# Hills Pharmacy, LLC; Decision and Order

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2016-17721

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** July 28, 2016
- **Citation:** 81 FR 49816

## Text

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 15-4]
Hills Pharmacy, LLC; Decision and Order

On October 8, 2014, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Hills Pharmacy, LLC (hereinafter, Hills or Respondent), which proposed the revocation of its DEA Certificate of Registration FH0772257, pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered location of 7730 W. Hillsborough Ave., Tampa, Florida. ALJ Ex. 1, at 1. As grounds for the proposed action (which also includes the denial of any pending applications), the Show Cause Order alleged that Respondent's “continued registration is inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f).”
Id.; see also
21 U.S.C. 824(a)(4).

More specifically, the Show Cause Order alleged that Respondent's “pharmacists repeatedly failed to exercise their corresponding responsibility to ensure that controlled substances they dispensed were dispensed pursuant to prescriptions issued for legitimate medical purposes by practitioners acting within the usual course of their professional practice” and that its “pharmacists ignored readily identifiable red flags that [the] controlled substances prescribed were being diverted and dispensed despite unresolved red flags.”
Id.
(citing 21 CFR 1306.04(a);
Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195,
77 FR 62315, 62319 (2012)). The Show Cause Order further alleged that Respondent's “pharmacists dispensed controlled substances when they knew or should have known that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose, including circumstances where the pharmacist knew or should have known that the controlled substances were abused and/or diverted by the customer.”
Id.
at 2.

The Show Cause Order listed various red flags which Respondent's pharmacists allegedly failed to resolve before dispensing prescriptions, including: (1) “multiple individuals presenting prescriptions for the same drugs in the same quantities from the same doctor”; (2) “individuals presenting prescriptions for controlled substances known to be highly abused, such as oxycodone and hydromorphone”; (3) “individuals paying high prices . . . for controlled substances with cash”; and (4) “individuals residing long distances from the pharmacy.”
Id.

The Show Cause Order then alleged that between July 28 and August 4, 2011, Respondent's “pharmacists dispensed large and substantially similar quantities of” oxycodone 30 mg tablets “to at least nine customers, all of whom received their prescriptions from physicians working at the same clinic,” and that seven of the customers “resided at least [50] miles from” Respondent and five of the customers “resided more than [100] miles from” it.
Id.
The Government specifically alleged that “on July 28, 2011, a Hills . . . pharmacist dispensed 210” tablets of oxycodone 30 mg “to T.V., who resided in Pensacola, . . . more than [450] miles from” Respondent. The Order also alleged that “on August 4, 2011, one or more Hills . . . pharmacists dispensed large quantities of oxycodone pursuant to prescriptions written by the same physician on the same day to two customers with the same last name” (J.P. and T.P.), both of whom “resided in St., Augustine, Florida, more than [180] miles from” it.
Id.

Next, the Show Cause Order alleged that “[o]n April 21, 2011, one or more Hills['] . . . pharmacists dispensed large and substantially similar quantities of . . . oxycodone 30 to at least [12] customers, three of whom resided more than [50] miles from [it], and two of whom resided more than [100] miles away.”
Id.
The Show Cause Order then alleged that “[a]ll of these prescriptions were written by physicians working at the same clinic and were for amounts ranging from 168 to 240 tablets.”
Id.

To similar effect, the Show Cause Order alleged that on January 16, 2012, Hills' pharmacists dispensed three prescriptions for oxycodone 30 mg tablets in quantities which ranged from 168 to 224 tablets to three persons who “resided more than [50] miles from Hills,” which were all “issued by physicians working at the same clinic.”
Id.
at 3. The Show Cause Order then alleged that on January 19, 2012, a Hills' pharmacist dispensed 120 oxycodone 30 tablets to a person who resided in Panama City, Florida, which is “located more than [350] miles from” it.
Id.

The Show Cause Order also alleged that on December 10, 2012, Hills' pharmacists engaged in a further instance of dispensing prescriptions (for 180 oxycodone 30) to two persons with the same last name on the same date “at or about the same time.”
Id.
at 3. With respect to these prescriptions, the Government also alleged that “both customers were willing to pay as much as [$7.50] per tablet despite evidence that Hills . . . was now charging double for oxycodone than it charged the previous year.”
Id.
And the Show Cause Order further alleged that on December 10, 2011, a Hills' pharmacist dispensed 224 tablets of oxycodone 30 to a resident of Bradenton, Florida, “who willingly paid . . . $1232 for the same prescription he purchased just four months earlier for . . . $896,” and that “[b]oth of these prescriptions were also facially invalid inasmuch as they contained no patient address.”
Id.

Finally, the Show Cause Order alleged that in October 2011, Hills' pharmacists dispensed prescriptions for 196 and 240 tablets of hydromorphone 8 mg to two persons.
Id.
The Show Cause Order alleged that the prescriptions, “if taken as directed, far exceeded the recommended [daily] dosage of” the drug.
Id.
The Order also alleged that both “prescriptions were issued by the same physician and one of them was facially invalid . . . as it contained no patient address.”
Id.

Next, the Show Cause Order alleged that Respondent “failed to create and maintain accurate records in violation of 21 U.S.C. 842(a)(5).”
Id.
at 4. More specifically, the Order alleged that: (1) Respondent “failed to complete a biennial inventory as required by 21 CFR 1304.11(c)”; (2) its DEA schedule II order forms did not contain the “receipt date or quantity received in violation of 21 U.S.C. 827(b) and 21 CFR 1305.13(e)”; (3) it “failed to retain Copy 3 of” its schedule II order forms “as required by 21 U.S.C. 827(b) and 21 CFR 1305.13(a) and 1305.17(a)”; and (4) its schedule II records were not “readily retrievable . . . at its registered location in violation of 21 CFR 1304.04(a) and (h)(2).”
Id.

Finally, the Show Cause Order alleged that a DEA audit of various schedule II drugs found both shortages and overages. The Order alleged that an audit for the period of July 24, 2012 through February 4, 2013 found “a shortage of 4,135” tablets of hydromorphone 4 mg and “an overage of 8,758” tablets of hydromorphone 8 mg.
Id.
The Order also alleged that an audit for the period of June 27, 2012 through February 4, 2013 found an overage of 1,306 tablets of oxycodone 30 mg, and an audit for the period of June 9, 2012 through February 4, 2013 found overages of 113 tablets of morphine 60 mg and 88 tablets of morphine 30 mg.
Id.

On October 17, 2014, the Order to Show Cause was served on Respondent

by delivery to an attorney who was representing it in the investigation, and who had emailed a Diversion Investigator the day before that he would “accept any service of process in that regard for Hills Pharmacy.” ALJ Ex. 4. On November 14, 2014, Respondent, through its counsel, filed a request for a hearing with the Office of Administrative Law Judges. ALJ Ex. 2. The matter was then assigned to ALJ Gail Randall, who proceeded to conduct pre-hearing proceedings.
1

1
Respondent raised no objection to the adequacy of service.

On December 2, 2014, the Government filed its Prehearing Statement. ALJ EX. 7. Of note, the Government's Prehearing Statement contained no additional information beyond that provided by the Show Cause Order as to the identities of the patients whose prescriptions were at issue.
Compare
ALJ Ex. 1, at 2-3,
with
ALJ Ex. 7, at 4-5. Thereafter, Respondent moved for an extension, which the Government did not oppose, and on December 16, 2014, the ALJ granted its motion.

On January 9, 2015, Respondent filed its Prehearing Statement. ALJ Ex. 14. Respondent proposed to call as witnesses, “[a]ny and all patients whose prescriptions were seized by . . . DEA pursuant to the Administrative Inspection Warrant [AIW] executed February 4, 2013 or whose prescriptions for controlled substances were dispensed between January 1, 2011 and February 4, 2013.”
Id.
at 3. Respondent further attached to its Prehearing Statement a list of 1,461 persons.
Id.
at Exhibit A. Respondent also proposed to call as witnesses all of the physicians who had issued the prescriptions that were seized pursuant to the AIW and the controlled substance prescriptions that it dispensed between January 1, 2011 and February 4, 2013.
Id.
at 3. Respondent attached to its Prehearing Statement a list of more than 130 doctors.
Id.
at Exhibit B. Respondent further estimated that it would require 45 to 60 days to present its case, exclusive of cross-examination and rebuttal.
2

Id.
at 9.

2
Respondent also sought to call the physicians who issued controlled substance prescriptions to the patients listed in Exhibit A after February 4, 2013, as well as the pharmacists who dispensed those prescriptions. ALJ Ex. 14, at 3. It also proposed to call as a witness,“[e]ach and every . . . Diversion Investigator, Special Agent, and/or Task Force Officer who participated in the preparation of the application for the” AIW or the “the execution of the” AIW, and “[a]ny and all witnesses identified in the Government's Prehearing Statement.”
Id.
at 4.

Respondent also proposed to call a consultant, who was a former Supervisory Diversion Investigator, who would testify regarding “his knowledge and experience in the investigation, preparation and execution of” AIWs, purported errors in the audits, and Respondent's “procedure for resolving potential `red flag' issues and compliance with recordkeeping requirements.”
Id.
at 3, 5-6. Finally, Respondent proposed to call its own expert who would testify as to “the legal and ethical responsibilities of the pharmacists dispensing prescriptions at” it, the procedures used by it to resolve red flags, and his review of “the prescriptions at issue.”
Id.
at 6.

On January 14, 2015, the ALJ conducted an on-the-record prehearing conference. Noting that the Government had referred to the patients by their initials, the ALJ ascertained that Government intended to request a protective order. Tr. 6 (Jan. 14, 2015). Continuing, the ALJ noted “the scope of the Respondent's [counsel's] prehearing statement and his inability up to this point to identify the witnesses” and asked the Government if it was “willing to exchange the prescriptions which it intend[ed] to utilize . . . so Respondent can ID the actual patients involved?”
Id.
at 6-7. Government counsel represented that the prescriptions would be sent by Fed Ex that day.
Id.
at 7. Subsequently, the ALJ noted that Respondent's counsel had “proposed in excess of 1,500 named witnesses and approximately 13,500 pages of documents” and asked if this was “still [his] current plan?”
Id.
at 10. Respondent's counsel replied that if “the Court limits the scope of the Government's case to just those prescriptions that are provided to us, I may be able to wean that down slightly.”
Id.

The ALJ then asked Respondent's counsel to explain the purpose of the patients' testimony.
Id.
Respondent's counsel stated that “the Government ha[d] not listed in their list of witnesses any of the patients . . . to whom prescriptions were dispensed and ha[d] not identified any of the physicians who issued [the] prescriptions.”
Id.
at 11. Respondent's counsel then explained that it was his position that the Government's Expert's “testimony should be excluded because he hasn't had any contact with any of the patients or prescribers to determine whether or not the red flags that he's identified can be resolved.”
Id.
at 11-12. Respondent's counsel then maintained that if the Government's Expert was allowed to testify on these issues, “it would be incumbent upon Respondent to demonstrate by the testimony of the patients regarding the inquiry and discussion between the patients and the pharmacists to resolve any of those red flags as identified by [the Expert], and for those prescribers to testify about their basis for issuing the prescriptions for those particular patients.”
Id.
at 12.

On January 15, the ALJ issued a Preliminary Order Regarding Scope Of Proceedings. ALJ Ex. 19. Therein, the ALJ explained that “any of those proposed patient and physician witnesses who are not linked to a prescription transaction which the Government asserts created a `red flag' present[s] the potential for providing no relevant evidence.”
Id.
at 3. However, the ALJ also held that “to the extent warranted by the Government's disclosure (and potentially its case-in-chief at the hearing), the Respondent may seek leave to present evidence from prescribing practitioners and/or patient-customers on the narrow issue of rebutting Government evidence that controlled substances were dispensed in the face of `red flags' of diversion with no attempts made to contact those witnesses to attempt to resolve the `red flag(s).' ”
Id.
The ALJ thus concluded that “[a]s the proffer stands now . . . an insufficient basis has been presented for presenting the testimony of all of these 1598 proposed witnesses.”
Id.
(citing Respondent's Prehearing Statement, at 3 and Exhibits A & B).

Addressing Respondents' proffers of 13,510 pages of documents, the ALJ found “that many of these documents are not relevant to this proceeding.”
Id.
at 4. The ALJ thus excluded Respondent from admitting any documents “not linked to inventory practices, the controlled substance audit, or prescription transactions specified in the Order to Show Cause.”
Id.
Finally, the ALJ precluded Respondent's Pharmacy Expert from testifying “regarding applicable legal standards and any aspect of the Respondent's legal obligations as a DEA registrant.”
Id.
at 5. However, the ALJ held that Respondent's Pharmacy Expert would be permitted to testify as to other areas in accordance with Respondent's proffer.
Id.
at 4.

The same day, the ALJ also issued her Prehearing Ruling. In addition to setting the date of the evidentiary hearing, the Ruling also advised each party that if it chose to amend its witness list to include a new witness, it must file a supplement to its Prehearing Statement and include a summary of the witness's proposed testimony. ALJ Ex. 20, at 3. The Ruling further explained “that witnesses not properly identified and testimony not summarized in prehearing statements or supplements thereto will be excluded at the hearing,” and that if either party “wished to raise any issues of inadequacies or ambiguities regarding the proposed witness' testimony . . . [it] may do so by motion.”
Id.
Finally, the Ruling specified the date by which all

documentary evidence as well as any affidavits were to be provided to both the tribunal and the opposing party.
3

Id.

3
There were numerous motions filed during the course of the pre-hearing procedures. My discussion of the motions and rulings is confined to those which limited the scope of the proceeding and the evidence that was admissible.

Thereafter, both of Respondent's counsels moved to withdraw; the ALJ granted the motions. ALJ Exs. 24, 25, 29, 31. Subsequently, new counsel entered an appearance and simultaneously moved for a continuance. ALJ Ex. 27, 30. The ALJ granted the motion and continued the hearing for three weeks, scheduling it for March 10 through March 13, 2015. ALJ Ex. 40. In the meantime, both parties filed supplemental prehearing statements, ALJ Ex. 34 & 37, requests for subpoenas, and additional motions.

On March 10 through 12, 2015, the ALJ conducted an evidentiary hearing in Tampa, Florida.
See
Recommended Decision (hereinafter, cited as R.D.), at 5. At the hearing, both parties elicited testimony from multiple witnesses and submitted various exhibits. Following the hearing, the ALJ left the record open so that the Government could submit an affidavit from a Special Agent who was then out of the country. Tr. 613. On April 16, 2015, the Government submitted the affidavit, and on April 21, 2015, the ALJ admitted the affidavit and closed the record. ALJ 52. Thereafter, both parties filed briefs containing their proposed findings of fact, conclusions of law, and argument.

On April 29, 2015, the ALJ issued her Recommended Decision. Therein, the ALJ found that the Government had “proved its
prima facie
case for revocation through the failing of Respondent's accountability practice and its violation of its corresponding responsibility by dispensing controlled substances without first resolving red flags raised by the prescriptions.” R.D. 50 (citing 21 CFR 1306.04(a)). The ALJ further held that the testimony of Respondent's pharmacist-in-charge (PIC) on the issue of acceptance of responsibility “lack[ed] credibility.”
Id.
at 52. Noting that while its PIC had stated that he had done due diligence in accordance with its protocols prior to dispensing the prescriptions at issue, the ALJ drew an adverse inference based on Respondent's failure to produce evidence to corroborate the PIC's assertion.
Id.
The ALJ thus “conclude[d] that the Respondent's representatives have not accepted responsibility for the full extent of their actions proven by the Government,” thus rendering its evidence of remedial measures irrelevant.
Id.
The ALJ then recommended that Respondent's registration be revoked and that any pending applications be denied.
Id.
at 53.

Respondent filed Exceptions to the Recommended Decision and the Government filed a Response to Respondent's Exceptions. Thereafter, the record was forwarded to me for Final Agency Action.

Having considered the record in its entirety, including Respondent's Exceptions (which I discuss throughout this decision), I adopt the ALJ's legal conclusions that Respondent violated the corresponding responsibility rule of 21 CFR 1306.04(a) with respect to many of the prescriptions. I also agree with her legal conclusion that Respondent failed to maintain accurate records as required by 21 U.S.C. 827. And I further agree with her legal conclusion that Respondent has failed to accept responsibility for the misconduct which has been proven on the record of the proceeding. Accordingly, I agree with the ALJ's ultimate conclusion that Respondent has committed acts which render its continued registration inconsistent with the public interest and will adopt her recommendation that I revoke Respondent's registration and deny any pending applications. I make the following

Findings of Fact

Respondent is the holder of DEA Certificate of Registration FH0772257, pursuant to which it is authorized to dispense controlled substances in schedules II through V, as a retail pharmacy, at the registered location of 7730 W. Hillsborough Ave., Tampa, Florida 33615. GX 1. This registration does not expire until October 31, 2016.
Id.
According to Respondent's registration, it is owned by Hills Pharmacy, L.L.C.
4

Id.
No evidence was put forward as to Respondent's current licensure status with the Florida Department of Health.

4
Notwithstanding its representation in its opening statement that it would “show that Hills Pharmacy is owned by Hope” Aladiume and “her brother is Victor Obi Aladiume,” Tr. 9, the Government put forward no evidence establishing Hope Aladiume's relationship to Respondent, or whether Victor Obi is her brother. Of note, Victor Obi was the owner of two Tampa pharmacies whose registrations I recently revoked.
Superior Pharmacy I and Superior Pharmacy II,
81 FR 31310, 31341 (2016). Moreover, Victor Obi served as “the designated representative of the Respondent” during this proceeding. Tr. 4.

The Investigation of Respondent

On February 4, 2013, DEA Investigators executed an Administrative Inspection Warrant (AIW) at Respondent. Tr. 233. The lead Investigator presented the AIW to Respondent's PIC (Mr. George), and obtained various records from Respondent including inventory records, receipt records, and prescriptions.
Id.
According to the Investigator, he asked for two years' worth of records.
5

Id.
The DI further testified that while Respondent provided him with a perpetual inventory of various schedule II drugs, the document “did have physical inventory dates in there.”
6

Id.
at 235. According to the Investigator, “there was not one date [when] every controlled substance was inventoried.”
Id.
Thus, the beginning dates for the drugs that were audited varied.
Id.
at 236.

5
According to the DI, “not all of the required records were onsite.” Tr. 252. The DI specifically identified the offsite records as including prescriptions from February 4, 2011 through April 2011, inventories from February 4, 2011 through the end of 2011, and receiving records from February 4, 2011 through the end of 2011.
Id.
at 253. The DI further testified that Respondent's attorney had stated that the records were offsite and that the office manager had the key and was not available that day.
Id.

Respondent, however, disputed that the records were offsite. Its PIC testified that the records were onsite in a locked storage room, but that he had left the storeroom key at home that day, and that when Respondent's owner arrived with the duplicate key “two hours later,” “the officers [had] left” so he provided the records to its lawyer.
Id.
at 536.

6
According to the transcript, the Government asked the DI: “Did you inquire whether Hills had a bi-annual inventory?” Tr. 234. After he explained that he was provided with the above-mentioned perpetual inventory, the Government asked the DI: “So that's how you conclude there was no bi-annual inventory?”
Id.
at 235. The DI answered “correct.”
Id.

Federal law requires, however, that a registrant take biennial and not biannual inventories. 21 U.S.C. 827(a). Moreover, the transcript was not corrected. Thus, I take the transcript as it is.

The DI further testified that as part of executing the AIW, a closing inventory was taken in which various schedule II drugs were physically counted.
Id.
at 237. According to the DI, the closing counts were taken by Mr. George (Respondent's PIC) and were recorded on a document.
7

Id.;
GX 7. However, the closing inventory was signed by another Diversion Investigator and witnessed by a DEA Special Agent rather than Mr. George. GXs 7 & 16; Tr. 312.

7
However, other testimony was to the effect that the closing inventory counts were done by the PIC, another DI, and the Special Agent who signed the inventory as a witness. Tr. 287, 312. Moreover, Mr. George testified that he did not participate in the counting of the drugs on hand. Tr. 535. And he further testified that the Investigators did not tell him that they were “doing the actual count.”
Id.
Be that as it may, I find no reason to reject the closing count.

Using the inventories and the records of Respondent's receipts and prescriptions, the DI conducted an audit of Hills' handling of seven schedule II

controlled substances. According to the DI, he conducted the audit by adding Respondent's purchases to the initial inventory figures to calculate the quantity of each drug that Respondent was accountable for. Tr. 237. The DI then explained that the “total accounted for” was calculated by using the closing inventory (
i.e.,
the inventory taken on the date of the inspection) and adding the amounts distributed or transferred of each drug.
Id.
According to the DI, the latter was “basically . . . what they filled at the pharmacy” as the Investigators did not “come across” any “sales . . . to other pharmacies.”
Id.
He further testified that in calculating Respondent's purchases, “the only numbers that [he] used was stuff that we actually had a physical 222 [form] or [a] CSOS representation” and that he did not count product which was recorded in the perpetual inventory if there was no 222 form for it.
Id.
at 273.

Comparing the “total accountable for” with the “total accounted for” for the seven drugs, the DI found that Respondent had overages in six of the drugs, the most significant being 1,306 dosage units (du) of oxycodone 30 mg and 8,758 du of hydromorphone 8 mg.
8

GX 4. Moreover, Respondent had a shortage of 4,135 du of hydromorphone 4 mg.
Id.

8
According to the Government, Respondent had overages of 5 du in methadone 10 mg, 82 or 88 du in morphine sulfate 30 mg, 113 du in morphine sulfate 60 mg, and 2 du in morphine sulfate 100 mg. GX 4, at 1.

Respondent disputed the accuracy of the audits. Specifically, its PIC testified that there were controlled substances in the will-call bins. Tr. 536-37. Respondent's PIC then explained that these drugs would be prescriptions that were finished in “vials with the label” and “waiting for the patient to come and collect it.”
Id.
at 537. Moreover, a DI testified that the audit team did not count the prescriptions in the will-call bins.
Id.
at 290. He also did not recall if drugs that were quarantined for disposal were counted.
Id.

Respondent, however, put forward no evidence that there were any drugs quarantined for disposal on the date that the AIW was executed, let alone that any of those drugs were those being audited. Subsequently, the DI testified that “[w]e asked where the controlled substances were,” and counted the drugs in the safe because “that's where we were shown.”
Id.
at 291.

Respondent's PIC also testified that there were some medications that were returned to the pharmacy's stock when they were not picked up by the customer. Tr. 525. He further identified a document (RX 6, at 3) which lists six instances (by date, RX number, patient name, and quantity) in which a patient apparently did not pick up a prescription for hydromorphone 8 and the drugs were returned to stock. Tr. 525. The PIC testified that he did not know if DEA counted the pills that were returned to stock if they were still on hand.
Id.

Respondent did, however, introduce into evidence various documents for each of the audited drugs, including a list of the prescriptions that were dispensed, its perpetual inventory for the drug, the invoices and scheduled II order forms for its receipts, and, as explained above, in some instances, a document listing “returns to stock” from patients. As discussed later in this decision, with respect to the overages alleged by the Government as to oxycodone 30 mg and hydromorphone 8 mg, the records show that Respondent placed additional orders that were not counted by the Government and establish that the overages in these two drugs were substantially less than the quantities alleged by the Government. Respondent's records do not, however, call into question the conclusion that it had a large shortage in hydromorphone 4 mg and actually support the conclusion that the shortage was even larger than that alleged by the Government.

The same DI also testified as to other alleged violations. More specifically, the DI testified that several DEA Order Forms for Schedule II drugs (Form 222) were not properly completed, because “[w]hen they don't receive a drug, they need to write a zero if they didn't receive anything.” Tr. 255. While the DI did identify an instance in which Respondent had notated the receipt of six packages of methadone 10 mg, he noted that Respondent had failed to include the date that the packages were received.
Id.; see also
GX 10, at 9. He then testified regarding a further order form, on which three of the four line items had been filled in with both the quantity received and the date received, explaining with respect to an entry that was not completed, that the forms “are missing [the] number of packages received, [the] date received.” Tr. 255. However, when asked by the ALJ whether the pharmacist would “put the date that he entered the zero” for a similar entry which was left blank (GX 10, at 1, line 2), the DI testified; “I'm not sure about that, but we need the number zero at least.” Tr. 256.

The DI also testified that there were some instances in which Respondent provided him with a photocopy of the purchaser's copy of the 222 form, rather than the original which it is required to maintain for a period of two years.
Id.
at 257 (discussing GX 11, at 2). The DI also testified that Respondent did not have any inventory document other than the perpetual inventory documents that its PIC provided.
Id.
at 270. Re-emphasizing the point, the DI subsequently testified that “that's all we had, so we had to use it.”
Id.
at 278.

The Allegations of Dispensing Violations

Following the execution of the warrant, another DI provided a CD which contained copies of the schedule II prescriptions
9

that were seized to Robert Parrado, R.Ph., who reviewed them and testified as an Expert for the Government. The DI testified that the Investigators did not obtain the patient profiles (which apparently could have been extracted from the computer which was imaged by the inspection team) and thus did not provide them to Mr. Parrado. Tr. 300.

9
According to the DI, the Investigator did not seize “any noncontrolled prescriptions” and “just took [the] [s]chedule [II] scrips.” Tr. 299.

Mr. Parrado testified that he obtained his B.S. in Pharmacy in 1970 from the University of Florida College of Pharmacy and that he has held a Florida pharmacist's license since 1971. Tr. 14; GX 2, at 1. Mr. Parrado testified that he has practiced as a pharmacist at both community pharmacies as well as hospital pharmacies; he also testified that he had been the pharmacy department manager at multiple pharmacies, including two pharmacies that he owned for approximately 19 years. Tr. 15-16; GX 2, at 1-2.

Mr. Parrado was a member of the Florida Board of Pharmacy from January 2001 through February 2009, and served as both Vice Chairman and Chairman of the Board. Tr. 17; GX 2, at 3. He is a member of the Florida Pharmacy Association, having served as both its President and then Chairman of the Board. GX 2, at 3. He is also a member of the Hillsborough County Alcohol & Drug Abuse Task Force, the National Community Pharmacists Association, and the American Society for Pharmacy Law.
Id.
Finally, he has made numerous presentations on the dispensing of controlled substances by pharmacists,
id.
at 3-7, and has testified as an expert witness for both the prosecution and defense in criminal and administrative matters. Tr. 18.

On
voir dire,
Mr. Parrado explained that he reviewed only the front and back of the prescriptions in forming his opinions, and that while he had also recently been provided with and looked at “some Respondent exhibits [that]

looked like partial . . . medical records . . . for about 25 patients,” he had already formed his opinion before he reviewed those documents. Tr. 29-30, 32. Mr. Parrado also testified that he did not interview any patients, doctors or pharmacists, and that he was not provided with any information regarding interviews conducted by DEA personnel of the patients, doctors, or pharmacists.
Id.
at 39. Mr. Parrado testified that he did a limited amount of research on his own, which included doing Google map searches to determine how far the patients lived from Tampa, looking to see whether the doctors had a valid license, looking up the pharmacy on the Board of Pharmacy's Web site to determine its ownership and prescription department manager, and looking to see whether the pharmacists had valid licenses and a disciplinary history.
Id.
at 40-42. After an extensive
voir dire
by Respondent's counsel, Respondent objected to Mr. Parrado's being recognized as an expert in community pharmacy practice.
Id.
at 50. The ALJ properly overruled the objection, finding that Mr. Parrado was qualified to testify as an expert in retail pharmacy practice based on “his knowledge, skill, experience, training, and education.”
Id.
at 52.

On resumption of direct examination, the Government asked Mr. Parrado if there is “a specific protocol” that a pharmacist must follow “before dispensing a controlled substance?”
Id.
at 53-54. Mr. Parrado explained that a pharmacist “has to ensure that the prescription is valid,” and that under both the Florida Statutes and federal regulations, “a pharmacist has to ensure the prescription is valid by making sure that it was written by a doctor in the course of his professional practice and that it was for a legitimate medical purpose.”
Id.
at 54. Asked what a pharmacist is “required to look for on the actual prescription,” Mr. Parrado testified:

Well, there are certain requirements that have to be on a prescription. What creates a red flag is anything that causes a pharmacist concern about that prescription. . . . [T]here is a thing a pharmacist has to do before he fills a prescription that is called prospective drug review. He has to go over that prescription. He has to evaluate the prescription for appropriateness of therapy, for seeing if there is any therapeutic duplications of medications. Are there any drug/drug interactions? Are there any drug/disease interactions? Is the prescription for—does it show signs of clinical abuse or misuse? You know, that's just a basic thing a pharmacist does before he fills a prescription.

And then, knowing all the requirement of a prescription, what must be on that prescription as far as the patient name and address, the physician's name and address, the DEA number, the name of the medication, the strength, the directions, all those things, the quantity, have to be on that prescription.

Id.
at 54-55.

Asked by the Government to explain what a “red flag” is and to give examples, Mr. Parrado testified that “a red flag . . . is anything that would cause a pharmacist concern,” and that “[t]here are lots of things that lead to red flags” when a pharmacist is “trying to determine” if a prescription was issued “for a legitimate medical purpose.”
Id.
at 55-56. Mr. Parrado then identified multiple red flags, including, what he termed the “first red flag,” that being “the drug itself,” as there are “known drugs of abuse” that are being “commonly” abused.
Id.
at 56. Mr. Parrado then identified additional red flags to include: the “the dosing”; “[a] person travelling a long distance to acquire that drug”; “a person willing to pay a lot, a lot of money in cash to obtain that drug”; and “a person getting . . . certain cocktails of drugs.”
Id.
As to the latter, Mr. Parrado explained that:

A cocktail is multiple drugs . . . that are known to be abused on the street, and the most common . . . has a name, it's called the Holy Trinity, which would be oxycodone, which is an opioid, a benzodiazepine, which would be a tranquilizer such as Xanax, and a muscle relaxer like Soma. Those three together are well known combinations or cocktails that are abused on the street.

Id.

Next, the Government asked whether “a pharmacist look[s] at the actual amounts that are prescribed when determining whether there's a red flag on that prescription?”
Id.
Mr. Parrado answered that a pharmacist is “required by law . . . to make sure that the dosing is not excessive or inappropriate” and “[t]hat's one of our things that we are trained in.”
Id.
at 57. Continuing, Mr. Parrado explained that:

One of the things that a pharmacist knows or should know is that oxycodone . . . that 80 milligrams a day has been listed in the literature as a lethal dose for an opioid naïve patient. So, when being presented with a prescription for a dose that would exceed 80 milligrams in one day, that pharmacist would need to stop and take a look and verify that the patient is not opioid naïve and has been on a regiment [sic] that has led him to develop a tolerance to that dose.

Id.

Mr. Parrado further identified as a red flag the simultaneous prescribing of two immediate release opioids, which he stated “would be inappropriate therapy.”
Id.
at 58. He also identified as a red flag “pattern prescribing,” which he defined as “when I see the same medications, the same groups of medications, same combinations of medications in very similar quantities and very similar doses coming out of one . . . clinic.”
Id.
Continuing, Mr. Parrado testified:

When I see multiple people presenting with a very similar group or combination of prescriptions coming from one particular clinic, that is very much a red flag. That's not what happens in the average course of a day in a pharmacy. You don't see groups of people coming in from the same clinic, all getting the same drugs in large quantities and all willing to pay cash.

Id.
at 59.

Mr. Parrado identified a further red flag as “multiple people living in one household all receiving the same medications.”
Id.
Mr. Parrado then testified: “[i]s it possible? It could be, but it's just not—it doesn't happen on an everyday basis” and that he “would have to resolve [this red flag] before [he] could fill” the prescriptions.
Id.

Mr. Parrado testified that “the basic way of resolving a red flag is . . . to verify [the prescription] with the prescriber,” and that “you consult with the prescriber” and not his staff or nurse, “over your concerns.”
Id.
at 60. According to Mr. Parrado, the pharmacist must then “use [his/her] professional judgment” and ask “[d]id I believe what I just heard? . . . [Are] there any red flags in the conversation I just had?”
Id.
Mr. Parrado added that “I've had many, many instances where after a conversation with the physician I said absolutely I'm not going to fill that prescription.”
Id.

Mr. Parrado further testified that some red flags are unresolvable.
Id.
As an example of unresolvable red flags that would lead him to refuse to fill a prescription, he identified “a group of multiple people travelling a long distance, all getting the exact same or very similar prescriptions from one physician and all coming in with very, very large quantities of cash.”
Id.
at 60-61. Mr. Parrado then testified that “if you do see a red flag and you can resolve it, you document it on the prescription and then you fill it.”
Id.
at 61. Mr. Parrado reiterated that the resolution is written “[o]n the prescription itself.”
Id.

To counter Mr. Parrado's testimony as to the procedures a pharmacist must follow in dispensing controlled substances, Respondent called Dr. Sam Badawi. Dr. Badawi obtained his Doctor of Pharmacy degree from Samford University in 2002, and he is licensed to practice pharmacy in both Alabama and Florida, becoming licensed in the latter State in 2010. Tr. 346. He also

holds Juris Doctor degrees from both the Birmingham School of Law (2008) and Stetson University (2014), as well as an L.L.M. (2011) from Stetson in international intellectual property.
Id.

Mr. Badawi testified that he had worked as a full-time retail pharmacist in Alabama until sometime in 2004 or 2005, when he “transitioned into clinical pharmacy and IV infusion,” which involved working “with hospice patients who required intravenous pain prescriptions” and “morphine pumps.” Tr. 348. While Mr. Badawi asserted that he continued to work on a part-time basis in retail pharmacy, he subsequently went to work for Amgen, a biotechnology company where his duties involved clinical trial design.
Id.
at 366.

On
voir dire,
Mr. Badawi testified that while he had worked in retail pharmacy for about ten years, four of those years were as an intern. And while he then asserted that he had worked in retail pharmacy “from 02 all the way up to 08, when [he] moved to Florida,”
id.
372, his testimony was that for much of this time he worked only on a “floating” or “part-time basis.”
Id.
at 374. Mr. Badawi also acknowledged that when he worked at Amgen, as well as when he worked as a clinical pharmacy director, he did not interact directly with patients.
Id.
at 374-76. He further acknowledged that he had never taught pharmacy or published any articles; he also testified that his experience managing a pharmacy was limited to doing so on an interim basis “for a couple of months.”
Id.
at 376.

Mr. Badawi further acknowledged that he is not currently practicing pharmacy.
Id.
at 377. As for his experience testifying as an expert witness, Mr. Badawi testified that it is limited to a single criminal case in which he was listed as a witness but did not testify.
Id.
at 381. While the Government objected to Mr. Badawi's being qualified as an expert witness on the standard of pharmacy practice as it affects the dispensing of controlled substances, the ALJ overruled the objection and deemed him qualified “as an expert in the standard of [pharmacy] practice as to the effective dispensing of controlled substances.”
Id.
at 390.

On direct examination, Mr. Badawi testified that when a controlled substance prescription presents a red flag, “[a] reasonable, prudent pharmacist will follow the DEA [Pharmacist's] Manual,” which was published in 2010 and which at “page 67” lists criteria that “may be an indication . . . that [the] prescription was not issued for a legitimate medical purpose.”
Id.
at 391. Continuing, Mr. Badawi testified that “[a]nd you have six options. And then it tells you what to do.”
Id.
at 391-92. Mr. Badawi then referenced a Florida Board of Pharmacy Rule (Fla. Admin. Code r.64B16-27.831), which states that “a prescription that is not issued for a legitimate medical purpose is not a valid prescription,” and “gives you five different scenarios” before adding that “in a retail setting, I would follow first the DEA Manual.”
Id.
at 392.

Mr. Badawi then testified as to the prevention techniques listed in the Manual, which include “[k]now[ing] your patient . . . what's the story behind that patient,” “know[ing] your drug, and know[ing] the prescriber and the DEA.”
Id.
at 393. Mr. Badawi asserted that this is what a reasonably prudent pharmacist would do, ignoring that the Manual then states that “[w]hen there is a question about any aspect of the prescription order, the pharmacist should contact the prescriber for verification or clarification.” Pharmacist's Manual, at 67.

Mr. Badawi then testified that “[a] red flag is a caution sign for the pharmacist,” but “on its face alone does not mean the prescription is invalid.”
Id.
at 394. Continuing, Mr. Badawi testified that the Manual says that:

if any of these criterias [sic] are found . . . the prescription may not be issued for [a] legitimate medical purpose. So actually it's a caution sign. You stop and you look, meaning that you default back on your training, your knowledge, state laws, federal laws, common sense as a professional, and you exercise that professional judgment, meaning a discretion.

So after you stop with that red flag, and then you proceed with caution, and you exercise your discretion. So, if a pharmacist chooses to exercise that discretion favorably by resolving the red flag, then you dispense it. If not, then you don't dispense it.

Id.
at 395.

Respondent's counsel then questioned Mr. Badawi about the specific red flags identified by the Government's Expert and how a pharmacist should resolve the red flag.
Id.
at 395-96. As to how a pharmacist should resolve the circumstance where prescriptions are presented “from multiple individuals for the same or similar types of drugs [narcotics] in similar quantities,” Mr. Badawi acknowledged that this is a red flag.
Id.
Mr. Badawi then testified that a pharmacist should “fall back to the DEA Manual rules” and “[k]now the patient. So I have two patients with the same address from the same prescriber, so I would actually inquire into the circumstance of these two patients.”
Id.
at 396. Continuing, Mr. Badawi added that “then you want to know the doctor” and whether he is “a pain management” or “an ortho surgeon” and “[w]hat's the origination of that prescription?”
Id.
According to Mr. Badawi, if the pharmacist still had doubts despite knowing this:

you pick up the phone and ask to speak to the prescriber to find out more of the story because sometimes your patients are not going to tell you everything. So I don't want to miss the whole picture. So I would call the prescriber and verify. And if I still have doubts, I would not dispense that prescription. So that goes all under professional judgment, not just looking at the piece of paper and making a decision.

Id.
at 396-97. Mr. Badawi maintained, however, that this red flag could be resolved and the prescription could be dispensed.
Id.
at 397.

Respondent's counsel then asked Mr. Badawi whether the fact the drug alone was for oxycodone 30 mg was a red flag of the prescription's potential illegitimacy.
Id.
at 397-98. While Mr. Badawi initially answered that “[t]he drug by itself, no,” he then testified that a Board of Pharmacy Regulation “says that if the patient, all he or she is getting [is a] controlled substance, the oxycodone by itself could be under Florida law a red flag because it meets that criteria.”
Id.
at 399. Then asked what a pharmacist should do to meet the standard of practice where a patient presents only a prescription for oxycodone 30 mg, Mr. Badawi answered: “Know your patient. So I would actually look into the patient profile history of that patient” to see “if there are any notes being documented in the computer from prior pharmacists that actually dispense [sic] for this individual.”
Id.
Mr. Badawi then explained that one of the reasons for reviewing the patient profile is that “there are certain drugs” that you “want to steer away from opioid-naïve patients” and that a pharmacist “want[s to] make sure that the patient is able to tolerate the drug because it's a CNS-depressant.”
Id.
at 400. Mr. Badawi also explained that the pharmacist must review the patient profile to determine whether there are any “drug-drug interactions.”
Id.
at 401.

Mr. Badawi acknowledged his agreement with Mr. Parrado's testimony that a prescription that calls for the dispensing of a “very large or larger than normal amounts of a narcotic” raises a red flag which requires that the pharmacist make an inquiry.
Id.
at 402-03. He also acknowledged that a narcotic prescription which provides for dosing that is “larger-than-normal,” or “larger-than the manufacturer's recommended dosage” also creates a red flag which requires the pharmacist to

look at the patient profile and determine if the patient has developed tolerance.
Id.
at 403-04. Mr. Badawi then explained that the doses of patients being treated with narcotics “typically increase[ ] over time to achieve the pharmacological effect and also with respect to tolerance,” and it “very common” for a patient to be prescribed both an extended release drug and immediate release drug “for breakthrough pain.”
Id.
at 404.

As for the circumstance of a patient presenting prescriptions for two short acting narcotics, Mr. Badawi testified that he “would consider it as a red flag, and I would investigate further, and I would exercise my professional judgment.”
Id.
at 418-19. When later asked on cross-examination, what possible explanation there could be for a patient to be prescribed two short-acting opiates together, Mr. Badawi suggested that a patient with kidney failure who is undergoing dialysis three times a week may require a combination because “the drug is being excreted by the kidneys.”
Id.
at 435-36.

Mr. Badawi further testified that it is “common for physicians to issue prescriptions for [schedule II] drugs without the address being on the face of the prescription.”
Id.
at 406. However, he testified that DEA had issued guidance that a pharmacist is to look at his/her State's rule” to determine whether the patient's address could be added to the prescription.
Id.
at 406-07.

As for how a pharmacist would address the circumstance in which a patient lives “a significant distance . . . from the pharmacy,” Mr. Badawi testified that “you want to know the patient, the reason why they're 100 miles way.”
Id.
at 407-08. Mr. Badawi then suggested that the patient could be “on a special assignment to MacDill Air Force Base,” which is located in South Tampa; that the patient could be a snowbird and that Florida has “a lot of snowbirds”; the patient could be on a three-month job assignment in Tampa or “moving in with his fiancée.”
Id.
at 408. Mr. Badawi then testified that he was “not discounting that” this “is a red flag,” and that a pharmacist should “investigate more.”
Id.
He then maintained that “there is a professional judgment for the pharmacist to exercise, and based on the fact, you act accordingly.”
Id.
And he further asserted that the proximity of the prescribing doctor to the pharmacy could explain why the patient who had travelled a long distance was filling the prescription at the pharmacy.
Id.
at 409.

Later, in response to a question by the ALJ, Mr. Badawi maintained that even if the patient was travelling a long distance, if the patient was a regular patron, “that would actually resolve the distance.”
Id.
at 437-38. However, after again testifying that the pharmacist should know his patient, the prescriber and the medical condition, Mr. Badawi explained that the pharmacist “may want to inquire more about the patient [sic] reasons for being in hypothetically Tampa.”
Id.
at 438.

Asked what types of prescriptions a reasonable pharmacist would “expect to see” when “there is a pain management facility that is seeing a large number of patients for chronic pain,” Mr. Badawi testified that a pharmacist would expect the prescriptions to be for “primarily opioids.”
Id.
at 416. Then asked what a pharmacist should do “to adhere to the standard of practice . . . and address that issue,” Mr. Badawi testified that “when I was there, most of the patients . . . were regulars, and they were getting it actually on set intervals.”
Id.
at 416. As for “a new patient, you would go through ID verification [and] [y]ou would actually have them fill out more of a history, diagnosis.”
Id.
at 417. Mr. Badawi then agreed with Respondent's counsel's suggestion that knowing that the clinic administered random drugs screens would “assist a reasonable pharmacist.”
Id.
Asked what other information a pharmacist would want to know about the practices of a pain management clinic, Mr. Badawi testified that a pharmacist would want know that the practitioners “hold a valid DEA license” and that the clinic has “an active state license to conduct business.”
Id.
at 418. Continuing, Mr. Badawi explained that “you utilize the [Prescription Drug Monitoring Program] and the patient profile. So it's the totality of the circumstances, not just one angle, like a tunnel vision, when you actually want to verify these red flags.”
Id.

Mr. Badawi then testified that standing alone, none of the red flags identified by the Government's Expert render a prescription invalid.
Id.
at 419. He then explained that “[r]ed flags are meant for the pharmacist to stop and inquire. So, now, if you have a combination thereof, not just one flag, maybe the weight of the inquiry is probably more than just one red flag.”
Id.
at 419-20. He then testified that none of the red flags or combinations thereof identified by the Government's Expert required that the pharmacist reject the prescription.
Id.

Mr. Badawi then testified that with the exception of a Board rule which requires a pharmacist to make a photocopy of a patient's identification, or if a copier is not available, to document descriptive information on the back of a prescription, there is no requirement that a pharmacist document his resolution of a red flag on the prescription.
Id.
at 421. Asked whether it is the standard practice for a pharmacist to document how he/she resolved every red flag, Mr. Badawi answered:

. . . I don't know if you could document every single thing. I mean, you pick your battles. You want to document the major issues, and documentation nowadays, especially with these computer systems that would make you approve a prescription via a thumbprint scan, you don't even have to put a code on the computer anymore. These electronic records are kept.

I would rather, as a reasonable, prudent pharmacist, and to benefit my other colleagues who are working after my shift, to have access to this documentation is to have it on the computer under the patient notes so they can see what I've done versus the paper trail.

Id.
at 422. However, when asked on cross-examination if it is “within the standard of practice . . . to not document how a red flag is resolved,” Mr. Badawi answered: “No, it is not in the standard of practice to make a blanket statement and not to document any red flags that are being resolved.”
Id.
at 436-37.

Mr. Badawi also testified that he had attended a presentation by Mr. Parrado two years earlier on dispensing controlled substances, during which Mr. Parrado “said there is a lot of gray area, it's not black or white, and to always use your professional judgment.”
Id.
at 425. According to Mr. Badawi, during the presentation Mr. Parrado did not mention that the distance a patient travels is a red flag and that Mr. Parrado also told the attendees that “there is no ceiling on” the quantity of narcotics that a patient can be prescribed.
Id.
at 426. Mr. Badawi also testified that Mr. Parrado did not identify as a red flag the circumstance of a prescription missing a patient's address.
Id.
at 426-27. He also asserted that Mr. Parrado did not identify as a red flag the circumstance of patients residing at the same address.
Id.
at 427. While the Government objected to Mr. Badawi's testimony regarding the presentation on the ground that it had not been disclosed in advance of the hearing, to which Respondent's counsel asserted that this testimony was offered to impeach Mr. Parrado,
id.
at 424-25, 427; the ALJ overruled the objection.
Id.
at 427.

On cross-examination, Mr. Badawi acknowledged that he had not looked at any of the prescriptions.
Id.
at 430. Nor did he look at any of the patient profiles.
Id.
Asked if “traveling hundreds of miles to see a physician is

a potential red flag,” Mr. Badawi testified: “It's not a potential red flag. It is a red flag.”
Id.
When then asked if travelling hundreds of miles to see a physician whose clinic was affiliated with the pharmacy was a red flag,
id.,
Mr. Badawi testified that the affiliation raised a separate issue regarding possible “kickbacks and Stark laws,” but that “has nothing to do with the controlled substance dispensing.”
Id.
at 431. However, after again agreeing that distance “is a red flag,” Mr. Badawi stated that “[i]f they're sending patients in the back door and the pharmacists suspect that's a red flag, that's a separate issue on its own.”
Id.

On questioning by the ALJ, Mr. Badawi acknowledged that there are some red flags that are not resolvable such as a prescription for some astronomical number of a drug such as morphine.
Id.
at 439. As an example, he testified: “a 12-year old with [a] high doses of opioids, maybe in the hundred, for a broken bone. That seems excessive. So I would actually consult with the physician.”
Id.
Mr. Badawi did not, however, explain what action he would take if the physician asserted that the prescription was legitimate.

As another example of an unresolvable prescription, Mr. Badawi offered where “there is any drug-drug interactions that would deem that the prescription is not in the best interests of the patient.”
Id.
However, in Mr. Badawi's view, this involved a “medical issue” and “therapeutic appropriateness” and “not necessarily the validity of the prescription.”
Id.
As an example, he then identified a patient being prescribed opioids when she was pregnant because even though the prescriptions may have been valid “medically speaking,” the fetus could be born addicted.
Id.
at 440. Mr. Badawi did not, however, address whether the simultaneous prescribing of drugs such as oxycodone 30, alprazolam, and carisoprodol also raises an issue of drug-drug interactions.

As between Mr. Parrado's and Mr. Badawi's testimony, there was substantial agreement on a number of issues. Where, however, there are areas of disagreement, I generally find that Mr. Parrado's testimony was more credible based on his years of service on the Florida Board of Pharmacy and because his experience in retail pharmacy is far lengthier and more current than that of Mr. Badawi.

The Prescription Evidence

At the hearing, the Government introduced into evidence copies of the front and back of 83 prescriptions for schedule II controlled substances which it alleged were dispensed by Respondent's pharmacists in violation of 21 CFR 1306.04(a) because they presented red flags which were not resolved.
See
GXs 3, 13, 14, and 15. Nearly all of the prescriptions were issued by physicians at the 24th Century Medical Center,
10

which was located at 7747 W. Hillsborough Ave. in Tampa,
id.,
a short walk from Respondent. According to a DEA Intelligence Research Specialist (IRS) who reviewed data that came from Respondent's dispensing software, 1,460 patients filled a total of 4,287 schedule II prescriptions at Respondent between January 3, 2011 and February 2, 2013. GX 12, at 2; Tr. 219. The IRS further determined that 3,867 of these prescriptions—more than 90 percent—were written by six doctors who worked for Victor Obi. Tr. 219, 223; GX 12, at 2. These doctors include S. A.-H., P.C., R.R., H.D., V.S., and J.E., who worked at the 24th Century clinic. According to the online records of the Florida Department of Health, 24th Century is a pain management clinic which has been owned by Mr. Obi since January 4, 2010.
11

10
Throughout this decision, the 24th Century Medical Center is also referred to as the 24th Century clinic and 24th Century.

11
I take official notice of the online records of the Florida Department of Health which establish that Victor Obi-Anadiume is the owner of 24th Century Medical Center and has been since January 4, 2010. Under 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). In accordance with the APA and DEA's regulation, Respondent is “entitled on timely request to an opportunity to show to the contrary.” 5 U.S.C. 556(e);
see also
21 CFR 1316.59(e). Respondent may dispute my finding by filing a properly supported motion within fifteen calendar days of this Order which shall commence on the date this Order is mailed.

For example, the Government introduced a prescription issued by Dr. P.C. of the 24th Century Medical Center on July 28, 2011 to T.V. for 210 oxycodone 30 mg, which Respondent filled the same day. GX 3, at 1. While T.V.'s address was not written on the prescription, the prescription bears an address label listing T.V.'s address as being in Pensacola, Florida, a distance of 472 miles from Respondent. R.D. at 6.

Mr. Parrado testified that the prescription presented several red flags, including the lack of the patient's address; that it was for oxycodone 30 mg, a known drug of abuse; and that it was for a minimum of 180 milligrams a day, which is “well above the 80 milligrams threshold” and “a very high dose” and large quantity. Tr. 63. Mr. Parrado then noted that the patient's address was in Pensacola, 472 miles from Respondent.
Id.
at 64; R.D. at 6.

Mr. Parrado testified there was no indication on the prescription that “anything was done . . . except that it was filled.”
Id.
Asked whether it was possible to resolve the various red flags, Mr. Parrado replied that it was possible, “but it would have taken a lot of investigation” and that he “would have had to have a good reason why that patient had to travel all the way to this clinic to get a prescription filled.”
Id.
at 64-65. Continuing, Mr. Parrado stated that he could “see if a patient is driving that far because they're . . . see[ing] a specific physician that has a specialty that's not available anywhere else.”
Id.
at 65. Mr. Parrado subsequently testified that he was not aware that the physician has any specific specialty.
Id.
at 68. After the ALJ properly overruled Respondent's counsel's objection that Mr. Parrado was testifying beyond the scope of his expertise, the ALJ asked “what would indicate on a prescription to you as a pharmacist of what you're looking for in this physician?”
Id.
at 69. Mr. Parrado answered:

. . . When I look at a prescription, I look and see where it came from. . . . You know a pharmacist has to exert his professional judgment on all prescriptions before he fills them. So I would be looking to see . . . I'm looking at a high dose of a very strong opioid narcotic. Where is that coming from . . . ? Is that coming from a cancer center, from an orthopedic office, somebody just had a big surgery? . . . I look for things like that, and I didn't see anything like that on here or I didn't see anything on this prescription that would indicate that a pharmacist had called to verify any of those things.

Id.
at 69-70.

Next, on August 4, 2011, Dr. S.A.-H., also of the 24th Century Medical Center, issued a prescription to J.P. for 196 oxycodone 30 mg; Respondent filled the prescription the same day. GX 3, at 2. Here too, J.P.'s address was not written on the prescription; rather a label was attached which listed J.P.'s address as being in St. Augustine, Florida, a distance of 196 miles from Respondent.
Id.;
R.D. at 6.

Asked if the prescription presented any red flags, Mr. Parrado identified the lack of the patient's address; that is was written for oxycodone 30, “a known drug of abuse”; that “it's a very high quantity”; that the patient lived “a rather good distance” from Tampa; that it came from the 24th Century clinic; and that “[t]he patient paid $784 in cash.”
Id.
at 70-71. As to the cost of the prescription, Mr. Parrado testified that:

You don't see people paying $784 in cash. You tell a person they have a $50 co-pay and

they go ballistic on you. And for a person to willingly pay $784 and not have any documentation as to why they did that and to see that over and over every day is a concern to me. . . . That's a red flag that I couldn't resolve.

Id.
at 71. Mr. Parrado then explained that “there were multiple red flags on here” and that “[a]ny attempt to have . . . done anything with them to resolve them would have been documented on the prescription.”
Id.
at 71-72. However, Mr. Parrado “did not see any documentation on this prescription that led me to believe anything was done.”
Id.

Also on August 4, 2011, Dr. P.C. of the 24th Century Medical Center issued a prescription to T.P.—who has the same last name as J.P.—for 224 oxycodone 30 mg; Respondent filled the prescription the same day. GX 3, at 3. Here too, T.P.'s address was not written on the prescription; rather a label was attached which listed her address as also being in St. Augustine, Florida.
Id.;
R.D. at 6. Moreover, Respondent`s dispensing software assigned the number 2037897 to J.P.'s prescription and the number 2037898 to T.P.'s prescription. GX 3, at 2-3.

Asked if T.P.'s prescription presented any red flags, Mr. Parrado testified that “[h]ere we have two people with the same last name traveling from St. Augustine . . . to get very similar prescriptions.” Tr. 72. After noting the quantity of each prescription, Mr. Parrado testified that there were “the same red flags as before. No address, the known drug of abuse, the high quantity, traveling the long distances” and that T.P. “paid $896 in cash.”
Id.
According to Mr. Parrado, T.P.'s prescription “was the very next prescription entered” in the dispensing software after J.P.'s.
Id.
at 74.

Also on August 4, 2011, Dr. P.C. issued a prescription for 240 oxycodone 30 to W.J.; Respondent filled the prescription the same day. GX 3, at 4-5. Here too, W.J.'s address was not written on the prescription and had been added by a label which listed his address as being in San Antonio, Florida, a distance of 36 miles from Respondent.
Id.;
R.D. 6.

Mr. Parrado testified that the prescription presented red flags which included the lack of the patient's address; that the drug was for oxycodone 30, a known drug abuse; that the quantity was very high; that the patient was travelling from a town which is “40 miles from Tampa”; that the patient paid $960; that the prescription was written by a doctor from the same clinic; and that the prescription number (2037895) preceded the numbers on the prescriptions presented to J.P. and T.P. Tr. 75. Mr. Parrado explained that “[t]hese were all filled on the same day, so you have multiple prescriptions coming in from people travelling a long way, from the same clinic, for very similar drugs, and paying in cash, very large quantities of cash.”
Id.
at 75-76. Mr. Parrado then testified that there was no evidence on the prescription that the red flags were resolved.
Id.
at 76.

On July 29, 2011, Dr. S.A.-H. issued a prescription for 140 oxycodone 30 to W.D.; Respondent filled the prescription the same day. GX 3, at 6-7. Here again, the prescriber had not written W.D.'s address on the prescription and his address was added by label which listed it as being in St. Cloud, Florida, a distance of 92 miles from Respondent.
Id.; see also
R.D. at 6. Mr. Parrado testified that the prescription presented “the exact same red flags as . . . the previous prescriptions,” and that there was no documentation that the red flags were resolved. Tr. 76-77.

Mr. Parrado provided testimony to the effect that other prescriptions in GX 3 presented the same red flags as he had previously identified. These included two prescriptions written on July 29, 2011 by Dr. P.C. for 168 oxycodone 30 to C.D. and 224 oxycodone 30 to D.M., as well as two prescriptions written by Dr. S.A.-H. the same day for 168 oxycodone 30 to B.P. and 224 oxycodone 30 to C.C. GX 3, at 8-15. Respondent dispensed the prescriptions the same day. GX 3, at 8-15. As written, none of the prescriptions contained the patient's address.
See id.
at 8, 10, 12, and 14. However, the prescriptions bear labels which show that C.D. and B.P. lived in Gainesville, 134 miles from Respondent; D.M. lived in Hudson, 36 miles from Respondent; and C.C. lived in Spring Hill, 42 miles from Respondent.
See id.; see also
R.D. at 6.

Mr. Parrado testified that these prescriptions raised an additional red flag, in that he was “starting to see a pattern . . . coming from this one clinic of the same prescriptions” and that “[t]here is no individualization of therapy, which is important.” Tr. 80. He also testified that he did not see any evidence that the red flags were resolved.
Id.
at 82.

On April 21, 2011, Dr. P.C. issued a prescription for 196 oxycodone 30 to C.B., which Respondent filled the same day. GX 3, at 16. Again, Dr. P.C. did not write C.B.'s address on the prescription.
Id.
According to the address label, C.B. lived in Big Pine Key, which is near Key West and a distance of 400 miles from Respondent.
Id.;
R.D. at 6. Mr. Parrado testified that he did not see any evidence that the red flags were resolved.
Id.
at 82.

Also on April 21, 2011, Dr. R.R. issued a prescription for 224 oxycodone 30 to S.S., which Respondent filled the same day. GX 3, at 17. Dr. R.R. did not write S.S.'s address on the prescription.
See id.
According to the address label, S.S. lived in Lakeland, a distance of 44 miles from Respondent.
Id.; see also
R.D. at 7.

After testifying that the prescription raised the same red flags as the previous prescriptions, Mr. Parrado explained that there was documentation on the prescription that the pharmacist had dispensed two different brands. Tr. 82-83;
see also
GX 3, at 17. However, Mr. Parrado did not see any evidence that the red flags were resolved.
Id.
at 83.

Pages 18 through 25 of Government Exhibit 3 contain copies of eight prescriptions which were also written on April 21, 2011 by physicians from the 24th Century clinic for oxycodone 30 (in quantities that range from 140 to 240 tablets) and filled the same day. As with the previous prescriptions, none of the prescribers wrote the patient's address on the prescription; instead, the prescriptions bear a label with the address.
See
GX 3, at 18-25. Asked whether these prescriptions presented any additional red flags, Mr. Parrado testified that:

It's just another day of doing the same thing. Yeah, could something like this happen once occasionally a person travels a long way and pays cash? Of course. Does it happen consistently day after day after day? No. That's what would be a nonresolvable red flag.

Tr. 84.

The Government then asked Mr. Parrado if he knew where Hudson is in relation to Tampa.
12

Tr. 85. Mr. Parrado answered that it is 30 to 40 miles on the way to New Port Richie (which was the town or residence of one of these patients).
Id.
The Government then asked why it would “be a red flag if it's just 30 miles?”
Id.
Mr. Parrado explained:

12
None of the patients whose prescriptions are reproduced at pages 18 through 25 resided in Hudson.
See
GX 3, at 18-25. Rather, the patients were from Tampa, Wildwood (79 miles), Dunedin (14 miles), Palm Harbor (14 miles), New Port Richey (25 miles), Port Richey (26 miles), Gainesville (134 miles) and Lutz (18 miles). R.D., at 6-7.

It's not so much just the red flag, it's the rapidity of people coming from other cities. You know, there's a lot of physicians' office, a lot of pharmacies between Hudson and Tampa. Why did they choose this pharmacy? That would have been the red flag I would have wanted resolved.

Id.
Mr. Parrado then testified that he did not see any documentation that the red

flags presented by the April 21, 2011 prescriptions had been resolved.
Id.

Next, the Government asked Mr. Parrado about the price of a prescription written by Dr. H.V.D. (also of 24th Century) on January 16, 2012 for 224 tablets of oxycodone 30, which Respondent filled the same day.
13

Tr. 86. The price of the prescription was $1,232.
Id.; see also
GX 3, at 28. The Government then asked Mr. Parrado if he had “any independent knowledge of what oxycodone normally sold for at that time?” Tr. 86. Respondent objected to the question on the basis that there was no foundation as to Mr. Parrado's knowledge.
Id.
While the ALJ sustained the objection she allowed the Government to establish a foundation.
Id.
at 87. The Government then asked Mr. Parrado if, in his “view as an experienced pharmacist,” the price was “a red flag.”
Id.
Mr. Parrado answered “yes,” and explained:

13
Here too, the patient's address was added by a label and had not been written by the physician; the label shows that the patient lived in Floral City, Florida, 63 miles from Respondent. GX 3, at 28.

It's a very high price. I do know that about this time, in this timeframe, 2012, average wholesale price of oxycodone ran anywhere between $33 100 to maybe, depending on what wholesaler you went to, it could run as high as $150, $200 100. But that would still—this price would still be far exceeding anything that I would have ever, ever considered charging.

Id.
at 87-88. Mr. Parrado subsequently testified that “I cannot say in my 40 plus years as a pharmacist I have ever sold a prescription for $1,232 cash. That's just not something I've ever seen in my practice.”
Id.
at 89. Mr. Parrado then testified that he was practicing pharmacy “[i]n 2012.”
Id.
Asked to look at the prescriptions reproduced at pages 29 and 30, both of which were written by doctors with 24th Century, Mr. Parrado testified that they presented the same red flags.
14

Id.

14
The first of these prescriptions was written by Dr. R.R. on January 18, 2012 for 224 oxycodone 30. GX 3, at 29. The patient's address was added by a label and showed that he lived in Dunnellon, Florida, 88 miles from Respondent.
Id.; see also
R.D. at 7. The patient paid $1232 for the prescription. GX 3, at 29.

The second prescription was written by Dr. P.C. on January 19, 2012 for 168 oxycodone 30. GX 3, at 30. The patient's address was added by a label and showed he lived in Inglis, Florida, 80 miles from Respondent.
Id.; see also
R.D. at 7. The patient paid $966 for the prescription. GX 3, at 30.

Next, the Government asked Mr. Parrado about two Dilaudid (hydromorphone
15

) prescriptions which were written by Dr. R.R. of 24th Century on October 10 and 13, 2011, which Respondent filled. GX 3, at 31-32. The first prescription authorized the dispensing of 240 tablets of Dilaudid 8 mg to D.K.; the second authorized the dispensing of 196 tablets of Dilaudid 8 mg. to G.C.
16

See id.
The labels for both prescriptions included the initials “KG,” thus indicating that they were dispensed by Kasey George, Respondent's PIC.

15
Mr. Parrado testified that “[h]ydromorphone is the generic name of Dilaudid.” Tr. 92.

16
As before, Dr. R.R. did not write either patient's address on the prescription. GX 3, at 31-32. Labels attached to the prescriptions show that D.K. lived in Clearwater, a distance of 19 miles from Respondent, and that G.C. lived in Largo, a distance of 21 miles from Respondent.
See id.;
R.D. 7.

Asked whether these prescriptions presented any other red flags, Mr. Parrado testified:

Yeah. For starters, the drug. Dilaudid 8 milligram, extremely, extremely potent opioid. From my education, experience, and training, the average daily dose of Dilaudid would be probably between 12 and 24 milligrams a day. It would be a dose that would be a high dose because mostly people don't take Dilaudid 8 milligrams unless they're in a terminal stage of cancer. . . . [T]hat's just a drug that's very rarely dispensed anymore because of the potency, especially in that quantity. And to see a patient come in and get 200 plus of these tablets would be a . . . concern. To see multiple prescriptions for 200 tablets would be almost a nonresolvable red flag to me.

Tr. 90. Mr. Parrado further clarified that his opinion regarding the quantity applied to both prescriptions.
Id.
at 91. He then testified that he saw no evidence that the red flags had been resolved and added that the dose “is almost double the recommended upper daily dose.”
Id.

On January 19, 2012, Dr. R.R. of 24th Century issued a prescription for 120 oxycodone 30 to S.D. GX 3, at 33. According to the address label (Dr. R.R. again not having written the patient's address on the prescription), S.D. lived in Panama City, Florida. GX 3, at 33. Mr. Parrado testified that Panama City is in the western panhandle of Florida, and the parties stipulated that it is 331 miles from Respondent. Tr. 92; R.D. at 7. Mr. Parrado again found no evidence that the red flags had been resolved. Tr. 93.

Continuing, the Government questioned Mr. Parrado about prescription labels found at pages 34 and 35 of its Exhibit 3 which showed the prices Respondent was charging for oxycodone 30 in late April 2011 and in early December 2011. Specifically, the evidence showed that in late April 2011, Respondent was charging $3.75 for a tablet of oxycodone 30, but that in early December 2012, it was charging $7.50 a tablet. GX 3, at 34-35. Mr. Parrado explained that he determined the price per tablet because he knew “in that time frame that the wholesale costs had not doubled.” Tr. 96. Mr. Parrado then testified that the price Respondent charged raised a red flag.
Id.
at 96-97. However, after recognizing that “we don't have the prescription,” the Government did not ask whether there was any evidence that the red flags had been resolved.
Id.

The last page of Government Exhibit 3 contains the front and back of a prescription (dated April 25, 2011) which was written by a doctor from Tampa who was not affiliated with 24th Century. GX 3, at 36. The prescription authorized the dispensing of 120 tablets of methadone 10 mg for pain to B.V. but did not list B.V.'s address.
Id.
Of note, the front of the prescription contains the notation: “verified by Dave” with the date and time.
Id.
The back of the prescription contains a photo copy of a state-issued identification card and the prescription label which list B.V.'s address as Riverside, Florida.
Id.
According to the stipulation, Riverside is 200 miles from Respondent. R.D. at 7.

After noting that the prescription “had some documentation that somebody verified something,” Mr. Parrado testified to the effect that it was unclear what the pharmacist verified. Tr. 97;
see also id.
(“What does this mean? What did they verify? Who is this somebody? Was that the prescriber? You know, what were they verifying?”). Then asked what red flags were presented by the prescription, Mr. Parrado testified:

Methadone . . . it is a drug that . . . it's being abused on the street. There's a lot of concern. I have a lot of concern about the use of . . . methadone because of the pharmacokinetics of the drug and the way it acts on patients. And . . . taking two tablets every 12 hours would probably be okay. I would want to verify with the doctor if the patient had developed a tolerance to this. I've seen people that have overdosed and died on methadone on the third dose of methadone because of the kinetics of that drug.

Id.
at 97-98. Subsequently, Mr. Parrado reiterated his testimony that he did not know what the pharmacist had verified with respect to the prescription and that he did not see any evidence that “red flag of distance” had been resolved.
Id.
at 102.

Thereafter, the Government showed its Exhibit Number 13 to Mr. Parrado. This exhibit includes 20 prescriptions for schedule II narcotics including oxycodone 30, MS Contin 30 (morphine sulfate continuous release), and Dilaudid in both eight and four milligrams per dosage unit.
See generally
GX 13. Each of the prescriptions was issued by a physician with 24th Century between April 14 and 20, 2011, and on each of the

prescriptions, the patient's address had not been written on the prescription but had been added by a label.
Id.

Also, each prescription presented the issue of the distance travelled by the patient, with the closest any patient resided being in Tarpon Springs, a distance of 18 miles to Respondent.
See
GX 13, at 23; R.D., at 7. The other patients lived in Brooksville (46 miles), Gainesville (134 miles), Newberry (145 miles), Ocala (100 miles), High Springs (158 miles), Spring Hill (42 miles), Sarasota (58 miles), Weeki Wachee (48 miles), Silver Springs (107 miles), Dunnellon (88 miles), and Lecanto (70 miles).
See generally
GX 13; R.D. at 6-7.

Asked by the Government whether the GX 13 prescriptions raised the same or additional red flags, Mr. Parrado answered: “[i]t's all the same.” Tr. 105. After noting that one of the prescriptions was for a patient from Dunnellon, Mr. Parrado then testified that he did not see any indication that the red flags had been resolved.
Id.
at 105-06.

Next, the Government asked Mr. Parrado about two prescriptions issued on January 8, 2013, by Dr. P.C. to B.W. and filled by Respondent the same day. Tr. 107-8; GX 14, at 1-5. The prescriptions were for 100 Dilaudid 8 mg and 60 methadone 10 mg. GX 14, at 1-4. While Dr. P.C. was not affiliated with 24th Century, he also failed to include B.W.'s address on the prescriptions; however, both prescriptions bear an address label which lists B.W.'s address as Tallevast, Florida, which is 54 miles from Respondent.
Id.,
at 2, 4; R.D. 7. The evidence also showed that B.W. presented a Florida Identification Card. GX 14, at 5.

Asked if these prescriptions presented any red flags, Mr. Parrado testified that the dosing instruction on the Dilaudid prescription called for taking one tablet every four hours, which would result in a daily dosage of 48 milligrams, “double the upper recommended dose.” Tr. 107. Mr. Parrado then noted that the prescriptions raised an additional and serious concern because both Dilaudid and methadone were being prescribed and both drugs “are immediate release opioids . . . which could contribute to respiratory depression.”
Id.
Mr. Parrado subsequently testified that B.W.'s address and presentation of an identification card raised additional issues that “a reasonable pharmacist [would] want to investigate.”
Id.
at 110.

The record includes prescriptions for 75 Dilaudid 8 mg and 90 methadone 10 mg issued on January 21, 2013, by Dr. E.G.-R. (who was not affiliated with 24th Century) to T.F. of Brooksville; Respondent filled the prescriptions the same day. GX 14, at 7-8. While the back of each prescription includes a handwritten notation dated “1/21/13,”
id.
at 8, Mr. Parrado testified that he did not “know what that is” and the notation “doesn't tell me anything.” Tr. 110. After testifying that the distance in miles between Brooksville and Tampa is “maybe 30, 40 miles,” Mr. Parrado testified that it is “not so much the distance” but that “it's not an easy drive” as there are “a lot of stop lights and a lot of traffic to get” to the doctor's clinic, which was located “several miles” from Respondent.
Id.
at 111. Mr. Parrado then explained that he would want to know why the patient had “come there,” that he “would have had concern” as to the methadone dose, and that he “would have wanted to verify” why the doctor had prescribed “two immediate release medications.”
Id.
However, Mr. Parrado did not see any evidence that the red flags were resolved.
Id.

Mr. Parrado testified that while a prescription (GX 14, at 11-12), which was written by Dr. S.A.-H. of 24th Century, was for “only 90 tablets” of oxycodone 30 mg, the patient's address was in Middleburg, Florida, which is “a good ways from Tampa.” Tr. 111. According to the stipulation, Middleburg is 175 miles from Tampa. R.D. at 7. Mr. Parrado also testified that the price of the prescription, “$675 for just 90 tablets[,] seems like a very high price.” Tr. 112.

Aside from the first four prescriptions in GX 14, each of the remaining 16 prescriptions was written by a doctor with the 24th Century clinic.
See
GX 14, at 11-42. Asked if the red flags of “the distance where the patient lived” and “the fact that they came from the same clinic” were “inherent in all” of the 16 prescriptions, Mr. Parrado answered “yes,” and that he did not “see any evidence of any kind of documentation” that the red flags were resolved. Tr. 112-13.

While the back of each of the prescriptions issued by the 24th Century physicians also contains checkmarks or scribble, Mr. Parrado testified that “that just looks like they're verifying the quantity and possibly the directions, but . . . not addressing the red flag.”
Id.
at 113. Mr. Parrado then explained that “[i]t's common for pharmacists when they're verifying a prescription . . . before a prescription can be dispensed, the pharmacist has to look at [it] to make sure the right drug is being dispensed, the right quantity, directions are correct on the label. That looks like that's what was being checked off there.”
Id.

Government Exhibit 15 contains an additional 13 prescriptions. GX 15. The first two prescriptions were written by Dr. V.S. on January 28, 2013 to J.A. and were for 56 Adderall 30 mg and 84 Dilaudid 8 mg.
Id.
at 1, 3. While the prescriptions list Dr. V.S.'s affiliation as the MD Plus Clinic in Lakeland, Florida,
id.,
Dr. V.S. was also listed as one of the prescribers affiliated with 24th Century. GX 3, at 33; GX 13, at 1.
Id.
On neither prescription did Dr. V.S. write J.A.'s address; according to the labels attached to the back of each prescription, J.A. resided in Winter Haven, which is 60 miles from Respondent. GX 15, at 2, 4; R.D., at 7.

Mr. Parrado testified that Adderall is a stimulant and that the patient was “getting an upper and downer together.” Tr. 114. Asked if this was a red flag, Mr. Parrado testified that “I would have wanted to know why they were giving an upper and a downer together. Maybe the patient was having some kind of narcolepsy . . . from one drug to cause him to need a stimulant from the other side, but I would have expected to see some documentation on that.”
Id.
Mr. Parrado then testified that Winter Haven is “a very long way from Tampa,” although he erroneously stated that the distance was “a hundred plus miles.”
Id.
He then testified that he did not see any evidence that the red flags were resolved.
Id.
at 115.

As for the rest of the prescriptions in GX 15, the patients lived in Citra (117 miles from Respondent), Brooksville (46 miles), Gainesville (134 miles), Tarpon Springs (18 miles), Ocala (100 miles), Nokomis (79 miles), and Newberry (145 miles). GX 15, at 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26. Mr. Parrado testified that the distances travelled by the patients raised red flags and that he did not see any evidence on the prescriptions that there was any attempt to resolve the red flags. Tr. 116.

Asked by the Government whether Respondent's pharmacists “exercise[d] the appropriate standard of care in the State of Florida,”
id.
at 119-20, Mr. Parrado testified:

No. In my opinion, there are multiple things that a pharmacist has to do before he dispenses a prescription. He has to establish the appropriateness of the therapy. He has to discuss the . . . excessive and inappropriate quantities. He has to assess the therapeutic duplication of the two immediate release medications, all of which are in the laws and rules of the practice of pharmacy.

* * *

There are probably four or five other notations in the Florida law that things the pharmacist would have had to have done to verify the prescription and make sure it was

appropriate and everything was correct before he dispensed it, and I didn't see where any of that was done. Therefore, I didn't think he reached the standard of care.

Id.
at 120. After a series of objections to the Government's questions were sustained by the ALJ, Mr. Parrado subsequently testified that he “would not have dispensed these [prescriptions] without having resolved any of the red flags.”
Id.

On cross-examination, Mr. Parrado acknowledged that every red flag he had “talked about . . . could potentially be resolved.”
Id.
at 127. He further acknowledged that there are millions of people who do not have insurance and must pay for their prescriptions with cash.
Id.
at 131. However, when asked whether he had ever filled a controlled substance prescription for someone who did not have “insurance to cover their [sic] prescription,” Mr. Parrado answered that he was not going to give “a yes or no answer because . . . a person who . . . can't afford insurance . . . is not going to pay 1,200 or 1,300 dollars for a prescription.”
Id.
at 132. Mr. Parrado further testified that whether the prescription was paid for with cash, credit card, or check, it's “all the same to me.”
Id.
at 133.

After Mr. Parrado reiterated his earlier testimony that he “didn't see where anything [as to the resolution of red flags] was documented,” Respondent's counsel asked if it is “true that Florida does not require a pharmacist to document the resolution of red flags on the face of the prescription?”
Id.
at 134. Mr. Parrado answered: “I would never document it on the face, I'd write it on the back.”
Id.
at 135. Mr. Parrado then acknowledged that “there's no regulation that says you have to, but that's just the standard of practice and has been for decades.”
Id.
When then asked whether a pharmacist could document the resolution of a red flag “somewhere other than the back of the prescriptions,” Mr. Parrado replied: “I've never seen it documented anywhere other than that.”
Id.

However, Mr. Parrado subsequently acknowledged that resolution of a red flag could be documented other than on the back of a prescription.
Id.
at 136. And he later agreed with Respondent's counsel that if a patient had been a regular and long standing patient of the pharmacy, it would not be “necessary to do the full-blown documentation that you would do on the first prescription once you've resolved the red flag.”
Id.
at 177. However, he maintained that some notation should still be made on the prescription so that if the prescription was questioned by a regulatory agency, there would be some evidence to defend the dispensing decision.
Id.; see also id.
at 190. Mr. Parrado also acknowledged that “some pharmacists document [the] resolution of red flags so that it is . . . available to help their colleagues who [are] filling in for them.”
Id.
at 191.

Mr. Parrado rejected, however, the suggestion of Respondent's counsel that documentation need not be placed on the prescription because “there's no way for the floater pharmacist . . . who takes over to actually go through [the prescription file] and know where those [notes] are because they're all written on the back of prescriptions.”
Id.
at 192. As Mr. Parrado explained, the pharmacist would see the prescription number when he looked up the patient's profile on the computer, and “it would be very easy to go pull that prescription out of the file.”
Id.
Then asked how a pharmacist would know which prescription to pull if the patient had been filling the prescription every month for ten years, Mr. Parrado testified: “That's why you would have documented this as a regular patient. You would have done something on that scrip[t].”
Id.
at 192. However, he then acknowledged that notes generally can be made in the pharmacy's dispensing software.
Id.
at 193.

Mr. Parrado acknowledged that a patient who has been on opiates for a significant time and who has developed tolerance may need to exceed the manufacturer's daily recommended dosage.
Id.
at 137. He acknowledged that the dosing depends on “the specifics” of the patient's condition.
Id.
He also agreed that having a patient on a narcotic contract so that the patient only obtains narcotics from a single clinic could be helpful in resolving red flags.
Id.
at 137-38. He further agreed that if the narcotic contract “called for routine urine screens to ensure that the patient was actually taking the drug,” that would “be helpful” in “prevent[ing] diversion.”
Id.
at 138.

Asked if he had reviewed PMP data to determine the drug history of any of the patient, Mr. Parrado said that he had not and that the law did not allow him to.
Id.
While he testified that he looked at thousands of prescriptions from Respondent which covered more than two years, DEA did not give him noncontrolled prescriptions and he looked only at the schedule II prescriptions.
Id.
Given this, Respondent's counsel later asked Mr. Parrado if he had “no way of knowing what . . . adjunct drug therapies . . . any of these patients were taking?”
Id.
at 160. Mr. Parrado answered:

Well, only because of what I saw in the Respondent's exhibits where there were some partial medical records that did have all the drugs the patient was taking on a very few cases, and on those it was the same on every one of them, the same group, same combination.

Id.

Mr. Parrado acknowledged that Florida law (Fla. Stat. § 893.04(2)(a)) states that a pharmacist may dispense a controlled substance in the exercise of his professional judgment when the pharmacist or pharmacist's agent has obtained satisfactory patient information from the patient or the patients' agent. Tr. 139. After Respondent's counsel pointed that this provision does not require that the pharmacist alone talk to the physician alone and allows a pharmacist to talk to the patient or the patient's agent, Mr. Parrado testified that “it says in [Fla. Admin. Code r.] 64B16-27.831 that when you have a concern you shall contact the prescriber.”
Id.
at 139-40.

Turning to J.A., the patient who had received prescriptions for Adderall and Dilaudid, Mr. Parrado conceded that while opiates “have a respiratory depressant effect,” they are not categorized as depressants under the Controlled Substances Act.
Id.
at 141-42. He also acknowledged that when a drug has a shortage and its wholesale price rises, the retail price would also rise.
Id.
When then asked whether it is standard practice to input the average wholesale price of a drug into a pharmacy's dispensing software and that the software has algorithms that actually generate the retail price, Mr. Parrado explained that “[t]here are different ways to fix that algorithm” and that he had sometimes overridden the price set by the software.
Id.
at 143. While Mr. Parrado acknowledged that, in 2008 and 2009, two major oxycodone manufacturers had recalled their products resulting in shortages and that wholesalers would take advantage of this and charge higher prices, he disagreed with the suggestion that “those shortages continued and had ripple effects throughout Florida well into 2010 and 2011.”
Id.
at 144. Rather, he testified that the shortages did not have “that much” of an effect and “[o]nce it became available again the prices were not that far skewed”
17

Id.

17
By contrast, Mr. George testified that from 2010 through 2012, the wholesale “price sometimes went three times to 10 times more.” Tr. 538-39.

While Mr. Parrado acknowledged that he did not go to the pharmacy closest to his home because he knows the pharmacist at the pharmacy he goes to, he explained that “[m]ost people go to

a pharmacy for . . . some sort of a convenience, or a reason, and he [the patient] had to have a reason to go to that pharmacy. That's what I would want to know. That's what I would want to document.”
Id.
at 146. Asked if he documented on the back of every controlled substance prescription the reason a patient had driven 10 or 15 miles on roads with stop lights to get to his pharmacy, Mr. Parrado answered: “No, of course not.”
Id.
at 148. However, he then adhered to his position that “[s]tandard practice is if you have the red flag to document it.”
Id.
As for whether it would be a red flag if the patient “lives 20 or 30 miles away and [has] seen a doctor who's in close proximity to the pharmacy” and “[t]hat red flag then is resolved?”; Mr. Parrado testified that “I'd still want to know the address. There's going to be multiple red flags here.”
Id.
at 148-49. On a further question regarding “the red flag of someone driving 10 or 15 miles” and “[i]f the physician happens to be in close proximity to the pharmacy, that resolves the red flag, doesn't it?”; Mr. Parrado testified: “Not necessarily” and explained that: “[i]t's not just one thing. It's multiple things. That's the combination of red flags.”
Id.
at 149.

Mr. Parrado testified that the drugs themselves (hydromorphone and oxycodone 30) raised a red flag as they are known drugs of abuse.
Id.
at 149-50. While Mr. Parrado acknowledged that he had filled prescriptions for oxycodone 30, he could not “remember ever filling a prescription for hydromorphone.”
Id.
at 150. However, when asked what he would document on a prescription when he was practicing and was presented with a prescription for oxycodone 30 but there were no other red flags, Mr. Parrado testified: “[n]othing because it wasn't a red flag.”
Id.
at 151;
see also id.
at 166.

Asked the same question with respect to hydromorphone, Mr. Parrado answered: “Well, you know, there again, looking at the dose, I would have to look at the patient profile, see if the patient has developed a tolerance to that drug, and at that point the red flag—there's nothing to write down because there isn't a red flag.”
Id.
at 151. Later, on cross-examination, Mr. Parrado acknowledged that his review of the prescriptions did not include any information that would have allowed him to determine whether the patients had been on narcotics for a significant period and developed tolerance as he reviewed only what DEA gave him.
Id.
at 161-62. He also acknowledged that neither the prescription nor the prescription label “tells you anything about the patient [sic] history.”
Id.
at 177.

Turning to the red flag of pattern prescribing, Mr. Parrado acknowledged that if a physician prescribed different narcotics for different patients, sometimes wrote for extended release drugs and other times immediate release drugs, and varied the strength of the drugs, this would not be pattern prescribing. Tr. 153. Mr. Parrado then agreed that the same would hold true for the clinic itself.
Id.
And he subsequently acknowledged that pain management is a legitimate medical practice, which often times requires the prescribing of opioids in significant quantities as patients develop tolerance.
Id.
at 154.

As for the red flag of therapeutic duplication, Mr. Parrado agreed that extended release drugs “were expensive” even though “[t]here were some generics available” during the time period at issue and that a patient who lacked insurance “would have difficulty paying for an extended release oxycodone product.”
Id.
at 155-56. Mr. Parrado then acknowledged that if a patient required oxycodone 30 for his “normal pain,” the physician would not be acting illegally if he prescribed a lower strength drug for the patient's “breakthrough pain.”
Id.
at 156.

Turning to the methadone prescription which Respondent filled for B.W. (GX 14, at 3) (on the same day it also filled a Dilaudid prescription for him), Mr. Parrado conceded that he did not have any evidence that B.W. had overdosed, abused the drug, or sold it on the street. Tr. 158-59. Mr. Parrado then acknowledged that he had no evidence that any of the prescriptions were abused or sold on the street.
Id.
at 159.

Asked whether his concern about methadone-related overdoses was a general concern or a specific concern related to B.W., Mr. Parrado testified:

That was a concern that I would have wanted to have seen a red flag resolved. Why is he on hydromorphone and methadone both, which are both immediate release . . . you know, you don't use two immediate release opioids for breakthrough pain. You use a long acting as a base and then the immediate release for breakthrough.

Id.
Later, on cross examination, Mr. Parrado explained that the problem with using methadone for pain management “is that the pain relief you get . . . probably peaks at about three to four hours and tapers off rather quickly after that, but the respiratory depressant part . . . continues to grow even after the pain relief has gone down, so people are apt to take another pill,” thus increasing the respiratory depressant effect.
Id.
at 174. However, Mr. Parrado acknowledged that methadone may be appropriate for certain patients.
Id.

Mr. Parrado then agreed with Respondent's counsel that “it's not common, but it's not completely unheard of for individuals who may not have insurance or may have allergies or other reasons why certain long-acting drugs do not work”
18

Id.
at 159-60. And he also agreed with Respondent's counsel that because of genetic differences, some persons may metabolize certain opiates in a more effective manner than others.
Id.

18
Mr. Parrado subsequently acknowledged that extended release opioids could be problematic for patients who have had bariatric surgery. Tr. 175. Also, on questioning by the ALJ, he testified that if a patient was allergic to a medication, “you wouldn't be filling” that prescription.
Id.
at 213.

Mr. Parrado further acknowledged that the DEA Pharmacist's Manual does not use the term red flag and does not specifically tell pharmacists how to identify red flags.
Id.
at 163. However, he then testified that the “[M]anual gives you a lot of information that you have to use your professional judgment . . . . It's not going to list line by line, but that's why you have pharmacists exercising professional judgment.”
Id.
Mr. Parrado further testified that a pharmacist “should be able to defend that professional judgment.”
Id.

After acknowledging that neither the CSA nor DEA regulations use the term “red flags,” as well as that the CSA and DEA regulations do not “talk about distances from patients,” Mr. Parrado agreed that “there is no bright line that . . . if it's beyond a certain distance, it's always wrong.”
Id.
at 164. However, Mr. Parrado subsequently testified that if patient lived more than 40 miles from the doctor's office, that would be “one of the red flags for diversion.”
Id.
at 208.

As for whether family members seeing the same doctor “makes the doctor's prescriptions for those family members invalid,” Mr. Parrado testified that “[i]t raises a question. It may not make it invalid.”
Id.
at 164. Mr. Parrado then explained that “I have to validate—I have to verify the validity of that script.”
Id.
at 165. While Mr. Parrado acknowledged that a pharmacist could “possibly” resolve the red flags created by the circumstances of two people in the same household “need[ing] the exact same drug and pay[ing] those large quantities of money,” he rejected the suggestion of Respondent's counsel that this could legitimately occur where “family members . . . live together, didn't have insurance” and had to “pay out of pocket.”
Id.
Mr. Parrado then testified: “You can buy a lot of insurance for $2,700” and that the costs

of the prescriptions would be a red flag that he “could not have resolved.”
Id.

Mr. Parrado further acknowledged that in evaluating whether a pharmacist had complied with the standards of practice in dispensing a prescription, “it would be helpful” to know various information.
Id.
at 177. These include “what the pharmacist knew” about: (1) The patient, including his/her medical condition, history, diagnosis, cause of the pain and drug utilization; (2) the prescribing physician, including his/her specialty, board certifications, practice location, and reputation; and (3) the drug being prescribed .
Id.
at 178;
see also id.
at 202-03.

Asked if he was aware that one of the physicians who issued the prescriptions he had testified about “is a noted anesthesiologist,” Mr. Parrado testified that “if it doesn't say it on the prescriptions itself, I wouldn't know it.”
Id.
at 183-84. Then asked by Respondent if he knew “that that particular noted anesthesiologist was a physician at a major regional hospital before being involved in the practice of pain management care,” Mr. Parrado answered: “[n]o, I would not have known that.”
Id.
at 184. Mr. Parrado also testified to the effect that the fact that the physicians (with the exception of one who had since died) who practiced at 24th Century have had their registrations renewed would not change his opinion.
Id.
at 186.

Mr. Parrado further acknowledged that the issue of prescribers not placing the patient's address on prescriptions has become “very common,” but that the pharmacist has to verify the patient's address.
Id.
at 193. He also testified that in 2008, DEA sent a letter to pharmacists which stated that the pharmacist “could add in” the patient's address.
Id.
at 194. Mr. Parrado then agreed that if the prescription was only missing the patient's address, this does not raise “a concern about diversion.”
Id.
at 195. Subsequently, the Government identified several prescriptions where the patient's address had not been placed on the front of the prescription.
Id.
at 206 (discussing GX 13, at 3, 5, 21, 27, and 29). However, in each instance, the patient's address was on the dispensing label which was affixed to the back of the prescription.
19

See id.
at 4, 6, 22, 28, and 30.

19
Asked by Respondent's counsel if “Florida law says there shall appear on the face of the prescription or written record thereof” and thus allows for the patient's address to be placed on the back, Mr. Parrado testified: “[t]hat law was changed. At the time these prescriptions were written, that law did not say on the prescription record thereof. . . . It just said it had to be on the face of the prescription.” Tr. 209. According to the 2011 Florida statutes, Section 893.04(c) stated that “[t]here shall appear on the face of the prescription or written record thereof for the controlled substance . . . [t]he full name and address of the person for whom . . . the controlled substance is prescribed.” Fla Stat. Ann. § 893.04(c) (2011). Contrary to Mr. Parrado's testimony, the statute had the same wording throughout the relevant time period.

While Mr. Parrado continued practicing through 2012, he could not remember the pharmacies he worked at having ever filled prescriptions written by a doctor at the 24th Century clinic.
Id.
at 195-96. While Mr. Parrado acknowledged filling prescriptions that came from the Kenaday Clinic (
see
GX 14, at 7-10), he testified that “[o]n the ones I filled, I called and checked them very carefully.” Tr. 196-97. Asked what he did to resolve the red flags, Mr. Parrado testified that there was an issue of dosing and whether “the patient had developed a tolerance for that dose,” and that he called the doctor.
20

Id.
Mr. Parrado added that he had spoken to the doctor twice, after which he “wouldn't fill anymore.”
Id.
at 199.

20
At this point the Government objected that the question was “beyond the scope of direct examination.” Tr. 197. Respondent's counsel replied that the question went to Mr. Parrado's credibility, and the ALJ overruled the objection.
Id.
at 198.

Asked whether there were other concerns besides the dosing with the prescriptions written by the Kenaday doctor, Mr. Parrado testified that another prescription presented a distance concern and he did not fill the prescription and gave it back to the patient.
Id.
Subsequently, Mr. Parrado then acknowledged that the prescription that presented the dosing issue may also have presented another issue, that being that the doctor had prescribed “a combination of hydrocodone, Xanax, [and] Soma.”
Id.
at 200. Mr. Parrado testified that after talking to the physician and believing that the prescriptions had a legitimate medical purpose, “after that I didn't feel comfortable anymore and after speaking with the doctor a couple more times I decided I could not take his word for the validity and I wouldn't fill them anymore.”
Id.
at 201. As Mr. Parrado further testified, “[o]nce I saw the pattern of prescribing coming from that clinic is when I stopped.”
Id.
at 202.

Finally, Mr. Parrado acknowledged that a doctor can issue a prescription for a legitimate medical purpose and the patient may nonetheless misuse it or sell it on the street, but that this does not make the prescription invalid.
Id.
at 204. Nor does a patient's misuse or selling of the drug to another make a pharmacist's decision to dispense the prescription wrong unless the pharmacist knew or should have known that the patient was going to misuse or sell the drug.
Id.
at 205.

Respondent's PIC's Testimony

As noted above, Respondent's Expert Mr. Badawi did not address any of the prescriptions which the Government submitted into evidence. Kasey George, Respondent's PIC, did offer testimony as to why some of the prescriptions were dispensed.

Mr. George testified that he has been a pharmacist for 21 years, that he has 12 to 13 years of experience in retail pharmacy, and that he has been Respondent's PIC for seven years. Tr. 445-46. Mr. George holds an active pharmacist's license in Florida and holds inactive licenses in three other States.
Id.
at 446. He testified that he does not have either a criminal history or a disciplinary history on his pharmacy license.
Id.
at 445. He also testified that he had obtained his pharmacy degree from Temple University in 1994, that he had taken continuing education classes, and that he had attended a class on dispensing controlled substances in 2013 at which Mr. Parrado had spoken.
Id.
at 447-48.

Mr. George testified that he is the only full-time pharmacist at Respondent, which is open six days a week, and that if he has a day off, he schedules a temporary pharmacist to work that day.
Id.
at 448. Respondent's counsel then asked what controlled substance dispensing protocols were in place at Respondent from 2011 through February 2013, when the Administrative Inspection Warrant was served.
Id.
at 448-49. According to Mr. George, the protocol:

involves many things, including first we have check [sic] that the doctor's office is located within 20 miles from the pharmacy. Then we check the patient's ID, Florida ID, and make sure that the patient has a Florida ID. The next step we do is we check the prescribing physician's address and their phone number, and we check in the publicly listed Web site to see that it matches what's printed on the prescription. Then we check that the doctor has a valid DEA license active and also an active NPI number.

. . . And we check the—call the doctor's office and get the diagnosis for the condition treated. And also we ask for the diagnosis studies they have done and make sure that the studies are consistent with the medical condition that is being treated and also the prescription. . . . And we ask for all the records to be sent to the pharmacy, and we check that they have the narcotic contract with the patient. . . . And also we ask for the urine drug test result and those records. Then we are not done with that.

And we have to check the patient's ID, which is present with the DMV Web site to

see that address is correct. Then . . . end of 2011, PDMP came. From that day onwards, we check for every new patient, and every time they come we have to check the PDMP to see any doctor shopping or any early filling and check also . . . the patient's credibility because if their [sic] address is available there. And after that, all that pharmacist's professional judgment also comes into that protocol.

Id.
at 449-51.

Mr. George testified that he reviewed the prescriptions submitted by the Government and he acknowledged that he was the dispensing pharmacist on “the vast majority of” them.
Id.
at 451. He testified that he had used the above protocol in dispensing the prescriptions.
Id.
He then denied that he was required to fill prescriptions that originated at certain clinics or that were presented by certain patients.
Id.

Mr. George testified that he was “required to document every conversation with a patient or physician if the conversation was about concern related to” a controlled substance prescription.
Id.
at 451-52. Asked by Respondent's counsel “where was that documented?”; Mr. George testified: “[w]e have a two-page pharmacist's due diligence checklist separately filed in a binder in an A to Z format according to patient's last name, and all the documents pertaining to that patient's prescription is [sic] attached to that in the file.”
Id.
at 452. Mr. George further testified that he had used the due diligence forms for the patients whose prescriptions were at issue in this case.
Id.
Mr. George then testified that when DEA executed the AIW, they did not ask him to provide the due diligence forms and did not take them.
Id.
Nor did they ask him to provide documentation showing that he had made inquiries and resolved red flags.
Id.
at 452-53.

Asked by Respondent's counsel where he would “document the resolution of questions about” a controlled substance prescription, Mr. George answered:

It used to be if it is one or two items you used to document on the face of the prescription. Since the information needed to prevent the abuse and misuse and diversion, a lot of documents [sic] involved, if I decided to go extra step to get all the available documents filed in a separate sheet and document a pharmacist's checklist so I can do beyond the required, more than the required and go and fill in in vast places.

Id.
at 455-56. Noting his testimony that he had formerly documented the resolution of such questions on the back of the prescription, Respondent's counsel asked Mr. George when he changed to using checklists and obtaining the records he described.
Id.
at 456. Mr. George testified that it was “[f]rom 2010 onwards.”
Id.
at 457.

Mr. George then explained that his protocol also included interviewing the patients to “ask them their conditions and why they're being [sic] taken [sic] these prescriptions.”
Id.
Mr. George further asserted that “in that interview, I can find out what is the real need and also if they have any intention to abuse or misuse or any diversion involved in that scheme.”
Id.
at 458.

Mr. George testified that “we verify . . . the credibility of the doctors through the paperwork and the documents.”
Id.
He further stated that “I visit the doctor's office and the clinic occasionally and get to know the doctors,” and “I talk personally to the doctors and also make sure that they have a protocol in place, which I also make sure that that is inconsistent of our protocol.”
Id.
Continuing, Mr. George testified that “I make sure that all that paper which I mentioned, narcotic contract and opiate contract, all are in place.”
Id.

Mr. George acknowledged that he was familiar with the physicians who wrote the prescriptions at issue, and that most of them worked for 24th Century, which “is a pain management clinic.”
Id.
at 459. Asked by Respondent's counsel what he knows about the specialties and certifications of 24th Century's doctors, Mr. George answered:

One doctor, he is no more. He's [sic] passed away three or four years ago. He was the director of this clinic, and he was the chief anesthesiologist in [sic] Tampa General Hospital. He was a famous doctor, and his expertise was a big asset at clinic, and many patients liked him.

Id.
Subsequently, Mr. George testified that the name of this doctor was Cornelius Ruperto.
Id.
at 466.

Notably, Dr. Ruperto did not write any of the prescriptions at issue in this matter.
See generally
GXs 3, 13, 14, and 15. Moreover, his name is not listed on any of the prescription forms.
See generally
GXs 3, 13, 14, and 15. This is for good reason, as according to Dr. Ruperto's online obituary of which I take official notice,
21

Dr. Ruperto died on December 8, 2008, more than two years before the earliest prescription in evidence. And of further note, Mr. George offered no testimony regarding the specialties or board certifications of the doctors who actually wrote the prescriptions at issue in this matter.

21

See www.legacy.com/obituaries/tbo/obituary.aspx?n=cornelio-aquino-ruperto&pid=121231660.
Respondent may dispute my finding by filing a properly supported motion no later than 15 calendar days from the date this Order is mailed.

Asked by Respondent's counsel how he resolved the red flag of multiple patients presenting similar narcotic prescriptions which were written by the same doctor, Mr. George acknowledged that “[i]f I see that a doctor is writing a certain medication and the same quantity and same way to every patient, then it is a red flag to me.”
Id.
at 467. Continuing, Mr. George explained: “[b]ut . . . when I see that doctor write the medications, but in different doses and different quantity . . . it's different, and they write different medication along with it, and their treatment plan is different, then after my due diligence is being done, I feel comfortable filling that prescription.”
Id.
Mr. George subsequently testified that the 24th Century doctors prescribed oxycodone in both 15 and 30 mg dosages, methadone in 5 and 10 mg dosages, morphine in 30, 60 and 100 mg dosages, hydromorphone in 4 and 8 mg dosages, and sometimes Opana.
Id.
at 475-76.

Next, Respondent's counsel asked Mr. George about the oxycodone 30 prescriptions whose labels bear sequential RX Numbers and which were dispensed on August 4, 2011 to J.P. and T.P., who have the same last name and had travelled from Saint Augustine (196 miles). GX 3, at 2-3. Mr. George asserted that “I remember that case in detail” and that J.P. and T.P. were husband and wife and that T.P. had a bulged disc from a 1998 accident and “was our patient from 2009.” Tr. 468. He also asserted that J.P. had “a motor vehicle accident” and “had problems with his neck and . . . back.”
Id.
at 468-69. Mr. George did not explain when J.P.'s accident had occurred or how long he had been Respondent's patient.
See id.
While Mr. George asserted that he filled the prescriptions, because “after doing all the due diligence and following the protocols, talking to the doctors, I was comfortable within my professional judgment to fill that prescription,”
id.,
Respondent produced no evidence to corroborate his testimony, not even the two-page due diligence checklists. Of consequence, the ALJ did not find Mr. George's testimony credible as to the actions he took to resolve the red flags presented by J.P.'s and T.P.'s prescriptions.
22

R.D. 48.

22
Mr. George further testified that in 2012, “J.P. was filling the prescription in the pharmacy, and when I called the doctor's office, I found that J.P. had an admission” to a hospital in St. Augustine.
Id.
at 469-70. According to Mr. George, the doctor then requested the records from the hospital in St. Augustine; the records showed that J.P. “was positive for his oxycodone and Valium he was on,” as well as cocaine.
Id.
at 470. According to Mr. George, J.P. was then discharged from the clinic for breaching his contract and he decided to stop filling prescriptions for him.
Id.
Mr. George did not explain, however, why J.P. had the prescription he was attempting to fill if he had been discharged from 24th Century.

Mr. George also acknowledged that a prescription that exceeds the manufacturer's recommended daily dosage presents a red flag. Tr. 470. Mr. George testified that the prescription “does not say the whole story” and when the patient's dose is above the manufacturer's recommended dose, the pharmacist “ha[s] to go and look at the patient's profile and profile history to make sure why this patient is taking higher doses.”
Id.
at 471. Mr. George further testified that “everybody know [sic] that tolerance plays a big role in the doses prescribed” and that “there is no ceiling doses for opiates.”
Id.
Mr. George then testified that when a prescription is for a higher dose than the recommended dose, “the pharmacist's duty is to call the physician and check with them . . . and go through [the] profile and see how long [the patient's] been on that medication and . . . learn how much the tolerance is.”
Id.
Mr. George then maintained that when he filled prescriptions that exceeded the maximum recommended dosage, he did all of these steps “and I write my notes on my due diligence checklist why I did it.”
Id.
at 472.

Addressing the prescriptions that were missing patient addresses, Mr. George testified that the former head of the Office of Diversion Control had published a memo which “says that if the pharmacist has to make any changes in C2 prescriptions, they have to follow state laws and guidelines.” Tr. 472. Mr. George then noted that Florida law “clearly says that [the address] shall be on the face of the prescription or the written record thereof,” and added that he would “verify the patient's address though the DMV Web site[] [a]nd also check the PDMP” and use the prescription label to provide the address.
Id.
at 472-73.

As for the instances in which patients presented prescriptions for two short-acting opiates, Mr. George testified that “there are many reasons” that “doctors write two prescriptions,” including that “the patient is allergic to certain medications,” “has intolerance for the drug,” may have had “gastric bypass surgery,” or be a “dialysis patient.”
Id.
at 474. However, Mr. George testified that “[n]ormally doctors write the long-acting medication along with the short-acting.”
Id.

As for how he resolved the red flag, Mr. George testified that “you . . . study the situations [sic] and what is the condition of the patient through talking to the doctors and talking to the patients and checking their profiles [and] history.”
Id.
Asked by Respondent's counsel if those are “actual examples of things that

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2016-17721. Public record. Not legal advice.