[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56705-56708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19988]



[[Page 56705]]

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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,6 7

[[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.
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    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