[Federal Register Volume 91, Number 10 (Thursday, January 15, 2026)]
[Notices]
[Pages 1818-1823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-00629]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Pine Pharmacy; Decision and Order
I. Introduction
On April 9, 2025, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Shreeji 16 Inc. d/b/a Pine Pharmacy, of
Ocala, Florida (Registrant). Request for Final Agency Action (RFAA),
Exhibit (RFAAX) 1, at 1. The OSC/ISO informed Registrant of the
immediate suspension of its DEA Certificate of Registration, No.
FS1451222, pursuant to 21 U.S.C. 824(d), alleging that Registrant's
continued registration constitutes `` `an imminent danger to the public
health or safety.' '' Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also
proposed the revocation of Registrant's registration, alleging that
Registrant's continued registration is inconsistent with the public
interest. Id. at 1-2 (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
More specifically, the OSC/ISO alleged that as recently as December
5, 2024, Registrant repeatedly filled prescriptions for Schedule II
through V controlled substances without addressing, resolving, and/or
documenting resolution of red flags of abuse and diversion prior to
dispensing. Id. The OSC/ISO alleges that filling these prescriptions
violated federal and Florida state law. Id. (citing 21 CFR 1306.04(a),
1306.06; Fla. Admin. Code Ann. r. 64B16-27.810, 64B16-27.831).\1\ The
OSC/ISO also alleges that Registrant allowed a non-certificate holder
to use Registrant's digital certificate and private key to order
controlled substances in the Controlled Substances Ordering System
(CSOS), in violation of 21 CFR 1311.30(a) and (b). Id. at 9. Finally,
the OSC/ISO alleges that Registrant maintained a collection bin for
pharmaceutical drugs without the authorization required under 21 CFR
1317.40(a). Id.
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\1\ The Agency need not adjudicate the criminal violations
alleged in the OSC/ISO. Ruan v. United States, 597 U.S. 450 (2022)
(decided in the context of criminal proceedings).
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On June 3, 2025, the Government submitted a request for final
agency action (RFAA) requesting that the Agency issue a default final
order revoking Registrant's registration. RFAA, at 1-4. After carefully
reviewing the entire record and conducting the analysis as set forth in
more detail below, the Agency grants the Government's request for final
agency action and revokes Registrant's registration.
II. Default Determination
Under 21 CFR 1301.43, a registrant entitled to a hearing who fails
to file a timely hearing request ``within 30 days after the date of
receipt of the [OSC] . . . shall be deemed to have waived their right
to a hearing and to be in default'' unless ``good cause'' is
established for the failure. 21 CFR 1301.43(a) & (c)(1). In the absence
of a demonstration of good cause, a
[[Page 1819]]
registrant who fails to timely file an answer also is ``deemed to have
waived their right to a hearing and to be in default.'' 21 CFR
1301.43(c)(2). Unless excused, a default is deemed to constitute ``an
admission of the factual allegations of the [OSC].'' 21 CFR 1301.43(e).
Here, the OSC/ISO notified Registrant of its right to file with DEA
a written request for hearing and that if it failed to file such a
request, it would be deemed to have waived its right to a hearing and
be in default. RFAAX 1, at 11 (citing 21 CFR 1301.43). Here, Registrant
did not request a hearing. RFAA, at 1.\2\ Thus, the Agency finds that
Registrant is in default and therefore has admitted to the factual
allegations in the OSC/ISO. 21 CFR 1301.43(e); 21 CFR 1301.43(c)(1).
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\2\ Based on the Government's submissions in its RFAA dated June
3, 2025, the Agency finds that service of the OSC/ISO on Registrant
was adequate. Specifically, the RFAA represents that the OSC/ISO was
personally served on Registrant, RFAA, at 1, and attaches a DEA Form
12 Receipt for Cash or Other Items signed by the Pharmacist in
Charge. RFAAX 2, at 1.
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III. Applicable Law
A. The Alleged Statutory and Regulatory Violations
As discussed above, the OSC/ISO alleges that Registrant violated
provisions of the CSA and its implementing regulations. As the Supreme
Court stated in Gonzales v. Raich, 545 U.S. 1 (2005), ``the main
objectives of the [Controlled Substances Act (CSA)] were to conquer
drug abuse and control the legitimate and illegitimate traffic in
controlled substances.'' 545 U.S. at 12. Gonzales explained that:
Congress was particularly concerned with the need to prevent the
diversion of drugs from legitimate to illicit channels. To
effectuate these goals, Congress devised a closed regulatory system
making it unlawful to manufacture, distribute, dispense, or possess
any controlled substance except in a manner authorized by the CSA .
. . . The CSA and its implementing regulations set forth strict
requirements regarding registration, labeling and packaging,
production quotas, drug security, and recordkeeping.
Id. at 12-14.
The OSC's allegations concern the CSA's ``statutory and regulatory
provisions . . . mandating . . . compliance with . . . prescription
requirements'' and, therefore, go to the heart of the CSA's ``closed
regulatory system'' specifically designed ``to conquer drug abuse and
to control the legitimate and illegitimate traffic in controlled
substances,'' and ``to prevent the diversion of drugs from legitimate
to illicit channels.'' Id. at 12-14, 27.
B. The Allegation That Registrant Improperly Dispensed Controlled
Substances
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.'').
As for state law, Florida Administrative Code Sec. 64B16-27.810
requires that, prior to dispensing, a pharmacist ``review the patient
record and each new and refill prescription . . . to promote
therapeutic appropriateness by identifying: (a) Over-utilization or
under-utilization; (b) Therapeutic duplication; (c) Drug-disease
contraindications; (d) Drug-drug interactions; (e) Incorrect drug
dosage or duration of drug treatment; (f) Drug-allergy interactions;
[and] (g) Clinical abuse/misuse.'' Fla. Admin. Code Sec. 64B16-27.810.
The regulation further states that ``[u]pon recognizing any of the
above, the pharmacist shall take appropriate steps to avoid or resolve
the potential problems which shall, if necessary, include consultation
with the prescriber.'' Id. Sec. 64B16-27.810(2).
Additionally, Florida Administrative Code Sec. 64B16-27.831 states
that ``in filling valid prescriptions for controlled substances,''
pharmacists should ``exercise[e] sound professional judgment,'' and
``dispens[e] controlled substances for a legitimate medical purpose in
the usual course of professional practice'' considering ``each
patient's unique situation.'' Fla. Admin. Code Sec. 64B16-27.831.
C. The Allegation That Registrant Permitted Unauthorized Use of Its
Digital Certificate for CSOS
Under the CSA's implementing regulations, a person must ``obtain a
CSOS digital certificate from the DEA Certification Authority to sign
electronic orders for controlled substances.'' 21 CFR 1311.10. A person
is eligible to obtain a CSOS digital certificate only if he/she: (1) is
the person who ``signed the most recent registration application or
renewal application,'' (2) is ``a person authorized to sign a
registration application,'' or (3) has been ``granted power of attorney
by [the] registrant to sign orders for one or more schedules of
controlled substances.'' Id. The regulations further provide that
``[o]nly the certificate holder may access or use his or her digital
certificate and private key,'' and ``[a] certificate holder must ensure
that no one else use the private key'' and ``prevent unauthorized use
of that private key.'' Id. Sec. 1311.30.
D. The Allegation That Registrant Maintained an Unregistered Drug
Collection Receptacle
The CSA's implementing regulations provide that ``retail pharmacies
that desire to be collectors shall modify their registration to obtain
authorization to be a collector in accordance with [21 CFR] Sec.
1301.51 of this chapter.'' 21 CFR 1317.40(a). The regulations further
provide that collection may only occur at the ``registered locations .
. . that are
[[Page 1820]]
authorized for collection'' and ``[l]ong-term care facilities at which
registered hospitals/clinics or retail pharmacies are authorized to
maintain collection receptacles.'' Id. 1317.40(b).
IV. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC/ISO are deemed admitted.
A. The Allegation That Registrant Improperly Dispensed Controlled
Substances
Registrant is deemed to have admitted and the Agency finds that
from March 2023 through December 2024 Registrant repeatedly filled
prescriptions for Schedule II through V controlled substances that
evidenced multiple red flags indicative of diversion and/or abuse,
without addressing, resolving, and/or documenting resolution of those
red flags prior to dispensing. RFAAX 1, at 1-3.
Long-Term Use of Immediate-Release Opioids and High Opioid Dosages
As discussed above, see supra Section I, Florida law requires
pharmacists to identify and address the red flag of over-utilization.
See Fla. Admin. Code Ann. r. 64B16-27.810. Registrant is deemed to have
admitted that DEA has found that extended use of immediate-release
opioids is a red flag of abuse or diversion because extended-release
opioids are generally more appropriate for treatment of chronic pain.
RFAAX 1, at 3 (citing Pharmacy 4 Less, 86 FR 54550 (2021)). Registrant
is deemed to have admitted that high dosages of opioids can be a red
flag because they can significantly increase the risk of overdose and
death. Id.
Registrant admits that it repeatedly filled prescriptions for
oxycodone, an immediate-release Schedule II opioid, to the following
individuals without addressing or resolving the red flag of extended
use of immediate-release opioids:
A.G.: Between April 16, 2024, and December 5, 2024, Registrant
filled approximately nine prescriptions for A.G. for oxycodone 30 mg
(90 tablets). Id. at 4.
T.M.: Between August 15, 2023, and November 27, 2024, Registrant
filled approximately 15 prescriptions for T.M. for oxycodone 30 mg (90
tablets). Id.
R.R.: Between April 8, 2024, and November 26, 2024, Registrant
failed approximately nine prescriptions for R.R. for oxycodone 30 mg
(90 tablets). Id.
C.P.: Between April 29, 2024, and November 21, 2024, Registrant
filled approximately eight prescriptions for C.P. for oxycodone 7.5 mg
(120 tablets). Id.
J.J.: Between August 21, 2023, and November 18, 2024, Registrant
filled approximately 14 prescriptions for J.J. for oxycodone 30 mg (90
tablets). Id. In addition, Registrant filled prescriptions for J.J. on
September 20, 2023, for oxycodone 30 mg (42 tablets), and on October 3,
2023, for oxycodone (48 tablets). Id.
A.R.: Between August 9, 2023, and June 12, 2024, Registrant filled
approximately 11 prescriptions for A.R. for oxycodone 20 mg (120
tablets). Id. On November 28, 2023, Registrant filled a prescription
for A.R. for oxycodone 30 mg (90 tablets). Id.
J.P.: Between July 31, 2023, and May 6, 2024, Registrant filled
approximately 10 prescriptions for J.P. for oxycodone 30 mg (90
tablets). Id.
C.R.: Between August 7, 2023, and April 5, 2024, Registrant filled
approximately nine prescriptions for C.R. for oxycodone 30 mg (90
tablets). Id.
M.Sw.: Between March 16, 2023, and February 5, 2024, Registrant
filled approximately 12 prescriptions for M.Sw. for oxycodone 30 mg (84
tablets). Id.
Accordingly, the Agency finds substantial record evidence that
Registrant filled at least 100 oxycodone prescriptions without first
resolving and documenting resolution of the red flag arising from
extended use of immediate-release opioids.
Drug Cocktails and Commonly Abused Drugs
As discussed above, see supra Section I, Florida law requires
pharmacists to identify and address the red flag of drug-drug
interactions and clinical abuse or misuse. RFAAX 1, at 5; Fla. Admin.
Code Ann. r. 64B16-27.810. Registrant admits that DEA has long
recognized the prescribing of so-called ``drug cocktails'' as a red
flag of abuse or diversion. RFAAX 1, at 5 (citing Jones Total Health
Care Pharmacy, LLC, 81 FR 79,188, 79,199 (2016)). Drug cocktails arc
combinations of controlled substances that are widely known to be
abused or diverted and that significantly increase the risk of serious
medical consequences. Id. These risks require pharmacists to carefully
review whether the prescriptions were issued for a legitimate medical
purpose. Id.
Common drug cocktails include the combination of an opioid and a
benzodiazepine, an opioid and a stimulant, or an opioid and a muscle
relaxant. Id. Registrant admits that DEA has long held that these
cocktails are highly abused and associated with diversion. Id. (citing
Craig Rosenblum, MD., 87 FR 21, 18 l, 21,189 (2022); Jacobo Dreszer,
MD., 76 FR 19,386, 19,389 (2011)).
Registrant admits that it repeatedly filled prescriptions for the
following individuals without addressing, resolving, or documenting the
resolution of the red flag of ``drug cocktails'':
A.G.: On at least eight occasions between April 16, 2024, and
December 5, 2024, Registrant filled prescriptions for A.G. for a drug
cocktail consisting of oxycodone and cyclobenzaprine (an unscheduled
muscle relaxer). Id. These prescriptions were filled on the same day or
in close succession. Id. Registrant admits that this combination of
controlled substances is a red flag associated with abuse, overdose,
and death. Id.
R.R.: On at least eight occasions between May 13, 2024, and
November 26, 2024, the Pharmacy filled prescriptions for R.R. for a
drug cocktail consisting of oxycodone and cyclobenzaprine. Id. These
prescriptions were filled on the same day or in close succession. Id.
C.R.: On at least eight occasions between September 7, 2023, and
April 5, 2024, Registrant filled prescriptions for C.R. for a drug
cocktail consisting of oxycodone and cyclobenzaprine. Id. These
prescriptions were filled on the same day or in close succession. Id.
A.R.: On at least 11 occasions between August 9, 2023, and June 12,
2024, Registrant filled prescriptions for A.R. for a drug cocktail
consisting of oxycodone and pregabalin (a Schedule V anticonvulsant).
Id. at 6. These prescriptions were filled on the same day or in close
succession. Id. Registrant admits that this combination of controlled
substances is a red flag associated with abuse, overdose, and death.
Id.
C.P.: On at least three occasions between August 27, 2024, and
December 6, 2024, Registrant filled prescriptions for C.P. for a drug
cocktail consisting of oxycodone and carisoprodol (a Schedule IV muscle
relaxer). Id. Although not filled on the same day, each prescription
was written for a 30-day supply and filled on a near-monthly schedule.
Id. Registrant admits that this combination of controlled substances is
a red flag associated with abuse, overdose, and death. Id.
Accordingly, the Agency finds that Registrant filled at least 38
prescriptions without first resolving and documenting resolution of the
red flag arising from drug cocktails.
[[Page 1821]]
Long Distances
Registrant admits that DEA has found that traveling abnormally long
distances to obtain or fill controlled substance prescriptions is a
well-known red flag of abuse or diversion because patients ordinarily
should be able to get their prescriptions filled without having to
travel abnormally long distances. Id. (citing E. Main St. Pharmacy, 75
FR 66,149, 66,164 (2010)).
Registrant admits that it repeatedly filled controlled substance
prescriptions for individuals whose addresses revealed they had
traveled abnormally long distances to obtain and fill prescriptions,
and Registrant admits that it consistently failed to resolve this red
flag prior to dispensing. Id. Specifically, Registrant admits that it
filled prescriptions for the following individuals, whose record
addresses show that they traveled long distances:
T.M. at Fort Lauderdale Address: On at least eight occasions
between August 15, 2023, and April 11, 2024, Registrant dispensed
oxycodone to T.M. Id. T.M. had an approximately 634-mile round trip
to obtain controlled substance prescriptions from his/her physician
and fill them at Registrant. Id. This trip included approximately
314 miles from T.M.'s address in Fort Lauderdale, Florida, to the
prescribing physician's office, approximately 41 miles from the
prescribing physician's office to Registrant, and approximately 279
miles from Registrant back to T.M.'s address. Id.
T.M. at Gainesville Address: On at least eight occasions between
May 10, 2024, and November 27, 2024, Registrant dispensed oxycodone
to T.M. Id. at 7. T.M. had an approximately 86-mile round trip to
obtain controlled substance prescriptions from his/her physician and
fill them at Registrant. Id. This trip included approximately 3
miles from T.M.'s address in Gainesville, Florida, to the
prescribing physician's office, approximately 41 miles from the
prescribing physician's office to Registrant, and approximately 42
miles from Registrant back to T.M.'s address. Id.
J.J.: On at least 17 occasions between August 21, 2023, and
November 18, 2024, Registrant dispensed oxycodone to J.J. Id. J.J.
had an approximately 88-mile round trip to obtain controlled
substance prescriptions from his/her physician and fill them at
Registrant. Id. This trip included approximately six miles from
J.J.'s address in Gainsville, Florida, to the prescribing
physician's office, approximately 41 miles from the prescribing
physician's office to Registrant, and approximately 41 miles from
Registrant back to J.J.'s address. Id.
M.Sw.: On at least 11 occasions between April 27, 2023, and
February 5, 2024, Registrant dispensed oxycodone to M.Sw. Id. M.Sw.
had an approximately 151-mile round trip to obtain controlled
substance prescriptions from his/her physician and fill them at
Registrant. Id. This trip included approximately nine miles from
M.Sw.'s address in Orlando, Florida, to the prescribing physician's
office, approximately 69 miles from the prescribing physician's
office to Registrant, and approximately 68 miles from Registrant
back to M.Sw.'s address. Id.
C.R.: On at least nine occasions between August 7, 2023, and
April 5, 2024, Registrant dispensed oxycodone to C.R. Id. at 8. C.R.
had an approximately 176-mile round trip to obtain controlled
substance prescriptions from his/her physician and fill them at
Registrant. Id. at 7. This trip included approximately 58 miles from
C.R.'s address in Green Cove Springs, Florida, to the prescribing
physician's office, approximately 41 miles from the prescribing
physician's office to Registrant, and approximately 77 miles from
Registrant back to C.R.'s address. Id.
A.R.: On at least seven occasions between November 2, 2023, and
June 12, 2024, the Pharmacy dispensed pregabalin to A.R., and on at
least seven occasions between these dates, Registrant dispensed
oxycodone to A.R. Id. at 8. A.R. had an approximately 82-mile round
trip to obtain controlled substance prescriptions from his/her
physician and fill them at Registrant. Id. This trip included
approximately 38 miles from A.R.'s address in Belleview, Florida, to
the prescribing physician's office, approximately 34 miles from the
prescribing physician's office to Registrant, and approximately 10
miles from Registrant back to A.R.'s address. Id.
Accordingly, the Agency finds substantial record evidence that
Registrant filled at least 67 prescriptions without resolving the red
flag that customers were traveling abnormally long distances to obtain
and fill controlled substance prescriptions.
Pattern Prescribing
Registrant admits that ``pattern prescribing''--which occurs when a
practitioner prescribes the same controlled substance in identical or
substantially similar quantities to multiple individuals--is a red flag
because it indicates a lack of individualized therapy for each patient
and it indicates that the ``prescriber is not prescribing the
controlled substances for a legitimate medical purpose.'' Id. (citing
Pharmacy Place, 86 FR 21,008, 21,011 (2021)). Registrant admits that
while ``pattern prescribing can manifest over an extended period of
time and may not be immediately recognizable to a pharmacist,'' a
pharmacist still has an obligation to resolve such controlled
substances prescriptions and should refuse to fill them if the
pharmacist is unable to resolve this red flag. Id. (citing Pharmacy
Place, 86 FR at 21,011; Med. Pharmacy, 86 FR 72,030, 72,049 (2021)).
Registrant admits that it filled approximately 64 prescriptions
issued by Dr. N.A. to six different individuals for 90 tablets of
oxycodone 30 mg between July 31, 2023, and December 5, 2024.\3\ Id. at
8-9. Registrant admits that Dr. N.A. was engaging in pattern
prescribing. Id. at 8. Accordingly, the Agency finds substantial record
evidence that Registrant filled approximately 64 prescriptions without
addressing, resolving, and documenting resolution of the red flag of
pattern prescribing.
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\3\ These prescriptions included approximately nine
prescriptions for A.G filled between April 16, 2024, and December 5,
2024; approximately 13 prescriptions for T.M. filled between
November 14, 2023, and November 27, 2024; approximately nine
prescriptions for R.R. filled between April 8, 2024, and November
26, 2024; approximately 14 prescriptions for J.J. filled between
October 20, 2023, and November 8, 2024; approximately 10
prescriptions for J.P. filled between July 31, 2023, and May 6,
2024; and approximately nine prescriptions for C.R. filled between
August 7, 2023, and April 5, 2024. RFAAX 1, at 8-9.
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Expert Review
DEA retained an independent pharmacy expert who concluded that the
above prescription data presented multiple red flags that were highly
indicative of abuse and diversion. Id. at 9. The expert further
concluded, and Registrant admits that, ``[t]hese red flags were not
resolved by a pharmacist acting in the usual course of professional
practice prior to dispensing, and therefore, each prescription was
filled outside the standard of care of pharmacy practice in Florida.''
Id.
Accordingly, the Agency finds substantial record evidence that
Registrant filled at least 269 prescriptions without first resolving
the red flags of long-term use of immediate-release opioids, drug
cocktails, long distances, and pattern prescribing, and that
Registrant's filling of these prescriptions was outside the usual
course of professional practice.
B. The Allegation That Registrant Permitted Unauthorized Use of Its
Digital Certificate for CSOS
Registrant admits and the Agency finds substantial evidence that
between May 15, 2023, and April 9, 2024, a non-certificate holder used
Registrant's digital certificate and private key to order controlled
substances in CSOS. Id. Registrant admits that the authorized holder
for the certificate was not present at the time these controlled
substances were ordered. Id.
C. The Allegation That Registrant Maintained an Unregistered Drug
Collection Receptacle
Registrant admits and the Agency finds substantial record evidence
that it maintained a collection bin for
[[Page 1822]]
pharmaceutical drugs without the authorization required under 21 CFR
1317.40(a).
V. Public Interest Determination
A. Legal Background on the Public Interest Determination
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. 243, 251 (2006) (quoting 21 U.S.C.
824(a)(4)). In the case of a ``practitioner,'' which is defined in 21
U.S.C. 802(21) to include a ``pharmacy,'' Congress directed the
Attorney General to consider five factors in making the public interest
determination. 21 U.S.C. 823(g)(1)(A-E).\4\
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\4\ The five factors of 21 U.S.C. 823(g)(1)(A-E) 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.
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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 for sanction is confined to Factors B and D. RFAA 2-4, RFAAX
1. 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).
i. The Allegation That Registrant Improperly Dispensed Controlled
Substances
Here, as found above, Registrant is deemed to have admitted and the
Agency finds that between March 2023 and December 2024, Registrant
repeatedly filled at least 269 prescriptions without addressing,
resolving, and documenting red flags of drug abuse and diversion. RFAAX
2, at 5-8. Registrant has further admitted and the Agency finds that
all of the above-referenced prescriptions were filled outside the usual
course of professional practice, beneath the standard of care in
Florida, and in violation of the pharmacy's corresponding
responsibility.\5\ Id. As such, the Agency finds substantial record
evidence that Registrant violated 21 CFR 1306.04 and Fla. Admin. Code
Ann. r. 64B16-27.810(1).
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\5\ Agency decisions have consistently found that prescriptions
with the same red flags at issue here were so suspicious as to
support a finding that the pharmacists who filled them violated
their corresponding responsibility rule due to actual knowledge of,
or willful blindness to, the prescriptions' illegitimacy. 21 CFR
1306.04(a); see, e.g., Morning Star Pharmacy and Medical Supply 1,
85 FR 51045, 51061 (2020) (pattern prescribing; distance; cash
payments; high doses/quantities of high-alert controlled
substances); Pharmacy Doctors Enterprises d/b/a Zion Clinic
Pharmacy, 83 FR 10876, 10898 (2018), pet. for rev. denied, 789 F.
App'x 724 (11th Cir. 2019) (long distances; pattern prescribing;
cash payments); Hills Pharmacy, 81 FR 49816, 49836-39 (2016)
(multiple customers presenting prescriptions written by the same
prescriber for the same drugs in the same quantities; customers with
the same last name and street address presenting similar
prescriptions on the same day; long distances); The Medicine Shoppe,
79 FR 59504, 59507, 59512-13 (2014) (unusually large quantity of a
controlled substance; pattern prescribing).
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ii. The Allegation That Registrant Permitted Unauthorized Use of Its
Digital Certificate for CSOS
Further, as found above, Registrant is deemed to have admitted and
the Agency finds that between May 15, 2023, and April 9, 2024, a non-
certificate holder used Registrant's digital certificate and private
key to order controlled substances in CSOS, while the authorized holder
of the certificate was not present. Id. Accordingly, the Agency finds
substantial record evidence that Registrant violated 21 CFR 1311.30(a),
(c). Id.
iii. The Allegation That Registrant Maintained an Unregistered Drug
Collection Receptacle
Here, as found above, Registrant is deemed to have admitted and the
Agency finds that Registrant maintained a collection bin for
pharmaceutical drugs without the authorization required under 21 CFR
1317.40(a). Accordingly, the Agency finds substantial record evidence
that Registrant violated 21 CFR 1317.40(a). RFAAX 1, at 9.
The Agency further finds that after considering the factors of 21
U.S.C. 823(g)(1) Registrant's continued registration is ``inconsistent
with the public interest.'' 21 U.S.C. 824(a)(4). Accordingly, the
Government satisfied its prima facie burden of showing that
Registrant's continued registration would be ``inconsistent with the
public interest.'' 21 U.S.C. 824(a)(4). The Agency also finds that
there is insufficient mitigating evidence to rebut the Government's
prima facie case. Thus, the only remaining issue is whether, in spite
of the public interest determination, Registrant can be trusted with a
registration.
[[Page 1823]]
VI. 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 it can be
entrusted with a registration. Morall, 412 F.3d. at 174; Jones Total
Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th
Cir. 2018); Garrett Howard Smith, M.D., 83 FR 18882, 18904 (2018). The
issue of trust is necessarily a fact-dependent determination based on
the circumstances presented by the individual registrant. Jeffrey
Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total Health
Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is the
best predictor of future performance, the Agency requires that a
registrant that has committed acts inconsistent with the public
interest accept responsibility for those acts and demonstrate that it
will not engage in future misconduct. See Jones Total Health Care
Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54
F.3d 450, 452 (7th Cir. 1995). The Agency requires a registrant's
unequivocal acceptance of responsibility. Janet S. Pettyjohn, D.O., 89
FR 82639, 82641 (2024); Mohammed Asgar, M.D., 83 FR 29569, 29573
(2018); see also Jones Total Health Care Pharmacy, 881 F.3d at 830-31.
In addition, a registrant's candor during the investigation and hearing
is an important factor in determining acceptance of responsibility and
the appropriate sanction. See Jones Total Health Care Pharmacy, 881
F.3d at 830-31; Hoxie, 419 F.3d at 483-84. Further, the Agency
considers the egregiousness and extent of the misconduct as significant
factors in determining the appropriate sanction. See Jones Total Health
Care Pharmacy, 881 F.3d at 834 & n.4. The Agency also considers the
need to deter similar acts by a registrant and by the community of
registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Here, Registrant did not request a hearing and was deemed to be in
default. 21 CFR 1301.43(c)(1), (e), (f)(1); RFAA, at 1-2. To date,
Registrant has not filed a motion with the Office of the Administrator
to excuse the default. 21 CFR 1301.43(c)(1). Registrant has thus failed
to answer the allegations contained in the OSC and has not otherwise
availed itself of the opportunity to refute the Government's case. As
such, Registrant has made no representations as to its future
compliance with the CSA nor made any demonstration that it can be
entrusted with registration. Moreover, the evidence presented by the
Government shows that Registrant filled hundreds of prescriptions
outside the usual course of professional practice in Florida and in
violation of the CSA, further indicating that Registrant cannot be
entrusted.
Accordingly, the Agency will order the revocation of Registrant's
registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate
of Registration No. FS1451222 issued to Pine Pharmacy. Further,
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 deny any pending applications
of Pine Pharmacy to renew or modify the named registrations, as well as
any other pending application of Pine Pharmacy for additional
registration in Florida. This Order is effective February 17, 2026.
Signing Authority
This document of the Drug Enforcement Administration was signed on
January 8, 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. 2026-00629 Filed 1-14-26; 8:45 am]
BILLING CODE 4410-09-P