Liberty Pharmacy Inc.; Metro Care Pharmacy Inc.; Ritecare Pharmacy Inc.; United Pharmacy Upper Darby Inc.; Decision and Order, 17452-17454 [2025-07175]

Download as PDF 17452 Federal Register / Vol. 90, No. 79 / Friday, April 25, 2025 / Notices this drug code is authorized for this registration. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2025–07154 Filed 4–24–25; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration ddrumheller on DSK120RN23PROD with NOTICES1 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 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 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). VerDate Sep<11>2014 17:42 Apr 24, 2025 Jkt 265001 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). 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] § 1316.67.’’ Id. § 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 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. PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 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 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’ E:\FR\FM\25APN1.SGM 25APN1 Federal Register / Vol. 90, No. 79 / Friday, April 25, 2025 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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. Accordingly, the Agency finds substantial record evidence that each Registrant failed to maintain accurate 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. VerDate Sep<11>2014 17:42 Apr 24, 2025 Jkt 265001 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). 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. 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). 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. 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. PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 17453 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 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., 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. E:\FR\FM\25APN1.SGM 25APN1 ddrumheller on DSK120RN23PROD with NOTICES1 17454 Federal Register / Vol. 90, No. 79 / Friday, April 25, 2025 / Notices 83 FR 18882, 18904 (2018); supra sections III and IV. The issue of trust is necessarily a factdependent 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 VerDate Sep<11>2014 17:42 Apr 24, 2025 Jkt 265001 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 DEPARTMENT OF JUSTICE Drug Enforcement Administration Syed Warsi, M.D.; Decision and Order On August 25, 2022, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Syed Warsi, M.D., of North Aurora, Illinois (Registrant). Request for Final Agency Action (RFAA), Appendix (RFAAX) A, at 1, 3. The OSC proposed the revocation of Registrant’s Certificate of Registration No. BW8048022, alleging that Registrant’s registration should be revoked because Registrant is ‘‘currently without authority to prescribe, administer, dispense, or otherwise handle controlled substances in Illinois, the jurisdiction in which [he is] PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 registered with DEA.’’ Id. at 2 (citing 21 U.S.C. 824(a)(3)).1 The Agency makes the following findings of fact based on the uncontroverted evidence submitted by the Government in its RFAA dated October 12, 2023.2 Findings of Fact On July 13, 2022, the Illinois Department of Financial and Professional Regulation suspended Registrant’s Illinois medical license and Illinois controlled substance license. RFAAX C, at 4–5. According to Illinois’s online records, of which the Agency takes official notice, Registrant’s Illinois medical license and Illinois controlled substance license both remain suspended.3 Illinois Department of Financial and Professional Regulation License Search, https://onlinedfpr.micropact.com/lookup/ licenselookup.aspx/ (last visited date of signature of this Order). Accordingly, the Agency finds that Registrant is not licensed to practice medicine nor to handle controlled substances in Illinois, the state in which he is registered with DEA.4 Discussion Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to 1 According to Agency records, Registrant’s registration expired on May 31, 2023. The fact that a registrant allows his registration to expire during the pendency of an OSC does not impact the Agency’s jurisdiction or prerogative under the Controlled Substances Act (CSA) to adjudicate the OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 68474, 68476–79 (2019). 2 Based on the Declaration from a DEA Diversion Investigator, the Agency finds that the Government’s service of the OSC on Registrant was adequate. RFAAX B, at 1. Further, based on the Government’s assertions in its RFAA, the Agency finds that more than thirty days have passed since Registrant was served with the OSC and Registrant has neither requested a hearing nor submitted a corrective action plan and therefore has waived any such rights. RFAA, at 2; see also 21 CFR 1301.43 and 21 U.S.C. 824(c)(2). 3 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). 4 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.’’ The material fact here is that Registrant, as of the date of this decision, is not licensed to practice medicine nor to handle controlled substances in Illinois. Accordingly, Registrant may dispute the Agency’s finding this fact by filing a properly supported motion for reconsideration of findings of fact within fifteen calendar days of the date of this Order. Any such motion and response shall be filed and served by email to the other party and to the DEA Office of the Administrator, Drug Enforcement Administration at dea.addo.attorneys@dea.gov. E:\FR\FM\25APN1.SGM 25APN1

Agencies

[Federal Register Volume 90, Number 79 (Friday, April 25, 2025)]
[Notices]
[Pages 17452-17454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07175]


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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.
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    \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).
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    \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.
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    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.
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    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\
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    \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.
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    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

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