[Federal Register Volume 90, Number 70 (Monday, April 14, 2025)]
[Notices]
[Pages 15580-15583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06311]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Eagle Pharmacy; Decision and Order
On June 2, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Eagle Pharmacy of
Houston, Texas (Registrant). Request for Final Agency Action (RFAA),
Exhibit (RFAAX) 2, at 1, 9. The OSC proposed the revocation of
Registrant's DEA registration, No. FE4992257, alleging that
Registrant's continued registration is inconsistent with the public
interest. Id. at 1 (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
Specifically, the OSC alleges that ``[Registrant] repeatedly filled
prescriptions for Schedule II through V controlled substances that
contained multiple red flags indicative of diversion and/or abuse
without addressing or resolving those red flags, and [that Registrant's
decision] to fill those prescriptions despite unresolved red flags, . .
. [violated] federal and Texas law, including 21 CFR 1306.04(a) [and]
1306.06; and Tex. Health & Safety Code Sec. 481.074(a).'' RFAAX 2, at
4.
The OSC notified Registrant of its right to file with DEA a written
request for hearing within 30 days after the date of receipt of the
OSC. RFAAX 2, at 8 (citing 21 CFR 1301.43(a)). The OSC also notified
Registrant that if it failed to file such a request, it would be deemed
to have waived its right to a hearing and be in default. Id. (citing 21
CFR 1301.43(c)(1)). The OSC further notified Registrant that ``[a]
default, unless excused, shall be deemed to constitute a waiver of the
[Registrant's] right to a hearing and an admission of the factual
allegations of the [OSC].'' Id. (citing 21 CFR 1301.43(e)).
Here, the OSC was served on Registrant and its counsel on June 5,
2023. RFAAX 7. On August 2, 2023, 58 days after service of the OSC,
Registrant submitted to the DEA Office of Administrative Law Judges
(OALJ) a Request for Hearing, a Motion of Leave to File Late Answer,
and an Answer to Show Cause Order (Answer). RFAAX 3-5. On August 3,
2023, a DEA Administrative Law Judge (ALJ) issued an Order Terminating
Proceedings (Order), finding that Registrant was in default because
Registrant had failed to timely request a hearing and had failed to
timely show good cause to excuse the default. RFAAX 6. The ALJ's Order
explained that ``because [Registrant] filed its [hearing request] more
than 45 days after receiving the OSC, . . . [Registrant] can only be
excused from the default by the Office of the Administrator.'' Id. at 3
(citing 21 CFR 1301.43(c)(1)). To date, Registrant has not filed a
motion to excuse the default with the Office of the Administrator. 21
CFR 1301.43(c)(1). Accordingly, Registrant remains in default.
``In 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.'' 21 CFR 1301.43(f)(1). Here, the
Government has requested final agency action based on Registrant's
default pursuant to 21 CFR 1301.43(c), (f), because Registrant has not
timely requested a hearing, nor filed a motion with the Administrator
seeking to excuse the default. See also id. Sec. 1316.67.
I. Applicable Law
As already discussed, the OSC alleges that Registrant violated
multiple provisions of the Controlled Substances Act (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.
The OSC's allegations concern the CSA's ``statutory and regulatory
provisions . . . mandating . . . compliance with . . . prescription
requirements'' 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.
The Allegation That Registrant Filled Prescriptions Without Addressing
or Resolving Red Flags of Abuse and/or Diversion
According to the CSA's implementing regulations, a lawful
prescription for controlled substances is one that is ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional
[[Page 15581]]
practice.'' 21 CFR 1306.04(a); see Gonzales v. Oregon, 546 U.S. 243,
274 (2006); United States v. Hayes, 595 F.2d 258 (5th Cir. 1979),
rehearing den., 598 F.2d 620 (5th Cir. 1979), cert. denied, 444 U.S.
866 (1979); RFAAX 2, at 1-2. Although ``[t]he responsibility for the
proper prescribing and dispensing of controlled substances is upon the
prescribing practitioner . . . a corresponding responsibility rests
with the pharmacist who fills the prescription.'' 21 CFR 1306.04(a);
United States v. Moore, 423 U.S. 122, 136 n.12 (1975); United States v.
Armstrong, 550 F.3d 382, 387 n.6 (5th Cir. 2008); RFAAX 2, at 1-2. The
corresponding responsibility requires ``pharmacists to identify and
resolve suspicions that a prescription is illegitimate . . . before
`knowingly filling such a purported prescription.' '' Trinity Pharmacy
II, 83 FR 7304, 7331 (2018); RFAAX 2, at 2; see also Suntree Pharmacy
and Suntree Medical Equipment, LLC v. Drug Enf't Agency, 2022 WL
444,357, *6 (11th Cir.) (upholding the Agency's revocation order, which
was ``[b]ased on [the] finding that Suntree violated its corresponding
responsibility by filling prescriptions for controlled substances
without resolving obvious red flags that the prescriptions lacked a
legitimate medical purpose''). A registrant pharmacy ``fail[s] to
comply with its corresponding responsibility not to fill prescriptions
written for illegitimate purposes'' when it fails to ``tak[e] and
document[ ] steps to resolve . . . red flags or refus[e] to fill
prescriptions with unresolvable red flags.'' Pharmacy Doctors
Enterprises Inc., d.b.a. Zion Clinic Pharmacy, 789 F. App'x 724, 731
(11th Cir. 2020). DEA regulations further require that a ``prescription
for a controlled substance may only be filled by a pharmacist, acting
in the usual course of his [or her] professional practice.'' 21 CFR
1306.06; RFAAX 2, at 1-2.
Texas regulations have a similar requirement that pharmacists
ensure that controlled substance prescriptions are ``issued for a
legitimate medical purpose by a practitioner in the course of medical
practice.'' 22 Tex. Admin. Code section 291.29(b); RFAAX 2, at 2; see
also Tex. Health & Safety Code sections 481.074(a), 481.128(a)(1). If
the pharmacist observes any problem that raises doubts about the
legitimacy of a prescription, the pharmacist must ``verify the order
with the practitioner prior to dispensing.'' Id. section 291.29(a);
RFAAX 2, at 2.
Texas regulations set forth various ``red flag factors'' that a
pharmacist must consider in preventing the non-therapeutic dispensing
of controlled substances. 22 Tex. Admin. Code section 291.29(f); RFAAX
2, at 3-4. Pharmacists should consider these red flags ``by evaluating
the totality of the circumstances rather than any single factor.'' 22
Tex. Admin. Code section 291.29(f). These red flags include instances
where:
(f)(1) ``the pharmacy dispenses a reasonably discernible pattern
of substantially identical prescriptions for the same controlled
substances . . . , ''
(f)(3) ``prescriptions by a prescriber presented to the pharmacy
are routinely for controlled substances commonly known to be abused
drugs, including opioids, benzodiazepines, muscle relaxants,
psychostimulants, and/or cough syrups containing codeine, or any
combination of these drugs,''
(f)(5) ``prescriptions for controlled substances are commonly
for the highest strength of the drug and/or for large quantities . .
. , indicating a lack of individual drug therapy in prescriptions
issued by the practitioner,''
(f)(6) ``dangerous drugs or over-the-counter products . . . are
consistently added by the prescriber to prescriptions for controlled
substances presented to the pharmacy, indicating a lack of
individual drug therapy in prescriptions issued by the
practitioner,''
(f)(10) ``the Texas Prescription Monitoring Program indicates
the person presenting the prescriptions is obtaining similar drugs
from multiple practitioners, and/or that the persons [sic] is being
dispensed similar drugs at multiple pharmacies,''
(f)(12) ``persons consistently pay for controlled substance
prescriptions with cash or cash equivalents more often than through
insurance.''
RFAAX 2, at 3-8. In addition to evaluating these red flag factors,
a Texas pharmacist may not fill a prescription when a pharmacist has
reason to believe that a prescription is inaccurate, inauthentic, or
not issued for a legitimate medical purpose. See 22 Tex. Admin. Code
section 291.29(a), (b).
Texas regulations further require pharmacists to ``review the
patient's medication record'' to ensure the ``therapeutic
appropriateness'' of the prescription, and if a problem is observed,
the pharmacist must ``avoid or resolve the problem including
consultation with the prescribing practitioner.'' 22 Tex. Admin. Code
sections 291.33(c)(2)(A)(i)-(ii); RFAAX 2, at 3. A pharmacist must
resolve all problems raised by a prescription before dispensing it and
must document how the problem was resolved. Id. section
291.33(c)(2)(A)(iv); RFAAX 2, at 3; see also section 291.33(c)(2)(C)
(outlining the information that such documentation must include).
II. Findings of Fact
The Allegation That Registrant Filled Prescriptions Without Addressing
or Resolving Red Flags of Abuse and/or Diversion
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Registrant is deemed to have admitted and the Agency finds
that from August 7, 2020 to December 6, 2022, Registrant filled
numerous controlled substance prescriptions without resolving red flags
of abuse and diversion raised by those prescriptions. RFAAX 2, at 2-8.
Registrant is further deemed to have admitted and the Agency finds that
from August 7, 2020 to December 6, 2022, Registrant repeatedly filled
prescriptions outside the usual course of professional pharmacy
practice in Texas and beneath the standard of care in Texas. Id. at 1,
4.
A. Pattern Prescribing, Substances of Abuse, and Strength and Quantity
As discussed above, see supra Section I, Texas regulations identify
the following prescribing patterns as red flag factors: ``[T]he
pharmacy dispenses a reasonably discernible pattern of substantially
identical prescriptions for the same controlled substances . . . .'';
``[P]rescriptions . . . are routinely for controlled substances
commonly known to be abused drugs . . . .''; and ``[P]rescriptions for
controlled substances are commonly for the highest strength of the drug
and/or for large quantities . . . .'' 22 Tex. Admin. Code sections
291.29(f)(1), (3), (5); RFAAX 2, at 4-5.
Registrant is deemed to have admitted and the Agency finds that
Registrant filled a total of 359 prescriptions that raised the red
flags of pattern prescribing, prescriptions for controlled substances
commonly known to be abused, and prescriptions for controlled
substances in their highest strengths and/or in large quantities. RFAAX
2, at 4-7. Specifically, among these prescriptions, from September 2020
to August 2022 Registrant filled 127 prescriptions for hydrocodone \1\
10 mg and 122 prescriptions for carisoprodol \2\ 350 mg issued by Dr.
J.R. to 11 individuals. Id. at 5-6. The hydrocodone prescriptions
ranged from 100 to 110 tablets each and the
[[Page 15582]]
carisoprodol prescriptions ranged from 30 to 66 tablets each. Id.
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\1\ Hydrocodone is a schedule II opioid. 21 CFR
1308.12(b)(1)(vi).
\2\ Carisoprodol is a schedule IV depressant. 21 CFR
1308.14(c)(7).
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Additionally, from August 2020 to January 2023 Registrant filled
six prescriptions for hydrocodone 10 mg and 90 prescriptions for
oxycodone \3\ 30 mg issued by Dr. B.R. to five individuals. Id. at 6.
The hydrocodone prescriptions were for 110 tablets each and the
oxycodone prescriptions ranged from 100 to 110 tablets each. Id.
Finally, from May 2022 to December 2022 Registrant filled 14
prescriptions for oxycodone 30 mg issued by Dr. R.V. to four
individuals. Id. at 6-7. These prescriptions ranged from 100 to 110
tablets each. Id.
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\3\ Oxycodone is a schedule II opioid. 21 CFR
1308.12(b)(1)(xiv).
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Accordingly, the Agency finds substantial record evidence that
Registrant filled 359 prescriptions without first resolving the red
flags of pattern prescribing, prescriptions for controlled substances
commonly known to be abused, and prescriptions for controlled
substances in their highest strengths and/or in large quantities. Id.
at 4, 8.
B. Lack of Individualized Therapy
Texas regulations identify the following prescribing pattern as a
red flag factor: ``[D]angerous drugs or over-the-counter products [OTC]
. . . are consistently added by the prescriber to prescriptions for
controlled substances presented to the pharmacy, indicating a lack of
individual drug therapy . . . .'' 22 Tex. Admin. Code section
291.29(f)(6); RFAAX 2, at 7. Registrant is deemed to have admitted that
from August 2020 to December 2022 Registrant filled numerous
prescriptions that combined dangerous drugs and OTC products for 16
individuals. RFAAX 2, at 7. Respondent admits that these prescriptions
raise a red flag for a lack of individualized therapy, and further
admits that the prescriptions were dispensed without documentation or
resolution of that red flag. RFAAX 2, at 7.
Accordingly, the Agency finds substantial record evidence that
Registrant filled numerous prescriptions without first resolving the
red flag of lack of individualized therapy. Id. at 4, 7-8.
C. Long Distances
Registrant is deemed to have admitted and the Agency finds that
individuals who travel long distances to obtain controlled substances
is a well-known red flag of abuse or diversion. RFAAX 2, at 7.
Registrant is deemed to have admitted that on three separate occasions
in April 2022, June 2022, and July 2022, Registrant filled three
prescriptions for hydrocodone 10 mg and three prescriptions for
carisoprodol 350 mg for an individual who traveled 201 miles one-way to
visit the pharmacy. Id.
Accordingly, the Agency finds substantial record evidence that
Registrant filled six prescriptions without resolving the red flag of
individuals traveling long distances. Id. at 4, 7-8.
D. Cash Payments
Texas regulations identify the following prescribing pattern as a
red flag factor: ``[P]ersons consistently pay for controlled substance
prescriptions with cash or cash equivalents more often than through
insurance.'' 22 Tex. Admin. Code section 291.29(f)(12); RFAAX 2, at 7-
8. Registrant is deemed to have admitted that all but three of the
above-mentioned prescriptions were paid for in cash. RFAAX 2, at 4-8.
In addition, Registrant is deemed to have admitted that Registrant
filled these prescriptions without first identifying and resolving the
red flag of cash payments, which is a common red flag because it allows
a patient to avoid the scrutiny associated with the use of insurance.
Id. at 7-8.
Accordingly, the Agency finds substantial record evidence that
Registrant filled controlled substance prescriptions without first
resolving the red flag arising from cash payments.
E. Expert Review
DEA retained an independent pharmacy expert who concluded that the
above prescription data presented multiple red flags that were highly
indicative of abuse and diversion. Id. at 8. The expert further
concluded, and Registrant admits that, ``[t]hese red flags were not
properly documented or resolved by a pharmacist acting in the usual
course of professional practice prior to dispensing, and, therefore,
each prescription was filled outside the standard of care of pharmacy
practice in Texas.'' Id.
Accordingly, the Agency finds substantial record evidence that
Registrant dispensed each of the above-referenced prescriptions without
first resolving the red flags of pattern prescribing, prescriptions for
controlled substances commonly known to be abused, prescriptions for
controlled substances in their highest strengths and/or in large
quantities, lack of individualized therapy, individuals traveling long
distances, and/or individuals paying with cash or cash equivalents. The
Agency finds substantial record evidence that Registrant's dispensing
of these prescriptions was outside the usual course of professional
practice and beneath the standard of care in Texas.
III. 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).\4\ 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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\4\ 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. See
RFAAX 1, at 6. 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 Registrant's continued registration
would be ``inconsistent with the public interest.'' 21 U.S.C.
823(g)(1).
[[Page 15583]]
B. Factors B and D
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 Registrant repeatedly filled prescriptions for
controlled substances that contained red flags of abuse and/or
diversion without addressing or resolving those red flags. RFAAX 2, at
4-8. Registrant has further admitted and the Agency finds that all of
the above-referenced prescriptions were filled outside the usual course
of professional practice and beneath the standard of care in Texas. Id.
As such, the Agency finds substantial record evidence that Registrant
violated 21 CFR 1306.04, 1306.06, Texas Health & Safety Code section
481.074, and 22 Texas Administrative Code sections 291.29, 291.33.
The Agency further finds that Factors B and D weigh in favor of
revoking Registrant's registration as continued registration would be
inconsistent with the public interest in balancing the factors of 21
U.S.C. 823(g)(1). Accordingly, the Agency finds that the Government
established a prima facie case, that Registrant did not rebut that
prima facie case, and that there is substantial record evidence
supporting the revocation of Registrant's registration. 21 U.S.C.
823(g)(1).
III. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Registrant's registration is inconsistent with the public
interest due to its numerous violations pertaining to controlled
substances, the burden shifts to Registrant to show why it can be
entrusted with a registration. Morall, 412 F.3d. at 174; Jones Total
Health Care Pharmacy, 881 F.3d 823, 830 (11th Cir. 2018); Garrett
Howard Smith, M.D., 83 FR 18882 (2018). 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 it will not
engage in future misconduct. Jones Total Health Care Pharmacy, 881 F.3d
at 833. A registrant's acceptance of responsibility must be
unequivocal. Id. 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, DEA Administrators have found that the egregiousness and
extent of the misconduct are significant factors in determining the
appropriate sanction. Id. at 834 and n.4. DEA Administrators have also
considered the need to deter similar acts by the specific registrant
and by the community of registrants. Jeffrey Stein, M.D., 84 FR 46972-
73.
Here, Registrant did not timely request a hearing and was deemed to
be in default. 21 CFR 1301.43(c)(1), (e), (f)(1); RFAAX 6, at 2. To
date, Registrant has not filed a motion with the Office of the
Administrator to excuse the default. 21 CFR 1301.43(c)(1). The only
submission that addresses the topic of mitigating evidence is
Registrant's untimely Answer, which primarily denies the Government's
allegations. RFAAX 4. As such, the record does not contain any evidence
from Registrant demonstrating future compliance with the CSA,
trustworthiness regarding the responsibilities of holding a DEA
registration, acceptance of responsibility, or remedial measures.
Accordingly, the Agency will order the revocation of Registrant's
registration.
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.
FE4992257 issued to Eagle Pharmacy. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Eagle Pharmacy to renew or
modify this registration, as well as any other pending application of
Eagle Pharmacy for additional registration in Texas. This Order is
effective May 14, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 8, 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. 2025-06311 Filed 4-11-25; 8:45 am]
BILLING CODE 4410-09-P