[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21719-21720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07512]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Emed Medical Company LLC and Med Assist Pharmacy; Decision and
Order
On September 15, 2022, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) proposing to revoke the
registrations of and deny any pending applications of Emed Medical
Company LLC and Med Assist Pharmacy (collectively Registrants).\1\
Request for Final Agency Action (RFAA), Exhibit (RFAAX) 38 (OSC), at 1,
2, 3, 7. The OSC alleged that Registrants materially falsified multiple
applications for registration and renewal. Id. at 2-6 (citing 21 U.S.C.
824(a)(1)).
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\1\ The OSC proposed to revoke Emed Medical Company LLC's
Certificate of Registration No. RE0357271 at the registered address
of 11551 Adie Road, Maryland Heights, Missouri 63043, and Med Assist
Pharmacy's Certificate of Registration No. FM2022008 at the
registered address of 11551 Adie Road, Maryland Heights, Missouri
63043.
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The Agency makes the following findings of fact based on the
uncontroverted evidence submitted by the Government in its RFAA dated
February 10, 2023.\2\
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\2\ Based on a Declaration from a DEA Diversion Investigator,
the Agency finds that the Government's service of the OSC on
Registrants was adequate. RFAAX 39, at 2. Further, based on the
Government's assertions in its RFAA, the Agency finds that more than
thirty days have passed since Registrants were served with the OSC
and Registrants have neither requested a hearing nor submitted a
corrective action plan and therefore have waived any such rights.
RFAA, at 10; see also 21 U.S.C. 824(c)(2); 21 CFR 1301.43.
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I. Findings of Fact
a. Relationship Between Registrants
The OSC was addressed to both Emed Medical Company LLC and Med
Assist Pharmacy. RFAAX 38, at 1. The Agency finds that for the purposes
of this matter, Registrants are one and the same. The Missouri
``Registration of Fictitious Name'' documentation provides that Emed
Medical Company LLC is the sole owner of Med Assist Pharmacy and
identifies Eric Bailey, who is the sole owner and operator of Emed
Medical Company LLC, as the point of contact. RFAAX 2; RFAAX 7, at 2.
Further, both Agency records and publicly available Missouri records
show that Registrants share a registered address and share a President/
contact, Eric Bailey. RFAAX 1, at 2-3; RFAAX 3; RFAAX 4; RFAAX 5, at 1-
2; RFAAX 6; RFAAX 34, at 1-2.
b. Registrants' Falsified Applications
At all times relevant to this matter (July 2007 through August
2022), the DEA ``Application for Registration Under Controlled
Substances Act of 1970'' (Application) asked as a question regarding
liability information: ``3. Has the applicant ever surrendered (for
cause) or had a state professional license or controlled substance
registration revoked, suspended, denied, restricted, or placed on
probation, or is any such action pending?'' RFAAX 18, at 1; see also
RFAAX 19-33, 37.
As part of a settlement agreement with the Missouri State Board of
Pharmacy, Eric Bailey, signing on behalf of Emed Medical Products,\3\
agreed that Emed's license as a wholesale distributor would be placed
on probation for two years beginning on or about January 17, 2003.
RFAAX 7, at 1, 6, 9.\4\ Despite clear evidence of having had their
wholesale distributor license placed on probation, Registrants answered
``No'' to liability question 3 for their initial application with DEA
on July 7, 2007, and on each of the sixteen subsequent applications
submitted by Registrants annually between 2008 and 2022. RFAAX 18-33,
37.
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\3\ The record shows that in Missouri, Emed Medical Company does
business as Emed Medical Products. RFAAX 16, at 1; (compare the
registration numbers in RFAAX 7, at 2 with RFAAX 16, at 2).
\4\ The agreement settled an allegation that Mr. Bailey
purchased medication through Emed for his personal use rather than
for distribution. Id. at 2-3.
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Moreover, the following events occurred but were never disclosed by
Registrants in response to liability question 3 on any of their
applications.\5\ See RFAAX 18-33, 37. On January 28, 2013, the State
Board of Pharmacy of South Carolina temporarily suspended Emed Medical
Company's pharmacy permit. RFAAX 10, at 1. Further, on January 22,
2019, the State Board of Pharmacy of South Carolina permanently revoked
Emed Medical Company's pharmacy permit as a result of, among other
things, a criminal
[[Page 21720]]
conviction.\6\ RFAAX 14, at 1, 3. On August 8, 2019, the State of Ohio
Board of Pharmacy permanently revoked Emed Medical Company's license as
a wholesale distributor of dangerous drugs. RFAAX 15, at 4-5; see also
id. at 6-9 (May 3, 2019, letter proposing to revoke Emed Medical
Company's license). Finally, on December 28, 2020, Registrants entered
into settlement agreements with the Missouri Board of Pharmacy that
placed both Emed Medical Products' drug distributor permit and Med
Assist Pharmacy's pharmacy permit on probation for three years
beginning on or about January 23, 2021. RFAAX 16, at 6, 9; RFAAX 35, at
5, 9.
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\5\ On September 14, 2012, Eric Bailey, on behalf of Emed
Medical Company, entered into a Consent Agreement with the Maine
Board of Pharmacy. RFAAX 9, at 1, 3. The Consent Agreement stated
that ``Emed Medical Company admit[ed] to failing to disclose
disciplinary action to the Board for [its] initial Wholesaler
application,'' and that based on that information, ``the Board voted
to preliminarily deny Emed Medical Company's application for
licensure as a Wholesaler.'' Id. at 1, 2. However, the Consent
Agreement also stated that because Emed Medical Company executed the
Consent Agreement, ``the Board [would] not deny Emed Medical
Company's application . . . and [would] approve the application.''
Id. at 2. In the current matter, because there are various other
grounds for revocation, the Agency does not have to determine
whether the Maine Board of Pharmacy's vote to preliminarily deny was
required to be disclosed on Registrants' DEA applications under the
circumstances. This information is included here as background
information.
\6\ On March 12, 2015, Eric Bailey plead guilty to conspiracy to
commit mail and wire fraud after allowing Emed Medical Products'
license to be used by a criminal codefendant and facilitating the
writing of funds for shipment of pharmaceuticals. RFAAX 12, at 1, 9-
10; see also RFAAX 11; RFAAX 13. In the current matter, the OSC does
not allege that Registrants' failure to disclose this criminal
conviction in response to liability question 4 on their various DEA
applications constitutes additional incidents of material
falsification; instead, these facts are provided as background only
and are immaterial to the Agency's decision.
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In sum, despite numerous periods of probation, suspension, and
revocation in multiple state jurisdictions, Registrants answered ``No''
to liability question 3 on each of the seventeen applications they
submitted prior to issuance of the OSC. See RFAAX 18-33, 37. As such,
the Agency finds that Registrants' answers were clearly false because
Registrants, on multiple occasions, had their state controlled
substance registrations or licensures placed on probation, suspended,
and/or revoked for cause.
II. Discussion
The Administrator may suspend or revoke a registration if a
registrant materially falsified an application for registration. 21
U.S.C. 824(a)(1). Here, Registrants provided false information to
liability question 3 on each of their seventeen applications--falsely
responding that they had never had a state controlled substance
registration placed on probation, suspended, and/or revoked for cause.
See RFAAX 18-33, 37. Agency decisions have repeatedly held that false
responses to the liability questions on an application for registration
are material. E.g., Crosby Pharmacy and Wellness, 87 FR 21,212, 21,214
(2022); Frank Joseph Stirlacci, M.D., 85 FR 45,229, 45,234-35 (2020).
Accordingly, the Agency finds that the Government has established
grounds to revoke Registrants' registrations and to deny any pending
applications of Registrants.
III. Sanction
Where, as here, the Government has established grounds to revoke a
registration or deny an application, the burden shifts to the
registrants to show why they can be entrusted with the responsibility
carried by a registration. Garret Howard Smith, M.D., 83 FR 18,882,
18,910 (2018) (citing Samuel S. Jackson, 72 FR 23,848, 23,853 (2007)).
The issue of trust is necessarily a fact-dependent determination based
on the circumstances presented by the individual registrant; therefore,
the Agency looks at factors, such as the acceptance of responsibility
and the credibility of that acceptance as it relates to the probability
of repeat violations or behavior and the nature of the misconduct that
forms the basis for sanction, while also considering the Agency's
interest in deterring similar acts. See Arvinder Singh, M.D., 81 FR
8,247, 8,248 (2016).
Here, Registrants did not avail themselves of the opportunity to
refute the Government's case or demonstrate why they can be entrusted
with registration. Moreover, Registrants repeated their misconduct for
years, rendering it particularly egregious. Accordingly, the Agency
will order the sanctions requested by the Government, as contained in
the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(g)(1) and 824(a)(2), I hereby revoke Emed Medical Company
LLC's DEA Certificate of Registration No. RE0357271 and Med Assist
Pharmacy's DEA Certificate of Registration No. FM2022008. Further,
pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C.
823(g)(1), I hereby deny any pending applications of Emed Medical
Company LLC or Med Assist Pharmacy to renew or modify their
registrations, as well as any other pending application(s) that they
may have for addition registration in Missouri. This Order is effective
May 11, 2023.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 4, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-07512 Filed 4-10-23; 8:45 am]
BILLING CODE 4410-09-P