Hills Pharmacy, LLC; Decision and Order

Federal RegisterJul 28, 2016

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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.

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.

Id.

at 9.

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.

Id.

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.

Id.

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

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.

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.”

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.

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.

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.

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.

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.

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

Id.

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

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.

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.

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.

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,

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.

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

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 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.

See id.

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

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.

Id.

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

Id.

at 199.

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,

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.

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.

R.D. 48.

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 occurred where you got information like that from patients who filled prescriptions,” Mr. George answered: “Yeah. We will get information. That's the case.”

Id.

at 474-75. Mr. George did not, however, offer any testimony identifying the specific conditions of those patients who presented two prescriptions for short-acting narcotics which were filled by Respondent.

Mr. George further testified that he obtained medical records from the 24th Century clinic.

Id.

at 477. Respondent's counsel then asked Mr. George if he had “seen Respondent's Exhibit 3 before today?”

Id.

at 479. Mr. George answered “yeah,” and added that “it is actually from one of the copies which I get from the clinic”; he then testified that these records “were maintained at” Respondent and that the records were present when DEA executed the AIW.

Id.

Mr. George also testified that the Exhibit contained an accurate representation of the records Respondent maintained on three of its patients, K.D. (pages 1 through 17); S.D. (pages 18 through 33); and H.C., Jr. (pages 34 through 51). Tr. 480, 482. Notably, the records contained such items as driver's license verifications, radiology reports, progress notes, and opioid contracts.

See generally

RX 3.

voir dire,

the Government asked Mr. George how he received the records from the clinic. Tr. 490-91. Mr. George answered: “sometimes it is in a block of a—I send my technician to get it because patients are waiting in my—I go and ask them to get the copy and get it to me so I can verify it before filling it.”

Id.

at 491. Mr. George subsequently testified that Respondent's Exhibit 3 was “a representative sample of the type of record [he] got for hundreds of patients [of his] pharmacy.”

Id.

at 498.

Asked by Respondent's counsel “what, if any information on pages 20 through 29 . . . was important to [him] at the time” he was deciding to fill controlled substance prescriptions for S.D., Mr. George testified that the records told him “what the diagnosis is, why this patient [is] being treated for the medication they [sic] are [sic] prescribed.”

Id.

at 480-81. He further asserted that he looked at the progress notes (RX 3, at 29) to “see any changes in there,” as well as page 30, which told him that “the patient has [an] opiate contract there.”

Id.

at 481.

Mr. George then testified that he looked at these records as “an extra step to prevent the abuse and misuse of the controlled substances.”

Id.

Asked whether his training as a pharmacist gives him “the ability to understand certain things within the medical record as far as the diagnosis and the condition of the patient,” Mr. George testified that “[t]hrough experience, I learned to look through these forms and understand it [sic].”

Id.

Mr. George then testified that the records included indications of conditions that would cause pain.

Id.

at 481-82.

Asked whether there was information on page 44 (a December 6, 2012 Visit Note for H.C., Jr.) that would allow a layperson and pharmacist “to determine what condition the patient was being treated for,” Mr. George answered “yes.”

Id.

at 482. Asked if “the information contained in these medical records [is] consistent with the patient having pain and needing a controlled substance prescription from a pharmacist's perspective?”, Mr. George again answered “yes.”

Id.

at 482-83.

Next, Mr. George was asked about the prescription (GX 3, at 1) Respondent dispensed on July 28, 2011 to T.V., who lived in Pensacola—472 miles from Respondent—for 210 tablets of oxycodone 30. Tr. 493. Mr. George testified that she had been his patient “since 2009,” and that in deciding to fill her prescription, he had had done “all my due diligence, checked with the doctors, checked all the medical records [he] could” and “interviewed the patient.”

Id.

at 494. Mr. George further testified that “when this patient came in the counseling and when I was talking . . . [the] patient knew that distance is a very fact that pharmacist may not fill it.”

Id.

According to Mr. George, T.V. said she had gone “through four back surgeries” and had tried “interventional pain injections” which “failed.”

Id.

Mr. George then testified that T.V. “lifted her shirt and said, look at my back, and I looked that there were four scars” and T.V. “mentioned that there were rods and plates placed here.”

Id.

at 495. Mr. George thus maintained that “even though the distance was far, through my experience and the need of the patients [sic], it made me come to a conclusion that this patient, I will fill the prescriptions.”

Id.

While on cross-examination, Mr. George testified that another pharmacist had filled this specific prescription,

id.

at 578-79, he reiterated his earlier testimony that T.V. had “been coming from 2009 onwards.”

Id.

at 579. He then added that “I know this patient very well, and I have a very well written record on this patient.”

Id.

After again stating that he did not fill the prescription, Mr. George testified that “every pharmacist who worked in that Hills Pharmacy have [sic] that file. That's the reason the due diligence paper is filed separately.”

Id.

at 579-80. Mr. George then testified that “[w]hen this patient comes again, that

pharmacist has the opportunity to go and look at why this patient's prescription was filled last month” and ask “[i]s there any reason, or should I reject this?”

Id.

at 580. Continuing, Mr. George testified: “[w]hen they [sic] see other pharmacist, especially my notes, saying that all the due diligence were [sic] done and all the red flags were resolved, that pharmacist will be comfortable looking at. And they will probably call the doctors, I don't know [sic] he called or not. But that is his duty to call the doctor and verify.”

Id.

Mr. George again reiterated that this documentation was written down “[i]n my due diligence sheet” which is “in the pharmacy.”

Id.; see also id.

at 551 (Mr. George's testimony that the due diligence forms are in a binder which is “[s]till in the pharmacy.”).

Subsequently, the ALJ asked Mr. George if he recalled why T.V. “travelled from Pensacola to Hills Pharmacy?”

Id.

at 588. After answering “yes,” Mr. George testified:

This patient had multiple surgeries done in Tampa General Hospital and that time the doctor, the chief anesthesiologist was Dr. Cornelio Ruperto, and he become [sic] the director of the clinic where this prescription was written. So she used to come

and see that doctor always.

And while I was interviewing that patient she said she likes the doctor and she wanted to continue seeing that doctor. That's why she was coming from that 450 miles.

Id.

(emphasis added).

Respondent's counsel then asked Mr. George about the back side of two prescriptions for 180 oxycodone 30 (GX 3, at 35) which cost $1350 each and were written for H.C., Sr., and H.C., Jr.; the latter is the same person whose records are found at pages 34 through 51 of Respondent's Exhibit 3. Tr. 495-96. Asked to explain what inquiry he made to learn about him and his condition, Mr. George testified:

[W]hen I got this prescription, I did all my due diligence and followed my protocols. Then I looked—he has a bulging disc, and I filled this prescription. He is coming in my pharmacy from 2009 onwards. And when he came to pharmacy with all these conditions, he'd been filling for [sic] insurance—he had insurance coverage that time. Then that time he was paying $35, was the copay. So he'd been paying that from 2009 `till end . . . of 2010.

Then he left the pharmacy. Then two years he did not come to the pharmacy. Then in 2012, he came back to the pharmacy with a prescription, and he did not have insurance, which Hills Pharmacy always ask when he was in where is your insurance, and he said he lost the insurance. He didn't have any insurance coverage.

Then he said that I need this medication, I'm on this medication. And he brought a profile also where he was. And I don't remember that it is a—and he showed me he was taking this medication. So he said he's willing to pay whatever the cash price at that time. And I filled this prescription for cash.

Id.

at 496-97. Mr. George then testified that H.C., Jr.'s drug therapy had not changed from when he had insurance.

Id.

at 497. Mr. George did not, however, offer any testimony regarding his decision to also dispense oxycodone 30 to H.C., Sr.

Mr. George subsequently testified that he had no knowledge that any of the patients who received the prescriptions at issue abused or diverted the drugs he dispensed to them.

Id.

at 498. Respondent's counsel then asked him “how do you respond to the allegations . . . that you filled prescriptions that had red flags on them?”

Id.

at 498-99. Mr. George testified:

From 2013 onwards, I modified my protocol and changed it to print out patients' residence to less than 15 miles, and also in our protocol changes that we only fill the doses consistent with the manufacturer's recommended doses, and also we will not fill for patient for the controlled substances who reside in the same addresses. So after making that [sic] changes, if it—today I will—that red flag will be considered in a different way and say that this is not according to my protocol, so I will not be comfortable.

That doesn't mean that what I did before that was not written for legitimate medical purpose, but at this point, because my protocol is more stringent and more strong, in my effort to prevent the misuse and abuse and diversion, I will check one more time.

Id.

at 499-500.

Mr. George then testified that as of February 19, 2015 (three weeks before the hearing), Respondent “completely stopped” filling controlled substance prescriptions “issued from any pain management clinic.”

Id.

at 500. Asked why he had made this change, Mr. George testified that “I know we all have a part to do to prevent the abuse and misuse and diversion of the controlled substances. As a professional provider, and the Government—DEA is trying to prevent that. And as a professional provider, I also have a responsibility for that.”

Id.

at 500-01. He then added that part of the reason he had changed his policies was because “always there are bad apples everywhere” and “I know that I'm less than the perfect.”

Id.

at 501. Mr. George then testified that he had “never” filled a controlled substance prescription having “knowledge that it was not issued for a legitimate medical purpose.”

Id.

at 502.

On cross-examination, however, Mr. George was asked if a patient's address being 63 miles from Tampa presented a red flag. Tr. 570. Mr. George testified:

Sixty-three miles, this time, yes, I will not fill that 63 miles, above 50 miles because my protocol has changed after the administrative warrant then to less than 50 miles. But at that time then when I filled it, it was a red flag, but I did my due diligence and followed the protocol, so that time it was okay in that I resolved that red flag.

Id.

at 570-71.

Next, Mr. George testified regarding a chart he had created which shows from January 1, 2011 through November 30, 2014, the total prescriptions dispensed by Respondent during each year (except for 2014), the total non-controlled and schedule II prescriptions dispensed, and the total schedule III through V prescriptions dispensed. RX 2, at 1. Notably, the chart does not provide any data for the schedule II prescriptions alone, and instead adds them to the non-controlled prescriptions.

See id.

The chart also purports to show the percentage of Respondent's total dispensings comprised by schedule III through V drugs, the “percentage change from previous year” and the “percentage change from 2011.”

Id.

While five of the six entries in the latter two columns show percentage reductions, the chart does not state whether the percentage change is in the total schedule III through Vs dispensings or in the percentage of total dispensings comprised by schedule III through V drugs. Moreover, the 2014 figures do not include data for the month of December.

Another chart shows data for Schedule II through V for the years 2011 through 2013 and for 2014 through November 30. RX 2, at 3. The chart reflects a decrease in the total number of controlled substance prescriptions dispensed and a decrease in the percentage of total dispensings comprised by schedule II through V dispensings.

See id.

Subsequently, Mr. George answered “yes” when asked by Respondent's counsel: “[d]o you accept responsibility for the fact that you filled prescriptions for controlled substances that had red flags on them?” Tr. 507. However, when then asked if he had “ever knowingly ignored your duties as a pharmacist to exercise your professional judgment?”, Mr. George answered: “No, I never did.”

Id.

at 507-08. Mr. George further testified that “even though I did my best, our best to control that and prevent the abuse and misuse, that is not perfect. It is always less than perfect. Human beings are not perfect. I accept that responsibility.”

Id.

at 539-40.

On cross-examination, Mr. George acknowledged that a prescription which calls for the dispensing of “a high quantity” of a controlled substance presents a red flag as do “patients coming from long distance.”

Id.

at 552. However, he then maintained that he

had resolved all the red flags and had documented this on the due diligence checklists which were in the binder “in the pharmacy.”

Id.

He further testified that he would consult the medical records he obtained before dispensing controlled substances.

Id.

at 553. Asked by the Government if he “understand[s] medical records,” Mr. George testified:

I don't understand it the way the doctors are trained to understand. By experience, I look whether this prescription was issued for a legitimate medical reason. This is not my duty as a pharmacist. I would do something above and beyond in order to support the effort to prevent abuse and misuse. It is not part of my duty to read the medical report. I am doing an extra step for myself and to serve the community.

Id.

at 554-55.

The Government then asked Mr. George about Respondent's dispensing of 240 oxycodone 30 tablets to K.D., on April 21, 2011, pursuant to a prescription issued by Dr. S.A.-H. of the 24th Century Clinic (GX 3, at 20); K.D. is one of the patients whose partial records were submitted into evidence.

See

RX 3, at 1-17. Asked whether he “consult[ed] the medical record that is accompanying this prescription before dispensing that prescription,” Mr. George answered: “I didn't say that. I said my medical records are filed in the pharmacy, not with this prescription.” Tr. 557. Then asked whether he had dispensed the prescription, Mr. George testified that he did not dispense “[t]hat particular prescription” and that “another pharmacist” had filled the prescription.

Id.

When asked “who would that person be,” Mr. George testified that the copy was “very faint” and that could not see “the signature on that page, because the copy is faded.”

Id.

I find, however, that the prescription label is readable and bears Mr. George's initials.

The Government then asked Mr. George if he had dispensed the prescription found in the patient file for S.D., who resided in Panama City, Florida.

Id.

at 560. This prescription, which was written on January 19, 2012 by Dr. R.R. of 24th Century clinic, authorized the dispensing of 120 tablets of oxycodone 30. RX 3, at 33. Mr. George acknowledged that he had dispensed the prescription. Tr. 560. He also acknowledged that he had reviewed the partial medical file before dispensing the prescription.

Id.

at 560-61. However, when then asked if he could “tell from this medical record what other controlled substances were dispensed on that particular day,” Mr. George testified:

No. I look only for my prescription which is received in my hand. That is only my concern on that time. Where other places or where the patient got the medication, if I have the PDMP, that will support me on that cause. If I get the medical record, I have no way of saying and understanding where the patient had a different prescription unless I talk to the patient or doctors if he write any other prescriptions. I cannot guess where the prescription was filled for that patient.

And . . . I have one more thing to add on that question. This, as I said, these documents I am looking at, looking [sic] all these documents, above and beyond what the duty required of me because to help. It is not my pharmacist job to read, that is doctor's job. DEA give [sic] license to the doctors and they are well trained in writing these prescriptions, and they have the capacity to look at the patient's record and they are the one who is writing this prescription. I call them—give me a second. I call them, verify them, why they did it, what is the treatment plan, and I look above and beyond what are required of pharmacist. I go all the papers and I make my professional judgment whether this patient can be—this prescription can be dispensed.

Id.

at 561-62.

Asked whether he saw a treatment plan in S.D.'s medical record, Mr. George testified:

In this, all records when you go through the records, there is a medical, the copy of the MRIs and the report from the radiologist and why they are treating it and the notes from the doctor's office, and it say what medication they are writing there, and the doctors notes, the visitation notes there.

Id.

at 562.

Then asked whether he looked at S.D.'s MRI, Mr. George testified: “I don't look at MRI. I look at what is the diagnosis in that, whether patient, if it says that a patient has a bulging disc. A couple of the reasons why this medication being prescribed. That's my scope there.” Tr. 563. Mr. George then testified that he did look at the MRI report before dispensing the prescription.

Id.

Mr. George then denied that he was familiar with the term drug cocktail.

Id.

at 563-64. Significantly, the note for S.D.'s January 19, 2012 visit lists multiple drugs that were prescribed by the doctor, including 120 oxycodone 30, MS Contin, Soma (carisoprodol), Xanax, and also included the note of “add Dilaudid 8 mg #120.” RX 3, at 29.

S.D.'s patient file also includes a visit note dated June 13, 2012. RX 3, at 24-27. This note states that “Pt. has not taken meds in 5 months” and lists S.D.'s current medications as including five drugs: (1) Carisoprodol 350 mg, one tablet twice daily; (2) Dilaudid 8 mg

; (3) MS Contin CR 30 mg, one tablet daily; (4) oxycodone 30 mg, one tablet “every 4-6 hours”; and (5) Xanax 1 mg., one tablet “twice daily.”

Id.

at 25. According to the visit note, a drug screen was conducted and S.D. tested negative for opiates.

Id.

at 26. Finally, the visit note lists the prescriptions issued by the physician at this visit; with the exception of Dilaudid, which was discontinued, the prescriptions for carisoprodol, MS Contin, oxycodone 30, and Xanax were re-issued with the previous dosing instructions.

Id.

at 27. However, none of the prescriptions issued to S.D. at this visit are in the record.

No dosing instruction was listed.

Subsequently, the Government asked Mr. George if he had filled the prescription (GX 3, at 16) issued by Dr. P.C. (24th Century) to C.B. of Big Pine Key, which authorized the dispensing of 196 oxycodone 30. Tr. 568-69. Mr. George acknowledged that he had filled the prescription.

Id.

at 569. Asked if he knew where Big Pine Key is, Mr. George stated that he knew that it was in Florida.

Id.

Then asked if he knew how far it was from Respondent, Mr. George testified: “I don't know. It is written in my due diligence list.”

Id.

When later asked if he recalled investigating why C.B. had travelled from Big Pine Key to get the prescription, Mr. George answered:

On this particular patient I don't remember, but I know that when it is more than this distance, definitely I did counsel the patient and record it in the due diligence sheet why they travel. In many cases, I don't remember particularly this patient again. Many cases the reasons are their [sic] spouse are [sic] living in Tampa, they're [sic] in job assignment, or their [sic] doctor is here and they like the doctor. So there are many reasons, but I don't particularly remember. This is from 2011.

Id.

at 573.

To similar effect, the Government asked Mr. George if he knew where Floral City is. Tr. 569. Mr. George answered: “Again, I don't know where the city [sic] located in, but I know it is in Florida.”

Id.

After acknowledging that the distance from Floral City to Tampa (63 miles) was a red flag, Mr. George maintained that “I resolved the red flag looking at all the, doing the due diligence and checking with the doctors whether the patient need [sic] the medications and now all the treatment.”

Id.

at 571. And asked whether he ever determined why the patient had travelled 63 miles to get the prescription, Mr. George stated that “[o]n most of the patients when I talk to them and interview them and counsel them why they are traveling, and the reasons I get I will put in my due diligence sheet.”

Id.

Then asked by the Government “[s]o you don't know the reason right now,” Mr. George answered: “right now, because if you said yesterday I would have looked at it.”

Id.

On re-direct, Respondent's counsel, having noted the Government's questions “about remembering specifics about certain patients,” asked Mr. George how many patients he had “dispensed controlled substances for in the last five years?”

Id.

at 586. Mr. George testified that “I cannot remember because daily three, four patients comes [sic], in five years,

how I calculate it, it's not possible. And it is very hard to remember that. And I am a human being doing other business too, so I cannot remember everything, keep everything.”

Id.

at 586-87.

While that may be, Respondent certainly knew what prescriptions were at issue well in advance of the hearing, and if it was true that Respondent was maintaining the due diligence checklists, Mr. George could have reviewed those checklists with respect to the patients who filled the prescriptions.

The Government's Rebuttal Case

Subsequently, the Government recalled Mr. Parrado to question him about Mr. George's testimony with respect to the medical records in Respondent's Exhibit 3. Tr. 598-99. Mr. Parrado testified that he had “never had medical records in any pharmacy I've ever worked in or managed.”

Id.

at 599.

With respect to the medical record for S.D., which, as found above, showed that he had received prescriptions for oxycodone 30, MS Contin, carisoprodol and Xanax, even though he had not been on medications for five months and had tested negative for opiates, Mr. Parrado explained that “[t]here were some notations in his chart that caused me concern.”

Id.

at 601. Mr. Parrado specifically noted the notation that SD “had not taken his medication in five months” and that his drug screen was negative for opiates “but yet he was prescribed a lethal dose of oxycodone that day.”

Id.

Asked on cross-examination that “you know that there's no ceiling on narcotics, don't you,” Mr. Parrado answered: “[W]ell, but there is. On an opioid naïve patient there is.”

Id.

at 601-02. Asked “[d]o you know whether S.D. was opioid naïve,” Mr. Parrado testified: “[F]rom seeing the record, yes. He had not taken the medication in five months per his own dosing.”

Id.

at 602. Mr. Parrado then added that the S.D.'s visit note stated that he had tested negative for opioids.

Id.

Asked if he knew from Respondent's Exhibit that “S.D. had been taking opioids for years?

”, Mr. Parrado answered: “[y]es, but he had not taken them in five months per his own.”

Id.

at 603. While Mr. Parrado acknowledged that he had no personal knowledge that S.D. had not taken the drugs for five months, Mr. Parrado explained: “[W]hat I'm talking about, if I as a pharmacist was looking at that chart and seeing that, I could not have dispensed that. My professional judgment would have prevented me from dispensing that prescription.”

Id.

And after Respondent's counsel asked whether he knew if the notation meant “that the patient didn't get medication from the clinic for five months or whether . . . the patient was not seen at all anywhere for five months?”,

id.

at 604, Mr. Parrado testified:

Notwithstanding the question, there is nothing in the 16 pages of S.D.'s records that establish that he had been taking opioids for years. To be sure, there is a 2009 MRI report; a document indicating that a driver license check was performed on June 24, 2010, and another document indicating that S.D. made visits on monthly basis from August 12, 2011 through January 19, 2012, before reappearing five months later on June 13, 2012. However, the only evidence as to the prescriptions he had received prior to the June 2012 visit is the January 19, 2012 Progress Note and the prescription of the same date. In any event, Mr. Badawi was “still present in the hearing room” when Mr. Parrado was called in rebuttal and the ALJ explained that “if there's some expert conflict over this testimony, there's an opportunity for counsel to explore that.” Tr. 597. Respondent did not call Mr. Badawi to challenge Mr. Parrado's testimony that S.D. was opioid naïve at the time he presented the June 2012 prescription.

The notations said, and if I'm going to be looking at a chart as a pharmacist to determine if there was something, if this dose is appropriate to begin with, the fact the patient said he had not taken the medication, I'm seeing in the medical record that the drug screen says opiate negative. That's telling me I now have an opioid naïve patient. I have a concern.

Id.

at 605.

On further questioning by Respondent's counsel, Mr. Parrado reiterated that the patient's statement that he had not taken medication in five months “was in that chart that I looked at.”

Id.

However, notwithstanding that Respondent obtained the visit note, which lists multiple controlled substance prescriptions that were issued to S.D. at his June 13, 2012 visit, the Government did not submit any prescriptions (and their labels) showing that Respondent actually dispensed any of the prescriptions listed in the visit note.

Discussion

Under the CSA, “[a] registration pursuant to section 823 of this title to manufacture, distribute, or dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a)(4). In the case of a retail pharmacy, which is deemed to be a practitioner,

see id.

§ 802(21), Congress directed the Attorney General to consider the following factors in making the public interest determination:

(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.

(2) The applicant's experience in dispensing or conducting research with respect to controlled substances.

(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.

(5) Such other conduct which may threaten the public health and safety.

Id.

“[T]hese factors are . . . considered in the disjunctive.”

Robert A. Leslie, M.D.,

68 FR 15227, 15230 (2003). It is well settled that I “may rely on any one or a combination of factors, and may give each factor the weight [I] deem[] appropriate in determining whether” to suspend or revoke an existing registration.

Id.; see also MacKay

DEA,

664 F.3d 808, 816 (10th Cir. 2011);

Volkman

DEA,

567 F.3d 215, 222 (6th Cir. 2009);

Hoxie

DEA,

419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I “need not make explicit findings as to each one.”

MacKay,

664 F.3d at 816 (quoting

Volkman,

567 F.3d at 222);