James E. Ranochak, M.D.; Decision and Order, 7221-7223 [2018-03301]
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Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
DEPARTMENT OF JUSTICE
Controlled
substance
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Johnson
Matthey Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.33(a) on
or before April 23, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on
November 09, 2017, Johnson Matthey
Inc., 2003 Nolte Drive, West Deptford,
NJ 08066, applied to be registered as a
bulk manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
Controlled
substance
Gamma Hydroxybutyric
Acid.
Marihuana .........................
Tetrahydrocannabinols .....
Dihydromorphine ...............
Difenoxin ...........................
Propiram ...........................
Amphetamine ....................
Methamphetamine ............
Lisdexamfetamine .............
Methylphenidate ................
Nabilone ............................
Cocaine .............................
Codeine .............................
Dihydrocodeine .................
Oxycodone ........................
Hydromorphone ................
VerDate Sep<11>2014
Drug
code
Schedule
2010
I
7360
7370
9145
9168
9649
1100
1105
1205
1724
7379
9041
9050
9120
9143
9150
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
17:55 Feb 16, 2018
Jkt 244001
Diphenoxylate ...................
Ecgonine ...........................
Hydrocodone .....................
Meperidine ........................
Methadone ........................
Methadone intermediate ...
Morphine ...........................
Thebaine ...........................
Oxymorphone ...................
Noroxymorphone ..............
Alfentanil ...........................
Remifentanil ......................
Sufentanil ..........................
Tapentadol ........................
Fentanyl ............................
Drug
code
9170
9180
9193
9230
9250
9254
9300
9333
9652
9668
9737
9739
9740
9780
9801
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the above-listed controlled substances
in bulk for sale to its customers.
Thebaine (9333) will be used to
manufacture other controlled substances
for sale in bulk to its customers.
In reference to drug codes 7360
(marihuana), and 7370 (THC), the
company plans to bulk manufacture
these drugs as synthetics. No other
activities for these drug codes are
authorized for this registration.
Dated: February 6, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–03293 Filed 2–16–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Taylor Animal Shelter; Order
On October 4, 2017, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration, issued an Order to
Show Cause proposing the revocation of
the DEA Certificate of Registration
issued to Taylor Animal Shelter of
Taylor, Michigan (Respondent). GX 1, at
1. The basis of the proposed action was
that, on June 30, 2017, Respondent’s
Michigan Controlled Substance Sodium
Pentobarbital Facility license lapsed,
and thus, it was ‘‘currently without
authority to handle controlled
substances in the State of Michigan, the
[S]tate in which [it is] registered with
the’’ Agency. Id.; see also 21 U.S.C.
§ 824(a)(3).
Following service of the Show Cause
Order, Respondent submitted a timely
written statement of position with
exhibits while waiving its right to a
hearing. In its position statement,
Respondent represented that its state
controlled substances registration was
renewed on October 30, 2017. Resp.’s
Statement at 3, ¶ 10. Respondent
attached a copy of a document which
states that it is a ‘‘Sodium Pentobarbital
PO 00000
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Fmt 4703
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Permit for Practice of Animal
Euthanasia (Facility Permit).’’ Resp.’s
Statement, at Exhibit E. While much of
this document is unreadable, and it is
unclear from the document when this
permit was issued or expires,
Respondent provided an affidavit of the
Operations Manager for the Department
of Public Works of the City of Taylor,
Michigan, which states that on October
30, 2017, he received the renewed state
license for the facility. Affidavit of Matt
Bonza, at 2. Moreover, the Government
does not dispute that the facility has reobtained state authority to dispense
controlled substances. Request for Order
Dismissing Order to Show Cause, at 2.
As the Government acknowledges, the
sole basis for seeking revocation of
Respondent’s DEA registration was ‘‘its
lack of state authority to handle
controlled substances’’ and ‘‘this ground
for revocation no longer exists.’’ Id. The
Government thus seeks an order
dismissing the Order to Show Cause. Id.
at 3. Accordingly, I will grant the
Government’s request and dismiss the
Order to Show Cause. Id.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824 and 28 CFR 0.100(b),
I order that the Order to Show Cause
issued to Taylor Animal Shelter be, and
it hereby is, dismissed. This Order is
effective immediately.
Dated: February 6, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018–03298 Filed 2–16–18; 8:45 am]
BILLING CODE 4410–09–P
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]
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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.
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.
VerDate Sep<11>2014
17:55 Feb 16, 2018
Jkt 244001
21 CFR 1301.43(d)–(e). I make the
following findings.
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.
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
2 See
PO 00000
5 U.S.C. 556(e).
Frm 00087
Fmt 4703
Sfmt 4703
‘‘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 § 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 § 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. § 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. § 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
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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
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17–37]
sradovich on DSK3GMQ082PROD with NOTICES
Kenneth N. Woliner, M.D.; Decision
and Order
On June 6, 2017, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to Kenneth N. Woliner,
M.D. (Respondent), of Boca Raton,
Florida. The Show Cause Order
proposed the revocation of
Respondent’s DEA Certificate of
Registration No. BW6830500 on the
ground that he ‘‘do[es] not have
authority to handle controlled
substances in the State of Florida, the
[S]tate in which [he is] registered with
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.
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17:55 Feb 16, 2018
Jkt 244001
the DEA.’’ Order to Show Cause, at 1
(citing 21 U.S.C. 823(f) and 824(a)(3)).
With respect to the Agency’s
jurisdiction, the Show Cause Order
alleged that Respondent is the holder of
Certificate of Registration No.
BW6830500, pursuant to which he is
authorized to dispense controlled
substances as a practitioner in schedules
II through V, at the registered address of
9325 Glades Road, Suite 104, Boca
Raton, Florida. Id. The Order also
alleged that this registration does not
expire until May 31, 2018. Id.
Regarding the substantive grounds for
the proceeding, the Show Cause Order
alleged that on December 29, 2016, the
Florida Board of Medicine ‘‘revoked
[his] authority to practice medicine,’’
and he is therefore ‘‘without authority to
handle controlled substances in Florida,
the [S]tate in which [he is] registered
with the DEA.’’ Id. Based on his ‘‘lack
of authority to [dispense] controlled
substances in . . . Florida,’’ the Order
asserted that ‘‘DEA must revoke’’ his
registration. Id. (citing 21 U.S.C.
823(f)(1) and 824(a)(3)).
The Show Cause Order notified
Respondent of (1) his right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing,
(2) the procedure for electing either
option, and (3) the consequence for
failing to elect either option. Id. at 2
(citing 21 CFR 1301.43). The Show
Cause Order also notified Respondent of
his right to submit a corrective action
plan (hereinafter, CAP) to the Assistant
Administrator, Diversion Control
Division, and the procedure for doing
so. Id. at 2–3.
On July 6, 2017, Respondent filed a
letter with the Office of Administrative
Law Judges pursuant to which he
requested a hearing on the allegations of
the Show Cause Order. Letter from
Respondent to Hearing Clerk (dated July
3, 2017) (hereinafter, Hearing Request).
In his letter, Respondent did not dispute
that his Florida medical license ‘‘was
revoked.’’ Id. at 1. He maintained,
however, that his license ‘‘was revoked
for issues not relating to controlled
substances; and that the revocation . . .
is currently under appeal at Florida’s
District Court of Appeal.’’ Id.
Respondent also advised that he ‘‘has
not been convicted of any crime, much
less one involving controlled
substances.’’ Id. Also on July 6, 2017,
Respondent submitted his CAP by letter
to the Assistant Administrator,
Diversion Control Division. Letter from
Respondent to Assistant Administrator
Louis J. Milione (dated July 3, 2017). In
his CAP, Respondent explained:
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7223
My corrective action plan is to have my
case overturned on appeal. The Initial Brief
on the Merits was filed on 6/7/2017. Barring
the Court granting extensions of time (if
filed), the Department of Health is was [sic]
required to file their Answer Brief by 6/27/
2017, and our Reply is due 20 days after
service of the Answer Brief.
It would seem prudent for the DEA to
‘‘postpone the proceedings’’ until the 1st
District Court of Appeal rules on this matter.
Id. at 1.
Upon receipt of Respondent’s Hearing
Request and CAP, the matter was placed
on the docket of the Office of
Administrative Law Judges and assigned
to Chief Administrative Law Judge John
J. Mulrooney, II (hereinafter, CALJ). On
July 6, 2017, the CALJ issued an order
noting that Respondent was appearing
pro se and advised him ‘‘that he has the
right to seek representation by a
qualified attorney at his own expense.’’
Order Directing the Filing of
Government Evidence of Lack of State
Authority Allegation and Briefing
Schedule, at 1 & n.1 (citing 21 CFR
1316.50). The CALJ also ordered the
Government to file evidence to support
the allegation that Respondent lacks
state authority to handle controlled
substances and an accompanying
motion for summary disposition no later
than July 18, 2017. Id. The CALJ further
directed Respondent to file his response
to any summary disposition motion no
later than August 1, 2017. Id. at 2.
On July 6, 2017, the Acting Assistant
Administrator received Respondent’s
CAP letter. See Letter from Acting
Assistant Administrator Demetra Ashley
to Respondent (dated July 11, 2017)
(hereinafter CAP Rejection Ltr), at 1.
However, on July 10, 2017, before the
Acting Assistant Administrator had
ruled on Respondent’s CAP (and eight
days before its summary disposition
motion was due), the Government filed
its Motion for Summary Disposition. In
its Motion, the Government argued that
it is undisputed that the Florida Board
of Medicine revoked Respondent’s
Florida medical license. Government’s
Motion for Summary Disposition (Govt.
Mot.), at 2. The Government further
argued ‘‘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
both obtaining and maintaining a
practitioner’s registration’’ under the
Controlled Substances Act (CSA). Id. at
3 (citation omitted). As support for its
summary disposition request, the
Government attached, inter alia, a
certified copy of the Florida Board of
Medicine’s December 29, 2016 ‘‘Final
Order’’ revoking Respondent’s license to
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]]>Agencies
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7221-7223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
