[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73777-73778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25533]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


ECO Apothecary, LLC; Decision and Order

    On December 2, 2019, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause (hereinafter, OSC) to Eco 
Apothecary, LLC (hereinafter, Registrant or Registrant Pharmacy), of 
Salt Lake City, Utah. Government's Request for Final Agency Action 
Exhibit (hereinafter, RFAAX) 2 (OSC), at 1. The OSC proposed the 
revocation of Registrant's Certificate of Registration No. FE7288497. 
It alleged that Registrant is without ``authority to handle controlled 
substances in the State of Utah, the state in which [Registrant] is 
registered with the DEA.'' Id. (citing 21 U.S.C. 824(a)(3)).
    Specifically, the OSC alleged that Registrant's Utah pharmacy 
license is expired. Id. The OSC further alleged that, because 
Registrant's Utah pharmacy license is expired, Registrant lacks the 
authority to handle controlled substances in Utah, and is, therefore, 
ineligible to maintain a DEA registration. Id. at 1-2.
    The OSC notified Registrant of the right to either request a 
hearing on the allegations or submit a written statement in lieu of 
exercising 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 Registrant of the 
opportunity to submit a corrective action plan. Id. at 2-3 (citing 21 
U.S.C. 824(c)(2)(C)).

I. Adequacy of Service

    A DEA Diversion Investigator declared that he personally served 
James Ammon, Rph, with the OSC at the Registrant Pharmacy on December 
10, 2019. RFAAX 4 (Declaration of Diversion Investigator). James Ammon 
signed Registrant's online application for a DEA registration on 
November 23, 2017. RFAAX 1 (Certification of Registration History). The 
DEA Diversion Investigator declared that he recognized James Ammon 
because the Diversion Investigator had previously met with him. RFAAX 
4.
    The Government forwarded its RFAA, along with the evidentiary 
record, to this office on May 19, 2020. In its RFAA, the Government 
represents that ``Registrant has not requested a hearing . . . .'' RFAA 
at 1. DEA did receive a letter from Registrant dated February 25, 2020, 
which stated that the purpose of the letter was ``to complete its duty, 
and report to the DEA the record of the pharmacy's final inventory, as 
well as report to the DEA its disposition and transfer of control of 
the controlled substances previously in the pharmacy's control.'' RFAAX 
6, at 1. Registrant's February 25 letter did not request a hearing and 
was sent more than thirty days after Registrant received the OSC. See 
id.
    Based on the Diversion Investigator's Declaration, the Government's 
written representations, and my review of the record, I find that the 
Government accomplished service of the OSC on Registrant on December 
10, 2019. I also find that more than thirty days have now passed since 
the Government accomplished service of the OSC. Further, based on the 
Government's written representations, I find that neither Registrant, 
nor anyone purporting to represent Registrant, requested a hearing, 
submitted a written statement while waiving Registrant's right to a 
hearing, or submitted a corrective action plan. Accordingly, I find 
that Registrant has waived the right to a hearing and the right to 
submit a written statement and corrective action plan. 21 CFR 
1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this 
Decision and Order based on the record submitted by the Government, 
which constitutes the entire record before me. 21 CFR 1301.43(e).

[[Page 73778]]

II. Findings of Fact

A. Registrant's DEA Registration

    Registrant is the holder of DEA Certificate of Registration No. 
FE7288497 at the registered address of 3702 S. State Street, Suite 117, 
Salt Lake City 84115. RFAAX 2 (Certification of Registration History). 
Pursuant to this registration, Registrant is authorized to dispense 
controlled substances in schedules II-V as a retail pharmacy. Id.

B. The Status of Registrant's State License

    Registrant was previously the holder of a Utah Pharmacy--Class B 
license. RFAAX 3 (Verification of Utah Licensure). Registrant's Utah 
pharmacy license expired on September 30, 2019. Id. A certified 
Verification of Utah Licensure dated November 13, 2019, from the State 
of Utah, Department of Commerce, Division of Occupational and 
Professional Licensing, shows the status of Registrant's Utah pharmacy 
license as ``Denied.'' Id.
    According to Utah's online records, of which I take official 
notice, Registrant's pharmacy license status is still listed as 
``Denied.'' \1\ https://secure.utah.gov/llv/search/index.html (last 
visited October 27, 2020). Utah's online records further show that 
Registrant's Controlled Substance License also expired on September 30, 
2019, and the license status is also listed as ``Denied.'' Id.
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    \1\ 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, Registrant may dispute my finding by filing 
a properly supported motion for reconsideration within fifteen 
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 Registrant files a motion, 
the Government shall have fifteen calendar days to file a response. 
Any such motion and response may be filed and served by email 
([email protected]).
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    Accordingly, I find that Registrant does not have a valid pharmacy 
license or controlled substance license in Utah, the state in which 
Registrant is registered with DEA.

III. 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.'' A pharmacy is a ``practitioner'' under the CSA. 21 U.S.C. 
802(21). 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., Palafox Pharmacy, 
84 FR 18,320 (2019); James L. Hooper, M.D., 76 FR 71,371 (2011), pet. 
for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Roots 
Pharmaceuticals, Inc., 76 FR 51,430 (2011); Bourne Pharmacy, Inc., 72 
FR 18,273 (2007); Frederick Marsh Blanton, M.D., 43 FR 27,616 (1978).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined the term ``practitioner'' to mean ``a 
physician, . . . pharmacy, . . . 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., Palafox Pharmacy, 84 FR at 18,321; James L. 
Hooper, 76 FR at 71,371-72; Roots Pharmaceuticals, Inc., 76 FR at 
51,430; Bourne Pharmacy, Inc., 72 FR at 18,274; Frederick Marsh 
Blanton, 43 FR at 27,617.
    As found above, Registrant's state pharmacy and controlled 
substance licenses have expired, and thus, it no longer holds authority 
in Utah, the state in which it is registered with DEA, to dispense 
controlled substances. See Utah Code Ann. Sec. Sec.  58-17b-302(1) 
(requiring a license to act as a pharmacy); 58-37-6(2)(a)(i) (requiring 
a license to dispense controlled substances) (West 2020). As such, 
Registrant is not qualified to dispense controlled substances as a 
``practitioner.'' I will, therefore, order that Registrant's DEA 
registration be revoked.

IV. 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. 
FE7288497 issued to Eco Apothecary, LLC. Further, 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 Eco Apothecary, LLC to renew or modify 
this registration, as well as any pending application of Eco 
Apothecary, LLC for registration in Utah. This Order is applicable 
December 21, 2020.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-25533 Filed 11-18-20; 8:45 am]
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