[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]


-----------------------------------------------------------------------

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)).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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