Notice2026-02902
John Bender, M.D.; Decision and Order
Primary source
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Published
February 13, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 91 Issue 30 (Friday, February 13, 2026)</title>
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[Federal Register Volume 91, Number 30 (Friday, February 13, 2026)]
[Notices]
[Pages 6891-6900]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02902]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
John Bender, M.D.; Decision and Order
On October 17, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to John Bender, M.D., of Fort Collins, Florida
(Respondent). OSC/ISO, at 1. The OSC/ISO informed Respondent of the
immediate suspension of his DEA Certificates of Registration Nos.
BB3697577 and FB3064831, alleging that Respondent's continued
registration is ``an imminent danger to the public health or safety.''
Id. (quoting 21 U.S.C. 824(d)). The OSC also proposed the revocation of
Respondent's registration because Respondent has committed such acts as
would render his registration inconsistent with the public interest.
Id. (citing 21 U.S.C. 823(g)(1); 824(a)(4)).
More specifically, the OSC alleges that between April 25, 2022, and
June 11, 2024, Respondent filled approximately 4,244 controlled
substance prescriptions issued by practitioners at his clinic without
possessing a state pharmacy license or a DEA pharmacy registration, in
violation of state and federal law. Id. at 4 (citing 21 CFR 1306.04 and
1306.06, and Colo. Rev. Stat. 12-280-120(1) and 12-280-
129(1)(d)).<SUP>1 2</SUP> The OSC further alleges that the two office
locations where Respondent dispensed controlled substances operated as
unregistered pharmacies. Id. (citing 21 U.S.C. 823(g)(1), 21 CFR
1301.11(a), 1301.13(e), Colo. Rev. Stat 12-280-120(1), 12-280-
129(1)(d)).
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\1\ The Government further alleges that Respondent violated 21
CFR 1307.11 but does not reference this provision in its Post-
Hearing Brief. See OSC, at 4. The OSC also alleges that Respondent
failed to report prescriptions to the Colorado Prescription
Monitoring Program but the Government does not reference these
allegations in its Post-Hearing Brief. Id. at 3. Accordingly, the
Agency considers these allegations as abandoned and does address
them.
\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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After conducting a hearing, Administrative Law Judge, Paul E.
Soeffing issued his Recommended Rulings, Findings of Fact, Conclusions
of Law, and Decision of the Administrative Law Judge (Recommended
Decision or RD) on June 2, 2025. The RD recommended that the Agency
revoke Respondent's registration. RD, at 32. Respondent filed untimely
exceptions to the RD.\3\ The Agency adopts and hereby incorporates by
reference the ALJ's credibility findings,\4\ findings of fact,
sanctions analysis, and recommended sanction, and summarizes and
clarifies portions
[[Page 6892]]
thereof herein. The Agency does not adopt the ALJ's conclusions of law,
but ultimately agrees with the ALJ that revocation is the appropriate
sanction.
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\3\ Respondent's Exceptions were filed on July 28, 2025, over a
month after the regulatory deadline of June 22, 2025. See 21 CFR
1316.66 (requiring Exceptions to be filed ``[w]ithin twenty days
after the date upon which a party is served a copy of the report of
the presiding officer''); June 30, 2025 Transmittal Letter from the
Chief ALJ (stating that the ALJ's Recommended Decision was sent to
the parties on June 2, 2025). Respondent states in its Motion for
Leave to File Exceptions Out of Time that ``[u]nder 21 CFR 1316.66,
a party may be granted leave to file exceptions out of time when it
serves the interests of justice and the other party is not
prejudiced.'' This is a misstatement of 21 CFR 1316.66, which
outlines the foregoing standard for assessing whether a party may
file a response to the opposing party's Exceptions after the 20-day
deadline has lapsed. Here, the Government did not file Exceptions.
In the absence of a more specific standard for assessing the
timeliness of Respondent's Exceptions, the Agency considers whether
Respondent has provided good cause for the untimely filing, and
finds that Respondent has not. Respondent did not provide any
explanation for why his Exceptions were over a month late, why he
did not request an extension from the ALJ, or why the late filing
should be excused. July 17, 2025 Motion for Leave. Respondent simply
argued that the interests of justice require his Exceptions to be
considered because the ALJ's recommendations were incorrect,
unsupported, and infringed upon his constitutional rights. Id. at 1-
2. In other words, Respondent's justification for the late filing
was that he disagreed with the Recommended Decision.
Notwithstanding Respondent's failure to demonstrate good cause,
the Agency exercises its discretion to consider Respondent's
untimely Exceptions, in part because the Agency has not adopted the
ALJ's legal analysis and finds that addressing Respondent's
Exceptions provides important guidance to the registrant community
on DEA's interpretations of the relevant provisions of the CSA.
Ultimately, the Agency rejects Respondent's Exceptions and agrees
with the ALJ's recommended sanction.
\4\ The Agency adopts the ALJ's summary of each witness's
testimony, as well as the ALJ's assessment of each witness's
credibility. See RD, at 3-10.
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I. 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. Here, the OSC's allegations concern the CSA's
``strict requirements regarding registration[,] . . . [and] drug
security'' 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.'' Id.
A. The Allegation That Respondent Unlawfully Filled Controlled
Substance Prescriptions Without a Pharmacy State License or Pharmacy
Registration
The CSA requires ``[e]very person who dispenses, or proposes to
dispense, any controlled substance'' to obtain a registration according
to DEA regulations, unless exempted. 21 U.S.C. 822(a)(2). The CSA
defines ``dispense'' as ``to deliver a controlled substance to an
ultimate user . . . by, or pursuant to the lawful order of, a
practitioner, including the prescribing and 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). Registrants are authorized to dispense controlled substances
``to the extent authorized by their registration and in conformity with
other provisions of [title 21 of the United States Code].'' 21 U.S.C.
822(b).
There are two primary categories of dispensing: (1) filling
prescriptions and (2) dispensing or administering medications directly
to patients without a prescription. 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. The regulations define a prescription as:
an order for medication which is dispensed to or for an ultimate
user but does not include an order for medication which is dispensed
for immediate administration to the ultimate user (e.g., an order to
dispense a drug to a bed patient for immediate administration in a
hospital is not a prescription).
21 CFR 1300.01.
A practitioner may not fill a prescription. 21 CFR 1306.06.
However, a practitioner may dispense or administer a controlled
substance directly to the ultimate user, without a prescription, in the
usual course of his professional practice. See supra Section II.B.
(discussing 21 U.S.C. 829(a), (b); 21 CFR 1306.11; 21 CFR 1306.21).
I. Findings of Fact
Respondent is a licensed physician in Colorado. Tr. 214-16, 241-42,
381, 408, 449; GX 2; RX 3; RD, at 17. Respondent has two DEA
practitioner registrations in Fort Collins, Colorado, and Parker,
Colorado. Tr. 70-71; GX 1; RD, at 4.
The Miramont Wellness Clinic (MWC)
Respondent has an ownership interest in Miramont Wellness Clinic
(MWC), which has three office locations in Colorado, including two in
Fort Collins (the Drake Road and Snow Mesa locations) and one in Parker
(the Parker location). Tr. 79; RD, at 4. Each office has a retail
store. Tr. 39-40, 78; GX 5. As of April 24, 2024, MWC employed several
mid-level practitioners and physicians, including Dr. K.L., who was
identified as a top ten recipient of controlled substances in Colorado.
Tr. 31; RD, at 3. Dr. K.L. was the principal practitioner at the Drake
Road location, while Respondent was the principal practitioner at the
Snow Mesa and Parker locations. Tr. 79; RD, at 4. MWC also employed
administrative staff and pharmacy technicians who were not practicing
under a pharmacist's license. Tr. 58-59, 407; \5\ GX 7; RD, at 5.
Respondent does not possess, and has never possessed, any pharmacy
registrations for MWC with DEA or the State of Colorado. Tr. 75-76,
381; GX 69; RD, at 4-5, 16.
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\5\ Respondent testified that MWC ``did hire people who had
degrees in pharmacy technician, but they weren't practicing under a
pharmacist's license. When they come to work for me, they're
practicing under a medical doctor license.'' Tr. 407. Respondent
further testified that one of MWC's employees, Ms. J.T., was trained
as a Certified Pharmacy Technician, but she was not licensed by the
Colorado Board of Pharmacy. Id. at 442.
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MWC's Dispensing of Controlled Substances
On April 25, 2024, the Diversion Investigator (DI) assigned to this
case inspected MWC's Drake Road location during an investigation of Dr.
K.L. Tr. 31; RD, at 3. DI observed that this location appeared to be
operating like a retail pharmacy. Tr. 35-36. There was a drive-thru for
patients to fill their prescriptions and an area inside the office
identified with a sign ``Dispensary Rx,'' that contained a pharmacy
counter, a cash register, a retail waiting area, and a prescription
vending machine, called VendRx, that dispensed medications. Tr. 35-39,
54-55; GX 7, at 5-7; GX 71, at 3; RD, at 3, 5. MWC's website includes a
picture of the VendRx machine and states, ``We also offer low-cost
Prescription Dispensing, with 24 hour* prescription refills at our
DirectRX vending machines.'' Tr. 43; GX 5, at 1. The asterisk language
states ``*24 Hour dispensing available at our Miramont Drake
Location.'' Tr. 43-44; GX 5, at 2. Each MWC location has a VendRx
machine that fills prescriptions issued by MWC's practitioners. Tr.
242; RD, at 7.
Respondent prepared a video demonstrating how the VendRx machine
works. RX 7. The practitioner first generates an electronic
prescription through the VendRx software by clicking on the ``Write
Rx'' tab and entering the patient's name, gender, and date of birth,
and then adding the drug type, strength, quantity, usage instructions,
days' supply, number of refills, and practitioner's signature. Id. The
practitioner then hits the ``prescribe'' button, and the prescription
can be filled by the patient at the VendRx machine. Id.
The record includes video from MWC's website showing how the VendRx
machine operates from the patient's perspective. Tr. 44-47, 51; GX 6.
The video contains a spoken narrative that informs patients that MWC
``pioneered a robotic prescription dispensing machine . . . calle[d]
DirectRX . . . [that] allows [MWC's] doctors to prescribe your
medications quickly during your office visits.'' GX 6; GX 70. It
instructs patients to ``simply walk up to the machine, type in your
last name, follow the prompt, pay with your credit card, and you will
receive your prescription and your receipt.'' GX 6; GX 70. As the
patient begins typing in her last name, the machine auto generates a
list of patients with last names containing those letters. For example,
in Respondent's demonstrative video, a woman types in ``M-A,'' and the
machine offers two individuals with
[[Page 6893]]
a last name beginning with those letters. RX 7. After the woman selects
the correct name and enters the patient's date of birth, a screen pops
up that reads, ``retrieving prescription data,'' followed by a screen
that lists the prescription(s) that will be filled and asks for the
patient's signature. Id.
Respondent testified that the VendRx machine cannot dispense any
medications that are in a box or in small or large bottles. Tr. 389.
Because of these limitations, the VendRx can only fill about 10% of the
controlled substance prescriptions filled at MWC. Id. When medications
cannot be dispensed by the machine, the machine generates a receipt,
which the patient takes to the retail manager, who confirms the
identity of the patient, that the patient's signature is present, and
that payment has been made. Id. at 397. The retail manager confirms
that the medication on the claim ticket matches what is in the system,
prepares a label, and dispenses the medication. Id.
Respondent testified that even when VendRx does not dispense the
medication, its inventory control system keeps a permanent log of all
medications dispensed at MWC. Id. at 248, 389, 399. Respondent
testified that MWC does not fill prescriptions for individuals who are
not patients of MWC. Id. at 399.
Respondent's Purchases of Controlled Substances From Suppliers
DEA maintains an internal system called ARCOS (Automated Reporting
and Consolidated Ordering System) that contains reports of all
controlled substances that a supplier has sold to an entity. Tr. 81;
RD, at 5. Suppliers are required to report to ARCOS what they have sold
to DEA registrants. Tr. 83; RD, at 5. ARCOS contains the name of the
supplier, the name, quantity, and strength of the controlled substance,
the size of the bottles or packaging, and the National Drug Code
numbers for the controlled substance. Tr. 81-82; RD, at 5. DI searched
ARCOS for all practitioners at MWC, including Respondent, for the two-
year period from April 24, 2022, through April 24, 2024. Tr. 83-84, 94;
RD, at 5. The ARCOS information for Respondent returned numerous
orders, consistent with his ranking as the fourth highest recipient of
controlled substances in Colorado. Tr. 95-96, 104; GX 8-9; RD, at 5. DI
testified that, in contrast, the ARCOS information for the other
practitioners at MWC (aside from Dr. K.L., who ordered controlled
substances for the Drake location) showed that they ordered little or
no controlled substances for MWC. Tr. 96-97, 104, 208; GX 10-22; RD, at
5.
DI served administrative subpoenas on three of Respondent's
suppliers, as well as VendRx, the Colorado Board of Pharmacy, and
Walgreens to authenticate the ARCOS information for Respondent. Tr.
105-11; GX 23, 25, 31, 33, 35, 37, 39, 41, 43, 58, 62, 64, 66, and 68;
RD, at 5. The subpoena responses showed, and Respondent admits, that
Respondent purchased the vast majority of the controlled substances
that were dispensed at the Snow Mesa and Parker locations. Tr. 112-13,
116-17, 125-26, 156, 159, 208, 428-29; GX 24, 26-30, 32, 34, 36, 38,
40, 42, 67, 69; Resp. Post-hearing brief, at 24 (``[Respondent] does
not dispute, that he ordered many of the medications, including
controlled substances, that were dispensed at the Miramont Snow Mesa
and Parker offices.''); RD, at 5; but see Tr. 325 (Respondent's
testimony that he did not begin ordering controlled substances for the
Parker location until June 2023).
Dispensing of Controlled Substances at MWC
From April 25, 2022 to April 25, 2024, MWC filled approximately
4,244 controlled substance prescriptions that were issued by
practitioners other than Respondent at the Snow Mesa and Parker
locations. Tr. 158-61; GX 40, 42, 67; RD, at 5. These prescriptions
were filled by the VendRx machines and by unlicensed employees, and
they were filled with controlled substances that Respondent had
purchased. Id. Tr. 112-13, 116-17, 125-26, 156, 159, 208; GX 24, 26-30,
32, 34, 36, 38, 40, 42, 67, 69; Resp. Post-hearing brief, at 24; RD, at
5. The controlled substances dispensed included a schedule II opioid
(hydrocodone-acetaminophen); a schedule III hormone (testosterone-
cypionate); schedule IV benzodiazepines, sedatives, painkillers, and
weight loss drugs (lorazepam, diazepam, alprazolam, clonazepam,
zolpidem, carisoprodol, tramadol, eszopiclone, and phentermine); and a
schedule V opioid (codeine-guaifenesin). Tr. 161-63; GX 40, 42, 67; RD,
at 2-3, 5, 14, 23. The practitioners who issued these prescriptions
included physicians, nurse practitioners, and physician assistants. Tr.
201-02; GX 3.
For example, Dr. P.M.J. is a physician at MWC's Snow Mesa location.
Tr. 382; RX 21, 22; RD, at 9. Dr. P.M.J. is a primary care physician
who primarily serves diabetic patients, but she dispenses some
controlled substances, including alprazolam, lorazepam, clonazepam,
phentermine, tramadol, testosterone, and zolpidem. Tr. 385-866, 445; GX
40, at 36-37; RD, at 9. The dispensing data for the VendRx machine
shows that approximately 50 controlled substance prescriptions issued
by Dr. P.M.J. were filled from ``staff storage'' at the Snow Mesa
location. GX 40, at 36-37. Dr. P.M.J.'s data shows that she did not
purchase any controlled substances for any of the MWC locations, GX 13;
these prescriptions were filled from Respondent's stock. Respondent
admitted on cross-examination that he purchased the phentermine that
Dr. P.M.J. dispensed. Tr. 446; RD, at 9.
Government Exhibits 40 and 42 list the additional prescriptions
that were filled at MWC for patients of MWC's practitioners from the
stock of controlled substances that Respondent purchased.
Accordingly, the Agency finds based on substantial evidence that
Respondent allowed thousands \6\ of prescriptions \7\ issued by MWC's
practitioners to be filled from the stock of controlled substances that
Respondent purchased. The Agency finds based on substantial evidence
that these prescriptions were filled by a machine or by unlicensed
individuals and that neither Respondent nor the prescribing
practitioner was involved in filling them. Finally, the Agency finds
based on substantial evidence that MWC did not possess a pharmacy
license with DEA or the State of Colorado.
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\6\ Respondent testified that he did not begin ordering
controlled substances for the Parker location until June 2023. Tr.
325. Government Exhibit 42 shows that approximately 1,000
prescriptions were filled at the Parker location before or during
June 2023. GX 42, at 1-13. Thus, out of the 4,244 prescriptions
filled at the Parker and Snow Mesa locations from April 25, 2022 to
April 25, 2024, approximately 1,000 were not filled using controlled
substances that Respondent purchased. The Agency is not considering
these 1,000 as part of its decision in this matter.
\7\ The orders submitted by MWC's practitioners through the
VendRx software were prescriptions under 21 CFR 1300.01 because they
were ``order[s] for medication which [were] dispensed to or for an
ultimate user,'' and they were not for ``immediate administration to
the ultimate user.'' Respondent's video demonstration of the VendRx
software showed the practitioner generate an electronic prescription
by clicking on the ``Write Rx'' tab and entering the details
required for the prescription, including the patient's identifying
details, the medication details and instructions, and the
practitioner's signature. RX 7. The practitioner then hit the
``prescribe'' button, and the prescription was filled by the patient
at the machine. Id.
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II. Public Interest Determination
A. Legal Background on Public Interest Determinations
When the CSA's requirements are not met, 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.
[[Page 6894]]
243, 251 (2006) (quoting 21 U.S.C. 824(a)(4)). In the case of a
``practitioner,'' Congress directed the Attorney General to consider
five factors in making the public interest determination. Id.; 21
U.S.C. 823(g)(1)(A-E).\8\
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\8\ 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 five 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).
B. 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 is confined to Factors B and D. OSC, at 3-4. Evidence is
considered under Factors B and D when it reflects compliance or non-
compliance with laws related to controlled substances and experience
dispensing controlled substances. Kareem Hubbard, M.D., 87 FR 21156,
21162 (2022).
Here, as found above, the Agency finds that Respondent allowed
thousands of prescriptions issued by MWC's practitioners to be filled
at MWC from a stock of controlled substances that Respondent had
purchased. The controlled substances were dispensed by a machine and by
unlicensed employees, and neither Respondent nor the prescribing
practitioner was involved in the process of filling them. MWC did not
have a pharmacy registration that would permit Respondent or MWC to
fill controlled substance prescriptions. Accordingly, the Agency finds
substantial record evidence that Respondent violated 21 CFR 1306.06,
which provides that ``[a] prescription for a controlled substance may
only be filled by a pharmacist, acting in the usual course of his
professional practice . . . .''
Respondent's Exceptions
In his Exceptions, Respondent quotes various statutes and
regulations out of context to imply that a practitioner may fill a
controlled substance prescription for another practitioner. See
Respondent's Exceptions, at 6-9 (``Hence, regulations permit delivery
to a patient by the practitioner, or by another individual pursuant to
the practitioner's lawful order.'') This interpretation is clearly
contradicted by the plain language of the pertinent statutes and
regulations. The CSA's definitions of ``dispense'' and ``dispenser,''
along with corresponding statutes and regulations, delineate a clear
distinction between lawful direct dispensing of controlled substances
by practitioners and lawful filling of prescriptions by pharmacists.
The CSA defines dispense as:
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 and 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). The conjunction ``or'' signals that dispensing
may be done ``by . . . a practitioner'' or ``pursuant to the lawful
order of, a practitioner.'' When read together with 21 CFR 1306.06's
mandate that only pharmacists may fill prescriptions, the CSA creates
two categories of permissible dispensing: (1) delivery/dispensing of a
controlled substance by a practitioner ``to an ultimate user,'' and (2)
delivery/dispensing of a controlled substance by a pharmacist ``to an
ultimate user . . . pursuant to the lawful order of, a practitioner.''
In other words, a practitioner may dispense a controlled substance to
the ultimate user without a prescription, and a pharmacist may dispense
a controlled substance to the ultimate user pursuant to a prescription
issued by a practitioner.
The CSA and its implementing regulations further clarify that
practitioners may only dispense controlled substances ``directly . . .
to an ultimate user'' in the usual course of their professional
practice. 21 U.S.C. 829(a), (b) (``Except when dispensed directly by a
practitioner . . . to an ultimate user, no controlled substance in
schedule[s II through IV], . . . may be dispensed without the written
prescription of a practitioner . . . .''); 21 CFR 1306.11 (``An
individual practitioner may administer or dispense directly a
controlled substance listed in Schedule II in the course of his
professional practice without a prescription''); 21 CFR 1306.21 (``An
individual practitioner may administer or dispense directly a
controlled substance listed in Schedule III, IV, or V in the course of
his/her professional practice without a prescription, subject to''
regulations pertaining to narcotic drugs.). The CSA defines ``ultimate
user'' as ``a person who has lawfully obtained, and who possesses, a
controlled substance for his own use or for the use of a member of his
household . . . .'' Id.
Neither the CSA nor its implementing regulations provides further
guidance on what it means for a practitioner to dispense a controlled
substance ``directly . . . to an ultimate user.'' However, the word
``directly'' leaves
[[Page 6895]]
little ambiguity as to Congress's intent. Representative definitions of
the words ``direct'' and ``directly'' from various dictionaries
include: ``without anyone or anything else being involved or between,''
\9\ ``[i]n a straight line or course,'' \10\ ``immediately,'' \11\ ``in
immediate physical contact,'' \12\ and ``to cause to turn, move, or
point undeviatingly or to follow a straight course.'' \13\ These
definitions support the Agency's plain language reading that when a
practitioner dispenses a controlled substance without a prescription,
the practitioner must personally deliver the controlled substance to
his patient without using an intermediary.\14\
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\9\ Cambridge Online Dictionary, available at <a href="https://dictionary.cambridge.org/us/dictionary/english/direct">https://dictionary.cambridge.org/us/dictionary/english/direct</a>.
\10\ Black's Law Dictionary (12th ed. 2024).
\11\ Black's Law Dictionary (12th ed. 2024).
\12\ Merriam-Webster Online Dictionary, available at <a href="https://www.merriam-webster.com/dictionary/directly">https://www.merriam-webster.com/dictionary/directly</a>.
\13\ Merriam-Webster Online Dictionary, available at <a href="https://www.merriam-webster.com/dictionary/direct">https://www.merriam-webster.com/dictionary/direct</a>.
\14\ Respondent argues in his Exceptions that ``[n]either the
ALJ's Decision nor DEA's Order cites a statute or regulation
requiring that the ordering practitioner physically deliver a
controlled substance to the patient,'' and asserts that courts have
interpreted 1306.04(a) ``to prohibit a provider from dispensing a
controlled substance for an illegitimate purpose outside the usual
course of medical practice--not to require that the provider
personally deliver the medication to the patient.'' Resp.
Exceptions, at 7. However, none of the cases that Respondent cites
involves a physician who authorized unlicensed employees to dispense
controlled substances purchased by that physician, and Respondent
has not identified any language in these cases that contradicts the
Agency's reasonable interpretation of the relevant statutes and
regulations discussed herein. Respondent's assertion that ``[i]t is
undisputed that [Respondent] dispensed controlled substances for
legitimate medical purposes in the course of professional practice''
is not supported by the record. Respondent's Exceptions, 8.
Respondent's dispensing of controlled substances violated the CSA's
implementing regulations, which require that a practitioner directly
dispense controlled substances to the ultimate user.
Respondent also asserts that ``[t]here is no evidence that [he]
committed a knowing or intentional violation.'' Resp. Exceptions, at
3, 8. The Agency, however, has repeatedly held that ``misconduct
need not be intentional to revoke a registrant's registration,'' and
that ``[c]areless or negligent handling of controlled substances
creates the opportunity for diversion and could justify revocation
or denial.'' See, e.g., Peter Dashkoff, M.D., 90 FR 19313, 19316 n.9
(2025) (citing Paul J. Caragine, 63 FR 51592, 51601 (1998)).
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This plain language reading is clearly consistent with Congress's
intent when considered in the context of the CSA's implementation of a
``closed regulatory system'' with ``strict requirements'' intended to
``to conquer drug abuse and to control the legitimate and illegitimate
traffic in controlled substances.'' Gonzales v. Raich, 545 U.S. at 12-
14. The manner in which Respondent permitted controlled substances to
be dispensed at MWC could have led to the abuse and diversion of the
controlled substances that Respondent purchased. Because the controlled
substances were dispensed by the VendRx machine or unlicensed
employees, no licensed practitioner or pharmacist physically handled
the medication to ensure that the correct medication was dispensed or
that it was dispensed in the correct quantity or dosage. Nor did a
practitioner confirm that a patient who received a controlled substance
from the machine was the same patient to whom the prescription was
issued. As Respondent's video exhibit demonstrates, a prescription can
be filled at the VendRx machine by any individual who knows the name
and date of birth of an individual prescribed a controlled substance at
MWC, with no photo identification required.\15\ GX 7; Tr. 393, 436-37,
444; but see Tr. 436-37 (Respondent's testimony that his employees
``are watching the area and on guard in their control of the lobby''),
444-45. Thus, the controlled substances that Respondent dispensed
exited the closed regulatory loop established by Congress when they
were dispensed by individuals not trained to assess the legitimacy of
prescriptions or ensure that prescriptions were filled in accordance
with applicable state and federal laws and regulations. See 21 CFR
1306.04 (``The responsibility for the proper prescribing and dispensing
of controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the
prescription.''); see also Trinity Pharmacy II, 83 FR 7304, 7331 (2018)
(The corresponding responsibility requires ``pharmacists to identify
and resolve suspicions that a prescription is illegitimate . . . before
`knowingly filling such a purported prescription.' '').
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\15\ Respondent's video also demonstrated that the VendRx
machine begins populating a list of names after the user types in
only two letters. RX 7. For example, when the user types in ``M-A,''
the machine provides two names where the letters ``M-A'' begin the
patient's first or last name. Id. With the breadth of personal
information currently available on the internet, a user could
quickly type a few sets of letters that are common in first or last
names, select a name, and conduct a quick internet search using the
patient's name and general location to potentially find the
patient's date of birth. The user could then purchase a controlled
substance that was not prescribed for him.
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DEA's interpretation of the CSA in this context is not new or
unexpected. The Agency has previously sanctioned practitioners for
filling prescriptions issued by other practitioners. For example, in
Margy Temponeras, M.D., the Agency revoked a physician's registration
who--despite not holding a pharmacy registration--operated a dispensary
out of which she dispensed ``thousands of controlled substance
prescriptions which were issued by her father, who was not registered
at the location of [the respondent's] practice.'' \16\ 77 FR 45675,
45676 (2022); RD, at 15. The respondent's dispensary was located at the
same address as her medical practice. Id. at 45,677; RD, at 15. The
Administrator held that the
[[Page 6896]]
respondent violated 21 CFR 1306.06 ``because she exceeded the authority
granted by her registration when she dispensed controlled substance
prescriptions issued by her father without holding a pharmacy
registration.'' Id. (citing 21 U.S.C. 822(b)). The Agency also held in
Fred Samimi, M.D., that a physician's practice of allowing his office
staff to dispense controlled substances violated the CSA and its
regulations, and articulated the Agency's concerns about the heighted
risk of abuse and diversion from this practice:
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\16\ Respondent attempts to distinguish Temponeras because the
physician whose prescriptions were filled by the respondent in
Temponeras was not registered at the office where the respondent
filled his prescriptions, whereas the practitioners in this case
were registered where Respondent filled their prescriptions. Resp.
Exceptions, at 10-11. However, 1306.06 clearly mandates that
prescriptions may only be filled by registered pharmacists, without
any exceptions for practitioners registered at the same office
location, and Respondent does not cite to any authority suggesting
that the registered address of the prescribing practitioner is
relevant.
Respondent further argues that the Temponeras decision ``is the
primary cited basis for findings that [Respondent] violated federal
law,'' and this decision ``is not binding and would not even be
entitled to judicial deference.'' Id. (citing Loper Bright
Enterprises v. Raimondo, 603 U.S. 369, 412-13 (2024)). Although
Respondent is correct that Loper Bright instructs federal courts to
independently interpret statutes rather than relying on an Agency's
interpretation, an Agency is still charged with enforcing and
interpreting the statutes that it implements, and may reference
prior Agency decisions in doing so. Temponeras, and this Decision,
are based on a logical, plain language interpretation of federal
regulations that state that only pharmacists may fill controlled
substance prescriptions, and that practitioners must dispense
controlled substances directly to the ultimate user. Moreover, the
Temponeras decision is also relevant to show that Respondent had
notice of the Agency's reasonable interpretation of the applicable
statutes and regulations.
Finally, Respondent argues that Temponeras involved an Ohio law
that required prescribing physicians to personally furnish drugs to
the patient, whereas the ALJ in this case found that Colorado law
did not require personal dispensation by the prescribing
practitioner. Resp. Exceptions, at 11. As discussed throughout this
Decision, the Agency does not adopt the ALJ's legal analysis and,
accordingly, does not adopt his conclusions regarding Colorado law.
The Agency need not make findings regarding Colorado state law,
because the CSA's mandate that practitioners dispense controlled
substances directly to their patients requires practitioners to
personally deliver controlled substances to their patient without an
intermediary. Federal law supersedes any state law that does not
require direct dispensation.
The Agency notes, however, that the language of the applicable
Colorado law is very similar to the Ohio law cited in Temponeras.
The Ohio law exempts a physician from the unauthorized practice of
pharmacy if he ``personally furnish[es] . . . [his] patients with
drugs, within [his] scope of professional practice.'' Temponeras, 77
FR at 45678 (citing Ohio Rev. Code Ann.Sec. 4729.29(A)(1)).
Similarly, the pertinent Colorado law states that ``[a] practitioner
may personally compound and dispense for any patient under the
practitioner's care any drug that the practitioner is authorized to
prescribe and that the practitioner deems desirable or necessary in
the treatment of any condition being treated by the practitioner.''
Colo. Rev. Stat. Sec. Sec. 12-280-120(6).
[T]he unsupervised dispensing of controlled substances by
unlicensed individuals creates a heightened risk that those
individuals will divert the drugs. . . . So too, allowing unlicensed
persons, who likely have no training in identifying persons engaged
in drug abuse or diversion, to dispense controlled substances
without supervision, increases the opportunity for those persons who
are self-abusing or engaged in diversion to obtain controlled
---------------------------------------------------------------------------
substances.
79 FR 18698, 18710 (2014) (citing Temponeras 77 FR at 45677-78;
Gonzales v. Oregon, 546 U.S. at 274).\17\
---------------------------------------------------------------------------
\17\ While Respondent correctly observes in its Exceptions that
the CSA permits agents or employees of registrants to possess
controlled substances, they may only do so while ``acting in the
usual course of [their] business or employment,'' which does not
include performing activities that they are not trained or
registered to do, such as dispensing controlled substances, which
must be done by registered pharmacists or practitioners. See Resp.
Exceptions, at 7; 21 CFR 1306.04, 1306.06.
---------------------------------------------------------------------------
Although Respondent tries to muddy the distinction between filling
prescriptions and dispensing controlled substances, Respondent was
unable to avoid referring to MWC's dispensing activities as ``filling
prescriptions.'' Cf. Tr. 242 (``[W]e don't fill outside prescriptions.
We only dispense and fill medication orders.''); Respondent's Post-
Hearing Brief, at 7 (stating that ``[the medical office] does not fill
prescriptions for patients issued by providers outside of [the medical
office]''). Nevertheless, MWC's distribution of controlled substances
was clearly unlawful whether considered under the standards applicable
to practitioners dispensing controlled substances or pharmacists
filling prescriptions.
In the RD, the ALJ sustained violations of 21 CFR 1306.06
(requiring that prescriptions be filled by pharmacists) and 21 CFR
1306.04 (providing that ``[t]he responsibility for the proper
prescribing and dispensing of controlled substances is upon the
prescribing practitioner, but a corresponding responsibility rests with
the pharmacist who fills the prescription''). Respondent argues that
the ALJ erred in finding that he violated 21 CFR 1306.04, and espouses
two primary arguments in support: First, that the way in which the ALJ
phrased the 1306.04 violation was different than what the Government
alleged in the OSC, therefore raising a notice issue; and second, that
the Government has not proven the requisite elements of 21 CFR 1306.04.
The Agency does not adopt the ALJ's legal analysis in this Final
Order and does not sustain a violation of 21 CFR 1306.04. Thus,
Respondent's notice concerns are moot. The Agency finds that
Respondent's dispensing activities are more accurately portrayed as
``filling prescriptions'' than ``dispensing controlled substances,''
which makes 21 CFR 1306.06 the more pertinent regulation. The Agency
need not find violations of both 21 CFR 1306.04 and 1306.06 where 21
CFR 1306.06 more directly addresses Respondent's unauthorized filling
of prescriptions. However, the Agency notes that 21 CFR 1306.04 does
not support Respondent's defense. In fact, the error of Respondent's
dispensing practices is evident from a close examination of 21 CFR
1306.04, which states that:
A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional
practice. The responsibility for the proper prescribing and
dispensing of controlled substances is upon the prescribing
practitioner, but a corresponding responsibility rests with the
pharmacist who fills the prescription.
This regulation reinforces the distinction between filling
prescriptions and dispensing controlled substances and makes clear that
a licensed professional--either a pharmacist or a practitioner--must be
responsible for ensuring that dispensing is ``proper.'' Id. Here,
Respondent delegated the responsibility for proper dispensing to an
unlicensed employee (and/or a machine), which clearly contravenes the
structure outlined by 21 CFR 1306.04. Thus, while the Agency does not
sustain a violation of 21 CFR 1306.04 because the nature of his
misconduct is more accurately captured under 21 CFR 1306.06,
Respondent's attempt to use 21 CFR 1306.04 as a defense fails.
Respondent also argues that he did not violate 21 CFR 1306.06.
Respondent argues that 21 CFR 1306.06 ``addresses requirements that a
pharmacist be properly registered and acting in the usual course of
professional practice when filling a prescription,'' and here,
Respondent argues that ``controlled substances were dispensed to
patients pursuant to lawful practitioner orders, as authorized by
federal and state law.'' Respondent's Exceptions, at 9. Respondent
argues that the ALJ made conflicting findings that on the one hand he
violated 1306.06 because the prescriptions were not filled by a
pharmacist, and on the other hand that he was not required to have a
pharmacy registration because he was not operating a pharmacy. As
stated above, the Agency does not adopt the ALJ's legal analysis in
this case. The Agency finds that MWC's staff was filling prescriptions
issued by MWC's practitioners, which is an activity that may only be
done by a pharmacist.\18\ The only lawful way for Respondent, a
practitioner, to distribute the large quantity of controlled substances
that he purchased would have been for him to dispense them directly to
his own patients.\19\
---------------------------------------------------------------------------
\18\ The ALJ did not sustain the Government's allegations that
MWC's locations were operating as unregistered pharmacies. RD, at
24-25. The Agency agrees with the ALJ that the Government did not
prove that Respondent violated Colorado law by ``falsely assum[ing]
the title of or falsely represent[ing] that [he was] a pharmacist''
or by ``falsely represent[ing]'' that MWC was a ``registered
outlet.'' Id. at 26 (declining to find a violation of Colo. Rev.
Stat. 12-280-129(1)(d)). Although MWC did advertise that it
dispensed medications, there is no evidence that Respondent or MWC
falsely represented that MWC was a pharmacy, and MWC did not fill
prescriptions of outside patients. The Agency also agrees with the
ALJ that the Government did not prove that Respondent violated 21
CFR 1301.13(e), which requires that any person engaging in more than
one group of ``independent activities'' obtain a separate
registration for each group of activities, because 21 CFR 1301.13(e)
does not distinguish among different dispensing activities (e.g.,
pharmacists filling prescriptions versus practitioners dispensing
medications) in its definition of ``independent activities.'' RD, at
22. The Agency further finds that the Government did not adequately
develop its arguments as to why the other provisions cited--
including 21 U.S.C. 823(g)(1), which governs registration
requirements for practitioners, Colo. Rev. Stat. 12-280-120(1),
which requires that controlled substances be dispensed only in
accordance with that section, and 21 CFR 1301.11(a), which requires
that every person who dispenses controlled substances obtain a DEA
registration--support the allegation that Respondent was operating
unregistered pharmacies. OSC/ISO, at 4.
However, the Agency notes that MWC's unlicensed staff filled
prescriptions, which is an activity that may only be done by a
pharmacist. Respondent's practitioner registration did not authorize
him to allow unlicensed staff to fill prescriptions for controlled
substance or dispense controlled substances that he purchased. In
other words, Respondent exceeded the authority granted by his
practitioner registration.
\19\ Respondent argues that Colorado law permits mid-level
practitioners to dispense controlled substances purchased by their
supervising physician. See, e.g., Resp. Exceptions, at 17. The
Agency does not make any findings related to Colorado law, because
Respondent's conduct clearly violated the CSA and its implementing
regulations. However, the Agency notes that even if Colorado law
permitted mid-level practitioners to dispense the controlled
substances that Respondent purchased, the CSA required them to
dispense the controlled substances directly to their patients. As
found above, neither Respondent nor the prescribing practitioner was
involved in dispensing the controlled substances to the patients.
The prescribing practitioners issued prescriptions in the VendRx
software that were then filled by the VendRx machine or by MWC's
employees.
---------------------------------------------------------------------------
[[Page 6897]]
Respondent further argues that the ALJ improperly weighed the
public interest factors by failing to consider positive evidence under
factors B and D and failing to consider that factors A, C, and E weigh
in his favor. However, as previously stated, federal courts have
repeatedly affirmed that ``the Agency is not required to mechanically
count up the factors and determine how many favor the Government and
how many favor the registrant.'' Jayam Krishna-Iyer, 74 FR at 462.
Because the public interest inquiry ``focuses on protecting the public
interest[,] what matters is the seriousness of the registrant's
misconduct,'' id., and findings under a single factor can support the
revocation of a registration. MacKay, 664 F.3d at 821. Here, the Agency
finds that the Government has presented substantial evidence of
Respondent's non-compliance with federal law (factor D) and negative
experience dispensing controlled substances (factor B), which weighs
strongly against Respondent under factors B and D. Respondent allowed
thousands of prescriptions for controlled substances to be filled
outside of the CSA's closed regulatory system, which could have led to
abuse and diversion.
Respondent argues that the Agency should consider under factor B
that only a small portion of the medications dispensed at MWC were
controlled substances, that the amount of controlled substances
dispensed was appropriate considering the number of patients and
practitioners at MWC, that only 10% of controlled substances were
dispensed through the VendRx machine, that only 10% of the
prescriptions issued to MWC patients were filled at MWC, that the only
schedule II controlled substance dispensed at MWC was hydrocodone, and
that any patient receiving hydrocodone was subject to a urine drug
screen and controlled substance contract. Respondent's Exceptions, at
16. Respondent also argues that it is relevant to factor B that he has
been licensed as a physician since July of 1993, and that he has
supervised and consulted with numerous physician assistants and nurse
practitioners who issue prescriptions for controlled substances.\20\
Id. Finally, Respondent notes that he and all MWC providers stopped
dispensing while this matter has been pending. Id.
---------------------------------------------------------------------------
\20\ Respondent's lengthy tenure as a physician and his
supervision of mid-level practitioners is not persuasive considering
the substantial evidence of noncompliance with the CSA. The factor B
analysis focuses on the registrant's acts that are inconsistent with
the public interest, rather than on a registrant's neutral or
positive acts and experience. Kansky J. Delisma, M.D., 85 FR 23845,
23852 (2020) (citing Randall L. Wolff, M.D., 77 FR 5106, 5121 n.25
(2012)).
---------------------------------------------------------------------------
The Agency does not find that these facts influence its factor B
analysis. The Government's allegations focused on the large volume of
controlled substance prescriptions that MWC filled unlawfully, not
whether prescriptions at MWC were issued lawfully or whether the
percentage or volume of controlled substances was appropriate given the
number of patients and practitioners.\21\ The Government need not prove
generally that all operations at MWC were unlawful to demonstrate that
revocation is warranted. The Agency has repeatedly held that ``the
public interest inquiry is not a numbers game in which the Government
must prove a certain number of violations,'' and has revoked
registrations even where the Government has demonstrated only a few
instances of unlawful prescribing or dispensing. See Larry Daniels, 82
FR at 14984 (collecting cases). Here, the Government proved that MWC
unlawfully filled thousands of prescriptions for controlled substances,
including at least 400 hydrocodone prescriptions, which weighs strongly
against Respondent under Factors B and D.
---------------------------------------------------------------------------
\21\ In the absence of evidence of illegality, the Agency
assumes that controlled substances at MWC were prescribed
legitimately. See, e.g., Larry C. Daniels, M.D., 86 FR 61630, 61611
(2021) (``With respect to consideration given to a practitioner's
positive experience in prescribing, the DEA assumes that all of the
prescriptions a registrant has issued were issued lawfully, except
for those prescriptions that the Government alleges were issued
unlawfully.'') (citing Wesley Pope, M.D., 82 FR 14944, 14984 (2017).
DEA gives no more than nominal weight to evidence that a
practitioner has engaged in lawful dispensing to thousands of
patients. Syed Jawed Akhtar-Zaidi, M.D., 80 FR 42962, 42968 (2015)
(citing Krishna-Iyer, 74 FR at 463); see also Medicine Shoppe-
Jonesborough, 73 FR 364, 386 n.56 (2008) (ruling that no amount of
lawful conduct could outweigh ``flagrant violations'' and make the
misconduct somehow consistent with the public interest), aff'd
Medicine Shoppe-Jonesborough v. DEA, 300 F. App'x 409 (6th Cir.
2008).
---------------------------------------------------------------------------
Moreover, Respondent's implementation of urine drug screens and
opioid contracts does not negate the unlawfulness of MWC's dispensing
procedures, nor does the fact that hydrocodone was the only schedule II
substance dispensed mitigate the Agency's concerns about potential
abuse and diversion of the more than 400 hydrocodone prescriptions
filled unlawfully. Additionally, the fact that only 10% of controlled
substances were dispensed through the VendRx machine is immaterial
because the remainder were dispensed by Respondent's unlicensed
employees, which is also unlawful. Finally, Respondent's and MWC's
cessation of dispensing does not weigh in Respondent's favor, because
the immediate suspension of Respondent's registration made it unlawful
for Respondent to prescribe or dispense controlled substances.
With respect to Factor D, ``[c]ompliance with applicable State,
Federal, or local laws relating to controlled substances,'' Respondent
notes that the ALJ did not find any violations of Colorado law, that
Respondent reasonably believed he was in compliance with Colorado and
federal law, that Respondent had communicated with Colorado officials
regarding ``his understanding of governing Medical Board Rules [ ] that
Physician Assistants and Nurse Practitioners can carry out delegated
work for a physician's patients including medication dispensing,'' that
DEA did not take action against Respondent in 2017 when it previously
audited Respondent's dispensing practices.\22\ Respondent's Exceptions,
at 17.
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\22\ Because the Government's allegations in this case range
from April 25, 2022, to June 11, 2024, an audit in 2017 is
irrelevant. OSC/ISO, at 4. Respondent argues that MWC's ``ordering
and dispensing practices were functionally the same before and after
2017,'' but there is no evidence on the record regarding
Respondent's 2017 practices, and Respondent acknowledges that the
VendRx was not added until after DEA's 2017 audit. Resp. Exceptions,
at 17. It was not reasonable for Respondent to assume that a
successful audit in one year portended a successful audit in later
years, especially when MWC incorporated a new dispensing machine
into its practice. See, e.g., Svetlana Burtman, N.P., 90 FR 16881,
16882 n.3 (2025) (``Further, the Agency rejects Respondent's theory
that, if a registrant's `storage and record-keeping practices' are
compliant in one year, the registrant may maintain a `reasonable
belief' that she will remain compliant going forward regardless of
changes in the registrant's practices or without the registrant
continuously monitoring for required changes.''). Moreover, even if
Respondent's practices were identical in 2017, DEA is not precluded
from enforcing the CSA simply because it did not do so in the past.
---------------------------------------------------------------------------
As discussed throughout this Decision, the Agency does not adopt
the ALJ's legal analysis or his conclusions regarding state law, and
the Agency does not make any findings regarding Respondent's compliance
with state law because Respondent's practice of allowing unlicensed
staff to fill prescriptions clearly violated federal law. Respondent's
belief that he was operating in compliance with federal law was not
reasonable because MWC's dispensing practices conflicted with a
[[Page 6898]]
plain language reading of federal regulations governing dispensing and
with prior Agency decisions espousing that interpretation. See
Temponeras, 77 FR at 45677; Samimi, 79 FR at 18710. Thus, the Agency
finds that factor D weighs strongly against Respondent's continued
registration, as Respondent permitted thousands of controlled
substances to be dispensed unlawfully over an extended time.
Although the Agency agrees with Respondent that the remaining
factors do not weigh against his continued registration, the Agency
need not find that each factor weighs against a registration to find
that a registration is inconsistent with the public interest. See,
MacKay, 664 F.3d at 821. Regarding factor A, although there is no
record evidence of disciplinary action against Registrant's state
medical license, 21 U.S.C. 823(g)(1)(A), state authority to practice
medicine is ``a necessary, but not a sufficient condition for
registration.'' Robert A. Leslie, M.D., 68 FR at 15230. Therefore,
``[t]he fact that the record contains no evidence of a recommendation
by a state licensing board does not weigh for or against a
determination as to whether continuation of the Respondent's DEA
certification is consistent with the public interest.'' Roni Dreszer,
M.D., 76 FR 19434, 19444 (2011). As to factor C, there is no evidence
in the record that Registrant has been convicted of any federal or
state law offense ``relating to the manufacture, distribution, or
dispensing of controlled substances.'' 21 U.S.C. 823(g)(1)(C). However,
as Agency cases have noted, ``the absence of such a conviction is of
considerably less consequence in the public interest inquiry'' and is
therefore not dispositive. Dewey C. MacKay, M.D., 75 FR 49956, 49973
(2010). As to factor E, the Government's evidence fits squarely within
the parameters of factors B and D and does not raise ``other conduct
which may threaten the public health and safety.'' 21 U.S.C.
823(g)(1)(E).\23\ Accordingly, factor E does not weigh for or against
Registrant.
---------------------------------------------------------------------------
\23\ Respondent argues that his career accomplishments--such as
his service of thousands of patients over 30 years of medical
practice and his service in the army and navy--should weigh in his
favor under factor E. Respondent's Exceptions, at 15. While the
Agency appreciates that Respondent is a highly-qualified and
hardworking physician who has made substantial contributions to his
community, community impact evidence is considered to be irrelevant
to DEA revocation proceedings. See Carol Hippenmeyer, M.D., 86 FR
33,748, 33,771 n.70 (2021) (citing Frank Joseph Stirlacci, M.D., 85
FR 45,229, 45,239 (2020)).
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Accordingly, the Agency has fully considered Respondent's
Exceptions and still finds that after considering the factors of 21
U.S.C. 823(g)(1), Respondent's continued registration is ``inconsistent
with the public interest.'' 21 U.S.C. 824(a)(4). The Agency further
finds that the Government satisfied its prima facie burden of showing
that Respondent'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, Respondent can be trusted with a
registration.
III. Sanction
Where, as here, the Government has met the burden of showing that
Registrant's continued registration is inconsistent with the public
interest, the burden shifts to Registrant to show why he can be
entrusted with a registration. Morall, 412 F.3d. at 174; Jones Total
Health Care Pharmacy, 881 F.3d 823, 830 (11th Cir. 2018); Garrett
Howard Smith, M.D., 83 FR 18882, 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 who has
committed acts inconsistent with the public interest accept
responsibility for those acts and demonstrate that he will not engage
in future misconduct. See Jones Total Health Care Pharmacy, 881 F.3d at
833; ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir.
1995). The Agency requires a registrant's unequivocal acceptance of
responsibility. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024);
Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see also Jones Total
Health Care Pharmacy, 881 F.3d at 830-31. In addition, a registrant's
candor during the investigation and hearing is an important factor in
determining acceptance of responsibility and the appropriate sanction.
See Jones Total Health Care Pharmacy, 881 F.3d at 830-31; Hoxie, 419
F.3d at 483-84. Further, the Agency considers the egregiousness and
extent of the misconduct as significant factors in determining the
appropriate sanction. See Jones Total Health Care Pharmacy, 881 F.3d at
834 & n.4. The Agency also considers the need to deter similar acts by
a Registrant and by the community of registrants. Jeffrey Stein, M.D.,
84 FR at 46972-73.
Here, the Agency agrees with the ALJ that Respondent did not accept
responsibility for his conduct. RD, at 30. Respondent repeatedly
testified that he believed that MWC's dispensing practices complied
with federal and state law, e.g., Tr. 306-07, 423, and he continued to
defend MWC's conduct in his Post-hearing brief.\24\ Respondent
testified that he is very familiar with physician dispensing practices
across Colorado and that MWC was ``simply doing what physicians have
done for 150 years in the state of Colorado, which is dispense meds.''
\25\ Tr. 306-07.
[[Page 6899]]
Respondent testified that in 25 years of private practice he has never
heard of limitations within a practice group of providers dispensing
from a stock of controlled substances purchased by another member of
the group. Id. at 423.
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\24\ Respondent cites two cases where the Agency determined that
registrants accepted responsibility for overbilling Medicaid even
though they offered an explanation for why they overbilled.
Respondent's Exceptions, at 20 (citing Melvin N. Seglin, M.D., 63 FR
70431, 70433 (1998); Anibal P. Herrera, M.D., 61 FR 65075, 65078
(1996). These cases are not relevant here, because Respondent did
not acknowledge that his conduct was unlawful as these registrants
did. Moreover, these cases are more than two decades old and apply
an outdated sanctions analysis. See infra n.26.
\25\ Respondent testified at the hearing that MWC operated in a
similar manner to urgent care and health clinics where one physician
orders controlled substances for the whole office. Tr. 307, 422.
Although there are circumstances where practitioners who are agents
or employees of another practitioner or institution may dispense
using the DEA registration of that practitioner or institution, MWC
operations did not comply with regulations governing affiliated
physicians. Pursuant to 21 CFR 1301.22, which governs a practitioner
using the registration of another practitioner:
An individual practitioner who is an agent or employee of
another practitioner . . . registered to dispense controlled
substances may, when acting in the normal course of business or
employment, administer or dispense (other than by issuance of
prescription) controlled substances if and to the extent that such
individual practitioner is authorized or permitted to do so by the
jurisdiction in which he or she practices, under the registration of
the employer or principal practitioner in lieu of being registered
him/herself.
This regulation is not applicable to MWC's dispensing practices
because MWC's practitioners used their own DEA registrations (not
Respondent's) and they issued prescriptions, which is expressly
disallowed under this provision. See, e.g., GX 13 (DEA registration
for Dr. P.J.); GX 40, at 36 (Dispensing data for Snow Mesa showing
that Dr. P.J. issued prescriptions under her DEA registration).
Similarly, 21 CFR 1301.22(c), which governs practitioners using the
registration of a hospital or other institution, requires the
institution to designate a specific internal code number for each
individual practitioner, and the practitioner prescribes or
dispenses using the hospital's registration. By contrast, MWC's
practitioners issued prescriptions under their own DEA
registrations, and the prescriptions were filled from Respondent's
stock of controlled substances. Thus, MWC's dispensing practices can
be distinguished from urgent care facilities and hospitals that are
operating in compliance with 21 CFR 1301.22.
Respondent argues in his post-hearing brief that the
Government's expectation that each practitioner order his own
controlled substances is impracticable and will lead to waste and
stockpiling of medications. Resp. Post-Hearing Brief, at 27.
However, as demonstrated above, the CSA has developed a framework
for members of an affiliated medical group to dispense from a common
stockpile of controlled substances if they comply with the
requirements of the regulations.
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Respondent also attempted to minimize his conduct, which further
suggests that the Agency cannot trust him with a registration. See,
e.g., Rachel Kientcha-Tita, M.D., 90 FR 45811, 45812 (2025) (citing
Michael A. White v. Drug Enf't Admin., 626 F. App'x 493, 496-97 (5th
Cir. 2015)). For example, Respondent testified that only a fraction of
the medications dispensed at MWC were controlled substances and that
hydrocodone was the only schedule II drug dispensed at MWC. Tr. 249.
However, any controlled substance dispensed outside of the CSA's closed
regulatory system can result in abuse and diversion, and Respondent
permitted thousands of controlled substance prescriptions, including
more than 400 hydrocodone prescriptions, to be dispensed in this
manner. GX 40, 42.
Respondent argues in his Exceptions that ``[he] is entitled to
explain why he believed the challenged conduct was permitted, while
making clear that he respects the agency's interpretation and will not
engage in alleged improper conduct.'' Resp. Exceptions, at 20.
Respondent argues that there would be ``significant due process
implications'' if the Agency ``interpret[ed] acceptance of
responsibility as requiring that he also admit premeditated
wrongdoing,'' because it ``would nullify his right to defend against
the government's [case].'' Id. at 21. However, DEA has long held that
``[w]hen a registrant has committed acts inconsistent with the public
interest, [he] must both accept responsibility and demonstrate that
[he] has undertaken corrective measures.'' Janet S. Pettyjohn, D.O., 89
FR at 82641. Federal courts have affirmed that ``DEA may properly
consider a registrant's acceptance of responsibility in determining if
registration should be revoked.'' Jones Total Health Care Pharmacy, 881
F.3d at 830. According to the eleventh circuit, ``[i]f a [registrant]
has failed to comply with its responsibilities in the past, it makes
sense for the agency to consider whether the [registrant] will change
its behavior in the future.'' Id.
Here, Respondent's assertions that he reasonably believed that
MWC's dispensing practices complied with federal law suggest that the
Agency cannot trust Respondent to comply with the CSA in the future.
The CSA and its implementing regulations clearly state that
prescriptions may only be filled by pharmacists, and DEA has published
two decisions informing the registrant community that it is unlawful
for practitioners to allow unlicensed employees to fill controlled
substance prescriptions.
Respondent also argues that he ``t[ook] responsibility for the
underlying conduct'' because he testified that ``the buck stops with
him'' at MWC and he has ``the ultimate responsibility'' for MWC's
patients and employees. Resp. Exceptions, at 19-20 (citing Tr. 294,
426-27, 393, 447-48). However, these statements were vague and did not
address the legality of MWC's dispensing practices. Respondent
maintained at the hearing and in post-hearing filings that MWC's
dispensing practices were legal under federal and state law. See, e.g.,
Tr. 306-07, 423; Resp. Post-Hearing Brief, at 17 (``[Respondent]
reasonably believed that practices at [MWC] were in compliance with
state and federal law.''); Resp. Exceptions, at 6-19. Accordingly, the
Agency rejects Respondent's Exceptions and agrees with the ALJ that
Respondent failed to unequivocally accept responsibility for his
misconduct.
Acceptance of responsibility and remedial measures are assessed in
the context of the ``egregiousness of the violations and the [DEA's]
interest in deterring similar misconduct by [the] Respondent in the
future as well as on the part of others.'' Daniel A. Glick, D.D.S., 80
FR 74800, 74810 (2015); OakmontScript Limited Partnership, 87 FR 21546,
21545 (2022). Here, the Agency agrees with the ALJ that the
egregiousness of Respondent's conduct favors revocation. RD, at 31. As
the ALJ stated, ``Respondent's violations were not limited to a single
instance or a single type of violation, but consisted of widespread
violations involving numerous practitioners at his medical offices and
thousands of controlled substance prescriptions.'' Id. Respondent was
the fourth highest purchaser of controlled substances in Colorado, tr.
95-96, and authorized MWC's staff to fill thousands of prescriptions
without a pharmacy registration. Over 400 of these prescriptions were
for a dangerous and highly-abused schedule II opioid. GX 40.
Furthermore, considerations of specific and general deterrence in
this case militate in favor of revocation. RD, at 31. Although
Respondent testified that he will respect DEA's interpretation of the
CSA and cease filling controlled substance prescriptions going forward,
Respondent's failure to accept responsibility suggests that he does not
appreciate the registrant's obligation to be knowledgeable of the CSA
and DEA's plain language interpretations of the CSA, and, therefore,
may not be deterred from violating the CSA in the future.\26\ Interests
of general deterrence
[[Page 6900]]
also support a sanction of revocation. Any sanction less than
revocation would signal to the registrant community that allowing
unlicensed employees to fill thousands of prescriptions for schedule II
through V controlled substances may be excused, even where Respondent
has failed to accept responsibility. See Joseph Gaudio, M.D., 74 FR
10083, 10095 (2009). Distributing such a large volume of controlled
substances outside of the closed regulatory system poses a significant
risk to the public, and the Agency bears the responsibility of
deterring misconduct that endangers the public. David A. Ruben, M.D.,
78 FR 38363, 38385 (2013). Therefore, the Agency finds that the
egregiousness of the Respondent's behavior and the interests of
specific and general deterrence support a sanction of revocation.
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\26\ Respondent argues that it would be improper for DEA to
revoke his registration because ``[t]here is no evidence that any
alleged improper practice would recur,'' and Respondent has
implemented ``remedial systems that preclude recurrence.'' Resp.
Exceptions, at 18. While the Agency is not required to consider
remedial evidence when a Respondent has not accepted responsibility,
see Salman Akbar, M.D., 86 FR 52181, 52195 (2021), Respondent's only
evidence of remediation appears to be the cessation of MWC's
unlawful dispensing practices. Cessation of unlawful behavior after
Government action is not remedial evidence, especially here, where
the ISO stripped Respondent of all authority to dispense, prescribe,
or handle controlled substances. OSC/ISO, at 1, 5. The Agency has
determined that revocation is the appropriate remedy in this case
based on the extent and egregiousness of Respondent's misconduct and
his failure to accept responsibility.
Respondent argues that ``[t]his case is markedly distinct from
others in which DEA has imposed revocation or a lesser sanction,''
and references several cases that are more than two decades old.
Resp. Exceptions, at 18. As the Agency recently stated in Mary A.
Vreeke, M.D., the opioid epidemic has surged in the past decade, and
``[t]he Agency has [ ] departed from some of its more lenient
sanction policies, citing the need to protect the public from abuse
and diversion.'' 89 FR 75567, 75572 (2024). For example, the Agency
has repeatedly reaffirmed that an unequivocal acceptance of
responsibility is critical for a registrant to regain the Agency's
trust and maintain a registration. See, e.g., Jones Total Health
Care Pharmacy, 881 F.3d at 833 (rejecting respondent's argument that
its conduct was not egregious enough to warrant a sanction of
revocation and highlighting the Agency's historical focus on
acceptance of responsibility: ``The DEA decisions Petitioners rely
on are distinguishable because, in each of the decisions, the agency
found that the registrant had rebutted the government's case by,
among other things, admitting fault or expressing remorse. . . .
Petitioners . . . do not cite any decision in which the DEA has
continued a registration despite finding that the registrant did not
fully accept responsibility''); MacKay, 664 F.3d at 822 (finding
that ``because [the respondent] ha[d] not accepted responsibility
for his conduct, revocation of his registration [was] entirely
consistent with DEA policy''); Jeffery J. Becker, D.D.S., 77 FR
72387, 72408 (2012) (``Agency precedent has firmly placed
acknowledgement of guilt and acceptance of responsibility as
conditions precedent to merit the granting or continuation of status
as a registrant.''); Jayam Krishna-Iyer, 74 FR at 464 (``even where
the Agency's proof establishes that a practitioner has committed
only a few acts of diversion, this Agency will not grant or continue
the practitioner's registration unless he accepts responsibility for
his misconduct'').
Not only do the decisions Respondent references use an outdated
sanctions framework, but they are factually distinguishable from
this case. Resp. Exceptions, at 19-20. Several of these cases
involve registrants with substance abuse issues, which raise
distinct considerations, and the Agency has occasionally shown
leniency towards registrants who accept responsibility and
demonstrate that they have undergone successful treatment for
substance abuse. For example, although the registrant in Karen A.
Kruger, M.D., unlawfully prescribed diethylpropion to herself using
fictitious names, she accepted responsibility, testified that she
was addicted, and underwent successful treatment for her addiction.
69 FR 7016 (2004). The Agency highlighted the importance of the
respondent's acceptance of responsibility in its decision not to
revoke, and noted that ``[t]he Acting Deputy Administrator finds
significant the Respondent's ready willingness to cooperate with law
enforcement authorities when questioned about allegations of her
improperly prescribing.'' Id. at 7017-18. In Theodore Neujahr,
D.V.M., the Agency likewise noted that much of the respondent's
unlawful behavior was a result of his addiction, and because the
respondent had been sober for at least a decade when the decision
was issued, the Agency determined that there was a low likelihood of
relapse. 65 FR 5680, 5681 (2000). Similarly, the allegations against
Jeffrey Martin Ford, D.D.S., largely concerned self-abuse of
controlled substances, and the respondent had successfully undergone
treatment and been sober for over a decade at the time of the
decision, which largely mitigated the Agency's concerns. 68 FR
10750, 10753 (2003). Finally, in Paul W. Sexton, the Agency did not
sustain the majority of the Government's allegations but found that
the respondent had unlawfully prescribed anabolic steroids and
failed to keep complete and accurate records of controlled
substances. 64 FR 25073, 25079 (1999). The Agency felt that
revocation was too harsh of a sanction because the respondent
accepted responsibility for the unlawful prescribing and
recordkeeping deficiencies and demonstrated that he had remedied
both. Id. By contrast, the Respondent in this case failed to accept
responsibility for his misconduct and therefore failed to restore
trust with the Agency.
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In sum, Respondent has not offered sufficient credible evidence on
the record to rebut the Government's case for revocation and Respondent
has not demonstrated that he can be entrusted with the responsibility
of registration. Accordingly, the Agency will order that Respondent's
registration be revoked.
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 Certificates
of Registration Nos. BB3697577 and FB3064831 issued to John Bender,
M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in
me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of
John Bender, M.D., to renew or modify this registration, as well as any
other pending application of John Bender, M.D., for registration in
Colorado. This Order is effective March 16, 2026.
Signing Authority
This document of the Drug Enforcement Administration was signed on
January 30, 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. 2026-02902 Filed 2-12-26; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on February 13, 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.