Trinity Pharmacy II; Decision and Order

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 15-28]

Trinity Pharmacy II; Decision and Order

On July 10, 2015, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Trinity Pharmacy II, Inc. (hereinafter “Trinity II” or Respondent), which proposed the revocation of its DEA Certificate of Registration FT0531586, pursuant to which Trinity II is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered location of 1474 South Belcher Road, Clearwater, Florida. Administrative Law Judge Exhibit (ALJ Ex.) 1b, at 1. As grounds for the proposed action, the Show Cause Order alleged that Respondent's “continued registration is inconsistent with the public interest.”

Id.

(citing 21 U.S.C. 823(f) and 824(a)(4)).

More specifically, the Show Cause Order set forth seven independent reasons why Respondent's registration should be revoked.

Id.

at 2-17.

First,

the Show Cause Order charged that, between February 2012 and February 2014, Trinity II “committed acts as would render its continued registration inconsistent with the public interest” pursuant to 21 U.S.C. 824(a)(4) because Respondent (1) “failed to comply with applicable federal and Florida state laws relating to controlled substances” (citing 21 U.S.C. 823(f)(4)) and (2) “exhibited negative experience in its dispensing of controlled substances” (citing 21 U.S.C. 823(f)(2)).

Id.

at 1, 2. During this period, the Order alleged that pharmacists at Trinity II “filled [prescriptions for] and dispensed controlled substances on numerous occasions outside the usual course of pharmacy practice and in contravention of their corresponding responsibility,” and that such pharmacists did so even when such prescriptions “contained one or more `red flags' [f]or drug abuse or diversion without resolving the red flag(s) and, in certain circumstances, w[h]ere the red flags were unresolvable.”

Id.

at 2-3 (citing

Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195,

77 FR 62316, 62321-22 (2012)).

The Show Cause Order listed six red flags of diversion which Respondent's pharmacists allegedly failed to resolve before dispensing prescriptions, including: (1) “[e]arly [f]ills,” in which nine customers sought “to fill a new controlled substance prescription or refill an existing controlled substance prescription well before the customer should have exhausted the supply . . . obtained from the previous prescription;” (2) unusual distance traveled, in which six customers “present[ed] a prescription bearing an address for the customer and doctor showing that the customer had travelled an unusual or suspicious route to obtain their prescriptions and fill them at Trinity II;” (3) “[c]ocktail prescriptions,” in which eight customers “present[ed] multiple prescriptions that provided the individual with the cocktail of an opioid, a benzodiazepine, and a muscle relaxer;” (4) “[d]uplicative drug therapies,” whereby eight customers “present[ed] multiple prescriptions which provided the person duplicative drug treatment;” (5) “[t]wo prescriptions for the same drug,” in which 10 “customers present[ed] two prescriptions for the same drug on the same date;” and (6) “pattern prescribing,” or a lack of individualized drug therapy, in which two sets of “two individuals present[ed] prescriptions on the same day for the same drugs that were issued by the same prescriber.”

Id.

at 3-14.

Second,

the Show Cause Order charged Trinity II with violating federal law when it dispensed “a Schedule II controlled substance outside the usual course of professional practice . . . and in contravention of its corresponding responsibility . . . [when it] filled a prescription for customer D.G.” on November 8, 2013 for “7 patches of Duragesic 50 mcg/hr (fentanyl).”

Id.

at 14 (citing 21 CFR 1306.04(a), 1306.06). The Order alleged that Trinity II filled this prescription even though D.G. had 12 days left on a prescription issued by a different doctor and filled by Trinity II on October 21, 2013 for a “thirty-day supply” of fentanyl patches that should have lasted D.G. until November 20, 2013.

Id.

The Order further alleged that when Trinity II filled the second prescription for D.G. 12 days early, Trinity II “ignored the bright red flags that D.G. was abusing and/or diverting the fentanyl by doctor-shopping and seeking an early fill of fentanyl.”

Id.

Third

and

fourth,

the Show Cause Order charged that Trinity II violated federal law when it twice dispensed to D.G. “a Schedule II controlled substance without a valid prescription,” “outside the usual course of professional practice,” “and in contravention of its corresponding responsibility.”

Id.

at 14, 15 (citing 21 U.S.C. 829; 21 CFR 1306.04(a), 1306.06, 1306.11(a)). In the third charge, the Order alleged that D.G. presented Trinity II with a prescription dated November 15, 2013 “for 15 patches of Duragesic 50 mcg/hr (fentanyl), a Schedule II controlled substance,” that also contained the following instruction from the prescribing practitioner: “NO EXCEPTIONS DO NOT FILL UNTIL 12-06-2013.”

Id.

at 14. The Order alleged that Trinity II nevertheless filled the prescription on November 20, 2013.

Id.

In the fourth charge, the Order alleged that D.G. presented Trinity II with a prescription in December 2013, also “for 15 patches of Duragesic 50 mcg/hr (fentanyl), a Schedule II controlled substance,” that also contained the following instruction from the prescribing practitioner: “NO EXCEPTIONS DO NOT FILL UNTIL 1-05-2014.”

Id.

at 15. The Order alleged that Trinity II nevertheless filled the prescription on December 18, 2013.

Id.

As a result, and with respect to each of these charges, the Order alleged that Trinity II “filled and dispensed this controlled substance to D.G. approximately two weeks before the prescriber had authorized it to do so, and, thus, before the prescription was valid for filling.”

Id.

at 15.

Fifth,

the Show Cause Order charged that, on eight occasions between July 12, 2012 and January 25, 2013, Trinity II violated federal law when it dispensed to J.T. “a Schedule II controlled substance without a valid prescription” and “outside the usual course of professional practice.”

Id.

(citing 21 U.S.C. 829; 21 CFR 1306.06, 1306.11(a)). Specifically, the Order alleged that Trinity II dispensed to J.T. “a morphine sulfate solution” “that was five times more potent than the doctor had prescribed, and instructed J.T. to take a dosage amount that would result in him receiving five times the amount” prescribed.

Id.

The Order further alleged that such prescriptions “placed the health and safety of J.T. at risk and, thus, engaged in conduct that may have threatened the public health and safety” pursuant to 21 U.S.C. 823(f)(5).

Id.

at 16.

Sixth,

the Show Cause Order charged that “Trinity II unlawfully distributed controlled substances in violation of federal and Florida state law by utilizing non-pharmacists to fill controlled substances prescriptions on numerous occasions between February, 2012 and February, 2014.”

Id.

The Order alleged that when Trinity II allowed its non-pharmacist “pharmacy interns” to fill a prescription, it was not filled by a pharmacist “acting in the usual course of his professional practice,” pursuant to 21 CFR 1306.06, nor were Trinity II's pharmacists properly exercising their “corresponding responsibility” under 21 CFR 1306.04(a).

Id.

The Order further

alleged that such prescriptions violated Florida law's requirement that “[a] pharmacist, in good faith and in the course of professional practice only, may dispense controlled substances.”

Id.

(citing Fla. Stat., Ch. 893.04(1)).

Seventh,

and lastly, the Show Cause Order charged that, “if Trinity II's pharmacists in fact filled the prescriptions referenced in [the sixth charge], then Trinity II violated federal and Florida state law on numerous occasions between February 2012 and February 2014 by failing to maintain accurate records of the controlled substances it dispensed because they do not identify a pharmacist who filled the controlled substance prescription.”

Id.

at 16-17 (citing 21 CFR 1304.22(c), 1306.06; Fla. Stat., Ch. 893.04(1)(c)(6)).

In a letter from its counsel dated August 12, 2015, Trinity II acknowledged receipt of the Show Cause Order and requested a hearing on the allegations. ALJ Ex. 2b. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ), who proceeded to conduct pre-hearing proceedings as follows.

1

1

Respondent raised no objection to the adequacy of service.

On August 13, 2015, the CALJ issued an Order for Prehearing Statements (hereinafter, Prehearing Order).

See

ALJ Ex. 3b. In the Prehearing Order, the CALJ directed the Government to file its Prehearing Statement no later than 2 p.m. on August 24, 2015, Respondent to file its Prehearing Statement no later than 2 p.m. on September 8, 2015, and scheduled a Prehearing Conference for 1:30 p.m. on September 9, 2015.

Id.

at 1-2. The Order also directed the parties to provide the “[n]ames and current addresses of all witnesses whose testimony is to be presented,” and that if the Respondent's corporate representative intends to testify, the representative “must be listed as a witness, and a summary of his/her testimony as described below must be provided.”

Id.

at 2. The CALJ's Order provided the following instruction regarding the summaries of testimony:

Brief summary of the testimony of each witness (counsel for the Government to indicate clearly each and every act, omission or occurrence upon which it relies in seeking to revoke the Respondent's [Certificate of Registration]; counsel for Respondent to indicate clearly each and every matter as to which Respondent intends to introduce evidence in opposition). The summaries are to state what the testimony will be rather than merely listing the areas to be covered. The parties are reminded that testimony not disclosed in the prehearing statements or pursuant to subsequent rulings is likely to be excluded at the hearing.

Id.

The Order further emphasized that “[f]ailure to timely file a prehearing statement

that complies with the directions provided above

may be considered a waiver of hearing and an implied withdrawal of a request for hearing.”

Id.

at 3.

On August 21, 2015, the Government filed its Prehearing Statement. ALJ Ex. 4b. On August 24, 2015, the CALJ issued an “Order Rescheduling Prehearing Conference” moving the prehearing conference up to 10:30 a.m. on September 3, 2015 in light of Respondent's counsel's August 20, 2015 notice of a conflict with the scheduled hearing on October 26, 2015. ALJ Ex. 8b at 1.

2

Although this Order stated that “[a]ll other dates specified in the [Prehearing Order], including the filing date for the Respondent's Prehearing Statement, remain in effect,”

id.

at 1 n.1, the CALJ (through his staff) later requested that Respondent file its Prehearing Statement early. ALJ Ex. 10 at 1 n.1 (“Upon my realization that the status conference was now scheduled several days prior to the date that the Respondents' prehearing statements were due under the terms of the [Prehearing Order], chambers staff (at my direction) reached out to Respondents' counsel and requested (but not directed) that, if it was possible to do so, their prehearing statements be filed prior to the commencement of the now-rescheduled Status Conference . . . with the assurance that (as is customary) both sides would be permitted to file supplemental prehearing statements”).

2

According to the CALJ, “[t]he hearing commencement date [was] continued on multiple occasions at the Respondents' request.” ALJ Ex. 34, at 1 n.1. The hearing was ultimately noticed to begin on January 4, 2016. ALJ Ex. 27.

Per the CALJ's request, Trinity II filed its “Preliminary Prehearing Statement” on September 3, 2015. ALJ Ex. 9b. Trinity II proposed to call 77 witnesses in addition to “[a]ny and all witnesses identified in the Government's Prehearing Statement.”

Id.

at 3-7. Trinity II then provided a “Summary of Anticipated Testimony” for nine of these witnesses, all of whom were the owners or employees of Trinity II.

Id.

at 7-14. Trinity II stated that it anticipated calling an expert witness but had not yet identified one “given the preliminary nature of this statement.”

Id.

at 14. Trinity II offered an identical one-sentence summary of the testimony for each of 39 “patients,” and a separate identical one-sentence summary of the testimony for each of 32 “prescribing physicians.”

Id.

at 14-15. Trinity II also proposed as documents for the hearing copies of “all prescriptions, patient profiles and related documents maintained by Trinity Pharmacy II in connection with each patient described in the [Show Cause Order].”

Id.

at 16.

On September 3, 2015, the CALJ conducted an on-the-record prehearing conference. During that conference, the CALJ noted the Government's motion to consolidate the hearings for Trinity II and Trinity Pharmacy I

3

(hereinafter, collectively, Respondents) and asked Respondents' counsel to file something confirming that Trinity I and Trinity II waive any potential conflict in having him represent them both at a consolidated hearing. Transcript (“Tr.”) 5; ALJ Ex. 10 n.4 (same).

4

The CALJ also noted during the proceedings that the Government was seeking an “Order of Protection” to limit disclosure of personally identifiable information of patients and confirmed that Respondent had no objection to such an order. Tr. 55-56. Lastly, the CALJ accepted Respondents' counsel's representation that neither Trinity I nor Trinity II were the subject of pending state administrative cases or “criminal parallel proceedings.”

Id.

at 63.

3

Trinity Pharmacy (“Trinity I”), located in Seminole, Florida, was served with a separate July 10, 2015 Order to Show Cause by the Government. ALJ Ex. 1a. Although the CALJ eventually ordered the consolidation of the evidentiary hearings for Trinity I and Trinity II,

see

ALJ Ex. 10 at 2, the CALJ wrote separate recommendations regarding each Respondent, and I therefore have written a separate Order regarding the disposition of the Show Cause Order directed at Trinity I.

4

On November 13, 2017, Mr. Michael Stanton filed a “Notice of Appearance on Behalf of Respondents” in which he entered “an appearance as co-counsel for Respondents, Trinity Pharmacy I and Trinity Pharmacy II, along with Dale Sisco of Sisco Law.” ALJ Ex. 35b, at 2. Although both counsel maintained that they represented both Respondents, at the evidentiary hearing, Mr. Sisco stated that “[f]or the purposes of this hearing, I will be representing Trinity I and questioning witnesses on behalf of that pharmacy,” and Mr. Stanton stated that “for purposes of this hearing and to avoid any duplication, I will be handling the objections and the questioning on behalf of Trinity II.” Tr. 83-84.

On September 4, 2015, the CALJ issued a “Consolidation Order, Prehearing Ruling, and Protective Order” (hereinafter “Consolidation Order”). ALJ Ex. 10 at 2. In this Order, the CALJ granted the Government's request for the aforementioned protective order and the Government's motion to consolidate the hearings, and the CALJ directed all parties to file a consolidated exhibit and witness list by October 16, 2015.

Id.

at 2, 9-11. The Order noted that the parties would be able to cross-examine the others' witnesses and stated that the “parties are also reminded that testimony not

summarized in prehearing statements, or supplements thereto, may be excluded at the hearing.”

Id.

at 4. The Order also directed the parties to serve each other with all documents it intends to identify as exhibits no later than September 11, 2015, and directed Respondents to supply the identity and curriculum vitae of their proposed expert witness by September 18, 2015.

Id.

at 4, 8. The Order further directed the parties to file supplemental prehearing statements and any additional exhibits, as well as any motions seeking relief, by 2 p.m. on October 16, 2015, and any responsive filings by 2 p.m. on October 23, 2015.

Id.

at 8. Finally, the Order reminded the parties that “documents not noticed in prehearing statements, or supplements thereto, or not timely supplied to the opposing party may (and likely will) be excluded at the hearing.”

Id.

at 4.

Although the Prehearing Order had directed Trinity II to supply a compliant prehearing statement by September 8, 2015, ALJ Ex. 3b at 1, and the Order Rescheduling Prehearing Conference iterated that Trinity II's prehearing statement filing deadline remained the same, ALJ Ex. 8b at 1 n.1, Trinity II failed to do so. On September 24, 2015, the Government filed a Motion to Compel Respondents' Compliance with the Prehearing Order and the Consolidation Order and a Motion Requesting a New Supplemental Prehearing Statement and Motion Deadline. ALJ Exs. 11a, 11b.

On September 28, 2015, Respondents filed their response. ALJ Ex. 13. On the same day, the CALJ issued an Order that generally denied the Government's motions and stated that honoring the CALJ's request for an earlier prehearing statement may have caused Respondents to have had the:

mistaken impression that compliant prehearing statements were no longer required until the filing of supplemental prehearing statements. To alleviate any remaining misunderstanding in this regard and to afford the Respondents the time and ability to file both a fulsome prehearing statement and a supplemental prehearing statement, it is ORDERED that Respondents are to file prehearing statements that comply with the terms of the [Prehearing Statement] no later than 2 p.m. on October 5, 2015.

ALJ Ex. 14, at 3-4.

On October 5, 2015, Trinity II filed its Prehearing Statement. ALJ Ex. 15b. Trinity II provided the names and address of 79 proposed witnesses, in addition to “[a]ny and all witnesses identified in the Government's Prehearing Statement.”

Id.

at 4-7. Trinity II also provided a “Summary of Anticipated Testimony” for nine witnesses who were either owners or employees of Trinity II, a putative expert, and short but similar descriptions of testimony for 39 patients and 32 prescribing physicians.

Id.

at 7-54.

5

The Prehearing Statement also identified 70 documents “intended to be used at the consolidated hearing regarding both Trinity Pharmacy I and Trinity Pharmacy II.”

Id.

at 55-57, 55 n.2. On October 15, 2015, Respondents filed a “Consolidated Witness and Exhibit List” that listed 133 witnesses, in addition to “[a]ny and all witnesses identified in the Government's Prehearing Statement,” 69 exhibits of “[d]ocuments and information related to” various individuals, and one exhibit that would be the CV of their putative expert. ALJ Ex. 15e.

5

For example, for patient S.B., Trinity II stated that it anticipated her testimony to be as follows:

[S.B.] was a patient whose prescriptions are identified in the various categories of allegations contained in the July 10, 2015 Order to Show Cause issued to Trinity Pharmacy II. It is anticipated that [S.B.] will testify regarding the inquiry done by the pharmacists and the staff at Trinity II regarding verification of her prescriptions and for the resolution of any potential red flags. [S.B.] will further confirm the information obtained from her by Trinity Pharmacy II prior to any prescription being dispensed, including but not limited to explanations for any significant distances traveled, the type of payment they made for the prescriptions, the circumstances of any refills and physician authorization for same.

ALJ Ex. 15b, at 29. The proposed testimony of most of the other patients used similar language.

See id.

at 27-43. Likewise, the physician summaries used language similar or identical to the following example:

[J.M.], M.D. was a prescribing physician for one or more of the patients who tendered prescriptions to Trinity Pharmacy II. [J.M.], M.D. will confirm the prescriptions he authorized were for a legitimate medical purpose and issued in the usual course of professional practice to patients that were known to him. Further, [J.M.], M.D. will describe his interaction with the pharmacists and staff at Trinity Pharmacy II, the authorization of refills or early fills, if any, and explanations for any duplicative drug therapy, combinations of medications or alleged “drug cocktails.”

Id.

at 45.

On October 16, 2015, the Government filed its “Consolidated Supplemental Prehearing Statement.” ALJ Ex. 16a. In this filing, the Government proposed two new witnesses, provided a summary of their testimony, and provided additional summaries for the testimony of the fact and expert witness identified in the Government's original Prehearing Statement.

Id.

at 6-10. Lastly, the Government supplemented its list of proposed Government exhibits with a list of additional documents that it intended to introduce as exhibits at the hearing.

Id.

at 10-12. The Government also filed its consolidated witness list and exhibit list. ALJ Exs. 16b, 16c.

Trinity II did not file a supplemental prehearing statement or any other prehearing statement by October 16, 2015 as required by the CALJ's Consolidation Order. As a result, the Government filed a “Motion in Limine to Exclude Certain Testimony.” ALJ Ex. 28. In its Motion, the Government contended that Respondents had failed in their prehearing statements to follow the requirements set forth in the CALJ's prehearing orders; namely, to “state what the testimony will be rather than merely listing areas to be covered” for each proposed witness.”

Id.

at 2 (internal citations omitted). For example, the Government noted that Respondents proposed 69 witnesses identified as patients and that “nearly every single patient of the sixty-nine listed by the Respondents is expected to testify identically.”

Id.

at 4. The Government contended that, not only did the proposed patient “testimony fail to make clear exactly what `information' each patient will `confirm,' thus preventing the Government from determining what specific defense(s) Respondents allege; the [proposed] testimony also fails to provide any basis upon which the Government can evaluate [whether] such information is even relevant or material to this case.”

Id.

at 4-5. Such proposed testimony, the Government argued, “is nothing more than `merely areas to be covered,' rather than any substantive recitation of `what the testimony will be,' ” as the prehearing orders required, “offering no facts that, if proven, would rebut the Government's

prima facie

case or offer credible evidence in mitigation.

Id.

Finally, the Government argued that “it is unclear from the Respondents' Prehearing Statements how the purported testimony of these various patients related to each of the dispensing events charged in the [Show Cause Orders], and how it affected the pharmacist's compliance with the standard of care and exercise of his corresponding responsibility in each charged instance.”

Id.

With respect to the prescribing physicians that Respondents had proposed as witnesses, the Government noted that Respondents “intend to call fifty-nine doctors as witnesses, who, again, will each testify identically. . . . Other than to blithely forecast that the physicians will approve their own prescriptions, Respondent provides no facts which, if proven, would rebut the Government's

prima facie

case.”

Id.

at 6. This too, the Government contended, violated the requirement of the prehearing orders that the parties set forth “what the testimony will be”

rather than “areas to be covered.”

Id.

The Government argued that the summary of the physicians' proposed testimony failed to disclose sufficient facts to allow the Government to determine what specific defenses Respondents allege, nor provide any basis upon which the Government can evaluate how such information is relevant to the charges in the Show Cause Order.

Id.

at 6-7.

In its Motion, the Government also challenged the adequacy of Respondents' disclosure of the proposed testimony of its owners and employees, contending that it too set forth “a generalized statement of `areas to be covered' ” rather than “a summary of `what the testimony will be' for each witness.”

Id.

at 9. These generalized statements, the Government contended, failed “to reveal the specific `actions' each employee purportedly is going to `describe' ” or “to provide the Government (or the ALJ) any information upon which it can discern the relevance and materiality of the `actions' to the issues to be litigated in this case.”

Id.

Although Respondents stated in their prehearing statements that certain employees would testify to describe the “process” Trinity II used “to verify prescriptions and resolve concerns, if any, regarding the validity of those prescriptions,” the Government argued that the statements “fail[ed] to provide any information about the `process' ” employed to verify prescriptions and resolve concerns.

Id.

at 9-10. Similarly, the Government observed that Respondents' offer of testimony from employees who would provide “a description and demonstration of the computer software used by the pharmacy in this process” was not matched by a proposed “exhibit containing each pharmacy's computer software that each witness purportedly would demonstrate for the court.”

Id.

And while Respondents proposed its co-owners would testify about their knowledge of both their customers' medical conditions and the treating physicians efforts to “resolve[ ] any concerns,” the Government further alleged that Respondents failed to disclose “each customer's medical condition . . . , how it related to each dispensing activity, or how and when each pharmacy purportedly became `aware' of it.”

Id.

at 11.

In its Motion, the Government also sought to preclude Respondents' proposed expert, Mr. Sam Badawi, from rendering an opinion concerning whether the prescriptions referenced in the Show Cause Orders “were filled in compliance with federal and/or state law requirements.”

Id.

at 14. Specifically, the Government alleged that Respondents failed to give the Government “notice [of] a proposed opinion from Mr. Badawi as to the lawfulness of each prescription alleged in each” Show Cause Order.

Id.

at 17 (“Respondents have had multiple opportunities to provide a compliant disclosure, yet have repeatedly failed to do so.”).

As a result of these alleged deficiencies, the Government requested that the CALJ exclude “the non-conforming testimony” set forth in its Motion because Respondents had only provided “vague summaries of areas to be covered by the Respondent's witnesses” that unduly prejudiced the Government.

Id.

at 18-19 (“Agency precedent favors exclusion of evidence when the names of witnesses and `an adequate summary of their testimony' has `not been previously disclosed as required by the ALJ's Order for Pre-Hearing Statements.' ”) (citing

East Main Street Pharmacy,

75 FR 66149, 66150 (2010)).

On November 5, 2015, the CALJ issued an “Order Granting the Government's Unopposed Motion

in Limine

to Exclude Certain Testimony.” ALJ Ex. 29. After noting the Government's timely filed Motion and that Respondents' deadline to file a responsive pleading was October 23, 2015, the CALJ noted:

Respondents never filed a response. Not even a late or unpersuasive response. Nothing. The language of the [Prehearing Order] about the nature of the required notice proffers is clear and unambiguous; yet, notwithstanding multiple opportunities to do so, the Respondents have elected not to comply. The [Prehearing Statement] plainly states that “testimony not disclosed in the prehearing statements or pursuant to subsequent rulings is likely to be excluded at the hearing.”

ALJ Ex. 29, at 2. Although the CALJ posited that Respondents' repeated failure to comply with his orders could constitute a waiver of a hearing request, the CALJ also noted that the Government “does not seek (as it could have) the draconian remedy of hearing waiver, but asks for the lesser sanction of preemptive exclusion of a limited subset of the noticed evidence,” and the CALJ deemed the Motion unopposed and granted it.

Id.

at 3-4. Specifically, the CALJ's Order precluded Respondents from offering the following:

1. “testimony from sixty-nine patients identified as proposed witnesses;”

2. “testimony from fifty-nine physicians identified as proposed witnesses;”

3. “testimony from proposed witness Nina Ghobrial;”

4. “evidence regarding the actions of DEA personnel and the cooperation of pharmacy staff during the Administrative Inspection of both pharmacies;”

5. “evidence regarding the process the pharmacies used to verify prescriptions and resolve concerns, including a description and demonstration of the computer software utilized;”

6. “evidence regarding the medical condition of patients who received early refills;”

7. “evidence of the pharmacy's knowledge of cocktail prescription and duplicative drug therapy patients, their medical condition, and their treating physicians;”

8. “evidence regarding circumstances surrounding an early fill for patient T.B.;”

9. “evidence regarding circumstances surrounding an early fill for patient C.F.;”

10. “evidence regarding information that Trinity I allegedly possessed relating to an early fill for patient J.K.;”

11. “evidence regarding circumstances surrounding an early fill for patient G.S.;”

12. “evidence regarding distances traveled by patients who either commuted, lived, or worked close to both pharmacies;” and

13. “evidence from the Respondents' proposed expert, Sam Badawi, regarding the lawful or unlawful nature of the numerous prescriptions referenced in each of the [Show Cause Orders].”

Id.

at 3-4 (citing ALJ Ex. 28 at 4-18).

Over a month later, on December 7, 2015, Respondents filed their “Motion for Reconsideration on Behalf of Respondents” in which they “request[ed] an order reconsidering [the CALJ's] order granting the Government's motion

in limine,

and allowing Respondents to provide [the CALJ] with the necessary evidence needed for [the] final determination.” ALJ Ex. 32, at 1. Respondents stated that “due process requires that Respondents be entitled to present testimony from its witnesses, which were properly disclosed.”

Id.

at 3. Respondents also stated that they “recognize that the physician and patient disclosures lack particularity” because “Respondents cannot exercise sufficient control over these witnesses without first having them under subpoena to provide more detail.”

Id.

at 3 n.1. Respondents added that “[n]either the Government nor the Respondents should fear the Court learning the full truth . . . even if there may not be a way for any party to control that message before the hearing.”

Id.

Respondents also contended that “those same deficiencies . . . do not apply” to their employee, expert, and owner witness disclosures.

Id.

Indeed, Respondents argued that “it is disingenuous for the Government to alleged [sic] that the [expert witness] disclosure fails to provide adequate notice to allow it to prepare for a cross-examination when its prehearing statements provide a comparable

opportunity for notice to Respondents.”

Id

at 4-5. Respondents contend that their “representatives and pharmacist” witness disclosures were “similarly robust and detailed,” and that their “remaining pharmacy employees['] [witness] disclosures are brief.”

Id.

at 5. Finally, Respondents claim that “an intermediate remedial order requiring supplementation or a limit to the testimony would have been more appropriate than granting the motion

in limine

in its entirety.”

Id.

The Government filed its “Opposition to Respondents' Motion for Reconsideration” on December 10, 2015. ALJ Ex. 33. In its Opposition, the Government argued that, as a threshold matter, “Respondents have not even provided a basis—not to mention a plausible one that would demonstrate good cause—upon which to reconsider the decision.”

Id.

at 4 (Respondents gave no “explanation or justification for their failure to file a timely response on October 23, 2015.”).

Id.

“Respondents['] Reconsideration Motion is a request for the ALJ to reconsider his decision on a Motion that they did not see fit to oppose in the first place, and have not seen/did not see fit [ ] to oppose for the past month.”

Id.

In response to Respondents' concession that their patient and physician witness disclosures lacked particularity because they lacked subpoena authority, the Government contended that “Respondents are unable to explain why they needed a subpoena to talk to their own customers and the physicians about prescriptions Respondents contend were lawfully issued. Nor do Respondents indicate that they attempted to contact these individuals and were rebuffed.”

Id.

And finally, with respect to Respondents' Due Process argument, the Government noted that, “despite hav[ing] been given multiple opportunities to correct their mistakes and provide the Government the requisite notice it was due,” Respondents were attempting “to shift the blame” by “now claiming that the ALJ is denying them a fair hearing.”

Id.

at 4-5.

On December 10, 2015, the CALJ issued his “Order Denying the Respondents' Motion for Reconsideration.” ALJ Ex. 34. In this Order, the CALJ noted that Respondents “filed neither a response to the Government's motion [in

Limine

] nor a motion for an extension of time to do so. Indeed, the Respondents filed nothing.”

Id.

at 1. The CALJ also observed that he waited an additional 13 “days after the responsive filing deadline” before issuing his Order granting the Government's Motion

in Limine,

“perhaps hoping in vain for even a late response.”

Id.

Indeed, the CALJ emphasized that Respondents did not file their Motion for Reconsideration until “over forty-five days from the date their motion response was due and less than a month prior to the . . . commencement of the hearing.”

Id.

(Respondents “do[ ] not even mention the fact that no response was filed, as if it never happened”). The CALJ noted that Respondents asked for another order to give Respondents additional opportunities to cure any alleged deficiencies in their disclosures “[u]nder th[e] theory[ ] this new, additional order would somehow carry more force and would result in compliance where the other orders had failed. Enough.”

Id.

at 2. The CALJ found that Respondents “have tendered no explanation for their failure to answer the Government's motion and no basis upon which to base good cause for reconsideration, even if such relief was warranted—which it is not.”

Id.

Accordingly, the CALJ denied Respondents' reconsideration motion.

Id.

at 3.

6

6

On December 11, 2015, the CALJ granted Respondents' requests for subpoenas for their pharmacy employees and denied Respondents' requests vis-à-vis their proposed practitioner witnesses pursuant to the Order granting the Government's Motion

in Limine.

ALJ Ex. 36.

The CALJ conducted an evidentiary hearing on January 4-8, 2016, in Arlington, Virginia, and on January 11-12, 2016, in Tampa, Florida.

See

Recommended Decision (R.D.), at 2. At the hearing, both parties elicited testimony from multiple witnesses, and the Government submitted various exhibits. Following the hearing, on February 26, 2016, both parties filed briefs containing their proposed findings of fact, conclusions of law, and argument. ALJ Exs. 40a, 41. On February 29, 2016, the CALJ issued an “Order Regarding the Exhibit (and Appended Attachments) Included with the Government's Closing Brief” noting that the Government's proposed findings of fact and conclusions of law had attached a declaration from the Government's lead attorney as well as six attachments thereto and asking Respondents if they intended “to take a position on the Agency's consideration of factual matters set forth” in the declaration and attachments. ALJ Ex. 40b, at 1. Respondents filed joint objections to the declaration and attachments. ALJ Ex. 40c. On March 4, 2016, the CALJ issued an Order sustaining Respondents' objections, ruling that the declaration and attachments are “EXCLUDED from the record, and will not be considered as evidence in these matters” and “will not be considered by this tribunal in its recommended decision.” ALJ Ex. 40d, at 1 & n.3.

On May 12, 2016, the CALJ issued and served his Recommended Decision. Specifically, the CALJ found that the Government had “supplied sufficient evidence to make out a

prima facie

case that maintaining the Respondent's [DEA Registration] would be contrary to the requirements of 21 U.S.C. 823 and 824” based on the third, fourth, and fifth charges set forth in the Show Cause Order. R.D. at 51. The CALJ further held that the testimony of the Government's expert was “insufficiently reliable to establish a breach of the Respondent pharmacy's corresponding responsibility regarding the dispensing of controlled substances” pursuant to 21 CFR 1306.04 as set forth in the first two charges of the Order.

Id.

at 43.

7

Although the CALJ acknowledged that his decision not “to rely on the Government's expert witness dramatically pared down the number of noticed transgressions that could be and were established by a preponderance” of the evidence, the CALJ concluded that “the evidence demonstrates a culture in the Respondent pharmacy of ignoring regulations deemed inconvenient . . . this pharmacy is dangerous, and the owners have given not even the smallest indication to the Agency that there is any inclination to change.”

Id.

at 53-54. The CALJ also concluded that the Respondent “fail[ed] to accept responsibility.”

Id.

at 54. Thus, the CALJ recommended that I revoke Respondent's registration and deny any pending applications for renewal.

Id.

On June 2, 2016, the Government and Respondents each filed Exceptions to the CALJ's Recommended Decision. Thereafter, the record was forwarded to me for final agency action.

7

The CALJ also found that the Government failed to sustain the sixth and seventh charges of the Show Cause Order related to prescriptions filled by pharmacy interns. R.D. at 43-46.

Having considered the record in its entirety, including the parties' Exceptions (which I discuss throughout this decision), I do agree with the CALJ's conclusions that the Government sustained the Order's third, fourth and fifth charges. I also agree with the CALJ's conclusions that the Government failed to sustain the Order's second, sixth and seventh charges. And I further agree with his legal conclusion that Trinity II has failed to accept responsibility for the misconduct which has been proven on the record of the proceeding. However, I disagree with the CALJ's conclusion that the

Government did not prove the first charge of the Show Cause Order alleging that Trinity II violated its corresponding responsibility pursuant to 21 CFR 1306.04(a).

8

Accordingly, I agree with the ALJ's ultimate conclusion that Trinity II has committed acts which render its continued registration inconsistent with the public interest and will adopt his recommendation that I revoke Trinity II's registration and deny any pending applications. As the ultimate fact finder, I make the following findings of fact.

8

Although I do not rely on the Government expert's testimony in making my ruling, as set forth

infra,

I also disagree with the CALJ's conclusion that the Government's expert was not reliable.

Findings of Fact

Trinity II is the holder of DEA Certificate of Registration FT0531586, pursuant to which it is authorized to dispense controlled substances in schedules II through V, as a retail pharmacy, at the registered location of 1474 Belcher Rd., Clearwater, Florida. Government Exhibit (“GX”) 34; Tr. 120, 685-86. Respondent's registration was due to expire on November 16, 2016, R.D. at 3; however, having reviewed the Agency's registration records, I take official notice that on October 3, 2016, Trinity II submitted a renewal application.

9

Because Trinity II has timely submitted a renewal application, I find that Trinity II's registration has remained in effect pending the issuance of this Decision and Final Order.

See

5 U.S.C. 558(c). No evidence was put forward as to Trinity II's current licensure status with the Florida Department of Health.

9

In accordance with the Administrative Procedure Act (APA), an agency “may take official notice of facts at any stage in a proceeding—even in the final decision.” U.S. Dept. of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979).

The Investigation of Trinity II

On February 10, 2014, DEA Investigators (“DI” or “DIs”) conducted inspections of Trinity II. Tr. 119-20, 684-86, 709. The Government called three DIs as witnesses in its case-in-chief.

See id.

The lead investigator testified that when the DIs arrived at Trinity II for the inspection, they asked to speak to Trinity II's pharmacist-in-charge (“PIC”) or owner and were greeted by Mr. Mark Abdelmaseeh, who identified himself as Trinity II's PIC.

Id.

at 124-26. The DIs presented Trinity II's PIC with a Notice of Inspection, and the PIC consented to the inspection after reviewing the Notice.

Id.

at 126. The lead investigator also testified that the DIs obtained, by consent from Trinity II, photocopies of the driver's licenses of the employees present when the investigators arrived and the original prescriptions for the two-year period of February 2012 to February 2014.

Id.

at 127-32, 135-36.

10

Another DI separately testified that his role during the inspection included identifying employees at the pharmacy and obtaining copies of their drivers' licenses.

Id.

at 686-88, 694. He also spoke with some of Trinity II's employees to obtain their job descriptions.

Id.

at 688-89.

10

The lead investigator also testified that during the inspection of Trinity II, DIs reviewed DEA-222 order forms and the CSOS electronic ordering system. Tr. 134. He testified that CSOS, which stands for Controlled Substance Ordering System, provides an electronic version of the DEA-222 order form.

Id.

at 134-35.

The lead investigator also testified that during the inspection at Trinity II, some employees represented to him that the pharmacy only dispensed controlled substances to patients with Florida addresses, that the pharmacist inspected each prescription for alteration or forgery, and that each physician's status was confirmed through the Florida Department of Health website.

Id.

at 577-78, 595-97. He also testified that someone at Trinity II claimed that its computer software “automatically confirmed the prescriber's DEA registration.”

Id.

at 578, 595-97. He further testified that the owners of the pharmacy, Mina and Emad Yousef, told him that they would call the doctor's office—a practice followed at Trinity I and Trinity II; however, the DI also testified that he did not recall either of them telling him that the owners called a doctor's office for every controlled substance prescription and exactly what they would discuss with the doctor.

Id.

at 126, 133, 579, 595-97, 666-67. He testified that the majority of prescriptions contained no evidence that anyone at Trinity II had called a doctor's office, and that neither the patient profiles nor the dispensing reports that he reviewed reflected such contacts.

Id.

at 666-68. He also testified that Yousef told him during the inspection that the pharmacist would check the patient profile for medication history.

Id.

at 597.

The lead investigator testified that he reviewed the original prescriptions and “looked for the red flags of diversion that we had been trained on,” such as distances, drug cocktails, drug interactions, and short fills.

Id.

at 147. He also reviewed them to make sure that the prescriptions included all of the required information such as the doctor's signature, patient name, patient address, and drug strength.

Id.

He then identified any prescriptions that were of interest and copied such prescriptions for review by the expert.

Id.

at 147-48, 538. He testified that the investigators did not make a forensic image of Trinity II's computer system.

Id

at 137.

In addition to the prescriptions obtained by DEA during the inspection of Trinity II, the DIs obtained dispensing reports

11

in May 2014 pursuant to a DEA administrative subpoena issued to Trinity II by facsimile.

Id.

at 156-57, 543 (“global dispensing report”), 544-45. The May 9, 2014 subpoena specifically asked for Trinity II to provide, for the time period of February 10, 2012 through February 10, 2014, “[d]ispensing records of controlled substances in schedules II-V to include: Prescription number; patient's full name, date of birth, and address; drug name, strength, dosage form, quantity prescribed, and directions for use; prescriber's full name, address, and DEA number; method of payment; whether it is a new prescription or refill; and the pharmacist who filled [the] prescription.” GX 95, at 4; Tr. 157-58, 201-02, 608. On May 21, 2014, counsel for Respondents Trinity I and Trinity II, Mr. Dale Sisco, emailed to the lead investigator Trinity II's response to the administrative subpoena, which included a Microsoft Excel spreadsheet of Trinity II's dispensing report (hereinafter, “global dispensing report”) as an attachment to that email. GX 96; Tr. 158, 172-73, 175, 627, 643.

12

The DI testified that after receiving this global dispensing report, he created individual dispensing reports for individual patients to see the dispensing history for certain patients, and then he matched the original prescriptions with the dispensing report. Tr. 180-81, 219, 227.

13

He also noted that the global dispensing report included a “Filled By” column which either contained the initials “EFY,” “MAG,” or “MIA.”

Id.

at 271-72, 338, 344, 345.

11

Because witnesses and counsel used the phrases “dispensing report” and “dispensing log” interchangeably throughout the hearing, I also use those phrases interchangeably in this decision.

12

Government Exhibit 84 is a printed copy of the global dispensing report entered into evidence. Tr. 177-79.

13

The lead investigator also testified that when he created the individual dispensing reports, using the global dispensing report, he did not alter any of the information in the global dispensing report, and that the individual dispensing reports are true and accurate representations of the information contained in the global dispensing report.

Id.

at 241, 247-48, 253, 256, 259, 264, 268, 278, 285, 291-92, 297, 303-04, 348-49.

On October 16, 2014, two DIs and Government counsel met with Trinity II's counsel, Mr. Sisco, and the co-owners of Trinity II—Emad Yousef and

Mina Yousef

14

—at Mr. Sisco's office.

Id.

at 186-88. The purpose of the meeting was to ask the Yousefs about information contained on the fill stickers of the prescriptions.

Id.

at 188-89. Emad Yousef was asked what “MAG” stood for, and the lead investigator testified that Yousef responded that it stood for Mina Ghobrial, a pharmacist intern at Trinity II.

Id.

at 339, 446-47. The DI testified that he conducted a license verification on Florida's Department of Health license verification website and learned that Mina Ghobrial is a pharmacist intern in Florida.

Id.

at 339, 444. Another DI testified that he also conducted the same license verification search on August 20, 2015 that confirmed Mr. Ghobrial's status as a licensed pharmacy intern.

Id.

at 711; GX 78. The lead investigator also testified that “EFY” are the initials for Emad Yousef, and “MIA” are the initials for pharmacist Mark Abdelmaseeh. Tr. 271-72, 338, 345.

14

The lead investigator testified that, during the inspection of Trinity II, he spoke with Emad Yousef, and that Yousef had stated that he and his brother, Mina Yousef, were co-owners of Trinity I and Trinity II. Tr. 128, 133.

On December 4, 2014, the lead investigator issued an administrative subpoena to Trinity II asking that the pharmacy “provide a copy of the complete patient profile your pharmacy maintained pursuant to Florida Administrative Rule 64B16-27.800 (`Requirement for Patient Records')” for 23 specific patients. GX 98, at 2; Tr. 159, 548-49. The CALJ took official notice of the version of this Rule applicable between February 2012 and February 2014. ALJ Ex. 38. The Florida Board of Pharmacy adopted the Florida Administrative Rules pursuant to its authority under Chapters 465.022 and 465.0155 of the Florida Statutes. This Rule requires “all pharmacies” to “maintain[ ]” “[a] patient record system . . . for patients to whom new or refill prescriptions are dispensed” that “shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a new or refill prescription is presented for dispensing.” ALJ Ex. 38, at 1 (Rule 64B16-27.800(1)). The Rule also states that the “pharmacist shall ensure that a reasonable effort is made to obtain, record and maintain” certain patient-related information, including “[p]harmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.”

Id.

(Rule 64B16-27.800(1)(f)). This Rule further requires the pharmacist to “record any related information indicated by a licensed health care practitioner.”

Id.

(Rule 64B16-27.800(2)). Finally, this Rule requires pharmacists to maintain “[a] patient record for a period of not less than two years from the date of the last entry in the profile record” in “hard copy or a computerized form.”

Id.

(Rule 64B16-27.800(3)).

The lead investigator testified that he requested the patient profiles because “another place to resolve red flags, from my training and experience, was in the patient profiles,” and “a lot of pharmacists, instead of writing it on the prescription, they will actually type it into a note section in the patient profile in the computer.” Tr. 182, 572-73. He further testified that the patient profile is generally “part of the pharmacy's electronic system, where it will list out the prescriptions that the individual patient has received. It also contains note sections and other information regarding the patient.”

Id.

at 159. On December 22, 2014, Mr. Sisco sent an email to the lead investigator stating that “[e]nclosed please find documents responsive to the referenced subpoena.” GX 98, at 1. Attached to this email were patient profiles stored in portable document format (“PDF”).

Id.;

Tr. 159-60, 175, 182-83.

The lead investigator testified that he reviewed all the prescriptions, dispensing reports, and patient records obtained from Trinity II and received from its counsel. Tr. 183-84, 241, 247-48, 253-54, 256, 259, 264, 268, 278, 285, 291, 297, 303, 572-73, 666-67. He testified that none of the patient records received in response to the December 4, 2014 administrative subpoena contained a “notes and comment section” or documentation of contact with a doctor's office.

Id.

at 183-84, 667-68. He also testified that the majority of the prescriptions did not contain evidence that a doctor's office had been called.

Id.

at 666-67.

Finally, he testified that he created Google Maps printouts to show certain patient's travel.

Id.

at 238. Specifically, he testified that when he created these maps, he would use the patient's home address as the starting point, the physician's address as the next stop, the pharmacy as the stop after that, and sometimes the patient's home address as the final stop.

Id.

at 237. The CALJ found that the testimony of each of the DIs called by the Government “was sufficiently detailed, plausible, consistent and cogent to be fully credited in this recommended decision.” R.D. at 14.

The Allegations of Dispensing Violations

The lead investigator testified that DEA investigators provided the following information to Professor Paul Doering, M.S., the Expert for the Government: (1) Copies of the original prescriptions for certain patients flagged by the lead investigator, (2) a copy of all of the E-FORCSE

15

data for the Respondent from February 2012 to February 2014, (3) the aforementioned individualized dispensing reports prepared by the lead investigator, (4) a copy of one of his DEA-6

16

forms, (5) the subpoenaed patients' profiles, and (6) maps for certain patients. Tr. 581, 589-90, 597-98, 601-02. Professor Doering testified that he also received an electronic copy of the “master dispensing report” for Trinity II.

Id.

at 861. He further testified that he relied on the following materials in forming his opinion in this case: “the dispensing logs, the copies of the individual prescriptions, the patient profiles, and what could best be called as Google Maps and/or MapQuest indicators of distances between two spots.”

Id.

at 863.

15

E-FORCSE stands for “Electronic-Florida Online Reporting of Controlled Substances Evaluation” and is the prescription drug monitoring program in Florida. Tr. 553, 857.

16

A DEA-6 is the form where DIs write their report of an investigation. Tr. 582. Pursuant to 21 CFR 1316.46(b)(4), the information contained in investigatory reports are not available for inspection as part of the administrative record. Thus, the CALJ properly precluded Respondents' counsel from asking the agent on cross-examination to reveal the contents of his DEA-6. Tr. 583 (“He can't be compelled to answer or reveal anything that's in his DEA-6.”), 584 (“he can't be compelled to discuss the investigative contents of the DEA-6”).

Professor Doering was retained by the Government to be its Expert and was tendered as such at the hearing. Tr. 147, 834. Professor Doering has taught the practice of pharmacy in Florida for 40 years and at one time also worked in a retail pharmacy.

Id.

at 812-13, 824, 830-31; GX 32. His teaching has included courses related to the standards of pharmacy practice in the State of Florida. Tr. 814-15. He has also conducted research and published extensively regarding the standards of pharmacy practice in Florida.

Id.

at 816-17; GX 32. Professor Doering was also the one professor to have ever been given the honorary title of Distinguished Service Professor Emeritus in the 95-year history of the University of Florida's School of Pharmacy, a status he received in 2011.

17

Tr. 811-12.

Professor Doering testified that he keeps current on the latest developments in pharmacy practice.

Id.

at 817.

17

According to his CV, he was “[a]warded `Emeritus' status upon official retirement on January 31, 2011. Despite retirement, [he] continues to teach the same course as before retirement, except on a volunteer basis. [He e]ngages in special

projects for the College of Pharmacy, Shands Hospital, and other agencies and organizations.” GX 32, at 1.

At the hearing, the CALJ accepted Professor Doering as an expert in the practice of pharmacy in the State of Florida and in the standard of care for pharmacists in the dispensing of controlled substances in Florida.

Id.

at 843-844. In his Recommended Decision, the CALJ also stated that Professor Doering “has decades of experience in academia with honors and numerous publications” and that “[h]is credentials are extremely impressive, and the pride and commitment he displayed toward the field of pharmacy were undeniable and palpable in his testimony.” R.D. at 14.

In that capacity, Professor Doering testified that he sought to “identify[ ] individual patients that might demonstrate some of the activities and issues that have come to be called red flags” or “indicators.”

Id.

at 864. In his opinion, a red flag is “anything that raises concern.”

Id.

“In the area of pharmacy it's a term that's come to be used to give examples to pharmacies of things that might indicate or suggest that prescriptions were filled outside the usual course of pharmacy practice.”

Id.

He also testified that a red flag “could be indicative of abuse or misuse,” “over or under compliance,” “drug-drug interactions,” or a “forged” or “altered” prescription.

Id.

at 869. He further testified that these issues would be reviewed and resolved by a pharmacist “before filling any prescription” as part of the “prospective drug utilization review, or prospective drug use review.”

See id.

Resolution of red flags, he continued, “would be documented on the face of the prescription, on the rear of the prescription, or in the patient profile.”

Id.

at 882. Professor Doering testified that the standard of practice in Florida regarding the contents of such documentation is that it has to include “a reason that makes sense that, to the average pharmacist, is understandable how a person could find themselves in that predicament,” and the standard of practice also requires documentation of “potentially reasonable removals of red flags” and some link back to the prescribing physician.

Id.

at 1169-70. He further testified that “if it's not written down[,] you didn't do it.”

Id.

at 1353.

Professor Doering testified that the standard of care for a prospective drug utilization review (also referred to as a prospective drug use review) is already “specified in the Florida Administrative Code,” which requires pharmacists to perform a prospective drug utilization review before dispensing a medication.

Id.

at 869-70 (“It says, pharmacists shall, before dispensing a medication, perform what [is] called . . . prospective drug utilization review.”), 958-59 (“it's crystal clear what it says, the pharmacist shall before dispensing any prescription do a drug utilization review”). The CALJ took official notice of (and entered into evidence) the applicable version of Florida Administrative Code Rule 64B16-27.810, entitled “Prospective Drug Use Review,” which states that “[a] pharmacist shall review the patient record and each new and refill prescription presented for dispensing in order to promote therapeutic appropriateness by identifying: (a) Over-utilization [ ]; (b) Therapeutic duplication; . . . (d) Drug-drug interactions; (e) Incorrect drug dosage or duration of drug treatment; . . . (g) Clinical abuse/misuse.” ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)); Tr. 946, 1852. This Rule also 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.

(Fla. Admin. Code Rule 64B16-27.810(2)). This prospective drug use review, according to Professor Doering, applies to all prescription drugs, including prescriptions for controlled substances and narcotics.

18

See

Tr. 870.

18

Professor Doering testified that “[n]arcotics prescriptions . . . are referred to as high alert medications” that “have a higher than ordinary potential to cause harm if used inappropriately.” Tr. 865, 867-68.

Professor Doering testified that the drug utilization review process “begins when the prescription is presented” and should be “performed at the time the information is given to the pharmacist.”

Id.

at 873. He also stated that the standard of care in Florida requires pharmacists to use the notes and comments fields in a patient profile to document the resolution of issues identified during the drug utilization review process.

Id.

at 1015-16. In the absence of notes resolving such issues in the patient profile, Professor Doering testified that he would also look to the front and back of the prescription to determine whether a pharmacist had resolved a red flag.

Id.

at 1055, 1101. He further testified that he did not find any notes and comments section in any of the patient profiles he reviewed.

19

Id.

at 1054, 2087.

19

Professor Doering testified that he also reviewed dispensing logs, which are typically “spreadsheet[s] that contain[ ] information regarding drugs that were dispensed by the pharmacy,” and that the data in the dispensing log should “correspond” to the patient profile's data. Tr. 1018-19.

Professor Doering testified that only after the pharmacist has identified, resolved, and documented his/her resolution of red flags of diversion and other issues identified during the drug utilization review process can the pharmacist fill the prescription.

Id.

at 873-74, 1093-94, 1099-1100. If the pharmacist cannot resolve the issue, then the standard of care calls for pharmacists not to fill the prescription.

E.g., id.

at 879.

Professor Doering also explained some specific issues, or red flags, that pharmacists must look for as part of the prospective drug review process pursuant to Rule 64B16-27.810. For instance, he testified that the term “over-utilization” in this Rule is a red flag, and he explained that it “can be two things. So it can be taking more of the medication at a single administration. Or it could be obtaining more medication than the physician had desired, and using it in a time span that is less than the medication was supposed to last.” ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(a)); Tr. 872, 876. He offered the following example: “So if it's a 30-day supply of medicine, having lasted only 15 days is suggestive of one of two things. One, is taking too much of it. Or two, might be distributing it to other persons. That would be over[-] utilization.”

Id.

at 872. He testified that when a pharmacist identifies an over-utilization issue when a patient presents a prescription, the pharmacist must resolve that issue (and document that resolution) before filling the prescription.

Id.

at 873-74, 879.

Professor Doering also explained that the term “therapeutic duplication,” as set forth in Rule 64B16-27.810(1)(b), “is the presenting of two prescriptions, either for the identical drug, or drugs that are so closely allied that they would be overlapping in their actions in the body.”

Id.

at 884-85, 1520 (therapeutic duplication” occurs when “two drugs with the same action [are] being prescribed under the same circumstances”), 1541 (“Essentially two drugs with the same net effect.”). “[F]rom a pharmacist's standpoint, [that] is duplication of therapy.”

Id.

at 885. Professor Doering testified that therapeutic duplication is a red flag.

Id.

at 886. “Therapeutic duplication signifies that there are two or more

drugs that appear to be essentially doing the same thing, that together might pose the issue of adverse drug-drug interactions.”

Id.

at 883;

see

ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(b), (d)). “[I]t also may involve intentional duplication of drugs.” Tr. 883. In this way, he added that a prescription raising a “therapeutic duplication” concern might lead to another issue for the pharmacist to resolve regarding drug-drug interactions.

Id.

at 883-84. As a result, Professor Doering stated that therapeutic duplication raises many concerns, including the “safety of the patient. But it could also indicate an attempt to obtain more medication for over[-]utilization, which touches upon some of the other issues, which means clinical use or abuse, or diversion to some other use.”

Id.

at 885-86. As with other red flags, he reiterated that the standard of care requires pharmacists receiving a prescription raising the red flag of therapeutic duplication to resolve that issue (and document such resolution) before filling the prescription.

Id.

at 886-91.

Professor Doering next explained the term “[d]rug-drug interactions.” ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(d)). He testified that this “refers to the fact that two drugs, when given together, can have outcomes that are not what was intended initially by either one or the other drug together.” Tr. 893. He testified that when presented with prescriptions presenting potentially harmful drug-drug interactions, the standard of care requires the pharmacist to either (1) resolve this red flag and document the resolution once the pharmacist is satisfied that it is in the best interest of the patient, or (2) not fill the prescriptions.

Id.

at 1419-20.

Professor Doering also testified, however, that drug cocktails that include an opioid, benzodiazepine, and a muscle relaxer present red flags that must be resolved.

See, e.g.,

id.

at 1413-16, 1427. “[F]or example, oxycodone, or some other potent narcotic, along with a tranquilizer drug, such as alprazolam or Xanax, combined with a muscle relaxant, say for example, Soma,” also known as carisoprodol.

Id.

at 894. “[T]hose three drugs, which have been come to be called the unholy trinity, or . . . cocktail prescriptions, whatever you want to call them, are symbolic of drug interactions that might cause harms to the patient.”

Id.; see also id.

at 1416-17. According to Professor Doering's testimony, these drugs “have added central nervous system depressant properties and can present a real and present danger to the patient.”

Id.

at 1417. Moreover, he testified that this combination of drugs “constitute what I would call drugs with abuse potential, serious abuse potential” and “are often diverted to non-medical or recreational use.”

Id.

at 1416.

20

During the prospective drug utilization review process, pharmacists, “check for drug/drug interactions. And this would be subject to, in my opinion, very severe drug/drug interactions.”

Id.

at 1418.

20

He also testified that “[t]he nature of the drug combination, a potent narcotic analgesic, along with a potent anxiolytic medicine, along with a potent muscle relaxant . . . It's just come to be associated with a high potential for abuse.” Tr. 1417.

Professor Doering testified to what a pharmacist would look for in identifying “[c]linical abuse/misuse” as part of the prospective drug use review. ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(g)). He defined clinical abuse or misuse as “recreational use” or “drug abuse” which “typically involves taking more of the prescribed drug or focusing on certain drugs that have [ ] mood altering properties . . . that individuals . . . will use for other than medical purposes.” Tr. 952, 953 (it is “any time you use the drug outside the conditions for which it could be prescribed”). To identify such clinical abuse/misuse as part of the drug utilization review process, Professor Doering testified that a pharmacist “would look for quantities of drugs that are being sought beyond those which were authorized by the prescriber or they might look for certain combinations of drugs that are known to be used frequently for non-medical reasons.”

Id.

at 953. Again, as with the other red flags that may arise during a prospective drug use review (

i.e.,

the drug utilization review process), if the pharmacist cannot resolve the clinical abuse/misuse red flag, then he or she must not fill the prescription.

Id.

at 955.

Professor Doering also offered testimony regarding patient address information that appears on a prescription and the distance a patient travels to a pharmacy to fill a prescription. He testified that both Florida and federal law require a patient's address to appear on prescriptions “so that the pharmacist has some idea of where this patient resides and that can be useful for a couple of different reasons . . . it's also useful to know what geographic area this patient lives in because that may become important information as the prospective drug use review takes place.”

Id.

at 973. In the same vein, he testified that a physician's address must also appear on the prescription to indicate where the patient met with the practitioner.

Id.

at 970. “Typically you would look to patients that are in the same geographic area [as the pharmacy]. I would say within the same county or geographic area.”

Id.

at 1692. “[W]hen the distances are very great, it raises . . . a question of why is somebody needing to travel this far to get this prescription filled.”

Id.

Professor Doering also explained what type of information is generated after a pharmacist has decided to fill a prescription. “When the computer prints out the information there are different versions of the [fill sticker]. One version of it doesn't contain necessarily all this information, but that's the one that gets applied to the prescription vial. Th[e other version] is the one for pharmacists' record keeping purposes. It has additional info that the one on the vial does not.”

Id.

at 978.

Significantly, he testified that the fill sticker is generated after the drug utilization review process has been completed, and that the date appearing on the fill sticker represents the date when the pharmacy filled the prescription.

Id.

at 979-80. He explained that the fill sticker is “generated one step before the prescription label is actually applied to the vial . . . by the pharmacist. The significance of that is that the prescription has gone through all the proper steps and its certified ready for dispensing to the patient.”

Id.

at 979. Professor Doering further testified that, in his opinion, the date on the fill sticker also represents when the prescription is dispensed.

Id.

at 1186.

Respondents did not proffer an expert witness at the hearing, and I find that Professor Doering's testimony was credible.

21

21

Although the CALJ expressly declined to offer a view of Professor Doering's credibility, he nonetheless disregarded his opinions as “insufficiently reliable to form the basis of a sanction under the APA.” R.D., at 33 (“To be clear, however, this is not an issue of credibility, and no credibility determination is entered here.”). As I discuss

infra,

I disagree with the CALJ's assessment of the expert's reliability.

The Prescription Evidence

At the hearing, the Government introduced into evidence copies of dispensing logs, patient profiles, and the front and back of prescriptions for controlled substances which it alleged Trinity II filled in violation of 21 CFR 1306.04(a) and 1306.06 because they presented red flags of diversion that Trinity II failed to resolve as set forth in the first two charges of the Show Cause Order. As already noted, the first charge of the Show Cause Order outlined six different categories of red flags of diversion that the Government alleged

that Trinity II failed to resolve before filling the pertinent prescriptions. When taken together, the Government alleged that Trinity II's failure to resolve these red flags before filling these prescriptions demonstrated that Trinity II knowingly filled prescriptions for controlled substances in contravention of its corresponding responsibility and outside the usual course of pharmacy practice.

Early Fills

The Government introduced prescription evidence to show that Trinity II failed to resolve the first alleged red flag of diversion, “early fills,” with respect to at least four of its customers identified in the first charge of the Show Cause Order and whose patient records the Government had requested pursuant to its December 4, 2014 subpoena.

22

For one such customer, J.T., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled early at least nine prescriptions issued to J.T. for oxycodone 30 milligrams (hereinafter, “mg”), a schedule II controlled substance, under the brand name Roxicodone. GX 35; Tr. 1198-1234. Specifically, the Government introduced evidence that on February 23, 2012, Trinity II filled a prescription issued by physician W.F. to customer J.T. for 336 pills of “Roxicodone 30 mg,” and with directions from the prescribing physician for J.T. to take up to eight pills per day. GX 35, at 1, 3, 10, 11; Tr. 1199-1202. Although the fill sticker and patient profile both state that the prescription was for a 30-day supply, in fact, the 336 pills prescribed to be taken at the rate of eight pills per day constitutes a 42-day supply that should have lasted J.T. until at least April 6, 2012.

Id.

Nevertheless, on March 22, 2012, Trinity II then filled another prescription (from the same prescriber) for another 336 pills of Roxicodone 30 mg with instructions to take up to eight pills per day. GX 35, at 1, 3, 16, 17; Tr. 1202-05. Thus, I find that when Trinity II filled this second prescription on March 22, 2012, Trinity II filled it 15 days early.

Accord

Tr. 1205.

23

I also find that the front of the prescription, the back of the prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescription early. GX 35, at 1, 3, 15, 16; Tr. 1198, 1199, 1205-06.

22

For reasons I discuss

infra,

and as it relates to the first and second charges of the Show Cause Order only, I limit my fact findings to evidence related to those patients discussed at the hearing who were also identified in the December 4, 2014 subpoena.

23

Notably, the CALJ failed to make recommended fact findings related to the alleged early fills, or most of the other allegations set forth in paragraphs 7-8 of the Show Cause Order (

i.e.,

the first two charges of the Order) because of his concerns related to Professor Doering's reliability as an expert. R.D., at 43. However, as discussed further

infra,

this concern, even if well-founded, does not categorically relieve the Agency from making fact findings on allegations about Trinity II's filling conduct that can be decided without expert opinion. Accordingly, I will make such ultimate fact findings, even where the CALJ chose not to recommend any.

Professor Doering testified that, in Florida, whereas a fill (or refill) that is 2-3 days early may not signify a problem, a fill that is more than two-to-three days early is a red flag that a pharmacist is expected to resolve during the drug utilization review process “to avoid overuse or misuse.”

See

Tr. 989-91, 1009. “If someone is coming back fifteen days early, then that signifies a problem.”

Id.

at 990. In the case of J.T.'s presentation of the aforementioned March 22, 2012 Roxicodone 30 mg prescription 15 days early, the evidence established that there are no notes or comments—much less any evidence that Trinity II resolved this red flag—reflected in J.T.'s patient profile, dispensing log, or the front-and-back of this prescription. GX 35, at 1, 3, 15, 16; Tr. 1198-99, 1205-06. As a result, Professor Doering testified that this prescription was inconsistent with Florida's standard of care, not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1206.

In each of the next eight months, J.T. presented prescriptions to Trinity II for Roxicodone 30 mg in the same quantities and with the same dosing instructions; and in each instance, I find that Trinity II filled those prescriptions 14, 15, or 16 days early. GX 35, at 1, 3, 16, 17, 20, 21; Tr. 1208-09 (prescription for 42-day supply that Trinity II filled 15 days early on April 19, 2012); GX 35, at 1, 3, 20, 21, 30, 31; Tr. 1209-12 (prescription for 42-day supply that Trinity II filled 15 days early on May 17, 2012); GX 35, at 1, 3, 30, 31, 36, 37; Tr. 1213-17 (prescription for 42-day supply that Trinity II filled 15 days early on June 14, 2012); GX 35, at 1, 3, 36, 37, 44, 45; Tr. 1220-23 (prescription for 42-day supply that Trinity II filled 15 days early on July 12, 2012); GX 35, at 1, 3, 44, 45, 50, 51; Tr. 1223-25 (prescription for 42-day supply that Trinity II filled 16 days early on August 8, 2012); GX 35, at 1, 3, 50, 51, 54, 55; Tr. 1225-28 (prescription for 42-day supply that Trinity II filled 14 days early on September 6, 2012); GX 35, at 1, 3, 54, 55, 62, 63; Tr. 1228-31 (prescription for 42-day supply that Trinity II filled 16 days early on October 3, 2012); GX 35, at 1, 3, 62, 63, 70, 71; Tr. 1231-34 (prescription for 42-day supply that Trinity II filled 14 days early on November 1, 2012). When considering the cumulative effect of these consecutive monthly early fills from March-November 2012, I find that Trinity II filled prescriptions for J.T. that resulted in the filling of 135 days of extra oxycodone 30 mg.

And as with the earlier prescription that Trinity II filled for J.T. on March 22, 2012, I find that the prescriptions (front or back), patient profile, and dispensing log do not reflect any notes or comments, much less documentation, explaining how Trinity II resolved the early refill red flag presented by these prescriptions over the eight subsequent months.

See

GX 35, at 1, 3, 16, 17, 20, 21, 30, 31, 36, 37, 44, 45, 50, 51, 54, 55, 62, 63, 70, 71; Tr. 1198-99, 1205-06, 1212, 1216, 1218, 1222, 1225, 1228, 1230, 1234. And in each instance, Professor Doering testified that, because all of these early fills were well beyond 3 days early, Trinity II should have identified these early fills as red flags during the drug utilization review process to avoid drug abuse, overuse or misuse. Tr. 1208-09, 1211-12, 1215-17, 1222-25, 1227-28, 1230-31, 1234. He further testified that Trinity II's decision to fill these prescriptions without resolving these red flags was inconsistent with Florida's standard of care, not in the usual course of professional practice, and did not reflect the proper exercise of the pharmacist's corresponding responsibility.

Id.

For a second customer, M.A., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled early at least 8 prescriptions issued to M.A. for hydromorphone 8 mg, a schedule II controlled substance, under the brand name Dilaudid. GX 36; Tr. 1237-68. The Government introduced evidence that on May 2, 2013, Trinity II filled a prescription issued by physician R.A. at the Genesis Medical Clinic to customer M.A. for 165 pills of “Dilaudid Oral Tablet 8 MG,” with directions from the prescribing physician for M.A. to “[t]ake one tablet every 5 to 6 hours for 30 days.” GX 36, at 1-2, 4-5; Tr. 1237-42. Although the prescription and the fill sticker both stated that the prescription was for a 30-day supply, in fact, the 165 pills prescribed to be taken at the rate

of five pills

24

per day constitutes a 33-day supply that should have lasted M.A. until at least June 4, 2013.

Id.

Nevertheless, on May 28, 2013, Trinity II then filled another prescription (from another prescriber, J.S., at the same practice group—Genesis Medical Clinic) for another 165 pills of Dilaudid 8 mg with instructions to take one tablet every five to six hours for 30 days. GX 36, at 1-2, 4-7; Tr. 1242-45. Thus, I find that when Trinity II filled this second prescription on May 28, 2013, Trinity II filled it seven days early. I also find that the front of the prescription, the back of the prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescription early. GX 36, at 1-2, 6-7; Tr. 1236, 1237, 1245.

24

If M.A. took the tablets every six hours as instructed, then the daily tablet dosage would be four tablets/day; if M.A. took the tablets every five hours as alternatively instructed, then the daily dosage would be 4.8 tablets per day.

Accord

Tr. 1239-40. For purposes of this early fill fact-finding, I will round up to and use the rate of five tablets/day—a calculation that offers Trinity II the greatest lenity for purposes of calculating an early fill.

In each of the next seven months, M.A. presented to Trinity II prescriptions from the same Genesis Medical Clinic for Dilaudid 8 mg in the same quantities and with the same dosing instructions; and in each instance, I find that Trinity II filled those prescriptions six days early. GX 36, at 1-2, 6-9; Tr. 1245-49 (prescription for 33-day supply that Trinity II filled six days early on June 25, 2013); GX 36, at 1-2, 8-10; Tr. 1249-51 (prescription for 33-day supply that Trinity II filled six days early on July 23, 2013); GX 36, at 1-2, 10-11; Tr. 1251-54 (prescription for 33-day supply that Trinity II filled six days early on August 20, 2013); GX 36, at 1-2, 11, 13-14; Tr. 1254-55 (prescription for 33-day supply that Trinity II filled six days early on September 17, 2013); GX 36, at 1-3, 13-16; Tr. 1256-58 (prescription for 33-day supply that Trinity II filled six days early on October 15, 2013); GX 36, at 1, 3, 15-18; Tr. 1259-61 (prescription for 33-day supply that Trinity II filled six days early on November 12, 2013); GX 36, at 1, 3, 17-20; Tr. 1262-64 (prescription for 33-day supply that Trinity II filled six days early on December 10, 2013). When considering the cumulative effect of these consecutive monthly early fills from May 2013 to December 2013, I find that Trinity II filled prescriptions for M.A. that resulted in the filling of 50 days of extra hydromorphone 8 mg.

As with the earlier prescription that Trinity II filled for M.A. on May 28, 2013, I find that the prescriptions (front or back), patient profile, and dispensing log do not reflect any notes or comments, much less documentation, explaining how Trinity II resolved these early refill red flags over the seven subsequent months.

See

GX 36, at 1-3, 4-11, 13-20; Tr. 1236-37, 1245, 1248, 1251, 1253, 1255, 1258, 1261, 1263. Professor Doering testified that, because all of these early fills were well beyond three days early, Trinity II should have identified these early fills as red flags during the drug utilization review process to avoid drug abuse, overuse or misuse. Tr. 1240-41, 1245, 1248-49, 1251, 1253-54, 1255, 1256, 1258, 1261, 1263-64. He further testified that Trinity II's decision to fill these prescriptions without resolving these red flags was inconsistent with Florida's standard of care, not in the usual course of professional practice, and did not reflect the proper exercise of the pharmacist's corresponding responsibility.

Id.

For a third customer, J.G., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled early or refilled early prescriptions issued to J.G. at least seven times—one time for a prescription of lorazepam 2 mg, and six times for prescriptions of alprazolam 2 mg, both of which are schedule IV controlled substances. GX 39; Tr. 1364-84. Regarding the lorazepam prescription, the Government introduced evidence that on May 29, 2012, Trinity II filled a prescription issued by physician G.C. to customer J.G. for 30 pills of lorazepam 2 mg, and with directions from the prescribing physician for J.G. to “[t]ake

1/2

[one-half of one] tablet(s) . . ., 2 times per day, for 30 days.” GX 39, at 1-2, 4; Tr. 1365-66. Hence, the 30 pills prescribed to be taken at the rate of one pill per day constitute a 30-day supply that should have lasted J.G. until at least June 28, 2012.

Id.

Nevertheless, on June 19, 2012, Trinity II then filled another prescription from the same prescribing physician for another 30 pills of lorazepam 2 mg with the same instructions—one pill per day. GX 39, at 1-2, 4-5; Tr. 1366-70. Thus, I find that when Trinity II filled this second prescription on June 19, 2012, Trinity II filled it nine days early.

Accord

Tr. 1367. I also find that the front of the prescription, the back of the prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescription early. GX 39, at 1-2, 5; Tr. 1364-65, 1369.

With respect to the alprazolam prescriptions for J.G., the Government introduced evidence that on September 18, 2012, Trinity II filled a prescription issued by physician G.C. to customer J.G. for 30 pills of Xanax 2 mg, which is the brand name for alprazolam 2 mg, that could be refilled twice and with directions from the prescribing physician for J.G. to “[t]ake

1/2

[one-half of one] tablet(s) . . ., 2 times per day, for 30 days, as needed for anxiety.” GX 39, at 1-2, 6; Tr. 1370-71. Hence, the 30 pills prescribed to be taken at the rate of one pill per day constitute a 30-day supply that should have lasted J.G. until at least October 18, 2012 (assuming J.G. needed to take it every day for 30 days).

Id.

Nevertheless, the dispensing log and patient profile show that on October 10, 2012, Trinity II then refilled the prescription for another 30 pills of alprazolam 2 mg. GX 39, at 1-2, 6; Tr. 1371-73. Thus, I find that when Trinity II refilled this prescription on October 10, 2012, Trinity II refilled it eight days early.

Accord

Tr. 1372. The dispensing log and patient profile also establish that on October 29, 2012, Trinity II refilled the prescription again for another 30 pills of alprazolam 2 mg. GX 39, at 1-2, 6; Tr. 1373. Thus, I find that when Trinity II refilled this prescription on October 29, 2012, Trinity II refilled it 10 days early because the earlier refill should have lasted until November 8, 2012.

Accord

Tr. 1374. I also find that the front of the original prescription, the back of the original prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II refilled the prescription early on October 10 and October 29, 2012. GX 39, at 1-2, 6; Tr. 1373.

On February 26, 2013, Trinity II filled another prescription issued by physician G.C. to customer J.G. for 30 pills of alprazolam 2 mg (a 30-day supply), even though the dispensing log and J.G.'s patient profile show that Trinity II had already filled a 30-day supply of alprazolam 2 mg for J.G. on February 14, 2013.

25

GX 39, at 1-2, 8-9; Tr. 1375-77. I find that when Trinity II filled the February 26, 2013 prescription, Trinity II filled it at least 17 days early because the February 14, 2013 refill should have lasted J.G. until at least March 15, 2013.

Accord

Tr. 1377. Over the next two months, Trinity II then refilled this prescription twice (on March 18, 2013 and on April 12,

2013), and in each instance I find that Trinity II refilled it 10 and five days early, respectively. GX 39, at 1-2, 9; Tr. 1377-79 (prescription for 30-day supply that Trinity II filled 10 days early on March 18, 2013); GX 39, at 1-2; Tr. 1377-79 (prescription for 30-day supply that Trinity II filled five days early on April 12, 2013). I find that the front of the original prescription, the back of the original prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the February 26, 2013 prescription early, and twice refilled that prescription early on March 18 and April 12, 2013. GX 39, at 1-2, 8-9; Tr. 1373, 1379.

25

The February 14, 2013 filling by Trinity II was the second refill of a December 18, 2012 prescription (also issued by physician G.C.) that J.G. had filled at Trinity II on December 18, 2012.

See

GX 39, at 1-2, 8.

In addition, even though Trinity II filled a new prescription for a 30-day supply of alprazolam 2 mg issued by physician G.C. to J.G. on May 14, 2013 that should have lasted J.G. until at least June 12, 2013, Trinity II refilled this prescription with another 30-day supply of alprazolam 2 mg on June 6, 2013. GX 39, at 1, 3, 10; Tr. 1380-83. Thus, I find that the June 6, 2013 refill by Trinity II was six days early.

Accord

Tr. 1383. As with the other prescriptions and early fills and refills related to J.G., I find that the front of the original prescription, the back of the original prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled and refilled the prescription early. GX 39, at 1, 3, 10; Tr. 1383.

With respect to all the early fills and refills by Trinity II with respect to lorazepam 2 mg and alprazolam 2 mg prescriptions issued by physician G.C. to J.G., Professor Doering testified that, because all of these early fills and early refills were well beyond three days early, Trinity II should have identified them as red flags during the drug utilization review process to avoid drug abuse, overuse or misuse. Tr. 1369, 1372, 1374, 1377, 1383. He further testified that Trinity II's decision to fill these prescriptions without resolving these red flags was inconsistent with Florida's standard of care, not in the usual course of professional practice, and did not reflect the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1370, 1373-74, 1377, 1379, 1384.

For a fourth customer, L.H., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled early at least 2 prescriptions issued to L.H. for hydromorphone 8 mg, a schedule II controlled substance, under the brand name Dilaudid. GX 40; Tr. 1384-94. The Government introduced evidence that on June 5, 2012, Trinity II filled a prescription issued by physician J.I. at the Creative Health Center to customer L.H. for 180 pills of “Dilaudid Tablet 8 mg,” and with directions from the prescribing physician for L.H. to take one tablet by mouth every four hours as needed. GX 40, at 1, 3, 12-13; Tr. 1387-88. Hence, the 180 pills prescribed to be taken at the rate of six pills per day constitute a 30-day supply that should have lasted L.H. until at least July 5, 2012 (assuming L.H. needed to take every dose, every day).

Accord

Tr. 1392. Nevertheless, on June 28, 2012, Trinity II filled another prescription (dated June 18, 2012 from another prescriber, E.P. at Morton Plant Hospital)

26

for another 84 pills of Dilaudid 8 mg with instructions to take one tablet every 4 hours for 14 days. GX 40, at 1, 4, 14-15; Tr. 1388-89, 1392. Thus, I find that when Trinity II filled this second prescription on June 28, 2012, Trinity II filled it at least seven days early.

Accord

Tr. 1389. On July 3, 2012, Trinity II filled a third prescription, this time from physician J.I. (who issued the June 5, 2012 prescription) to L.H., for another 96 pills of Dilaudid 8 mg with instructions to take one tablet every four hours for 16 days. GX 40, at 1, 4, 16-17; Tr. 1392-93. As a result, I find that when Trinity II filled this third prescription on July 3, 2012, Trinity II filled it nine days early because the June 28, 2012 fill should have lasted L.H. until July 12, 2012.

Accord

Tr. 1393. I also find that the front of these prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled these prescriptions early. GX 40, at 1-4, 12-17; Tr. 1391, 1393-94.

26

The fact that the same patient, L.H., went to two different prescribers in the same month for the same schedule II drug also demonstrates the appearance of doctor shopping—another red flag of overuse or misuse. Professor Doering testified that this too should have been identified during the drug utilization process as indicative of overuse, misuse, or abuse. Tr. 1390. There is no evidence in the record that Trinity II attempted to resolve this red flag before filling the second of these prescriptions on June 28, 2012. Professor Doering also testified that Trinity II's decision to fill the June 18, 2012 prescription on June 28, 2012 without resolving these red flags was inconsistent with Florida's standard of care, not in the usual course of professional practice, and did not reflect the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1391.

Therapeutic Duplication

The Government introduced prescription evidence at the hearing to show that Trinity II failed to resolve the red flag of “therapeutic duplication” with respect to one of its customers, R.H., identified in the first charge of the Show Cause Order and whose patient records the Government had requested pursuant to its December 4, 2014 subpoena. The Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled two therapeutically duplicative prescriptions issued by physician J.I. for R.H. on December 2, 2013. The first prescription was for 120 tablets of hydromorphone 8 mg, an immediate release opioid under the Dilaudid brand name, with directions to “Take 1 Tablet by Mouth Every 6 Hours As Needed.” GX 63, at 1, 4-6; Tr. 1560-61. The second prescription was for 120 tablets of oxycodone 30 mg, another immediate-release opiate, with the same directions to take one tablet every six hours as needed. GX 63, at 1, 4, 7-8; Tr. 1561-63. I find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled these two schedule II opiate prescriptions on December 2, 2013. GX 63, at 1, 4-8;

accord

Tr. 1563-64.

According to Professor Doering, when a Florida pharmacist receives two prescriptions from the same individual for two different opioids, both with the same or similar directions for use, and those two are immediate release dosage forms, the standard of care requires the pharmacist to identify that as a red flag and to initiate steps to resolve that red flag. Tr. at 2111. However, Professor Doering also testified that, in his opinion, the therapeutic duplication of hydromorphone and oxycodone with respect to R.H., or any other pharmacy customer, is not a resolvable flag.

Id.

at 1520, 1563. “[P]harmacists would fall below the standard of care to dispense these two [opioids] together because of the inherent dangers that go along with giving both of these very potent narcotic analgesics . . . [t]hat could in fact be used together, at the same time.”

Id.

at 1520. He also testified that therapeutic duplication should be identified during the drug utilization review process.

Id.

at 1526, 1541-42. Professor Doering testified that Trinity II's filling of these prescriptions for R.H. were inconsistent with the standard of care, not filled in the usual course of professional practice, and inconsistent with the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1563-64.

Two Prescriptions for the Same Drug on the Same Date

The Government introduced prescription evidence at the hearing to show that Trinity II failed to resolve the red flag of receiving two prescriptions for the same drug on the same date from the same customer (J.K.)—another form of “therapeutic duplication.” The customer, J.K., was identified in the first charge of the Show Cause Order, and the Government had requested his patient records pursuant to its December 4, 2014 subpoena. The Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled two prescriptions issued by physician M.L. for J.K. on the same day—December 4, 2013. The first prescription was for 100 tablets of hydromorphone 8 mg, under the Dilaudid brand name, with instructions that the patient take one tablet every four to six hours—a 16-day supply. GX 69, at 1, 3-5; Tr. 1584-86. The second prescription was for 50 tablets of Dilaudid 8 mg with the same directions for use—an eight-day supply. GX 69, at 1, 3, 6-7; Tr. 1584-86. The dispensing log also shows that J.K. paid “cash” for these two prescriptions, just as he had for every other prescription that Trinity II had filled for J.K. between March 5, 2012 and February 3, 2014. GX 69, at 1. According to Professor Doering, two prescriptions for the same medication filled on the same date for the same customer is an unresolvable red flag of diversion that should have been identified during the drug utilization process. Tr. 1568, 1586-87. Regardless of whether it is resolvable, I find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled these two prescriptions for the same drug and for the same customer (J.K.) on December 4, 2013. GX 69, at 1, 3-7;

accord

Tr. 1584-85, 1587.

Distances

The Government introduced prescription evidence at the hearing to show that Trinity II failed to resolve the red flag of customers who had allegedly travelled unusually long distances and/or had taken suspicious routes for the purpose of obtaining, presenting, and filling prescriptions for controlled substances. Specifically, the Government introduced evidence exhibiting this red flag with respect to four of Trinity II's customers identified in the first charge of the Show Cause Order and whose patient records the Government had requested pursuant to its December 4, 2014 subpoena.

For one such customer, S.S., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that on June 5, 2013, Trinity II filled a prescription for S.S. for 150 tablets of hydromorphone 8 mg, with instructions to take one tablet every four hours as needed for breakthrough pain. GX 44, at 1, 2, 8-9; Tr. 1676-80. Although the front of the prescription did not include S.S.'s address,

27

the other prescription evidence—the fill sticker attached to the back of the prescription, the dispensing log, and the patient profile—all show S.S.'s address to be in Orange Park, Florida, which is a city located near Jacksonville, Florida. GX 44, at 1, 2, 9; Tr. 1680.

27

See

GX 44, at 8. The Show Cause Order alleges that Trinity II's filling of this prescription also constitutes an independent violation of 21 CFR 1306.05, which requires,

inter alia,

all prescriptions for controlled substances to bear the full name and address of the patient and imposes a corresponding liability “upon the pharmacist . . . who fills a prescription not prepared in the form prescribed by DEA regulations.”

Id.

at § 1306.05(a), (f). As set forth more fully

infra,

I agree.

It is undisputed that Trinity II is located in Clearwater, Florida, and that both the front of the prescription and Trinity II's dispensing log show that the prescribing physician's address was in Tampa, Florida. GX 44, at 1, 8. The Government also introduced Google Maps evidence showing that S.S. would have traveled: (1) 175 miles from his home address to the prescribing physician, (2) about 23 miles from there to Trinity II, and then (3) 199 miles from Trinity II back to his home address. GX 44, at 4-7; Tr. 1681-83. Indeed, S.S. would have to travel across the entire state of Florida—from the Jacksonville area on the East Coast of Florida to the greater Tampa Bay area on the West Coast of Florida—to obtain and to fill this schedule II prescription. Thus, I find that S.S. would have to travel approximately 397 miles roundtrip to obtain the June 5, 2013 hydromorphone 8 mg prescription from his physician, and that S.S. would have to travel at least 198 miles after picking up his prescription to return home.

See id.

I also find that Trinity II knew the addresses of both S.S. and his prescribing physician.

See

GX 44, at 1, 2, 8-9. I further find that the front of the prescription, the back of the prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescription given the unusual distances S.S. traveled to obtain and to fill this prescription. GX 44, at 1, 2, 8-9;

accord

Tr. 1676-77, 1685, 2113.

Although Professor Doering testified that there is no magical “distance cutoff” in determining when a particular distance constitutes a red flag, Tr. 1692-93, in response to hypothetical questions, he did testify that when a pharmacist in Florida receives a prescription for a controlled substance from a customer whose address is, for example, 75 miles away, “[t]he standard of care calls for the pharmacist to identify that as a red flag and to initiate steps that may resolve that red flag” and to document any such resolution. Tr. 2112. He testified that this standard of care “requires the pharmacist to find out the address of where the person resides” and “to ask the patient for that address information” by, for instance, “ask[ing] for identification.” Tr. 2119-20;

see also id.

at 1684. He further testified that in his opinion the distance red flag for this prescription should have been identified as part of the drug utilization process, and the fact that S.S. also paid cash

28

raised an additional red flag. Tr. 1684, 1686 (“patients paying cash for their prescriptions is a recognized red flag”), 1696. As a result, Professor Doering testified that filling this prescription was inconsistent with Florida's standard of care, that it was not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1701-02.

29

28

Trinity II's own dispensing report states that S.S. paid “cash” for the July 5, 2013 prescription, and I find that S.S. did indeed pay for this prescription (rather than a third-party payer).

See

GX 44, at 1. The prescription evidence also does not reflect that Trinity II ever attempted to resolve the “paying cash” red flag. Tr. 1686.

29

As discussed

infra

in the context of cocktail prescriptions, on June 27, 2013 and July 23, 2013, Trinity II also filled prescriptions for S.S. on each date for carisoprodol 350 mg, hydromorphone 8 mg and Xanax 2 mg. GX 44, at 1, 2, 14-19, 22-27; Tr. 1697-98; 1703-05. I also find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments whatsoever explaining why Trinity II filled these prescriptions given the unusual distances S.S. traveled to obtain and to fill these prescriptions. GX 44, at 1, 2, 14-19, 22-27;

accord

Tr. 1700, 1705. Professor Doering also testified that filling the June 27, 2013 and July 23, 2013 prescriptions were inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice or in the proper exercise of the pharmacist's corresponding responsibility. Tr. 1701, 1705.

For a second customer, D.W., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that on March 8, 2012, Trinity II filled two prescriptions for D.W.—one for 120 tablets of oxycodone 30 mg with

ginger

30

(with instructions to take one capsule four times daily) and the other for 30 tablets of carisoprodol 350 mg under the brand name Soma (with instructions to take one tablet every night). GX 45, at 1, 2, 8-11; Tr. 1710, 1713-14.

30

Professor Doering testified that physicians will issue a prescription calling for compounding with ginger “to deter one from injecting the drug intravenously” because ginger will “make it sting and burn if someone were to try to inject it intravenously.” Tr. 1265. It is also a deterrent to “nasal insufflation” (snorting) of the drug because “it would be [an] irritant to the lining of the nasal mucous membranes.”

Id.

at 1558.

According to the front of the oxycodone prescription,

31

the fill sticker attached to the back of both prescriptions, the dispensing log, and the patient profile, D.W.'s address was in Wellborn, Florida. GX 45, at 1, 2, 8, 9, 11; Tr. 1708-09. It is undisputed that the front of both prescriptions and Trinity II's fill stickers show that the prescribing physician's address was in Tampa, Florida. GX 45, at 8-11; Tr. 1709-1712. The Government also introduced Google Maps evidence showing that D.W. would have traveled: (1) 184 miles from his home address to the prescribing physician, (2) about 18 miles from there to Trinity II, and then (3) 202 miles from Trinity II back to his home address. GX 45, at 4-7.

31

The front of the second prescription for Soma did not bear the patient's address.

See

GX 45, at 10.

Thus, I find that D.W. would have to travel approximately 404 miles roundtrip to obtain the March 8, 2012 oxycodone and Soma prescriptions from his prescribing physician, fill them at Trinity II, and then return home.

See id.

I also find that Trinity II knew the address of both D.W. and his prescribing physician.

See

GX 45, at 1, 2, 8-11. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescriptions given the unusual distances D.W. traveled to obtain and to fill these prescriptions. GX 45, at 1, 2, 8-11;

accord

Tr. 1712.

Professor Doering testified that in his opinion “[t]he long distance between the patient's home and the doctor's office” was a red flag that was presented by D.W.'s prescriptions and which Trinity II should have identified as part of the drug utilization process. Tr. 1712. As a result, Professor Doering testified that filling these prescriptions was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1712-13.

On April 5, 2012 and on May 3, 2012, Trinity II also filled prescriptions for D.W. for 120 tablets of oxycodone 30 mg with ginger each time—with the same instructions and from the same prescribing physician as in the March 8, 2012 oxycodone prescription that Trinity II had filled for D.W. GX 45, at 1, 2, 12-13, 16-17; Tr. 1714-17. On April 19, 2012 and May 11, 2012, Trinity II filled prescriptions for D.W. for 30 tablets of Soma 350 mg each time—again, with the same instructions and from the prescribing physician as the Soma prescription that Trinity II had filled for D.W. on March 8, 2012. GX 45, at 1, 2, 14-15, 18-19;

32

Tr. 1716, 1718. As with the March 8, 2012 prescriptions for oxycodone and Soma, I find that D.W. would have traveled approximately 404 miles roundtrip to obtain the April 5, 2012 and May 3, 2012 oxycodone prescriptions, as well as the April 19, 2012 and May 11, 2012 Soma prescriptions, from his prescribing physician, and that D.W. would have traveled at least 202 miles after picking up his prescription to return home.

See

GX 45, at 4-7. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescriptions given the unusual distances D.W. traveled to obtain and to fill these prescriptions. GX 45, at 1, 2, 12-19;

accord

Tr. 1715, 1717.

32

And like the March 8, 2012 Soma prescription to D.W., the front of these Soma prescriptions lacked the patient's address.

See id.

Professor Doering testified that these four prescriptions also presented the same unusual distance red flag that Trinity II should have identified as part of the drug utilization process.

See

Tr. 1715-18. He also testified that, unlike the March 8, 2012 oxycodone and Soma prescriptions that Trinity II had filled on the same day, the fact that D.W. had to make two separate trips in April and in May to get the same prescriptions further emphasized the significance of the distance red flag of diversion.

See id.

at 1716 (“it sort of adds emphasis to that long distance thing because that meant two trips instead of one”). As a result, Professor Doering testified that filling these prescriptions was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1715-19.

For a third customer, C.V., the Government introduced a dispensing log, patient profile, and the front and back of a prescription to establish that on May 10, 2012, Trinity II filled a prescription for C.V. for 90 tablets of hydromorphone 8 mg, under the brand name Dilaudid, with instructions to take one tablet every eight hours. GX 46, at 1-2, 7-8; Tr. 1719-21. According to the front of the prescription, the fill sticker attached to the back of the prescription, the dispensing log, and the patient profile, C.V.'s address was in Port Charlotte, Florida. GX 46, at 1-2, 7-8; Tr. 1720-21. It is undisputed that the front of the prescription and Trinity II's fill stickers show that the prescribing physician's address was in Tampa, Florida. GX 46, at 7-8; Tr. 1720-21. The Government also introduced Google Maps evidence showing that C.V. would have traveled: (1) 105 miles from his home address to the prescribing physician, (2) about 22 miles from there to Trinity II, and then (3) 97 miles from Trinity II back to his home address. GX 46, at 3-6. Thus, I find that C.V. would have to travel approximately 224 miles roundtrip to obtain the May 10, 2012 prescription from his prescribing physician, fill it at Trinity II, and then return to his home.

See id.

I also find that Trinity II knew the address of both C.V. and his prescribing physician, and that C.V. paid “cash” for the prescription.

See

GX 46, at 1-2, 7-8. I further find that the front of the prescription, the back of the prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments whatsoever explaining why Trinity II filled the prescription given the unusual distances C.V. traveled to obtain and to fill this prescription (or the fact that C.V. paid “cash” to fill it).

Id.; accord

Tr. 1719, 1722.

Professor Doering testified that this prescription presents “the distance red flag” that Trinity II should have identified as part of the drug utilization process.

See

Tr. 1722. As a result, he testified that filling this prescription was inconsistent with Florida's standard of care, that it was not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1722-23.

For a fourth customer, D.E., the Government introduced a dispensing log, patient profile, and the front and back of a prescription to establish that on June 13, 2013 and on July 3, 2013, Trinity II filled two prescriptions for D.E. for 120 tablets of hydromorphone 8 mg for each prescription, both under the brand name Dilaudid, with the same

instructions to take one tablet every six hours for 30 days. GX 48, at 1-2, 8, 10-11; Tr. 1724-25, 1728. According to the front of the prescriptions, the fill stickers attached to the back of the prescriptions, the dispensing log, and the patient profile, D.E.'s address was in Brooksville, Florida. GX 48, at 1-2, 8; Tr. 1724, 1728-29. It is undisputed that the front of the prescriptions show that the prescribing physician's address was in Tampa, Florida. GX 48, at 8, 10; Tr. 1725. The Government also introduced Google Maps evidence showing that D.E. would have traveled: (1) 44 miles from his home address to the prescribing physician,

33

(2) about 20 miles from there to Trinity II, and then (3) 55 miles from Trinity II back to his home address. GX 48, at 3-7. Thus, I find that D.E. would have to travel approximately 119 miles roundtrip to obtain the June 13, 2013 prescription from his prescribing physician, fill it at Trinity II, and then return to his home.

See id.

I also find that Trinity II knew the address of both D.E. and his prescribing physician, and that D.E. paid “cash” for the prescription.

See

GX 46, at 1-2, 8, 10. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescription given the unusual distances D.E. traveled to obtain and to fill this prescription (or the fact that D.E. paid “cash” to fill it).

Id.; accord

Tr. 1727, 1732.

33

The street address of the prescribing physician reflected on the front of the prescriptions was different from what was shown on Trinity II's dispensing report and fill sticker; however, the identity and the city (Tampa, Florida) of the physician was the same in every address.

Compare

GX 46, at 1

with id.

at 8, 10. Although the distance calculation from the same city (Tampa) would have been very similar using either Tampa address, I find that the address on the prescriptions themselves is the most reliable evidence of the prescribing physician's address because it came directly from the physician. I find that the calculation of the distances to and from D.E.'s prescribing physician—as reflected in the Government's Google Maps evidence—is based, appropriately, on the street address reflected on the front of the June 13, 2013 and July 3, 2013 prescriptions.

Id.

at 4.

Moreover, I find that when Trinity II filled D.E.'s Dilaudid prescription on July 3, 2013, Trinity II filled that prescription early—yet another red flag. Specifically, D.E.'s prescription that Trinity II filled on June 13, 2013 was for 120 tablets of Dilaudid 8 mg and instructions for D.E. to take one tablet every six hours for 30 days. GX 48, at 1-2, 8; Tr. 1729-30. Hence, the 120 pills prescribed to be taken at the rate of four pills per day constitute a 30-day supply that should have lasted D.E. until at least July 12, 2013. Nevertheless, on July 3, 2013, Trinity II filled another prescription for another 120 pills of Dilaudid 8 mg with instructions to take one tablet every 6 hours for 30 days. GX 48, at 1-2, 10-11; Tr. 1731. Thus, I find that when Trinity II filled this second prescription on July 3, 2013, Trinity II filled it 9 days early.

Accord

Tr. 1731. I also find that the front of these prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled this prescription early. GX 48, at 1-2, 8, 10-11; Tr. 1731-32.

Professor Doering testified that this prescription presents “[t]he combination of the red flags. It's too early and the distance red flag.” Tr. 1731, 1727 (“the distance is a long ways. Which in the judgment of my opinion, the pharmacist, it should raise a red flag.”). As a result, he testified that filling these prescriptions was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1727-28, 1732.

Cocktail Prescriptions

The Government introduced prescription evidence at the hearing to show that Trinity II failed to resolve the red flag of “cocktail prescriptions,” which the Government alleged occurs when a customer presents multiple prescriptions that would provide the same patient an opioid, a benzodiazepine, and a muscle relaxer. Specifically, the Government introduced evidence exhibiting this red flag with respect to three of Trinity II's customers identified in the first charge of the Show Cause Order and whose patient records the Government had requested pursuant to its December 4, 2014 subpoena.

For one such customer, S.S., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that on June 27, 2013, Trinity II filled three prescriptions issued by the same prescribing physician for him: (1) 150 tablets of hydromorphone 8 mg (with instructions to take one tablet “every 4 hours as needed [for] breakthrough pain”); (2) 60 tablets of carisoprodol 350 mg, under the brand name Soma (with instructions to take one tablet “twice daily as needed”); and (3) 45 tablets of alprazolam 2 mg, under the brand name Xanax (with instructions to take half of a tablet “three times daily as needed for anxiety”) . GX 44, at 1, 2, 14-19; Tr. 1697-98. On July 23, 2013, Trinity II filled for S.S. the same three prescriptions from the same prescribing physician for hydromorphone 8 mg, carisoprodol 350 mg, and alprazolam 2 mg in the same amounts and with the same dosage instructions as for the June 27, 2013 prescriptions. GX 44, at 1, 2, 22-27; Tr. 1703-05. Thus, I find that the evidence establishes that Trinity II twice (on June 27, 2013 and on July 23, 2013) filled prescriptions for S.S. for the same combination of controlled substances—an opioid (hydromorphone), a benzodiazepine (alprazolam), and a muscle relaxant (carisoprodol). GX 44, at 1, 2, 14-19, 22-27. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled this combination, or cocktail, of prescriptions.

Id.; accord

Tr. 1700, 1705.

For a second customer, J.Ha., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that on March 7, 2012, Trinity II filled three prescriptions issued by the same prescribing physician for her: (1) 120 tablets of oxycodone 30 mg (with instructions to take 1 tablet every 6 hours as needed); (2) 30 tablets of carisoprodol 350 mg, under the brand name Soma (with instructions to take 1 tablet every night); and (3) 30 tablets of alprazolam 2 mg, under the brand name Xanax (with instructions to take one tablet daily). GX 73, at 1, 2, 4-9; Tr. 1594-98. On May 3, 2012 and May 31, 2012, Trinity II filled for J.Ha. prescriptions from the same prescribing physician for oxycodone 30 mg, carisoprodol 350 mg, and alprazolam 2 mg in the same amounts and with the same dosage instructions

34

as for the March 7, 2012 prescriptions. GX 73, 1-2, 10-21; Tr. at 1605-12. Thus, I find that the evidence establishes that on three separate occasions Trinity II filled for J.Ha. prescriptions for the following combination of controlled substances—an opioid (oxycodone), a benzodiazepine (alprazolam), and a muscle relaxant (carisoprodol). GX 73, at 1, 2, 4-21. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled this

combination, or cocktail, of prescriptions.

Id.; accord

Tr. 1594, 1597, 1604, 1608, 1612.

34

The fill sticker for the May 31, 2012 oxycodone 30 mg prescription for J.Ha. reflected the additional phrase “for pain” to the otherwise identical instruction that J.Ha. had received on the March 7, 2012 and May 3, 2012 prescriptions to take one tablet of oxycodone 30 mg every six hours as needed. GX 73, at 17.

For a third customer, R.Ha., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that on March 7, 2012, Trinity II filled the following three prescriptions issued by the same prescribing physician for him: (1) 180 tablets of oxycodone 30 mg (with instructions to take one tablet every four to six hours as needed); (2) 60 tablets of carisoprodol 350 mg, under the brand name Soma (with instructions to take one tablet twice daily); and (3) 30 tablets of alprazolam 1 mg, under the brand name Xanax (with instructions to take one tablet every night). GX 74, at 1, 2, 4-9; Tr. 1598-1600. On May 3, 2012 and May 31, 2012, Trinity II filled for R.Ha. the same three prescriptions from the same prescribing physician for oxycodone 30 mg, carisoprodol 350 mg, and alprazolam 2 mg in the same amounts and with the same dosage instructions

35

as for the March 7, 2012 prescriptions. GX 74, 1-2, 10-21; Tr. at 1606-08, 1611-12. Thus, I find that the evidence establishes that on three separate occasions Trinity II filled for R.Ha. prescriptions for the following combination of controlled substances—an opioid (oxycodone), a benzodiazepine (alprazolam), and a muscle relaxant (carisoprodol). GX 74, at 1, 2, 4-21. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled this combination, or cocktail, of prescriptions.

Id.; accord

Tr. 1597, 1604, 1608, 1612.

35

The fill sticker for the May 3, 2012 and May 31 2012 alprazolam 1 mg prescriptions instructed R.Ha. to take one-half to 1 tablet every day as needed, which is slightly different from the instruction in the March 7, 2012 prescription to take one tablet every night.

Compare

GX 74, at 7

with id. at

13, 19. Professor Doering testified that, in his opinion, this was a labeling error. Tr. 1601-02.

Professor Doering testified that the combination of these three drugs that Trinity II filled for customers like S.S., J.Ha., and R.Ha. constituted “the unholy trinity” or “cocktail prescriptions” that present a “drug-drug interaction” red flag because they are “symbolic of drug interactions that might cause harm to the patient.” Tr. 894-96. He emphasized that this “combination of drugs” risks harm to the patient because they “have additive central nervous system depressant properties.”

Id.

at 1698,

see also id.

at 1603 (“that's also the red flag of the so called accumulative additive effects of drugs with CNS depressant properties”). In his opinion, this is a red flag that Trinity II should have identified and resolved during the drug utilization review process with respect to customers S.S., J.Ha., and R.Ha.

Id.

at 1446, 1448.

36

As a result, he testified that filling these cocktail prescriptions without resolving the drug-drug interaction red flag was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1604-05, 1609, 1612-13, 1701, 1705.

36

Professor Doering also testified that the fact that Trinity II filled the cocktail prescriptions for S.S. 14 days after the prescriptions were issued presented another red flag because patients who are legitimately “in pain and or having symptoms that might require these medications[ ] will get the prescriptions filled soon after they're written.” Tr. 1700;

compare

GX 44, at 14, 16, 18 (prescriptions dated June 13, 2013)

with id.

at 15, 17, 19 (corresponding fill stickers dated June 27, 2013). I find that the front of these prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled this combination, or cocktail, of prescriptions 14 days after the prescriptions were issued.

Id.; accord

Tr. 1700.

Pattern Prescribing to Patients With the Same Last Name and Address

The Government introduced prescription evidence at the hearing to show that Trinity II failed to resolve the red flag of “pattern prescribing” reflecting a lack of individualized drug therapy, and which the Government alleges occurs whenever two related individuals present prescriptions issued (1) by the same prescribing physician, (2) on the same day, and (3) for the same drugs. Specifically, the Government introduced evidence exhibiting this red flag with respect to two sets of Trinity II's customers, in which each set of two customers shared a last name and home address, and who were also identified in the first charge of the Show Cause Order and whose patient records the Government had requested pursuant to its December 4, 2014 subpoena.

For the first set of customers, J.Ha. and R.Ha., and as noted above in the “cocktail prescription” fact findings, the Government introduced dispensing logs, patient profiles, and the front and back of prescriptions to establish that on March 7, 2012, May 3, 2012, and May 31, 2012, J.Ha. and R.Ha. presented and Trinity II filled three prescriptions for the same controlled substances on each date: (1) Oxycodone, (2) carisoprodol, and (3) alprazolam. GX 73, at 1, 2, 4-21; GX 74, 1, 2, 4-21. The same evidence also shows that J.Ha. and R.Ha. share the same: (1) Home address in Clearwater, Florida; (2) last name; and (3) prescribing physician.

Id.

As a result, I find that on three separate occasions, the same prescribing physician issued prescriptions for the same combination of drugs (oxycodone, carisoprodol, and alprazolam) to J.Ha. and R.Ha. on the same dates. GX 73, at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20; GX 74, at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20. In addition, I find that on March 7, 2012, May 3, 2012, and May 31, 2012, Trinity II filled each of these prescriptions even though Trinity II knew that they came: (1) From the same prescribing physician; (2) for the same combination of drugs; and (3) for patients with the same last name and same home address. GX 73, at 1, 2, 5, 7, 9, 11, 13, 15, 19, 21; GX 74, at 1, 2, 5, 7, 9, 11, 13, 15, 19, 21. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II nonetheless filled these prescriptions.

Id.; accord

Tr. 1594, 1597, 1604, 1608, 1612.

For the second set of customers, M.W. and J.W., the Government introduced dispensing logs, patient profiles, and the front and back of prescriptions to establish that on November 20, 2013 and on December 18, 2013, M.W. and J.W. presented and Trinity II filled identical prescriptions for 150 capsules of oxycodone 30 mg compounded with ginger, with the same dosage instructions to take one capsule every four to six hours for pain.

37

GX 75, at 1, 3, 4-7; GX 76, at 1, 3, 4-7. The same evidence also shows that M.W. and J.W. share the same: (1) Home address in Clearwater, Florida; (2) last name; and (3) prescribing physician.

Id.

As a result, I find that on two separate occasions, the same prescribing physician issued prescriptions for the same controlled substance (oxycodone) to M.W. and J.W. on November 20, 2013 and on December 18, 2013. GX 75, at 1, 3, 4, 6; GX 76, at 1, 3, 4, 6. In addition, I find that on those same dates Trinity II filled each of these prescriptions, even though Trinity II knew that they came: (1) From the same prescribing physician; (2) for the same controlled substance; and (3) for patients with the same last name and home address. GX 75, at 1, 3, 5, 7; GX 76, at 1, 3, 5, 7. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments whatsoever explaining why Trinity II nonetheless filled these

prescriptions.

Id.; accord

Tr. 1616, 1619-21, 1623.

37

M.W.'s prescriptions also instructed a “LIMIT [of] 5 [capsules] per day.” GX 75, at 4, 6.

Professor Doering testified that when two patients with the same last name and address, like J.Ha. and R.Ha. or M.W. and J.W., present prescriptions on the same day from the same prescribing physician for the same controlled substance and with the same dosage instructions, “it's what some have come to call pattern prescribing.” Tr. 1602-03;

see also id.

at 1608, 1612, 1620, 1623. In his opinion, this is a red flag that Trinity II should have identified and resolved during the drug utilization review process “[b]y contacting the prescriber and/or discussing it with the patient” before filling.

See id.

at 1603. As a result, he testified that filling these prescriptions without resolving the pattern prescription red flag was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility.

Id.

at 1604-05, 1609, 1612-13, 1620-21, 1623-24.

Controlled Substances Filled Before Authorized Date

At the hearing, the Government introduced into evidence copies of a dispensing log and the front and back of two prescriptions for controlled substances that the Government alleged Trinity II twice filled for customer D.G. before the date authorized by the prescribing physician and in violation of 21 CFR 1306.04(a), 1306.06, 1306.11, and 21 U.S.C. 829 as set forth in the third and fourth charges of the Show Cause Order. For example, the Government introduced a dispensing log and the front and back of a prescription dated November 15, 2013 showing that Trinity II filled a prescription for D.G. on November 20, 2013 for 7 patches of fentanyl-50 mcg/hr, a schedule II controlled substance, under the brand name Duragesic. GX 77, at 1, 6, 7; Tr. 1508-09, 1513-15. The front of the prescription, however, expressly instructed “NO EXCEPTIONS DO NOT FILL UNTIL 12-06-2013.” GX 77, at 6; Tr. 1514.

Although the CALJ did not recommend findings of fact related to the Government's allegations that Trinity II filled prescriptions early as set forth in the first two charges of the Show Cause Order, for this (third) charge of the Order, the CALJ did choose to recommend findings of fact. Specifically, he recommended that I find that Trinity II filled a prescription for a schedule II controlled substance for D.G. early because it was filled on November 20, 2013—contrary to the prescription's instruction that the prescription not be filled until December 6, 2013. R.D. at 48-49. I agree and make this finding of fact.

Similarly, the Government introduced the front and back of a prescription dated December 16, 2013 showing that Trinity II filled a prescription for D.G. on December 18, 2013 for 15 patches of fentanyl-50 mcg/hr under the brand name Duragesic. GX 77, at 8, 9; Tr. 1508-11. The Government also introduced a dispensing log showing that Trinity II filled the prescription on December 23, 2013. GX 77, at 1; Tr. 1511. The front of the prescription, however, expressly instructed “NO EXCEPTIONS DO NOT FILL UNTIL 1-5-2014.” GX 77, at 8; Tr. 1511-12. The CALJ recommended for this (fourth) charge of the Show Cause Order that I find that, regardless of whether Trinity II filled this prescription on December 18 or December 23, 2013, Trinity II nonetheless filled the prescription contrary to the prescribing physician's express instruction that the prescription not be filled until January 5, 2014. R.D. 48-49, 48 n. 114. I agree and make this finding of fact.

With respect to these two prescriptions filled by Trinity II, Professor Doering testified that filling these prescriptions before the date set forth in a “DO NOT FILL UNTIL” instruction was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility. Tr. 1512, 1515-16.

Controlled Substances Filled in Stronger Concentration Than Authorized

At the hearing, the Government introduced into evidence copies of a dispensing log, patient profile, and the front and back of seven prescriptions for controlled substances that the Government alleged Trinity II filled for customer J.T. at dosages that were no less than five times stronger than authorized by the prescribing physician and in violation of 21 CFR 1306.06 and 1306.11 as set forth in the fifth charge of the Show Cause Order. For example, the Government introduced the front of a prescription dated July 11, 2013 showing that the prescribing physician issued to J.T. a prescription for 20 mg/5 ml of morphine liquid, which is a liquid dosage of morphine and a schedule II controlled substance, with instructions to take five milliliters every six hours for rescue pain. GX 35, at 40; Tr. 1394-96, 1412. However, the Government also introduced a dispensing log, patient profile, and the back of the same prescription to show that when Trinity II filled this prescription for J.T. on July 12, 2012, Trinity II filled the prescription for 20 mg/ml of morphine liquid—a concentration that is five times stronger than what the prescribing physician had authorized—and restating the same dosage directions to take five milliliters every six hours for pain. GX 35, at 1, 3, 41; Tr. 1396-98. The CALJ recommended that I find that, in fact, on July 12, 2013, Trinity II filled a prescription for J.T. for 20 mg/ml that was five times stronger than the authorized dosage. R.D. at 50. I agree and make this finding of fact.

The Government also introduced evidence at the hearing showing that Trinity II repeatedly filled prescriptions for J.T. for morphine liquid at the same concentration (20 mg/ml) that was either five or 15 times the prescribed concentration (20 mg/5 ml or 20 mg/15 ml)

38

on six other occasions—August 8, 2012, September 6, 2012, October 3, 2012, November 1, 2012, December 27, 2012, and January 25, 2012. GX 35, 1, 3, 52-53, 58-59, 66-67, 76-77, 84-87. The CALJ recommended that I find that, in fact, on each of these occasions Trinity II filled prescriptions for J.T. for 20 mg/ml and that this dosage was either five times or 15 times stronger than the authorized dosage.

39

R.D. at 50. I agree and make these fact findings.

38

I agree with the CALJ that the prescribing physician's handwriting regarding the dosages for these prescriptions is not always clear because they appear to state either 20 mg/5 ml or 20 mg/15 ml. R.D. at 50. In the Show Cause Order, the Government alleged that the dosage for each of these prescriptions were for 20 mg/5 ml. ALJ Ex. 1b, at 15-16. However, in its Proposed Findings of Fact, the Government asked that the Agency find that all the prescriptions reflect a dosage instruction of 20 mg/5 ml except for the October 3, 2012 and November 1, 2012, prescriptions, which the Government claimed reflect a dosage instruction of 20 mg/15 ml. ALJ Ex. 40a, at 56-57. In any event, I agree with the CALJ's recommendation that for each of these prescriptions, the prescribed dosage strengths are either for 20 mg/5 ml or 20 mg/15 ml. R.D. at 50 n.120.

39

The CALJ also recommended that I find that on November 29, 2012, Trinity II filled a prescription issued to J.T. for morphine liquid for 20 mg/ml when the dosage instruction on the corresponding prescription was for 20 mg/5 ml. R.D. at 50 & n.119 (citing GX 35, at 1, 80-81). Although this particular prescription was not the subject of testimony at the hearing nor included in the Government's Proposed Findings of Fact, the Show Cause Order does allege that on November 20, 2012, Trinity II received a prescription issued to J.T. for 20 mg/5 ml of morphine liquid but nonetheless filled it at the dosage strength of 20 mg/ml. ALJ Ex. 1b at 16. The CALJ acknowledged that the date in the Show Cause Order (November 20, 2012) does not match the date on the fill sticker (November 29, 2012), but he recommended this fact-finding anyway and implied that the discrepancy was the result of a scrivener's error in the Show Cause Order. R.D. at 50 & n.119. Because neither the dispensing log nor the patient profile for J.T. show that Trinity II filled

any prescriptions for J.T. on November 20, 2012 (much less one corresponding to the morphine liquid prescription described in the Show Cause Order), GX 35, at 1, 3, I find that this mistake in the Show Cause Order was merely a scrivener's error. Thus, I agree that the Government intended to state in the Order that Trinity II filled this prescription on November 29, 2012. And I agree with the CALJ's recommendation that I find (and I do so find) that Trinity II filled this prescription on November 29, 2012 at a dosage that was five times stronger than the prescribing physician had instructed.

Professor Doering testified that the filling of these prescriptions at dosages that were at least “five times more potent that it was supposed to be” constituted “a misfill.” Tr. 1398. “This issue has been communicated to pharmacists. Be careful when you fill liquid morphine solutions, because it's a very concentrated form of the drug.”

Id.

He testified that the issue “should have been identified in the global dispensing process.”

Id.

at 1400. He further testified that these prescriptions were not filled consistent with the standard of care in Florida nor filled in the usual course of pharmacy practice.

Id.

at 1399, 1402, 1404, 1406-07, 1409, 1411-12.

Prescriptions Filled by Pharmacy Interns

The Government introduced prescription evidence at the hearing for the purpose of showing that Trinity II unlawfully allowed pharmacist interns, instead of pharmacists, to fill controlled substances prescriptions. The Government specifically alleged that Mina A. Ghobrial, a pharmacist intern at Trinity II, filled such prescriptions based on the presence of the initials “MAG” or “MG” in the “filled by” field of the fill stickers.

See, e.g.,

GX 79-82;

see also

Tr. 339, 452. The CALJ recommended that I find that the Government failed to present evidence to suggest that Ghobrial was not supervised by a registered pharmacist. R.D. at 46. I agree and make this finding of fact.

Respondent's Case

Respondent presented the testimony of Mark Abdelmaseeh, a pharmacist at Trinity II.

40

T. 2340-42. Abdelmaseeh testified that he worked two days per week as a pharmacist at Trinity II.

Id.

at 2342. He testified that, although technicians and interns worked with the pharmacists at Trinity II, pharmacy interns and technicians did not dispense any prescriptions.

Id.

at 2342-43. He further testified that his role included “overlook[ing] and supervis[ing] what's going on in the pharmacy” and “keep[ing] open communication with the doctors to make sure that all prescriptions are legitimate and needed for the patient.”

Id.

at 2355-56. “I check to see if there are any contraindications or interactions, if the patient has allergies. I look to see if the prescription is valid or not. I look to see if the prescription is being filled early or not. I look to see if the prescription has any mistakes on it, and I call and verify with the doctor on every prescription that I fill.”

Id.

at 2356.

40

Although Respondents presented the testimony of one other witness, Kristen Quinette, a former pharmacy technician at Trinity I, the CALJ did not consider her testimony in his Recommended Decision. After testifying that she had worked at one time at Trinity II, the CALJ sustained the Government's objection to her testimony since she was not noticed as a witness against Trinity II. Tr. 2232, 2247-49.

Abdelmaseeh testified that Trinity II maintains “records, notes and all types of other information other than just the plain prescription information” and that “[i]t's all documented in the computer system.”

Id.

at 2345. He specifically testified that Trinity II “maintain[ed] documentation regarding patient allergies” and “interactions with the physicians.”

Id.

at 2360-61. He also testified that “[w]hen the customer does pick up the medication they sign off for it that they picked up and that they do not have any questions in regards to the prescription that was picked up. . . . [a]t the point of sale.”

Id.

at 2357. Specifically, he testified that the customer signs an electronic pad at the register confirming pick up and that the customer has no questions for the pharmacist.

Id.

at 2357-58. He further testified that he can access that information “[a]t the register in the computer system.”

Id.

at 2359.

The CALJ noted that Abdelmaseeh has some built-in bias because he was still an employee of Trinity II when he testified, giving him “some stake in the proceedings.” R.D. at 34. The CALJ found that this bias was reflected in the fact that Abdelmaseeh “affirmatively and deliberately disregarded Respondent's counsel's . . . efforts to elicit testimony that stood within the bounds of the

in Limine

Order when there was no question pending in order to provide information that was directly the subject of the Government's objections.”

Id.

at 34-35. The CALJ believed that this was Abdelmaseeh's “effort to cram in as much objectionable testimony as possible” to get around the terms of his

in Limine

Order.

Id.

at 35. As a result, the CALJ concluded that “it is difficult to afford this witness's testimony the full weight that it otherwise might have received in this recommended decision.”

Id.

The CALJ sustained the Government's objections to Respondent's attempts to have Abdelmaseeh testify about evidence regarding the process the pharmacies used to verify prescriptions and resolve concerns, including a description and demonstration of the computer software utilized, because such testimony was excluded by the

in Limine

Order.

See generally

Tr. 2344-66. However, the CALJ nonetheless allowed Respondent's counsel to proffer how the witness would have testified on that topic.

Id.

at 2366-2372. Counsel proffered that Trinity II used computer software that requires a pharmacist to sign-in and approve prescriptions.

Id.

at 2367. Respondent's counsel also proffered “that the software comes with a particular screen and tab for printing what is commonly referred to and has been referred to by Professor Doering as a patient profile which includes dispensing history, and it's limited to the dispensing history. It's a pre-programmed function of that software.”

Id.

at 2368, 2370 (“It's an F-11 tab to print a profile.”). He also proffered that “other fields that are maintained or other screens that are maintained” by Trinity II's software “include an area for notes on each prescription and that that information is maintained at the pharmacy in that . . . software.”

Id.

at 2369, 2370-71 (“It has a tab for prescription notes, RX notes, and it operates not only by the tab but by a function key, F-3, and patient information tab that uses a function key, F-4” and includes “a date and time stamp entry so you can determine on which date those entries were made.”). According to counsel, Trinity II's pharmacists “used this software as a mechanism to assist them . . . with identifying red flags and then documenting the resolution of those.”

Id.

at 2371-72.

The proffered facts related to Trinity II's computerized record-keeping and prescription verification process are only relevant to the Show Cause Order's first two charges related to the identification and resolution of red flags of diversion. The CALJ properly stated that he would not consider the proffer as evidence in making his recommendation, but he allowed Respondent's counsel to make the proffer to preserve the issue for review.

See id.

at 2352.

Based principally on this proffer and the Government's failure to image Trinity II's computers, Trinity II contends that DEA cannot prove that it failed to document resolution of such red flags because “DEA failed to request or obtain Respondent's records where such notes and comments were stored.” Trinity II's Closing Submission and Proposed Findings of Fact and

Conclusions of Law (hereinafter “Trinity II's Post-Hearing Brief”), AJL Ex. 41, at 6. This general argument has some merit (again, assuming the proffered facts are true) regarding Trinity II's customers for whom the Government never requested “records where such notes and comments were stored.”

Id.

However, Trinity II's argument does not account for the fact that the Government's December 4, 2014 subpoena required Trinity II to produce the complete patient profile that Trinity II maintained for 23 customers as required by Florida Administrative Rule 64B16-27.800, entitled “Requirement for Patient Records.” GX 98, at 2 (“For each of the following patients, please provide a copy of the complete patient profile your pharmacy maintained pursuant to Florida Administrative Rule 64B16-27.800”). As already noted, this rule expressly required Trinity II to maintain in its “patient record system” a record of every entry “in the profile record” for each patient for two years, including “[p]harmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.” ALJ Ex. 38; Fla. Admin. R. 64B16-27.800. This Rule also mandated that Trinity II “obtain from the patient . . . and shall record” patient information “which may relate to prospective drug review. The pharmacist shall record any related information indicated by a licensed health care practitioner.”

Id.

at 64B16-27.800(2).

In short, and as discussed more fully

infra,

Rule 64B16-27.800 required Trinity II to maintain patient records that included copies of any notes and comments reflecting their pharmacists' resolution of any red flags of diversion. I find that when the Government requested the complete patient profile Trinity II maintained pursuant to Rule 64B16-27.800 related to the 23 customers in the December 4, 2014 subpoena, the Government did in fact request all patient records maintained by Trinity II for those customers pursuant to that Rule—including the pharmacists' notes and comments for those customers. Thus, I reject Trinity II's contention that the Government failed to request records including Trinity II's notes and comments.

41

41

And it is also for this reason that I have limited my fact findings,

supra,

regarding the Show Cause Order's first two charges relating to violations of Trinity II's corresponding responsibility to allegations involving those 23 patients.

Most significantly, Respondent's counsel never stated in his proffer that Trinity II did in fact maintain notes and comments resolving the alleged red flags for the 23 customers whose records were subpoenaed in this case. Although it is possible that Trinity II deliberately withheld this evidence in response to the December 4, 2014 subpoena,

42

I find that it is more likely than not that, in fact, Trinity II failed to produce notes and comments reflecting Trinity II's resolution of the red flags in response to the Government's subpoena because Trinity II did not actually resolve them and hence had no notes or comments reflecting any such resolution. Respondent's counsel was careful never to aver during cross-examination of the Government's witnesses that Trinity II actually had notes or comments regarding the 23 patients identified in the subpoena. The CALJ gave Respondent's counsel's more than enough latitude to make this claim during his proffer or during cross-examination, yet he chose not to do so. Respondent's counsel also chose not to impeach Government witnesses during cross-examination by using actual notes and comments (or any other information) reflecting Trinity II's resolution of red flags for any customer discussed at the hearing. Although the

in Limine

Order precluded Trinity II from,

inter alia,

offering such information as evidence in its case-in-chief (ALJ Ex. 29, at 3), nothing in that Order precluded Trinity II from using this information to impeach the Government's witnesses.

43

Indeed, it was in Trinity II's self-interest to use such notes and comments (if they existed) during cross-examination of the Government's witnesses because it would have been an effective way to impeach Government witnesses' testimony that they saw no evidence that Trinity II resolved any red flags of diversion. It would be a remarkable oversight for Respondent's counsel not to use such information during cross-examination if it did exist. As already noted, I find that it did not.

44

42

During Respondent's counsel's cross-examination of Professor Doering regarding the scope of the Government's December 4, 2014 subpoena request for 23 customers' patient profiles maintained pursuant to Rule 64B16-27.800, Respondent's counsel asked “Is the word `profile' anywhere in that Florida administrative code provision?” (Tr. 2174), expecting the witness to confirm counsel's own understanding regarding the rule. Professor Doering then validated that (mis)understanding by stating that the word “profile” “does not appear” to him as he quickly read the rule on the stand. Tr. 2176. This reading, of course, is incorrect—Rule 64B16-27.800(3) expressly references patient profiles. Government counsel immediately corrected this error on re-direct by asking Professor Doering to read that provision into the record: “A patient record shall be maintained for a period of not less than two years from the date of the last entry in the

profile

record. This record may be a hard copy or a computerized form.” Tr. 2207 (emphasis added). Although this exchange raises the possibility that Respondent's counsel advised his clients not to produce the notes and comments regarding the 23 customers referenced in the subpoena based on this misunderstanding of the rule, I find (for the reasons set forth in the text above) that it is more likely than not that Trinity II did not produce any notes or comments regarding these customers because they do not exist.

43

In fact, the CALJ lacks the authority to preclude a respondent from using relevant information to impeach a witness during cross-examination.

See Farmacia Yani,

80 FR 29053, 29063 n.25 (2015) (finding that it was prejudicial error to preclude a respondent from using a document to impeach a witness on cross-examination, even where respondent had failed to present the document to the Government in advance of the hearing). Moreover, the APA and our regulations preserve a respondent's right to present information on cross-examination for the purpose of impeaching the Government's witnesses.

See

5 U.S.C. 556(d) (“A party is entitled . . . to conduct such cross-examination as may be required for a full and true disclosure of the facts.”); 21 CFR 1316.60.

44

For the same reason, I reject Trinity II's Exception that the CALJ's

in Limine

Order “did not permit the Respondents to present relevant evidence to the charges set forth in the show cause order. As a result, the Respondents were limited in their ability to explain the computer system used by the Respondents, which would have clarified the record keeping questions.” Respondents Trinity Pharmacy (I)'s and Trinity Pharmacy (II)'s Exceptions to the Recommended Decision of the Administrative Law Judge (“Resp. Except.”), at 7. Although the CALJ did limit Trinity II's ability to present evidence as part of its case-in-chief, as already noted, the CALJ (1) gave Trinity II multiple opportunities to comply with his prehearing orders, (2) did not (and could not) limit its ability to present information during cross-examination of the Government's witnesses, and (3) even gave Trinity II the opportunity to provide an attorney proffer at the hearing in which Trinity II's counsel could have at least proffered facts which, if true, would have rebutted the Government's case. Again, as already noted, Trinity II chose not to do so. Accordingly, I find that the CALJ acted within his discretion when he issued his

in Limine

Order and denied Trinity II's reconsideration motion, and I reject Trinity II's Exception to the CALJ's

in Limine

Order.

Trinity II also raised in this Exception that the CALJ's

in Limine

Order precluded it from introducing evidence that “would have corroborated Kristen Quinette that pharmacy technicians were not permitted to dispense prescriptions.”

Id.

at 7. None of the allegations in the Show Cause Order relate to pharmacy technicians, and the CALJ limited her testimony's relevance to Trinity I. R.D. at 33 n. 86. In any event, and assuming Trinity II intended to state in its Exceptions that it would provide testimony related to pharmacy interns, I find that this Exception is moot because I find

infra

for Trinity II on the charges related to pharmacy interns.

Discussion

Before proceeding to analyze the evidence under the public interest factors, it is necessary to review the CALJ's discussion of two issues raised in the Government's Exceptions to the CALJ's Recommended Decision: (1) Whether the Government should have provided DEA-6s to Respondent that DEA had provided to its expert and (2) whether the expert's testimony was sufficiently “reliable” under the Administrative Procedure Act (“APA”)

to be given weight in my decision.

See

“Government Exceptions” (hereinafter “Gov. Except.”) at 13-54.

Requirement To Produce Documents Relied Upon by the Expert

In his Recommendation, the CALJ included a discussion of whether the Government should have produced to Respondent copies of a DEA-6 related to Trinity II that DEA had provided

45

to the Government's expert witness, Professor Doering. R.D. at 27-28, 28 nn. 78-79.

46

In that discussion, the CALJ stated his belief that the DEA's intent in providing documents to an expert is relevant to determining whether the expert relied upon these documents in forming his opinion. R.D. at 28 n. 78 (“Like the other documents forwarded by DEA to Professor Doering, DEA-6s were furnished to him to assist him in formulating his expert opinion on the Government's theory of the case.”),

id.

at 28 (“The proposition that the Government would supply DEA-6s (or any other form) to an expert with the expectation that those documents would play no role `whatsoever' is dubious at best. Professor Doering was sent DEA-6s so he would read, analyze, and utilize them in forming his expert opinion”). Contrary to the CALJ's belief, the Government's purported “expectation” that Professor Doering would rely on DEA-6s provided to him is both factually unsupported and legally irrelevant to the question at bar.

45

The Government also raised a separate Exception related to the CALJ's statement in his Recommended Decision that “[i]t is unfathomable that the Agency counsel would gratuitously release a document as closely held by the Agency as a DEA-6 with no expectation that it would be used by that person for any purpose.” Govt. Except. at 69 (emphasis omitted) (citing R.D. at 28 n. 78). The CALJ failed to indicate where the record indicates that Government counsel produced, much less “gratuitously released,” a DEA-6 to anyone. In fact, the record contradicts the CALJ's rendition of the facts. As Trinity II's counsel established during cross-examination of the lead DI at the hearing, it was the DIs, not “Agency counsel,” who provided a DEA-6 to Professor Doering.

[Mr. Sisco:] All right. Would you describe for me all of the information that you initially provided to Professor Doering?

[DI:] I believe we provided photocopies of the original prescriptions. I believe a copy of the E-FORCSE, the dispensing report. What else? And a copy of one of my 6s.

Q When you say a 6, you're talking about a DEA-6. It's your report of an investigation?

A Yes.

Tr. 581-82. Elsewhere in his Recommended Decision, the CALJ himself noted and accepted this same testimony. R.D. at 12 (accepting DI's testimony that he had “provided . . . a copy of one of his DEA-6 forms . . . to Professor Paul Doering, the Government's expert witness. Tr. 581, 589-90”). Professor Doering corroborated the DI's response during his own testimony on direct and cross-examination, stating that he received DEA-6s from the DIs who had retained him on behalf of DEA and before he had made first contact with Government counsel regarding the case.

Id.

at 855-59, 1783-84, 1786-89, 1800-01. As the Government observed, “[e]veryone is entitled to his own opinion, but not to his own facts.” Govt. Except. at 1. I expect all the ALJs working for DEA to ensure that that the statements in their Recommended Decisions are well-grounded in fact, especially before making statements disparaging counsel who appear before them.

46

This issue arose when, for the first time at the hearing, Respondent requested production of the DEA-6s that the Government had provided to its expert. R.D. at 28 n.79;

see

Tr. 586, 805-07. The Government responded at the hearing that Respondent's request was untimely because Government counsel had already notified Respondent's counsel by letter months before the hearing that DEA had previously provided DEA-6s to Professor Doering and that they would not be produced pursuant to

T.J. McNichol.

Tr. 807-08. The Government also proffered a copy of the contents of its unsigned expert discovery letter at the hearing.

Id.

The Government subsequently raised an Exception seeking a finding that it had provided notice to Respondent's counsel prior to the hearing, and the Government attached to its Exceptions an affidavit and a copy of the signed expert discovery letter addressed to Respondent's counsel consistent with its representation at the hearing. Gov. Except. at 64-69 & Attachment 1. In his Recommendation, the CALJ decided that ruling on whether this discovery request was timely was “unnecessary” because “the Respondent has not sought to develop the record regarding the timeliness of the request or even asked for the testimony to be stricken as unavailable to constitute substantial evidence.” R.D. at 28 n.79. I agree that Trinity II failed to carry its burden to prove that its request for production of the DEA-6s was timely. In any event, as discussed

infra,

I find that Professor Doering did not rely on any DEA-6 as the basis for his expert opinion, thereby obviating any putative production requirement.

As a threshold matter, the record does not support the CALJ's statement that DEA expected Professor Doering to rely on the DEA-6s. The CALJ's opinion on this supposed expectation is based solely on the fact that the Government provided them to him.

See

R.D. at 27-28. However, the Government may provide an expert with any number of documents for reasons that have nothing to do with formulating the substantive basis of an expert opinion—such as an index or a table of contents. In his Recommended Decision, the CALJ failed to indicate where in in the almost 2,400-page transcript and more than 90 exhibits in the case there are facts establishing that DEA's “expectation” was that Professor Doering use the DEA-6s “in formulating his expert opinion on the Government's theor

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