforcement Administration, issued an 
Order to Show Cause to James E. Ranochak, M.D. (hereinafter, 
Registrant), of Fort Wayne, Indiana. The Show Cause Order proposed the 
revocation of Registrant's DEA Certificate of Registration No. 
AR1591913, on the ground that he ``do[es] not have authority to handle 
controlled substances in . . . Indiana, the [S]tate in which [he is] 
registered with the'' Agency. GX 2, at 1 (citing 21 U.S.C. 823(f) and 
824(a)(3)).
    As to the jurisdictional basis of the proceeding, the Show Cause 
Order alleged that Registrant is registered ``as a practitioner in 
Schedules II [through]

[[Page 7222]]

V,'' under the above registration number, at the location of 3488-B 
Stellhorn Road, Fort Wayne, Indiana. Id. The Order further alleged that 
this registration does not expire until April 30, 2020. Id.
    As to the substantive ground for the proceeding, the Show Cause 
Order alleged that ``[o]n August 8, 2017, the Indiana Medical Licensing 
Board summarily suspended [Registrant's] medical license for 90 days, 
effective July 27, 2017'' and ``[t]his order remains in effect.'' Id. 
The Order thus alleged that Registrant is ``without authority to handle 
controlled substances in the State . . . in which [he is] registered.'' 
Id. The Order then asserted that Registrant is ``required to possess 
authority from a state in order to obtain or retain a DEA 
registration,'' and that ``[c]onsequently, . . . DEA must revoke'' his 
registration. Id. at 2 (citations omitted).
    The Show Cause Order also notified Registrant of his right to 
request a hearing on the allegations or to submit a written statement 
while waiving his right to a hearing, the procedure for electing either 
option, and the consequence of failing to elect either option. Id. 
(citing 21 CFR 1301.43). The Order also notified Registrant of his 
right to submit a corrective action plan in accordance with 21 U.S.C. 
824(c)(2)(C). Id. at 2-3.
    On September 14, 2017, a DEA Diversion Investigator went to 
Registrant's home address and personally served the Show Cause Order on 
Registrant. GX 3, at 2 (affidavit of DI). Moreover, in its Request for 
Final Agency Action which it submitted on November 9, 2017, the 
Government represents that since the date of service of the Show Cause 
Order, Registrant has not requested a hearing, nor submitted a written 
statement or a corrective action plan. Based on the DI's affidavit and 
the Government's representation, I find that more than 30 days have now 
passed since the date of service of the Show Cause Order and that 
Registrant has neither requested a hearing nor submitted a written 
statement or corrective action plan. I therefore find that Registrant 
has waived his right to request a hearing or submit a written statement 
and issue this Decision and Order based on relevant evidence submitted 
by the Government \1\ and matters of which I take official notice. 21 
CFR 1301.43(d)-(e). I make the following findings.
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    \1\ On January 12, 2018, the Government submitted a Supplement 
to its Request for Final Agency Action which contained an additional 
exhibit, this being a December 20, 2017 Order of the Medical 
Licensing Board.
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Findings of Fact

    Registrant is the holder of DEA Certificate of Registration No. 
AR1591913, pursuant to which he is authorized to dispense controlled 
substances in schedules II through V as a practitioner, at the 
registered address of 3488-B Stellhorn Road, Fort Wayne, Indiana. GX 1. 
This registration does not expire until April 30, 2020. Id.
    Registrant is also the holder of medical license No.01026732A 
issued by the Medical Licensing Board of Indiana (hereinafter, the 
Board). GX 3A (Order Granting Summary Suspension), at 1. However, on 
June 22, 2017, Registrant was indicted in the United States District 
Court for the Northern District of Indiana on 10 counts of Conspiracy 
to Commit Healthcare Fraud and Distributing a Controlled Substance. Id. 
at 2. Based on the indictment, on July 27, 2017, the Board summarily 
suspended Registrant's medical license for 90 days. Id. On December 7, 
2017, the Board extended the suspension for an additional 90 days. See 
GX 4, at 3 (Order Granting Summary Suspension Extension, at 2 (Dec. 20, 
2017)). Also, according to the Board's website (of which I take 
official notice),\2\ the suspension remains in effect as of the date of 
this Decision an Order; the website also reflects that Registrant's 
CSR-Physician License Nos. 01026732B and 01026732C have both expired.
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    \2\ See 5 U.S.C. 556(e).
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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 of the 
Controlled Substances Act (CSA), ``upon a finding that the registrant . 
. . has had his State license . . . 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, DEA has 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, 76 FR 71371 (2011), pet. for rev. denied, 
481 Fed. Appx. 826 (4th Cir. 2012); Frederick Marsh Blanton, 43 FR 
27616 (1978).
    The Agency's rule derives from the text of two other provisions of 
the CSA: Section 802(21), which defines the term ``practitioner,'' and 
section 823(f), which sets forth the registration requirements 
applicable to practitioners. Notably, in section 802(21), 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). The text of this provision 
makes clear that a physician is not a practitioner within the meaning 
of the CSA if he is not ``licensed, registered or otherwise permitted, 
by the jurisdiction in which he practices . . . to dispense [or] 
administer . . . a controlled substance in the course of professional 
practice.'' Id.
    To the same effect, Congress, in setting the requirements for 
obtaining a practitioner's registration, 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). Thus, based on 
these provisions, the Agency held nearly forty years ago that ``[s]tate 
authorization to dispense or otherwise handle controlled substances is 
a prerequisite to the issuance and maintenance of a Federal controlled 
substances registration.'' Blanton, 43 FR at 27617 (revoking 
physician's registration based on one-year suspension of his state 
license) (emphasis added).
    Here, based on the Summary Suspension Order of Registrant's medical 
license as well as the information that both of Registrant's state 
controlled substance licenses have expired, I find that Registrant is 
currently without authority to dispense controlled substances in 
Indiana, the State in which he is registered with DEA. See Ind. Code 
Sec.  35-48-3-3(b) (``Every person who dispenses . . . any controlled 
substance within Indiana must have a registration issued by the 
[pharmacy] board in accordance with its rules.''); see also Ind. Code 
Sec.  25-22.5-1-1.1(a)(1)(B) (the ``[p]ractice of medicine'' includes 
the ``prescription or administration of any form of treatment, without 
limitation''); id. Sec.  25-22.5-1-1(g) (defining ``[ ]physician'' to 
``mean any person . . . who holds [a] valid unlimited license to 
practice medicine'' in the state); id. Sec.  25-22.5-8-1 (``It is 
unlawful for any person to practice medicine . . . in this state 
without holding a license or permit to do so, as provided in this 
article.'').
    Moreover, because ``the controlling question'' in a proceeding 
brought

[[Page 7223]]

under 21 U.S.C. 824(a)(3) is whether the holder of a DEA registration 
``is currently authorized to handle controlled substances in the 
[S]tate,'' Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 FR 
12847, 12848 (1997)), the Agency has also long held that revocation is 
warranted even where a practitioner has lost his state authority by 
virtue of the State's use of summary process and the State has yet to 
provide a hearing to challenge the suspension. Bourne Pharmacy, 72 FR 
18273, 18274 (2007); Wingfield Drugs, 52 FR 27070, 27071 (1987). Thus, 
it is of no consequence that the Indiana Board has employed summary 
process in suspending Registrant's state license. What is consequential 
is that Registrant is no longer currently authorized to dispense 
controlled substances in Indiana, the State in which he is registered. 
I will therefore order that his registration be revoked.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well 
as 28 CFR 0.100(b), I order that DEA Certificate of Registration 
AR1591913, issued to James E. Ranochak, M.D., be, and it hereby is, 
revoked. This Order is effective immediately.\3\
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    \3\ For the same reasons that led the Indiana Board to summarily 
suspend Registrant's medical license (his indictment in federal 
district court on 10 counts of Conspiracy to Commit Health Care 
Fraud and Distributing a Controlled Substance), I find that the 
public interest necessitates that this Order be effective 
immediately. 21 CFR 1316.67.

    Dated: February 6, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-03301 Filed 2-16-18; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                        Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices                                                             7221

                                                DEPARTMENT OF JUSTICE                                                         Controlled                       Drug       Schedule
                                                                                                                                                                                     Permit for Practice of Animal
                                                                                                                              substance                        code                  Euthanasia (Facility Permit).’’ Resp.’s
                                                Drug Enforcement Administration                                    Diphenoxylate ...................             9170    II          Statement, at Exhibit E. While much of
                                                [Docket No. DEA–392]                                               Ecgonine ...........................          9180    II          this document is unreadable, and it is
                                                                                                                   Hydrocodone .....................             9193    II          unclear from the document when this
                                                                                                                   Meperidine ........................           9230    II
                                                Bulk Manufacturer of Controlled                                    Methadone ........................            9250    II
                                                                                                                                                                                     permit was issued or expires,
                                                Substances Application: Johnson                                    Methadone intermediate ...                    9254    II          Respondent provided an affidavit of the
                                                Matthey Inc.                                                       Morphine ...........................          9300    II          Operations Manager for the Department
                                                                                                                   Thebaine ...........................          9333    II          of Public Works of the City of Taylor,
                                                                                                                   Oxymorphone ...................               9652    II
                                                ACTION:       Notice of application.                               Noroxymorphone ..............                 9668    II          Michigan, which states that on October
                                                                                                                   Alfentanil ...........................        9737    II          30, 2017, he received the renewed state
                                                DATES:  Registered bulk manufacturers of                           Remifentanil ......................           9739    II          license for the facility. Affidavit of Matt
                                                the affected basic classes, and                                    Sufentanil ..........................         9740    II          Bonza, at 2. Moreover, the Government
                                                                                                                   Tapentadol ........................           9780    II
                                                applicants therefore, may file written                             Fentanyl ............................         9801    II          does not dispute that the facility has re-
                                                comments on or objections to the                                                                                                     obtained state authority to dispense
                                                issuance of the proposed registration in                             The company plans to manufacture                                controlled substances. Request for Order
                                                accordance with 21 CFR 1301.33(a) on                               the above-listed controlled substances                            Dismissing Order to Show Cause, at 2.
                                                or before April 23, 2018.                                          in bulk for sale to its customers.                                   As the Government acknowledges, the
                                                ADDRESSES: Written comments should                                 Thebaine (9333) will be used to                                   sole basis for seeking revocation of
                                                be sent to: Drug Enforcement                                       manufacture other controlled substances                           Respondent’s DEA registration was ‘‘its
                                                Administration, Attention: DEA Federal                             for sale in bulk to its customers.                                lack of state authority to handle
                                                Register Representative/DRW, 8701                                    In reference to drug codes 7360                                 controlled substances’’ and ‘‘this ground
                                                Morrissette Drive, Springfield, Virginia                           (marihuana), and 7370 (THC), the                                  for revocation no longer exists.’’ Id. The
                                                22152.                                                             company plans to bulk manufacture                                 Government thus seeks an order
                                                                                                                   these drugs as synthetics. No other                               dismissing the Order to Show Cause. Id.
                                                SUPPLEMENTARY INFORMATION:      The                                activities for these drug codes are                               at 3. Accordingly, I will grant the
                                                Attorney General has delegated his                                 authorized for this registration.                                 Government’s request and dismiss the
                                                authority under the Controlled                                                                                                       Order to Show Cause. Id.
                                                Substances Act to the Administrator of                               Dated: February 6, 2018.
                                                the Drug Enforcement Administration                                Susan A. Gibson,                                                  Order
                                                (DEA), 28 CFR 0.100(b). Authority to                               Deputy Assistant Administrator.
                                                                                                                                                                                        Pursuant to the authority vested in me
                                                exercise all necessary functions with                              [FR Doc. 2018–03293 Filed 2–16–18; 8:45 am]                       by 21 U.S.C. 824 and 28 CFR 0.100(b),
                                                respect to the promulgation and                                    BILLING CODE 4410–09–P                                            I order that the Order to Show Cause
                                                implementation of 21 CFR part 1301,                                                                                                  issued to Taylor Animal Shelter be, and
                                                incident to the registration of                                                                                                      it hereby is, dismissed. This Order is
                                                manufacturers, distributors, dispensers,                           DEPARTMENT OF JUSTICE                                             effective immediately.
                                                importers, and exporters of controlled
                                                                                                                   Drug Enforcement Administration                                     Dated: February 6, 2018.
                                                substances (other than final orders in
                                                connection with suspension, denial, or                                                                                               Robert W. Patterson,
                                                                                                                   Taylor Animal Shelter; Order                                      Acting Administrator.
                                                revocation of registration) has been
                                                redelegated to the Deputy Assistant                                   On October 4, 2017, the Acting                                 [FR Doc. 2018–03298 Filed 2–16–18; 8:45 am]
                                                Administrator of the DEA Office of                                 Assistant Administrator, Diversion                                BILLING CODE 4410–09–P
                                                Diversion Control (‘‘Deputy Assistant                              Control Division, Drug Enforcement
                                                Administrator’’) pursuant to section 7 of                          Administration, issued an Order to
                                                28 CFR part 0, appendix to subpart R.                              Show Cause proposing the revocation of                            DEPARTMENT OF JUSTICE
                                                  In accordance with 21 CFR                                        the DEA Certificate of Registration
                                                                                                                   issued to Taylor Animal Shelter of                                Drug Enforcement Administration
                                                1301.33(a), this is notice that on
                                                November 09, 2017, Johnson Matthey                                 Taylor, Michigan (Respondent). GX 1, at
                                                                                                                                                                                     James E. Ranochak, M.D.; Decision
                                                Inc., 2003 Nolte Drive, West Deptford,                             1. The basis of the proposed action was
                                                                                                                                                                                     and Order
                                                NJ 08066, applied to be registered as a                            that, on June 30, 2017, Respondent’s
                                                bulk manufacturer of the following basic                           Michigan Controlled Substance Sodium                                 On September 11, 2017, the Acting
                                                classes of controlled substances:                                  Pentobarbital Facility license lapsed,                            Assistant Administrator, Diversion
                                                                                                                   and thus, it was ‘‘currently without                              Control Division, Drug Enforcement
                                                           Controlled                    Drug           Schedule   authority to handle controlled                                    Administration, issued an Order to
                                                           substance                     code
                                                                                                                   substances in the State of Michigan, the                          Show Cause to James E. Ranochak, M.D.
                                                Gamma Hydroxybutyric                       2010     I              [S]tate in which [it is] registered with                          (hereinafter, Registrant), of Fort Wayne,
                                                  Acid.                                                            the’’ Agency. Id.; see also 21 U.S.C.                             Indiana. The Show Cause Order
                                                Marihuana .........................        7360     I              § 824(a)(3).                                                      proposed the revocation of Registrant’s
                                                Tetrahydrocannabinols .....                7370     I
                                                Dihydromorphine ...............            9145     I
                                                                                                                      Following service of the Show Cause                            DEA Certificate of Registration No.
                                                Difenoxin ...........................      9168     I              Order, Respondent submitted a timely                              AR1591913, on the ground that he
                                                Propiram ...........................       9649     I              written statement of position with                                ‘‘do[es] not have authority to handle
                                                Amphetamine ....................           1100     II             exhibits while waiving its right to a
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                                                                                                                                                                                     controlled substances in . . . Indiana,
                                                Methamphetamine ............               1105     II
                                                Lisdexamfetamine .............             1205     II
                                                                                                                   hearing. In its position statement,                               the [S]tate in which [he is] registered
                                                Methylphenidate ................           1724     II             Respondent represented that its state                             with the’’ Agency. GX 2, at 1 (citing 21
                                                Nabilone ............................      7379     II             controlled substances registration was                            U.S.C. 823(f) and 824(a)(3)).
                                                Cocaine .............................      9041     II             renewed on October 30, 2017. Resp.’s                                 As to the jurisdictional basis of the
                                                Codeine .............................      9050     II
                                                Dihydrocodeine .................           9120     II
                                                                                                                   Statement at 3, ¶ 10. Respondent                                  proceeding, the Show Cause Order
                                                Oxycodone ........................         9143     II             attached a copy of a document which                               alleged that Registrant is registered ‘‘as
                                                Hydromorphone ................             9150     II             states that it is a ‘‘Sodium Pentobarbital                        a practitioner in Schedules II [through]


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                                                7222                        Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices

                                                V,’’ under the above registration                       21 CFR 1301.43(d)–(e). I make the                      ‘‘practitioner,’’ and section 823(f),
                                                number, at the location of 3488–B                       following findings.                                    which sets forth the registration
                                                Stellhorn Road, Fort Wayne, Indiana. Id.                                                                       requirements applicable to practitioners.
                                                                                                        Findings of Fact
                                                The Order further alleged that this                                                                            Notably, in section 802(21), Congress
                                                registration does not expire until April                   Registrant is the holder of DEA                     defined ‘‘the term ‘practitioner’ [to]
                                                30, 2020. Id.                                           Certificate of Registration No.                        mean [ ] a . . . physician . . . or other
                                                                                                        AR1591913, pursuant to which he is                     person licensed, registered or otherwise
                                                   As to the substantive ground for the
                                                                                                        authorized to dispense controlled                      permitted, by . . . the jurisdiction in
                                                proceeding, the Show Cause Order
                                                                                                        substances in schedules II through V as                which he practices . . . to distribute,
                                                alleged that ‘‘[o]n August 8, 2017, the                 a practitioner, at the registered address
                                                Indiana Medical Licensing Board                                                                                dispense, [or] administer . . . a
                                                                                                        of 3488–B Stellhorn Road, Fort Wayne,                  controlled substance in the course of
                                                summarily suspended [Registrant’s]                      Indiana. GX 1. This registration does not
                                                medical license for 90 days, effective                                                                         professional practice.’’ 21 U.S.C.
                                                                                                        expire until April 30, 2020. Id.                       802(21). The text of this provision
                                                July 27, 2017’’ and ‘‘[t]his order remains                 Registrant is also the holder of
                                                in effect.’’ Id. The Order thus alleged                                                                        makes clear that a physician is not a
                                                                                                        medical license No.01026732A issued                    practitioner within the meaning of the
                                                that Registrant is ‘‘without authority to               by the Medical Licensing Board of                      CSA if he is not ‘‘licensed, registered or
                                                handle controlled substances in the                     Indiana (hereinafter, the Board). GX 3A                otherwise permitted, by the jurisdiction
                                                State . . . in which [he is] registered.’’              (Order Granting Summary Suspension),                   in which he practices . . . to dispense
                                                Id. The Order then asserted that                        at 1. However, on June 22, 2017,                       [or] administer . . . a controlled
                                                Registrant is ‘‘required to possess                     Registrant was indicted in the United                  substance in the course of professional
                                                authority from a state in order to obtain               States District Court for the Northern                 practice.’’ Id.
                                                or retain a DEA registration,’’ and that                District of Indiana on 10 counts of                       To the same effect, Congress, in
                                                ‘‘[c]onsequently, . . . DEA must                        Conspiracy to Commit Healthcare Fraud                  setting the requirements for obtaining a
                                                revoke’’ his registration. Id. at 2                     and Distributing a Controlled Substance.               practitioner’s registration, directed that
                                                (citations omitted).                                    Id. at 2. Based on the indictment, on                  ‘‘[t]he Attorney General shall register
                                                   The Show Cause Order also notified                   July 27, 2017, the Board summarily                     practitioners . . . if the applicant is
                                                Registrant of his right to request a                    suspended Registrant’s medical license                 authorized to dispense . . . controlled
                                                hearing on the allegations or to submit                 for 90 days. Id. On December 7, 2017,                  substances under the laws of the State
                                                a written statement while waiving his                   the Board extended the suspension for                  in which he practices.’’ 21 U.S.C. 823(f).
                                                right to a hearing, the procedure for                   an additional 90 days. See GX 4, at 3                  Thus, based on these provisions, the
                                                electing either option, and the                         (Order Granting Summary Suspension                     Agency held nearly forty years ago that
                                                consequence of failing to elect either                  Extension, at 2 (Dec. 20, 2017)). Also,                ‘‘[s]tate authorization to dispense or
                                                option. Id. (citing 21 CFR 1301.43). The                according to the Board’s website (of                   otherwise handle controlled substances
                                                Order also notified Registrant of his                   which I take official notice),2 the                    is a prerequisite to the issuance and
                                                right to submit a corrective action plan                suspension remains in effect as of the                 maintenance of a Federal controlled
                                                in accordance with 21 U.S.C.                            date of this Decision an Order; the                    substances registration.’’ Blanton, 43 FR
                                                824(c)(2)(C). Id. at 2–3.                               website also reflects that Registrant’s                at 27617 (revoking physician’s
                                                   On September 14, 2017, a DEA                         CSR-Physician License Nos. 01026732B                   registration based on one-year
                                                Diversion Investigator went to                          and 01026732C have both expired.                       suspension of his state license)
                                                Registrant’s home address and                                                                                  (emphasis added).
                                                                                                        Discussion                                                Here, based on the Summary
                                                personally served the Show Cause Order                     Pursuant to 21 U.S.C. 824(a)(3), the
                                                on Registrant. GX 3, at 2 (affidavit of DI).                                                                   Suspension Order of Registrant’s
                                                                                                        Attorney General is authorized to                      medical license as well as the
                                                Moreover, in its Request for Final                      suspend or revoke a registration issued                information that both of Registrant’s
                                                Agency Action which it submitted on                     under section 823 of the Controlled                    state controlled substance licenses have
                                                November 9, 2017, the Government                        Substances Act (CSA), ‘‘upon a finding                 expired, I find that Registrant is
                                                represents that since the date of service               that the registrant . . . has had his State            currently without authority to dispense
                                                of the Show Cause Order, Registrant has                 license . . . suspended [or] revoked                   controlled substances in Indiana, the
                                                not requested a hearing, nor submitted                  . . . by competent State authority and is              State in which he is registered with
                                                a written statement or a corrective                     no longer authorized by State law to                   DEA. See Ind. Code § 35–48–3–3(b)
                                                action plan. Based on the DI’s affidavit                engage in the . . . dispensing of                      (‘‘Every person who dispenses . . . any
                                                and the Government’s representation, I                  controlled substances.’’ With respect to               controlled substance within Indiana
                                                find that more than 30 days have now                    a practitioner, DEA has long held that                 must have a registration issued by the
                                                passed since the date of service of the                 the possession of authority to dispense                [pharmacy] board in accordance with its
                                                Show Cause Order and that Registrant                    controlled substances under the laws of                rules.’’); see also Ind. Code § 25–22.5–1–
                                                has neither requested a hearing nor                     the State in which a practitioner engages              1.1(a)(1)(B) (the ‘‘[p]ractice of medicine’’
                                                submitted a written statement or                        in professional practice is a                          includes the ‘‘prescription or
                                                corrective action plan. I therefore find                fundamental condition for obtaining                    administration of any form of treatment,
                                                that Registrant has waived his right to                 and maintaining a practitioner’s                       without limitation’’); id. § 25–22.5–1–
                                                request a hearing or submit a written                   registration. See, e.g., James L. Hooper,              1(g) (defining ‘‘[ ]physician’’ to ‘‘mean
                                                statement and issue this Decision and                   76 FR 71371 (2011), pet. for rev. denied,              any person . . . who holds [a] valid
                                                Order based on relevant evidence
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                                                                                                        481 Fed. Appx. 826 (4th Cir. 2012);                    unlimited license to practice medicine’’
                                                submitted by the Government 1 and                       Frederick Marsh Blanton, 43 FR 27616                   in the state); id. § 25–22.5–8–1 (‘‘It is
                                                matters of which I take official notice.                (1978).                                                unlawful for any person to practice
                                                                                                           The Agency’s rule derives from the                  medicine . . . in this state without
                                                  1 On January 12, 2018, the Government submitted
                                                                                                        text of two other provisions of the CSA:               holding a license or permit to do so, as
                                                a Supplement to its Request for Final Agency
                                                Action which contained an additional exhibit, this      Section 802(21), which defines the term                provided in this article.’’).
                                                being a December 20, 2017 Order of the Medical                                                                    Moreover, because ‘‘the controlling
                                                Licensing Board.                                          2 See   5 U.S.C. 556(e).                             question’’ in a proceeding brought


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                                                                             Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices                                                7223

                                                under 21 U.S.C. 824(a)(3) is whether the                the DEA.’’ Order to Show Cause, at 1                     My corrective action plan is to have my
                                                holder of a DEA registration ‘‘is                       (citing 21 U.S.C. 823(f) and 824(a)(3)).              case overturned on appeal. The Initial Brief
                                                currently authorized to handle                                                                                on the Merits was filed on 6/7/2017. Barring
                                                                                                           With respect to the Agency’s                       the Court granting extensions of time (if
                                                controlled substances in the [S]tate,’’                 jurisdiction, the Show Cause Order                    filed), the Department of Health is was [sic]
                                                Hooper, 76 FR at 71371 (quoting Anne                    alleged that Respondent is the holder of              required to file their Answer Brief by 6/27/
                                                Lazar Thorn, 62 FR 12847, 12848                         Certificate of Registration No.                       2017, and our Reply is due 20 days after
                                                (1997)), the Agency has also long held                  BW6830500, pursuant to which he is                    service of the Answer Brief.
                                                that revocation is warranted even where                 authorized to dispense controlled                        It would seem prudent for the DEA to
                                                a practitioner has lost his state authority             substances as a practitioner in schedules             ‘‘postpone the proceedings’’ until the 1st
                                                by virtue of the State’s use of summary                 II through V, at the registered address of
                                                                                                                                                              District Court of Appeal rules on this matter.
                                                process and the State has yet to provide                9325 Glades Road, Suite 104, Boca                     Id. at 1.
                                                a hearing to challenge the suspension.                  Raton, Florida. Id. The Order also                       Upon receipt of Respondent’s Hearing
                                                Bourne Pharmacy, 72 FR 18273, 18274                     alleged that this registration does not               Request and CAP, the matter was placed
                                                (2007); Wingfield Drugs, 52 FR 27070,                   expire until May 31, 2018. Id.                        on the docket of the Office of
                                                27071 (1987). Thus, it is of no                                                                               Administrative Law Judges and assigned
                                                consequence that the Indiana Board has                     Regarding the substantive grounds for
                                                                                                        the proceeding, the Show Cause Order                  to Chief Administrative Law Judge John
                                                employed summary process in                                                                                   J. Mulrooney, II (hereinafter, CALJ). On
                                                suspending Registrant’s state license.                  alleged that on December 29, 2016, the
                                                                                                        Florida Board of Medicine ‘‘revoked                   July 6, 2017, the CALJ issued an order
                                                What is consequential is that Registrant
                                                                                                        [his] authority to practice medicine,’’               noting that Respondent was appearing
                                                is no longer currently authorized to
                                                                                                        and he is therefore ‘‘without authority to            pro se and advised him ‘‘that he has the
                                                dispense controlled substances in
                                                                                                        handle controlled substances in Florida,              right to seek representation by a
                                                Indiana, the State in which he is
                                                                                                        the [S]tate in which [he is] registered               qualified attorney at his own expense.’’
                                                registered. I will therefore order that his
                                                                                                        with the DEA.’’ Id. Based on his ‘‘lack               Order Directing the Filing of
                                                registration be revoked.
                                                                                                        of authority to [dispense] controlled                 Government Evidence of Lack of State
                                                Order                                                   substances in . . . Florida,’’ the Order              Authority Allegation and Briefing
                                                   Pursuant to the authority vested in me               asserted that ‘‘DEA must revoke’’ his                 Schedule, at 1 & n.1 (citing 21 CFR
                                                by 21 U.S.C. 824(a), as well as 28 CFR                  registration. Id. (citing 21 U.S.C.                   1316.50). The CALJ also ordered the
                                                0.100(b), I order that DEA Certificate of               823(f)(1) and 824(a)(3)).                             Government to file evidence to support
                                                Registration AR1591913, issued to                                                                             the allegation that Respondent lacks
                                                                                                           The Show Cause Order notified                      state authority to handle controlled
                                                James E. Ranochak, M.D., be, and it                     Respondent of (1) his right to request a
                                                hereby is, revoked. This Order is                                                                             substances and an accompanying
                                                                                                        hearing on the allegations or to submit               motion for summary disposition no later
                                                effective immediately.3                                 a written statement in lieu of a hearing,             than July 18, 2017. Id. The CALJ further
                                                  Dated: February 6, 2018.                              (2) the procedure for electing either                 directed Respondent to file his response
                                                Robert W. Patterson,                                    option, and (3) the consequence for                   to any summary disposition motion no
                                                Acting Administrator.                                   failing to elect either option. Id. at 2              later than August 1, 2017. Id. at 2.
                                                [FR Doc. 2018–03301 Filed 2–16–18; 8:45 am]             (citing 21 CFR 1301.43). The Show                        On July 6, 2017, the Acting Assistant
                                                BILLING CODE 4410–09–P                                  Cause Order also notified Respondent of               Administrator received Respondent’s
                                                                                                        his right to submit a corrective action               CAP letter. See Letter from Acting
                                                                                                        plan (hereinafter, CAP) to the Assistant              Assistant Administrator Demetra Ashley
                                                DEPARTMENT OF JUSTICE                                   Administrator, Diversion Control                      to Respondent (dated July 11, 2017)
                                                                                                        Division, and the procedure for doing                 (hereinafter CAP Rejection Ltr), at 1.
                                                Drug Enforcement Administration                         so. Id. at 2–3.                                       However, on July 10, 2017, before the
                                                [Docket No. 17–37]                                         On July 6, 2017, Respondent filed a                Acting Assistant Administrator had
                                                                                                        letter with the Office of Administrative              ruled on Respondent’s CAP (and eight
                                                Kenneth N. Woliner, M.D.; Decision                      Law Judges pursuant to which he                       days before its summary disposition
                                                and Order                                               requested a hearing on the allegations of             motion was due), the Government filed
                                                  On June 6, 2017, the Assistant                        the Show Cause Order. Letter from                     its Motion for Summary Disposition. In
                                                Administrator, Diversion Control                        Respondent to Hearing Clerk (dated July               its Motion, the Government argued that
                                                Division, Drug Enforcement                              3, 2017) (hereinafter, Hearing Request).              it is undisputed that the Florida Board
                                                Administration (DEA), issued an Order                   In his letter, Respondent did not dispute             of Medicine revoked Respondent’s
                                                to Show Cause to Kenneth N. Woliner,                    that his Florida medical license ‘‘was                Florida medical license. Government’s
                                                M.D. (Respondent), of Boca Raton,                       revoked.’’ Id. at 1. He maintained,                   Motion for Summary Disposition (Govt.
                                                Florida. The Show Cause Order                           however, that his license ‘‘was revoked               Mot.), at 2. The Government further
                                                proposed the revocation of                              for issues not relating to controlled                 argued ‘‘that the possession of authority
                                                Respondent’s DEA Certificate of                         substances; and that the revocation . . .             to dispense controlled substances under
                                                Registration No. BW6830500 on the                       is currently under appeal at Florida’s                the laws of the State in which a
                                                ground that he ‘‘do[es] not have                        District Court of Appeal.’’ Id.                       practitioner engages in professional
                                                authority to handle controlled                          Respondent also advised that he ‘‘has                 practice is a fundamental condition for
                                                substances in the State of Florida, the                 not been convicted of any crime, much                 both obtaining and maintaining a
                                                                                                        less one involving controlled                         practitioner’s registration’’ under the
sradovich on DSK3GMQ082PROD with NOTICES




                                                [S]tate in which [he is] registered with
                                                                                                        substances.’’ Id. Also on July 6, 2017,               Controlled Substances Act (CSA). Id. at
                                                   3 For the same reasons that led the Indiana Board    Respondent submitted his CAP by letter                3 (citation omitted). As support for its
                                                to summarily suspend Registrant’s medical license       to the Assistant Administrator,                       summary disposition request, the
                                                (his indictment in federal district court on 10         Diversion Control Division. Letter from               Government attached, inter alia, a
                                                counts of Conspiracy to Commit Health Care Fraud
                                                and Distributing a Controlled Substance), I find that
                                                                                                        Respondent to Assistant Administrator                 certified copy of the Florida Board of
                                                the public interest necessitates that this Order be     Louis J. Milione (dated July 3, 2017). In             Medicine’s December 29, 2016 ‘‘Final
                                                effective immediately. 21 CFR 1316.67.                  his CAP, Respondent explained:                        Order’’ revoking Respondent’s license to


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Document Created: 2018-02-17 02:29:54
Document Modified: 2018-02-17 02:29:54
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 Citation83 FR 7221 

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