Notice2022-19988
Rayford ACP; Decision and Order
Primary source
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Published
September 15, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 87 Issue 178 (Thursday, September 15, 2022)</title>
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[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56705-56708]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19988]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 21-25]
Rayford ACP; Decision and Order
On June 15, 2021, the Drug Enforcement Administration (hereinafter,
DEA or Government) issued an Order to Show Cause and Immediate
Suspension of Registration (hereinafter, collectively OSC) to Rayford
ACP \1\ (hereinafter, Respondent) of Rayford, Texas. OSC, at 1 (citing
21 U.S.C. 823(f) and 824(a)(4), (d)).
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\1\ Respondent holds a DEA Certificate of Registration No.
FL1670341 at the registered address of 440 Rayford Road, Suite 155,
Rayford, Texas 77386. OSC, at 1-2.
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A hearing was held before DEA Administrative Law Judge Teresa A.
Wallbaum (hereinafter, the ALJ). On January 25, 2022, the ALJ issued
her Recommended Rulings, Findings of Fact, Conclusions of Law, and
Decision (hereinafter, ``RD''), which recommended revocation of
Respondent's registration. RD, at 69. Respondent filed Exceptions to
the RD \2\ and the Government filed a response. Having reviewed the
entire record, the Agency adopts and hereby incorporates by reference
the entirety of the ALJ's rulings, findings of fact, conclusions of
law, and recommended sanction in the RD and summarizes and expands upon
portions thereof herein.
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\2\ The Agency has reviewed and considered Respondent's
Exceptions and finds them to be without merit as further addressed
herein.
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I. Findings of Fact
Pursuant to 21 U.S.C. 823(f), 824(a)(4), the Government seeks
revocation of Respondent's DEA registration because Respondent
allegedly committed acts rendering its continued registration
inconsistent with the public interest, including repeatedly filling
prescriptions for controlled substances for seventeen patients in the
face of unresolved red flags of abuse and diversion in violation of 21
CFR 1306.04(a) and 1306.06, and Tex. Health & Safety Code 481.074(a).
OSC, at 2, 7.
A. Summary of the Proceeding and Relevant Facts
The Government presented its case through records and testimony
from two witnesses, a DEA Diversion Investigator (hereinafter, DI), Tr.
33-63, and Dr. DiGi Graham, D.Ph., Tr. 64-573, 1494-1552, who testified
as an expert witness in retail pharmacy, hospice pharmacy care, and the
practice of pharmacy in the State of Texas. RD, at 15-18.
Respondent presented its case through testimony from four
witnesses; including two experts, Ms. Jenna Head, RPh., BCGP (qualified
as an expert in Texas pharmacy law, hospice pharmacy, and a pharmacy's
corresponding obligation), Tr. 585-1029, and William C. Yarborough,
III, Pharm.D, J.D. (qualified as an expert in Texas and federal law and
retail pharmacy), Tr. 1406-1430; Tronown Thomas, Respondent's owner and
Pharmacist-in-Chief (PIC), Tr. 1032-1402, 1485-1492; and Shawn Stevens,
RN, a fact witness regarding early refills, Tr. 1480-1485. RD, at 18-
25.\3\
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\3\ The Agency adopts the ALJ's summary of each of the
witnesses' testimonies and her assessment of the witnesses'
credibility. RD, at 15-25. The Agency agrees with the ALJ that Dr.
Graham's testimony was persuasive and consistent with Texas statutes
regarding the standard of care. Id. at 18. It further agrees that
Ms. Head and Mr. Thomas repeatedly relied on presumptions and their
testimony therefore offered limited value. Id. at 21, 24-25. Ms.
Head's testimony is illustrative: ``I know that the nurse and the
physician are already monitoring for opioid-induced neurotoxicity .
. . [be]cause I know that's hospice and what they have to do, then I
don't see that that is a red flag, and I don't see I need to call to
ask them if they're doing their job.'' Tr. 741. Respondent and its
experts espouse a position that the prescriptions at issue do not
raise red flags because the prescriber presumably had a legitimate
reason for issuing the prescriptions. This position is not supported
in the law or the record. See infra n.4.
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B. Corresponding Responsibility
The Agency credits Dr. Graham's testimony that both federal and
Texas law impose an independent, corresponding responsibility on
pharmacists to ensure that a prescription is issued for a legitimate
medical purpose and within the usual course of professional practice
before dispensing.\4\ RD, at 26-27; Tr. 97-98; Tex. Health & Safety
Code 481.074(a). Further, the Agency finds, based on Dr. Graham's
credible expert testimony and Texas law, that the independent
corresponding responsibility requires a pharmacist to resolve red flags
and document their resolution. RD, at 27; Tr. 98-100, 128, 317; see 22
Tex. Admin. Code Sec. 291.29(f). Specifically, the Agency finds, as
Dr. Graham credibly testified, a pharmacist fulfilling his or her
corresponding responsibility and acting within the usual course of
professional practice in Texas must review controlled substance
prescriptions for red flags, such as cocktail prescriptions,\5\
clinically significant therapeutic duplication,<SUP>6 7</SUP>
[[Page 56706]]
early refills,\8\ and distance; \9\ and resolve those red flags prior
to dispensing and document their resolution. RD, at 30; Tr. 100, 183-
84, 340-41, 343, 400-01, 407-08, 1499-1502, 1523-24; see also Tr. 141-
397. According to Dr. Graham, documentation of the resolution of red
flags does not need to be complex. RD, at 27; Tr. 99, 163-64, 335, 356,
403-04. Respondent produced no documentation of its resolution of the
relevant red flags for the subject prescriptions. See RD, at 62.
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\4\ The Agency agrees with the RD that the record evidence
supports a finding that ``there is only one standard, applicable to
both retail and hospice patients, . . . [as] described by Dr.
Graham.'' RD, at 30. Ms. Head testified that there were key
distinctions between a hospice and a non-hospice pharmacy, see Resp
Exceptions, at 2-5, and that due to these distinctions, most, if not
all, of the red flags at issue in this case were never triggered
because the prescriptions were stamped ``hospice patient'' or
``terminally ill.'' RD, at 20-21, 32; Tr. 684, 689, 888, 969, 991.
Respondent's position directly conflicts with Texas law and the
notion that a pharmacist has a corresponding responsibility that is
separate and independent of the prescriber in 21 CFR 1306.04. See
infra n.11 and Discussion. Further, the importance of this
corresponding responsibility to ensure the legitimacy of
prescriptions is exemplified in Patient J.T., who had multiple
prescriptions that presented red flags and were incorrectly stamped
``terminally ill.'' RD, at 33-34. Respondent's position in this case
undermines the CSA's purpose of preventing diversion and abuse of
controlled substances. Therefore, I reject Respondent's argument
because it conflicts with a core principle of the CSA--the
establishment of a closed regulatory system devised to ``prevent the
diversion of drugs from legitimate to illicit channels.'' Gonzales
v. Raich, 545 U.S. 1, 13-14, 27 (2005); see Jennifer St. Croix,
M.D., 86 FR 19,010, 19,024 (2021). Additionally, Respondent notably
does not point to any regulation or law exempting pharmacies
dispensing to hospice patients from the requirements to resolve red
flags, which are specifically set forth in the relevant Texas law.
Dr. Graham credibly testified that, although the objective red flags
listed in the law apply regardless of the situation, the red flags
are often more easily resolved for hospice patients. Tr. 119-21,
175-76, 239-40, 249, 1519-20, 1527-28; RD, at 29. Respondent,
however, did not maintain documentation of its resolution of red
flags and continued to argue that the prescriptions did not present
any red flags at all. The law and the record evidence do not support
Respondent's arguments.
\5\ As further explained herein, 22 Tex. Admin. Code Sec.
291.29(f)(3) defines one relevant red flag factor as ``controlled
substances commonly known to be abused drugs, including opioids,
benzodiazepines, muscle relaxants . . . or any combination of these
drugs,'' and the Agency credits Dr. Graham's testimony in accordance
with this law that a pharmacist acting within the usual course of
professional practice and exercising his or her corresponding
responsibility must resolve and document this red flag without
exception. Compare ALJX 30, at 3 (Respondent arguing that certain
symptoms (pain, shortness of breath, and anxiety) are ``universal
symptoms of the end-of-life process'' such that ``a reasonable
hospice pharmacist following the standard of care would not consider
the combination of an opioid and a benzodiazepine an automatic red
flag''), with Tr. 109, 111-12, 136-37, 400-01, 1494-95, 1499-1503,
1523-24 (Dr. Graham opining that cocktail prescribing in hospice is
still a red flag because hospice patients are often dehydrated and
at a greater risk of dangerous accumulation of drugs in their
systems). See also RD, at 28; Tex. Admin. Code Sec. 291.29(f)(3).
Texas law does not exempt hospice pharmacies from this requirement.
\6\ Dr. Graham testified that therapeutic duplication is defined
as medications in the same category that ``work on the same receptor
site that alleviates the same symptoms.'' RD, at 28; Tr. 112-14; see
also Tr. 255-56, 330-31, 337-38, 1516. The Agency rejects
Respondent's Exceptions regarding therapeutic duplication. Resp
Exceptions, at 12-21. Dr. Graham testified that anything that could
harm the patient was clinically significant and explicitly testified
to the potential harm that could be caused by the duplications
presented in the subject prescriptions. Tr. 570; RD, at 61; see,
e.g., Tr. 116, 173, 205 (Dr. Graham's testimony addressing the harms
of therapeutic duplication). Dr. Graham's testimony was focused on
the pharmacological impact that the cited duplicative therapies
would have on the body, rather than the intended use of the
medication. Tr. 111-16. The Agency finds limited value in Ms. Head's
speculative opinions that certain liquid morphine prescriptions were
being used to treat breathing problems. See, e.g., Tr. 684-87.
Furthermore, Texas law specifically states that clinically
significant duplicative therapies present a red flag, and further
requires that red flags be resolved and documented. 22 Tex. Admin.
Code Sec. 291.33(c)(2)(A); see Discussion infra. There is no
evidence that Respondent identified and resolved the red flags of
clinically significant therapeutic duplication and documented their
resolution as required by Texas law. Tr. at 99, 163, 335, 356, 403-
04. Therefore, because the evidence does not establish that
Respondent resolved the red flag in any manner, both Dr. Graham's
testimony, Tr. 115, 331, and Ms. Head's testimony about how this red
flag could theoretically be resolved is largely irrelevant.
\7\ Mr. Thomas testified that Respondent used software that
would alert the pharmacist when a prescription was potentially
duplicative and the pharmacist would have to exercise his or her
judgment in dismissing the alert. Tr. 1073-74. Respondent argues,
without support, that the dismissal of this alert demonstrates that
there was no red flag. Resp Exceptions, at 12-13. Contrary to
Respondent's argument, the system appears to be alerting the
pharmacist to a red flag. As already established, a pharmacist
exercising his or her corresponding responsibility must resolve red
flags and is required to document such resolution under Texas law.
There is no such evidence of documentation in this case.
\8\ Respondent presented testimony that early refills were
permissible for hospice agencies at a much lower threshold than the
threshold identified by Dr. Graham. Compare Tr. 120, 439-40, 1519-
20, 1527, with Tr. 651-54, 1070-71, 1225; see also RD, at 29. Dr.
Graham credibly testified that Respondent's low threshold would not
fulfill the goal of identifying suspicious patterns. Tr. 1520; see
also RD, at 29; Tr. 240, 243. Respondent further argued that a
particular hospice agency set a lower refill threshold through
policy, Resp. Exceptions, at 22, and Dr. Graham rationally and
credibly testified that if that were the case, the early refill red
flag could easily be resolved with a notation documenting that
hospice agency's refill policy. RD, at 29; Tr. 1528. The Agency
agrees with the RD that Dr. Graham's testimony on the issue was more
compelling and more credible and has given it controlling weight.
See RD, at 29-30. Early refills of a prescription must be identified
and resolved under 22 Texas Admin. Code Sec. 291.33(c)(2)(A)(i)(X);
see infra Discussion. Respondent failed to document the resolution
of this red flag.
\9\ Texas law states that ``[r]easons to suspect that a
prescription may have been authorized in the absence of a valid
patient-practitioner relationship or in violation of the
practitioner's standard of practice include: . . . the geographical
distance between the practitioner and the patient or between the
pharmacy and the patient.'' See 22 Tex. Admin. Code Sec.
291.29(c)(4); RD, at 29-30; see also Tr. 122-23; 380-385 (Dr.
Graham's testimony that travelling long distances to a pharmacy
triggers the pharmacist's responsibility). The Agency rejects
Respondent's arguments and Exceptions that are contrary to the plain
language of Texas law, including Respondent's argument that the
dispensing to Patient J.T. was proper because the prescriber's
office was only 3.9 miles from Respondent. RD, at 37; Tr. 1423-27.
The Agency also rejects Respondent's argument that Rayford's
contract with Patient J.G.'s hospice agency, resolved any long
distance concerns, because Respondent did not produce the contract
on the record or otherwise demonstrate documentation of the
resolution of the red flag. See Resp Exceptions, at 23-24 (citing
Tr. 1350). Dr. Graham testified that a hospice agency's policy can
resolve the distance concern if documented, Tr. 381, 383-84, 387,
405-06; RD, at 30, but there is no evidence that Respondent resolved
the distance concern prior to dispensing and documented that
resolution in this case. See, e.g., George Pursley, M.D., 85 FR
80,162, (2020) (``Post hoc written or oral justifications . . . are
not controlling.'') Tr. 381, 383-84, 387, 405-06.
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C. The Subject Prescriptions
The Agency agrees with and incorporates the findings of the RD and,
based on the evidence in the record, finds that Respondent's dispensing
of each of the subject controlled substance prescriptions to each of
the relevant patients was outside of the usual course of professional
practice of pharmacy in Texas and in violation of Respondent's
corresponding responsibility. Respondent dispensed controlled
substances on numerous occasions without documenting the resolution of
the following red flags: cocktail prescribing for patients J.C., C.G.,
D.M., M.I., M.W., D.H., I.G., M.M., B.H., T.T., and M.J.; therapeutic
duplication for patients D.M., M.I., M.W., D.H., I.G., J.L., M.G.,
B.H., T.T., M.J., K.B., and L.F.; early refills for patients D.M., and
J.L.; and long distances for Patient J.G. and J.T. RD, at 34-54. For
example, the Government established that Respondent dispensed at least
thirty-nine prescriptions to Patient D.M. without documenting the
resolution of multiple red flags, including combination prescribing,
therapeutic duplication, and/or early refills. Id., at 38-41. Regarding
retail patients, J.C. and C.G., Respondent conceded that it ``did not
appropriately exercise its corresponding responsibility,'' because it
dispensed controlled substances without documenting the resolution of
red flags for combination prescribing. Tr. 1087, 1091; RD, at 15. The
Government also established that Respondent dispensed at least nineteen
prescriptions for controlled substances to another retail patient,
Patient J.T., who lived approximately sixty miles from Respondent
without documenting the resolution of the traveling a long distance red
flag. RD, at 37-38; Tr. 390-92.\10\
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\10\ Respondent objected to the ALJ's characterization of Dr.
Yarborough's testimony regarding the distance red flag. (Tr. 1426-
27). Resp Exceptions, at 25 (citing RD, at 37). Texas law is clear
that long distances travelled to a practitioner or a pharmacy
indicates a potential invalid patient-practitioner relationship,
therefore, the Agency fully credits Dr. Graham's testimony regarding
the existence of the red flag and the requirement to resolve it and
finds it unnecessary to address Respondent's Exception regarding the
wording of the RD. See supra n. 9. RD, at 37-38; Resp Exceptions, at
25.
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In accordance with Dr. Graham's credible expert testimony, the
ALJ's analysis, and the records as a whole, the Agency finds that in
dispensing the subject controlled substance prescriptions without
documenting the resolution of the applicable red flag(s), Respondent's
pharmacists did not fulfill their corresponding responsibility and
Respondent did not dispense the subject prescriptions in the usual
course of professional practice and within the applicable standard of
care.
II. Discussion
Section 304(a) of the Controlled Substances Act (hereinafter, CSA)
provides that ``[a] registration . . . to . . . dispense a controlled
substance . . . may be suspended or revoked by the Attorney General
upon a finding that the registrant . . . has committed such acts as
would render [its] registration under section 823 of this title
inconsistent with the public interest as determined under such
section.'' 21 U.S.C. 824(a). In the case of a practitioner, which
includes a pharmacy, the CSA requires the Agency consider the following
factors in determining whether Respondent's registration would be
inconsistent with the public interest:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(3) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
The DEA considers these public interest factors in the disjunctive.
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Each factor is
weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d
165, 173-74 (D.C. Cir. 2005). Any one factor, or combination of
factors, may be decisive. David H. Gillis, M.D., 58 FR 37,507, 37,508
(1993).
The Government has the burden of proving that the requirements for
revocation of a DEA registration in 21 U.S.C. 824(a) are satisfied. 21
CFR 1301.44(e). When the Government has
[[Page 56707]]
met its prima facie case, the burden then shifts to the Respondent to
show that revoking its registration would not be appropriate, given the
totality of the facts and circumstances on the record. Med. Shoppe-
Jonesborough, 73 FR 364, 387 (2008). Having reviewed the record and the
RD, the Agency agrees with the ALJ, adopts her analysis, and finds that
the Government has proven by substantial evidence that Respondent
committed acts which render its continued registration inconsistent
with the public interest. RD, at 54-64.
While the Agency has considered all of the public interest factors,
the Government's case invoking the public interest factors of 21 U.S.C.
823(f) seeks revocation of Respondent's registration based solely under
Public Interest Factors Two and Four. See RD, at 55, n.53 (finding that
factors 1, 3, and 5 do not weigh for or against revocation).
A. Factors Two and Four
Factors 2 and 4 are often analyzed together. See, e.g., Fred
Samimi, M.D., 79 FR 18,698, 18,709 (2014). Under Factor 2, the DEA
analyzes a registrant's ``experience in dispensing . . . controlled
substances.'' 21 U.S.C. 823(f)(2). Factor 2 analysis focuses on a
registrant's acts that are inconsistent with the public interest,
rather than on a registrant's neutral or positive acts and experience.
Randall L. Wolff, M.D., 77 FR 5106, 5121 n.25 (2012) (explaining that
``every registrant can undoubtedly point to an extensive body of
legitimate prescribing over the course of [the registrant's]
professional career''). Similarly, under Factor 4, the DEA analyzes a
registrant's compliance with federal and state controlled substance
laws. 21 U.S.C. 823(f)(4). Factor 4 analysis focuses on violations of
state and federal laws and regulations. Volkman v. DEA, 567 F.3d 215,
223-24 (6th Cir. 2009).
As the Agency found above, as supported by credible, expert
testimony, both federal and Texas law impose an independent,
corresponding responsibility on pharmacists to ensure that a
prescription is issued for a legitimate medical purpose and within the
usual course of professional practice. Texas Health & Safety Code Sec.
481.074(a); 21 CFR 1306.04; RD, at 26-27, 57; Tr. 97-98. ``The language
in 21 CFR 1306.04 and caselaw could not be more explicit. A pharmacist
has his own responsibility to ensure that controlled substances are not
dispensed for non-medical reasons.'' Ralph J. Bertolino, d/b/a Ralph J.
Bertolino Pharmacy, 55 FR 4729, 4730 (1990). Further, the record
testimony and state law demonstrate that a pharmacist who exercises his
or her corresponding responsibility in filling a controlled substance
prescription is required to resolve red flags and document the
resolution.\11\ RD, at 27; Tr. 98-100, 128, 317; see 22 Tex. Admin.
Code 291.29(f).
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\11\ The Agency agrees with the RD that Texas law and ``the
record evidence [do] not support an assumption that hospice care is
so highly-regulated and so closely-monitored that it alters a
pharmacy's independent, corresponding responsibility to dispense
only lawful prescriptions . . . .'' RD, at 34 (citing 21 CFR
1306.04(a) and The Pharmacy Place, 86 FR 21,008, 21,013 (2021)).
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To prove a pharmacist violated his or her 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 also 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.''
Bertolino, 55 FR at 4730 (citations omitted). Thus, 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.; Medicine Shoppe-Jonesborough, 300 F. App'x 409, 412
(6th Cir. 2008).
Specifically, the Agency has found based on credible expert
testimony and Texas law that a Texas pharmacy exercising its
corresponding responsibility and acting within the standard of care
must review for cocktail prescriptions, therapeutic duplication, early
refills, and distance; must resolve these red flags prior to
dispensing; and must document their resolution. RD, at 30; Tr. 100,
183-84, 340-41, 343, 400-01, 407-08, 1499-1502, 1523-24; see also Tr.
141-397.
In this matter, the Government did not allege that Respondent
dispensed the subject prescriptions having actual knowledge that the
prescriptions lacked a legitimate medical purpose. Instead, the
Government alleged that Respondent violated the corresponding
responsibility regulation for each of the patients at issue in this
matter by ``repeatedly dispens[ing] controlled substances without
addressing or resolving clear red flags.'' Gov Prehearing, at 16; see
also Gov Posthearing, at 2. 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 the Agency's 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, 85 FR 51,045,
51,061 (2020) (relevant red flags include distance, drug cocktails, and
therapeutic duplication); Gulf Med Pharmacy, 86 FR 72,694, 72,728
(2021) (relevant red flags include distance, drug cocktails, and
therapeutic duplication); Pharmacy 4 Less, 86 FR 54,550, 54,573-76
(2021) (relevant red flags include distance); East Main Street
Pharmacy, 75 FR 66,149, 66,163-65 (2010) (relevant red flags included
long distances; lack of individualized therapy or dosing; drug
cocktails; and early fills/refills).
Moreover, Texas law explicitly states that ``the geographical
distance between the practitioner and the patient or between the
pharmacy and the patient'' is a reason to suspect that a prescription
may have been authorized in violation of the practitioner's standard of
practice. 22 Tex. Admin. Code Sec. 291.29(c)(4); see also Morning Star
Pharmacy, 85 FR at 51,051 (applying 22 Tex. Admin. Code Sec.
291.29(c)(4)); RD, at 61. It further states that early refills must be
identified, resolved, and that resolution documented prior to
dispensing under 22 Texas Admin. Code Sec. 291.33(c)(2)(A)(i)(X),
which requires a pharmacist to review for ``proper utilization,
including overutilization or underutilization,'' Id.; see also Tr. 566
(Dr. Graham testifying that overutilization review includes early
refills); RD, at 61. When red flags are identified, a pharmacist must
resolve and document the resolution of any red flag or consultation. 22
Texas Admin. Code Sec. 291.33(c)(2)(A)(ii) (``[u]pon identifying any
clinically significant conditions [or] situations . . . the pharmacist
shall take appropriate steps to avoid or resolve the problem including
consultation with the prescribing practitioner''); id. Sec.
291.33(c)(2)(C) (a pharmacist has an obligation to document any
consultation); RD, at 61. Therefore, Respondent's failure to document
the resolution of a red flag violated Texas law. Id. at Sec. Sec.
291.33(c)(2)(A)(ii), 291.33(c)(2)(C).
The Agency agrees with the RD that Respondent dispensed controlled
substances on numerous occasions without documenting a resolution of
red flags for cocktail prescribing, therapeutic duplication, early
refills,
[[Page 56708]]
and long distances. RD, at 62-64; supra, at Findings of Fact C. For
many of these patients, the prescriptions filled contained multiple
unresolved red flags at once. See, e.g., RD 38-40 (Patient D.M. on
January 23, 2019, Respondent dispensed two short-acting opioids along
with a benzodiazepine, which raised red flags for both therapeutic
duplication and cocktail prescribing, and on March 20, 2020, Respondent
dispensed hydrocodone six days early along with alprazolam, which
raised red flags for both early refills and cocktail prescribing).
Accordingly, the Agency agrees with the RD that the Government has
established by substantial evidence that Respondent filled numerous
prescriptions to seventeen patients outside the usual course of
professional practice and without fulfilling its corresponding
responsibility in violation of 21 CFR 1306.04(a) and 1306.06. Further,
the Government established by substantial evidence that Respondent
acted in violation of Texas law as set forth in 22 Texas Admin. Code
Sec. Sec. 291.29 and 291.33 and Texas Health & Safety Code Sec.
481.074(a). See RD, at 64. The Government has made a prima facie case
that the Respondent has committed acts that render its registration
inconsistent with the public interest, and its misconduct supports the
revocation of its registration. RD, at 64.
III. Sanction
Where, as here, the Government has established grounds to revoke
Respondent's registration, the burden shifts to the respondent to show
why it can be entrusted with the responsibility carried by a
registration. Garret Howard Smith, M.D., 83 FR 18,882, 18,910 (2018).
When a registrant has committed acts inconsistent with the public
interest, it must both accept responsibility and demonstrate that it
has undertaken corrective measures. Holiday CVS LLC dba CVS Pharmacy
Nos 219 and 5195, 77 FR 62,316, 62,339 (2012) (internal quotations
omitted). Trust is necessarily a fact-dependent determination based on
individual circumstances; therefore, the Agency looks at factors such
as the acceptance of responsibility, the credibility of that acceptance
as it relates to the probability of repeat violations or behavior, the
nature of the misconduct that forms the basis for sanction, and the
Agency's interest in deterring similar acts. See, e.g., Robert Wayne
Locklear, M.D., 86 FR 33,738, 33,746 (2021).
Here, Respondent has failed to unequivocally accept responsibility.
Respondent did admit that it violated its corresponding responsibility
with respect to retail patients J.C. and C.G., Tr. 1087, 1091, but then
proceeded to deny that retail patient J.T.'s prescriptions presented a
red flag based on distance in spite of clear Texas law to the contrary.
RD, at 66 (internal citations omitted). Respondent also consistently
denied that the controlled substance prescriptions for its hospice
patients presented any red flags. Tr. 1377-78; ALJ Ex. 30, at 2-5; see
also, e.g., Tr. 1093-94, 1097, 1120-21, 1124-28, 1130, 1132-34, 1140,
1142-46, 1148-50, 1204-23, 1273-76, 1279-80, 1290, 1293; RD, at 66. For
example, PIC Thomas denied that Patient D.M.'s prescriptions presented
red flags, despite his own expert testifying to the contrary. Compare
Tr. 1105-06 (PIC Thomas), with Tr. 725-29, 731-32 (Ms. Head). A
registrant's acceptance of responsibility for misconduct is not
adequate when the registrant does not understand what the law requires.
See Zion Clinic Pharmacy, 83 FR 10,876, 10,903 (2018).\12\
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\12\ When a registrant fails to make the threshold showing of
acceptance of responsibility, the Agency need not address the
registrant's remedial measures. Ahuja, 84 FR at 5498 n.33; Daniel A.
Glick, D.D.S., 80 FR 74,800, 74,801, 74,810 (2015); see also Jones
Total Health Care Pharmacy, LLC, SND Healthcare, LLC, 881 F.3d 823,
833 (11th Cir. 2018) (upholding DEA's refusal to consider pharmacy's
remedial measures given lack of acceptance). The Agency agrees with
the ALJ that even if the Agency were to consider Respondent's
remedial measures, they would not affect the ultimate decision in
this matter. RD, at 67. Here, Respondent has made no showing of
remedial measures as to the hospice patients, because it denies any
error that requires remediation. Id. As to the retail patients,
Respondent's PIC testified that he does in-house training, including
``ten-minute huddles'' on a daily basis to emphasize the need for
documentation. Tr. 1379-80; RD, at 67. He also testified that the
pharmacy has a new software system that allows pharmacists to scan
and attach documents to the electronic patient file. Tr. 1074, 1253;
RD, at 67. The Agency does not find such measures to be adequate in
addressing the nature of the violations found here. See RD, at 67.
---------------------------------------------------------------------------
Furthermore, Respondent's misconduct was far from a one-time
occurrence. Respondent filled multiple prescriptions for Schedule II
controlled substances presenting numerous red flags. See Noah David,
P.A., 87 FR 21,165, 21,174 (2022); see also Garrett Howard Smith, M.D.,
83 FR 18,882, 18,910 (2018) (collecting cases) (``The egregiousness and
extent of the misconduct are significant factors in determining the
appropriate sanction.'')
In sanction determinations, the Agency has historically considered
its interest in deterring similar acts, both with respect to the
respondent in a particular case and the community of registrants. See
Joseph Gaudio, M.D., 74 FR 10,083, 10,095 (2009); Singh, 81 FR at 8248.
The Agency finds that considerations of both specific and general
deterrence weigh in favor of revocation in this case. A sanction less
than revocation would send a message to the current and prospective
registrant community that compliance with core controlled-substance
legal principles is not a condition precedent to receiving and
maintaining a DEA registration. Further, there is simply no evidence
that Respondent's behavior is not likely to recur in the future such
that the Agency can entrust it with a CSA registration; in other words,
the factors weigh in favor of revocation as a sanction. Accordingly,
the Agency shall order the sanctions the Government requested, as
contained in the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration
FL1670341 issued to Rayford ACP. Further, pursuant to 28 CFR 0.100(b)
and the authority vested in me by 21 U.S.C. 823(f), I further hereby
deny any pending applications for renewal or modification of this
registration, as well as any other pending application of Rayford ACP
for registration in Texas. This order is effective October 17, 2022.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 8, 2022, by Administrator Anne Milgram. 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. 2022-19988 Filed 9-14-22; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on September 15, 2022.
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.