# Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy; Decision and Order

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2018-05020

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** March 13, 2018
- **Citation:** 83 FR 10876

## Text

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 15-17]
Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy; Decision and Order

On February 23, 2015, the former Deputy Assistant Administrator of the then-Office of Diversion Control, Drug Enforcement Administration (hereinafter, DEA or Government) issued an Order to Show Cause to Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy (hereinafter, Respondent). ALJX 1. The Show Cause Order proposed the revocation of Respondent's registration pursuant to 21 U.S.C. 824(a)(4) and 823(f) on the ground that Respondent's registration is inconsistent with the public interest. ALJX 1, at 1. For the same reason, the Show Cause Order also proposed the denial of any pending application by Respondent for renewal or modification of its registration, and the denial of any application by Respondent for any other DEA registration.
Id.
(citing 21 U.S.C. 823(f)).

As the jurisdictional basis for the proceeding, the Show Cause Order alleged that Respondent's DEA Certification of Registration No. FP1049546 authorized it to dispense controlled substances in schedules II through V as a retail pharmacy at the registered location of 205 E. Hallandale Beach Blvd., Hallandale Beach, Florida 33009.
Id.
Respondent's registration was to expire on March 31, 2017.
Id.

As the substantive grounds for the proceeding, the Show Cause Order contained seven categories of violations. First, it alleged that “Zion dispensed controlled substances where it knew, or should have known, that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose and therefore failed to exercise its corresponding responsibility regarding the proper prescribing and dispensing of controlled substances.”
Id.
(citing 21 CFR 1306.04(a)). The Show Cause Order stated that Respondent's failure to exercise its corresponding responsibility was evidenced by its “dispensing of controlled substances despite the presence of red flags of diversion that Zion failed to clear prior to dispensing the drugs.”
Id.
at 1-2. The Show Cause Order listed seven red flags of diversion that Respondent allegedly did not resolve prior to filling prescriptions.
Id.
at 2-7. It cited
Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195,
77 FR 62,316 (2012) (hereinafter, Holiday CVS) as support for these allegations.

The Show Cause Order listed 13 prescriptions, for customers who allegedly traveled long round-trip distances of approximately 166 to 661 miles from home to physician to Respondent and back home, and alleged that Respondent filled them without having resolved the long distance red flags of diversion. ALJX 1, at 2-3. Each of the 13 prescription examples was for a controlled substance written some time during the period of February 2012 through January 2013.
Id.;
s
ee also
Government Exhibit (hereinafter, GX) 8/8a.

The Show Cause Order cited five prescriptions written by the same doctor on June 27, 2012 for five different customers for “1 ML Testosterone Cypionate 210mg/mL IM,” a controlled substance, that Respondent allegedly filled without first having resolved the red flags of diversion. ALJX 1, at 3-4; s
ee also
GX 10.

The Show Cause Order referenced two prescriptions for Dilaudid 8 mg., a controlled substance, written by the same doctor on June 22, 2012 for two individuals with the same last name and the exact same street address that Respondent allegedly filled without first having resolved the red flags of diversion. ALJX 1, at 4; s
ee also
GX 11. The Show Cause Order alleged that Respondent filled the two prescriptions on July 13, 2012 at 2:35 p.m. and 2:39 p.m., respectively. ALJX 1, at 4.

The Order to Show Cause alleged that Respondent filled two prescriptions for the same customer on the same day for the same immediate release controlled substance, but for different strengths,

without first having resolved the red flags of diversion.
Id.
The two pairs of prescriptions listed in the Show Cause Order to illustrate this allegation were issued for Dilaudid 8 mg. and Dilaudid 4 mg.
Id.; see also
GX 12. They were written during the period of September 2012 through November 2012. ALJX 1, at 4.

The Show Cause Order alleged that Respondent filled opiate (hydromorphone) and benzodiazepine (alprazolam, clonazepam, diazepam, or lorazepam) prescriptions, a “common `drug cocktail' popular with drug abusers,” for the same customer on the same day at about the same time without first having resolved the red flags of diversion.
Id.
The Show Cause Order cited 14 prescriptions, or seven pairs of “drug cocktail” prescriptions, that Respondent allegedly filled during the period of October 2012 through January 2013. ALJX 1, at 4-5; s
ee also
GX 13.

The Order to Show Cause alleged that “[c]ustomers paying for their prescriptions with cash, where other red flags of diversion were present,” were red flags of diversion that Respondent did not resolve prior to having filled the prescriptions. ALJX 1, at 5. The Show Cause Order listed 50 examples of prescriptions paid for with cash, costing as much as $1,008 for one prescription.
Id.; see also
GX 8, GX 10, GX 11, and GX 13.

The Show Cause Order alleged that Respondent filled prescriptions for “[c]ustomers [who] present[ed] new prescriptions for controlled substances when they should not have finished their previous prescription for that drug (`early fills' or `early refills')” without first having resolved the red flags of diversion. ALJX 1, at 5. The Order to Show Cause provided seven sets of examples of prescriptions that Respondent allegedly filled as many as 15 days early.
Id.
at 5-7; s
ee also
GX 14. The Show Cause Order specifically cited
Holiday CVS,
77 FR at 62,318 as precedent for this charge. ALJX 1, at 7.

Next, the Order to Show Cause alleged that Respondent “was unable to readily retrieve prescriptions it had dispensed.”
Id.
(citing subsections (a) and (h)(3) and (4) of 21 CFR 1304.04). Specifically, the Show Cause Order alleged that, on April 11, 2013, DEA investigators conducted an on-site inspection of Respondent and requested specific prescriptions that Florida's Prescription Drug Monitoring Program showed Respondent had filled.
1

Id.
The Show Cause Order listed 12 testosterone prescriptions that Respondent filled from February 2012 through January 2013 and DEA investigators requested, but that Respondent's staff was allegedly “unable to produce.”
Id.
at 7-8.

1
Florida's Prescription Drug Monitoring Program is called the Electronic-Florida Online Reporting of Controlled Substance Evaluation Program (hereinafter, E-FORCSE).

The Show Cause Order further alleged that Respondent filled controlled substance prescriptions and shipped them to Alabama, Georgia, Illinois, Kentucky, Massachusetts, and Vermont without meeting the out-of-state pharmacy requirements of four of those states.
2

Id.
at 8. It detailed eight prescriptions that Respondent allegedly filled and shipped out-of-state, though it did not allege that all eight were shipped in violation of a State's non-resident pharmacy requirements.
Id.
at 8-9; s
ee also
GX 15.

2
The Order to Show Cause cited the allegedly violated state legal requirements as Alabama: Rules of Ala. State Bd. of Pharm. § 680-x-2-.07(2); Illinois: Ill. Admin Code tit. 68, § 1330.550(a); Kentucky: Ky. Rev. Stat. § 315.0351(1); and Vermont: Admin. Rules Vt. Bd. of Pharm., Part 16.

The Order to Show Cause next alleged that Respondent filled controlled substance prescriptions that did not contain all of the required information, such as directions for use, patient address, prescriber name, prescriber address, prescriber DEA number, and prescriber signature. ALJX 1, at 9 (citing 21 CFR 1306.05(a) and (f)). It specified eight prescriptions and the required information each one allegedly lacked.
Id.
at 9-10;
see also
GX 16.

Next, the Show Cause Order alleged that Respondent filled prescriptions written for “office use” in violation of 21 CFR 1306.04(b). ALJX 1, at 10. It provided two examples of such prescriptions.
Id.
at 10;
see also
GX 17.

The Show Cause Order also alleged that Respondent filled prescriptions written by physicians for their personal use in violation of Florida law. ALJX 1, at 10 (citing Fla. Stat. § 458.331(r)). It referenced six examples of prescriptions where the name of the prescribing physician was the same name as the patient.
Id.; see also
GX 18.

And, lastly, the Order to Show Cause alleged that Respondent violated Florida law by “failing to report some prescriptions to E-FORCSE, in violation of Fla. Stat. § 893.055(4).” ALJX 1, at 10. It listed six prescriptions that Respondent allegedly did not report to E-FORCSE.
Id.
at 11;
see also
GX 19.

The Show Cause Order notified Registrant of its right to request a hearing on the allegations or to submit a written statement while waiving its right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. ALJX 1, at 11 (citing 21 CFR 1301.43).

On February 25, 2015, the DEA Diversion Investigator (hereinafter, DI) assigned to the investigation of Respondent, personally served the Order to Show Cause on Respondent's owner and operator, Veronica Taran (hereinafter, Respondent's Owner and PIC).
3

ALJX 5 (Government's Prehearing Statement dated March 27, 2015 (hereinafter, Govt. Prehearing Statement)), at 2; ALJX 7 (Respondent's Prehearing Statement dated April 10, 2015), at 2;
see also
Stipulation No. 4, ALJX 10, at 2.

3
She variously testified that she was “the owner of the respondent pharmacy” and that she was “an owner and a Pharmacist-in-Charge” of Respondent. Transcript Page (hereinafter, Tr.) 795, 798 (respectively); s
ee also
Stipulation No. 2, ALJX 10, at 1.

Her testimony cited in this Decision and Order is quoted verbatim from the hearing transcript, without correction or “[sic]” notations in addition to those already in the transcript.

By letter from its attorneys dated March 12, 2015, Respondent timely requested a hearing and asked that a “reasonable extension to respond to an Order to Show Cause” be granted. ALJX 3 (Hearing Request dated March 12, 2015), at 1; ALJX 4 (Order for Prehearing Statements dated March 17, 2015), at 1. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ). On March 17, 2015, the CALJ established the schedule for the filing of prehearing statements and granted Respondent's request for additional time “to the extent that the hearing date set in the OSC . . . will be continued as directed at the prehearing conference scheduled by this order.” ALJX 4 (Order for Prehearing Statements), at 1, 2.

On March 27, 2015, the Government filed its Prehearing Statement. ALJX 5. On April 10, 2015, Respondent served its Prehearing Statement. ALJX 7. The April 14, 2015 Prehearing Ruling and Protective Order found that four “stipulations have been mutually agreed to and are conclusively accepted as facts.” ALJX 10, at 1.

On May 6, 2015, the Government and Respondent filed Supplemental Prehearing Statements. ALJX 6 and ALJX 9, respectively. The parties' joint filing dated May 26, 2015 included their 11 additional joint stipulations. ALJX 20, at 1-2.

On June 9 through 11, 2015 and on August 4, 2015, the CALJ conducted an evidentiary hearing in Miami, Florida.

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge dated October 16, 2015 (hereinafter, R.D.), at 2. At the hearing, both parties called witnesses to testify and offered documents into evidence. Following the hearing, both parties submitted briefs containing proposed findings of fact, proposed conclusions of law, and argument.

On October 16, 2015, the CALJ issued his Recommended Decision, including that all but two of the Show Cause Order's allegations, the sixth (prescriptions written for “office use”) and the seventh (prescriptions written for the prescriber's personal use), be sustained.
Id.
at 33-36, 38-39 (respectively). Regarding those two allegations, the CALJ's recommendations were that there were substantive violations, but that the allegations should not be sustained “based exclusively on the lack of adequate notice under current Agency precedent.”
Id.
at 36, 39 (respectively).

The CALJ found that the Government “supplied sufficient evidence to make out a
prima facie
case.”
Id.
at 57. He also found that Respondent's acceptance of responsibility was insufficient.
Id.
at 58. Concerning remedial steps, he explained that Respondent's “intentional decision to decline to notice evidence of remedial steps resulted in their preclusion from consideration.”
Id.
In sum, he concluded that the record supported imposition of a sanction.
Id.

The CALJ included in his R.D. an assessment of the degree and extent of Respondent's misconduct and concluded that Respondent had not “accepted anything meaningful in terms of responsibility or learned anything.”
Id.
at 59. “Where no understanding is acquired about how the regulated conduct fell short of professional and federal and state legal standards,” he wrote, “it would be difficult (even illogical) to predict improvement.”
Id.
He determined that the Registrant “is likely to proceed in the future as it has in the past if not curtailed in its ability to do so.”
Id.
He concluded that the “sheer number of established transgressions of various types, coupled with the refusal to admit that issues existed, would render a sanction less than revocation as a message to the regulated community that due diligence is not a required condition precedent to operating as a registrant.”
Id.
at 59. He recommended revocation of Registrant's registration and the denial of any pending applications for renewal.
Id.
at 60.

On November 5, 2015, both parties filed Exceptions to the R.D. Respondent served supplemental Exceptions to the R.D. on November 16, 2015. By letter dated November 10, 2015, the record was forwarded to me for Final Agency Action.
4

4
By correspondence dated February 29, 2016, Respondent's counsel gave notice of “termination of legal representation and an attorney/client relationship with the Respondent.”

Having considered the record in its entirety, including all of the Exceptions filed by Respondent and the Government, I agree with the CALJ that Respondent's registration should be revoked and that any pending applications for its renewal or modification should be denied. I further agree with the CALJ's conclusions that Respondent dispensed controlled substances knowing that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose and, therefore, violated the corresponding responsibility rule of 21 CFR 1306.04(a). I agree with the CALJ that Respondent was unable to readily retrieve prescriptions it had dispensed and, therefore, violated 21 CFR 1304.04. I agree with the CALJ that Respondent filled controlled substance prescriptions and shipped them out-of-state in violation of four States' non-resident pharmacy requirements. I agree with the CALJ that Respondent violated 21 CFR 1306.05 by filling controlled substance prescriptions that did not contain all of the required information. Based on Respondent's admissions, I find that Respondent filled prescriptions written for “office use,” although I do not sustain this allegation due to the Government's failure to comply with the notice requirements for a Show Cause Order. 21 CFR 1301.37(c). I find that Respondent filled at least one controlled substance prescription written by a physician for the physician's personal use, although I do not sustain this allegation due to the Government's failure to comply with the notice requirements for a Show Cause Order. 21 CFR 1301.37(c). I agree with the CALJ's conclusion that Respondent failed to report controlled substance prescriptions to E-FORCSE in violation of Fla. Stat. § 893.055(4) (2012). I agree with the CALJ that Respondent's acceptance of responsibility was insufficient and that Respondent did not provide sufficient notice of remedial measures.

Accordingly, I find the record as a whole established by substantial evidence that Respondent committed acts which render its continued registration inconsistent with the public interest. I conclude that revocation of Respondent's registration and denial of any pending application to renew or modify Respondent's registration are appropriate sanctions. I make the following findings.

Findings of Fact

Respondent's DEA Registration

Respondent is registered with the DEA as a retail pharmacy in schedules II through V under DEA Certificate of Registration No. FP1049546 at 205 E. Hallandale Beach Blvd., Hallandale Beach, Florida 33009. ALJX 1, at 1; s
ee also
Stipulation No. 1; ALJX 10, at 1. Respondent's registration was to expire on March 31, 2017. Stipulation No. 1; ALJX 10, at 1. According to DEA's registration records, however, on January 31, 2017, Respondent timely filed a renewal application. I take official notice of that pending registration renewal application. 5 U.S.C. 556(e).
5

Respondent's registration, therefore, remains in effect pending the issuance of this Decision and Order. 5 U.S.C. 558(c).

5
Under the Administrative Procedure Act, an agency “may take official notice of facts at any stage in a proceeding—even in the final decision.” United States Department of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), “[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary.” Accordingly, Respondent or the Government may dispute my finding by filing a properly supported motion for reconsideration within 10 calendar days of the date of this Order. Any such motion shall be filed with the Office of the Administrator and a copy shall be served on the other party; in the event either party files a motion, the other party shall have 10 calendar days to file a response.

The Investigation of Respondent

According to the testimony of the DI, he decided to investigate Respondent after learning that it had ordered 41,700 dosage units of hydromorphone in 2012. Tr. 28. This raised his suspicion because the average pharmacy in the United States ordered approximately 5,900 dosage units of hydromorphone in the same time period.
Id.
at 28.

On April 11, 2013, the DI presented Ms. Veronica Taran, Respondent's Owner and PIC, with a Notice of Inspection.
Id.
at 38;
see also
Stipulation No. 3; ALJX 10, at 2. The DI testified that Respondent's Owner and PIC read the notice of inspection, did not have any questions for the DI about it, signed it, and consented to the inspection. Tr. 38. The DI then asked Respondent's Owner and PIC for various records, including order forms and prescriptions

filled for schedule II through V controlled substances.
Id.
The DI stated that “I asked Mrs. Taran if we could take records for further review, so we boxed them up and took them with us. She consented to that.”
Id.
at 52-53. When he left Respondent on the unannounced inspection day, he took with him “2011 to 2013 Schedule II through V prescriptions, . . . any invoices or receipts covering the same timeframe, and executed DEA 222 forms and . . . [Respondent's] biennial inventory.”
Id.
at 50.

The DI also testified about approximately a dozen problematic prescriptions he had identified from E-FORCSE that Respondent's Owner and PIC “was never able to locate . . . for me.”
Id.
at 42, 43. “They were written for different anabolic steroid substances to patients that were not in the State of Florida,” he testified.
Id.
at 42.

The DI testified that he asked Respondent's Owner and PIC questions, including how she would verify controlled substance prescriptions.
Id.
at 39. According to the DI, Respondent's Owner and PIC said that she used two forms, one to verify the prescription and a doctor-patient affidavit “that she makes the patient fill out,” and she checked the prescriber's DEA number on the DEA website and the prescriber's license on the Florida Department of Health website.
Id.
at 39-40. According to the DI, Respondent's Owner and PIC told him that she was familiar with her patients and visited the doctors and their offices.
Id.
at 40.

The DI testified that Respondent's Owner and PIC had posted lists: “[o]ne was for doctors she would fill prescriptions for, another list of doctors that she wouldn't fill prescriptions for, and ones that were pending verification.”
Id.
at 40;
see also id.
at 41. The DI stated that Respondent's Owner and PIC specifically told him “she does not check” E-FORCSE, she had never shipped a controlled substance out of state, and “the pharmacy was not licensed in any other state.”
Id.
at 40-41, 44. Regarding E-FORCSE, the DI testified that he asked Respondent's Owner and PIC to “go onto” it to “check a prescription for me” and that “she wasn't able to do that.”
Id.
at 48-49. When asked for elaboration on the meaning of “she wasn't able to do that,” the DI responded that she did not have access. He testified, “She had access to enter her data into, but not to query a patient. . . . I was standing next to her when she was logged onto the computer attempting to query a patient.”
Id.
at 49.

The Allegations of Dispensing and Non-Dispensing Violations

The Order to Show Cause alleged seven bases for the revocation of Respondent's registration pursuant to 21 U.S.C. 824(a)(4) and 823(f). One of them had seven subparts.

Witnesses

Four witnesses testified at the hearing: The DI and Dr. Tracey J. Gordon for the Government, and Louis Fisher and Respondent's Owner and PIC called by Respondent. There was factual agreement among the witnesses on a number of issues. When there was factual disagreement, I applied the CALJ's credibility recommendations.
See
R.D., at 5-25.

Regarding the DI, the CALJ stated that he “presented as an objective regulator with no stake in the outcome of the proceedings” and provided “testimony [that] was sufficiently detailed, plausible, consistent, and cogent to be fully credited.” R.D., at 8. I agree with the CALJ's assessment of the DI's credibility.

At the hearing, the Government also offered testimony from Dr. Tracey Gordon, a pharmacist licensed in Florida who had practiced pharmacy for 21 years. Dr. Gordon testified to “ten-plus years of retail” experience in “at least 200” Florida retail pharmacies serving as a clerk, tech, intern, assistant manager, and manager. Tr. 282, 284. She testified to having experience dispensing controlled substances for the treatment of chronic pain.
Id.
at 289. She stated that she has served as a pharmacist-in-charge.
Id.
at 351. She testified to training in, and experience with, issues regarding the use and diversion of controlled substances, and to familiarity with the pharmaceutical practice aspects of the use and abuse of controlled substances.
Id.
at 289-90. She stated that she was a licensed Consultant Pharmacist and, at the time, was serving as a clinical Hospice pharmacist.
Id.
at 278-79.

Dr. Gordon was accepted, without objection, “as an expert in the practice of pharmacy in the [S]tate of Florida regarding the dispensing of controlled substance prescriptions.” R.D., at 8;
see also
Tr. 294-95.
6

The CALJ found that Dr. Gordon's testimony was “internally consistent and logically persuasive” and her qualifications “reflected a wide breadth of pharmacy experience, including working in many pharmacies as a line pharmacist and a pharmacist in charge,” and as a consultant and teacher. R.D., at 11. I agree with the CALJ that Dr. Gordon's “answers rang of sufficient clarity, authority, and candor to merit controlling weight in these proceedings regarding the practice of pharmacy in Florida.”
Id.
at 11.

6
On cross-examination, Respondent elicited that, although Dr. Gordon had helped her father in his store before she was a pharmacist, she never worked as a pharmacist in a small independent pharmacy. Tr. 477-78. Respondent further elicited that Dr. Gordon was “never in charge of purchasing controlled substances for resale for a small independent pharmacy.”
Id.
at 482. Respondent's first Exception to the R.D. also asserts “[a]s evident from the record” that “Respondent challenged Dr. Gordon's qualifications to testify about dispensing patterns . . . for a small sized, independent pharmacy such as Respondent.” Respondent's Exceptions to the ALJ's Recommended Ruling dated Nov. 5, 2015 (hereinafter, Resp. Exceptions), at 2. Respondent did not, however, provide a citation to the record for its assertion and my review found none. 21 CFR 1316.66(a). Regardless, given that the Show Cause Order did not raise “dispensing patterns . . . for a small sized, independent pharmacy,” Respondent's assertion is not germane to the resolution of this matter.

Respondent offered the testimony of Louis Fisher, who graduated in 1971 from the Hampden College of Pharmacy and worked for DEA or its predecessor agency from 1971 to 2003. Tr. 565. Mr. Fisher testified that, during his government service, his positions included compliance investigator, quota operation staff assistant, diversion investigator, diversion program manager, and group supervisor.
Id.
at 565, 570. He stated that he was “familiar with a procedure of dispensing controlled medications pursuant to prescriptions in Florida,” even though he never practiced pharmacy, or was a licensed pharmacist, in Florida.
Id.
at 571-72, 574-75. He testified that he was a consultant in the field of “controlled substances abuse and diversion” at the time.
Id.
at 572. Respondent sought to qualify Mr. Fisher as a “specialist in preventing drug diversion.”
Id.
at 561.

The CALJ accepted Mr. Fisher as an expert on the issue of dispensing in Florida. R.D., at 11 n.74, at 17. I agree with the CALJ that it is appropriate to “afford . . . diminished weight [to Mr. Fisher's testimony] where it conflicts with other, more persuasive evidence of record, including the testimony of Dr. Gordon.”
7

Id.
at 17;
see also id.
at 11 n.74.

7
The CALJ explained that Mr. Fisher's “discrepant testimony regarding his licensure and experience was disquieting. . . . On this record, the issue of Mr. Fisher's qualifications to render an expert opinion is uniquely dependent upon his own representations of his experience and, thus, his credibility. Either Mr. Fisher was careless . . . and reckless . . ., or he was engaged in an intentional effort to inflate his own qualifications. Either option undermines the weight that can be logically afforded to his opinions, and where these opinions conflict with other opinions or evidence, they cannot be relied upon.” R.D., at 16 (footnote omitted).

At the hearing, Respondent also offered testimony from Respondent's

Owner and PIC. Tr. 798. Respondent's Owner and PIC testified that she had been, at the time, a practicing pharmacist in Florida for about ten years.
Id.
at 798. She testified that she was familiar with the Florida provision specifically addressing the dispensing of controlled substances, and that she had taken “[m]ultiple courses” on “red flag of diversions” as well as “read many articles online about the situation in Florida with the pain management.”
Id.
at 799. Respondent's Owner and PIC also testified that she was a custodian of records for Respondent and supervised, at the time, one technician, one intern, and one student.
Id.
at 798-99.

I agree with the CALJ's conclusion that, while “[t]here were, undoubtedly, aspects of . . . [the testimony of Respondent's Owner and PIC] during which she presented as generally credible, . . . on the present record, her testimony was not sufficiently consistent or plausible to be afforded full credibility.” R.D., at 25.

Florida Pharmacists' Standard of Practice

Dr. Gordon, Mr. Fisher, and Respondent's Owner and PIC testified about a Florida pharmacy's/pharmacist's standard of practice when presented with a controlled substance prescription.
8

There were some areas of agreement by at least two of the three witnesses on some aspects of that standard.

8
The DI also addressed the standard of practice. For example, he testified that his investigation identified issues concerning Respondent's compliance with the Controlled Substances Act and its implementing regulations.
See, e.g.,
Tr. 51, 54, 68, 71, 73, 74-75, 76-77, 99, 102, and 124.

According to Dr. Gordon, upon a customer's presentation of a controlled substance prescription, the pharmacist should protect the safety of the patient and the community by looking for red flags of diversion, or “something that makes a pharmacist pause and think about” whether the prescription was “really for a legitimate medical purpose.” Tr. 296, 303. She discussed red flags including the quantity and dosage of the controlled substance, the doctor and practice specialty, and the patient's geographic location, doctor/pharmacy patronage, and payment (insurance/cash) method.
Id.
at 295-97.

Regarding the quantity and dosage of a controlled substance used for pain management, Dr. Gordon explained that “I look . . . [for] a long-acting with the prescription . . . [because] [i]t helps the patient to be more adherent to therapy.”
Id.
at 296.

Regarding the doctor and practice specialty, Dr. Gordon explained that, “I feel pretty comfortable filling a prescription for a large quantity of pain medication” if an oncologist wrote it.
Id.
at 298. “But if it's from a general practitioner or an ob-gyn,” she continued, “then that causes me to take pause and reevaluate the legitimacy of the prescription.”
Id.
She testified that the National Provider Identification website showed physicians' specialties and helped the pharmacist evaluate prescriptions.
Id.
at 297-98, 345. She also testified that a pharmacist should routinely check the status of a controlled substance prescriber's State medical license and DEA registration.
Id.
at 301, 345.

Regarding the patient, Dr. Gordon stated that a chain pharmacy's computer would show if the customer had filled the prescription at another branch, and Florida's prescription drug monitoring program, E-FORCSE, would show what other controlled substances the customer had received from other pharmacies or doctors.
Id.
at 301-02, 345. She explained that E-FORCSE “gives you the date . . . [the prescription] was written, the date it was filled, the name of the drug, the quantity, the doctor, the pharmacy, and how the patron paid for the medication” which would tell the pharmacy “if the patient was either doctor-hopping or pharmacy-hopping.”
Id.
at 302.

Dr. Gordon testified about the importance of the customer's payment method, explaining that “[a] lot of drug-seekers only want to pay for their medications in cash because . . . the insurance company will actually create your red flag for you to say if a prescription is refilled too soon, which means they've . . . obtained a prescription from another pharmacy.”
Id.
at 297;
see also id.
at 298-99.

Dr. Gordon stated that what constituted a red flag “changed all the time. It's like the drug community gets smarter.”
Id.
at 303. She indicated that, when confronted with a red flag, a pharmacist would make further inquiries of the doctor, the customer, or the caregiver.
Id.
at 305. She noted that “some of the red flags really can't be resolved, especially if you see patterns.”
Id.
at 304-05. She testified that, if she could not resolve a prescription's red flags, she would not fill it.
Id.
at 305. She would either give the prescription back to the customer or, with the doctor's authorization, shred it.
Id.

Dr. Gordon testified that, although there is no codified Florida rule specifying where a pharmacist must document resolution of a red flag, the standard practice in Florida was for the resolution of a red flag to be documented on the front of the prescription.
Id.
at 346-48. As a pharmacist-in-charge, she would check the face of the prescription to see if a subordinate pharmacist resolved a concern about the prescription.
Id.
at 351-52. She testified that any notes about the patient, as opposed to notes about a specific prescription, would appear in the patient profile.
Id.
at 350, 352.

Mr. Fisher testified that red flags “are part of the pharmacist's responsibility.”
Id.
at 616. Regarding what a pharmacist should do to resolve a red flag, Mr. Fisher first stated that the pharmacist should “[c]heck the state E-FORCSE system to see if this person is a doctor-shopper.”
Id.
at 604;
see also id.
at 608-09. He also stated that he would check the doctor's license to make sure it was valid, check if the customer had any history in the pharmacy of previous prescriptions being filled, and “then talk to the doctor and see . . . what the—maybe the diagnosis is on this prescription.”
Id.
at 604. When asked “where would you see if these things were done, if they were documented,” Mr. Fisher responded that the documentation could be written on the back of the prescription, in a notebook, in a logbook “of any kind” or “whatever system they want to be put into effect.”
Id.
at. 604-05. When asked whether the red flags “would have to be documented someplace,” Mr. Fisher responded affirmatively.
Id.
at 605;
see also id.
at 598-600 (Mr. Fisher's testimony that a pharmacist needs to resolve a red flag before dispensing the prescription, and resolution of the red flag must be documented somewhere.). Mr. Fisher testified that he did not know if the red flags he had identified on the prescriptions in the Government's exhibit had been resolved.
Id.
at 605;
see also id.
at 766 (Mr. Fisher's testimony that the prescriptions contained no notations evidencing that Respondent had resolved any of their red flags.).

The testimony of Respondent's Owner and PIC about diversion and what a pharmacy needed to do when presented with a controlled substance prescription was largely inconsistent with the testimony of Dr. Gordon and Mr. Fisher. Further, her testimony admitted that Respondent did not even follow the steps she described. It also, though, evidenced her knowledge and awareness that schedule II controlled substances were prone to diversion. For example, Respondent's Owner and PIC testified that “[e]ach prescription it comes with chronic nonmalignant pain, has to be addressed as a highly risky—high risk medication. It has to be addressed with proper steps.”
Id.
at 1129. Also regarding prescriptions for

schedule II controlled substances, she testified that “on schedule II, each time it's presented it has to be—there's a lot of diversion.”
Id.
at 1116. Specifically, Respondent's Owner and PIC identified Dilaudid 8mg. and Dilaudid 4 mg. prescriptions as “highly risky.”
Id.
at 1129; GX 12, at 5 and 7. When asked whether she recalled identifying “any red flags” when she filled a prescription for 174 tablets of Dilaudid 8 mg., Respondent's Owner and PIC responded that “the major red flag of that prescription is for Schedule II medication, Dilaudid, 8 milligram. Also, prescribed on the quantities.” Tr. 880-81.

According to Respondent's Owner and PIC, Respondent, and she as its PIC, needed to implement specific procedures unique to schedule II prescriptions due to the diversion associated with them. Her “specific procedures” consisted of a series of steps.
See id.
at 883-897 (using as an example GX 19, at 1). First, according to her testimony, she would “talk to doctor on each [schedule II] prescription” because “there's a lot of diversion” of schedule II controlled substances.
Id.
at 1116. Her testimony underlined the importance of talking to the prescribing doctor “each time” a schedule II prescription was presented by comparing the diversion of schedule II controlled substances with schedule III controlled substances:

When all the schedule II prescriptions—I would talk to doctor on each prescription. On schedule III I would talk to doctor when there's initial prescriptions for it. But there's not that much schedule III situations. But on schedule II, each time it's presented it has to be—there's a lot of diversion.

Id.

Respondent's Owner and PIC described the conversation she had regarding the first prescription in GX 19, a prescription for 174 tablets of Dilaudid 8 mg. She stated that she called the office and asked to speak with the doctor. “[H]onestly,” she admitted, the “doctor not always were available. But I spoke with the manager.”
Id.
at 895. The “honest” admission of Respondent's Owner and PIC that she did not always speak with the prescribing doctor about a schedule II prescription contradicted other testimony she gave that she always spoke with the doctor regarding such prescriptions.
See, e.g., id.
at 1116.

Respondent's Owner and PIC continued to describe her conversation with the doctor's office. She testified that she “would ask a manager to tell me more what was happening with the patient; was he seen on that day?”
Id.
at 895.

So if the patient was seen on the day that the prescription was issued, and the quantity—the reason why he had prescribed that quantity this month? And they would tell me that he has diagnosis in the proper—that doctor has a note in his chart to consider alternative treatments . . . . I would ask them, What did you prescribe today for that patient? . . . So they have to spell out what did they write this day, the quantity, to make sure there is no alteration on the way—there is no forging of the prescription. Then I would say, Is it okay for me to fill it? And they would give me approval to fill.

Id.
at 896. Respondent's Owner and PIC testified that after these steps, including “verify[ing] all the information, the address, the phone number, the complete date of birth, the doctor DEA number on the front, the quantities and the medications, the signature . . . [a]nd that medication was hand signed by the doctor,” she filled the prescription.
Id.
at 897.

Despite her testimony and her stated awareness of the high risk nature of schedule II prescriptions and the risk of diversion associated with them, including the “red flag” of schedule II controlled substances being prescribed in large quantities, Respondent's Owner and PIC again admitted that she did not always follow her first step. Instead, she testified that she would have to “go one-by-one each [schedule II] prescription” before answering questions about whether or not she spoke with the doctor about any of them.
Id.
at 1137;
see also id.
at 1133-39. Thus, Respondent's Owner and PIC admitted more than once to not implementing her own requirement of speaking to the prescriber of every schedule II prescription.
9

In making this admission, she did not explain why she deviated from her own procedure. Nor did she justify that deviation.

9
In the context of describing the uses of the “approved” stamp and the name/telephone number stamp, Respondent's Owner and PIC also testified she verified that the prescriptions were issued within the scope of the prescriber's practice when she talked “to the [prescriber's] office.” Tr. 1132.

[The stamps mean that] I talk to the office and I spoke with the patient. And I fill out documentation appropriate for—I verified—and most important, I verified this prescription was issued within scope of the doctor's practice. The doctor was allowed to treat chronic pain. It was the scope of his practice. He made the decision to write this prescription according to his practice.

Id.
at 1132-33;
contra id.
at 1225-27. It is noteworthy that Respondent's quoted testimony concerned her calling “the office” as opposed to her “speak[ing] with the doctor.”
Id.
at 1138, 1132, respectively. It was the further admission of the Respondent's Owner and PIC that she did not always “speak with the doctor” as she had testified was appropriate due to the high risk nature of schedule II prescriptions and the risk of diversion associated with them. Given her testimony that she did not necessarily speak with the “doctor” about schedule II prescriptions, it also raises the question of whether Respondent's Owner and PIC actually “verified” that prescriptions were “issued within [the] scope of the doctor's practice.”
Id.
at 1133.

Second, Respondent's Owner and PIC testified that she made sure the prescriber's State medical license was active, and the prescription was within the scope of the prescriber's DEA registration. Regarding a prescriber's State license, she testified that she would make sure that “the doctor actually licensed in the State of Florida to prescribe controlled substances.”
10

Id.
at 894. Regarding a DEA registration, she testified that she “was instructed . . . [by DEA] to go on the website—diversion site and verify the physician DEA number” and “[s]ince that instruction I religiously did that.”
Id.
at 892;
see also id.
at 1131-32 (Pharmacies should “make sure that . . . [the] doctor[ ] . . . [was] legitimate, I mean, . . . has a DEA license.”).

10
Regarding the doctor who prescribed the first prescription in GX 19, Respondent's Owner and PIC testified that he was “licensed in the State of Florida to prescribe medication for chronic pain management.” Tr. 894-95. “He was actually special trained in the pain management,” she stated.
Id.
at 895.

According to Respondent's Owner and PIC, “[t]he decision of prescribing lies upon the physicians and the state who govern his practice.”
Id.
at 1108. She elaborated, asserting that a pharmacy must fill a controlled substance prescription issued by a practitioner with the appropriate State and DEA licenses unless there is “a very good reason not to fill it.”
Id.
at 1168.

The doctor tells you it's okay to fill, just by the filling—the filling prescription. When the patient comes to the office—to the doctor, he's seen by the doctor. Doctor asking how many pills you have, what are you taking? Then he decide to issue another prescription. Once he issue the prescription, it's an order for a pharmacy—keep in mind, we still working in the medical system here. The prescription is an order for the pharmacist to fill. For me not to fill that prescription, I have to have a very good reason not to fill it, because it's an order from the doctor to me to fill that prescription for that patient.

Id.
at 1167-68. Respondent's Owner and PIC did not explain what she meant by “a very good reason not to fill it.” Nevertheless, I found in the record evidence of numerous controlled substance prescriptions that Respondent's Owner and PIC admitted Respondent filled without having documented the existence or resolution of any of the red flags of diversion identified in the testimony of Dr. Gordon and Mr. Fisher.

Third, Respondent's Owner and PIC testified that her “main concern would be if this patient was checked and have relation with the doctor.”
Id.
at 885. In the context of GX 19, the six Dilaudid

8 mg. prescriptions the Show Cause Order alleged that Respondent did not report to E-FORCSE, Respondent's Owner and PIC testified about how she would establish the requisite doctor-patient relationship.
11

She testified that she would “ask . . . [the customers] to fill out the [“Pain Management Physician-Patient Relationship Affidavit,” hereinafter, Relationship Affidavit] form, and sign . . . written affidavit” and “then I would call to the office and start questioning the office about whether this—to substantiate the truth about it.”
Id.
at 885. She testified that the Relationship Affidavit was to be completed the “first time only” that a customer came to Respondent pharmacy.
Id.
at 1016. She testified as to what the Relationship Affidavit would “do to alleviate . . . [her] concerns that this prescription was not diverted.”
Id.
at 887. She stated that “the major red flag at that time” was “whether patient actually be seen by doctor, not just come to the office and have the prescription ready for them.”
Id.
She continued by stating that “[i]t was not about . . . whether this prescription written for Dilaudid or prescription written for—or quantities, it was a concern, but not the main concern.”
Id.
According to Respondent's Owner and PIC, “[t]he main concern—the problem at the time was the patient going and the doctor's [sic] are not properly executing the practice that's reflected in the medical practice law.”
12

Id.
Her testimony continued: “So we would check, . . . would require for the patient has issues . . . [a]nd she has a medical history and there is a logical connection between her and the doctor, there's relationship, it's not just to get a prescription for major narcotics.”
Id.
at 887-88. According to Respondent's Owner and PIC, the Relationship Affidavit “resolve[d]” these concerns.
Id.
at 889. She stated, “That form would resolve . . . that he's not attempted to fraudulently—to illegally get access to the controlled pain medication.”
Id.; see also id.
at 1149.
13

11
The six Dilaudid 8 mg. prescriptions in GX 19 were written by the same doctor for six different customers in the July-August-November 2012 time period. Specifically, the six Dilaudid 8 mg. prescriptions were for: (1) 174 tablets for a customer from Pompano Beach at a cash price of $870; (2) 96 tablets for a customer from Fort Lauderdale at a cash price of $480; (3) 150 tablets for a customer from Miami at a cash price of $750; (4) 180 tablets for a customer from Pompano Beach at a cash price of $900; (5) 168 tablets for a customer from Pompano Beach at a cash price of $840; and (6) 168 tablets for a customer from Coral Springs at a cash price of $840. Respondent's Owner and PIC had identified the first prescription for 174 Dilaudid 8 mg. tablets as showing a “major red flag” because it was for a schedule II medication and for 174 tablets. Tr. 881.

12
Apparently, the “medical practice law” Respondent's Owner and PIC referenced was the “Ryan Act.” She testified that the purpose of the Relationship Affidavit was to “establish the patient-doctor relationships and the legitimate ill of the patients” in compliance with the “Ryan Act.” Tr. 1015-16. According to Respondent's Owner and PIC, “by that law is rely if the patient actually has a logical relation with the doctor.”
Id.
at 1016.

She testified further about the “state statute and federal statutes”: “For . . . me was most important thing was to go to references of the state statute and federal statutes. So federal statute says, has to be clear relationship to establish the legitimate medical purpose. You rely on the doctors to establish the appropriateness of therapies. It's not on the pharmacy to establish the appropriateness of pharmacy. . . , that's how I understood the law. The pharmacist is just to establish that the prescription was valid—the validity of prescription based that the prescription as a requirement, and the doctor allowed to prescribe, and the doctor actually see the patients. Unless there's some issues that arise with that, like, for instance, if the patient is—not that the doctor overly treated or the patient has issues — or the doctor has issues with the patient, or I feel something suspicious, then I call the doctors. . . . Because standards only tell you that you have to actually establish the patient is not coming here for wrong reasons. That's only what the statute says. The statute says if the patient come for wrong reason you don't fill it. If the patient come from appropriate reason, you fill.”
Id.
at 1018-19, 1021.

13
She also testified that she interacted with Respondent's customers by asking them questions.

I would talk to the patient, ask him about why did he come to my pharmacy? Where did he fill before? What is the reason he doesn't use previous pharmacy? And also, what is the reason for—how long has he been on that medication? And whether he was checked by—and then I would ask him to look at the affidavit form and sign the affidavit form for the patient. . . . I have not written those questions out. But they would be the same questions that I would ask to establish . . . the history of the patient.

Tr. 882-83, 884. When asked whether she would “essentially” ask every customer the same questions, she responded affirmatively and identified other questions she asked.
Id.
at 884-85. Respondent's Owner and PIC, however, did not explain the purpose of these questions given her testimony that the signed Relationship Affidavits “resolved” the issue of whether customers were attempting to fraudulently or illegally get access to controlled pain medication.

The Relationship Affidavit was a one-page form with Respondent's name at the top, and name and contact information at the bottom.
See, e.g.,
Respondent Exhibit (hereinafter, RX) 5, at 2. Text on the Relationship Affidavit stated that individuals “who are receiving medications to treat chronic intractable pain are required to be seen and examined by the physician on the same date the prescription for pain has been issued.”
Id.
According to the Relationship Affidavit, a customer had to sign it before Respondent would fill a prescription. The Relationship Affidavit stated that:

In order for prescriptions to be filled by . . . [Respondent] patients are required to sign this affidavit to ensure the following elements exist. By affirming and satisfying the conditions mentioned below . . . [Respondent] assumes that the prescription is valid pursuant to a legal Physician Patient Relationship.
14

14
The referenced “elements” apparently were listed in the last section of the form, which stated: “By signing below, I ________agree that the following elements of a legal Pain Management Physician-Patient Relationship exist: 1. There is no fraudulent representation to illegally gain access to controlled pain medications 2. There are no multiple doctors “doctor shopping” treating me for pain management 3. A physician has seen and conducted a physical examination 4. A physician has reviewed the patient's medical history 5. The patient has a medical complaint 6. MRI has been conducted within 24 months of the prescription 7. There is a logical correlation between the following a. Medical Complaint b. Medical History c. Physical Exam d. Prescriptions. __________Patient Name ________Date of Birth ________Signature ________Date.” RX 5, at 2.

Id.
Notably, Respondent stated its “assumption” that a prescription was valid when customers affirmed and satisfied the Relationship Affidavit's “conditions mentioned below,” presumably the “elements.”
Id.

Also of note was the “Warning” on the Relationship Affidavit: “In the event . . . [Respondent] has reasons to believe that prescriptions for pain medication have been prescribed and/or received fraudulently we have a legal responsibility to report such activity and individuals to local and federal authorities. These authorities will handle such individual in the manner prescribed by law.”
Id.
Respondent's Owner and PIC discussed the Relationship Affidavit's “warning” in her testimony. She stated that “it was actually warning that's in the case if I find something which would jeopardize or compromise my belief in the validity of the prescription, we have responsibility to report such activity to local and federal police. And the patient knew about it.” Tr. 888. She testified that, “I would say if I . . . find something . . .—. . . like Your Honor giving me the benefit of the doubt, I would give the patient the benefit of the doubt. If I find out that you have a problem, it's fraudulent, I will report you. So you better not start that process.”
Id.

In sum, Respondent's Owner and PIC testified that (1) she assumed the legality of a prescription based on customers' completion of the Relationship Affidavit, (2) she gave customers “the benefit of the doubt” concerning their completion of the Relationship Affidavit, and (3) she warned customers to “better not start” the process of her “find[ing] out” that a prescription is “fraudulent.” She did not explain why it was reasonable to expect drug seekers to understand what they read, let alone be honest and

truthful as they completed and signed the Relationship Affidavit. She also did not explain how giving customers “the benefit of the doubt” was consistent with the requirements of the corresponding responsibility regulation. 21 CFR 1306.04(a).

Fourth, Respondent's Owner and PIC testified that she “validate[d] that . . . it's a signature . . . not rubber signed, . . . [the prescription] was actually signed by the physician.” Tr. 892;
see also id.
at 1116-17 (“[T]he issue at the time was not the strength. The issue they were looking for was actually the prescription legitimate . . . , it's not fake . . . . Make sure the doctor actually issue it. He didn't buy it from—on the side, on the street. He didn't get his prescription from other sources, and actually get it from the doctor.”).

Respondent's Owner and PIC testified that the concept of “red flags” stood in the way of getting medicine to deserving individuals. She testified that, “by strictly following these red flags, it will prevent legitimate patient from obtaining the medication.”
Id.
at 1108. She testified that she decided not to fill prescriptions for schedule II controlled substances altogether because “following the red flags will prevent me from filling the . . . prescriptions for legitimate medical purposes . . . and be unfair to the patient.”
Id.
15

15
She added, “Except two instances when I had this overstock and the patient was patient of mine for other reasons, we decide to fill. . . . And I don't purchase them [schedule II controlled substances].” Tr. 1108-09.

Before the time she testified to having decided not to fill schedule II prescriptions, Respondent's Owner and PIC testified that her “liability was to prevent the diversion the best that I can, considering it was very, very little guidelines was provided to us at that time. We tried to update it, it was confusing, the red flags was changing.”
Id.
at 890. Apparently based on the individual perspective of Respondent's Owner and PIC concerning what pharmacies should do, Respondent designed its own forms “to support the establishment of legitimate medical purpose to fill” prescriptions.
Id.
at 981.
16

16

See, e.g.,
RX 6 and RX 10. These exhibits include various items of documentation with respect to fourteen customers which Respondent represented were obtained to determine the validity of the prescriptions. Tr. 824. Each of the exhibits contains a copy of each customer's driver's license, and copies of the Pain Management Physician-Patient Relationship Affidavit for 11 of the customers. There are also copies of printouts from the DEA registration web page with respect to five of the customers. RX 6, at 3, 18, 35; RX 10, at 6, 12.

There are also copies of a “CII/CIII Rx Verification Form” for four customers in these two exhibits. This was a one-page form on which Respondent would document the date and time of a phone call to a prescriber's office and list the name of the person providing the information.
See
RX 6, at 6. The form was then used to document “yes” or “no” as to whether: (1) The prescription was written by the prescriber, (2) whether the patient was seen by the prescriber at the prescriber's office, and (3) whether the patient was physically examined by the prescriber, after which the form provided a space for writing the diagnosis.
Id.
The form then included boxes to check whether the prescription was approved or denied, three lines for notes, and a line for the pharmacist to initial. While Respondent's Owner and PIC testified that she used this one-page form “[i]nstead of writing scribbles on the back of the prescription,” Tr. 1002, and on each of the four forms, checked “yes” with respect to each question, listed diagnoses codes, and indicated that each prescription was “approve[d],” none of the forms contains additional notes and only two of the forms were initialed by the pharmacist.
See
RX 6, at 6, 10, 21, 29.

Finally, the exhibits contain copies of E-FORCSE printouts for five of the fourteen patients.
See
RX 6, at 4, 7, 17, 20, 30. Of note, three E-FORSCE printouts were not obtained until the middle of April 2013,
see id.
at 4, 7, 30, one was obtained on May 13, 2013,
see id.
at 20, and one was obtained on August 23, 2013.
Id.
at 17. As found above, the DI served the Notice of Inspection on Respondent on April 11, 2013.

Respondent's Owner and PIC offered multiple comments about these timing issues: She “would not necessarily print out every time,” “the record that I kept in the file obviously was the latest one,” and “every time I check, I would check with the PDMP—with the PMP report.”
Id.
at 994. When questioned further by the CALJ about the E-FORCSE printout for patient G.A., Respondent's Owner and PIC testified that the State of Florida “would not give us the access” and “for a while I relied on the physician offices to provide me that information. I would call the physician to run the PMP report until I actually were able to get the access myself . . . .”
Id.
at 996. Respondent's Owner and PIC stated that she got access to E-FORCSE “sometime during 2013.”
Id.
at 997-98.

Respondent's Owner and PIC testified that this information was important to her because it told her “that this patient . . . was seen by the same doctor for over . . . [a] seven-month period. And so this patient requires therapy. And the doctor was a very local doctor . . . [a]nd he was going only to my pharmacy. So [the customer] relied on me to fill her prescription.”
Id.
at 986-87. Yet, with respect to patient S.B., her E-FORCSE printout showed that she had filled her controlled substance prescriptions at three different pharmacies as well as through a mail order service, RX 6, at 7, and with respect to patient D.K., his E-FORSCE printout showed that he had filled his prescriptions for both oxycodone and hydromorphone at four pharmacies in addition to Respondent.
Id.
at 20.

While Respondent's Owner and PIC also testified that G.A.'s “established relationship” with the doctor was “one of the thing that you use—one of the tools that you use with—to establish legitimate medical purpose . . . [because] you can fairly assume that the patients are being taken [sic] by the physician properly,”
id.
at 988-89, Dr. Gordon testified that “[t]he first . . . [red flag] that is really bold to me is the doctor. I've worked on other cases, and I've seen this doctor [R.T.] write lots of illegitimate prescriptions.”
Id.
at 360-61. Notably, each of the seven prescriptions listed on G.A.'s E-FORCSE printout was written by Dr. R.T., and each prescription was for 150 or 160 dosage units of hydromorphone 8 mg. RX 6, at 4. Dr. R.T. also wrote five of the prescriptions listed on S.B.'s E-FORCSE printout (including all four hydromorphone prescriptions, three of these being for 160 dosage units or more of the 8mg. dosage),
see
RX 6, at 7, and all four hydromorphone prescriptions listed on T.S.'s E-FORCSE printout, each of these being for 150 or more dosage units of the 8 mg. dosage.
Id.
at 30.

Respondent submitted a further exhibit, RX 11, which contained documentation related to other customers. Respondent's Owner & PIC testified that this exhibit was “generated . . . [t]o show in good faith that we are actually conducting best practices. . . . That we document good practice when we fill the patient—we're filling pain medication for sick patient.” Tr. 1173-74. The exhibit consist of a photocopy of the driver's licenses of three of the six customers for whom the prescriptions in GX 14 were written; a Relationship Affidavit signed by two of the six customers; and a one page E-FORCSE printout dated months after the corresponding prescriptions in GX 14 were written and filled.

I afford Dr. Gordon's statement of the pharmacy's/pharmacist's standard of practice regarding controlled substances controlling weight in this proceeding. I find that the requirements incumbent on pharmacies/pharmacists espoused by Respondent's Owner and PIC are only entitled to credit as I determine what actions Respondent took and Respondent's suitability to be a registrant. Essentially, the views of Respondent's Owner and PIC about a pharmacy's/pharmacist's obligations with respect to dispensing controlled substances reflect an abdication of her legal responsibility to a prescriber with a valid State license and whose DEA registration covered the schedule of the prescribed medication when the customer simply signed the Relationship Affidavit. Significant aspects of the pharmacy's/pharmacist's obligations espoused by Respondent's Owner and PIC were contrary to statute, regulation, and Agency precedent. I categorically reject them.

Allegations That Respondent Failed To Exercise Its Corresponding Responsibility When It Dispensed Controlled Substances Pursuant to Prescriptions Not Issued in the Usual Course of Professional Practice or for a Legitimate Medical Purpose

The Show Cause Order alleged that Respondent failed to exercise its corresponding responsibility under 21 CFR 1306.04(a) as evidenced by its having dispensed controlled substances without resolving “red flags of diversion” that were present. The Government alleged seven “red flags of diversion” in the Show Cause Order: Prescriptions presented by customers who traveled long distances to Respondent; multiple customers filling prescriptions written by the same prescriber, for the same drugs, in the same quantities, on the same day; multiple customers from the same address coming to Respondent at the same time with prescriptions from the same doctor for the same drug and

strength; customers presenting two prescriptions, both for the same immediate release controlled substance, but for different strengths; customers presenting prescriptions with a combination of an opiate and a benzodiazepine or “drug cocktail” popular among drug abusers; customers paying for their prescriptions with cash, when other red flags of diversion were present; and customers presenting new prescriptions for controlled substances when they should not have finished their previous prescription for that drug (“early fills” or “early refills”).

Prescriptions Presented by Customers Who Traveled Long Distances to Respondent

The Government alleged that customers traveling long distances to fill their prescriptions was a “red flag of diversion,” and that Respondent dispensed controlled substances to customers who traveled long round-trip distances, from their homes, to the prescribers, to Respondent, and then back home, without addressing or resolving the distance red flags. To support this allegation, the Government submitted 13 such prescriptions filled by Respondent.
See
GX 8/8a;
17

see also
Tr. 53 (DI testifying that GX 8 contained fair and accurate copies of the documents Respondent provided to him). Of the 13 prescriptions in GX8/8a, nine were for Dilaudid 8mg.
18

17
The materials in GX 8 and GX 8a, 13 prescriptions and corresponding prescription labels, were identical. There were driver's licenses associated with nine of the 13 prescriptions/prescription labels. GX 8a contained better copies of most of the driver's licenses than GX 8. Tr. 793. Those better copies were added to GX 8 as GX 8a during the hearing on June 11, 2015.
Id.
at 794.

18
The other four were for buprenorphine (2), Xanax, and testosterone.

The DI testified that he initially identified the prescriptions in GX 8/8a as “problematic” because they showed “[p]eople traveling long distance[s] to the pharmacy.” Tr. 50-51. The parties stipulated to sets of round-trip (by road) miles within the State of Florida. ALJX 20, at 1-2. Those sets of round-trip miles corresponded to miles traveled by customers for whom Respondent filled prescriptions listed in the Show Cause Order and included in GX 8/8a. In sum, the round-trips ranged from 184 miles to 661 miles. I make the following findings:

• One bottle of Buprenorphine Hydrochloride 0.3 mg/mL issued to FW of Deltona by Dr. AF of Hallandale Beach. The parties stipulated that the distance by road from Deltona to Hallandale Beach and back to Deltona is 504 miles.

• 150 tables of Dilaudid 8 mg. issued to GA of Fort Pierce by Dr. RT of Miami. The parties stipulated that the distance by road from Fort Pierce to Miami to Hallandale Beach and back to Fort Pierce is 261 miles.

• 168 tablets of Dilaudid 8 mg. issued to SB of Fort Pierce by Dr. RT of Miami. The parties stipulated that the distance by road from Fort Pierce to Miami to

Hallandale Beach and back to Fort Pierce is 261 miles.

• 150 tablets of Dilaudid 8 mg. issued to CW of Fort Pierce by Dr. RT of Miami. The parties stipulated that the distance by road from Fort Pierce to Miami to Hallandale Beach and back to Fort Pierce is 261 miles.

• One bottle of Buprenorphine Hydrochloride 0.3 mg/mL issued to MW of Hobe Sound by Dr. AF of Hallandale Beach. The parties stipulated that the distance by road from Hobe Sound to Hallandale Beach and back to Hobe Sound is 166 miles.

• 140 tablets of Dilaudid 8 mg. issued to DK of Jensen Beach by Dr. NG of Hallandale Beach. The parties stipulated that the distance by road from Jensen Beach to Hallandale Beach and back to Jensen Beach is 195 miles.

• 56 tablets of Dilaudid 8 mg. issued to BS of Port St. Lucie by Dr. ML of Hollywood. The parties stipulated that the distance from Port Saint Lucie to Hollywood to Hallandale Beach and back to Port Saint Lucie is 201 miles.

• 150 tablets of Dilaudid 8 mg. issued to TS of Sebastian by Dr. RT of Miami. The parties stipulated that the distance from Sebastian to Miami to Hallandale Beach and back to Sebastian is 318 miles.

• One bottle of testosterone cypionate 210 mg/mL issued to RV of Sebring by Dr. AF of Hallandale Beach. The parties stipulated that the distance by road from Sebring to Hallandale Beach and back to Sebring is 312 miles.

• 112 tablets of Dilaudid 8 mg. issued to BR of St. Pete Beach by Dr. DJ of Deerfield Beach. The parties stipulated that the distance by road from Saint Pete Beach to Deerfield Beach to Hallandale Beach and back to Saint Pete Beach is 538 miles.

• 112 tablets of Dilaudid 8 mg. issued to WP of Stuart by Dr. GF of Pembroke Park. The parties stipulated that the distance by road from Stuart to Pembroke Park to Hallandale Beach and back to Stuart is 184 miles.

GX 8/8a.

Dr. Gordon testified that the long distances the customers traveled in connection with obtaining and filling all of the prescriptions in GX 8/8a were red flags. Tr. 353-62, 365, 368, 370, 372, 374-77, 380-82, 384-85, 387-92. She explained: “Pharmacies that dispense prescriptions that are not for legitimate medical purpose, they have a tendency to develop a reputation. And then the other drug seekers find out about it, and they'll go to any distance to get what they need for their—to satisfy their addiction.”
Id.
at 355.

For 12 of the 13 prescriptions, Dr. Gordon was asked to look for notations on the prescriptions evidencing that the filling pharmacist had taken steps to attempt to resolve the prescriptions' red flags, or she looked for notations herself. She found none.
Id.
at 356, 364, 369, 371, 373, 374, 377, 381-82, 384, 387-88, 389-90, 391. On cross examination, Dr. Gordon testified to the absence of documentation on the other prescription.
Id.
at 494. Dr. Gordon was asked whether the distance red flags on 12 of the prescriptions were resolvable. She testified they were not.
Id.
at 355, 367, 369, 371, 373, 374, 377-78, 382, 384, 388, 390, 391. She was not asked about the resolvability of the distance red flag on the other prescription, but said that its red flag had not been “resolved.”
Id.
at 364. Of that prescription, she also stated: “That's a very long distance [261 miles from Fort Pierce to Miami to Hallandale Beach to Fort Pierce] for somebody that has pain to be driving—sitting in a car for that long to obtain Dilaudid 8, which is the highest milligrams it comes in.”
Id.
at 361.

In sum, Dr. Gordon concluded that none of the 13 prescriptions was legitimate and that the pharmacist who filled the prescriptions had not exercised her corresponding responsibility to make sure the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
Id.
at 357, 364-65, 367-78, 370, 371, 373, 375, 378, 382, 385, 388, 390, 391-92.

Mr. Fisher's testimony about whether distance was a red flag was inconsistent. At one point, Mr. Fisher testified that the prescriptions included in GX 8 evidenced distance red flags, and that he believed they could have been resolved.
Id.
at 596-97. “Usually,” he stated, “a prescription is going to be filled close to where the physician is or close to where the person lives.”
Id.
at 597;
see also id. at
601 (Mr. Fisher's testimony that Fort Pierce is a “distance from the area.”). At another point, however, Mr. Fisher appeared to testify that distance was a red flag only when Respondent was asked to fill prescriptions for intrastate customers, as opposed to out-of-state customers, even though out-of-state customers would be located further from Respondent than intrastate customers.
Id.
at 745. The CALJ sought clarification, asking: “[I]f a person was a long distance but they were in Florida, that would be a red flag. But if a person was living a long distance . . . in Georgia, that's not a red flag? . . . So what's your final answer; that it is a distance red flag or it's not.”
Id.
at 745-46. Mr. Fisher responded: “It's a distance red flag, which is

resolvable.”
19

Id.
at 746;
see also id.
at 754. Thus, Mr. Fisher eventually agreed with the testimony of the Government's expert that customers who traveled long distances to fill controlled substance prescriptions were red flags.

19
When Respondent's counsel argued that Mr. Fisher “did not testify in all other cases that the distance was a factor and testified in this case—. . . I'm talking about as out-of-state prescriptions, that distance is not a factor” and that “[t]he method of delivery is completely different . . . [s]o those two are not even analogous,” the CALJ responded: “The record will stand as it is.” Tr. 746-47.

Respondent's Owner and PIC admitted that Respondent filled the prescriptions in GX 8/8a.
Id.
at 979. She testified that it was not a red flag “by itself” for customers within the State of Florida to come over 100 miles from their homes to fill a controlled substance prescription at her pharmacy.
Id.
at 1028;
see also id.
at 1021-22 (In 2012 and 2013, “the fact that a patient traveled a long distance . . . was not a major red flag, no.” There were “other red flags that I was concentrating on.”).

Respondent submitted CII/CIII Rx Verification Forms for four of the 13 prescriptions in GX 8/8a.
20

RX 6, at 6, 10, 21, and 29. According to Respondent's Owner and PIC, these four forms were part of Respondent's “patient files,” the “documents—prescriptions, prescription labels, and corresponding documents which assisted me to resolve the red flags made by . . . [Respondent] and kept in the regular course of business.” Tr. 824-25. She asserted that the CII/CIII Rx Verification Form was a “step ahead,” and “above and beyond” the “general practice of most of the pharmacies in the State of Florida.”
Id.
at 1001. She further testified that “[i]nstead of writing scribbles on the back of the prescription, . . . you have, more or less, here on form.”
Id.
at 1002.

20
The CII/CIII Rx Verification Forms concern the prescriptions in GX 8/8a written for SB, CW, DK, and TS.

While the forms contained diagnosis codes, only two of the forms were initialed by the pharmacist, and none of the forms contained any notes explaining how Respondent's pharmacist resolved whatever prompted her to call the prescriber even though the form contained three lines for this purpose. RX 6, at 6, 10, 21, 29. Regarding the incompletions, Respondent's Owner and PIC testified both that: (1) “Sometime we get busy, I know the office is called” and “I did look at the paper, because I would not fill the prescription unless I look at the paper;” and (2) “[i]f it's a routine patient who comes—who's been already established by me, . . . same prescription that's filled before, we would just—probably would be a little bit more routine in the call.”
Id.
at 1004, 1005-06 (respectively). This testimony of Respondent's Owner and PIC was inconsistent with her testimony that “When all the schedule II prescriptions—I would talk to doctor on each prescription.”
Id.
at 1116.

Respondent's Owner and PIC stated that she did not document all her conversations with doctors because “it's my kind of internal—I did it to make a proper, sound clinical judgment whether this patient appropriate to get . . . these filled prescriptions.”
Id.
at 1010. Notably, she stated that, “I do accept responsibility for that and I don't do it any more. Now I document every little thing that it's concerned to the conversation and the dispensing of controlled substances.”
Id.
She also said that, “again, like I said, I accept responsibility for that and I improve my practice now. I do document everything that's possible to. However, like I said, this happens all the time.”
Id.
at 1011. She added that “we cannot have 100 percent even if it's red flag. . . . You try to do the best that you can, but sometimes it happens.”
Id.
at 1012.

The CALJ noted that “it seems to me that on the form that you're giving me, the place that that should have been noted is down at the bottom where it says `notes,' and also the pharmacist's initials if you had made the call.”
21

Id.
at 1013. Respondent's Owner and PIC, correlating the exercise of her corresponding responsibility with her practice in school of “taking very little notes,” admitted that “I do have a tendency not to take too many notes” and confirmed that “I should learn how to take better notes.”
Id.
at 1014. She said that she “took remedial steps for it” by “hir[ing] new person who actually specifically look if I leaving the notes . . . and everything is properly taken right now.”
Id.
Further, Respondent's Owner and PIC admitted that red flags identified from E-FORCSE were not noted, nor was their resolution documented, on the corresponding CII/CIII Rx Verification Form.
Id.
at 1010.

21
Two of the forms' “Pharmacist's Initials” sections were completed. No form's “Notes” section contained a note.

Based on the testimony of both Dr. Gordon and Mr. Fisher, I reject the testimony of Respondent's Owner and PIC that “the fact that a patient traveled a long distance . . . was not a major red flag.” I further find not credible the testimony of Respondent's Owner and PIC that she did not consider a controlled substance prescription presented by a customer who travelled a long distance to be a red flag and conclude the exact opposite to be the case.

I find that each of the prescriptions in GX 8/8a raised at least one red flag that required resolution in that customers traveled long distances to obtain controlled substances, including schedule II controlled substances that even Respondent's Owner and PIC admitted were “highly risky” and subject to “a lot of diversion.”
Id.
at 1129, 1116, respectively. I find that Respondent admitted filling the prescriptions in GX 8/8a. Based on the testimony of both Dr. Gordon and Mr. Fisher, I find that, at a minimum, the distances the patients traveled to present the prescriptions in GX 8/8a required Respondent to resolve the distance red flags before dispensing controlled substances. I further find that Respondent did not address or resolve the red flags before filling the prescriptions in GX 8/8a.

Multiple Customers Filling Prescriptions Written by the Same Prescriber, for the Same Drugs, in the Same Quantities, on the Same Day

The Government alleged that prescriptions written by the same prescriber, for the same drugs, in the same quantities, and on the same day was a “red flag of diversion,” and that Respondent filled such prescriptions without resolving that red flag. As support for this allegation, the Government submitted five prescriptions that were written by the same doctor (Dr. A.F.) on the same day (June 27, 2012), and for the same strength of the same medication (testosterone cypionate).
See
GX 10;
see also
Tr. 394 (testimony of Dr. Gordon), Tr. 67 (DI testifying that GX 10 contained fair and accurate copies of documents he obtained from Respondent on April 11, 2013), and Tr. 68. Respondent filled them all on June 28, 2012, between 11:24 a.m. and 12:56 p.m., a period of about an hour and a half. GX 10.

In Dr. Gordon's view, “[t]hese prescriptions present a big red flag.” Tr. 394. “[I]t's odd,” she testified, “that a compounded script would be made exactly the same for each of these patients, which means there's not individualized therapy.”
Id.
The lack of individualized treatment meant to Dr. Gordon that “the prescriptions were not written for a legitimate medical purpose.”
Id.
at 396. She testified that she did not see any notations on the prescriptions evidencing that a pharmacist attempted to address the red flags.
Id.; see also
R.D., at 49 (Respondent's Owner and PIC “conceded that the paperwork furnished

to the DIs at the April 11th Inspection did not memorialize any attempts to resolve this red flag and agreed that she did not have any paperwork documenting her identification or resolution of the issue.”). Dr. Gordon's testimony was that this red flag was not resolvable. Tr. 396. She testified that the pharmacist who filled the prescriptions did not exercise her corresponding responsibility to ensure that the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
Id.
at 396-97.

At first, the “only comment” that Mr. Fisher had about the prescriptions in GX 10 was that “there doesn't seem to be a quantity that's identifiable.”
Id.
at 618. When asked specifically about the fact that the prescriptions came from the same doctor and for the same drug, Mr. Fisher testified that, “[i]f the doctor is specializing in men's health . . . , he could have multiple patients on the same regimen of drugs.”
Id.
at 619. On cross examination, however, Mr. Fisher admitted that the five prescriptions were an example of “pattern prescribing,” or when “a doctor . . . writes the same thing for every single patient that comes in.”
Id.
at 769. Mr. Fisher then testified that pattern prescribing was a “red flag for diversion.”
Id.

Respondent's Owner and PIC testified that the prescriptions raised a red flag because they were for a “schedule [sic] medication, testosterone.”
22

Id.
at 1084. She testified that she resolved this red flag by asking the prescribing doctor “if she knows the purpose of this . . . treatment, and if the patient are . . . taking it for an appropriate use.”
Id.

22
Respondent's Owner and PIC testified that the red flag for the testosterone prescription on page 3 of GX 10 was the customer's age, 27 years old. Tr. 1086. She stated that she spoke with the doctor about this prescription and the “doctor assured me that this patient has low testosterone and he needs because he feels very tired and he's not going to use it for athletic purposes. He was not an athlete.”
Id.

Respondent's Owner and PIC also testified that these five prescriptions raised red flags because “[t]hey came on the same day with the same medication at the same . . . dose . . . [a]nd the same doctor.”
Id.
at 1092. At this juncture, her testimony about how she resolved the red flags was that she spoke with the doctor.
Id.
at 1092-93. She testified that, “The reason . . . they come on the same day, because the doctor designated that day to see patients who need hormonal replacement. . . . [I]t helps her to keep the records straight . . . . [T]hey start out on the same dose. This way it's easier to achieve the day to day concentration of the dose.”
Id.
In response to whether she had any notes “anywhere” documenting her conversation with the physician, Respondent's Owner and PIC replied, “Not here, no.”
Id.
at 1094.

Based on all of the evidence in the record, I find that Respondent filled prescriptions that raised the red flag of multiple customers presenting prescriptions written by the same prescriber on the same day for the same medication in the same quantity. I further find that, even if these red flags were resolvable, there was no credible evidence that Respondent addressed or resolved them before filling the prescriptions. I cannot, and do not, place any weight on the testimony of Respondent's Owner and PIC that she resolved these red flags because she produced no documentary evidence to support her claim that she attempted to and, in fact, did resolve them before filling the prescriptions.

Multiple Customers From the Same Address Coming to Respondent at the Same Time With Prescriptions From the Same Doctor for the Same Drug and Strength

The Government alleged that multiple customers from the same address coming to Respondent at the same time with prescriptions written by the same doctor for the same drug and strength was a “red flag of diversion,” and that Respondent filled such prescriptions without resolving that red flag. To support this allegation, the Government submitted two prescriptions for Dilaudid 8 mg. that Respondent filled within five minutes of each other.
See
GX 11. The prescriptions were written by the same doctor on the same day with the same use directions to two individuals with the same last name and street address in Hollywood, Florida.
See
Tr. 397-98;
see also id.
at 70 (DI testifying that GX 11 consisted of true and accurate copies of prescriptions and labels he took from Respondent on April 11, 2013) and
id.
at 71 (DI testifying that the prescriptions in GX 11 were for two customers living at the same address, who saw the same doctor, were prescribed the exact same drug and strength, and then took those prescriptions to Respondent at the same time). The difference between the two prescriptions was that one was for 80 tablets and the other was for 85 tablets.
Id.
at 397;
see also
GX 11, at 1, 3.

In Dr. Gordon's opinion, these prescriptions raised multiple red flags that were not resolvable. Tr. 397-98. She testified that: “This to me is what's called rubber-stamping from a physician, and is not individualized therapy. . . . It's unusual that two patients that live at the same address would receive the same exact therapy. There's always an exception to the rule, but this is common in the drug-seeking community . . . .”
Id.
Dr. Gordon also testified that there were no notations on the prescriptions addressing the red flags.
Id.
at 398. Her opinion was that the prescriptions were not legitimate and that the pharmacist who filled the prescriptions had not exercised her corresponding responsibility to ensure the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
Id.
at 398-99.

Mr. Fisher agreed with Dr. Gordon that the prescriptions raised red flags. He testified that the “same address for two different people” and the “same drug” were red flags associated with these prescriptions.
Id.
at 620. He considered it “very possible” that the prescriptions were for husband and wife who had a reason for going to the same doctor at the same time.
Id.
He suggested that “[s]peaking to the physician would be the easiest way” to resolve those red flags.
Id.
On cross-examination, Mr. Fisher agreed that a pharmacist's “due diligence . . . [and] the standard way to try to prevent diversion of drugs” required the pharmacist to “check the other things available . . . [l]ike the E-FORCSE system, . . . the doctor's license number, and all that. The routine things you do with a Schedule II prescription.”
Id.
at 771. He also contradicted his earlier testimony when he admitted that, in this situation, a “simple phone call to the doctor” might not achieve the level of satisfaction concerning the prescriptions' legitimacy the “pharmacist has to get . . . before they can fill the prescription,” because “the doctor, himself, may not have issued . . . [the prescriptions] for legitimate medical purpose[s] in the course of his professional practice.”
Id.
at 771-72.

According to Respondent's Owner and PIC, the fact that the prescriptions were written by the same doctor, for the same drug and dosage, for individuals living at the same address who had the same last name and presented the prescriptions on the same day did not raise a red flag.
Id.
at 1097-98. She testified that she “would treat . . . [the prescriptions] the same way I treat every other schedule II medication.”
Id.
at 1098. She also stated that she filled the prescriptions because, at the time, “I thought the circumstances of the prescriptions were understandable.”
Id.
at 1103-04. She then stated that, as of 2015, she would not fill them “[b]ecause the DEA have restriction on filling those

prescriptions[,] . . . [n]ot because the patient are not legitimate and not because of doctor not legitimate or not legitimate medical purpose. Only because DEA said do not fill those prescriptions.”
Id.
at 1104. When asked if someone at DEA told her not to fill schedule II prescriptions, Respondent's Owner and PIC responded: “Obviously, if they bring me that case, that what they saying to me. They will try to take—intend to revoke my license for filling those prescriptions. . . . The[y] didn't tell me—not until they come with this order to show cause.”
Id.
at 1104-05.

Based on all of the evidence in the record, I find that the prescriptions in GX 11 raised red flags because customers with the same last name and street address presented them, and they were written on the same day by the same doctor for the same drug and strength. Further, I find that Respondent admitted filling the prescriptions even though these red flags were not resolvable, according to Dr. Gordon's testimony. I find that, even if these red flags were resolvable, there was no credible evidence in the record that Respondent addressed or resolved them before it filled the prescriptions. Respondent's Owner and PIC offered no evidence to substantiate her testimony that the circumstances of the prescriptions were “understandable” and did not raise red flags. I afford her testimony no weight.

Customers Presenting Two Prescriptions, Both for the Same Immediate Release Controlled Substance, but for Different Strengths

The Government alleged that a “red flag of diversion” was raised when customers presented two prescriptions for the same immediate release controlled substance, but for different strengths, and that Respondent filled such prescriptions without addressing or resolving the red flag. As support for this allegation, the Government submitted four such prescriptions filled by Respondent.
See
GX 12. The four prescriptions consisted of two prescriptions each for Dilaudid 8 mg. and Dilaudid 4 mg. written for two different people. Tr. 399, 405-06;
see also id.
at 72 (DI testifying that GX 12 contained true and accurate copies of documents he took from Respondent on April 11, 2013) and
id.
at 73 (DI testifying that the prescriptions in GX 12 belonged to two patients for the same immediate-release drugs and strengths). Dr. Gordon testified that the prescriptions raised red flags.
Id.
at 399-400, 403-04. The first red flag she identified was that the two prescriptions were written for the same immediate release controlled substance, but for different strengths.
Id.
at 399. The second red flag she identified was the diagnosis of “lumbar radiculopathy.”
Id.
at 400.

Dr. Gordon explained that giving one person two prescriptions for two immediate release opioids was not necessary because the Dilaudid 8 mg. could be broken in half to get a 4-milligram dose.
Id.
at 399. She pointed out that there was no long-acting medication accompanying the prescriptions in GX 12 and that “[t]wo immediate-release opioids is . . . a common red flag for diverted prescriptions.”
Id.; see also id.
at 399-400. She explained: “In pain management . . . you start out with a short-acting. Then based on the amount of short-acting, you prescribe a long-acting, because if you were in pain, I wouldn't want you to have to take something every four hours. . . . So what we do is we recommend . . . a long-acting . . . with a break-through.”
Id.
at 401. Her testimony further explained that “it looks like the practitioner was trying to say that you could only take Dilaudid, 4 milligrams, one, three times a day . . . [but] [i]t won't last eight hours. So that's the first red flag.”
Id.
at 403. She continued, asking rhetorically “why would you take a higher dose of a break-through? It doesn't make any sense.”
Id.
Drawing from her experience, she testified that “it would have made more sense for him to schedule the eight[;] . . . it's usually the same dose for break-through.”
Id.

Dr. Gordon also testified that the diagnosis of “lumbar radiculopathy” was “a red flag to take pause for any reasonable pharmacist to make sure the prescriptions are legit.”
Id.
at 400.
See
GX 12, at 1-2. She explained that, “on prescriptions that are not legit, that's the pattern I've seen—lumbago is big on illegitimate prescriptions—and most of my colleagues as well.” Tr. 404.

When asked if she would “reach out to the prescriber” if she “were in a retail pharmacy and . . . saw a prescription like this coming in with two short-actings,” Dr. Gordon responded “[n]o. . . . I would give the prescriptions back to the patron.”
Id.
at 402. She stated that the red flags raised by the prescriptions were not resolvable.
Id.
at 405, 406. Dr. Gordon testified that there were no notations on the prescriptions addressing the red flags, and gave her opinion that the prescriptions were not legitimate and that the pharmacist who filled the prescriptions did not exercise her corresponding responsibility to ensure the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
Id.
at 404-05, 406-07;
see
GX 12, at 1-8.

Mr. Fisher agreed that “two prescriptions written for the same person for the same drug but different strengths” was a red flag. Tr. 620-21. He testified that he would speak to the doctor to resolve it because it's “[c]ommonly done” to “try[ ] to achieve a certain therapeutic level by combining the two doses . . . [because] [t]he 8 milligrams is not enough for the patient, so they do 12.”
Id.
at 621. Mr. Fisher testified that a consistent therapeutic level would be achieved if the medication were taken as directed during a 24-hour cycle.
See id.
at 624. He stated that “three times a day, you're going to take it probably . . . . You're not taking it in the middle of the night. You're probably going to take it morning, noontime, and suppertime. And then he goes to work and he needs something stronger and he takes the stronger dose. . . . It is common.”
Id.
at 624-25.

Respondent's Owner and PIC testified that the only red flag she associated with the prescriptions in GX 12 was that they were for schedule II controlled substances.
Id.
at 1115, 1129. When asked if “the fact that there was two different strengths of the same medication, issued to the same patient on the same day by the same doctor . . . constitutes a red flag,” Respondent's Owner and PIC replied in the negative “because there is a logical explanation to it.”
Id.
at 1115. “That's done . . . to achieve certain dosage variance,” she stated.
Id.
After further questioning on the subject, Respondent's Owner and PIC stated that she “spoke with the doctor about it and doctor approved the dose.”
Id.
at 1121;
see also id.
at 1132-33. She added that the doctor was “still practicing . . . [a]nd the patient tells me that's how he benefits the most.”
Id.
at 1121. She testified similarly regarding the prescriber of the other prescriptions in GX 12.
Id.
at 1126.

When asked whether she had, for these prescriptions, “the same documentation that you've shown before . . . [l]ike . . . the patient agreement and the PMP report and a note that somebody checked with the doctor,” Respondent's Owner and PIC answered affirmatively.
Id.
at 1121-22. She admitted that she had not, however, provided the same documentation. Instead, she stated that the existence of the “approved” stamp and “my personal stamp with my signature on it” meant that “I spoke with the doctors. . . . And documents were obviously generated when he comes—visiting the

pharmacy, otherwise I would not dispense it.”
Id.
at 1122. When asked, however, whether “[e]very time you see that stamp, you spoke with the doctor,” Respondent's Owner and PIC declined to respond in the affirmative.
Id.
at 1136-37. She stated, “I have to go each prescription by—let's go one-by-one each prescription, I tell you each one I spoke with.”
Id.
at 1137. She testified that, “I called—as far as I remember, on each prescription, every time it's presented to me, I called the office. Not necessarily I would speak every time with the doctor. . . . But the practice was at the pharmacy, we verify every prescription.”
Id.
at 1138. During cross-examination, Respondent's Owner and PIC testified that the absence of the stamps would not mean that a prescription was not valid “[b]ecause, again, there's sometimes human distractions and errors, some paper can be missed. . . . Again, I was not obligated by either the State or law to stamp those prescriptions.”
Id.
at 1226. She testified that, “I did my best attempt to make sure there's no fraudulent prescription I fill there. Or there's no valid DEA numbers or there's, like, no major violation or diversion with the prescriptions.”
Id.
at 1227.

Respondent's Owner and PIC was satisfied, she testified, when she filled the prescriptions in GX 12 that each “prescription was filled for medical purpose within the scope of a physician practice.”
Id.
at 1139.

Based on all of the evidence in the record, I find that Respondent, without addressing or resolving the red flags, filled prescriptions that raised the red flag of customers presenting two prescriptions for the same immediate release controlled substance but for different strengths. The testimony of Respondent's Owner and PIC, including her testimony that she filled each prescription in GX 12 only after being satisfied they were for a medical purpose within the scope of a physician practice, was not credible. First, it directly conflicted with her original testimony denying that the circumstances raised a red flag and, second, she did not produce any documentary evidence to corroborate her statements.

Customers Presenting Prescriptions With a Combination of an Opiate and a Benzodiazepine or “Drug Cocktail” Popular with Drug Abusers

The Government alleged that prescriptions with a combination of an opiate and a benzodiazepine are “drug cocktails” popular with drug abusers and, therefore, raise “red flags of diversion,” and that Respondent filled such prescriptions without addressing or resolving those red flags. To support this allegation, the Government submitted seven sets of prescriptions (a total of 14 prescriptions) that Respondent filled and dispensed to its customers containing an opiate and a benzodiazepine.
Id.
at 407, 412, 414-15, 417, 421, 422-23, 424;
see
GX 13; s
ee also
Tr. 73-74 (DI testifying that GX 13 consisted of true and accurate copies of documents he took from Respondent during the unannounced inspection) and Tr. 74-75 (DI testifying that the prescriptions in GX 13 were for a common drug cocktail of a narcotic pain reliever and a benzodiazepine, both at their highest strengths).

Drug
Number of tablets
Date written
Customer's initials

Dilaudid 8 mg
116
11/20/12
D.C.

Xanax 2 mg
43
11/20/12
D.C.

Dilaudid 8 mg
140
12/27/12
D.C.

Xanax 2 mg
42
12/27/12
D.C.

Dilaudid 8 mg
140
1/24/13
D.C.

Xanax 2 mg
42
1/24/13
D.C.

Dilaudid 8 mg
162
10/26/12
L.F.

clonazepam 2 mg
30
10/26/12
L.F.

Dilaudid 8 mg
162
12/21/12
L.F.

clonazepam 2 mg
30
12/21/12
L.F.

Dilaudid 8 mg
70
10/12/12
B.K.

Valium 10 mg
42
10/12/12
B.K.

Dilaudid 8 mg
35
11/9/12
B.K.

Valium 10 mg
42
11/9/12
B.K.

According to Dr. Gordon, these seven pairings of prescriptions were considered “cocktail medications,” red flags, because they were multiple drugs that suppressed the central nervous system and, when taken together, could give euphoria. Tr. 408, 412, 414-15 (maximum strength of Dilaudid and Xanax), 417, 421, 422 (highest Valium dose available), 424 (highest doses available), 546, 547. She elaborated on what makes a drug cocktail by testifying that it consisted of “drugs that cause you to have a high.”
Id.
at 547. “So it could be an opioid, it could be an upper and a downer,” she stated.
Id.
She explained that the “person could be taking the drugs to get a high during the day and then a low at night. . . . “[I]t's not being used for what it's intended to be used for.”
23

Id.
She explained that “these two drugs are very highly sought after on the street.”
Id.
at 409. In her opinion, the drug pairings were “surrounded by diversion.”
24

Id.
at 410;
see also id.
at 413-14.

23
Dr. Gordon testified that the prescriptions would not raise a red flag for her if they were written by a “Hospice doctor [or] oncologist.” Tr. 545.

24
Dr. Gordon identified additional red flags regarding the prescriptions in GX 13: First, the prescriptions on pages 13 and 15 were written for a male (LF) living in Davie and traveling a long distance to Miami to see an OB/GYN (Dr. R.T.); second, the diagnosis written on the prescription on page 13 was lumbago, a common diagnosis that doctors used on diverted prescriptions; and third, the repeat customer (LF) for the prescriptions on pages 13 through 19 written by Dr. R.T. was receiving the same cocktail medications with no long-acting medication present. Tr. 16-17, 418, 420-21.

Dr. Gordon addressed whether a muscle relaxant had to be present to constitute a drug cocktail. She stated that, “Cocktail medications usually . . . are a combination of an opioid plus or minus a benzo plus or minus a muscle relaxant.”
Id.
at 408. Then she explained: “But what I've seen . . . lately is the doctors have stopped the Soma, and they are just doing, now, high doses of Dilaudid, high doses of benzos. It used to be Oxys. Now they've switched to hydromorphone. So you see . . . the flags change.”
Id.
She added that, “I see the physicians and drug diverters trying to eliminate one of the components of the cocktail to try to get away with diverted drugs.”
Id.
at 538.

Dr. Gordon testified that she saw no notations by the pharmacist on the prescriptions attempting to resolve the

red flags and, in her opinion, the “cocktail” red flags were not resolvable.
Id.
at 411, 414, 416, 418, 421, 423, 424-25. She specifically testified that the prescriptions were not legitimate and that the pharmacist who filled the prescription pairings did not exercise her corresponding responsibility to ensure that the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
Id.
at 411-12, 414, 416, 418-19, 421-22, 423, 425.

Mr. Fisher stated that he did not consider the drugs in the prescriptions in GX 13 to be cocktails.
Id.
at 629, 631, 632, 633. He elaborated: “To me a cocktail is when you have a combination of three drugs: alprazolam, oxycodone or hydrocodone, and carisoprodol. This to me looks like a simple case of a patient getting pain medication and some Xanax for anxiety.”
Id.
629;
see also id.
at 630 (“[I]n everything I have read and have seen and talked to and have heard at meetings, it's a combination of the three drugs represents the cocktail.”). Mr. Fisher agreed that “[a]s things have changed, yes, other drugs have been added like the hydromorphone that's come into play.”
Id.
at 629-30. He testified that what makes a cocktail is “more the street value of the drugs.”
Id.
at 630.

On cross-examination, Mr. Fisher reaffirmed his opinion that a cocktail involves an opioid, a benzodiazepine, and carisoprodol.
Id.
at 772. He acknowledged that a customer could obtain the opioid and the benzodiazepine from one pharmacy and the carisoprodol from a second pharmacy.
Id.
at 772-73. He agreed that “the only way to check for that would be through use of . . . E-FORCSE.”
Id.
at 773. Mr. Fisher also agreed that Respondent, “not having access to query E-FORCSE, would not be able to . . . check for that, those instances of drug seekers using other pharmacies or doctors to obtain a third drug that could be used in this cocktail.”
Id.
On re-direct, Mr. Fisher stated that, beside using E-FORCSE, other ways to resolve any red flags associated with GX 13 were “[c]all the physician, discuss their treatment modality for the patient, [c]heck the patient's profile if you maintain one[,] . . . [and] [i]f you have a computer system you could check and see if there's a history of the patient getting other prescriptions filled.”
Id.
at 779.

Respondent's Owner and PIC did not agree that the prescriptions in GX 13 constituted a drug cocktail because, in her view, a drug cocktail had four components: two opioids, carisoprodol, and a benzodiazepine.
Id.
at 1142. “It's multiple—it's two—for instance, oxycodone and Vicodin together with Soma and benzodiazepine,” she stated.
Id.
According to Respondent's Owner and PIC, she “didn't fill those prescriptions for the Soma, benzodiazepine, carisoprodol,” and she did not recall ever filling a benzodiazepine, Soma, and opiate combination for any patients.
Id.
at 1144, 1145.

Respondent produced an exhibit containing various documents concerning the three customers who asked Respondent to fill the prescriptions in GX 13. RX 10. According to the testimony of Respondent's Owner and PIC, Respondent compiled or generated the documents in RX 10 “at that time in 2013” because “[w]e tried to implement as much possible steps and follow them through as much as possible to make sure that . . . steps are taken . . . that's preventing. . . . Also, . . . that's why . . . when the patient knows the pharmacy takes extra steps and scrutinize the prescriptions, people who has non-valid prescription not come to me.” Tr. 1157-58.

Page 2 of RX 10 was the Relationship Affidavit signed by DC, the same DC associated with six prescriptions in GX 13 (pages 1 through 12).
See id. at
1145-46. Similarly, the Relationship Affidavit on page 5 of RX 10 was signed by LF, the same LF associated with pages 13 through 20 of GX 13.
25

See id. at
1148-49.

25
LF did not complete the Relationship Affidavit in full.

Respondent also provided registration validation pages purportedly printed from DEA's website. According to Respondent's Owner and PIC, the DEA registration validation website satisfied her that, on the day she filled LF's Dilaudid and clonazepam prescriptions, the prescribing physician was “allowed to prescribe the pain medications.”
Id.
at 1149;
see
RX 10, at 6; GX 13, at 17, 19. Likewise, according to Respondent's Owner and PIC, the DEA registration validation website showed her that the physician who prescribed prescriptions for BK “was actually scheduled to prescribe schedule II narcotics.” Tr. 1156;
see
RX 10, at 12; GX 13, at 21-27.

Respondent also submitted a hand-written note on a piece of prescription paper belonging to the doctor who issued Dilaudid and Valium prescriptions for BK.
See
RX 10, at 10; GX 13, at 21, 23, 25, and 27. The note was not addressed to anyone. It showed BK's name in the “patient” space, and an age, partial address, and date in the lines of the prescription paper calling for that information. It did not include a diagnosis. The note contained a signature which, according to Respondent's Owner and PIC, was the prescribing doctor's signature. Tr. 1152. The note stated that “the patient cannot tolerate for long periods of kneel, more than 20 minutes of sitting or standing.”
Id.
Significantly, the date on the note (August 9, 2011) was more than a year and two months before the date on the earliest prescription issued to BK and included in GX 13 as filled by Respondent (October 12, 2012).
Compare
RX 10, at 10 with GX 13, at 21. Yet, Respondent's Owner and PIC testified that: “Because I've been calling to the doctor and asking about this patient few times . . .[,] [w]e make sure the doctor just write a note.”
26

Tr. 1152. She continued, stating, “[T]his patient has such a difficult time to fill his prescriptions. . . . This patient could not fill prescription anywhere, and then he come to me.”
Id.
She did not explain how this note led her to conclude that the prescriptions issued to BK were legitimate.

26
She did not address the timing of how Respondent could have “made sure” the doctor wrote a note more than a year before Respondent filled the earliest prescription in the record.

Respondent also submitted a “Verification of legitimate purpose of prescribing CII-CV medications To establish legitimate Physician-patient relationship.” RX 10, at 11. It purported to be signed by BK, the individual for whom the Dilaudid and Valium prescriptions on pages 21, 23, 25, and 27 of GX 13 were written. This one-page sheet had space for the customer's name, signature, birth date, and appointment date, for the physician's name and address, and for “yes” or “no” responses to whether the physician or “qualified medical professional” conducted a medical examination, took a blood sample, and had an “MRI on file.”
Id.

I find, based on Dr. Gordon's testimony and consistent with my credibility determinations giving Dr. Gordon's testimony regarding the practice of pharmacy in Florida more weight than any other witness's testimony in these proceedings, that the prescriptions in GX 13 were “drug cocktails” popular with drug abusers. Based on all of the evidence in the record, I find that Respondent filled prescriptions without having resolved the red flags of customers presenting prescriptions with a combination of an opiate and a benzodiazepine which is a

common “drug cocktail” popular with drug abusers.

Customers Paying for Their Prescriptions With Cash, When Other Red Flags of Diversion Were Present

The Government alleged that customers paying cash for their prescriptions when other red flags of diversion were present was a “red flag of diversion,” and that Respondent dispensed controlled substances to customers without resolving the red flags those prescriptions presented. As support for this allegation, the Government listed 50 prescriptions in the Show Cause Order. ALJX 1, at 5. No testimony disputed the allegations that Respondent filled the 50 prescriptions and that those prescriptions were purchased with cash. I reviewed those 50 prescriptions. Thirty-two of them were for Dilaudid 8 mg. GX 8, 11, 12, 13, 14.

Drug
Number of tablets
Date written
Cash paid
Customer

Dilaudid 8 mg
150
12/10/12
$750.00
G.A.

Dilaudid 8 mg
168
11/20/12
840.00
S.B.

Dilaudid 8 mg
150
12/19/12
750.00
C.W.

Dilaudid 8 mg
56
7/9/12
280.00
J.S.

Dilaudid 8 mg
140
1/21/13
840.00
D.K.

Dilaudid 8 mg
56
9/6/12
40.00
B.S.

Dilaudid 8 mg
150
12/28/12
750.00
T.S.

Dilaudid 8 mg
112
4/26/12
560.00
B.R.

Dilaudid 8 mg
112
11/14/12
560.00
W.P.

Dilaudid 8 mg
80
6/22/12
400.00
D.S.

Dilaudid 8 mg
85
6/22/12
425.00
B.S.

Dilaudid 8 mg
75
9/27/12
375.00
J.F.

Dilaudid 8 mg
168
11/29/12
840.00
B.M.

Dilaudid 8 mg
116
11/20/12
580.00
D.C.

Dilaudid 8 mg
140
12/27/12
28.00
D.C.

Dilaudid 8 mg
140
1/24/13
840.00
D.C.

Dilaudid 8 mg
162
10/26/12
810.00
L.F.

Dilaudid 8 mg
162
12/21/12
810.00
L.F.

Dilaudid 8 mg
70
10/12/12
320.00
B.K.

Dilaudid 8 mg
35
11/9/12
175.00
B.K.

Dilaudid 8 mg
128
10/5/12
640.00
B.K.

Dilaudid 8 mg
40
11/2/12
200.00
B.K.

Dilaudid 8 mg
180
8/15/12
900.00
J.B.

Dilaudid 8 mg
150
9/6/12
750.00
J.B.

Dilaudid 8 mg
180
8/30/12
900.00
J.F.

Dilaudid 8 mg
150
9/27/12
750.00
J.F.

Dilaudid 8 mg
168
3/13/13
1,008.00
L.B.

Dilaudid 8 mg
168
4/10/13
1,008.00
L.B.

Dilaudid 8 mg
168
12/28/12
840.00
J.S.

Dilaudid 8 mg
168
1/23/13
1,008.00
J.S.

Dilaudid 8 mg
180
9/7/12
900.00
H.H.

Dilaudid 8 mg
180
10/5/12
900.00
H.H.

The evidence shows that customers paid as much as $1,008.00 for a month's worth of Dilaudid 8 mg.

Dr. Gordon's testimony explained that payment in cash for a controlled substance was always a red flag, even if a significant sector of the public did not have health insurance. Tr. 363. Paying in cash was a red flag, she testified, because it enabled evasion of processes established to alert a pharmacy that a prescription was being filled too soon. She stated, “A lot of drug-seekers only want to pay for their medications in cash because . . . the computer systems, the insurance company will actually create your red flag for you to say if a prescription is refilled too soon, which means they've gone—obtained a prescription from another pharmacy.”
Id.
at 297. She elaborated and provided a specific example: “[T]he insurance company will give you that red flag. Because they'll have a claim . . . and they'll . . . say, . . . the patient just got this prescription yesterday from Walgreen's . . . . So . . . the patrons will say, `I don't want you to charge my insurance company.' That way it kind of eliminates that flag.”
Id.
at 298-99.

In Dr. Gordon's opinion, the cash prices that Respondent charged its customers were as high as five times the cost Dr. Gordon would have expected.
Id.
at 362;
see also id.
at 417, 424, 502, 512. As Dr. Gordon concluded, “that to me means that maybe the pharmacist knew what was going on, and they were taking advantage of these patrons that were drug seeking.”
Id.
at 362;
see also id.
at 464-65 (Concerning Respondent's initial charge of $840 for a prescription and subsequent charge of $1,008 for the same exact prescription on the next visit, Dr. Gordon suggested that “the pharmacist actually knew the prescriptions were diverted and . . . was taking advantage of that patron . . . [b]ecause they knew they would pay whatever they needed to pay . . . .”). She explained that “the cost of that medication is high compared to what I've seen out in the field. That's a very high cost. And between Fort Pierce, Miami, and Hallandale, you pass like a zillion pharmacies. . . . It doesn't make sense.”
Id.
at 362. According to Dr. Gordon, there was no notation made by the pharmacist on the prescriptions showing any attempt to resolve the red flags.
See, e.g., id.
at 364, 369, 371, 373, 374, 377, 389-90, 398, 404-05, 406, 411, 416, 421, 423, 424-25, 467;
see also id.
at 133 (DI testimony that he did not see notations on the prescriptions from Respondent “clearing” any red flags).

Mr. Fisher agreed that “[c]ustomers paying for their prescriptions with cash where other red flags of diversion are present” was a red flag.
Id.
at 756.

Respondent challenged Dr. Gordon's cash price-level testimony based on her not having been in charge of purchasing controlled substances for resale for a small independent pharmacy.
Id.
at 502.

Yet, I find Dr. Gordon's testimony to be credible because she “actually looked up the national . . . price.”
Id.
at 503. Respondent also challenged Dr. Gordon by stating that pharmacies where Dr. Gordon worked “like Walgreens, are getting discounts from the supplier on purchasing controlled medication.”
Id.
at 502. However, Dr. Gordon testified she was “99 percent sure” that discounts are not available for generic opioids.
Id.
at 503. Respondent presented no pricing data or other evidence refuting Dr. Gordon's characterization of the higher-than-expected level of cash prices Respondent's customers paid for controlled substance prescriptions. Further, Respondent did not present evidence to establish that its cash prices for controlled substances were consistent with the prices charged by other pharmacies similar to Respondent. Nor did it present evidence to establish that it set the level of its cash prices for controlled substances for a reason other than that its customers were willing to pay those prices. Thus, I find no reason to reject Dr. Gordon's testimony. Rather, I shall credit it consistent with the CALJ's credibility determinations.

Based on all of the evidence in the record, I find that Respondent, without resolving the red flags, filled prescriptions that raised the red flag of customers paying cash for their prescriptions when other red flags were present. I further find that Respondent's customers were charged, and paid, exorbitantly high prices for their controlled substance prescriptions.

Customers Presenting New Prescriptions for Controlled Substances When They Should Not Have Finished Their Previous Prescription for That Drug (“Early Fills” or “Early Refills”)

The last red flag the Government alleged in the Show Cause Order concerned early fills. According to the Government, Respondent filled prescriptions for controlled substances that the customers presented before the customers' previous prescription for that controlled substance should have been consumed. To support this allegation, the Government submitted 22 prescriptions. GX 14, at 1-33, 37-47.
27

Twelve of the prescriptions concerned one customer. The other ten prescriptions concerned five different customers. All 22 prescriptions were for Dilaudid 8 mg.

27
GX 14 included 24 prescriptions, but there were two copies of two of the prescriptions.

I reviewed the prescriptions the Government submitted and analyzed them according to the standard Dr. Gordon described in her testimony. GX 14; Tr. 436 (“[W]hat most pharmacies do . . . [to determine whether a prescription is an early fill is] they start at when the first prescription was filled.”);
see also
Tr. 429-67 (Dr. Gordon's testimony concerning GX 14), Tr. 75-76 (DI testifying that GX 14 consisted of true and accurate copies of documents he took from Respondent during the unannounced inspection), and Tr. 76-77 (DI testifying that GX 14 showed Respondent filled new schedule II controlled substance prescriptions before the customers' previous prescriptions should have been exhausted). I make these findings.

First, Respondent filled 12 prescriptions for BK, dispensing a total of 840 Dilaudid 8 mg. tablets, from July 26, 2012 through November 8, 2012. GX 14, at 1-33, 37-47.

Customer B.K.

Drug
Number of tablets/SIG
Date written
Date filled

Dilaudid 8 mg
168—1 every 4 hrs. for pain
7/16/12
7/26/12

Dilaudid 8 mg
168—1 every 4 hrs. for pain
8/13/12
8/13/12

Dilaudid 8 mg
40—1 every 4 hrs. for pain
9/7/12
9/10/12

Dilaudid 8 mg
128—1 every 4 hrs. for pain
9/7/12
9/13/12

Dilaudid 8 mg
40—1 every 4 hrs. for pain
10/12/12
10/12/12

Dilaudid 8 mg
40—1 every 4 hrs. for pain
10/12/12
10/15/12

Dilaudid 8 mg
40—1 every 4 hrs. for pain
10/12/12
10/17/12

Dilaudid 8 mg
8—1 every 4 hrs. for pain
10/12/12
10/17/12

Dilaudid 8 mg
128—1 every 4 hrs. for pain
10/5/12
10/22/12

Dilaudid 8 mg
40—1 every 4 hrs. for pain
11/2/12
11/2/12

Dilaudid 8 mg
40—1 every 4 hrs. for pain
11/2/12
11/5/12

Dilaudid 8 mg
40—1 every 4 hrs. for pain
11/2/12
11/9/12

I note that Respondent filled all four of the prescriptions that were written on the same day, October 12, 2012.

Further, one prescription for “chronic pain due to trauma,” among other things, was written on July 16, 2012, yet BK did not have it filled until July 26, 2012. GX 14, at 1-2. Similarly, BK waited up to 16 days before filling another prescription for “chronic pain due to trauma,” among other things. GX 14, at 17-18. BK's delay in filling such Dilaudid 8 mg. prescriptions casts doubt on the prescriptions' legitimacy.

Based on the dosing instructions, six tablets each day, 840 tablets should have lasted 140 days. The number of days from July 26, 2012 through November 8, 2012, the day before BK filled the last prescription in GX 14, was 105 days. Thus, in this period, Respondent dispensed to BK a 140-day supply of Dilaudid 8 mg. in 105 days. According to my analysis, Respondent filled all but one of them significantly early, from about at least 6 days early to up to about at least 29 days early.
Id.

Second, concerning the two Dilaudid 8 mg. prescriptions in GX 14 issued to JB, Respondent filled the second prescription at least one week early.
Id.
at 25-28.

Customer J.B.

Drug
Number of tablets/SIG
Date written
Date filled

Dilaudid 8 mg
180—1 every 3 hrs. as needed
8/15/12
8/22/12

Dilaudid 8 mg
150—1 every 3 hrs. as needed
9/6/12
9/6/12

Third, concerning the two Dilaudid 8 mg. prescriptions in GX 14 issued to LB, Respondent filled the second prescription at least 5 days early.

Customer L.B.

Drug
Number of tablets/SIG
Date written
Date filled

Dilaudid 8 mg
168—1 every 4 hrs. as needed
3/13/13
3/18/13

Dilaudid 8 mg
168—1 every 4 hrs. as needed
4/10/13
4/10/13

Fourth, Respondent filled the second Dilaudid 8 mg. prescription in GX for JS at least 5 days early.

Customer J.S.

Drug
Number of tablets/SIG
Date written
Date filled

Dilaudid 8 mg
168—1 every 4 hrs. as needed
12/28/12
12/31/12

Dilaudid 8 mg
168—1 every 4 hrs. as needed
1/23/13
1/23/13

Fifth, Respondent filled the second Dilaudid 8 mg. prescription in GX 14 for HH at least six days early.

Customer H.H.

Drug
Number of tablets/SIG
Date written
Date filled

Dilaudid 8 mg
180—1 every 4-6 hrs. as needed
9/7/12
9/14/12

Dilaudid 8 mg
180—1 every 4-6 hrs. as needed
10/5/12
10/8/12

According to Dr. Gordon, the prescriptions in GX 14 exhibited multiple red flags, yet Respondent filled them all. Tr. 429-67. For none of the prescriptions in GX 14 did Dr. Gordon testify that it included any notation recognizing or addressing red flags, that its red flags were resolvable, that it was a legitimate prescription, or that the pharmacist had exercised her corresponding responsibility to ensure that the prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
Id.
at 437-38, 441, 442, 445-46, 446-47, 448-49, 450-51, 456, 458-59, 460-61, 464, 467.

Regarding these prescriptions and labels, Dr. Gordon testified that “the pharmacist was not exercising her corresponding responsibility, that most of these prescriptions should not have been filled or at least held until it was due to be filled.”
Id.
at 450. “However,” Dr. Gordon continued, “I wouldn't have filled any of these to begin with.”
Id.
at 451. She explained: “The multiple red flags would alert any pharmacist that none of these prescriptions were legit because of the distance, that certain physician is a well-known pill mill writer, the Dilaudid 8, the odd quantities, . . . the diagnosis of lumbago . . . and paying cash . . . And the early fills.”
Id.
Specifically regarding the multiple prescriptions for BK that Respondent filled on October 17, 2012 and why, in Dr. Gordon's experience, a patient would present two prescriptions for the same drug but different quantities on the same day, she testified: “I have no idea. That's very unusual. I would not fill either one of these scripts. . . . It's a huge red flag for any pharmacist to get the same exact Dilaudid 8 from the same doctor on the same date. Huge red flag. No reasonable pharmacist would fill this.”
Id.
at 443.

Mr. Fisher agreed that an early fill was a red flag for diversion.
Id.
at 774. He identified early fill red flags in GX 14 on at least 13 occasions.
Id.
at 635-36, 637-38, 685, 692-93, 696 (two prescriptions filled on the same day), 698, 703, 704, 711, 714, 718, 721, 725, 727. Mr. Fisher testified that filling the two prescriptions on October 17, 2012 was “highly unusual.”
Id.
at 696. His testimony was that it was “reasonable”

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2018-05020. Public record. Not legal advice.