Notice2026-20552
Wellwise Pharmacy Inc.; Decision and Order
Primary source
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Published
October 7, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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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 64162-64169]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20552]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Wellwise Pharmacy Inc.; Decision and Order
On September 25, 2025, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Wellwise Pharmacy Inc. of Houston, Texas, and
Conroe, 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 registration, No. FW2318497, pursuant
to 21 U.S.C. 824(d), finding 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 registration, 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)).\1\
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\1\ The Government's RFAA included a declaration by a DEA
Diversion Investigator (DI), in which DI declared under penalty of
perjury that on September 29, 2025, she and other DEA personnel
traveled to Registrant's registered location and personally served a
copy of the OSC/ISO on D.O., a representative of Registrant. RFAAX
2, at 1-2. Due to personal service of the OSC/ISO upon a
representative of Registrant, the Agency finds that due process
notice requirements have been satisfied.
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Specifically, the OSC/ISO alleges that from at least January 2023
to March 2025, Registrant violated federal and Texas law by repeatedly
filling prescriptions for controlled substances that presented multiple
flags of diversion and/or abuse without addressing or resolving those
red flags. RFAAX 1, at 4. The OSC/ISO alleged that these unresolved red
flags of abuse and/or diversion included pattern prescribing;
prescriptions for controlled substances commonly known to be abused;
prescriptions for controlled substances at their highest strength and/
or in large quantities; prescriptions for controlled substances for
multiple patients who shared the same address; patients who traveled
long distances to fill their controlled substance prescriptions; and
patients who were paying high prices or in cash, instead of using
insurance, for their controlled substance prescriptions. Id. at 5-9.
The OSC/ISO alleged that Registrant violated the following federal
regulations: 21 CFR 1306.04 and 21 CFR 1306.06. RFAAX 1, at 2. The OSC/
ISO also alleged that Registrant violated the following Texas state
laws: Tex. Health & Safety Code Sec. 481.074(a)(1); Tex. Health &
Safety Code Sec. 481.128(a)(1); 22 Tex. Admin. Code Sec. 291.29(a)-
(b), (f); 22 Tex. Admin. Code Sec. 291.33(c)(2)(A)(i)-(ii), (iv); 22
Tex. Admin. Code Sec. 291.33(c)(2)(C); 22 Tex. Admin. Code Sec.
291.34(b)(1). Id. at 2-4.
On November 19, 2025, the Government submitted an RFAA to the
Administrator requesting that the Agency issue a default final order
revoking Registrant's registration. RFAA, at 1, 10. After carefully
reviewing the entire record and conducting the analysis as set forth in
detail below, the Agency grants the
[[Page 64163]]
Government's RFAA and revokes Registrant's registration. As a
preliminary matter, this Decision addresses whether Registrant is in
default and finds that it is. Thereafter, this Decision makes specific
factual findings on the alleged violations as set forth in the OSC/ISO;
specifically, the allegations that Registrant repeatedly filled
controlled substance prescriptions without resolving red flags of abuse
and/or diversion. Next, this Decision considers whether Registrant's
registration is inconsistent with the public interest and finds that it
is. Lastly, this Decision determines that the appropriate sanction is
revocation of 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] . . . 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].'' 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 10-11 (citing 21 CFR 1301.43). According to
the Government's RFAA, Registrant failed to request a hearing. RFAA, at
1-2, 9. 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 Determination
A. Overview of Law
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., 167 F.4th 320, 323 (5th Cir. 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. 823(g)(1)(A)-(E).\2\ 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 purpose, 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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\2\ 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
[[Page 64164]]
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 2-4. 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.'').
B. Applicable State Law
According to the CSA's implementing regulations, a lawful
controlled substance prescription is one that is ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' RFAAX 1, at 2 (citing 21
CFR 1306.04(a)); see Gonzales v. Oregon, 546 U.S. at 274; United States
v. Hayes, 595 F.2d 258, 260 (5th Cir. 1979), rehearing den., 598 F.2d
620 (5th Cir. 1979), cert. denied, 444 U.S. 866 (1979). 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.'' RFAAX 1, at 2 (citing 21 CFR 1306.04(a)). Pursuant to
the CSA's implementing regulations, only a pharmacist ``acting in the
usual course of his professional practice'' may fill a prescription for
a controlled substance. RFAAX 1, at 2 (citing 21 CFR 1306.06).
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 Sec. 291.29(a)-(b); see also 22 Tex. Admin. Code 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 3-4. The statute further
states that these red flags ``shall be considered by evaluating the
totality of the circumstances rather than any single factor.'' Id.
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;
(11) multiple persons with the same address present substantially
similar controlled substance prescriptions from the same practitioner;
(12) persons consistently pay for controlled substance
prescriptions with cash or cash equivalents more often than through
insurance;
(13) persons presenting controlled substance prescriptions are
doing so in such a manner that varies from the manner in which persons
routinely seek pharmacy services (e.g., persons arriving in the same
vehicle with prescriptions from same practitioner; one person seeking
to pick up prescriptions for multiple others; drugs referenced by
street names[.]''
22 Tex. Admin. Code Sec. 291.29(f); RFAAX 1, at 3-4.
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 Sec. 291.33(c)(2)(A)(i)-
(ii), (iv); see 22 Tex. Admin. Code Sec. 291.33(c)(2)(C) (outlining
the information that such documentation must include); 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 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 Sec. 481.074(a)(1); see Tex. Health & Safety Code Sec.
481.128(a)(1) (``A registrant or dispenser commits an offense if the
registrant or dispenser knowingly . . . distributes, delivers,
administers, or dispenses a controlled substance in violation of''
Sections 481.061-481.080 of the Texas Health and Safety Code); RFAAX 1,
at 2.
[[Page 64165]]
III. Findings of Fact
Allegation That Registrant Filled Prescriptions Without Addressing or
Resolving Red Flags of Abuse and/or Diversion
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 that from January 2023 through March 2025
Registrant repeatedly filled prescriptions for controlled substances
that contained multiple red flags of diversion and/or abuse without
addressing or resolving those red flags, as detailed below. RFAAX 1, at
4.
A. Pattern Prescribing, Substances of Abuse, 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 to be 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)). Registrant also
admits that it is a red flag of abuse and/or diversion when
prescriptions are for controlled substances that are commonly known to
be abused, such as opioids and muscle relaxants, and for the highest
strength and/or large quantities, such as a monthly supply. RFAAX 1, at
5.
Further, as discussed above, see supra Section II, Texas
regulations have recognized pattern prescribing to be 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
3, 5. 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 Sec. Sec.
291.29(f)(3), (f)(5); RFAAX 1, at 3-5.
Registrant admits that between January 19, 2023, and March 31,
2025, Registrant routinely filled prescriptions for oxycodone 30 mg (a
Schedule II opioid), hydrocodone-acetaminophen 10-325 mg (a Schedule II
opioid), and carisoprodol 350 mg (a Schedule IV muscle relaxant). RFAAX
1, at 5. Registrant further admits that it repeatedly failed to
identify and resolve pattern prescribing from the same practitioners.
Id.
Specifically, Drs. C.I., M.L., and M.Q. prescribed 91-percent of
all prescriptions that Registrant dispensed for oxycodone 30 mg (599
prescriptions out of 655 total). RFAAX 1, at 5. Drs. C.I. and M.L.
prescribed 97-percent of all prescriptions that Registrant dispensed
for hydrocodone 10-325 mg (381 prescriptions out of 391 total). Id.
Drs. C.I. and M.L. prescribed 99-percent of all prescriptions that
Registrant dispensed for carisoprodol 350 mg (380 prescriptions out of
383 total). Id.
Specific examples of Registrant's failure to identify and resolve
red flags of pattern prescribing, substances of abuse, and highest
strength and/or large quantities raised by prescriptions issued by Dr.
C.I. include the following:
(a) Between December 26, 2024, and March 31, 2025, Registrant
filled three prescriptions for individual B.P. for hydrocodone-
acetaminophen 10-325 mg (100-108 tablets), and three prescriptions for
carisoprodol 350 mg (90 tablets). RFAAX 1, at 5.
(b) Between September 28, 2023, and March 18, 2025, Registrant
filled two prescriptions for individual B.S. for oxycodone 30 mg (110
tablets), three prescriptions for hydrocodone-acetaminophen 10-325 mg
(100 tablets), and three prescriptions for carisoprodol 350 mg (90
tablets). RFAAX 1, at 5-6.
(c) Between January 31, 2024, and February 19, 2025, Registrant
filled one prescription for individual S.H. for oxycodone 30 mg (109
tablets), two prescriptions for hydrocodone-acetaminophen 10-325 mg
(100 tablets), and two prescriptions for carisoprodol 350 mg (90
tablets). RFAAX 1, at 6.
(d) Between January 16, 2025, and February 19, 2025, Registrant
filled two prescriptions for individual C.B. for hydrocodone-
acetaminophen 10-325 mg (110 tablets), and two prescriptions for
carisoprodol 350 mg (90 tablets). RFAAX 1, at 6.
(e) Between October 4, 2023, and March 25, 2024, Registrant filled
three prescriptions for individual K.B. for oxycodone 30 mg (110
tablets). RFAAX 1, at 6.
(f) Between August 22, 2023, and February 20, 2024, Registrant
filled five prescriptions for individual T.D. for oxycodone 30 mg (105-
110 tablets). RFAAX 1, at 6.
(g) Between August 10, 2023, and September 8, 2023, Registrant
filled two prescriptions for individual Ke.B. for oxycodone 30 mg (100-
105 tablets). RFAAX 1, at 6.
Registrant's records do not indicate that Registrant addressed or
resolved the red flags discussed above. RFAAX 1, at 6. Accordingly, the
Agency finds substantial record evidence that over 26-months Registrant
repeatedly filled numerous prescriptions for controlled substances (at
least 1,360 prescriptions) without first resolving the prescriptions'
red flags of pattern prescribing, substances of abuse, and highest
strength and/or large quantities. RFAAX 1, at 5-6.
B. Shared Addresses
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 6. Registrant further
admits that under DEA and Texas rules, multiple persons with the same
address presenting the same or substantially similar controlled
substance prescriptions from the same practitioner is pattern
prescribing that must be resolved prior to filling the prescription.
Id. (citing 22 Tex. Admin. Code Sec. 291.29(f)(11); Holiday CVS,
L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195, 77 FR 62316, 62344
(2012)).
As discussed above, see supra Section II, 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). 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.
Holiday CVS, 77 FR at 62344.
Specifically, between August 22, 2023, and March 18, 2025,
Registrant filled seven prescriptions for oxycodone 30 mg, three
prescriptions for hydrocodone-acetaminophen 10-325 mg, and three
prescriptions for carisoprodol 350 mg for individuals B.S. and T.D. who
shared the same address. RFAAX 1, at 6. These prescriptions were all
issued by Dr. C.I. Id.
Between August 10, 2023, and February 19, 2025, Registrant filled
three prescriptions for oxycodone 30 mg for individuals S.H. and Ke.B.
RFAAX 1, at 6. Registrant also filled five prescriptions for
hydrocodone-acetaminophen 10-325 mg and five prescriptions for
carisoprodol 350 mg for individuals S.H. and C.B. Id. at 7. Individuals
S.H., Ke.B., and C.B. shared
[[Page 64166]]
the same address. Id. These prescriptions were all issued by Dr. C.I.
Id.
Registrant's records do not indicate that Registrant addressed or
resolved the red flags discussed above. RFAAX 1, at 7. Accordingly, the
Agency finds substantial record evidence that over approximately 19
months Registrant repeatedly filled numerous prescriptions for
controlled substances, at least 26 in total, without first resolving
the prescriptions' red flags of the recipients sharing the same
address. Id.
C. Long Distances
Registrant admits that DEA has recognized that traveling long
distances to obtain or fill controlled substance prescriptions is a red
flag of abuse and/or diversion. RFAAX 1, at 7 (citing E Main St.
Pharmacy, 75 FR 66149, 66164 (2010)).
Registrant is further deemed to have admitted that it repeatedly
filled controlled substance prescriptions without identifying and
resolving the red flag of patients traveling long distances to obtain
or fill the prescriptions.\4\ RFAAX 1, at 7. Specifically, Registrant
is deemed to have admitted that the following controlled substance
prescriptions it filled raised the red flag of long distances:
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\4\ Though long distances are not specifically mentioned in the
Texas regulations as a red flag factor, the OSC/ISO notes that ``DEA
has found that traveling long distances to obtain or fill controlled
substances prescriptions is a well-known red flag of abuse or
diversion.'' RFAAX 1, at 7 (citing E Main St. Pharmacy, 75 FR 66149,
66164 (2010) (finding that ``the fact that the patients were driving
so far to get their prescriptions filled `would be a major red flag
to any pharmacist' '')).
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(a) On six occasions between December 26, 2024, and March 31, 2025,
Registrant (Conroe location) \5\ filled prescriptions for hydrocodone-
acetaminophen 10-325 mg (100-108 tablets) or carisoprodol 350 mg (90
tablets) for individual B.P., whose home address was approximately 67
miles from Registrant. RFAAX 1, at 7.
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\5\ Registrant's registered address was in Richmond, Texas,
prior to September 2024, at which time it relocated to a registered
address in Conroe, Texas. RFAAX 1, at 4.
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(b) On six occasions between December 26, 2024, and March 18, 2025,
Registrant (Conroe location) filled prescriptions for hydrocodone-
acetaminophen 10-325 mg (100 tablets) or carisoprodol 350 mg (90
tablets) for individual B.S., whose home address is approximately 50
miles from Registrant. RFAAX 1, at 7. On two occasions between October
3, 2023, and April 23, 2024, Registrant (Richmond location) filled
prescriptions for oxycodone 30 mg (110 tablets) for individual B.S.,
whose home address was approximately 31 miles from Registrant. Id.
(c) On four occasions between January 15, 2025, and February 19,
2025, Registrant (Conroe location) filled prescriptions for
hydrocodone-acetaminophen 10-325 mg (100 tablets) or carisoprodol 350
mg (90 tablets) for individual S.H., whose home address is
approximately 52 miles from Registrant. RFAAX 1, at 7. On one occasion,
on January 31, 2024, Registrant (Richmond location) filled a
prescription for oxycodone 30 mg (109 tablets) for individual S.H.,
whose home address was approximately 29 miles from Registrant. Id.
(d) On four occasions between January 16, 2025, and February 19,
2025, Registrant (Conroe location) filled prescriptions for
hydrocodone-acetaminophen 10-325 mg (110 tablets) or carisoprodol 350
mg (90 tablets) for individual C.B., whose home address was
approximately 52 miles from Registrant. RFAAX 1, at 7-8.
(e) On three occasions between October 4, 2023, and March 25, 2024,
Registrant (Richmond location) filled prescriptions for oxycodone 30 mg
(110 tablets) for individual K.B., whose home address was approximately
303 miles from Registrant. RFAAX 1, at 8.
(f) On five occasions between August 22, 2023, and February 20,
2024, Registrant (Richmond location) filled prescriptions for oxycodone
30 mg (105-110 tablets) for individual T.D., whose home address was
approximately 31 miles from Registrant. RFAAX 1, at 8.
(g) On two occasions between August 10, 2023, and September 8,
2023, Registrant (Richmond location) filled prescriptions for oxycodone
30 mg (100-105 tablets) for individual Ke.B., whose home address was
approximately 29 miles from Registrant. RFAAX 1, at 8.
Registrant's records do not indicate that Registrant addressed or
resolved the red flag of individuals traveling long distances to fill
controlled substance prescriptions, as discussed above. RFAAX 1, at 7-
8. Accordingly, the Agency finds substantial record evidence that
Registrant repeatedly filled numerous prescriptions for controlled
substances without first resolving the prescriptions' red flag of the
recipients traveling long distances to fill them. Id.
D. Cash Payments and Inflated Prices
Registrant admits that individuals paying for controlled substance
prescriptions using cash instead of insurance is a red flag of abuse
and/or diversion. RFAAX 1, at 8.
Further, as discussed above, see supra Section II, 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 Sec. 291.29(f)(12); RFAAX 1, at 8.
DEA has also recognized that cash payments are a red flag. See E Main
St. Pharmacy, 75 FR at 66158, 66164 (``[A]ny reasonable pharmacist
knows that a patient that wants to pay cash for a large quantity of
controlled substances is immediately suspect.'') (internal quotations
omitted). Paying cash or a cash equivalent for controlled substance
prescriptions is a red flag of abuse and/or diversion because it allows
the individual to avoid the scrutiny associated with the use of
insurance. Id.; Jones Total Health Care Pharmacy, L.L.C., and SND
Health Care, L.L.C., 81 FR 79188, 79191 (2016).
In addition, DEA has recognized that individuals paying inflated
prices for controlled substance prescriptions is a red flag of abuse
and/or diversion, especially when the price is higher than that of
other pharmacies. Gulf Med Pharmacy, 86 FR 72694, 72696 (2021); Jones
Total Health Care Pharmacy, 81 FR at 79191; RFAAX 1, at 8. Inflating
prices for controlled substances is a red flag ``because a legitimate
patient, who could fill his or her prescription at any pharmacy, will
switch pharmacies in order to pay the fair market price for that
prescription,'' as opposed to a ``highly suspect patient [who] can only
fill prescriptions at a suspicious pharmacy'' and is willing to ``pay
whatever price that suspicious pharmacy sets.'' Gulf Med Pharmacy, 86
FR at 72696.
Registrant admits that it repeatedly filled controlled substance
prescriptions without identifying and resolving the red flags of cash
payments and inflated prices. RFAAX 1, at 8-9. Specifically, Registrant
is deemed to have admitted that the following controlled substance
prescriptions it filled raised the red flags of cash payments and/or
inflated prices:
(a) On six occasions between December 26, 2024, and March 31, 2025,
individual B.P. paid Registrant between $290.26-$340.26 in cash for
hydrocodone-acetaminophen 10-325 mg (100-108 tablets) prescriptions or
$90.67 in cash for carisoprodol 350 mg (90 tablets) prescriptions.
RFAAX 1, at 8-9.
(b) On eight occasions between September 28, 2023, and March 18,
2025, individual B.S. paid Registrant between $1,030.99-$1,180.99 in
cash for
[[Page 64167]]
oxycodone 30 mg prescriptions, between $290.06-$340.06 in cash for
hydrocodone-acetaminophen 10-325 mg prescriptions, or $90.67 in cash
for carisoprodol 350 mg prescriptions. RFAAX 1, at 9.
(c) On five occasions between January 31, 2024, and February 19,
2025, individual S.H. paid Registrant $1,030.90 in cash for oxycodone
30 mg prescriptions, $340.06 in cash for hydrocodone-acetaminophen 10-
325 mg prescriptions, or $90.67 in cash for carisoprodol 350 mg
prescriptions. RFAAX 1, at 9.
(d) On four occasions between January 16, 2025, and February 19,
2025, individual C.B. paid Registrant $340.96 in cash for hydrocodone-
acetaminophen 10-325 mg prescriptions or $90.67 in cash for
carisoprodol 350 mg prescriptions. RFAAX 1, at 9.
(e) On three occasions between October 4, 2023, and March 25, 2024,
individual K.B. paid Registrant between $1,030.99-$1,180.99 in cash for
oxycodone 30 mg prescriptions. RFAAX 1, at 9.
(f) On five occasions between August 22, 2023, and February 20,
2024, individual T.D. paid Registrant $1,030.72 in cash for oxycodone
30 mg prescriptions. RFAAX 1, at 9.
(g) On three occasions between August 10, 2023, and September 8,
2023, individual Ke.B. paid Registrant $1,030.30 in cash for oxycodone
30 mg prescriptions. RFAAX 1, at 9.
Registrant's records do not indicate that Registrant addressed or
resolved the red flags of individuals paying in cash or cash
equivalents, and/or inflated prices, for controlled substance
prescriptions, as discussed above. RFAAX 1, at 8-9. Accordingly, the
Agency finds substantial record evidence that Registrant repeatedly
filled numerous prescriptions for controlled substances without first
resolving the prescriptions' red flags of cash payments and/or inflated
prices. Id.
E. Expert Review
DEA retained an independent pharmacy expert who reviewed
Registrant's Prescription Monitoring Program data, the prescriptions
identified above (supra Section III.A-D), prescription profiles, and
patient notes, and concluded that Registrant filled the prescriptions
identified above without resolving red flags of drug abuse and/or
diversion. RFAAX 1, at 9. The independent pharmacy expert concluded
that from January 2023 to at least March 2025, Registrant filled the
above prescriptions in violation of federal law and binding minimal
standards that govern the practice of pharmacy in Texas. Id.
In consideration of all the above, the Agency finds substantial
record evidence that Registrant repeatedly dispensed the above-
referenced prescriptions without first resolving the above-referenced
red flags, and that Registrant's dispensing of these prescriptions was
outside the usual course of professional practice and lacked a
legitimate medical purpose.
IV. Public Interest Determination
A. Registrant's Registration Is Inconsistent With the Public Interest
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 9; 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.\6\
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\6\ The only limitation discussed in the legislative history on
DEA's authority under Factor B is that DEA should not ``construe
[this factor] in anyway 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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Historically, the Agency's Factor B \7\ 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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\7\ 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 Controlled Substances Act (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.''
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(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
[[Page 64168]]
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 a broad, discretionary term not
explicitly defined in the CSA, but Congress identifies the primary
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.\8\
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\8\ Analysis of whether a prescription is illegally filled,
distributed, or possessed also fit within Factor D, ``Compliance
with applicable State, Federal, or local laws relating to controlled
substances.'' 21 U.S.C. 823(g)(1)(D).
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Of course, the Agency is not only concerned with acts of
intentional diversion,\9\ 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, 4917-01 (2022) (citing Bienvenido Tan, 76 FR 17673, 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.
---------------------------------------------------------------------------
\9\ 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 FR
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.'' \10\ 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 public interest.'' \11\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 respondent'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).\12\
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\10\ 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.
\11\ ``[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.
\12\ In an unreported opinion, the Sixth Circuit affirmed DEA's
conclusion that the respondent'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 it ``repeatedly dispensed
prescriptions in violation of the minimum practice standards that
govern pharmacy practice in Texas.'' RFAAX 1, at 4. 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.\13\
---------------------------------------------------------------------------
\13\ 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.
---------------------------------------------------------------------------
[[Page 64169]]
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.
V. Sanction
Where, as here, the Government has met its burden of showing that
Registrant's continued registration is inconsistent with the public
interest, the burden shifts to Registrant to show why she can be
entrusted with a registration. Morall, 412 F.3d at 174; Jones Total
Health Care Pharmacy, 881 F.3d at 830; 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. Jones Total Health Care Pharmacy, 881 F.3d at
833; Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019). Moreover, as
``past performance is the best predictor of future performance,'' the
Agency requires that a registrant who has committed acts inconsistent
with the public interest accepts responsibility for those acts,
understands the gravity and seriousness of the misconduct, and
demonstrates that the registrant will not engage in future misconduct.
ALRA Labs., Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir.
1995); Jones Total Health Care Pharmacy, 881 F.3d at 831-33. 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); Jones Total Health Care Pharmacy, 881 F.3d at
830-31. In addition, a registrant's candor during the investigation and
hearing, if one is requested, is an important factor in determining
acceptance of responsibility and the appropriate sanction. 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. Jones Total Health Care Pharmacy, 881 F.3d at 834 & n.4. The
Agency also considers the need to deter similar acts by a registrant
and by the community of registrants. Stein, 84 FR at 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); RFAA, at 1-2, 9. 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 as
to its future compliance with the CSA nor made any demonstration that
it can be entrusted with registration. Moreover, the evidence presented
by the Government, and that is deemed admitted by way of Registrant's
default, shows that Registrant committed egregious violations of the
CSA by repeatedly filling controlled substance prescriptions over
several years without addressing or resolving serious red flags that
the controlled substances were being abused and/or diverted, further
indicating that Registrant cannot be entrusted with a registration.
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. 823(g)(1) and 824(a)(4), I hereby revoke DEA Certificate of
Registration, No. FW2318497, issued to Wellwise Pharmacy Inc. Further,
pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C.
823(g)(1) and 824(a)(4), I hereby deny any pending applications of
Wellwise Pharmacy Inc. to renew or modify this registration, as well as
any other pending application of Wellwise Pharmacy Inc. for additional
registration in Texas. This Order is effective November 6, 2026.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 2, 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. 2026-20552 Filed 10-6-26; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on October 7, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.