Poplar Grove Pharmacy Inc.;, 80189-80190 [2020-27234]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80189-80190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27234]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Poplar Grove Pharmacy Inc.;

    Decision and Order
    On November 20, 2019, the Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause (hereinafter, OSC) to Poplar 
Grove Pharmacy Inc. (hereinafter, Registrant) of Baltimore, Maryland. 
OSC, at 1. The OSC proposed the revocation of Registrant's Certificate 
of Registration No. FP3109027. Id. It alleged that Registrant ``has no 
state authority to handle controlled substances.'' Id. (citing 21 
U.S.C. 824(a)(3)).
    Specifically, the OSC alleged that, ``[o]n April 15, 2019, the 
Maryland State Board of Pharmacy (hereinafter, MBP) . . . issued an 
Order for Summary Suspension, suspending . . . [Registrant's] Maryland 
pharmacy permit.'' OSC, at 2. The OSC alleged that ``[c]onsequently, 
the DEA must revoke . . . [Registrant's] DEA registration based on . . 
. [its] lack of authority to handle controlled substances in the State 
of Maryland.'' Id.
    The OSC notified Registrant 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. (citing 21 CFR 
1301.43). The OSC also notified Registrant of the opportunity to submit 
a corrective action plan. OSC, at 3 (citing 21 U.S.C. 824(c)(2)(C)).

Adequacy of Service

    In a sworn Declaration, dated May 22, 2020, a DEA Diversion 
Investigator assigned to the Baltimore District Office (hereinafter, 
DI) stated that he accomplished personal service of the OSC on Susan 
Nwoga, Registrant's registration contact, at the Maryland Correctional 
Institution for Women on December 10, 2019. Request for Final Agency 
Action (hereinafter, RFAA), EX 4 (DI Declaration), at 1. The DI stated 
that Ms. Nwoga took the OSC. Id.
    Further evidence of the adequacy of the Government's service is 
Registrant's proposed Corrective Action Plan (hereinafter, CAP) dated 
December 16, 2019. RFAA EX 5 (CAP), at 1. Accordingly, based on the 
evidence in the RFAA and the Government's representations, I find that 
the Government's service of the OSC was adequate.

Registrant's Proposed CAP

    As already discussed, Registrant timely submitted a proposed CAP. 
Id. In the CAP, Registrant asked that ``DEA begin an internal 
investigation on it's [sic] failure to provide . . . [Ms. Nwoga] with 
whistle blower protection and why when big retail pharmacies are met 
with fines, the DEA set out to entrap . . . [her], a black woman who is 
an American of Nigerian descent.'' Id. at 4. Ms. Nwoga ``denied all 
charges'' and stated that she is ``entitled to all privileges of a 
licensed pharmacist.'' \1\ Id. In the CAP, Registrant did not address 
the status of its Maryland pharmacy permit, including whether the MBP 
suspended it.
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    \1\ Most of Registrant's CAP concerned Ms. Nwoga's allegations 
about ``the DEA's . . . failure to follow their own monitoring 
policy, thus, allowing the Baltimore city streets to become flooded 
with controlled narcotics.'' RFAA EX 5, at 2. The CAP stated that 
she ``satisfied all the requirements of whistle blower,'' but 
``[r]ather than protect . . . [her] the DEA began an illegal under 
cover [sic] operation that spanned many years'' and entrapped her. 
Id. at 2-3. According to the CAP, ``[t]his case is wrought with very 
ugly racism, anti-feminism, and anti-immigrant overtones in the 
Baltimore City DEA. The criminal case is under appeal and when 
reviewed by legal experts, the experts say I will absolutely be 
released from prison.'' Id. at 3.
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    I find that Registrant waived its right to a hearing and proposed a 
CAP. I find that the Assistant Administrator, Diversion Control 
Division, denied ``the request to discontinue or defer administrative 
proceedings.'' RFAA EX 6 (Letter Denying Proposed CAP), at 1. I also 
find that the Assistant Administrator concluded that ``there is no 
potential modification of . . . [the proposed CAP] that could or would 
alter . . . [his] decision in this regard.'' Id. I agree with the 
Assistant Administrator's CAP-related decisions.
    The Government forwarded its RFAA, along with the evidentiary 
record, to my office on May 28, 2020. In its RFAA, the Government 
represented that ``Registrant currently lacks authority to handle 
controlled substances in the state of Maryland, the jurisdiction where 
it was licensed as a pharmacy and where it is registered with DEA.'' 
RFAA, at 3. The Government requested ``a Final Order revoking 
Registrant's DEA registration.'' Id. at 4.
    I issue this Decision and Order based on the record submitted by 
the Government in its RFAA, which constitutes the entire record before 
me.\2\ 21 CFR 1301.43(e).
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    \2\ The RFAA includes Registrant's proposed CAP.
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Findings of Fact

Registrant's DEA Registration

    Registrant is the holder of DEA Certificate of Registration No. 
FP3109027 at the registered address of 709 Poplar Grove Street, 
Baltimore, MD 21216. RFAA, EX 1 (Certification of Registration), at 1. 
Pursuant to this registration, Registrant is authorized to dispense 
controlled substances in schedules II through V for the business 
activity of retail pharmacy. Id. Registrant's registration ``is in a 
renewal pending status until the resolution of administrative 
proceedings.'' Id.

The Status of Registrant's State License and Registration

    The Government submitted a certified copy of the ``Order for 
Summary Suspension'' concerning Registrant's pharmacy permit No. P05639 
that the MBP issued on April 15, 2019. RFAA, EX 3 (hereinafter, Summary 
Suspension Order). According to the Summary Suspension Order, 
Registrant's pharmacist ``pleaded guilty . . . to approximately three 
hundred (300) counts that included possession with . . . [the] intent 
to distribute a controlled dangerous substance, Medicaid fraud, and 
theft.'' Id. at 5. The Summary Suspension Order stated that, 
``[f]ollowing her conviction, Pharmacist A was ordered held in jail 
until the date of her sentencing.'' Id. It also stated that Registrant 
``failed to request or submit to a closing inspection by the . . . 
[MBP], as required by . . . [MBP] regulations, to ensure the proper 
transfer of controlled and non-controlled drug inventory and 
confidential prescription records.'' Id. at 6.
    After concluding that ``the public health, safety, or welfare 
imperatively requires emergency action,'' the MBP ``summarily 
suspended'' the permit issued to Registrant to operate as a pharmacy in 
Maryland. Id. The MBP thus prohibited Registrant from operating as a 
pharmacy in Maryland and ordered the immediate return of all pharmacy 
permits to the MBP. Id.
    The Government also submitted a MBP website screen print showing 
that Registrant's pharmacy permit is

[[Page 80190]]

``suspended.'' \3\ RFAA, EX 7 (State of Maryland Board of Pharmacy 
website Screen Print), at 1.
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    \3\ Although there is no date on RFAA EX 7, the Government 
represented in its RFAA that EX 7 shows Registrant's pharmacy permit 
``continues to be suspended.'' RFAA, at 3.
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    As already discussed, Registrant's proposed CAP did not address the 
status of its Maryland pharmacy permit. As such, the Government's 
record evidence that Registrant's pharmacy permit was summarily 
suspended is not rebutted.
    According to Maryland's online records, of which I take official 
notice, Registrant's pharmacy permit is still suspended today.\4\ State 
of Maryland Board of Pharmacy Web Lookup/Verification, https://mdbop.mylicense.com/Verification (last visited date of signature of 
this Order).
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    \4\ 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, Applicant may dispute my finding by filing 
a properly supported motion for reconsideration of finding of fact 
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 Applicant files 
a motion, the Government shall have fifteen calendar days to file a 
response. Any such motion and response shall be filed and served by 
email on the other party at the email address the party submitted 
for receipt of communications related to this administrative 
proceeding, and on the Office of the Administrator, Drug Enforcement 
Administration at [email protected].
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    In sum, there is no record evidence rebutting the evidence the 
Government submitted with its RFAA, EX 3 and EX 7, and the evidence 
from today's Maryland online records supports the Government's 
evidence. Accordingly, I find that Registrant's Maryland pharmacy 
permit is currently suspended.

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 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 Agency has long stated that the possession of 
authority to dispense controlled substances under the laws of the state 
in which the 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 71,371 (2011), 
pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh 
Blanton, M.D., 43 FR 27,616, 27,617 (1978).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined the term ``practitioner'' to mean ``a pharmacy 
. . . or other person licensed, registered, or otherwise permitted, by 
. . . the jurisdiction in which . . . [it] 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 Agency has repeatedly stated that 
revocation of a practitioner's registration is the appropriate sanction 
whenever it is no longer authorized to dispense controlled substances 
under the laws of the state in which she practices. See, e.g., James L. 
Hooper, M.D., 76 FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 
39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 
(1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh 
Blanton, M.D., 43 FR at 27,617.
    According to Maryland statute, ``a person shall be registered by 
the [Maryland] Department [of Health] before the person manufactures, 
distributes, or dispenses a controlled dangerous substance in the 
State.'' \5\ Md. Code Ann., Crim. Law Sec.  5-301(a)(1) (West, Westlaw 
current through all legislation from the 2020 Regular Session of the 
General Assembly). Also according to Maryland statute, a ``person shall 
hold a pharmacy permit issued by the (Maryland State) Board (of 
Pharmacy) before the person may establish or operate a pharmacy in this 
State.'' Md. Code Ann., Health. Occ. Sec.  12-401(a) (West, Westlaw 
current through all legislation from the 2020 Regular Session of the 
General Assembly). Accordingly, holding a permit issued by the MBP is a 
prerequisite to operating a pharmacy and dispensing a controlled 
substance in Maryland.
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    \5\ ``Dispense,'' under Maryland statute, means ``to deliver to 
the ultimate user . . . by or in accordance with the lawful order of 
an authorized provider.'' Md. Code Ann., Crim. Law Sec.  5-101(l)(1) 
(West, Westlaw current through all legislation from the 2020 Regular 
Session of the General Assembly).
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    Here, the undisputed evidence in the record is that Registrant's 
pharmacy permit is currently suspended. In Maryland, as already 
discussed, a pharmacy must hold a permit from the MBP to dispense a 
controlled substance lawfully. Md. Code Ann., Health. Occ. Sec.  12-
401(a); Md. Code Ann., Crim. Law Sec.  5-301(a)(1). Registrant 
currently lacks a pharmacy permit in Maryland and, thus, it is not 
eligible to dispense controlled substances in Maryland. 21 U.S.C. 
824(a)(3). Accordingly, I will order that Registrant'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. 
FP3109027 issued to Poplar Grove Pharmacy Inc. This Order is effective 
January 11, 2021.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-27234 Filed 12-10-20; 8:45 am]
BILLING CODE 4410-09-P