Arenbii Pharmacy LLC; Decision and Order

Issuing agencies

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<title>Federal Register, Volume 91 Issue 193 (Wednesday, October 7, 2026)</title>
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[Federal Register Volume 91, Number 193 (Wednesday, October 7, 2026)]
[Notices]
[Pages 64170-64176]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20535]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Arenbii Pharmacy LLC; Decision and Order

    On September 17, 2025, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO) to Arenbii Pharmacy LLC of Missouri City, Texas 
(Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 
1, at 1, 11. The OSC/ISO informed Registrant of the immediate 
suspension of its DEA Certificate of Registration, No. FA3529849, 
pursuant to 21 U.S.C. 824(d), alleging that Registrant's continued 
registration constitutes `` `an imminent danger to the public health or 
safety.' '' Id. at 1 (quoting 21 U.S.C. 824(d)). The OSC/ISO also 
proposed the revocation of Registrant's DEA Certificate of 
Registration, alleging that Registrant's continued registration is 
inconsistent with the public interest. Id. (citing 21 U.S.C. 823(g)(1); 
824(a)(4)).\1\ Specifically, the OSC/ISO alleged that as recently as 
May 12, 2025, Registrant violated federal and Texas state law by 
continuously filling Schedule II controlled substance prescriptions 
despite obvious red flags of abuse and/or diversion and without 
addressing or resolving those red flags.\2\ RFAAX 1, at 1-2.
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    \1\ Based on the Government's submissions in its RFAA dated 
February 5, 2026, the Agency finds that service of the OSC/ISO on 
Registrant was adequate. Specifically, the Declaration from a DEA 
Diversion Investigator (DI) indicates that on September 22, 2025, 
the OSC/ISO was personally served on Registrant at its registered 
address. RFAAX 2, at 1.
    \2\ The OSC/ISO also alleges that Registrant partially filled 
prescriptions in violation of federal law. RFAAX 1, at 2, 6-7. 
However, the OSC/ISO does not allege sufficient facts to support 
this allegation in a default final order.
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    On February 5, 2026, the Government submitted an RFAA requesting 
that the Agency issue a default final order revoking Registrant's 
registration. RFAA, at 1-3. After carefully reviewing the entire record 
and conducting the analysis as set forth in more detail below, the 
Agency grants the Government's RFAA and revokes Registrant's 
registration.

I. Default Determination

    Under 21 CFR 1301.43, a registrant entitled to a hearing who fails 
to file a timely hearing request ``within 30 days after the date of 
receipt of the [OSC/ISO] . . . shall be deemed to have waived their 
right to a hearing and to be in default'' unless ``good cause'' is 
established for the failure. 21 CFR 1301.43(a) & (c)(1). In the absence 
of a demonstration of good cause, a registrant who fails to timely file 
an answer also is ``deemed to have waived their right to a hearing and 
to be in default.'' 21 CFR 1301.43(c)(2). Unless excused, a default is 
deemed to constitute ``an admission of the factual allegations of the 
[OSC/ISO].'' 21 CFR 1301.43(e).
    Here, the OSC/ISO notified Registrant of its right to file a 
written request for hearing, and 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. RFAAX 1, at 10 (citing 21 CFR 1301.43). According to the 
Government's RFAA, Registrant failed to request a hearing. RFAA, at 2. 
Thus, the Agency finds that Registrant is in default and therefore has 
admitted to the factual allegations in the OSC/ISO. 21 CFR 1301.43(e).

II. Public Interest

A. Applicable Law

    As the Supreme Court stated in Gonzales v. Raich, 545 U.S. 1 
(2005), ``the main objectives of the [Controlled Substances Act (CSA)] 
were to conquer drug abuse and control the legitimate and illegitimate 
traffic in controlled substances.'' 545 U.S. at 12. Gonzales explained 
that:

    Congress was particularly concerned with the need to prevent the 
diversion of drugs from legitimate to illicit channels. To 
effectuate these goals, Congress devised a closed regulatory system 
making it unlawful to manufacture, distribute, dispense, or possess 
any controlled substance except in a manner authorized by the CSA. . 
. . The CSA and its implementing regulations set forth strict 
requirements regarding registration, labeling and packaging, 
production quotas, drug security, and recordkeeping.
    Id. at 12-14.

    The OSC/ISO's allegations concern the CSA's ``statutory and 
regulatory provisions . . . mandating . . . compliance with . . . 
security controls to guard against diversion, recordkeeping and 
reporting obligations, and 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.
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 a controlled substance is one that is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a); RFAAX 
1, at 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.'' Id. Pursuant to the CSA's 
implementing regulations, only a pharmacist ``acting in the usual 
course of his [or her] professional practice'' may fill a prescription 
for a controlled substance. 21 CFR 1306.06; RFAAX 1, at 2.

[[Page 64171]]

    As for state law, Texas regulations state that a Texas pharmacist 
``shall exercise sound professional judgment with respect to the 
accuracy and authenticity of any prescription drug order'' they 
dispense and ``shall make every reasonable effort to ensure that any 
prescription drug order . . . has been issued for a legitimate medical 
purpose by a practitioner in the course of medical practice.'' 22 Tex. 
Admin. Code Ann. Sec.  291.29(a)-(b); see also 22 Tex. Admin. Code Ann. 
Sec.  291.34(b)(1); RFAAX 1, at 3.
    Texas Administrative Code Sec.  291.29(f) states that ``[a] 
pharmacist shall make every reasonable effort to prevent inappropriate 
dispensing due to fraudulent, forged, invalid, or medically 
inappropriate prescriptions in violation of a pharmacist's 
corresponding responsibility,'' and provides a list of nineteen 
``patterns (i.e., red flag factors) [that] are relevant to preventing 
the non-therapeutic dispensing of controlled substances.'' 22 Tex. 
Admin. Code Sec.  291.29(f); RFAAX 1, at 4. The statute further states 
that these red flags ``shall be considered by evaluating the totality 
of the circumstances rather than any single factor.'' 22 Tex. Admin. 
Code Sec.  291.29(f); RFAAX 1, at 4. These ``red flag factors'' 
include:

    (1) the pharmacy dispenses a reasonably discernible pattern of 
substantially identical prescriptions for the same controlled 
substances, potentially paired with other drugs, for numerous 
persons, indicating a lack of individual drug therapy in 
prescriptions issued by the practitioner; . . .
    (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; . . .
    (5) prescriptions for controlled substances are commonly for the 
highest strength of the drug and/or for large quantities (e.g., 
monthly supply), indicating a lack of individual drug therapy in 
prescriptions issued by the practitioner; . . .
    (10) the Texas Prescription Monitoring Program indicates the 
person presenting the prescriptions is obtaining similar drugs from 
multiple practitioners, and/or that the person is being dispensed 
similar drugs at multiple pharmacies; [and]
    (11) multiple persons with the same address present 
substantially similar controlled substance prescriptions from the 
same practitioner.
    22 Tex. Admin. Code Ann. Sec.  291.29(f); RFAAX 1, at 4.

    Regarding the operational standards for a pharmacist filling a new 
prescription, the Texas Board of Pharmacy requires a pharmacist to: (i) 
review the patient's medication record and, at a minimum, identify 
clinically significant information such as ``reasonable dose and route 
of administration; . . . drug-drug interactions; . . . and [ ] proper 
utilization, including overutilization or underutilization,'' (ii) 
``take appropriate steps to avoid or resolve [any] problem'' 
identified, ``including consultation with the prescribing 
practitioner''; and (iv) resolve any questions with the prescriber and 
document the resolution. 22 Tex. Admin. Code Ann. Sec.  
291.33(c)(2)(A)(i)-(ii), (iv); RFAAX 1, at 3.\3\
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    \3\ Such documentation must be ``on the prescription or in the 
pharmacy's data processing system associated with the prescription . 
. . and shall include . . . (i) [the] date the prescriber was 
consulted; (ii) [the] name of the person communicating the 
prescriber's instructions; (iii) any applicable information 
pertaining to the consultation; and (iv) [the] initials or 
identification code of the pharmacist performing the consultation 
clearly recorded for the purpose of identifying the pharmacist who 
performed the consultation.'' 22 Tex. Admin. Code Ann. Sec.  
291.33(c)(2)(C); RFAAX 1, at 3.
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    Texas regulations further state that ``[a] pharmacist may not: (1) 
dispense . . . a controlled substance . . . except under a valid 
prescription and in the course of professional practice.'' Tex. Health 
& Safety Code Ann. Sec.  481.074(a)(1); RFAAX 1, at 3.

B. Findings of Fact

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/ISO are deemed admitted. 21 CFR 
1301.43(e). Accordingly, Registrant is deemed to have admitted and the 
Agency finds that from at least January 10, 2024, through at least May 
12, 2025, Registrant repeatedly filled controlled substance 
prescriptions that contained multiple red flags of abuse and/or 
diversion without addressing or resolving those red flags. RFAAX 1, at 
5-8.
Pattern Prescribing, Controlled Substances Known To Be Abused, and 
Highest Strength/Large Quantities
    Registrant admits that ``pattern prescribing'' occurs when 
practitioners prescribe the same controlled substances in identical or 
substantially similar quantities, thus indicating a lack of 
individualized care. RFAAX 1, at 5. Registrant admits that DEA has 
recognized pattern prescribing as a red flag consistent with abuse and/
or diversion that needs to be addressed prior to dispensing. Id. 
(citing The Med. Shoppe, 79 FR 59504, 59512 (2014)).
    Further, as discussed above, see Section III.A., Texas regulations 
have recognized pattern prescribing as a red flag consistent with abuse 
and/or diversion that needs to be addressed prior to dispensing. 22 
Tex. Admin. Code Ann. Sec.  291.29(f)(1); RFAAX 1, at 4. Texas 
regulations have also recognized that prescriptions for controlled 
substances commonly known to be abused (such as opioids and narcotics) 
and prescriptions for controlled substances prescribed at the highest 
strength and/or in large quantities (e.g., a monthly supply) are red 
flags consistent with abuse and/or diversion that need to be addressed 
prior to dispensing. 22 Tex. Admin. Code Ann. Sec.  291.29(f)(3), (5); 
RFAAX 1, at 5.
    Registrant admits that from at least January 2023 through at least 
February 2025, Registrant repeatedly failed to appropriately identify 
and resolve red flags associated with pattern prescribing of controlled 
substances that are commonly known to be abused and prescribed at the 
highest strength and/or in large quantities. RFAAX 1, at 5-6.
    Specifically, Registrant admits that between April 20, 2022, and 
May 12, 2025, more than 90% of the controlled substance prescriptions 
it filled for Schedule II opioids were issued by the same doctor, Dr. 
M.Q. Registrant admits that these prescriptions were written for 
similar strength and quantity and they exhibited a pattern of 
simultaneously changing medication strength or type in the same way for 
multiple patients. These red flag prescriptions included prescriptions 
written by Dr. M.Q. for the following patients:
    Patient Tr.H.: Registrant filled oxycodone prescriptions for 
Patient Tr.H. on June 28, 2024 (100 tablets, 30 mg), July 26, 2026 (100 
tablets, 30 mg), August 27, 2024 (100 tablets, 10 mg), and on five 
additional occasions between September 25, 2024, and February 24, 2025 
(100 tablets, 15 mg).
    Patient A.Lo.: Registrant filled oxycodone prescriptions for 
Patient Tr.H. on three occasions between May 14, 2024, and July 15, 
2024 (100 tablets, 30 mg), on August 26, 2024 (100 tablets, 10 mg), and 
on six occasions between September 25, 2024, and February 21, 2025 (100 
tablets, 15 mg).
    Patient Ti.H.: Registrant partially filled oxycodone prescriptions 
for Patient Ti.H. on three occasions between May 10, 2024, and July 15, 
2024 (110 tablets prescribed, 100 tablets dispensed, 30 mg), on August 
26, 2024, (110 tablets prescribed, 100 tablets dispensed, 10 mg), and 
on four occasions between September 25, 2024, and December 20, 2024, 
(110 tablets

[[Page 64172]]

prescribed, 100 tablets dispensed, 15 mg). Registrant also filled 
oxycodone prescriptions for Patient Ti.H. on January 23, 2025, and 
February 20, 2025 (100 tablets, 30 mg).
    Patient W.G.: Registrant partially filled oxycodone prescriptions 
for Patient W.G. on seven occasions between January 10, 2024, and July 
22, 2024 (104 tablets prescribed, 100 tablets dispensed, 30 mg), and on 
six occasions between September 11, 2024, and February 14, 2025 (104 
tablets prescribed, 100 tablets dispensed, 15 mg). Registrant also 
filled an oxycodone prescription for Patient W.G. on August 26, 2024 
(104 tablets, 10 mg).
    Patient E.B.: Registrant partially filled oxycodone prescriptions 
for Patient E.B. on seven occasions between January 25, 2024, and 
August 26, 2024, (108 tablets prescribed, 100 tablets dispensed, 30 
mg), and on six occasions between September 12, 2024, and February 13, 
2025 (108 tablets prescribed, 100 tablets dispensed, 15 mg).
    Patient C.B.: Registrant partially filled oxycodone prescriptions 
for Patient C.B. on seven occasions between January 25, 2024, and July 
22, 2024, (105 tablets prescribed, 100 tablets dispensed, 30 mg), and 
on six occasions between September 11, 2024, and February 13, 2025 (105 
tablets prescribed, 100 tablets dispensed, 15 mg). Registrant also 
filled an oxycodone prescription for Patient C.B. on August 26, 2024 
(105 tablets, 10 mg). RFAAX 1, at 6.
    Accordingly, the Agency finds substantial record evidence that 
Registrant filled at least 67 oxycodone prescriptions over a three-year 
period without first resolving the red flags arising from pattern 
prescribing of controlled substances known to be abused, at their 
highest strength and/or in large quantities.
    Registrant also admits that it filled prescriptions for 
promethazine with codeine (a Schedule V narcotic) in large quantities 
that are significantly more than is necessary for the duration of a 
single patient's cough symptoms. RFAAX 1, at 8. Specifically, 
Registrant admits that on at least 30 occasions between October 22, 
2024, and April 30, 2025, Registrant dispensed 240 milliliters 
(equivalent to approximately eight ounces) or more of promethazine with 
codeine. Id. Accordingly, the Agency finds substantial record evidence 
that Registrant filled at least 30 prescriptions for promethazine with 
codeine without addressing or resolving the red flag of controlled 
substances prescribed in their highest strength and/or in large 
quantities.
Shared Address
    Registrant admits that it is a red flag of abuse and/or diversion 
when multiple individuals presenting prescriptions for controlled 
substances share the same address. RFAAX 1, at 8. As discussed above, 
Texas regulations identify the following as a red flag factor of abuse 
and/or diversion that must be addressed and resolved before filling a 
prescription for a controlled substance: ``multiple persons with the 
same address present substantially similar controlled substance 
prescriptions from the same practitioner.'' 22 Tex. Admin. Code Sec.  
291.29(f)(11); RFAAX 1, at 4. DEA has recognized multiple individuals 
presenting the same or similar controlled substance prescriptions to be 
a red flag consistent with abuse and/or diversion that needs to be 
addressed prior to dispensing. See Suntree Pharmacy and Suntree Med. 
Equip., 85 FR 73753, 73770 (2020); Pharmacy Doctors Enters. d/b/a/Zion 
Clinic Pharmacy, 83 FR 10876, 10866 (2018); RFAAX 1, at 8.
    Registrant admits that between at least May 2, 2024, and December 
26, 2024, it filled multiple prescriptions from the same prescriber for 
two patients living at the same address in Houston, Texas, and these 
prescriptions fit a similar pattern in dosage and quantity. RFAAX 1, at 
9-10. Specifically, Registrant admits that it filled prescriptions for 
hydrocodone/acetaminophen 7.5/325 mg for Patients D.B. and M.F. with 
the same address on the following occasions in 2024: May 2, May 31, 
June 28, July 26, September 3, October 28, November 25, and December 
26. These prescriptions ranged from 90 tablets to 110 tablets. Id. On 
at least six of these occasions, Registrant admits that it received a 
record from the prescribing physician showing that these prescriptions 
had been issued within 25 minutes of each other. Id.
    Accordingly, the Agency finds substantial record evidence that 
Registrant filled at least 16 prescriptions for hydrocodone/
acetaminophen for Patients D.B. and M.F. without first resolving the 
red flag that the patients shared the same address.
Expert Review
    DEA retained an independent pharmacy expert to review, among other 
materials, Registrant's prescription data and patient profiles. Id. at 
9. The pharmacy expert concluded, and Registrant admits, that the 
prescriptions presented multiple red flags that were highly indicative 
of abuse and diversion. Id. The expert 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 binding minimal standards that govern the practice 
of pharmacy in Texas.'' Id. Finally, the expert concluded, and 
Registrant admits, that ``the Pharmacy's practice of filling 
prescriptions issued predominantly by one physician, together with the 
failure to resolve the red flags those prescriptions presented, 
violated the binding minimal standards that govern the practice of 
pharmacy in Texas.'' Id.
    In consideration of all of the above, the Agency finds substantial 
record evidence that Registrant repeatedly dispensed the above-
referenced prescriptions without first resolving the above-referenced 
red flags, in violation of the standard of care in Texas.

C. Legal Background on Public Interest Determinations

    The Attorney General ``may deny, suspend, or revoke [a] 
registration if . . . the [registrant's] registration would be 
`inconsistent with the public interest.' '' Gonzales v. Oregon, 546 
U.S. 243, 251 (2006) (quoting 21 U.S.C. 824(a)(4)). The Attorney 
General's ``discretion in exercising [the authority to register and 
deregister practitioners] is spelled out in very broad terms.'' Id. at 
292 (Scalia, J., dissenting); see also Neumann's Pharmacy, L.L.C. v. 
Drug Enf't Admin., No. 25-60068, 2026 WL 411942 (5th Cir. Feb. 13, 
2026) (``DEA unquestionably has broad authority to deregister 
pharmacies and substantial discretion to shape policy within statutory 
bounds.''). In executing this broad mandate, DEA must continuously 
balance the CSA's public interest goals of curbing the ``illegal . . . 
distribution[] and possession[,] and improper use of controlled 
substances[, which has] a substantial and detrimental effect on the 
health and general welfare of the American people,'' while ensuring 
that the public has access to medications that ``have a useful and 
legitimate medical purpose and are necessary to maintain the health and 
general welfare of the American people.'' 21 U.S.C. 801(1), (2); see 
Joanna R. Lampe, Cong. Rsch. Serv., R45948, The Controlled Substances 
Act (CSA): A Legal Overview for the 119th Congress (2025), <a href="https://www.congress.gov/crs-product/R45948">https://www.congress.gov/crs-product/R45948</a>.
    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.

[[Page 64173]]

823(g)(1)(A-E).\4\ Just as the phrase ``inconsistent with the public 
interest'' is broad, the five factors that Congress directed DEA to 
consider in determining the public interest are similarly broad, 
suggesting that Congress intended for DEA to have discretion and 
flexibility to interpret this language as necessary to implement its 
critical mission to protect the public from drug abuse and diversion. 
See Loper Bright Enters. v. Raimondo, 603 U.S 369, 394-95 (2024) 
(noting that ``[i]n a case involving an agency . . . the statute's 
meaning may well be that the agency is authorized to exercise a degree 
of discretion,'' such as where the statute uses terms or phrases like 
`appropriate or reasonable' '' (internal citations omitted)). Indeed, 
courts have recognized the Agency's broad discretion to deny 
applications and deregister practitioners for a wide variety of conduct 
that the Agency has determined is inconsistent with the public 
interest. See, e.g., Orusa v. Drug Enf't Admin., No. 22-3132, 2023 WL 
3886403 (6th Cir. June 8, 2023) (physician issuing prescriptions 
outside the usual course of professional practice and beneath the 
standard of care); St. Croix v. Drug Enf't Admin., No. 21-1116, 2022 WL 
2092177 (D.C. Cir. June 10, 2022) (physician failing to maintain 
adequate records, prescribing controlled substances without a 
legitimate medical purposes, storing controlled substances at an 
unregistered location, failing to provide effective controls to guard 
against theft or diversion of these substances); Suntree Pharmacy v. 
Drug Enf't Admin., No. 20-14626, 2022 WL 444357 (11th Cir. Feb. 14, 
2022), cert. denied, 143 S. Ct. 305 (2022) (pharmacy filling 
prescriptions outside the usual course of practice).
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    \4\ The five factors 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.
    21 U.S.C. 823(g)(1)(A-E).
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    The CSA's five public interest factors are considered in the 
disjunctive. Gonzales v. Oregon, 546 U.S. at 292-93 (Scalia, J., 
dissenting) (``It is well established that these factors are to be 
considered in the disjunctive,'' quoting 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. David H. Gillis, M.D., 58 FR 37507, 
37508 (1993); see Morall v. Drug Enf't Admin., 412 F.3d 165, 181 (D.C. 
Cir. 2005) (describing the Agency's adjudicative process as ``applying 
a multi-factor test through case-by-case adjudication,'' quoting 
LeMoyne-Owen Coll. v. N.L.R.B., 357 F.3d 55, 61 (D.C. Cir. 2004)). Any 
one factor, or combination of factors, may be decisive, David H. 
Gillis, M.D., 58 FR at 37508, and the Agency ``may give each factor the 
weight . . . deem[ed] appropriate in determining whether a registration 
should be revoked or an application for registration denied.'' Morall, 
412 F.3d. at 185 n.2 (Henderson, J., concurring) (quoting Robert A. 
Smith, M.D., 70 FR 33207, 33208 (2007)); see also Penick Corp. v. Drug 
Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007).
    Moreover, while the Agency is required to consider each of the 
factors, it ``need not make explicit findings as to each one.'' MacKay 
v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (quoting 
Volkman v. U.S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009)); 
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 
823, 830 (11th Cir. 2018); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 
482 (6th Cir. 2005). ``In short, . . . the Agency is not required to 
mechanically count up the factors and determine how many favor the 
Government and how many favor the registrant. Rather, it is an inquiry 
which focuses on protecting the public interest; what matters is the 
seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D., 
74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has 
recognized, Agency decisions have explained that findings under a 
single factor can support the revocation of a registration. MacKay, 664 
F.3d at 821.
    The Government has the burden of proof in this proceeding, 21 CFR 
1301.44(e), and the Agency must make its findings based on 
``substantial [record] evidence.'' 5 U.S.C. 556(d); see 5 U.S.C. 
706(2); 21 U.S.C. 877. If the Government meets its burden of 
establishing a prima facie case that Registrant's registration is not 
in the public interest, then the burden shifts to Registrant to rebut 
the Government's case. Pharmacy Doctor Enters., Inc. v. Drug Enf't 
Admin., 789 Fed. Appx. 724, 729 (11th Cir. 2019) (citing Jones Total 
Health Care Pharmacy, 881 F.3d at 830).
    Registrant is registered in Texas, and the OSC/ISO has alleged 
violations of state laws in Texas. RFAAX 1, at 2-5. Accordingly, the 
Agency must evaluate the Government's evidence under Texas law. See 
Henry Emery, M.D., 90 FR 46927, 46929 (2025) (explaining the Agency 
analyzes public interest allegations according to the laws in the state 
where registrant is registered with DEA); see also 21 U.S.C. 903 (``No 
provision of this subchapter shall be construed as indicating an intent 
on the part of the Congress to occupy the field in which that provision 
operates, including criminal penalties, to the exclusion of any State 
law on the same subject matter which would otherwise be within the 
authority of the State, unless there is a positive conflict between 
that provision of this subchapter and that State law so that the two 
cannot consistently stand together.'').

D. Discussion

    While the Agency has considered all the public interest factors of 
21 U.S.C. 823(g)(1), the Government's evidence in support of its prima 
facie case primarily implicates Factors B and D. RFAA, at 5-6; RFAAX 1, 
at 5. Evidence is considered under Factor B when it reflects experience 
dispensing controlled substances and under Factor D when it reflects 
compliance or non-compliance with laws related to controlled 
substances. Kareem Hubbard, M.D., 87 FR 21156, 21162 (2022). Although 
Factors B and D have some overlap such that the Agency has frequently 
analyzed them together, Congress must have intended Factor B to 
encompass conduct that is not captured under Factor D. See Kungys v. 
United States, 485 U.S. 759, 778 (1988) (referencing the ``cardinal 
rule of statutory interpretation that no provision should be construed 
to be entirely redundant'').
i. Factor B
    As already discussed, the CSA gives the Attorney General authority 
to revoke a registration if he determines that the registrant ``has 
committed such acts as would render his registration . . . inconsistent 
with the public interest as determined under [section 823].'' 21 U.S.C. 
824(a). One of the five factors that the Attorney General must consider 
in making this determination is the registrant's ``experience in 
dispensing . . . controlled substances.'' 21 U.S.C. 823(g)(1)(B) 
(Factor B). Neither the statute nor the implementing regulations 
defines the term ``experience'' or places any limitations on the type 
of conduct that may be considered as ``experience'' under Factor B.\5\
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    \5\ The only limitation discussed in the legislative history on 
DEA's authority under Factor B is that DEA should not ``construe 
[this factor] in any way to hinder registration of recent graduates 
of professional schools who may have no professional experience 
dispensing or conducting research with controlled substances.'' H.R. 
REP. NO. 98-835, pt. 1, at 14 (1984).

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[[Page 64174]]

    Historically, the Agency's Factor B \6\ analysis considered ``both 
the qualitative manner and quantitative volume of the [practitioner's] 
experience . . . as expressed through his patients and employees,'' and 
concluded that the record must contain quantitative evidence regarding 
the practitioner's experience for the Agency to find that Factor B 
weighs against a practitioner. E.g., Clair L. Pettinger, 78 FR 61592, 
61619 (2013). In 2015, the Agency abandoned this language, observing 
that the text of Factor B did not require DEA to consider the 
practitioner's ``quantity'' of prescribing. See JM Pharmacy Group, 
Inc., 80 FR 28667, 28667-68 (2015); see also Wesley Pope, M.D., 82 FR 
14944, 14982 (2017). The Agency reviewed dictionary definitions of 
``experience,'' including:
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    \6\ Historically, the Agency referred to ``Factor B'' as 
``Factor Two.'' Effective December 2, 2022, the Medical Marijuana 
and Cannabidiol Research Expansion Act, Public Law 117-215, 136 
Stat. 2257 (2022) (Marijuana Research Amendments or MRA), amended 
the CSA and other statutes. Relevant to this matter, the MRA 
redesignated the public interest factors outlined at 21 U.S.C. 
823(f)(1-5), which the Agency referred to as Factors One through 
Five, as 21 U.S.C. 823(g)(1)(A-E), which the Agency now refers to as 
Factors A through E. Accordingly, this Decision cites to the current 
designation, 21 U.S.C. 823(g)(1)(B), ``Factor B.''

    (1) The ``direct observation of or participation in events as a 
basis for knowledge,'' (2) ``the fact or state of having been 
affected by or gained knowledge through direct observation or 
participation,'' (3) ``practical knowledge, skill, or practice 
derived from direct observation of or participation in events or in 
a particular activity,'' and (4) ``the length of such 
---------------------------------------------------------------------------
participation.''

    80 FR at 28667 n.2 (citing Webster's Collegiate Dictionary 409 
(10th ed. 1998); The Random House Dictionary of the English Language 
681 (2d ed. 1987)).
    The word ``dispense'' means ``to deliver a controlled substance[] 
to an ultimate user or research subject by, or pursuant to the lawful 
order of a practitioner, including the prescribing or administering of 
a controlled substance and the packaging, labeling or compounding 
necessary to prepare the substance for such delivery.'' 21 U.S.C. 
802(10). This definition encompasses, among other things, practitioners 
who prescribe controlled substances and pharmacies who fill controlled 
substance prescriptions. Id. The term ``controlled substance'' simply 
means ``a drug or other substance . . . included in schedule I, II, 
III, IV, or V . . . .'' 21 U.S.C. 802(6). Thus, the phrase ``experience 
in dispensing'' means the direct participation in the act of 
delivering, prescribing, dispensing, or administrating a controlled 
substance to an ultimate user.
    The phrase ``experience in dispensing'' must be considered within 
the context of DEA's broad mandate under 21 U.S.C. 824(a) to deregister 
practitioners who ``ha[ve] committed such acts as would render [their] 
registration . . . inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4). In other words, in determining what type of conduct is 
relevant under Factor B, DEA's primary focus is to determine whether a 
registrant's ``experience in dispensing'' is ``inconsistent with the 
public interest'' or whether a registrant's dispensing constitutes 
``acts'' that are inconsistent with the public interest. 21 U.S.C. 
823(g)(1), 824(a)(4).
    The word ``inconsistent'' is not defined in the CSA, but it is 
commonly defined as ``lacking consistency: such as (a) not compatible 
with another fact or claim, [and] (b) containing incompatible 
elements.'' Inconsistent, Merriam-Webster, <a href="https://www.merriam-webster.com/dictionary/inconsistent">https://www.merriam-webster.com/dictionary/inconsistent</a> (last visited on the date of 
signature). ``Public interest'' is not explicitly defined in the CSA, 
but Congress identifies the primary ``public interest'' goals in the 
CSA's introductory section as ensuring access to controlled substances 
used for a ``legitimate medical purpose'' while protecting the public 
from the ``illegal . . . distribution . . . and improper use of 
controlled substances[, which] have a substantial and detrimental 
effect on the health and general welfare of the American people.'' 21 
U.S.C. 801(1) & (2).
    Considering these goals, DEA's Factor B analysis primarily concerns 
whether a registrant's ``experience in dispensing'' reflects illegal 
distribution or improper use of controlled substances that is 
inconsistent with the public interest. Id. In the context of a 
pharmacy, this would require the Agency to evaluate whether a pharmacy 
has dispensed controlled substances in a manner that is improper, 
illegal, or inconsistent with the public interest; for example, by 
ignoring indicators that a prescription lacked a legitimate medical 
purpose or would be improperly used, by filling a prescription in a 
manner that is inconsistent with state law or the state's standards of 
practice, or by distributing controlled substances in a way that 
creates a risk of diversion.\7\
---------------------------------------------------------------------------

    \7\ Analysis of whether a prescription is illegally filled, 
distributed, or possessed also fits within Factor D, ``Compliance 
with applicable State, Federal, or local laws relating to controlled 
substances.'' 21 U.S.C. 823(g)(1)(D).
---------------------------------------------------------------------------

    Of course, the Agency is not only concerned with acts of 
intentional diversion,\8\ as DEA has explained that ``[c]areless or 
negligent handling of controlled substances creates the opportunity for 
diversion and [can] justify the revocation of an existing registration 
. . .'' Samson K. Orusa, M.D., 87 FR 2986, 3018 (2022) (quoting Paul J. 
Caragine, Jr., 63 FR 51592, 51602 (1998)); Bradley H. Chesler, M.D., 87 
FR 4917-01 (citing Bienvenido Tan, 76 FR 1763, 17689 (2011)); Dewey C. 
MacKay, M.D., 75 FR 49956, 49974 n.35 (2010) (``Accordingly, under the 
public interest standard, DEA has authority to consider those 
prescribing practices of a physician, which, while not rising to the 
level of intentional or knowing misconduct, nonetheless create a 
substantial risk of diversion.''). Indeed, neither 21 U.S.C. 824(a) nor 
21 U.S.C. 823(g) requires DEA to find that a registrant has 
intentionally diverted controlled substances. Ultimately, a registrant 
whose dispensing practices create an environment that encourages or is 
indifferent to the abuse or diversion of controlled substances is 
acting outside the public's interest. As the opioid epidemic surges and 
other controlled substances, such as amphetamines, ketamine, and 
benzodiazepines, are increasingly abused, DEA must remain vigilant to 
protect the public against registrants who fail to employ the CSA's 
safeguards to ensure the health and general wellness of the American 
public.
---------------------------------------------------------------------------

    \8\ Only criminally unlawful conduct requires an act of 
intentional diversion such as proof that a physician ``used `his 
authority to prescribe controlled substances . . . not for treatment 
of a patient, but for the purpose of assisting another in the 
maintenance of a drug habit' or some other illegitimate purposes, 
such as his own `personal profit.' '' United States v. McIver, 470 
F.3d 550, 559 (4th Cir. 2006) (quoted in Laurence T. McKinney, 73 
Fed Reg 43260, 43266 (2008). Compare 21 U.S.C. 823 and 824 with 21 
U.S.C. 841, 842, 843.
---------------------------------------------------------------------------

    Registrants ``may continue to introduce evidence as to . . . lawful 
. . . dispensing activities.'' \9\ However, the Agency has found that 
``evidence that a practitioner has treated thousands of patients does 
not negate a prima facie showing that the practitioner has committed 
acts inconsistent with the

[[Page 64175]]

public interest.'' \10\ Krishna-Iyer, 74 FR at 463. Accordingly, the 
Agency has consistently rejected registrants' arguments that acts of 
unlawful prescribing were mitigated by years of lawful prescribing. 
See, e.g., Syed-Jawed Akhtar-Zaidi, 80 FR 42961, 42967 (2015), pet. for 
rev. denied, 841 F.3d 707, 713 (6th Cir. 2016) (rejecting Registrant's 
argument that he was denied a ``fair adjudication'' because the 
Government seized 400 patient files but only proved the illegality of a 
handful of prescriptions issued during undercover visits, and finding 
that ``the physician's prescribings to thousands of other patients do 
not . . . render her prescribings to the undercover officers any less 
unlawful, or any less acts which are inconsistent with the public 
interest'') (internal quotations and citations omitted).\11\
---------------------------------------------------------------------------

    \9\ Randall L. Wolff, M.D., 77 FR 5106, 5153 (2012) (finding 
that evidence of lawful prescribing is ``entitled to some 
evidentiary weight only in cases where a practitioner credibly 
demonstrates an acceptance of responsibility and reform of past 
practices''); see also Roberto Zayas, M.D., 82 FR 21410, 21422 n.27 
(2017) (``[T]he Agency properly considers a [registrant's] evidence 
of a lengthy history of compliance after the Government makes out 
its prima facie case, as determining what sanction is necessary to 
protect the public interest is the ultimate purpose of these 
provisions.''). In other words, this evidence may be relevant to the 
Agency's sanctions analysis.
    \10\ ``[E]very registrant can undoubtedly point to an extensive 
body of legitimate prescribing over the course of [their] 
professional career.'' Krishna-Iyer, 74 FR at 463. Accordingly, 
except where the Agency has found in its decision that a 
prescription was issued outside the public interest or in violation 
of law, the Agency assumes that all controlled substance 
prescriptions dispensed by a pharmacy are dispensed for a legitimate 
medical purpose and in accordance with relevant laws. See Dewey C. 
Mackay, M.D., 75 FR at 49977.
    \11\ In an unreported opinion, the Sixth Circuit affirmed DEA's 
conclusion that the Registrant's acts of unlawful prescribing 
outweighed his years of work experience. Orusa v. Drug Enf't Admin., 
2023 WL 3886403 at *5 (``Orusa's credentials and years of work 
experience, which the agency acknowledged, do nothing to disturb the 
agency's detailed review of his prescribing history--the relevant 
``experience in dispensing . . . controlled substances.'').
---------------------------------------------------------------------------

    Here, as found above, Registrant is deemed to have admitted and the 
Agency finds that Registrant repeatedly filled controlled substance 
prescriptions that contained multiple red flags of abuse and/or 
diversion without addressing or resolving those red flags. Registrant 
has further admitted 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 binding minimal standards that 
govern the practice of pharmacy in Texas.'' RFAAX 1, at 9. The Agency 
finds that Registrant's failure to adhere to the minimum standards 
governing Texas pharmacy practice and its repeated issuance of 
prescriptions without addressing or resolving red flags reflects 
``experience in dispensing . . . controlled substances'' that created 
an opportunity for the abuse or diversion of controlled substances and 
was outside the public interest. Registrant did not request a hearing 
and thus did not provide the Agency with any evidence related to its 
``experience in dispensing'' that served the public's interest. 
Accordingly, the Agency finds that Factor B weighs strongly against 
Registrant's continued registration.\12\
---------------------------------------------------------------------------

    \12\ While the Agency has determined that Registrant's 
dispensing conduct is relevant to Factors B and D, to the extent 
that the found conduct does not fall within these factors, it would 
nevertheless constitute ``other conduct which may threaten the 
public health and safety.'' 21 U.S.C. 823(g)(1)(E). Registrant's 
repeated dispensing of controlled substances without addressing or 
resolving red flags may threaten the public health and safety by 
creating the risk that controlled substances may leave the CSA's 
closed distribution system and be abused or diverted.
---------------------------------------------------------------------------

ii. Factor D
    Under Factor D, the Agency considers a registrant's ``[c]ompliance 
with applicable State, Federal, or local laws relating to controlled 
substances.'' 21 U.S.C. 823(g)(1)(D). Texas law establishes several 
factors that require resolution ``to prevent[ ] the non-therapeutic 
dispensing of controlled substances''--in other words, diversion--a 
concern that goes to the heart of the CSA's public interest goal to 
ensure controlled substances stay in legitimate channels and outside of 
illicit channels. 22 Tex. Admin. Code Sec.  291.29(f); 21 U.S.C. 801(1) 
& (2); Gonzales v. Raich, 545 U.S. at 12-13.
    Here, an independent medical expert reviewed the evidence in this 
matter and concluded that Registrant's dispensing failed to prevent 
diversion insofar as Registrant failed to resolve concerns that Texas 
law establishes are indicative of diversion, and therefore, require 
resolution. RFAAX 1, at 9. To this extent, as the expert concluded, 
Registrant's repeated failure to resolve red flags--that are indicative 
of diversion per Texas law--violated ``binding minimal standards that 
govern'' the dispensing of controlled substances, standards which are 
designed to prevent diversion and that align with the CSA's public 
interest goals. Id. In this way, Registrant's dispensing failed to 
comply with applicable state law relating to controlled substances and 
the prevention of diversion. 21 U.S.C. 823(g)(1)(D).
    Accordingly, as found above, Registrant is deemed to have admitted, 
and the Agency finds, that Registrant repeatedly dispensed controlled 
substances over a period of two years without resolving or documenting 
multiple red flags of drug abuse and/or diversion, as required by state 
law. As such, the Agency finds substantial record evidence that 
Registrant violated Texas law by failing to resolve red flags that are 
indicative of diversion. 22 Tex. Admin. Code Sec.  291.29(f).
    The Agency finds that after considering the public interest factors 
of 21 U.S.C. 823(g)(1), Factors B and D weigh in favor of revocation of 
Registrant's registration. Accordingly, the Government has satisfied 
its prima facie burden of showing that Registrant's continued 
registration would be ``inconsistent with the public interest.'' 21 
U.S.C. 824(a)(4). The Agency also finds that there is insufficient 
mitigating evidence to rebut the Government's prima facie case. Thus, 
the only remaining issue is whether, in spite of the public interest 
determination, Registrant can be trusted with a registration.

III. Sanction

    Where, as here, the Government has met the burden of showing that 
Registrant's registration is inconsistent with the public interest, 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, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); 
Garrett Howard Smith, M.D., 83 FR 18882, 18904 (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, the Agency requires that a registrant 
that has committed acts inconsistent with the public interest accept 
responsibility for those acts and demonstrate that it will not engage 
in future misconduct. See 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). The Agency requires a registrant's unequivocal acceptance of 
responsibility. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024); 
Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see also Jones Total 
Health Care Pharmacy, 881 F.3d at 830-31. In addition, a registrant's 
candor during the investigation and hearing is an important factor in 
determining acceptance of responsibility and the appropriate sanction. 
See Jones Total Health Care Pharmacy, 881 F.3d at 830-31; Hoxie, 419 
F.3d at 483-84. Further, the Agency considers the egregiousness and 
extent of the misconduct as significant factors in determining the 
appropriate sanction. See Jones Total Health Care Pharmacy, 881 F.3d at 
834 & n.4. The Agency also considers the

[[Page 64176]]

need to deter similar acts by a registrant and by the community of 
registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
    Here, Registrant did not request a hearing and was deemed to be in 
default. To date, Registrant has not filed a motion with the Office of 
the Administrator to excuse the default. 21 CFR 1301.43(c)(1). 
Registrant has thus failed to answer the allegations contained in the 
OSC/ISO and has not otherwise availed itself of the opportunity to 
refute the Government's case. As such, Registrant has made no 
representations regarding its future compliance with the CSA nor made 
any demonstration that it can be trusted with registration. Moreover, 
the evidence presented by the Government shows that Registrant 
repeatedly filled controlled substance prescriptions outside the usual 
course of professional practice in Texas and in violation of the CSA, 
indicating that Registrant cannot be entrusted.
    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) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate 
of Registration No. FA3529849 issued to Arenbii Pharmacy LLC. 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 application of Arenbii Pharmacy 
LLC to renew or modify this registration as well as any other pending 
application of Arenbii Pharmacy LLC for additional registration in 
Texas. This Order is effective November 6, 2026.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
September 30, 2026, by DEA Administrator Terrance C. Cole. 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. 2026-20535 Filed 10-6-26; 8:45 am]
BILLING CODE 4410-09-P


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