Robert Wayne Mosier, D.O.; Denial of Application, 49950-49951 [2010-20237]
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49950
Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
sroberts on DSKD5P82C1PROD with NOTICES
Robert Wayne Mosier, D.O.; Denial of
Application
On September 30, 2009, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Robert Wayne Mosier,
D.O. (Respondent), of Talihina,
Oklahoma. The Show Cause Order
proposed the denial of Respondent’s
application for a DEA Certificate of
Registration, as a practitioner, on the
ground that he is ‘‘currently without
authority to handle controlled
substances or practice medicine in the
State of Oklahoma, the state in which
[he is] registered with DEA.’’ Show
Cause Order at 1.
More specifically, the Show Cause
Order alleged that Respondent had
possessed a DEA Certificate of
Registration, BM5225289, which
expired by its terms on January 31,
2009, and that because he did not file
an application for renewal of his DEA
registration until April 23, 2009, his
renewal application ‘‘is treated as a new
application for DEA registration.’’ Id.
The Order further alleged that ‘‘[a]s a
result of actions by the Oklahoma State
Board of Osteopathic Examiners and the
Oklahoma Bureau of Narcotics and
Dangerous Drugs,’’ Respondent lacked
the authority to handle controlled
substances or to practice medicine in
Oklahoma Id. The Order further
explained that Respondent had the right
to request a hearing on the allegations
or to submit a statement in lieu of a
hearing, the procedures for doing so,
and the consequences if he failed to do
so. Id.
On October 6, 2009, the Order to
Show Cause was served on Respondent
by certified mail as evidenced by the
signed return receipt card. Since that
time, neither Respondent, nor any one
purporting to represent him, has
requested a hearing. Because more than
thirty days have passed since
Respondent was served with the Show
Cause Order, and Respondent has not
requested a hearing (or submitted a
written statement), I conclude that
Respondent has waived his rights to do
either. 21 CFR 1301.43(d). I therefore
enter this Decision and Final Order
based on relevant material contained in
the record and make the following
findings.
Findings
Respondent was previously registered
with DEA to dispense controlled
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18:51 Aug 13, 2010
Jkt 220001
substances in schedules II through V as
a practitioner, and was assigned
Certificate of Registration, BM5225289,
which expired by its terms on January
31, 2009. Ex. H. Although the DEA
mailed Respondent a renewal notice on
December 10, 2008 and a delinquency
notice on April 7, 2009, the Agency did
not receive a renewal application from
Respondent until April 23, 2009. Id.
Respondent holds a license to practice
osteopathic medicine in the State of
Oklahoma. However, on June 18, 2009,
the Oklahoma State Board of
Osteopathic Examiners found
Respondent to be in violation of various
provisions of the Oklahoma Osteopathic
Medicine Act and that ‘‘in the interest of
public safety,’’ Respondent’s license
‘‘shall be suspended immediately’’ and
‘‘remain suspended until further order of
the Board.’’ Order of Suspension with
Conditions 2–3, State Board of
Osteopathic Examiners v. R. Wayne
Mosier, D.O., No. 0712–0001 (June 18,
2009).
Respondent also held an Oklahoma
Controlled Substance Registration.
However, on February 10, 2009, the
Oklahoma State Bureau of Narcotics and
Dangerous Drugs (BNDD) issued an
Order to Show Cause to Respondent as
to why it should not revoke
Respondent’s state controlled substance
registration. Order to Show Cause at 1
& 9, Oklahoma ex rel. Oklahoma State
Bureau of Narcotics and Dangerous
Drugs Control v. Robert Wayne Mosier,
D.O., (No. SCH–2009–02). The Order
alleged that, between 2007 and 2008,
four of Respondent’s patients had died
from lethal overdoses of controlled
substances and that ‘‘each of these
patients had, not long before their death,
received prescriptions for various
controlled dangerous substances from
Respondent.’’ Id. at 4.
The BNDD also alleged that
Respondent had ‘‘failed to guard against
the diversion of controlled dangerous
substances,’’ that he ‘‘dispensed
controlled dangerous substances to
patients without a legitimate medical
need,’’ that he treated individuals
addicted to controlled substances for
addiction without being licensed to
provide a narcotic treatment program,
that he self-prescribed controlled
substances, that he failed to maintain
accurate dispensing records, and that
his office lacked the proper security
controls to store controlled substances.
Id. at 4–8.
On April 7, 2009, following a
proceeding before a state Administrative
Law Judge, BNDD immediately revoked
Respondent’s state controlled substance
registration. Final Order at 2, Oklahoma
ex rel. Oklahoma State Bureau of
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Frm 00065
Fmt 4703
Sfmt 4703
Narcotics and Dangerous Drugs Control
v. Robert Wayne Mosier, D.O. The
BNDD Order provided that Respondent
was further ‘‘prohibited from making
application for a[] [state] registration for
a period of at least one (1) year.’’ Id. A
printout from the BNDD Web site dated
January 13, 2010, indicates that
Respondent had undergone disciplinary
action and that the status of his
registration is ‘‘inactive.’’ Ex. E.
Discussion
DEA does not have statutory authority
to grant or maintain a DEA registration
if the applicant or registrant lacks
authority to handle controlled
substances under the laws of the State
in which he is engaged in professional
practice. See 21 U.S.C. 802(21) (defining
the term ‘‘practitioner’’ as a person
‘‘licensed, registered, or otherwise
permitted, by the United States or the
jurisdiction in which he practices * * *
to distribute, dispense * * * [or]
administer * * * a controlled
substance’’); id. § 823(f) (‘‘The Attorney
General shall register practitioners
* * * to dispense * * * controlled
substances * * * if the applicant is
authorized to dispense * * * controlled
substances under the laws of the State
in which he practices.’’); id. § 824(a)(3)
(authorizing revocation ‘‘upon a finding
that the registrant has had his State
license or registration suspended,
revoked, or denied by competent State
authority and is no longer authorized by
State law to engage in the distribution[]
or dispensing of controlled substances’’).
DEA has consistently held that holding
authority under state law is a
prerequisite for obtaining a registration
under the CSA. See Worth S. Wilkinson,
71 FR 30173 (2006); Stephen J. Graham,
69 FR 11661 (2004); Dominick A. Ricci,
58 FR 51104 (1993); Bobby Watts, 53 FR
11919 (1988).
Moreover, the Agency has held that
revocation is warranted (and denied
applications) even in those instances
where a practitioner’s state license has
only been suspended, and there is the
possibility of reinstatement. See Bourne
Pharmacy, 72 FR 18273, 18274 (2007);
Alton E. Ingram, Jr., 69 FR 22562 (2004);
Anne Lazar Thorn, 62 FR 12847 (1997)
(‘‘the controlling question is not whether
a practitioner’s license to practice
medicine in the state is suspended or
revoked; rather, it is whether the
Respondent is currently authorized to
handle controlled substances’’). As
Respondent clearly lacks authority to
handle controlled substances under
Oklahoma law, the State in which he
has applied for registration, his
application will be denied.
E:\FR\FM\16AUN1.SGM
16AUN1
Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Notices
Order
Pursuant to the authority invested in
me by 21 U.S.C. 823(f), as well as by 28
CFR 0.100(b) and 0.104, I hereby order
that the application of Robert Wayne
Mosier, M.D., for a DEA Certificate of
Registration as a practitioner be, and it
hereby is, denied. This order is effective
immediately.
Dated: July 30, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010–20237 Filed 8–13–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08–15]
sroberts on DSKD5P82C1PROD with NOTICES
Hilmes Distributing, Inc.; Dismissal of
Proceeding
On October 31, 2007, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to Hilmes Distributing,
Inc. (Respondent), of Trenton, Illinois.
The Order proposed the revocation of
Respondent’s DEA Certificate of
Registration, which authorizes it to
distribute List I chemicals, and the
denial of any pending applications for
renewal or modification of the
registration, on the ground that its
‘‘continued registration * * * is
inconsistent with the public interest, as
that term is defined in 21 U.S.C. 823(h).’’
ALJ Ex. 1, at 1.
The Show Cause Order specifically
alleged that ‘‘[c]onvenience stores and
gas stations continue to be the primary
source for precursors that are diverted to
illicit methamphetamine laboratory
operators in many states’’ and that
Respondent ‘‘distributes large amounts
of ephedrine-based products almost
exclusively to convenience stores and
gas stations.’’ Id. at 1–2. The Order
alleged that ‘‘the normal expected sales
range to meet legitimate demand for
combination ephedrine products is
between $0 and $25 per month, with an
average of $12.58 per month,’’ and that
Respondent’s ‘‘sales of combination
ephedrine products greatly surpass the
expected sales range to meet any
legitimate demand for combination
ephedrine products.’’ Id. at 2. The Order
further alleged that Respondent’s sales
to four stores during the months of June
through August 2006 ‘‘greatly
surpass[ed] the expected sales range to
meet any legitimate demand for
combination ephedrine products,’’ and
that while not ‘‘exhaustive,’’ these sales
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are ‘‘nonetheless representative of
[Respondent’s] sales pattern of [sic]
combination ephedrine products’’ in
amounts which ‘‘are inconsistent with
the known legitimate market.’’ Id. The
Order thus concluded by alleging that
‘‘these types of businesses do not sell
such inordinately large volumes of List
I chemicals for legitimate uses,’’ that
Respondent’s ‘‘continued registration
will result in the continued diversion of
List I chemicals,’’ and that it ‘‘is
inconsistent with the public interest.’’
Id.
On November 21, 2007, Respondent,
through its counsel, requested a hearing
on the allegations. ALJ Ex. 2. The matter
was placed on the docket of the
Agency’s Administrative Law Judges
(ALJs), and a hearing was held on April
15, 2008, in St. Louis, Missouri. At the
hearing, both parties called witnesses to
testify and introduced documentary
evidence. After the hearing, only
Respondent filed a brief.
On October 7, 2009, the ALJ issued
her recommended decision (also ALJ) in
the matter. Therein, the ALJ examined
the five public interest factors (see 21
U.S.C. 823(h)) and concluded that the
Government had not met its burden of
proving that Respondent’s continued
registration is inconsistent with the
public interest. ALJ at 25.
With respect to the first factor—the
maintenance of effective controls
against diversion—the ALJ noted that
during a November 2006 inspection of
Respondent, there were no deficiencies
in its physical security and that DEA
has never advised Respondent that its
‘‘physical security for its listed chemical
products was inadequate.’’ ALJ at 17.
The ALJ also found that Respondent had
implemented various procedures to
ensure its customers followed both
Federal and state laws applicable to the
retail distribution of listed chemicals.
Id. The ALJ thus concluded that this
factor weighed ‘‘in favor of renewing the
Respondent’s DEA registration.’’ ALJ at
17.
Examining the second and fourth
factors together—the registrant’s
compliance with applicable State,
Federal and local law, as well as its past
experience in the distribution of List I
chemicals—the ALJ noted that while
Respondent has held a registration since
1997, it has never been cited by DEA for
any regulatory violations. Id. at 18.
Moreover, the ALJ noted that the
Diversion Investigator (DI) who
performed the inspection had testified
that Respondent ‘‘is probably one of the
better distributors, as far as
recordkeeping goes.’’ Id.
With respect to the Government’s
principal allegation, the ALJ found that
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49951
the Government had not established a
baseline figure necessary to show that
Respondent’s sales were so excessive as
to support a finding that the products
were being diverted. Id. at 21. While the
ALJ noted that the Government had
submitted the declarations of an expert
witness as to the expected sales range of
combination ephedrine products at
convenience stores to meet legitimate
demand and had previously relied on
this evidence in several cases to prove
that diversion had occurred, the ALJ
noted that in a subsequent case, the
expert’s methodology was found to be
unreliable. Id. (citing Novelty
Distributors, Inc., 73 FR 52689, 52693–
95 (2008)). Accordingly, the ALJ
concluded that ‘‘the Government has not
established by a preponderance of the
evidence that these figures accurately
represent the average dollar amount of
expected sales of listed chemical
products.’’ Id.
Citing my decision in Novelty, 73 FR
at 52703–04, the ALJ calculated the
customers’ average monthly sales
(which she found to be $ 453.86) and
then used this as the baseline for
determining whether its sales to
individual stores were in excess of
legitimate demand. Id. The ALJ
concluded, however, that while its sales
to one gas station during a three-month
period ‘‘seem excessive,’’ these sales
created only a ‘‘suspicion of diversion,’’
which under agency precedent was not
sufficient to prove that its products were
being diverted. Id. at 21–22 (citing John
J. Fotinopoulos, 72 FR 24602, 24604
(2005)). The ALJ thus found that ‘‘th[es]e
factor[s] weigh[] in favor of Respondent
being allowed to continue handling
listed chemical products.’’ Id. at 24.
As for the third factor—Respondent’s
conviction record under Federal or State
laws relating to controlled substances or
listed chemicals—the ALJ found that
neither Respondent nor any of its
employees have been convicted of an
offense ‘‘related to their handling of
listed chemical products under either
Federal or State law.’’ Id. at 23. As for
the fifth factor—other factors relevant to
and consistent with public health and
safety—the ALJ concluded that ‘‘absent
evidence of such excessive sales that
diversion is a reliable conclusion * * *
Respondent’s continued sale of listed
chemical products to its customers, in
the manner in which [it] conducts its
business, does not create a risk of
diversion of these products to the illicit
market.’’ Id. at 24. The ALJ thus
concluded that the Government had not
proved that Respondent’s continued
registration would be inconsistent with
the public interest. Id. at 25.
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16AUN1
Agencies
[Federal Register Volume 75, Number 157 (Monday, August 16, 2010)]
[Notices]
[Pages 49950-49951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20237]
[[Page 49950]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Robert Wayne Mosier, D.O.; Denial of Application
On September 30, 2009, the Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement Administration, issued an Order
to Show Cause to Robert Wayne Mosier, D.O. (Respondent), of Talihina,
Oklahoma. The Show Cause Order proposed the denial of Respondent's
application for a DEA Certificate of Registration, as a practitioner,
on the ground that he is ``currently without authority to handle
controlled substances or practice medicine in the State of Oklahoma,
the state in which [he is] registered with DEA.'' Show Cause Order at
1.
More specifically, the Show Cause Order alleged that Respondent had
possessed a DEA Certificate of Registration, BM5225289, which expired
by its terms on January 31, 2009, and that because he did not file an
application for renewal of his DEA registration until April 23, 2009,
his renewal application ``is treated as a new application for DEA
registration.'' Id. The Order further alleged that ``[a]s a result of
actions by the Oklahoma State Board of Osteopathic Examiners and the
Oklahoma Bureau of Narcotics and Dangerous Drugs,'' Respondent lacked
the authority to handle controlled substances or to practice medicine
in Oklahoma Id. The Order further explained that Respondent had the
right to request a hearing on the allegations or to submit a statement
in lieu of a hearing, the procedures for doing so, and the consequences
if he failed to do so. Id.
On October 6, 2009, the Order to Show Cause was served on
Respondent by certified mail as evidenced by the signed return receipt
card. Since that time, neither Respondent, nor any one purporting to
represent him, has requested a hearing. Because more than thirty days
have passed since Respondent was served with the Show Cause Order, and
Respondent has not requested a hearing (or submitted a written
statement), I conclude that Respondent has waived his rights to do
either. 21 CFR 1301.43(d). I therefore enter this Decision and Final
Order based on relevant material contained in the record and make the
following findings.
Findings
Respondent was previously registered with DEA to dispense
controlled substances in schedules II through V as a practitioner, and
was assigned Certificate of Registration, BM5225289, which expired by
its terms on January 31, 2009. Ex. H. Although the DEA mailed
Respondent a renewal notice on December 10, 2008 and a delinquency
notice on April 7, 2009, the Agency did not receive a renewal
application from Respondent until April 23, 2009. Id.
Respondent holds a license to practice osteopathic medicine in the
State of Oklahoma. However, on June 18, 2009, the Oklahoma State Board
of Osteopathic Examiners found Respondent to be in violation of various
provisions of the Oklahoma Osteopathic Medicine Act and that ``in the
interest of public safety,'' Respondent's license ``shall be suspended
immediately'' and ``remain suspended until further order of the
Board.'' Order of Suspension with Conditions 2-3, State Board of
Osteopathic Examiners v. R. Wayne Mosier, D.O., No. 0712-0001 (June 18,
2009).
Respondent also held an Oklahoma Controlled Substance Registration.
However, on February 10, 2009, the Oklahoma State Bureau of Narcotics
and Dangerous Drugs (BNDD) issued an Order to Show Cause to Respondent
as to why it should not revoke Respondent's state controlled substance
registration. Order to Show Cause at 1 & 9, Oklahoma ex rel. Oklahoma
State Bureau of Narcotics and Dangerous Drugs Control v. Robert Wayne
Mosier, D.O., (No. SCH-2009-02). The Order alleged that, between 2007
and 2008, four of Respondent's patients had died from lethal overdoses
of controlled substances and that ``each of these patients had, not
long before their death, received prescriptions for various controlled
dangerous substances from Respondent.'' Id. at 4.
The BNDD also alleged that Respondent had ``failed to guard against
the diversion of controlled dangerous substances,'' that he ``dispensed
controlled dangerous substances to patients without a legitimate
medical need,'' that he treated individuals addicted to controlled
substances for addiction without being licensed to provide a narcotic
treatment program, that he self-prescribed controlled substances, that
he failed to maintain accurate dispensing records, and that his office
lacked the proper security controls to store controlled substances. Id.
at 4-8.
On April 7, 2009, following a proceeding before a state
Administrative Law Judge, BNDD immediately revoked Respondent's state
controlled substance registration. Final Order at 2, Oklahoma ex rel.
Oklahoma State Bureau of Narcotics and Dangerous Drugs Control v.
Robert Wayne Mosier, D.O. The BNDD Order provided that Respondent was
further ``prohibited from making application for a[] [state]
registration for a period of at least one (1) year.'' Id. A printout
from the BNDD Web site dated January 13, 2010, indicates that
Respondent had undergone disciplinary action and that the status of his
registration is ``inactive.'' Ex. E.
Discussion
DEA does not have statutory authority to grant or maintain a DEA
registration if the applicant or registrant lacks authority to handle
controlled substances under the laws of the State in which he is
engaged in professional practice. See 21 U.S.C. 802(21) (defining the
term ``practitioner'' as a person ``licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which he
practices * * * to distribute, dispense * * * [or] administer * * * a
controlled substance''); id. Sec. 823(f) (``The Attorney General shall
register practitioners * * * to dispense * * * controlled substances *
* * if the applicant is authorized to dispense * * * controlled
substances under the laws of the State in which he practices.''); id.
Sec. 824(a)(3) (authorizing revocation ``upon a finding that the
registrant has had his State license or registration suspended,
revoked, or denied by competent State authority and is no longer
authorized by State law to engage in the distribution[] or dispensing
of controlled substances''). DEA has consistently held that holding
authority under state law is a prerequisite for obtaining a
registration under the CSA. See Worth S. Wilkinson, 71 FR 30173 (2006);
Stephen J. Graham, 69 FR 11661 (2004); Dominick A. Ricci, 58 FR 51104
(1993); Bobby Watts, 53 FR 11919 (1988).
Moreover, the Agency has held that revocation is warranted (and
denied applications) even in those instances where a practitioner's
state license has only been suspended, and there is the possibility of
reinstatement. See Bourne Pharmacy, 72 FR 18273, 18274 (2007); Alton E.
Ingram, Jr., 69 FR 22562 (2004); Anne Lazar Thorn, 62 FR 12847 (1997)
(``the controlling question is not whether a practitioner's license to
practice medicine in the state is suspended or revoked; rather, it is
whether the Respondent is currently authorized to handle controlled
substances''). As Respondent clearly lacks authority to handle
controlled substances under Oklahoma law, the State in which he has
applied for registration, his application will be denied.
[[Page 49951]]
Order
Pursuant to the authority invested in me by 21 U.S.C. 823(f), as
well as by 28 CFR 0.100(b) and 0.104, I hereby order that the
application of Robert Wayne Mosier, M.D., for a DEA Certificate of
Registration as a practitioner be, and it hereby is, denied. This order
is effective immediately.
Dated: July 30, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-20237 Filed 8-13-10; 8:45 am]
BILLING CODE 4410-09-P