Notice2025-07175
Liberty Pharmacy Inc.; Metro Care Pharmacy Inc.; Ritecare Pharmacy Inc.; United Pharmacy Upper Darby Inc.; Decision and Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 25, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 79 (Friday, April 25, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 79 (Friday, April 25, 2025)]
[Notices]
[Pages 17452-17454]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07175]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Liberty Pharmacy Inc.; Metro Care Pharmacy Inc.; Ritecare
Pharmacy Inc.; United Pharmacy Upper Darby Inc.; Decision and Order
I. Introduction
On October 31, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registrations (OSC/ISO) to Liberty Pharmacy Inc., Metro Care Pharmacy
Inc., RiteCare Pharmacy Inc., and United Pharmacy Upper Darby Inc., of
Philadelphia, Pennsylvania (collectively, Registrants). Request for
Final Agency Action (RFAA), Exhibit (RFAAX) 2, at 1, 10. The OSC/ISO
informed Registrants of the immediate suspension of their DEA
Certificates of Registration, Nos. FL2056908, FM2936120, FR5934244, and
FU0598790, pursuant to 21 U.S.C. 824(d), alleging that Registrants'
continued registration constitutes `` `an imminent danger to the public
health or safety.' '' Id. at 1-2 (quoting 21 U.S.C. 824(d)). The OSC/
ISO also proposed the revocation of Registrants' registrations,
alleging that Registrants' continued registration is inconsistent with
the public interest. Id. at 2 (citing 21 U.S.C. 823(g)(1),
824(a)(4)).\1\
---------------------------------------------------------------------------
\1\ According to Agency records, Metro Care Pharmacy's
registration expired on January 31, 2024. The fact that a registrant
allows its registration to expire during the pendency of an
administrative enforcement proceeding does not impact the Agency's
jurisdiction or prerogative under the Controlled Substances Act
(CSA) to adjudicate the OSC/ISO to finality. Jeffrey D. Olsen, M.D.,
84 FR 68474, 68476-79 (2019).
---------------------------------------------------------------------------
Specifically, the OSC/ISO alleged that between February 1, 2019,
and August 30, 2023, Registrants failed to maintain accurate records of
their purchasing and dispensing of controlled substances, in violation
of federal and Pennsylvania state law. Id. at 2-3, 5-8 (citing 21 CFR
1304.04(a), 1304.11(a)-(c), 1304.21(a); 35 Pa. Cons. Stat. Ann. secs.
780-112(a)-(c), 780-113(a)(21)).
The OSC/ISO notified Registrants of their right to file with DEA a
written request for hearing and that if they failed to file such a
request, they would be deemed to have waived their right to a hearing
and be in default. RFAAX 2, at 9 (citing 21 CFR 1301.43). Here,
Registrants did not request a hearing. RFAA, at 2.\2\ ``A default,
unless excused, shall be deemed to constitute a waiver of the
registrant's/applicant's right to a hearing and an admission of the
factual allegations of the [OSC/ISO].'' 21 CFR 1301.43(e).
---------------------------------------------------------------------------
\2\ Based on the Government's submissions in its RFAA dated
February 9, 2024, the Agency finds that service of the OSC/ISO on
Registrants was adequate. Specifically, the included Declaration
from a DEA Special Agent asserts that on November 1, 2023, the OSC/
ISO was personally served at all of Registrants' registered
addresses during the execution of simultaneous search warrants at
each location. RFAAX 3, at 2. The Special Agent noted in the
Declaration that an individual who serves in a management role for
all four pharmacies was physically present at the location of
Liberty Pharmacy, Inc. during the execution of the search warrant
and service of the OSC/ISO. Id. This individual received a copy of
the OSC/ISO as well as instructions from DEA personnel. Id.
---------------------------------------------------------------------------
Further, ``[i]n the event that a registrant . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] Sec. 1316.67.'' Id. Sec. 1301.43(f)(1). Here,
the Government has requested final agency action based on Registrants'
default pursuant to 21 CFR 1301.43(c), (f), 1301.46. RFAA, at 1-2; see
also 21 CFR 1316.67.
II. Applicable Law
A. The Alleged Statutory and Regulatory Violations
As discussed above, the OSC/ISO alleges that Registrants violated
provisions of the CSA and its implementing regulations. As the Supreme
Court stated in Gonzales v. Raich, ``the main objectives of the CSA
were to conquer drug abuse and to control the legitimate and
illegitimate traffic in controlled substances. . . . To effectuate
these goals, Congress devised a closed regulatory system making it
unlawful to . . . dispense[ ] or possess any controlled substance
except in a manner authorized by the CSA.'' 545 U.S. 1, at 12-13
(2005). In maintaining this closed regulatory system, ``[t]he CSA and
its implementing regulations set forth strict requirements regarding
registration, . . . drug security, and recordkeeping.'' Id. at 14.
Here, the OSC/ISO's allegations concern the CSA's ``strict
requirements regarding registration . . . drug security, and
recordkeeping'' and, therefore, go to the heart of the CSA's ``closed
regulatory system'' specifically designed ``to conquer drug abuse and
to control the legitimate and illegitimate traffic in controlled
substances,'' and ``to prevent the diversion of drugs from legitimate
to illicit channels.'' Id. at 12-14, 27.
B. Improper Dispensing, Recordkeeping, and Unaccounted for Controlled
Substances
According to DEA's implementing regulations, pharmacies must
maintain ``a complete and accurate record of each controlled substance
. . . sold . . . .'' 21 CFR 1304.21(a). This includes conducting and
maintaining an ``initial inventory . . . of all stocks of controlled
substances on hand on the date [the pharmacy] first engages in the . .
. dispensing of controlled substances,'' as well as a ``biennial
inventory . . . of all stocks of controlled substances on hand.'' 21
CFR 1304.11(a)-(c). Pharmacies must retain these inventories ``for at
least 2 years from the date of such inventory or records, for
inspection and copying.'' 21 CFR 1304.04.
Pennsylvania law also requires pharmacies to keep accurate records
and maintain proper inventories regarding the purchase, sale, or
dispensing of any controlled substances. 35 Pa. Cons. Stat. Ann. sec.
780-112(a)-(c). In Pennsylvania, it is unlawful for a pharmacy to fail
to ``make, keep or furnish any record, notification, order form,
statement, invoice or information'' relating to the purchasing or
dispensing of a controlled substance. Id. sec. 780-113(a)(21).
III. Findings of Fact
The Agency finds that, in light of Registrants' default, the
factual allegations in the OSC/ISO are deemed admitted.\3\ Registrants
are deemed to
[[Page 17453]]
have admitted that from February 1, 2019, until at least August 30,
2023, Liberty Pharmacy failed to maintain accurate records of its
purchasing and dispensing of controlled substances. Id. at 6. For
example, Registrants admit that there were significant discrepancies
between Liberty's controlled substance order invoices and the data that
Liberty reported to Pennsylvania's PDMP. Id. at 6-7. Registrants admit
that a comparison of Liberty's PDMP data to Liberty's controlled
substance order invoices revealed discrepancies of: (1) approximately
283,400 dosage units of alprazolam 1 mg, (2) approximately 573,200
dosage units of alprazolam 2 mg, and (3) approximately 3,354 bottles of
promethazine with codeine. Id. at 7. These discrepancies amounted to an
approximately 100% variance between the PDMP data and Liberty's
invoices. Id. Registrant admits that there were also significant
discrepancies for Metro Care Pharmacy, United Pharmacy, and RiteCare
Pharmacy,\4\ and that all four pharmacies failed to maintain accurate
records of their purchasing and dispensing of controlled substances.
Id. at 5-8.
---------------------------------------------------------------------------
\3\ Registrants are deemed to have admitted and the Agency finds
that Registrants share common management and control. RFAAX 2, at 4.
The following facts, which illustrate that F.E. exercises management
and control over all four entities, are deemed admitted: (1)
``Liberty Pharmacy, Metro Care Pharmacy, and United Pharmacy share
common corporate management as reflected in their state corporate
filings . . .''; (2) at RiteCare Pharmacy, DEA investigators
observed an information sheet displaying proprietary information for
Liberty Pharmacy, Metro Care Pharmacy, and United Pharmacy, such as
contact information and relevant licensing numbers; (3) regarding
their controlled substance ordering, Registrants all ordered almost
exclusively large quantities of alprazolam tablets and promethazine
with codeine bottles; (4) DEA's search of trash from Liberty
Pharmacy revealed controlled substance order invoices for suppliers
to RiteCare Pharmacy, Metro Care Pharmacy, and United Pharmacy, as
well as cardboard boxes originally shipped to RiteCare Pharmacy,
Metro Care Pharmacy, and United Pharmacy; (5) DEA's interview with
an employee of a distributor company supplying Registrants revealed
the commonality of management between Registrants; (6) DEA's
administrative subpoenas issued to Registrants' suppliers reflected
F.E.'s name being associated as a generic buyer for all of them; and
(7) ``[n]one of [Registrants] appeared to have a customer base that
would support the significant ordering of controlled substances from
[Registrants'] distributors.'' RFAAX 2, at 4-5.
Given the fact that the same individual exercises management
and control over the entities, the misconduct of any entity is
relevant to the determination of whether the others can be entrusted
with a DEA registration. See Morning Star Pharmacy & Med. Supply, 85
FR 51045, 51062 (2020)) (``Due to the commonality of . . .
management, and key employees between Respondent Pharmacy and Ceder
Hill [Pharmacy], any misconduct related to controlled substances at
Cedar Hill is relevant to the determination of whether Respondent
pharmacy can be entrusted with a registration.''); RFAAX 2, at 4.
\4\ Registrants admit that when comparing Metro Care Pharmacy's
PDMP data to Metro Care's invoices, there was a discrepancy of
approximately 296,500 dosage units of alprazolam 1 mg, 574,320
dosage units of alprazolam 2 mg, and 3,150 bottles of promethazine
with codeine. These discrepancies amounted to an approximately 100%
variance between the PDMP data and Metro Care's invoices.
Registrants admit that when comparing United Pharmacy's PDMP
data to United's invoices, there was a discrepancy of approximately
300,300 dosage units of alprazolam 1 mg, 554,780 dosage units of
alprazolam 2 mg, and 2,841 bottles of promethazine with codeine.
These discrepancies amounted to an approximately 99-100% variance
between the PDMP data and United's invoices.
Registrants admit that when comparing RiteCare Pharmacy's PDMP
data to RiteCare's invoices, there was a discrepancy of
approximately 283,400 dosage units of alprazolam 1 mg, 573,200
dosage units of alprazolam 2 mg, and 2,679 bottles of promethazine
with codeine. These discrepancies amounted to an approximately 100%
variance between the PDMP data and United's invoices.
---------------------------------------------------------------------------
Accordingly, the Agency finds substantial record evidence that each
Registrant failed to maintain accurate records of its purchasing and
dispensing of controlled substances.
IV. Discussion
A. The Five Public Interest Factors
Under Section 304 of the CSA, ``[a] registration . . . to . . .
distribute[ ] or dispense a controlled substance . . . may be suspended
or revoked by the Attorney General upon a finding that the registrant .
. . has committed such acts as would render his registration under . .
. [21 U.S.C. 823] inconsistent with the public interest as determined
by such section.'' 21 U.S.C. 824(a)(4). In the case of a
``practitioner,'' which is defined in 21 U.S.C. 802(21) to include a
``pharmacy,'' Congress directed the Attorney General to consider five
factors in making the public interest determination. 21 U.S.C.
823(g)(1)(A-E).\5\ The five factors are considered in the disjunctive.
Gonzales v. Oregon, 546 U.S. at 292-93 (2006) (Scalia, J., dissenting)
(``It is well established that these factors are to be considered in
the disjunctive,'' citing In re Arora, 60 FR 4447, 4448 (1995)); Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a
case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d 165, 173-74
(D.C. Cir. 2005). Any one factor, or combination of factors, may be
decisive. Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C.
Cir. 2007); Morall, 412 F.3d. at n.2; David H. Gillis, M.D., 58 FR
37507, 37508 (1993).
---------------------------------------------------------------------------
\5\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
---------------------------------------------------------------------------
In this matter, while all of the 21 U.S.C. 823(g)(1) factors have
been considered, the Agency finds that the Government's evidence in
support of its prima facie case is confined to Factors B and D.\6\ See
RFAAX 1, at 4. Moreover, the Government has the burden of proof in this
proceeding. 21 CFR 1301.44.
---------------------------------------------------------------------------
\6\ The Agency has carefully considered the entire transmitted
record, and this Decision/Order is the result of its adjudication of
that record in its entirety.
---------------------------------------------------------------------------
Here, the Agency finds that the Government's evidence satisfies its
prima facie burden of showing that each Registrant's continued
registration would be ``inconsistent with the public interest.'' 21
U.S.C. 823(g)(1).
A. Allegation That Registrants' Registrations are Inconsistent With the
Public Interest
Factors B and/or D--Registrants' Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
Evidence is considered under Public Interest Factors B and D when
it reflects compliance or non-compliance with federal and local laws
related to controlled substances and experience dispensing controlled
substances. 21 U.S.C. 823(g)(1)(B) and (D); see also Kareem Hubbard,
M.D., 87 FR 21156, 21162 (2022). Here, as found above, Registrant is
deemed to have admitted and the Agency finds that between February 1,
2019, and August 30, 2023, Registrants failed to maintain accurate
records of their purchasing and dispensing of controlled substances.
RFAAX 2, at 5-8. Accordingly, the Agency finds substantial record
evidence that Registrants violated federal and state law, namely 21 CFR
1304.04(a), 1304.11(a)-(c), 1304.21(a); and 35 Pa. Cons. Stat. Ann.
secs. 780-112(a)-(c), 780-113(a)(21).\7\
---------------------------------------------------------------------------
\7\ The OSC/ISO alleges that Registrants violated additional
state statutes related to their failure to maintain adequate records
and their failure to adequately report their dispensing of
controlled substances to the Pennsylvania PDMP. See RFAAX 2, at 3
(citing 35 Pa. Cons. Stat. Ann. secs. 872.7(a), (c), 780-
113(a)(12)). However, neither the OSC/ISO nor the RFAA contains
sufficient analysis to allow the Agency to adjudicate these
allegations. However, the Agency finds that there is substantial
record evidence that Registrants' recordkeeping was extremely
deficient and violated federal and state law, which is more than
sufficient to support the Government's requested sanction of
revocation under these circumstances.
---------------------------------------------------------------------------
Accordingly, the Agency finds that Factors B and D weigh in favor
of revocation of Registrants' registrations and thus finds Registrants'
continued registration to be inconsistent with the public interest. The
Agency further finds that Registrants failed to provide any evidence to
rebut the Government's prima facie case.
V. Sanction
Here, the Government has met its prima facie burden of showing that
Registrants' continued registration is inconsistent with the public
interest due to their numerous violations pertaining to controlled
substance dispensing and recordkeeping. Accordingly, the burden shifts
to Registrants to show why they can be entrusted with registration.
Morall, 412 F.3d. at 174; Jones Total Health Care Pharmacy, LLC v. Drug
Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith,
M.D.,
[[Page 17454]]
83 FR 18882, 18904 (2018); supra sections III and IV.
The issue of trust is necessarily a fact-dependent determination
based on the circumstances presented by the individual registrant.
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total
Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is
the best predictor of future performance, DEA Administrators have
required that a registrant who has committed acts inconsistent with the
public interest must accept responsibility for those acts and
demonstrate that he will not engage in future misconduct. Jones Total
Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't
Admin., 54 F.3d 450, 452 (7th Cir. 1995). A registrant's acceptance of
responsibility must be unequivocal. Jones Total Health Care Pharmacy,
881 F.3d at 830-31. In addition, a registrant's candor during the
investigation and hearing has been an important factor in determining
acceptance of responsibility and the appropriate sanction. Id. Further,
the Agency has found that the egregiousness and extent of the
misconduct are significant factors in determining the appropriate
sanction. Id. at 834 & n.4. The Agency has also considered the need to
deter similar acts by the registrant and by the community of
registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Here, Registrants did not timely or properly request a hearing and
were deemed to be in default. 21 CFR 1301.43(c)(1), (e), (f)(1); RFAA,
at 1-2. To date, Registrants have not filed a motion with the Office of
the Administrator to excuse the default. 21 CFR 1301.43(c)(1).
Registrants have thus failed to answer the allegations contained in the
OSC and have not otherwise availed themselves of the opportunity to
refute the Government's case. As such, Registrants have made no
representations as to their future compliance with the CSA nor made any
demonstration that they can be entrusted with registration. Moreover,
the evidence presented by the Government shows that Registrants
violated the CSA, further indicating that Registrants cannot be
entrusted.
Accordingly, the Agency will order the revocation of Registrants'
registrations.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificates
of Registration Nos. FL2056908, FM2936120, FR5934244, and FU0598790
issued to Liberty Pharmacy Inc., Metro Care Pharmacy Inc., RiteCare
Pharmacy Inc., and United Pharmacy Upper Darby Inc. Further, pursuant
to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a)
and 21 U.S.C. 823(g)(1), I hereby deny any pending applications of
Liberty Pharmacy Inc., Metro Care Pharmacy Inc., RiteCare Pharmacy
Inc., and/or United Pharmacy Upper Darby Inc. to renew or modify the
named registrations, as well as any other pending application of
Liberty Pharmacy Inc., Metro Care Pharmacy Inc., RiteCare Pharmacy
Inc., and/or United Pharmacy Upper Darby Inc. for additional
registration in Pennsylvania. This Order is effective May 27, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 18, 2025, by Acting Administrator Derek Maltz. 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. 2025-07175 Filed 4-24-25; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on April 25, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.