St. Michael's Pharmacy; Decision and Order

Issuing agencies

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<title>Federal Register, Volume 91 Issue 190 (Friday, October 2, 2026)</title>
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[Federal Register Volume 91, Number 190 (Friday, October 2, 2026)]
[Notices]
[Pages 62754-62762]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20227]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


St. Michael's Pharmacy; Decision and Order

    On September 10, 2025, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO) to St. Michael's Pharmacy of Rosenberg, Texas 
(Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 
1, at 1. The OSC/ISO informed Registrant of the

[[Page 62755]]

immediate suspension of its DEA Certificate of Registration, No. 
FS0483951, 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. (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\
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    \1\ Based on the Government's submissions in its RFAA dated 
October 20, 2025, 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 12, 2025, 
the OSC/ISO was personally served on Registrant at its registered 
address. RFAAX 2, at 1; see also id., Attachment A (Form DEA-12 
signed by a representative of Registrant acknowledging receipt of 
the OSC/ISO).
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    The OSC/ISO alleged that from at least March 2023 through February 
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. RFAAX 1, at 1, 4-5. 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, the same patient obtaining similar 
drugs from multiple practitioners, and shared addresses of patients. 
Id. at 1-2, 5-7.
    Further, the OSC/ISO alleged that as recently as March 2025, 
Registrant failed to maintain effective controls against diversion or 
otherwise comply with the obligations of a registrant. Id. at 2, 7-8. 
Specifically, the OSC/ISO alleged that large quantities of controlled 
substances were unaccounted for and that records for those controlled 
substances were not kept in compliance with law. Id. at 2, 7-8.
    The OSC/ISO alleged that Registrant violated the following federal 
regulations: 21 CFR 1304.04(a); 21 CFR 1304.11(a)-(c); 21 CFR 
1304.21(a); 21 CFR 1306.04(a).\2\ RFAAX 1, at 2. The OSC/ISO also 
alleged that Registrant violated the following Texas state regulations: 
Tex. Health & Safety Code Ann. Sec.  481.074(a)(1); Tex. Health & 
Safety Code Ann. Sec.  481.128(a)(1); 22 Tex. Admin. Code Ann. 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 
Ann. Sec.  291.34(a), (b)(1). Id. at 3-4.
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    \2\ The Agency need not adjudicate the criminal violations 
alleged in the OSC/ISO. Ruan v. United States, 597 U.S. 450 (2022) 
(decided in the context of criminal proceedings).
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    On October 20, 2025, the Government submitted an RFAA requesting 
that the Agency issue a default final order revoking Registrant's 
registration. RFAA, at 6. Further, on June 8, 2026, the Government 
submitted a Notice of Change of [Registrant]'s State Authority (State 
Authority Notice). In its State Authority Notice, the Government 
indicated that on March 11, 2026, the Texas State Board of Pharmacy 
revoked Registrant's state pharmacy license, thus rendering Registrant 
without authority to handle controlled substances in Texas, the state 
in which Registrant is registered with DEA. State Authority Notice, at 
1.\3\
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    \3\ Although the lack of state authority allegation was not 
noticed in the OSC, previous Agency decisions have stated that the 
Government is not required to issue an amended OSC to notice an 
allegation of lack of state authority that arises during the 
pendency of a proceeding regarding a DEA registration. Hatem M. 
Ataya, M.D., 81 FR 8221, 8244-46 (2016). Additionally, previous 
Agency decisions have stated that because the possession of state 
authority is a prerequisite for obtaining and maintaining a 
registration, the issue of state authority can be raised at any 
stage of a proceeding, even sua sponte by the Administrator. ld. at 
8,244; 21 U.S.C. 824(a)(3); see also Joe W. Morgan, D.O., 78 FR 
61961, 61973-74 (2013). However, ``the Agency must give some sort of 
notice and an opportunity to contest the new allegations.'' Cypress 
Creek Pharmacy, LLC, 86 FR 71927, 71927 (2021); see also Shelton W. 
Barnes. M.D., 85 FR 5983, 5983 n.3 (2020); Maura Tuso, D.M.D., 86 FR 
59196, 59197 n.2 (2021); Lawrence E. Stewart, 86 FR 15257, 15257 
(2021).
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    On July 28, 2026, the Agency served Registrant via email with a 
Notice of Allegation and Briefing Order (Allegation Notice). In its 
Allegation Notice, the Agency notified Registrant of the Government's 
allegation that Registrant's lack of state authority to handle 
controlled substances in Texas was an additional basis for revocation 
of its DEA registration. Allegation Notice, at 2. Additionally in its 
Allegation Notion, the Agency notified Registrant that Registrant could 
contest the Government's allegation by submitting a written response 
and supporting documentary evidence within fifteen days of service of 
the Allegation Notice. Id. To date, the Agency has not received any 
correspondence from Registrant regarding the Allegation Notice.
    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 9-10 (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. Loss OF State Authority

    In addition to the above failures resulting in default, Registrant 
failed to exercise his opportunity to be heard on his loss of state 
authority by not responding to the Allegation Notice.

A. Findings of Fact

    According to Texas online records, of which the Agency takes 
official notice,\4\ Registrant's Texas pharmacy license 33705 is 
revoked. Texas State Board of Pharmacy, Texas Pharmacy Search, <a href="https://www.pharmacy.texas.gov/dbsearch/phy_search.asp">https://www.pharmacy.texas.gov/dbsearch/phy_search.asp</a> (last visited date of 
signature of this Order). Accordingly, the Agency finds that Registrant 
is not licensed to operate as a pharmacy in Texas, the state in which 
it is registered with DEA.\5\
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    \4\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979).
    \5\ Pursuant to 5 U.S.C. 556(e), ``[w]hen an agency decision 
rests on official notice of a material fact not appearing in the 
evidence in the record, a party is entitled, on timely request, to 
an opportunity to show the contrary.'' The material fact here is 
that Registrant, as of the date of this Order, is not licensed to 
operate as a pharmacy in Texas. Accordingly, Registrant may dispute 
the Agency's finding by filing a properly supported motion for 
reconsideration of findings of fact within fifteen calendar days of 
the date of this Order. Any such motion and response shall be filed 
and served by email to the other party and to the Office of the 
Administrator, Drug Enforcement Administration, at 
<a href="/cdn-cgi/l/email-protection#234746420d4247474c0d4257574c514d465a50634746420d444c55"><span class="__cf_email__" data-cfemail="680c0d0946090c0c0746091c1c071a060d111b280c0d09460f071e">[email&#160;protected]</span></a>.

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[[Page 62756]]

B. Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under 21 U.S.C. 823 ``upon a 
finding that the registrant . . . has had [its] State license or 
registration suspended . . . [or] revoked . . . by competent State 
authority and is no longer authorized by State law to engage in the . . 
. dispensing of controlled substances.'' With respect to a 
practitioner, DEA has also long held that the possession of authority 
to dispense controlled substances under the laws of the state in which 
a practitioner engages in professional practice is a fundamental 
condition for obtaining and maintaining a practitioner's registration. 
Gonzales v. Oregon, 546 U.S. at 270 (``The Attorney General can 
register a physician to dispense controlled substances `if the 
applicant is authorized to dispense . . . controlled substances under 
the laws of the State in which he practices.' . . . The very definition 
of a `practitioner' eligible to prescribe includes pharmacies and 
physicians `licensed, registered, or otherwise permitted, by the United 
States or the jurisdiction in which he practices' to dispense 
controlled substances. 802(21).''). The Agency has applied these 
principles consistently. See, e.g., Irina Gross, D.P.M., 91 FR 38016 
(2026); Phong H. Tran, M.D., 90 FR 14383 (2025); Palafox Pharmacy, 84 
FR 18320 (2019).\6\
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    \6\ This rule derives from the text of two provisions of the 
Controlled Substances Act (CSA). First, Congress defined the term 
``practitioner'' to mean ``a physician . . . pharmacy . . . or other 
person licensed, registered, or otherwise permitted, by . . . the 
jurisdiction in which he practices . . . , to distribute, dispense, 
. . . [or] administer . . . a controlled substance in the course of 
professional practice.'' 21 U.S.C. 802(21). Second, in setting the 
requirements for obtaining a practitioner's registration, Congress 
directed that ``[t]he Attorney General shall register practitioners 
. . . if the applicant is authorized to dispense . . . controlled 
substances under the laws of the State in which he practices.'' 21 
U.S.C. 823(g)(1). Because Congress has clearly mandated that a 
practitioner possess state authority in order to be deemed a 
practitioner under the CSA, DEA has held repeatedly that revocation 
of a practitioner's registration is the appropriate sanction 
whenever he is no longer authorized to dispense controlled 
substances under the laws of the state in which he practices. See, 
e.g., Irina Gross, D.PM., 91 FR 38016; Phong H. Tran, M.D., 90 FR 
14383; Palafox Pharmacy, 84 FR 18320.
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    According to Texas statute, ``dispense'' means ``the delivery of a 
controlled substance in the course of professional practice or 
research, by a practitioner or person acting under the lawful order of 
a practitioner, to an ultimate user or research subject. The term 
includes the prescribing, administering, packaging, labeling, or 
compounding necessary to prepare the substance for delivery.'' Tex. 
Health & Safety Code Ann. Sec.  481.002(12) (West 2026). Further, a 
``practitioner'' includes ``a pharmacy, hospital, or other institution 
licensed, registered, or otherwise permitted to distribute, dispense, 
conduct research with respect to, or administer a controlled substance 
in the course of professional practice or research in this state.'' Id. 
Sec.  481.002(39)(B).
    Here, the undisputed evidence in the record is that Registrant 
lacks authority to operate as a pharmacy in Texas because its Texas 
pharmacy license was revoked. As discussed above, a pharmacy must be 
licensed as a practitioner to dispense or prescribe a controlled 
substance in Texas. Thus, because Registrant currently lacks authority 
to operate as a pharmacy in Texas and, therefore, is not currently 
authorized to handle controlled substances in Texas, Registrant is not 
eligible to maintain a DEA registration. Accordingly, the Agency finds 
that Registrant's lack of state authority to handle controlled 
substances provides an independent basis for revocation of Registrant's 
DEA registration. 21 U.S.C. 824(a)(3).

III. 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). 
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.
    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). 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

[[Page 62757]]

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.\7\
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    \7\ 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.\8\
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    \8\ Texas regulations state that it is unlawful for a 
``registrant or dispenser'' to dispense a controlled substance in 
violation of Sections 481.061-481.080 of the Texas Health and Safety 
Code. Tex. Health & Safety Code Ann. Sec.  481.128(a)(1); RFAAX 1, 
at 3.
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Allegation That Registrant Failed to Adequately Maintain Complete and 
Accurate Records
    Federal law requires that pharmacies maintain current, complete, 
and accurate records of all controlled substances. 21 CFR 1304.11(a)-
(c); 21 CFR 1304.21(a) (as referenced in 21 CFR 1304.21(c)); RFAAX 1, 
at 2. This includes a requirement that pharmacies take a complete and 
accurate inventory of all stock of controlled substances on hand from 
the date the pharmacy first engages in the dispensing of controlled 
substances. 21 CFR 1304.11(a)-(c); RFAAX 1, at 2. Such inventories must 
be kept for at least two years from the date of their creation. 21 CFR 
1304.04(a); RFAAX 1, at 2. Federal law also requires that original 
signed electronic 222 order forms be retained, linked, and maintained 
on a central server. 21 CFR 1305.27(a), (c).

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 2023 through at least February 
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 5-7.
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 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)).
    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 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 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. RFAAX 1, at 
5-6. Moreover, the controlled substance prescriptions filled by 
Registrant that were indicative of pattern prescribing posed additional 
red flags because they were for controlled substances commonly known to 
be abused and were prescribed at the highest strength and/or in large 
quantities. Id.
    Registrant admits that between January 2023 and February 2025, 
Registrant routinely filled prescriptions for oxycodone 30 mg (a 
Schedule II opioid), hydrocodone (a Schedule II opioid), and oxycodone/
acetaminophen while repeatedly failing to identify and resolve the red 
flag of pattern prescribing from the same practitioners. Id. at 5. 
Specifically, Drs. C.I., D.C., A.P., C.H., L.B., and M.Q. prescribed 
65% of all prescriptions that Registrant dispensed for oxycodone 30 mg 
(786 prescriptions out of 1,213 total); Drs. M.Q., C.I., L.N., J.R., 
E.N., A.J., D.C., and C.H. prescribed 53% of all prescriptions that 
Registrant dispensed for hydrocodone 10/325 mg (442 prescriptions out 
of 830 total); and Drs. S.N., J.R., T.D., Z.M., E.N., M.C., L.N., and 
A.J. prescribed 62% of all prescriptions that Registrant dispensed for 
oxycodone/acetaminophen 10/325 mg (105 prescriptions out of 170 total). 
Id.
    Registrant also admits that it repeatedly failed to identify and 
resolve red flags of pattern prescribing controlled substances known to 
be abused and at the highest strength and/or large quantities, 
including the following:
    Dr. C.H.: Between June 16, 2023, and January 3, 2024, Registrant 
filled five prescriptions for oxycodone 30 mg (100-105 tablets) issued 
by Dr. C.H. for D.S. RFAAX 1, at 6. Between June 9, 2023, and November 
17, 2023, Registrant filled five prescriptions for oxycodone 30 mg 
(100-110 tablets) issued by Dr. C.H. for Q.R. Id. On November 4, 2023, 
Registrant filled a prescription for oxycodone 30 mg (100 tablets) 
issued by Dr. C.H. for J.J. Id.
    Dr. C.I.: On September 29, 2023, Registrant filled a prescription 
for oxycodone 30 mg (103 tablets) issued by Dr. C.I. for O.J. Id. On 
June 14, 2023, and September 19, 2023, Registrant filled a prescription 
for oxycodone 30 mg (100 tablets) issued by Dr. C.I. for A.B. Id.
    Dr. A.P.: On March 8, 2024, and June 15, 2024, Registrant filled a 
prescription for oxycodone 30 mg (100 tablets) issued by Dr. A.P. for 
J.J. Id. On January

[[Page 62758]]

13, 2024, and April 12, 2024, Registrant filled a prescription for 
oxycodone 30 mg (100 tablets) issued by Dr. A.P. for T.N. Id.
    Accordingly, the Agency finds substantial record evidence that 
Registrant dispensed over 1,000 tablets of oxycodone 30 mg over a two-
year period without first resolving the red flags arising from pattern 
prescribing controlled substances known to be abused, and at their 
highest strength and/or in large quantities.
Same Patient Obtaining Similar Drugs From Multiple Practitioners
    As discussed above, see Section III.A., Texas regulations have 
recognized that it is a red flag consistent with abuse and/or diversion 
that needs to be addressed prior to dispensing when ``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.'' 22 Tex. Admin. Code Ann. Sec.  291.29(f)(10); RFAAX 1, at 
6.
    Registrant admits that from at least September 2023 through at 
least February 2025, Registrant repeatedly filled prescriptions for 
individuals who presented prescriptions for the same or similar drugs 
from a combination of doctors, without resolving the red flag prior to 
dispensing. RFAAX 1, at 6-7. For example, Registrant filled a 
prescription for M.V., who received hydrocodone-acetaminophen 10/325 mg 
prescriptions from three doctors and filled them at five different 
pharmacies. Id. at 7. Registrant also filled a prescription for M.W., 
who received oxycodone 30 mg and hydrocodone-acetaminophen 10/325 mg 
prescriptions from five doctors and filled them at seven different 
pharmacies. Id. Registrant filled a prescription for C.G., who received 
oxycodone 30 mg and hydrocodone-acetaminophen 10/325 mg prescriptions 
from six doctors and filled them at five different pharmacies. Id. 
Finally, Registrant filled a prescription for J.J., who received 
oxycodone 30 mg prescriptions from five doctors and filled them at 
three different pharmacies. Id. at 7.
    Accordingly, the Agency finds substantial record evidence that 
Registrant filled four controlled substances prescriptions for 
individuals who presented prescriptions for the same or similar drugs 
from a combination of doctors, without resolving the red flag prior to 
dispensing.\9\
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    \9\ The OSC also alleges, and it is deemed admitted, that from 
at least March 2023 through at least January 2024, Registrant filled 
at least 13 prescriptions for oxycodone 30 mg written by Drs. A.M.P. 
and C.H., for Patients Q.R. and D.S., two individuals living at the 
same address. RFAAX 1, at 7. This admission is not sufficient to 
establish that Registrant ignored the red flag of a shared address. 
This red flag is implicated when ``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)(11) (emphasis added).
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Expert Review
    DEA retained an independent pharmacy expert to review, among other 
materials, Registrant's Prescription Monitoring Program data, 
prescriptions, prescription profiles, and patient notes. RFAAX 1, at 8. 
The pharmacy expert concluded, and Registrant admits, that Registrant 
repeatedly filled prescriptions without properly resolving red flags of 
drug abuse or diversion. Id. The pharmacy expert also concluded, and 
Registrant admits, that from March 2023 through at least February 2025, 
Registrant repeatedly filled prescriptions for controlled substances in 
violation of federal law and 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.
Allegation That Registrant Failed to Adequately Maintain Complete and 
Accurate Records
    On March 25, 2025, DEA investigators conducted an on-site 
administrative inspection at Registrant's registered address. RFAAX 1, 
at 7. Registrant admits that during this inspection, DEA investigators 
observed that Registrant did not possess the expected physical stock of 
controlled substances relative to its ordering practices. Id. 
Registrant admits and the Agency finds that between May 1, 2023, and 
March 5, 2025, a comparison of Registrant's dispensing data to 
Registrant's distributor ordering data demonstrated that Registrant 
could not account for at least the following controlled substances: 
43,003.5 dosage units of hydrocodone 10/325 mg tablets, which amounts 
to a 123.63% variance of calculated inventory; 25,960 dosage units of 
oxycodone 30 mg tablets, which amounts to a 39.91% variance of 
calculated inventory; 2,975 dosage units of oxycodone 10/325 mg 
tablets, which amounts to a 39.67% variance of calculated inventory; 
187 dosage units of methadone 10 mg tablets (a Schedule II opioid), 
which amounts to a 6.93% variance of calculated inventory; 100 dosage 
units of dextroamphetamine 20 mg tablets (a Schedule II stimulant), 
which amounts to a 25% variance of calculated inventory; 1,005 dosage 
units of acetaminophen/codeine 300/30 mg tablets (a Schedule III 
narcotic analgesic combination), which amounts to a 191.43% variance of 
calculated inventory; and 116 dosage units of tramadol 50 mg (a 
Schedule IV opioid), which amounts to a 13.83% variance of calculated 
inventory. RFAAX 1, at 7-8.
    Accordingly, the Agency finds substantial record evidence that 
Registrant failed to account for large quantities of controlled 
substances.
    Further, regarding recordkeeping of controlled substances, 
Registrant is deemed to have admitted and the Agency finds that 
Registrant failed to provide complete and accurate records, failed to 
meet general inventory requirements, and failed to retain, link, and 
maintain on a central server original signed electronic 222 Order 
Forms. Id. at 8.
    Accordingly, the Agency finds substantial record evidence that 
Registrant failed to keep and maintain complete and accurate controlled 
substance records as required by law.

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

[[Page 62759]]

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).\10\ 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).
---------------------------------------------------------------------------

    \10\ 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).
---------------------------------------------------------------------------

    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 3-4. 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.'').

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

[[Page 62760]]

. . . 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.\11\
---------------------------------------------------------------------------

    \11\ 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).
---------------------------------------------------------------------------

    Historically, the Agency's Factor B \12\ 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:
---------------------------------------------------------------------------

    \12\ 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 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.\13\
---------------------------------------------------------------------------

    \13\ 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,\14\ 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)); see also 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.
---------------------------------------------------------------------------

    \14\ 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.'' \15\ However,

[[Page 62761]]

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.'' \16\ 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).\17\
---------------------------------------------------------------------------

    \15\ 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.
    \16\ ``[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.
    \17\ 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 filled prescriptions for 
controlled substances in violation of federal law and binding minimal 
standards that govern the practice of pharmacy in the State of Texas.'' 
RFAAX 1, at 8-9. 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 also failed 
to maintain accurate records of controlled substances which created 
further opportunities for abuse and diversion--indeed Registrant could 
not account for over 73,000 dosage units of controlled substances. 
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.\18\
---------------------------------------------------------------------------

    \18\ While the Agency has determined that Respondent'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). Respondent's 
repeated dispensing of controlled substances without addressing or 
resolving red flags, and its failure to account for large quantities 
of controlled substances, 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). Here, as found above, Registrant 
is deemed to have admitted and the Agency finds that Registrant failed 
to account for large quantities of controlled substances--over 73,000 
dosage units--and failed to keep and maintain complete and accurate 
controlled substance records.\19\ As such, the Agency finds substantial 
record evidence that Registrant violated the maintenance of records and 
inventories requirements of 21 CFR 1304.04(a); the inventory 
requirements of 21 CFR 1304.11(a)-(c); and the recordkeeping 
requirements of 21 CFR 1304.21(a).\20\
---------------------------------------------------------------------------

    \19\ The inability to account for a significant number of dosage 
units creates a grave risk of diversion. The Medicine Shoppe, 79 FR 
59504, 59516 (2014); see also Paul H. Volkman, 73 FR 30630, 30644 
(2008), pet. for rev. denied 567 F.3d 215, 224 (6th Cir. 2009) 
(finding that ``a registrant's accurate and diligent adherence to 
[recordkeeping regulations] is absolutely essential to protect 
against the diversion of controlled substances'').
    \20\ See also 21 CFR 1304.21(c).
---------------------------------------------------------------------------

    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.

IV. 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 29,569, 29,573 (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 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. See supra I. 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

[[Page 62762]]

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 filled well over a thousand controlled 
substance prescriptions outside the usual course of professional 
practice in Texas and in violation of the CSA, as well as failed to 
maintain effective controls against diversion and failed to comply with 
its recordkeeping obligations, further 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. FS0483951 issued to St. Michael's Pharmacy. 
Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by
    21 U.S.C. 823(g)(1), I hereby deny any pending application of St. 
Michael's Pharmacy to renew or modify this registration as well as any 
other pending application of St. Michael's Pharmacy for additional 
registration in Texas. This Order is effective November 2, 2026.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
September 25, 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. 2026-20227 Filed 10-1-26; 8:45 am]
BILLING CODE 4410-09-P


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