John Yolman Salinas, M.D.; Decision and Order, 49552-49555 [2019-20420]
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according to the Consent Order,
Respondent was unable to produce a
biennial inventory, he failed to
adequately maintain dispensing records
for controlled substances, and he failed
to maintain inventory records of
controlled substances for two years. Id.
The DIs also determined that: (a)
Everyone in Respondent’s dental office
had access to the controlled substances
cabinet; (b) Respondent kept a fivehundred count bottle of Vicodin, a onehundred count bottle of Halcion, and a
five-hundred count bottle of Valium in
his home, a non-registered address; and
(c) Respondent kept a one-hundred
count bottle of Vicodin in his desk
drawer. Id.
Respondent also failed to complete
the required nine hours of continuing
education in sedation techniques for the
2009–2012 renewal cycle, and failed to
ensure that his staff had completed the
requisite training to assist him in dental
sedation procedures. Id.
Respondent and the IDFPR agreed, in
the Consent Order, that Respondent’s
Illinois dentist controlled substance
license would be indefinitely
suspended, and that his Illinois dentist
license would be placed on indefinite
probation with conditions for a
minimum period of two years. Id. at 4.
The Consent Order became effective on
September 11, 2018, upon the approval
and signature of the Director of the
Division of Professional Regulation for
the IDFPR. Id. at 7–8.
According to the online records for
the state of Illinois, of which I take
official notice, Respondent’s Illinois
dentist controlled substance license
remains suspended.3 https://
ilesonline.idfpr.illinois.gov/DFPR/
Lookup/LicenseLookup.aspx (last
visited September, 12, 2019).
Accordingly, I find that Respondent is
not currently licensed to dispense
controlled substances in Illinois, the
State in which Respondent is registered
with the DEA.
3 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an
agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an
opportunity to show the contrary.’’ Accordingly,
Respondent may dispute my finding by filing a
properly supported motion for reconsideration
within 15 calendar days of the date of this Order.
Any such motion shall be filed with the Office of
the Administrator and a copy shall be served on the
Government. In the event Respondent files a
motion, the Government shall have 15 calendar
days to file a response.
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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 (hereinafter, CSA)
‘‘upon a finding that the Respondent
. . . has had his State license or
registration suspended . . . [or] revoked
. . . by competent State authority and is
no longer authorized by State law to
engage in the . . . dispensing of
controlled substances.’’ With respect to
a practitioner, the DEA has also long
held that the possession of authority to
dispense controlled substances under
the laws of the State in which a
practitioner engages in professional
practice is a fundamental condition for
obtaining and maintaining a
practitioner’s registration. See, e.g.,
James L. Hooper, M.D., 76 FR 71371
(2011), pet. for rev. denied, 481 Fed.
Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27616,
27617 (1978).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined the term ‘‘practitioner’’ to mean
‘‘a physician . . . or other person
licensed, registered, or otherwise
permitted, by . . . the jurisdiction in
which he practices . . ., to distribute,
dispense . . . [or] administer . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). Second, in setting the
requirements for obtaining a
practitioner’s registration, Congress
directed that ‘‘[t]he Attorney General
shall register practitioners . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which he practices.’’ 21
U.S.C. 823(f). Because Congress has
clearly mandated that a practitioner
possess State authority in order to be
deemed a practitioner under the CSA,
the DEA has held repeatedly that
revocation of a practitioner’s registration
is the appropriate sanction whenever he
is no longer authorized to dispense
controlled substances under the laws of
the State in which he practices. See,
e.g., Hooper, supra, 76 FR at 71371–72;
Sheran Arden Yeates, M.D., 71 FR
39130, 39131 (2006); Dominick A. Ricci,
M.D., 58 FR 51104, 51105 (1993); Bobby
Watts, M.D., 53 FR 11919, 11920 (1988);
Blanton, supra, 43 FR at 27617.
Pursuant to the Illinois Controlled
Substances Act, a dentist is specifically
included in the definition of a
practitioner. ‘‘ ‘Practitioner’ means a
physician licensed to practice medicine
in all its branches, dentist . . . or other
person licensed, registered, or otherwise
lawfully permitted by the United States
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or this State to distribute, dispense,
conduct research with respect to,
administer or use in teaching or
chemical analysis, a controlled
substance in the course of professional
practice or research.’’ 720 Ill. Comp.
Stat. Ann. 570/102(kk) (Westlaw P.A.
100–863). Illinois law requires that
‘‘[e]very person who manufactures,
distributes, or dispenses any controlled
substances . . . must obtain a
registration issued by the Department of
Financial and Professional Regulation in
accordance with its rules.’’ Id. at 570/
302(a).
Further, under Illinois law, the
Illinois Controlled Substances Act
authorizes the IDFPR to discipline a
practitioner holding a dentist controlled
substance license. ‘‘A registration under
Section 303 to manufacture, distribute,
or dispense a controlled substance . . .
may be denied, refused renewal,
suspended, or revoked by the
Department of Financial and
Professional Regulation.’’ Id. at 570/
304(a).
Here, the undisputed evidence in the
record is that Respondent currently
lacks authority to handle controlled
substances as a dentist in Illinois. As
already discussed, a dentist must hold
a valid dentist controlled substance
license to dispense a controlled
substance in Illinois. Thus, because
Respondent lacks authority to handle
controlled substances in Illinois,
Respondent is not eligible to maintain a
DEA registration. Accordingly, I order
that Respondent’s DEA registration be
revoked.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. BW7668835 issued
to Peter J. Waidzunas, D.D.S. This Order
is effective October 21, 2019.
Dated: September 9, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019–20418 Filed 9–19–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 2019–10]
John Yolman Salinas, M.D.; Decision
and Order
On December 18, 2018, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
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Government), issued an Order to Show
Cause to John Yolman Salinas, M.D.,
(hereinafter, Respondent), of Atlanta,
Georgia. Order to Show Cause
(hereinafter, OSC), at 1. The OSC
proposes the revocation of Respondent’s
Certificate of Registration No.
BS4014332 on the ground that
Respondent does not have ‘‘state
authority to handle controlled
substances’’ in Georgia, the state in
which Respondent is registered with the
DEA. Id. (citing 21 U.S.C. 824(a)(3)).
The substantive ground for the
proceeding, as alleged in the OSC, is
that Respondent has ‘‘no state authority
to handle controlled substances.’’ OSC,
at 1. Specifically, the OSC alleges that
the Georgia Composite Medical Board
(hereinafter, GCMB) issued a Final
Decision revoking Respondent’s medical
license on September 21, 2018. Id. This
Georgia medical license revocation,
according to the OSC, means that
Respondent is ‘‘currently without
authority to handle controlled
substances in the State of Georgia’’ and,
‘‘[c]onsequently, DEA must revoke . . .
[Respondent’s] DEA registration.’’ Id.
The OSC notified Respondent of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 2 (citing 21
CFR 1301.43). The OSC also notified
Respondent of the opportunity to
submit a corrective action plan. OSC, at
2–3 (citing 21 U.S.C. 824(c)(2)(C)).
By a document entitled ‘‘Request for
Hearing’’ submitted on January 16,
2019, Respondent timely requested a
hearing.1 According to the Hearing
Request, Respondent ‘‘is interested in
continuing the practice of medicine in
another state or Territory of the United
States . . . and thus maintaining his
DEA Registration active.’’ Hearing
Request, at 1. Respondent’s Hearing
Request states that he ‘‘is not handling
any medications or drugs of ANY sort’’
and ‘‘has NEVER had any DEA
violations or complaint to the present
date.’’ Id. (emphases in original).
Respondent attached a ‘‘Corrective
Action Plan’’ (hereinafter, CAP) to his
Request for Hearing. Id. at 3. The CAP
states, among other things, that the
‘‘Georgia Medical Board did NOT find
any violations against . . . [Respondent]
of medication errors or standard of care
issues.’’ Id. (emphasis in original). It
states that Respondent ‘‘is NOT
1 The OSC is dated December 18, 2018. The
Hearing Request was emailed on January 16, 2019.
As such, I find that the Government’s service of the
OSC was adequate and that Respondent’s request
for a hearing was timely.
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currently practicing medicine in any
form . . . [and] wishes to continue the
practice of medicine for which he
trained for over a 24 years career.’’ Id.
(emphasis in original). Respondent’s
first proposed CAP concerns his
‘‘having submitted current applications
for medical licensure in several States
and U.S. Territories . . . . On
procurement of an active state medical
license, the DEA Registration will be
transferred to the active State licensed.’’
Id. Respondent’s second proposed CAP
concerns Respondent’s expressed
interest in ‘‘actively applying for a
position within the DEA with the hopes
of procuring a position as an undercover
physician to infiltrate pill mills and
help in the war against drugs.’’ 2 Id.
By letter dated January 30, 2019, the
Assistant Administrator of the Diversion
Control Division ‘‘den[ied] the request
to discontinue or defer administrative
proceedings’’ and stated that ‘‘there is
no potential modification of . . .
[Respondent’s proposed CAP] that could
or would alter my decision in this
regard.’’ Assistant Administrator CAP
Letter, at 1.
The Office of Administrative Law
Judges put the matter on the docket and
assigned it to the Chief Administrative
Law Judge. The matter was
subsequently reassigned to
Administrative Law Judge Mark M.
Dowd (hereinafter, ALJ). The
Government timely complied with the
‘‘Order Directing the Filing of
Government Evidence Regarding its
Lack of State Authority Allegation and
Briefing Schedule’’ by filing a Motion
for Summary Disposition on January 28,
2019 (hereinafter, Government Motion).
In its motion, the Government stated
that Respondent lacks authority to
handle controlled substances in Georgia
because of the revocation of his Georgia
medical license. Government Motion, at
3. ‘‘Because Respondent does not have
state authority to prescribe, administer,
or dispense controlled substances in the
State of Georgia,’’ the Government
Motion continued, ‘‘he is not entitled to
hold a DEA registration.’’ Id.
Respondent requested, and received,
an additional ten business days to
respond to the Government Motion.3
2 Respondent’s second proposed CAP ‘‘further
requests any assistance from any DEA personnel in
procurement of such a position.’’ Hearing Request,
at 3.
3 The ALJ denied Respondent’s request for an
extension of forty-five days. Respondent stated that
the bases for his request were pending applications
for medical licensure in Guam and Mississippi.
Respondent suggested that forty-five days would
give those jurisdictions time to act on his
applications and ‘‘thus make moot the
Administrative Law Court Summary Disposition.’’
Respondent’s Motion for Extension of Time to
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49553
Motion for Extension of Time to
Respond to Governments [sic] Motion
for Summary Disposition dated January
31, 2019, at 1; Order Granting the
Respondent’s Request for Extension of
Time dated February 4, 2019, at 1–2.
According to the ALJ’s ‘‘Order Granting
the Government’s Motion for Summary
Disposition and Recommended Rulings,
Findings of Fact, Conclusions of Law,
and Decision of the Administrative Law
Judge’’ dated February 21, 2019
(hereinafter, RD), ‘‘[t]o date, the
Respondent has not filed any reply to
the Government’s allegations.’’ RD, at 3.
After the ALJ issued the RD, Respondent
filed a ‘‘Motion for Reconsideration and
Clarification of Decision of
Administrative Law Judge’’ dated
February 22, 2019 (hereinafter, RMRC).
The ALJ construed the RMRC to be a
motion for leave to file an out of time
response to the Government Motion and
gave the Government the opportunity to
respond to it. The Government timely
opposed the RMRC on procedural and
substantive grounds. The ALJ denied
the RMRC. Order Denying Respondent’s
Motion to File an Out of Time Response
and Reaffirming the Recommended
Order Granting the Government’s
Motion for Summary Disposition dated
March 19, 2019 (hereinafter, RRD), at 5.
Although the ALJ denied the RMRC, he
addressed its substance in the RRD.
RRD, at 4–5.4
The ALJ, in both the RD and the RRD,
recommended that ‘‘Respondent’s
registration be revoked, and any
pending applications be denied’’
because ‘‘no dispute exists over the fact
that the Respondent currently lacks
state authority to handle controlled
substances in the state of Georgia
because the . . . [GCMB] has revoked
his medical license.’’ RD, at 7–8. By
letter dated March 19, 2019, the ALJ
certified and transmitted the record to
me.
I issue this Decision and Order based
on the entire record before me. 21 CFR
1301.43(e). I make the following
findings of fact.
Findings of Fact
Respondent’s DEA Registration
Respondent is the holder of DEA
Certificate of Registration No.
BS4014332 at the registered address of
3069 Amwiler Rd., Suite Two, Atlanta,
Respond to Governments [sic] Motion for Summary
Disposition dated January 31, 2019, at 2. I agree
with the ALJ’s denial of Respondent’s request for
an extension of forty-five days. The issue presented
in the OSC concerns Respondent’s registration in
Georgia, not his applications for medical licensure
in Guam or Mississippi.
4 I agree with the ALJ’s procedural disposition of
the RMRC.
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GA 30360. Government Motion, Exh. 1,
at 1. Pursuant to this registration,
Respondent is authorized to dispense
controlled substances in schedules II
through V as a practitioner. Id.
Respondent’s registration expires on
February 28, 2021, and is ‘‘in an active
pending status.’’ Id.
The Status of Respondent’s State
License
On June 18, 2018, an Administrative
Law Judge at the Georgia Office of State
Administrative Hearings (hereinafter,
Georgia ALJ) issued her Initial Decision
concerning a matter initiated by the
GCMB to sanction Respondent’s
medical license. Government Motion,
Exh. 2, at 1. According to the Initial
Decision, a ‘‘board certified family
practice physician with 39 years’
experience’’ completed a peer review of
Respondent’s treatment and care of two
individuals at the request of the GCMB.
Id. at 12.
Regarding the first individual, the
peer reviewer opined that Respondent’s
treatment fell below the standard of care
when he (1) treated the individual as a
patient when they were engaged in a
sexual relationship; (2) failed to
maintain medical records to support his
prescription of medications, including
controlled substances; (3) failed to
maintain a medical record to support
the ordering of a breast ultrasound and
diagnostic mammogram; (4) failed to
maintain a medical record when making
a ‘‘lumbago’’ diagnosis; and (5) failed to
use proper history, physical, laboratory
tests, and radiological procedures to
make a diagnosis. Id. at 12–13.
As to the other individual, the peer
reviewer opined that Respondent’s
treatment fell below the standard of care
when he (1) performed a gynecological
examination without a female
chaperone present; (2) had sexual
relations with the individual after
performing a gynecological
examination; (3) failed to put a date on
the purported record of the injections he
gave the individual and the individual’s
subsequent reaction; and (4) failed to
perform a gynecological examination,
pap smear, and mammogram before
purportedly administering an initial
injection of Depo-Provera. Id. at 21–22.
The Georgia ALJ concluded that the
GCMB established by a preponderance
of the evidence that Respondent (1)
knowingly made misleading, deceptive,
untrue, or fraudulent representations in
the practice of his profession in a
purported medical record and to the
GCMB; (2) indicated untrustworthiness
and engaged in conduct discrediting the
medical profession by his acts and
omissions; (3) failed to conform to the
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minimum standards of acceptable and
prevailing medical practice; (4)
mistreated both individuals; and (5)
failed to timely respond to an
investigative subpoena issued by the
GCMB. Id. at 24–26, 28–29. She found
that Respondent ‘‘was cavalier in
prescribing medications, including
controlled substances . . . [and] did not
document any objective data to justify
the prescriptions. Id. at 31. The Georgia
ALJ concluded that Respondent’s
conduct with regard to the two
individuals was ‘‘egregious’’ and
‘‘reprehensible,’’ making revocation the
appropriate sanction. Id. Thus, she
revoked Respondent’s medical license.
Id.
On September 21, 2018, the GCMB
issued a Final Decision (hereinafter,
Final Decision). The Final Decision
adopted the Findings of Fact and
Conclusions of Law set forth in the
Initial Decision and revoked
Respondent’s medical license No.
38600, effective upon docketing.
Government Motion, Exh. 3, at 2. The
GCMB also denied Respondent’s Motion
for Rehearing after finding that
Respondent had not demonstrated that
(1) the GCMB overlooked any material
fact, controlling authority, or
intervening change in controlling
authority; (2) the GCMB or the Georgia
ALJ made a clear error; (3) there was a
manifest injustice; or (4) the legal
authority was erroneously construed or
misapplied. Order Denying Rehearing
dated November 8, 2018, Government
Motion, Exh. 4, at 5.
According to Georgia’s online records,
of which I take official notice,
Respondent’s license is still revoked.5
GCMB Search for a Licensee, https://
gcmb.mylicense.com/verification (last
visited September 9, 2019).
Accordingly, I find that Respondent
currently is not licensed to practice
medicine in Georgia, the state in which
he is registered with the DEA.
5 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an
agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an
opportunity to show the contrary.’’ Accordingly,
Respondent may dispute my finding by filing a
properly supported motion for reconsideration
within 15 calendar days of the date of this Order.
Any such motion shall be filed with the Office of
the Administrator and a copy shall be served on the
Government. In the event Respondent files a
motion, the Government shall have 15 calendar
days to file a response.
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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 (hereinafter, CSA),
‘‘upon a finding that the registrant . . .
has had his State license or registration
suspended . . . [or] revoked . . . by
competent State authority and is no
longer authorized by State law to engage
in the . . . dispensing of controlled
substances.’’ With respect to a
practitioner, the DEA has also long held
that the possession of authority to
dispense controlled substances under
the laws of the state in which a
practitioner engages in professional
practice is a fundamental condition for
obtaining and maintaining a
practitioner’s registration. See, e.g.,
James L. Hooper, M.D., 76 FR 71371
(2011), pet. for rev. denied, 481 Fed.
Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27616,
27617 (1978).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined the term ‘‘practitioner’’ to mean
‘‘a physician . . . or other person
licensed, registered, or otherwise
permitted, by . . . the jurisdiction in
which he practices . . ., to distribute,
dispense, . . . [or] administer . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). Second, in setting the
requirements for obtaining a
practitioner’s registration, Congress
directed that ‘‘[t]he Attorney General
shall register practitioners . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which he practices.’’ 21
U.S.C. 823(f). Because Congress has
clearly mandated that a practitioner
possess state authority in order to be
deemed a practitioner under the CSA,
the DEA has held repeatedly that
revocation of a practitioner’s registration
is the appropriate sanction whenever he
is no longer authorized to dispense
controlled substances under the laws of
the state in which he practices. See, e.g.,
Hooper, supra, 76 FR at 71371–72;
Sheran Arden Yeates, M.D., 71 FR
39130, 39131 (2006); Dominick A. Ricci,
M.D., 58 FR 51104, 51,105 (1993); Bobby
Watts, M.D., 53 FR 11919, 11920 (1988);
Blanton, supra, 43 FR at 27617.
According to Georgia statute, ‘‘Every
person who . . . dispenses any
controlled substances within this state
. . . must obtain annually a registration
issued by the State Board of Pharmacy.’’
Ga. Code Ann. § 16–13.35(a) (Westlaw,
current through acts passed during the
2019 Session of the General Assembly).
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A person who is licensed as a physician,
however, is ‘‘registered’’ and exempt
from the statute’s registration fee and
application requirements. Ga. Code
Ann. § 16–13–35(g)(2) (Westlaw, current
through acts passed during the 2019
Session of the General Assembly). The
Georgia Code defines ‘‘physician’’ as ‘‘a
person licensed to practice medicine.’’
Ga. Code Ann. § 43–34–21(2) (Westlaw,
current through acts passed during the
2019 Session of the General Assembly).
Under Georgia law, ‘‘to practice
medicine’’ includes ‘‘attaching the title
‘M.D.’ . . . to one’s name, indicating
that such person is engaged in the
treatment or diagnosis of disease,
defects, or injuries to human beings.’’
Ga. Code Ann. § 43–34–21(3) (Westlaw,
current through acts passed during the
2019 Session of the General Assembly).
Here, the undisputed evidence in the
record, including Respondent’s
admission, is that Respondent currently
lacks authority to practice medicine in
Georgia. Government Motion, Exhs. 2–4;
RMRC, at 2. As already discussed, a
‘‘physician,’’ under Georgia law, is a
person licensed to practice medicine.
Further, under Georgia law, a
‘‘physician’’ is registered to dispense
controlled substances. Because
Respondent lacks authority to practice
medicine in Georgia, he is not registered
to handle controlled substances in
Georgia according to Georgia law.
Accordingly, Respondent is not eligible
to maintain a DEA registration and I will
order that Respondent’s DEA
registration be revoked.6
Order
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Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. BS4014332 issued to
John Yolman Salinas, M.D. Pursuant to
28 CFR 0.100(b) and the authority
vested in me by 21 U.S.C. 823(f), I
hereby deny any pending application of
John Yolman Salinas to renew or to
modify this registration, and any
pending application of John Yolman
Salinas to be registered in the state of
Georgia. This Order is effective October
21, 2019.
6 Given my findings that Respondent is registered
with the DEA in Georgia, that his Georgia medical
license is revoked, and that he lacks authority in
Georgia to dispense controlled substances, I find
that both of Respondent’s CAPs—changing his
registered address to another state or a Territory of
the United States, and ‘‘procuring a position as an
undercover physician to infiltrate pill mills and
help in the war against drugs’’—provide no basis for
me to discontinue or defer this proceeding. 21
U.S.C. 824(c)(3).
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Dated: September 9, 2019.
Uttam Dhillon,
Acting Administrator.
Dated: August 19, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
[FR Doc. 2019–20420 Filed 9–19–19; 8:45 am]
[FR Doc. 2019–20414 Filed 9–19–19; 8:45 am]
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Fisher Clinical Services,
Inc.
Importer of Controlled Substances
Application: Galephar Pharmaceutical
Research Inc.
ACTION:
ACTION:
Notice of application.
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 on
or before October 21, 2019. Such
persons may also file a written request
for a hearing on the application on or
before October 21, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on June 10, 2019, Galephar
Pharmaceutical Research Inc., #100 Carr
198 Industrial Park, Juncos, Puerto Rico,
00777 applied to be registered as an
importer of the following basic class of
controlled substance:
DATES:
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 on
or before October 21, 2019. Such
persons may also file a written request
for a hearing on the application on or
before October 21, 2019.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 19, 2019, Fisher
Clinical Services, Inc., 700A–C Nestle
Way, Breinigsville, Pennsylvania
18031–1522 applied to be registered as
an importer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Psilocybin .................
Methylphenidate .......
Levorphanol ..............
Noroxymorphone ......
Tapentadol ................
Drug
code
7437
1724
9220
9668
9780
Schedule
I
II
II
II
II
The company plans to import the
listed controlled substances for clinical
trials.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Controlled substance
Hydromorphone ........
Drug
code
9150
Schedule
II
The company plans to import the
listed controlled substance in finished
dosage form for analytical purpose only.
Dated: August 22, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
[FR Doc. 2019–20412 Filed 9–19–19; 8:45 am]
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E:\FR\FM\20SEN1.SGM
20SEN1
Agencies
[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Notices]
[Pages 49552-49555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20420]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 2019-10]
John Yolman Salinas, M.D.; Decision and Order
On December 18, 2018, the Assistant Administrator, Diversion
Control Division, Drug Enforcement Administration (hereinafter, DEA or
[[Page 49553]]
Government), issued an Order to Show Cause to John Yolman Salinas,
M.D., (hereinafter, Respondent), of Atlanta, Georgia. Order to Show
Cause (hereinafter, OSC), at 1. The OSC proposes the revocation of
Respondent's Certificate of Registration No. BS4014332 on the ground
that Respondent does not have ``state authority to handle controlled
substances'' in Georgia, the state in which Respondent is registered
with the DEA. Id. (citing 21 U.S.C. 824(a)(3)).
The substantive ground for the proceeding, as alleged in the OSC,
is that Respondent has ``no state authority to handle controlled
substances.'' OSC, at 1. Specifically, the OSC alleges that the Georgia
Composite Medical Board (hereinafter, GCMB) issued a Final Decision
revoking Respondent's medical license on September 21, 2018. Id. This
Georgia medical license revocation, according to the OSC, means that
Respondent is ``currently without authority to handle controlled
substances in the State of Georgia'' and, ``[c]onsequently, DEA must
revoke . . . [Respondent's] DEA registration.'' Id.
The OSC notified Respondent of the right to request a hearing on
the allegations or to submit a written statement, while waiving the
right to a hearing, the procedures for electing each option, and the
consequences for failing to elect either option. Id. at 2 (citing 21
CFR 1301.43). The OSC also notified Respondent of the opportunity to
submit a corrective action plan. OSC, at 2-3 (citing 21 U.S.C.
824(c)(2)(C)).
By a document entitled ``Request for Hearing'' submitted on January
16, 2019, Respondent timely requested a hearing.\1\ According to the
Hearing Request, Respondent ``is interested in continuing the practice
of medicine in another state or Territory of the United States . . .
and thus maintaining his DEA Registration active.'' Hearing Request, at
1. Respondent's Hearing Request states that he ``is not handling any
medications or drugs of ANY sort'' and ``has NEVER had any DEA
violations or complaint to the present date.'' Id. (emphases in
original).
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\1\ The OSC is dated December 18, 2018. The Hearing Request was
emailed on January 16, 2019. As such, I find that the Government's
service of the OSC was adequate and that Respondent's request for a
hearing was timely.
---------------------------------------------------------------------------
Respondent attached a ``Corrective Action Plan'' (hereinafter, CAP)
to his Request for Hearing. Id. at 3. The CAP states, among other
things, that the ``Georgia Medical Board did NOT find any violations
against . . . [Respondent] of medication errors or standard of care
issues.'' Id. (emphasis in original). It states that Respondent ``is
NOT currently practicing medicine in any form . . . [and] wishes to
continue the practice of medicine for which he trained for over a 24
years career.'' Id. (emphasis in original). Respondent's first proposed
CAP concerns his ``having submitted current applications for medical
licensure in several States and U.S. Territories . . . . On procurement
of an active state medical license, the DEA Registration will be
transferred to the active State licensed.'' Id. Respondent's second
proposed CAP concerns Respondent's expressed interest in ``actively
applying for a position within the DEA with the hopes of procuring a
position as an undercover physician to infiltrate pill mills and help
in the war against drugs.'' \2\ Id.
---------------------------------------------------------------------------
\2\ Respondent's second proposed CAP ``further requests any
assistance from any DEA personnel in procurement of such a
position.'' Hearing Request, at 3.
---------------------------------------------------------------------------
By letter dated January 30, 2019, the Assistant Administrator of
the Diversion Control Division ``den[ied] the request to discontinue or
defer administrative proceedings'' and stated that ``there is no
potential modification of . . . [Respondent's proposed CAP] that could
or would alter my decision in this regard.'' Assistant Administrator
CAP Letter, at 1.
The Office of Administrative Law Judges put the matter on the
docket and assigned it to the Chief Administrative Law Judge. The
matter was subsequently reassigned to Administrative Law Judge Mark M.
Dowd (hereinafter, ALJ). The Government timely complied with the
``Order Directing the Filing of Government Evidence Regarding its Lack
of State Authority Allegation and Briefing Schedule'' by filing a
Motion for Summary Disposition on January 28, 2019 (hereinafter,
Government Motion). In its motion, the Government stated that
Respondent lacks authority to handle controlled substances in Georgia
because of the revocation of his Georgia medical license. Government
Motion, at 3. ``Because Respondent does not have state authority to
prescribe, administer, or dispense controlled substances in the State
of Georgia,'' the Government Motion continued, ``he is not entitled to
hold a DEA registration.'' Id.
Respondent requested, and received, an additional ten business days
to respond to the Government Motion.\3\ Motion for Extension of Time to
Respond to Governments [sic] Motion for Summary Disposition dated
January 31, 2019, at 1; Order Granting the Respondent's Request for
Extension of Time dated February 4, 2019, at 1-2. According to the
ALJ's ``Order Granting the Government's Motion for Summary Disposition
and Recommended Rulings, Findings of Fact, Conclusions of Law, and
Decision of the Administrative Law Judge'' dated February 21, 2019
(hereinafter, RD), ``[t]o date, the Respondent has not filed any reply
to the Government's allegations.'' RD, at 3. After the ALJ issued the
RD, Respondent filed a ``Motion for Reconsideration and Clarification
of Decision of Administrative Law Judge'' dated February 22, 2019
(hereinafter, RMRC). The ALJ construed the RMRC to be a motion for
leave to file an out of time response to the Government Motion and gave
the Government the opportunity to respond to it. The Government timely
opposed the RMRC on procedural and substantive grounds. The ALJ denied
the RMRC. Order Denying Respondent's Motion to File an Out of Time
Response and Reaffirming the Recommended Order Granting the
Government's Motion for Summary Disposition dated March 19, 2019
(hereinafter, RRD), at 5. Although the ALJ denied the RMRC, he
addressed its substance in the RRD. RRD, at 4-5.\4\
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\3\ The ALJ denied Respondent's request for an extension of
forty-five days. Respondent stated that the bases for his request
were pending applications for medical licensure in Guam and
Mississippi. Respondent suggested that forty-five days would give
those jurisdictions time to act on his applications and ``thus make
moot the Administrative Law Court Summary Disposition.''
Respondent's Motion for Extension of Time to Respond to Governments
[sic] Motion for Summary Disposition dated January 31, 2019, at 2. I
agree with the ALJ's denial of Respondent's request for an extension
of forty-five days. The issue presented in the OSC concerns
Respondent's registration in Georgia, not his applications for
medical licensure in Guam or Mississippi.
\4\ I agree with the ALJ's procedural disposition of the RMRC.
---------------------------------------------------------------------------
The ALJ, in both the RD and the RRD, recommended that
``Respondent's registration be revoked, and any pending applications be
denied'' because ``no dispute exists over the fact that the Respondent
currently lacks state authority to handle controlled substances in the
state of Georgia because the . . . [GCMB] has revoked his medical
license.'' RD, at 7-8. By letter dated March 19, 2019, the ALJ
certified and transmitted the record to me.
I issue this Decision and Order based on the entire record before
me. 21 CFR 1301.43(e). I make the following findings of fact.
Findings of Fact
Respondent's DEA Registration
Respondent is the holder of DEA Certificate of Registration No.
BS4014332 at the registered address of 3069 Amwiler Rd., Suite Two,
Atlanta,
[[Page 49554]]
GA 30360. Government Motion, Exh. 1, at 1. Pursuant to this
registration, Respondent is authorized to dispense controlled
substances in schedules II through V as a practitioner. Id.
Respondent's registration expires on February 28, 2021, and is ``in an
active pending status.'' Id.
The Status of Respondent's State License
On June 18, 2018, an Administrative Law Judge at the Georgia Office
of State Administrative Hearings (hereinafter, Georgia ALJ) issued her
Initial Decision concerning a matter initiated by the GCMB to sanction
Respondent's medical license. Government Motion, Exh. 2, at 1.
According to the Initial Decision, a ``board certified family practice
physician with 39 years' experience'' completed a peer review of
Respondent's treatment and care of two individuals at the request of
the GCMB. Id. at 12.
Regarding the first individual, the peer reviewer opined that
Respondent's treatment fell below the standard of care when he (1)
treated the individual as a patient when they were engaged in a sexual
relationship; (2) failed to maintain medical records to support his
prescription of medications, including controlled substances; (3)
failed to maintain a medical record to support the ordering of a breast
ultrasound and diagnostic mammogram; (4) failed to maintain a medical
record when making a ``lumbago'' diagnosis; and (5) failed to use
proper history, physical, laboratory tests, and radiological procedures
to make a diagnosis. Id. at 12-13.
As to the other individual, the peer reviewer opined that
Respondent's treatment fell below the standard of care when he (1)
performed a gynecological examination without a female chaperone
present; (2) had sexual relations with the individual after performing
a gynecological examination; (3) failed to put a date on the purported
record of the injections he gave the individual and the individual's
subsequent reaction; and (4) failed to perform a gynecological
examination, pap smear, and mammogram before purportedly administering
an initial injection of Depo-Provera. Id. at 21-22.
The Georgia ALJ concluded that the GCMB established by a
preponderance of the evidence that Respondent (1) knowingly made
misleading, deceptive, untrue, or fraudulent representations in the
practice of his profession in a purported medical record and to the
GCMB; (2) indicated untrustworthiness and engaged in conduct
discrediting the medical profession by his acts and omissions; (3)
failed to conform to the minimum standards of acceptable and prevailing
medical practice; (4) mistreated both individuals; and (5) failed to
timely respond to an investigative subpoena issued by the GCMB. Id. at
24-26, 28-29. She found that Respondent ``was cavalier in prescribing
medications, including controlled substances . . . [and] did not
document any objective data to justify the prescriptions. Id. at 31.
The Georgia ALJ concluded that Respondent's conduct with regard to the
two individuals was ``egregious'' and ``reprehensible,'' making
revocation the appropriate sanction. Id. Thus, she revoked Respondent's
medical license. Id.
On September 21, 2018, the GCMB issued a Final Decision
(hereinafter, Final Decision). The Final Decision adopted the Findings
of Fact and Conclusions of Law set forth in the Initial Decision and
revoked Respondent's medical license No. 38600, effective upon
docketing. Government Motion, Exh. 3, at 2. The GCMB also denied
Respondent's Motion for Rehearing after finding that Respondent had not
demonstrated that (1) the GCMB overlooked any material fact,
controlling authority, or intervening change in controlling authority;
(2) the GCMB or the Georgia ALJ made a clear error; (3) there was a
manifest injustice; or (4) the legal authority was erroneously
construed or misapplied. Order Denying Rehearing dated November 8,
2018, Government Motion, Exh. 4, at 5.
According to Georgia's online records, of which I take official
notice, Respondent's license is still revoked.\5\ GCMB Search for a
Licensee, https://gcmb.mylicense.com/verification (last visited
September 9, 2019).
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\5\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e),
``[w]hen an agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a party is
entitled, on timely request, to an opportunity to show the
contrary.'' Accordingly, Respondent may dispute my finding by filing
a properly supported motion for reconsideration within 15 calendar
days of the date of this Order. Any such motion shall be filed with
the Office of the Administrator and a copy shall be served on the
Government. In the event Respondent files a motion, the Government
shall have 15 calendar days to file a response.
---------------------------------------------------------------------------
Accordingly, I find that Respondent currently is not licensed to
practice medicine in Georgia, the state in which he is registered with
the DEA.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the
Controlled Substances Act (hereinafter, CSA), ``upon a finding that the
registrant . . . has had his State license or registration suspended .
. . [or] revoked . . . by competent State authority and is no longer
authorized by State law to engage in the . . . dispensing of controlled
substances.'' With respect to a practitioner, the DEA has also long
held that the possession of authority to dispense controlled substances
under the laws of the state in which a practitioner engages in
professional practice is a fundamental condition for obtaining and
maintaining a practitioner's registration. See, e.g., James L. Hooper,
M.D., 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (1978).
This rule derives from the text of two provisions of the CSA.
First, Congress defined the term ``practitioner'' to mean ``a physician
. . . or other person licensed, registered, or otherwise permitted, by
. . . the jurisdiction in which he practices . . ., to distribute,
dispense, . . . [or] administer . . . a controlled substance in the
course of professional practice.'' 21 U.S.C. 802(21). Second, in
setting the requirements for obtaining a practitioner's registration,
Congress directed that ``[t]he Attorney General shall register
practitioners . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated
that a practitioner possess state authority in order to be deemed a
practitioner under the CSA, the DEA has held repeatedly that revocation
of a practitioner's registration is the appropriate sanction whenever
he is no longer authorized to dispense controlled substances under the
laws of the state in which he practices. See, e.g., Hooper, supra, 76
FR at 71371-72; Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006);
Dominick A. Ricci, M.D., 58 FR 51104, 51,105 (1993); Bobby Watts, M.D.,
53 FR 11919, 11920 (1988); Blanton, supra, 43 FR at 27617.
According to Georgia statute, ``Every person who . . . dispenses
any controlled substances within this state . . . must obtain annually
a registration issued by the State Board of Pharmacy.'' Ga. Code Ann.
Sec. 16-13.35(a) (Westlaw, current through acts passed during the 2019
Session of the General Assembly).
[[Page 49555]]
A person who is licensed as a physician, however, is ``registered'' and
exempt from the statute's registration fee and application
requirements. Ga. Code Ann. Sec. 16-13-35(g)(2) (Westlaw, current
through acts passed during the 2019 Session of the General Assembly).
The Georgia Code defines ``physician'' as ``a person licensed to
practice medicine.'' Ga. Code Ann. Sec. 43-34-21(2) (Westlaw, current
through acts passed during the 2019 Session of the General Assembly).
Under Georgia law, ``to practice medicine'' includes ``attaching the
title `M.D.' . . . to one's name, indicating that such person is
engaged in the treatment or diagnosis of disease, defects, or injuries
to human beings.'' Ga. Code Ann. Sec. 43-34-21(3) (Westlaw, current
through acts passed during the 2019 Session of the General Assembly).
Here, the undisputed evidence in the record, including Respondent's
admission, is that Respondent currently lacks authority to practice
medicine in Georgia. Government Motion, Exhs. 2-4; RMRC, at 2. As
already discussed, a ``physician,'' under Georgia law, is a person
licensed to practice medicine. Further, under Georgia law, a
``physician'' is registered to dispense controlled substances. Because
Respondent lacks authority to practice medicine in Georgia, he is not
registered to handle controlled substances in Georgia according to
Georgia law. Accordingly, Respondent is not eligible to maintain a DEA
registration and I will order that Respondent's DEA registration be
revoked.\6\
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\6\ Given my findings that Respondent is registered with the DEA
in Georgia, that his Georgia medical license is revoked, and that he
lacks authority in Georgia to dispense controlled substances, I find
that both of Respondent's CAPs--changing his registered address to
another state or a Territory of the United States, and ``procuring a
position as an undercover physician to infiltrate pill mills and
help in the war against drugs''--provide no basis for me to
discontinue or defer this proceeding. 21 U.S.C. 824(c)(3).
---------------------------------------------------------------------------
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
BS4014332 issued to John Yolman Salinas, M.D. Pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby
deny any pending application of John Yolman Salinas to renew or to
modify this registration, and any pending application of John Yolman
Salinas to be registered in the state of Georgia. This Order is
effective October 21, 2019.
Dated: September 9, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-20420 Filed 9-19-19; 8:45 am]
BILLING CODE 4410-09-P