Notice2026-01498
Complete Care Pharmacy, LLC; Decision and Order
Primary source
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Published
January 27, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 91 Issue 17 (Tuesday, January 27, 2026)</title>
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[Federal Register Volume 91, Number 17 (Tuesday, January 27, 2026)]
[Notices]
[Pages 3547-3550]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01498]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Complete Care Pharmacy, LLC; Decision and Order
I. Introduction
On April 2, 2025, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Complete Care
Pharmacy, LLC, of Corrales, New Mexico (Registrant). Request for Final
Agency Action (RFAA), Exhibit (RFAAX) 1, at 1, 6. The OSC proposed the
revocation of Registrant's DEA Certificate of Registration, number
FC4167121, alleging that its registration is inconsistent with the
public interest. Id. at 1 (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
Specifically, the OSC alleged that Registrant's owner and pharmacist-
in-charge (PIC) issued 26 controlled substance prescriptions when he no
longer had state prescriptive authority and that Registrant, acting
through its owner and PIC who had also written the prescriptions
without authority, then filled these 26 prescriptions, even though it
knew they were issued by a person who lacked prescriptive authority.
On June 2, 2025, the Government submitted an RFAA to the
Administrator requesting that the Agency \1\ issue a default final
order revoking Registrant's registration. RFAA, at 1, 4-5. After
carefully reviewing the entire record and conducting the analysis as
set forth in detail below, the Agency grants the Government's request
for final agency action 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;
specifically, the allegation that Registrant knowingly filled 26
illegitimate controlled substance prescriptions that were issued by a
person who lacked prescriptive authority. 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.
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\1\ The Controlled Substances Act delegates authority to the
Attorney General, who has delegated it to the Administrator of DEA
(the Agency). 28 CFR 0.100.
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II. Default Determination
The Government's RFAA included a declaration by a DEA Diversion
[[Page 3548]]
Investigator (DI), in which DI declared under penalty of perjury that
on April 15, 2025, she personally served a copy of the OSC on Mike
Gallegos (Mr. Gallegos), Registrant's owner, operator, and PIC. RFAAX
2, at 1; see also RFAAX 1, at 3. The declaration states that Mr.
Gallegos signed a copy of the OSC confirming receipt. RFAAX 2, at 2;
see also RFAAX 2, Attachment A (copy of the signed OSC). Accordingly,
due to personal service of the OSC on Registrant's owner, operator, and
PIC, the Agency finds that due process notice requirements have been
satisfied.
Under 21 CFR 1301.43, a registrant or applicant 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 or applicant
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).
The OSC notified Registrant of its right to file a written request
for a hearing and an answer, and that if it failed to file such a
request and answer, it would be deemed to have waived its right to a
hearing and be in default. RFAAX 1, at 4-5 (citing 21 CFR 1301.43).
Here, Registrant did not request a hearing, file an answer, or respond
to the OSC in any way. RFAA, at 1-2, 4. Accordingly, Registrant is in
default. 21 CFR 1301.43(c)(1).
``A default, unless excused, shall be deemed to constitute a waiver
of [Registrant's] right to a hearing and an admission of the factual
allegations of the [OSC].'' 21 CFR 1301.43(e). Because Registrant is in
default and has not moved to excuse the default, the Agency finds that
Registrant has admitted to the factual allegations in the OSC. 21 CFR
1301.43(c)(1), (e), (f)(1).
Further, ``[i]n the event that [a registrant] . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] 1316.67.'' 21 CFR 1301.43(f)(1). Here, the
Government has requested final agency action based on Registrant's
default pursuant to 21 CFR 1301.43(c), (f), and 1301.46. RFAA, at 1, 5;
see also 21 CFR 1316.67.
III. Public Interest Determination
A. Overview of Law
Congress enacted the Controlled Substances Act (CSA) ``to conquer
drug abuse and control the legitimate and illegitimate traffic in
controlled substances.'' Gonzales v. Raich, 545 U.S. 1, 12 (2005). A
particular concern of Congress was ``the need to prevent the diversion
of drugs from legitimate to illicit channels,'' and it ``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.'' Id. at 12-13.
The CSA's requirements under this closed regulatory system include
that ``every person who dispenses, or who proposes to dispense, any
controlled substance, shall obtain from the [DEA] a registration.'' 21
U.S.C. 822(a)(2); see also Gonzales v. Raich, 545 U.S. at 27-28. To
protect the American people and ensure compliance with the CSA,
Congress empowered the Agency to deny, suspend, or revoke a
registration if it would be inconsistent with the public interest. 21
U.S.C. 823(g)(1), 824(a)(4); Gonzales v. Oregon, 546 U.S. 243, 251
(2006).
In determining whether a registrant's registration is inconsistent
with the public interest, the Agency analyzes five statutorily
established ``public interest factors.'' Gonzales v. Oregon, 546 U.S.
at 251; 21 U.S.C. 823(g)(1)(A)-(E). 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).
These 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 4,447,
4,448 (1995))); Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003).
Each factor is weighed on a case-by-case basis. David H. Gillis, M.D.,
58 FR 37,507, 37,508 (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,
Gillis, 58 FR at 37,508, 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 33,207, 33,208 (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 Eleventh Circuit has
recognized, Agency decisions have explained that findings under a
single factor can support the imposition of a sanction. Jones Total
Health Care Pharmacy, 881 F.3d at 830; Pharmacy Doctors Enters., Inc.
v. Drug Enf't Admin., 789 Fed. Appx. 724, 729 (11th Cir. 2019).
In this matter, the Government's evidence is confined to factor D.
RFAA, at 4. Evidence is considered 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). To
determine whether Registrant's registration is in the public interest,
the Agency has evaluated the Government's allegations of Registrant's
non-compliance with applicable federal and state laws. Specifically,
the Agency has evaluated the Government's allegation that Registrant
filled illegitimate controlled substance prescriptions.
The Government has the burden of proof in this proceeding, Tracy
Amerson-Rivers, A.P.R.N., 90 FR 48884, 48885 n.8 (2025) (citing 21 CFR
1301.44(e)), and the Agency must make its findings based on
``substantial [record] evidence.'' 5 U.S.C. 556(d); see also 5 U.S.C.
706(2); 21 U.S.C. 877. If
[[Page 3549]]
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
Doctors Enters., 789 Fed. Appx. at 729 (citing Jones Total Health Care
Pharmacy, 881 F.3d at 830).
B. Public Interest Issue 1: Registrant Filled Illegitimate
Prescriptions
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.'' 21 CFR 1306.04(a). While
the ``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.
To prove that a pharmacist violated his corresponding
responsibility, the Government must show that the pharmacist acted with
the requisite degree of scienter. See 21 CFR 1306.04(a) (``[T]he person
knowingly filling [a prescription issued not in the usual course of
professional treatment] . . . shall be subject to the penalties
provided for violations of the provisions of law relating to controlled
substances.'') (emphasis added). DEA has consistently interpreted the
corresponding responsibility regulation such that ``[w]hen
prescriptions are clearly not issued for legitimate medical purposes, a
pharmacist may not intentionally close his eyes and thereby avoid
[actual] knowledge of the real purpose of the prescription.'' Ralph J.
Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730 (1990)
(citations omitted); see also JM Pharmacy Group, Inc. d/b/a Pharmacia
Nueva and Best Pharmacy Corp., 80 FR 28667, 28670-72 (2015) (applying
the standard of willful blindness in assessing whether a pharmacist
acted with the requisite scienter). Pursuant to their corresponding
responsibility, pharmacists must exercise ``common sense and
professional judgment'' when filling a prescription issued by a
physician. Bertolino, 55 FR at 4730. When a pharmacist's suspicions are
aroused by a red flag, the pharmacist must question the prescription
and, if unable to resolve the red flag, refuse to fill the
prescription. Id.; see also Med. Shoppe-Jonesborough v. Drug Enf't
Admin., 300 Fed. Appx. 409, 412 (6th Cir. 2008) (``When pharmacists'
suspicions are aroused as reasonable professionals, they must at least
verify the prescription's propriety, and if not satisfied by the answer
they must refuse to dispense.'').
Turning to the relevant state law, New Mexico regulations implement
the Pharmacist Prescriptive Authority Act by establishing ``minimum
standards, terms and conditions for the certification, registration,
practice, and supervision of pharmacist clinicians.'' N.M. Admin. Code
16.19.4.17(A). New Mexico regulations further provide that ``[o]nly a
registered pharmacist clinician with current protocols, registered with
the New Mexico medical board or the New Mexico board of osteopathic
medical examiners, may exercise prescriptive authority.'' Id. at
16.19.4.17(D)(1). To exercise prescriptive authority, a pharmacist
clinician must submit an application, including ``the supervising
physicians' name and current medical license, protocol of collaborative
practice and other information requested by the board.'' Id. at
16.19.4.17(D)(2). ``A pharmacist clinician shall perform only those
services that are delineated in the protocol and are within the scope
of practice of the supervising physician or alternate supervising
physician(s).'' Id. at 16.19.4.17(E)(1).
New Mexico regulations define a ``prescriber'' as ``a licensed
practitioner who generates a prescription order and assumes
responsibility for the content of the prescription.'' N.M. Admin. Code
16.19.6.7(G) (emphasis added). New Mexico regulations further define a
``valid prescription'' as ``an order for a dangerous drug given
individually for the person for whom prescribed, either directly from
the prescribing practitioner to the pharmacist, or indirectly by means
of a written order signed by the practitioner.'' Id. at 16.19.6.23(A).
Here, the Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Registrant is deemed to have admitted to each of the
following facts.\2\
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\2\ According to the CSA, ``[f]indings of fact by the [DEA
Administrator], if supported by substantial evidence, shall be
conclusive.'' 21 U.S.C. 877. Here, where Registrant is found to be
in default, all the factual allegations in the OSC are deemed to be
admitted. These uncontested and deemed admitted facts constitute
evidence that exceeds the ``substantial evidence'' standard of 21
U.S.C. 877; it is unrebutted evidence.
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Mr. Gallegos is Registrant's owner and PIC. RFAAX 1, at 3. Mr.
Gallegos had a Pharmacist Clinician Protocol with prescriptive
authority in New Mexico that identified the supervising physician as
Dr. A.M.R., whose New Mexico medical license expired on July 1, 2021.
RFAAX 1, at 4. Thus, by virtue of the supervising physician no longer
being a licensed prescriber in New Mexico as of July 1, 2021, Mr.
Gallegos did not have prescriptive authority under New Mexico law as a
pharmacist clinician as of July 1, 2021. Id.; N.M. Admin. Code
16.19.6.7(G); N.M. Admin. Code 16.19.4.17(E)(1). And yet, between July
1, 2021, and July 23, 2022, Mr. Gallegos issued approximately 26
prescriptions for controlled substances without prescriptive authority,
including prescriptions for dextro-amphetamine,\3\
dexmethylphenidate,\4\ lorazepam,\5\ alprazolam,\6\ eszopiclone,\7\
zolpidem,\8\ and tramadol.\9\ RFAAX 1, at 4. Then Registrant, through
Mr. Gallegos in his capacity as PIC, filled these 26 controlled
substance prescriptions, knowing that they were invalid under state law
as a result of being issued by himself without prescriptive authority.
Id.
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\3\ Amphetamine is a Schedule II stimulant. 21 CFR
1308.12(d)(1); RFAAX 1, at 4.
\4\ Methylphenidate is a Schedule II stimulant. 21 CFR
1308.12(d)(4); RFAAX 1, at 4.
\5\ Lorazepam is a Schedule IV depressant. 21 CFR
1308.14(c)(33); RFAAX 1, at 4.
\6\ Alprazolam is a Schedule IV depressant. 21 CFR
1308.14(c)(2); RFAAX 1, at 4.
\7\ Zopiclone is a Schedule IV depressant. 21 CFR
1308.14(c)(59); RFAAX 1, at 4.
\8\ Zolpidem is a Schedule IV depressant. 21 CFR 1308.14(c)(58);
RFAAX 1, at 4.
\9\ Tramadol is a Schedule IV narcotic. 21 CFR 1308.14(b)(3);
RFAAX 1, at 4.
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Therefore, the Agency finds substantial record evidence that
Registrant filled 26 controlled substance prescriptions that Registrant
knew were illegitimate because they were issued by a person without
valid state prescriptive authority to so do. RFAAX 1, at 4; 21 CFR
1306.04(a); N.M. Admin. Code 16.19.4.17(A), (D)(1)-(2), (E)(1); N.M.
Admin. Code 16.19.6.7(G), .23(A); Trinity Pharmacy II, 83 FR 7304, 7331
(2018); Wheatland Pharmacy, 78 FR 69441, 69445 (2013).
C. Public Interest Conclusion
While the Agency considered all the public interest factors of 21
U.S.C. 823(g)(1),\10\ its findings are relevant to factor D (compliance
or non-compliance with laws related to controlled substances). 21
U.S.C. 823(g)(1); Hubbard, 87 FR at 21162. Here, the Agency found
substantial record evidence that between July 1, 2021, and July 23,
2022, Registrant knowingly filled 26 prescriptions for controlled
substances that were illegitimate because they were issued by a person
[[Page 3550]]
who lacked the authority to issue them, in violation of state law. See
supra Section III.B. Registrant's misconduct, therefore, constitutes
violations of both federal controlled substance regulations and New
Mexico state law. 21 U.S.C. 823(g)(1)(D); 21 CFR 1306.04(a); N.M.
Admin. Code 16.19.4.17(A), (D)(1)-(2), (E)(1); N.M. Admin. Code
16.19.6.7(G), .23(A); Trinity Pharmacy II, 83 FR at 7331; Wheatland
Pharmacy, 78 FR at 69445.
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\10\ The lack of evidence regarding the other public interest
factors is not dispositive, and weighs neither for nor against a
finding that Registrant's registration is inconsistent with the
public interest. See, e.g., Amerson-Rivers, 90 FR at 48886 n.10.
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Accordingly, the Agency finds that after considering the factors of
21 U.S.C. 823(g)(1), the Government satisfied its prima facie burden
showing that Registrant's registration is ``inconsistent with the
public interest.'' 21 U.S.C. 824(a)(4). The Agency further finds that
there is insufficient mitigating evidence to rebut the Government's
prima facie case. See supra Section II. Thus, the only remaining issue
is whether revocation of Registrant's registration is the appropriate
sanction.
IV. Sanction
When the Agency concludes that a registrant's registration is
inconsistent with the public interest, the Agency then determines the
appropriate sanction, which may include revocation of the registration.
21 U.S.C. 824(a)(4); see also Pharmacy Doctors Enters., 789 Fed. Appx.
at 734 (the Agency is entitled to choose a sanction); Scott Hansen,
A.R.N.P., 90 FR 27,338, 27,341 (2025); Jeffrey Stein, M.D., 84 FR
46,968, 46,972-73 (2019). At this stage, the burden is on registrants
to show why they can be trusted to maintain their registration. Morall,
412 F.3d at 174; Jones Total Health Care Pharmacy, 881 F.3d at 830;
Garrett Howard Smith, M.D., 83 FR 18,882, 18,904 (2018). The issue of
trust is necessarily a fact-dependent determination based on the
circumstances presented by the individual respondent. Stein, 84 FR at
46,972; see also Jones Total Health Care Pharmacy, 881 F.3d at 833.
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 accept responsibility for those
acts and demonstrate that they will not engage in future misconduct.
Jones Total Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v.
Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). Moreover, the
Agency requires a registrant's unequivocal acceptance of
responsibility. Janet S. Pettyjohn, D.O., 89 FR 82,639, 82,641 (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. Jones Total Health Care
Pharmacy, 881 F.3d at 830-31; Hoxie, 419 F.3d at 483-84. The Agency
also considers the need to deter similar acts by Registrant and by the
community of registrants. Stein, 84 FR at 46,972-73.
Here, Registrant failed to answer the allegations contained in the
OSC and did not otherwise avail itself of the opportunity to prove to
the Agency that it can be trusted to maintain its registration. See
supra Section II. Thus, there is no record evidence that Registrant
takes responsibility, let alone unequivocal responsibility, for the
misconduct. Accordingly, it has not convinced the Agency that its
future controlled-substance-related actions will comply with the CSA
such that it can be entrusted with the responsibilities of a
registration.
Further, the interests of specific and general deterrence weigh in
favor of revocation. Registrant's conduct in this matter goes 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.'' Gonzales v. Raich, 545 U.S. at 12-
14. If the Agency were to allow Registrant to maintain its registration
under these circumstances, it would send a dangerous message that
compliance with the law is not essential to maintaining a registration.
In sum, Registrant has not offered any evidence on the record that
rebuts the Government's case for revocation of its registration, and
Registrant has not demonstrated that it can be entrusted with the
responsibility of 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. 824(a)(4) and 21 U.S.C. 823(g)(1), I hereby revoke DEA
Certificate of Registration No. FC4167121 issued to Complete Care
Pharmacy, LLC. Further, pursuant to 28 CFR 0.100(b) and the authority
vested in me by 21 U.S.C. 824(a)(4) and 21 U.S.C. 823(g)(1), I hereby
deny any pending applications of Complete Care Pharmacy, LLC, to renew
or modify this registration, as well as any other pending application
of Complete Care Pharmacy, LLC, for additional registration in New
Mexico. This Order is effective February 26, 2026.
Signing Authority
This document of the Drug Enforcement Administration was signed on
January 16, 2026, by 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. 2026-01498 Filed 1-26-26; 8:45 am]
BILLING CODE 4410-09-P
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