# Jones Total Health Care Pharmacy, L.L.C., and SND Health Care, L.L.C.; Decision and Order

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2016-27120

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** November 10, 2016
- **Citation:** 81 FR 79188

## Text

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 15-2]
Jones Total Health Care Pharmacy, L.L.C., and SND Health Care, L.L.C.; Decision and Order

On April 29, 2015, Administrative Law Judge Gail A. Randall (hereinafter, ALJ) issued the attached Recommended Decision.
1

Therein, the ALJ found that “Respondents violated recordkeeping requirements by failing to record whether Jones Pharmacy's biennial inventory was taken at the opening or close of business, and by failing to indicate the number of tablets per opened commercial container, the number of tablets shipped in each commercial container, and the number of commercial containers that [were] on hand.” R.D. at 59 (citing 21 CFR 1304.11(e)(3)).

1
All citations to the Recommended Decision are to the slip opinion as issued by the ALJ.

Most significantly, the ALJ further found that Respondent's (Jones Pharmacy) pharmacists dispensed controlled substance prescriptions in violation of their corresponding responsibility,
see id.
at 60-64, pursuant to which it is a violation of federal law for a pharmacist to knowingly dispense a controlled substance prescription which was not “issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.” 21 CFR 1306.04(a). The ALJ credited the testimony of the Government's Expert that the prescriptions presented various red flags,
i.e.,
indicia that the prescriptions were not issued for a legitimate medical purpose. These included that: (1) The patients were traveling long distances (and many came from out-of-state) to obtain the prescriptions; (2) that the patients were prescribed cocktails which included narcotics such as oxycodone, benzodiazepines such as Xanax (alprazolam), and muscle relaxants such as Soma (carisoprodol) which were known to be highly abused; (3) that on some occasions, two patients came from the same out-of-state location and presented identical or nearly identical prescriptions; (4) that purported pain patients presented only prescriptions for short-acting but not long-acting narcotics; and (5) that the patients paid for their prescriptions with cash.
Id.
at 61-62. The ALJ further credited the testimony of the Government's Expert in pharmacy practice that the red flags presented by many of the prescriptions could not be resolved by the pharmacists.
Id.
at 64.

The ALJ specifically rejected Respondent's contention that its owner (Ms. Cherese Jones) was simply naïve or unaware of various indicia (otherwise known as red flags) that the prescriptions her pharmacy filled lacked a legitimate medical purpose as well as its contention that during the relevant time period, Florida pharmacists were generally “unaware of the . . . concept of `red flags.' ” R.D. at 66-69. The ALJ was unpersuaded by the testimony of Respondent's Expert that pharmacists were generally unaware of the concept of red flags during the relevant time period, noting that while Respondent's Expert claimed to have based her opinion on a review of the Agency's administrative decisions, those decisions contradicted her testimony.
Id.
at 68-69.

Finding that the Government met its burden of proof, the ALJ then addressed whether Respondent had put forward sufficient evidence to show why it could be entrusted with a registration. The ALJ specifically found that Ms. Jones had “carefully avoided any admission that she failed to exercise her corresponding responsibility” and that her “wavering responses on cross-examination undoubtedly show her lack of understanding of a pharmacist's corresponding responsibility.” R.D. 71-72 & n.27. Based on her conclusion that Ms. Jones “had not accepted responsibility for the unlawful dispensing that occurred at” Respondent, the ALJ declined to consider Respondent's testimony regarding its remedial efforts.
Id.
at 73. And while finding that Jones Pharmacy and SND Healthcare “are separate entities,”
id.,
the ALJ found that Ms. Jones was the owner and operator of both entities and that “there is no dispute that SND Healthcare and Jones Pharmacy are one integrated enterprise.”
Id.
at 74. The ALJ thus “conclude[d] that the unlawful dispensing practices at Jones . . . Pharmacy, L.L.C., are an appropriate basis to deny the pending application” of SND Healthcare for a registration.
Id.
The ALJ thus recommended that I revoke Jones Pharmacy's registration and deny any pending application by Jones to renew or modify its registration.
Id.
at 75. With respect to SND Healthcare, the ALJ recommended that I deny its pending application.

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

Having considered the record in its entirety including Respondent's Exceptions, I find that while several of its contentions with respect to the ALJ's factual findings are not without merit, I adopt the ALJ's credibility findings and conclude that most of the ALJ's factual findings are supported by a preponderance of the evidence. I further conclude that the ALJ's factual findings support her legal conclusions that: (1) Respondent's pharmacists dispensed numerous controlled substance prescriptions in violation of the Agency's corresponding responsibility rule,
see
21 CFR 1306.04(a); (2) Respondent has not accepted responsibility for its misconduct; and (3) that there is sufficient overlap in the ownership and control of Jones Pharmacy and SND Healthcare such that Jones' misconduct supports the denial of SND's application.
2

2
I also adopt the ALJ's conclusion that Respondent Jones Pharmacy's inventories were non-compliant with DEA regulations. R.D. 59-60.

Accordingly, I adopt the ALJ's legal conclusions, as well as her implicit conclusions that granting Jones' renewal application and SND's application “would be inconsistent with the public interest.”
3

21 U.S.C. § 823(f). I will therefore also adopt the ALJ's recommendations that I deny Jones Total Health's renewal application and SND's pending application. A discussion of Respondent's Exceptions follows.

3
While the ALJ also recommended that I revoke Jones Total Health Pharmacy's registration, R.D. at 75, I take official notice of the Agency's registration records which show that Jones did not submit a renewal application until December 30, 2015, the day before its registration was due to expire. Because Jones had previously been issued the Show Cause Order, to continue its registration past the expiration date, it was required to file its renewal application “at least 45 days before the date on which [its] existing registration [was] due to expire.” 21 CFR 1301.36(i). Respondent did not seek to continue its registration past the expiration date, and based on the evidence in this record, I find that extension of its registration was not “consistent with the public health and safety.”
Id.
I therefore find that Jones Total Health Pharmacy's registration expired on December 31, 2015.
See, e.g.,

Ralph J. Chambers,
79 FR 4962, 4962 (2014);
Paul H. Volkman,
73 FR 30630, 30641 (2008). However, Jones Total Health Pharmacy's application does remain pending before the Agency. Respondent may dispute this finding (as well as any other finding which is the subject of official notice) by filing a properly supported motion within ten days of the date of this Order. 5 U.S.C. § 556(e).

Exceptions to the ALJ's Findings of Fact

Exceptions to Findings Related to the DOH Inspection

Respondent first takes exception to several of the factual findings made by the ALJ with respect to the June 2012 inspection which was conducted by the Florida Department of Health (DOH).

Exceptions, at 3-7. Specifically, Respondent excepts to the ALJ's finding (FoF #69) that during the inspection, the DOH Inspector (who testified at the hearing) “found that the majority of [its] business was the sale of controlled substances, which the pharmacy was filling for cash and that very little business was for non-controlled substances.”
Id.
Respondent argues that “[t]his finding is erroneous and contradicted by the record.”
Id.

While Respondent argues “that objective evidence contradicts [the inspector's] testimony,” the ALJ found the Inspector's testimony credible and the Government produced a second page of the Inspection report on which the Inspector listed “Additional Remarks” and stated in part:

Inspection reveals that the pharmacy fills mostly CII narcotics. They are charging $9.00 per tablet for Oxycodone 30 mg or $1620/180. CII dispensing is cash though they take insurance for other medications. Profits on the CII run between $2,000 and $6600 per day. The non-controls are mostly filler RXs and some HIV meds filled with insurance. Profit on the non-controls are [sic] usually less than $200/day, often less than $50/day. The primary business of the pharmacy is the cash sale of narcotics. The total number of prescriptions filled daily is extremely low.

GX 12, at 2.

Respondent asserts that the Inspector's testimony that this page of the report “was created at the time of such inspection is not credible” because it “was never shown to Ms. Jones, [and] was . . . [n]ever signed by Ms. Jones” during the inspection. Exceptions, at 4. Respondent further argues that “[t]he fact that [the DOH Inspector] never shared page 2 . . . with Ms. Jones contradicts her testimony that if she saw things that a pharmacist was doing wrong, she would tell” the pharmacist.
Id.
Respondent ignores, however, that the Inspector testified that the notes on page two were created so that the inspector on any subsequent inspection “would know what to look for.” Tr. 166. The Inspector also explained that her comments about Respondent's dispensing of narcotics were not placed on the first page of the inspection form because “[w]e had had complaints about us putting things about narcotics on the front of an inspection, because people hang them, so we were told to put them on another page.”
Id.
at 165-66.
4

4
Respondent also argues that the Inspector's failure to provide page 2 to Ms. Jones violated Florida DOH's “Licensee Bill of Rights, which . . . requires that a pharmacy be presented for review . . . all inspection reports at the time of the inspection.” Exceptions, at 4. Even if the Inspector's failure to provide this page to Ms. Jones violated the State's Licensee Bill of Rights, Respondent cites no authority pursuant to which the document would be rendered inadmissible in either administrative or judicial proceedings, and even if there is such authority, it would not be controlling in this proceeding.

However, even if page 2 of the report was not shown to Ms. Jones, I find no reason to reject the Inspector's testimony that she made the notes based on her observations during the inspection she conducted on June 7, 2012.
Id.
at 165-67.

Respondent further attempts to question the validity of page two of the report. It asserts that the DOH Inspector “testified that the date field on the top of the document could not be altered on reports after they are finalized.” Exceptions, at 5. Respondent then notes that the “[t]he report marked as Respondents' Exhibit 8 [at p. 5] contains a typewritten data field, while the” first page of the report submitted by the Government “contains a blank in the date field next to Ms. Jones' signature.”
Id.
Respondent then maintains that “[t]his appears to contradict testimony than any date field on the report cannot be changed or manipulated and creates further doubt that page 2 . . . was created contemporaneous to the June 7, 2012 inspection.”
Id.

Respondent, however, failed to cite to the portion of the transcript which purportedly contains this testimony.
See id.
While this is reason alone to reject its contention,
see
21 CFR 1316.66(a),
5

Respondent ignores that the blank date field next to Ms. Jones' signature is located at the bottom of the page and not “on the top of the document.” Thus, I find no reason to reject the testimony of the Inspector regarding when she created the document.

5
This regulation provides that “[t]he party shall include a statement of supporting reasons for such exceptions, together with evidence of record (including specific and complete citations of the pages of the transcript and exhibits) . . .”

Respondent also argues that the Inspector's testimony and the report's statement that “the majority of Jones' Pharmacy's business was the sale of schedule II controlled substances . . . is inconsistent with the objective evidence.” Exceptions, at 5. Putting aside that the report actually used the word “primary” rather than “majority” to describe the nature of Respondent's business, I find the contention unavailing. While Respondent points to data showing that during 2012, Respondent “made a gross profit of $58,123 on sales of non-controlled substances” and notes that it filled “over 2,956 prescriptions” for non-controlled drugs and filled “only 769 prescriptions” for controlled substances,
id.
at 5-6, Respondent ignores that its own prescription log report for the year shows that its gross profit on its sales of controlled substances was $316,942.
6

RX 17, at 19. Thus, the objective evidence shows that in terms of Respondent's gross profit, its primary business during 2012 was the sale of controlled substances.

6
So too, the data for Respondent's previous years in business (2010 and 2011) supports the view that its primary business was the sale of controlled substances. Specifically, in 2010, it dispensed 1847 controlled substance prescriptions and had a gross profit on these of $530,483. RX 13, at 40. By contrast, during 2010, it dispensed a total of 1072 prescriptions (including refills) for non-controlled drugs and had a gross profit of only $10,189 on these dispensings. RX 14, at 25. And while during 2011, the number of non-controlled prescriptions (including refills) it filled (3053) clearly overtook the number of controlled prescriptions it filled (1093), its gross profit on controlled substances was $439,990, more than 11 times its gross profit of $38,242 on the non-controlled drugs it sold.
Compare
RX 15, at 25,
with
RX 16, at 66.

Respondent also takes issue with the ALJ's crediting of the DOH Inspector's “annotation in her report that [Respondent] sold a 180 pill prescription for $1620, when [in the Inspector's] opinion the more reasonable price to pay was $200 to $250.” Exceptions, at 6 (citing ALJ FoF #70). While it is unclear whether Respondent is challenging the Inspector's annotation as to the price Respondent was charging at the time of the inspection or what the Inspector testified as being the “more reasonable price,” or both, the “objective evidence” shows that in this time period, Respondent was, in fact, charging $1620 for 180 dosage units of oxycodone 30.
See
GX 23, at 5 (RX for 180 Roxicodone 30 issued on July 2, 2102 and dispensed the same day as oxycodone 30
7

for $1620 cash);
see also
GX 24, at 11-14 (Rxs for 180 oxycodone 30 dispensed on May 29, 2012 and June 26, 2012, each for $1620 cash).

7
Of note, the prescription label lists the National Drug Code number of 0406-8530-01. GX 23, at 5. I take official notice that, according to the FDA's National Drug Code Directory website, this is the drug code for generic oxycodone 30 mg tablets marketed by Mallinckrodt, Inc. Respondent may refute this finding by filing a properly supported motion within ten (10) days of the date of this Decision and Order.

Respondent further argues that the DOH Inspector “conceded on cross-examination that she had no basis to know what an appropriate mark-up would be” and her “testimony in this regard should have been rejected.” Exceptions, at 6 (citing Tr. 136). However, Respondent wrongly attributes this testimony to the DOH Inspector rather than the Supervisory Diversion Investigator who provided it.
See
Tr. 136.

As for the DOH's Inspector's testimony that a “more reasonable

price” to pay for a 180 oxycodone 30 prescription was $200 to $250, it is true that she testified that did not know what price Respondent was paying for oxycodone in June 2012.
Id.
at 183. She also testified that she did not prepare a written analysis of the prevailing prices being charged for controlled substances during the period of February 2010 through July 2012.
Id.
at 181. However, the Inspector also testified that, based on her “experience as an inspector of pharmacies
8

in the same area as [Respondent] on or around that time,” “less than $200” and “at most $250” was a more typical price for 180 dosage units of oxycodone 30.
Id.
at 168. Notwithstanding that the Inspector did not know what price Respondent was paying for oxycodone and did not prepare a written report, based on her experience as a pharmacy inspector, she was clearly competent to testify as to the prices being charged by other pharmacies for 180 dosage units of oxycodone 30.
See also
Tr. 161-62 (Inspector's testimony that in determining whether pharmacies are filling legitimate controlled substances she looks at the prices being charged). I thus reject Respondent's contention on this issue as well.

8
The DOH Inspector had previously worked as a pharmacist for 33 years. Tr. 161. She also testified that in the three and a half years that she has been a DOH Inspector, she had inspected “[c]lose to 1,500” pharmacies in the Dade and Broward County areas.
Id.
at 160.

Next, Respondent argues that “[t]he ALJ incorrectly found based on [GX] 14 that sales of controlled substances were in the top ten products that [Respondent] sold from January 1, 2010 through August 29, 2014.” Exceptions, at 6 (citing FOF # 72). Respondent contends that “[t]he finding was erroneous and misleading because [the Exhibit] was an aggregate report of [its dispensing] for multiple years.”
Id.

The ALJ's finding was neither erroneous nor misleading as it specifically stated that this “report indicated that controlled substances were in the top 10 products that [Respondent] sold
from January 1, 2010 to August 29, 2014
.” R.D. at 15 (emphasis added). And even crediting Respondent's evidence that shows that after 2010, the number of non-controlled prescriptions it dispensed “far exceeded the number of controlled” prescriptions that were dispensed, the evidence is what it is—a report of the dispensings during that time period. I thus reject Respondent's challenge to this finding.

Respondent also challenges the ALJ's finding that “[d]uring the four inspections conducted by the [DOH], [Respondent's] dispensing and corresponding responsibilities were discussed.” Exceptions, at 7 (citing FOF #76). Respondent maintains that “only two of the reports shown to Ms. Jones could be argued to relate to [the] corresponding responsibility—the reports of May 14, 2014 and August 29, 2014.”
Id.
Respondent discounts the inspection of April 14, 2011, during which the Inspector noted on the report (a copy of which was provided to Respondent's representative) that:

[t]his pharmacy is filling and dispensing what appears to be a large amount of Schedule II Controlled Substance[ ] written prescriptions, especially for OXYCODONE Tablets, from patients whose home addresses are in Ohio, Kentucky, Tennessee, Connecticut, Indiana, Georgia, Massachusetts, South Carolina, New Jersey, West Virginia, New Hampshire,
as well as from out of area locations in Florida such as Panama City, Fernandina Beach, Kissimmee, Sanford, Orange Park, Gainesville, Crestview, Port Orange, Daytona Beach, St. Cloud, Wesley Chapel, and Tavares.

GX 13, at 1.

In Respondent's view, this report apparently does not establish that the corresponding responsibility was discussed at the inspection because Respondent “ceased filling prescriptions for out-of-state residents on April 1, 2011.” Exceptions, at 7 n.8. Respondent ignores, however, that the Inspector's concerns were not limited to the oxycodone prescriptions dispensed to persons who came from other States and included the prescriptions it dispensed to Florida residents who came from out-of-area. Thus, even if the Inspector's remarks did not specifically use the words “corresponding responsibility,” the remarks nonetheless put Respondent on notice that the Inspector was concerned about whether it was dispensing legitimate prescriptions.

In any event, the Agency's corresponding responsibility rule has been in force for decades and numerous decisions of both the courts and the Agency have provided ample guidance as to the scope of a pharmacist's duty under the rule.
See, e.g., Medicine Shoppe-Jonesborough
v.
DEA
, 300 Fed. Appx. 409, 412 (6th Cir. 2008);
United States
v.
Henry
, 727 F.2d 1373, 1378-79

(5th Cir. 1984);
United States
v.
Seelig
, 622 F.2d 207 (6th Cir. 1980);
United States
v.
Hayes
, 595 F.2d 258 (5th Cir. 1979);
see also Frank's Corner Pharmacy
, 60 FR 17574 (1995);
Medic-Aid Pharmacy
, 55 FR 30043 (1990);
Ralph J. Bertolino
, 55 FR 4729 (1990). Having obtained a DEA registration and commenced dispensing controlled substance prescriptions, Respondent's pharmacists were obligated to not fill prescriptions when they either knew or were willfully blind to the fact that the prescriptions lacked a legitimate medical purpose. 21 CFR 1306.04(a). Thus, it is irrelevant whether the DOH Inspectors discussed with Respondent's pharmacists their obligations under the Agency's corresponding responsibility rule.

Exceptions to Findings Regarding the 2013 DEA Inspection

Respondent asserts that “[t]he ALJ's finding of fact that [Respondent's] inventory only indicated the name of the controlled substances, the strength of the controlled substances, the quantity, and `one' of the NDC number was also erroneous.” Exceptions, at 8 (citing FOF #84). The ALJ's Finding of Fact No. 84 stated:

DI Gonzales also noted that Ms. Jones' biennial inventory was missing some of the required information. The inventory was supposed to indicate amounts of finished form in each container and the amount of commercial bottles that she had on hand during her inventory. Ms. Jones' inventory only indicated the name of the controlled substances, the strength of the controlled substances, the quantity, and one of the NDC numbers.

R.D. at 17-18 (citing Tr. 35). According to Respondent, this finding was erroneous because the evidence “reflect[s] [that] the entire NDC number for the particular strength was listed on the biennial inventories not just ‘one’ of the NDC numbers.” Exceptions, at 8 (citing Tr. 472-73; 687; GX 5).

To be sure, the DI actually testified that Ms. Jones “only listed the name of the controlled substances, the strength of it, the quantity, and I believe on one of them the NDC number,” Tr. 35, thus suggesting that the ALJ misread the testimony. Nonetheless, the Agency's regulation which sets forth the information which must be included on a pharmacy's inventory does not require that the pharmacy list the NDC number for any drug.
See
21 CFR 1304.11(e)(3) (requiring that a dispenser's inventory include “the same information required of manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this section,” which does not include the NDC number). As Respondent was not required to list any NDC number, to the extent the finding erroneously states that the inventory “only indicated . . . one of the NDC numbers,” it is immaterial.

What is material is that the inventories were missing required information. Specifically, the inventory was required to include “[t]he number of units or volume of each finished form in each commercial container (
e.g.
, 100-tablet bottle or 3-milliliter vial); and

[t]he number of commercial containers of each such finished form (
e.g.
, four 100-tablet bottles or six 3-milliliter vials).”
Id.
§ 1304.11(e)(1)(iii)(C) & (D). Neither Respondent's November 3, 2011 inventory nor its April 13, 2013 inventory listed this information.
See
GX 5, at 1-14; Tr. 34-36, 38. Moreover, neither inventory indicated whether it was “taken either as of the opening of business or as of the close of business on the inventory date” as required by 21 CFR 1304.11(a). Tr. 36, 38.

Respondent nonetheless argues that Ms. Jones provided “unrebutted testimony . . . that the last two digits of the NDC number represent the bottle size of the medication (
i.e.
, the number of tablets per bottle).” Exceptions, at 8. Respondent further asserts that when it fills prescriptions, it uses “the contents of open containers first, before opening another closed container of the same controlled substance,” and thus, “while the biennial inventory did not contain a column for the number of containers, that number was easily derived from the information on . . . the biennial inventory.”
Id.
Respondent then contends that “any factual finding that the DEA was unaware of the number of containers of controlled substances on hand is simply an argument of form over substance.”
Id.
at 8-9.

This argument does not, however, establish that the ALJ's factual findings as to what information was missing from the inventory were not supported by substantial evidence. Rather, it is an argument which goes to the weight to be given to the violations. With the exception of the discussion in Finding of Fact No. 84 that the inventories contained just “one NDC” number, I find that the rest of the ALJ's findings as to what required information was missing from the inventories are supported by substantial evidence.

Respondent also takes exception to the ALJ's Finding of Fact No. 91, which was based on the testimony of a Diversion Investigator, that upon reviewing Respondent's electronic schedule II orders forms (DEA E222 forms), he found “480 line items that were done incorrectly.”
9

Exceptions, at 9 (quoting R.D. 19, FOF #91). Respondent submits that this finding is erroneous, because while the DI “testified to this, . . . DEA . . . bears the burden of proof [and] provided no independent evidence of the 480 line items that were allegedly inappropriate.”
Id.

9
Prior to testifying as to the number of line items that were done incorrectly, the DI testified regarding several E222 order forms that were submitted for the record, noting that the forms “did not indicate how many packages Ms. Jones received or the date that she received the ordered packages.” Tr. 39-43;
see also
GX 6.

According to the DI, these E222 forms were not properly completed because while the distributor shipped the orders, Respondent's owner did not go back online and “input[ ] how many packages she received or the date she received them.” Tr. 43. The Government also introduced various records showing several instances in which this occurred. GX 6, at 1-2; 3-5.

As evidenced by her factual finding, the ALJ clearly found credible the DI's testimony as to the number of line items that were not properly completed. Contrary to Respondent's contention, the DI's testimony alone provides substantial evidence to support these violations. I therefore reject this contention.

Exceptions to the Testimony of the Government's Expert

Respondent challenges several of the ALJ's factual findings that are based on the Government's Expert's testimony regarding a pharmacist's obligations in dispensing controlled substance prescriptions, and that in 2010, Florida pharmacists were generally aware of various red flags of abuse and diversion. R.D. 22-31; Tr. 240. First, Respondent challenges the ALJ's finding that “[i]n her role as a retail pharmacist, [the Expert] interacted frequently with other pharmacists in the area.” R.D. 23, FOF #108 (citing Tr. 216) (cited in Exceptions, at 9-10). Respondent contends that the ALJ should not have credited this testimony because “[o]n cross-examination it became clear that [the Expert] could not identify any specific pharmacist she had talked to regarding the particular issues.” Exceptions, at 10. However, the ALJ specifically addressed this portion of the Expert's testimony and while she noted that the Expert became hostile, the ALJ nonetheless found the Expert's testimony credible based on her years of experience. R.D. 24 n.13. Because the ALJ was in the best position to observe the Expert's testimony, and her testimony is not inherently implausible or inconsistent, I find no reason to reject the ALJ's credibility finding.

Next, Respondent challenges the ALJ's factual finding No. 113, which was based on the Expert's testimony that in determining whether a controlled substance prescription is issued for a legitimate medical purpose, one of “the biggest [signs] is when a patient asks you not to bill their insurance company and to pay cash for the prescription.” Tr. 226;
see also
R.D. at 24; Exceptions, at 10. According to Respondent, “[t]his finding is erroneous as the record is devoid of any evidence that anyone associated with the prescriptions at issue or otherwise, paid cash and simultaneously requested that [Respondent] not bill their insurance.” Exceptions, at 10.

While it is true that there is no evidence in the record that any particular patients asked Respondent's pharmacists not to bill their insurance for the prescriptions, that does not render the finding erroneous. Indeed, other testimony, which stands unrefuted, is that drug seekers are willing to pay high prices in cash to obtain controlled substances and that “[o]ften the addicts will sell part of their prescription in order to pay this exorbitant amount of money
10

for the prescription. So they take some and they sell some.” Tr. 170. Moreover, a Supervisory Diversion Investigator, with 35 years of experience as a Diversion Investigator, testified that “paying cash” is a “red flag[ ] of diversion.” Tr. 124. This witness further testified that:

10
This testimony was provided by the DOH Inspector in reference to the $1,620 price for 180 oxycodone 30 which Respondent was charging at the time of the June 2012 inspection.
See generally
Tr. 165-67.

Normally people pay with insurance. And these type of narcotics don't cost that much money, so that is usually an indication that the patient and the pharmacist know that these drugs are going to be diverted, that they'd be willing to pay more than $1,000 for one prescription, for instance.

Id.
at 125.
See also id.
at 33 (testimony of DI that upon review of Respondent's schedule II prescriptions, “we started discussing what we call as red flags, which a majority of [the prescriptions] were for Oxycodone 30 milligram . . . . And then we also noticed that they were all being paid for in cash.”);
id.
at 51 (DI's testimony that upon reviewing the dispensing records, one of the concerns was that “a majority of the prescriptions were being paid [for] by cash.”).

The evidence further shows that 93 percent of the controlled substance prescriptions dispensed by Respondent from February 15, 2010 through July 3, 2012 were paid for with cash or cash equivalents. Tr. 57;
see also
GX 2 (spreadsheet of the controlled substance prescriptions showing,
inter alia
, the method of payment). The Government's Expert testified that in her experience, “only . . . maybe five percent of the patients pay cash,” Tr. 285, a figure which is consistent with other evidence provided by the Government, specifically, an April 2012 report prepared by the IMS Institute for Healthcare Informatics, which, based on

its National Prescription Audit, found that out of 4.024 billion prescriptions dispensed during 2011, cash was the method of payment for only 258 million prescriptions or 6.4 percent. GX 29, at 42.

Respondent takes issue with the ALJ's having allowed the Government's Expert “to testify about the . . . report.” Exceptions, at 11. It argues that the Government's Expert “had no personal knowledge to how the report was compiled and the report was not reflective of the South Florida community [sic] which [Respondent] was located.”
Id.
Respondent also argues that the report “did not address the record evidence that Florida had one of the highest uninsured rates for individuals.”
Id.

While Respondent is correct that the Government's Expert did not have personal knowledge as to how the report was compiled and the report does reflect nationwide data, Respondent ignores that the Expert testified that in her experience, which includes 17 years as a retail pharmacist and a substantial period working at pharmacies in Broward and Dade County, only five percent of patients pay cash for their prescriptions. Respondent also ignores that its Expert agreed that six percent was an accurate figure for the nationwide average.

Moreover, while Respondent produced a Census Bureau Report which shows that in 2012, 20.1 percent of Floridians did not have what the Census Bureau defines as “comprehensive health insurance” coverage, the Report clearly stated that “[t]his definition excluded single service plans, such as accident, disability, dental, vision or prescription medicine.” RX 33, at 7, 24. Thus, the actual percentage of persons lacking insurance covering their prescriptions is likely less than the 20.1 percent figure.
11

Moreover, even ignoring that 49 percent of the prescriptions in GX 2 were filled for out-of-state customers, there is still a wide disparity between the percentage of prescriptions that were paid for with cash and what one would expect based on the Census Bureau's figure regarding the percentage of uninsured Floridians.

11
Respondent also produced a reprint of an article from the Kaiser Health News which was attributed to the Miami Herald; the article states that Broward County's uninsured rate was 26 percent and was purportedly based on census data. RX 33, at 1. However, this document is hearsay and actually contains hearsay within hearsay. In contrast to the figure provided in the IMS Report, which has been corroborated by both the Government's and Respondent's experts, Respondent has made no showing to establish the reliability of the statements in the Miami Herald article.
See J.A.M. Builders v OSHA,
233 F.3d 1350 (2000). Nor is there any tradition of courts accepting newspaper articles as reliable evidence of the statements contained in them.

Finally, Respondent takes exception to the ALJ's crediting the Government Expert's “testimony that `a pharmacist could also go to the [DOH's] website and lookup the prescriber's specialty.' ” Exceptions, at 10 (citing FOF #115). According to Respondent, the Government's Expert “was impeached” on cross-examination “and conceded that with regard to the cited example the DOH website only lists the training that a particular physician had and not necessarily their area of expertise.”
Id.
at 10-11 (citing Tr. 339).

To be sure, in this portion of the transcript, Respondent's counsel questioned the Government's Expert about a physician whose profile showed that he had done a residency in pediatrics but did not list any specialty certification.
See
GX 35, at 3. However, the DOH profiles for other physicians do include their “certifications from specialty boards recognized by the Florida board which regulates the profession for which he/she is licensed.” GX 36, at 2-3 (profile of Dr. S.K. showing that he was board certified in “Family Practice” by the “American Board of Family Medicine.”);
see also, e.g.,
GX 37, at 2-3 (profile of Dr. J.F. showing that he was board certified in “Family Practice” by the “American Osteopathic Board of Family Phy[sicians]”); GX 38, at 2-3 (profile of Dr. R.T. showing that he was board certified in “Obstetrics and Gynecology” by the “American Board of Obstetrics & Gynecolog[y]”); GX 42, at 2-3 (profile of Dr. R.W. showing that he was board certified in “Emergency Medicine” and “Internal Medicine” by the American Boards of Emergency Medicine and Internal Medicine).

Moreover, many of the prescriptions in the record also listed the prescriber's NPI (National Provider Identifier) number and the Government's Expert provided unrefuted testimony that a pharmacist can use an NPI number and look up a physician's specialty. Tr. 228. Notably, Respondent did not take exception to this portion of the ALJ's factual finding number 115.
See
Exceptions, at 10.

Respondent also argues that the Government's Expert acknowledged on cross-examination that the prescriptions contained, in the words of Respondent's counsel, “no indication that a doctor is practicing within any particular scope,” Tr. 337, and that “there is no prohibition in the medical field [against] a physician writing a prescription for a particular drug regardless of the area in which they may specialize.” Exceptions, at 11 (citing Tr. 337, 339). As for the first concession, while it is true that the prescriptions typically did not list the doctor's specialty, the Government's Expert provided testimony which the ALJ found credible that it is important for a pharmacist to know the scope of the physician's practice because a doctor's deviation from his specialty “could indicate a possible red flag.” R.D. 25 (FOF# 115). So too, even assuming that in Florida, a physician is not prohibited from prescribing a particular drug regardless of the area in which he/she specializes, certainly when physicians issue prescriptions for large quantities of highly abused controlled substances such as oxycodone 30, alprazolam 2, and in many cases carisoprodol, and these drugs are not usually prescribed by physicians with a particular specialty, there is a compelling reason to question the legitimacy of the prescription. I thus reject Respondent's challenges to the testimony of the Government's Expert.
12

12
For the same reason, I reject Respondent's Exceptions to the ALJ Factual Findings Nos. 128 and 130. As for Finding No. 128, it discussed prescriptions written by one Dr. K., who was affiliated with “The Pain Center of Broward,” for D.T., a male patient whose address was in West Virginia. Exceptions, at 13. Specifically, Dr. K. prescribed 107 du of oxycodone 30, 41 du of oxycodone 15, and 30 alprazolam 2mg, which D.T. filled at Respondent paying $791 in cash for the drugs. GX 48.

While Respondent argues that the Government presented no evidence concerning Dr. K.'s “then current practice area,” the DOH website shows that he was board certified in Obstetrics and Gynecology.
See
GX 40, at 4. And even though the prescription did not indicate that Dr. K. was practicing in an area different than his specialty, the Government's Expert provided credible testimony that a pharmacist needs to know a prescriber's practice area when evaluating whether a controlled substance prescription has been issued for a legitimate medical purpose. Indeed, the circumstances attendant with D.T.'s prescriptions provided compelling evidence that the prescriptions lacked a legitimate medical purpose and should have prompted additional investigation into Dr. K.'s background.

Exceptions to “Alleged Red Flags Within Jones Pharmacy's Prescriptions”

Next, Respondent argues that the ALJ erred in finding that Respondent “filled prescriptions for patients that `traveled from North Carolina to see doctors in Deerfield Beach.' ” Exceptions, at 12 (quoting R.D. 28, FOF # 123 and citing GXs 16 and 44). Respondent argues that “there was no evidence in the record that any particular patients travelled from North Carolina” and that the Government provided “no evidence that such individuals had traveled to Florida for the purposes of obtaining the prescription as opposed to already staying in Florida for an extended period of time.”
Id.
Continuing, Respondent maintains that “[t]he only

evidence in the record concerning these individuals [sic] residence was the fact that the individuals presented licenses from the State of North Carolina.”
Id.

With respect to these two patients (L.S. and J.S.), whose driver's licenses showed that they had the same last name and resided at the same residence in Charlotte, North Carolina, the prescriptions they presented raised numerous other red flags. Specifically, each of these individuals went to the same pain clinic in Deerfield Beach and obtained prescriptions for large quantities of oxycodone and alprazolam that were frequently identical and paid approximately $500 to $600 in cash (or cash equivalents) for their drugs when they filled the prescriptions.
See
GX 16; GX 44; Tr. at 230 (discussing red flags). Moreover, at each visit, the patients obtained prescriptions for two short-acting formulations of oxycodone. According to the Government's Expert, this is a red flag because with legitimate chronic pain management, “the patient should present a prescription for a long acting plus a short acting,” with the latter being used for breakthrough dosing. Tr. 229. The Government's Expert further explained that “drug seekers tend to want the short acting medications because those are the ones that will give them those immediate highs” and you “don't get the high you do from the long acting that you do from the short.”
Id.

As the evidence shows, on March 11, 2010, L.S. and J.S. received the exact same three prescriptions from the same doctor, Rene Casanova,
13

which Respondent filled the next day: 210 oxycodone 30, 90 oxycodone 15 and 75 alprazolam 2.
See
GX 16, at 1-11. At their April 8, 2010 visit to the clinic, L.S. and J.S. saw Dr. Randall Wolff.
14

While Dr. Wolff did not prescribe alprazolam to them, he nonetheless issued both of them prescriptions for 210 oxycodone 30 and 90 oxycodone 15.
Id.
at 13-19. While at their next visit (May 6, 2010) to the pain clinic, a different doctor, Charles Neuringer,
15

issued them slightly different prescriptions for oxycodone 30 (210 du to L.S. and 180 to J.S.), he provided them with identical prescriptions for 90 oxycodone 15 and 60 alprazolam 2, at their June 2, 2010 visit, Dr. Neuringer provided them with identical prescriptions for 180 du of oxycodone 30, 90 oxycodone 15, and 60 alprazolam 2.
16

Id
at 21-44. Thus, even if the Government did not produce evidence that these two persons were travelling from North Carolina each time they obtained the prescriptions, there were ample other red flags that provided compelling evidence that the prescriptions they presented and Respondent filled lacked a legitimate medical purpose.

13
I take official notice that following a hearing, on September 19, 2012, the former Administrator revoked Dr. Casanova's registration based on her findings that he issued controlled substance prescriptions which lacked a legitimate medical purpose in violation of 21 CFR 1306.04(a).
See Rene Casanova
, 77 FR 58150, 58151-52 (2012).

14
Following a hearing, on January 19, 2012, the former Administrator revoked Dr. Wolff's registration based on her findings that he issued controlled substance prescriptions which lacked a legitimate medical purpose in violation of 21 CFR 1306.04(a).
See
GX 42, at 1;
see also Randall L. Wolff
, 77 FR 5106, 5121-22 (2012).

15
On or about December 17, 2010, Dr. Neuringer surrendered his registration for cause. GX 41, at 1.

16
Respondent filled the May 6 and June 2 prescriptions the same day they were issued.

Moreover, even if the Government did not show that L.S. and J.S. were travelling from North Carolina each time they obtained prescriptions and filled them at Respondent, the evidence shows that between February 15, 2010 and April 1, 2011, Respondent dispensed more than 1,500 controlled substance prescriptions to more than 500 patients whose addresses indicated that they did not live in Florida. GX 2. The patients came from such States as North Carolina, Ohio, West Virginia, Kentucky, Tennessee, Mississippi, Georgia, and others.
Id.
Given the number of these patients, I find it likely that many of them were traveling to Florida in search of controlled substances.

Respondent also takes exception to the ALJ's crediting of the testimony of Government's Expert regarding prescriptions issued by Dr. M. to R.H. for 180 oxycodone 30, 112 Endocet (oxycodone/acetaminophen) 10/325, and 90 carisoprodol 350. Respondent dispensed the prescriptions, and charged R.H. $945 for the oxycodone 30, $196 for the Endocet, and $41.08 for the carisoprodol, for a total of $1182 in cash. GX 19; GX 47. According to the prescriptions, R.H. resided in Panama City, Florida, which is in the Florida panhandle and on the other side of the State from Fort Lauderdale.
Id.

Respondent objects to the ALJ's finding that these medications were “prescribed to a 56 year old man
17

by a pediatrician,” arguing that the prescriptions “on their face solely indicated that the physician . . . was associated with the Intercoastal [sic] Medical Group” and did not reflect that the doctor was a pediatrician. Exceptions, at 12. Respondent further contends that Dr. M.'s DOH Physician Profile indicated only that he had done a residency in pediatrics and there was no testimony as to his current practice.
Id.

17
The prescription label lists R.H.'s birthdate as April 2, 1954. GX 19, at 2.

However, even ignoring that Dr. M.'s DOH profile did not list Dr. M. as having any specialty certification,
see
GX 35, at 3; let alone certification in a specialty such as pain management, oncology, or hospice and palliative medicine,
see
Tr. 229, these prescriptions raised numerous other red flags which provided compelling evidence that the prescriptions likely lacked a legitimate medical purpose. These included the drugs, strength of the dosage units and quantities prescribed; the distance R.H. likely travelled to obtain the prescriptions; and R.H.'s willingness to pay nearly $1200 in cash for the drugs. Indeed, were R.H. a legitimate chronic pain patient, these prescriptions would have cost him more than $14,000 a year. Thus, I reject Respondent's exception to the ALJ's Finding of Fact No.128.

Next, Respondent takes exception to the ALJ's crediting of the Government's Expert's testimony regarding Respondent's dispensing of prescriptions for 180 oxycodone 30 and 30 Xanax 2 which were written by a doctor in Sunrise, Florida for three persons from West Palm Beach. Exceptions, at 13 (citing R.D. 30-31, FOF# 130). Respondent states that “[t]he ALJ accepted [the Expert's] statement that the doctor was `rubberstamping the prescriptions and there was no individualized treatment.' ”
Id.
(quoting FOF #130). Respondent argues that the Expert's testimony was “wholesale speculation” because she did not review patient files, or interview the patients or the doctors.
Id.

Putting aside that ALJ's actual finding was that “this
appeared
to be an instance where the doctor was `rubber stamping' the prescriptions,” R.D. at 30 (emphasis added), Respondent does not address other portions of the ALJ's findings, including that the prescriptions were for cocktail medications and that Xanax 2 mg is a high dose of Xanax.
Id; see also
Tr. 270-71. Moreover, the prescription numbers assigned by Respondent show that the prescriptions were presented sequentially, and the evidence shows that each of the patients paid $900 in cash for the oxycodone 30 prescriptions. GX 50, at 2; GX 2 (line items 2541-2546). Respondent also fails to explain why legitimate patients would be willing to travel from West Palm Beach

down to Sunrise
18

to obtain prescriptions and pay $900 cash for just the narcotic, which was highly sought after by drug abusers and diverters. Thus, even accepting that three persons presenting the same prescriptions on a single day from the same doctor does not conclusively establish that the latter was engaged in “rubber stamping” or “pattern prescribing,” there were ample other indicia which created a strong suspicion that the prescriptions lacked a legitimate medical purpose.

18
According to a query conducted on Mapquest, of which I take official notice, Pt. W.F. resided approximately 47 miles from Dr. A.M.'s office.

Exceptions to the ALJ's Findings Regarding the Testimony of Respondent's Expert

Respondent also argues that in her Finding of Fact #190, “[t]he ALJ erroneously made findings . . . concerning [its Expert's] testimony as it relates to corresponding responsibility.” Exceptions, at 14. According to Respondent, “the ALJ made findings . . . that [its Expert] indicated that she has not done any research about the corresponding responsibility of a pharmacist; had not given any presentations about the corresponding responsibility of a pharmacist since 2007; and has not published any research on corresponding responsibility issues.”
Id.
(citing R.D. 46). Respondent contends that these findings are contrary to its Expert's unrebutted testimony that “she sat on the National Association for Board of Pharmacy and sat on a task force for the DEA” on “the implementation of prescription monitoring programs.”
Id.
(citing Tr. 795). According to Respondent, its Expert testified that “it was very conceivable that [the] corresponding responsibility did come up in this context.”
Id.
Respondent further notes that its Expert “testified that she has done research on the area of corresponding responsibility” because she teaches students in simulated pharmacy dispensing exercises and “needed to know that knowledge as well for regulatory compliance in the stores I supervise.”
Id.
(quoting Tr. 799).

As an initial matter, Respondent's Expert actually testified that she “needed to know that knowledge as well for regulatory compliance in the stores I
supervised
.” Tr. 799 (emphasis added). Notably, the evidence shows that the Expert last supervised retail pharmacy stores in 2006, when she went to work for the Institute for Safe Medication Practices. Tr. 717; RX 24 (Expert's Resume). Thus, as of the hearing, Respondent's Expert had not worked in regulatory compliance in nearly a decade.

As for her participation on the task force on prescription monitoring programs, her actually testimony was: “I don't know if we ever discussed that . . . that term [
i.e.
, the corresponding responsibility], but we had a task force with DEA, so to the extent that the DEA wanted to bring that up, we would talk about it.” Tr. 794. When pressed by the Government if the term came up, Respondent's Expert answered: “But I can't remember it. I don't remember,” after which she testified that she did not remember one way or the other but stated that it was “very conceivable that the term would have come up.”
Id.
at 794-95.

Respondent also cites to other portions of its Expert's testimony regarding her knowledge of a pharmacist's corresponding responsibility, including her testimony that she has reviewed administrative decisions published by the Agency, the DEA Pharmacist's Manual, and “pharmacy journals to the extent that they've published anything about that.” Tr. 800;
see also
Exceptions, at 14. Respondent also notes that its Expert “is a member of the American Society of Pharmacy Law.” Exceptions, at 14-15. However, when asked whether the corresponding responsibility had been discussed at any of the Society's meetings, Respondent's Expert answered: “I don't remember.” Tr. 801.

The ALJ specifically found that “the testimony of Respondent's Expert . . . is not credible as it relates to the general knowledge of Florida pharmacists from 2010 to 2012.” R.D. 68. Having reviewed the record and ALJ's findings, I agree with the ALJ and her reasons for declining to credit the testimony of Respondent's Expert.

As explained above, Respondent's Expert has not supervised retail pharmacies in nearly a decade and, in her own testimony, she acknowledged that she has not filled a prescription in 15 years. Tr. 794. Moreover, Respondent's Expert is licensed only in Massachusetts and while she “did a consulting job in Florida,” she has not worked as a dispensing pharmacist in the State.
19

RX 24, at 1; Tr. 737.

19
Respondent's Expert did not further explain what the “consulting job” involved. Tr. 737.

Also, much of her testimony as to how she has become knowledgeable on a pharmacist's corresponding responsibility was vague. While Respondent's Expert claimed to have reviewed various Agency decisions including
East Main Street Pharmacy
, 75 FR 66149 (2010), in determining what red flags of abuse and diversion were generally known to pharmacists during the period of 2010 through 2012, she then opined that she did not believe that many of the red flags identified in that decision
20

were widely known to be indicators of diversion and abuse.

20
Of note, the
East Main Street
findings were based on the testimony of an expert witness for the Government. 75 FR at 66156.

For example, Respondent testified that in her opinion, the combination of prescriptions for a narcotic, a benzodiazepine, and carisoprodol “would [not] signify a pattern of drug abuse to pharmacists in 2010.” Tr. 865. Yet, based on the expert testimony in
East Main Street Pharmacy
, the Agency found that “the combination of a benzodiazepine, a narcotic and carisoprodol is `well known in the pharmacy profession' as being used `by patients abusing prescription drugs.' ”
21

75 FR at 66163.

21
In
East Main Street
, the Agency also noted the Government Expert's testimony that “these cocktails would have a synergistic effect on a person's central nervous system and could cause respiratory depression.” 75 FR at 66163.

Respondent also testified that she did not believe that it was widely known in 2010 that a patient paying cash was an indicator of abuse or diversion. Tr. 864. However, in
East Main Street
, the Agency found, based on expert testimony, that “`any reasonable pharmacist knows that a patient that wants to pay cash for a large quantity of controlled substances is immediately suspect.' ” 75 FR at 66158.

Respondent's Expert also opined that she did not believe that patients travelling long distances to obtain prescriptions was widely known in 2010 to be an indicator of abuse or diversion of prescription drugs. Tr. 864. However, in
East Main Street
,
22

the Agency found that “the fact that the patients were driving so far to get their prescriptions filled `would be a major red flag to any pharmacist.' ” 75 FR at 66164;
see also id.
at 66158 (discussing testimony of expert witness that the fact that patients were “driving 2 + hours” to fill prescriptions “would be a major red flag to any pharmacist and that a reasonable pharmacist would seriously question why these patients were driving such a long distance to have their prescriptions filled” and that “the number one reason” consumers shop at certain pharmacies “is proximity to where they live”).

22
In
East Main Street
, the patients were generally travelling from the Portsmouth, Ohio and northern Kentucky to Columbus, Ohio, a considerably shorter distance than that travelled by many of the patients in this matter.
See
75 FR at 66158.

As for whether, in 2010, pattern prescribing was also an indicator that prescriptions were not issued for a legitimate medical purpose, Respondent's Expert opined that she did not believe that this “was widely known by pharmacists” to be “happening.” Tr. 865. Yet, in
East Main Street
, the Agency found that “in the prescriptions he reviewed, the Government['s] Expert observed that there was `no individualization of dosing based on pain in these patients' with respect to the hydrocodone and alprazolam prescriptions and that `any pharmacist would have known that this was a problem and a strong indicator of a doctor operating a controlled substance prescribing mill.' ” 75 FR at 66163.

Finally, when asked whether in her view, it was widely known in 2010 that Xanax in the two milligram dosage was to be used in “only very rare circumstances,” Respondent asserted that “it was not widely known that Xanax should be reserved for certain circumstances.” Tr. 865-66. However, in
East Main Street
, the Agency found that “with respect to the alprazolam, the Government's Expert explained . . . that the two-milligram strength . . . is generally only prescribed for a patient with post-traumatic stress disorder.” 75 FR at 66163.

Respondent's Expert further maintained that the first time DEA publicly addressed the issue of out-of-state patients coming to pharmacies was in the 2012
Holiday CVS
decision. Tr. 752-53;
see also Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195
, 77 FR 62316, 62321 (2012). However, in
East Main Street
, the Agency had noted that “approximately half” of the pharmacy's patients “were coming from Kentucky,” which “was more than two hours away,” and that this “would be a major red flag to any pharmacist.” 75 FR 66164. Beyond this, it is obvious that patients travelling great distances to obtain large quantities of potent narcotics such as oxycodone 30 are likely seeking the drugs to either abuse them or divert them to others.
23

23
Respondent's Expert also testified that the first reference to the term “red flag” that she could find in DEA's public pronouncements was in the
Holiday CVS
decision. Tr. 753. However, the term appears in DEA administrative decisions involving practitioners including pharmacies even earlier than in
East Main Street. See Paul J. Caragine
, 63 FR 51592, 51600 (1998);
see also Medicine Shoppe-Jonesborough
, 73 FR 364 (2008);
United Prescription Services, Inc.
, 72 FR 50397 (2007). It also has appeared in federal court decisions that predate 2010.
See United States
v.
Johnston
, 322 Fed. Appx. 660, 666-68 (11th Cir. 2009);
Medicine Shoppe-Jonesborough
v.
DEA
, 300 Fed. Appx. 409, 413 (6th Cir. 2008);
United States
v.
Alerre
, 430 F.3d 681,686 (4th Cir. 2005);
United States
v.
Chin
, 795 F.2d 496, 502 (5th Cir.1986).

In any event, the term “red flag” has been part of the lexicon for more than 200 years, and whether the Agency has used this term, or such terms as “warning signs” or “suspicious circumstances,” is of no consequence.
See
III The Compact Edition of the Oxford English Dictionary 1132 (1987) (noting term's use “[a]s a sign of danger, a warning, or a signal to stop”);
Jayam Krishna-Iyer
, 74 FR 459, 460-61 n.3 (2009). What matters is whether Respondent's pharmacists either knew or were willfully blind to the fact that the controlled substance prescriptions they dispensed lacked a legitimate medical purpose. 21 CFR 1306.04(a).

Respondent also argues that the ALJ “erroneously made findings that suggested [that its Expert's] opinions in this case that [it] should maintain its . . . registration was based solely on her `conversations with Ms. Jones.' ” Exceptions, at 15 (quoting R.D. 47, FOF#194). The ALJ did not, however, find that the Expert's Opinion was based “solely” on her conversations with Ms. Jones.
See
R.D. 47, FOF#194. Indeed, the ALJ specifically noted the Expert's testimony that Respondent “has displayed a `positive trend downwards as to the amount of controlleds that are dispensed per non-controlleds.' ”
Id.
(quoting Tr. 785). And the ALJ also acknowledged that Respondent's Expert had reviewed Respondent's policies and “opined that Ms. Jones has changes `policies and procedures as she [has] learned about things.' ” R.D. 48, FOF#197 (citing Tr. 832-33 and quoting Tr. 850).

However, the ALJ also noted that Respondent's Expert “did not offer any opinions as to whether or not [Respondent's] dispensing of controlled substances was abnormal in 2010 [through] 2012.” R.D. 47, FOF #195. Indeed, when asked if she was offering any opinion as to whether Respondent's dispensing in this period “was atypical or abnormal,” Respondent's Expert answered: “No, but I do think she did exercise her corresponding responsibility in 2014.” Tr. 809. Respondent's Expert further admitted that she was not “offering any opinions . . . on whether . . . any specific prescriptions was or was not filled by [Respondent] in compliance with [its] corresponding responsibility.”
Id.
Respondent's Expert also testified that she was not offering any opinions as to whether the extent to which Respondent filled prescriptions for cash or for out of state patients was atypical or abnormal.
Id.
at 810-812.

In short, having reviewed Respondent's exceptions to the ALJ's findings as to the testimony of its Expert, I find no reason to reject the ALJ's credibility finding.
24

24
In this section of its Exceptions, Respondent also takes issue with the ALJ's finding that “[t]he Florida E-FORSCE website indicated that the system was created in 2009 by the Florida legislature.” Exceptions, at 15 (citing R.D. 41 n. 21). Respondent argues that “[i]t appears the ALJ may have performed independent research concerning the E-FORSCE system because it does not appear that either party introduced the website” into evidence.
Id.
Respondent notes that neither party requested that the ALJ to take judicial notice of the website.
Id.
Respondent further argues that the E-FORSCE system did not become operational until September 1, 2011. Exceptions, at 15-16 (citing a fact sheet at the website).

The ALJ did not, however, base her finding that Respondent's pharmacists violated their corresponding responsibility on their failure to use the E-FORSCE system in determining whether to dispense the prescriptions. Nor do I. Thus, the ALJ's noting that the Florida legislature enacted the legislation creating the system in 2009 is not a material fact and no error was committed.
See
5 U.S.C. § 556(e) (“When 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.”).

Exceptions to the ALJ's Conclusions of Law

Exceptions to the ALJ's Legal Conclusion as to Factor One

In discussing Factor One—the recommendation of the state licensing board—the ALJ found that the record did not contain a recommendation from the Florida Board or any evidence of disciplinary action taken against Respondent or Ms. Jones. R.D. at 57-58. Noting that under DEA precedent, “[t]he ultimate responsibility to determine whether a registration is consistent with the public interest has been delegated exclusively to the DEA [and] not to entities within state government,” the ALJ held that the absence of a recommendation or disciplinary action against Respondent (or Ms. Jones) is not dispositive and neither weighs in favor of, or against, a determination as to whether Respondent's continued registration is consistent with the public interest. R.D. at 58 (citing
Top Rx
, 78 FR 26069, 26081 (2013);
Edmund Chein
, 72 FR 6,580, 6590 (2007),
pet. for rev. denied Chein
v.
DEA
, 533 F.3d 828 (D.C. Cir. 2008)).

Respondent argues that the actions of the DOH in conducting six inspections, which found that “in virtually all of those exams, and certainly all exams subsequent to 2012,” Respondent “was in compliance with all rules and regulations including those relating to the maintenance of ordering forms and inventory,” “should be deemed as persuasive for continued registration.” Exceptions, at 16. However, this statement is contradicted by the record evidence related to the DOH inspections.
25

25
For example during the June 10, 2013 Inspection, the Inspector found that Respondent was non-compliant with the requirement that it report controlled substance dispensings to the PDMP within 7 days. RX 8, at 3. Also, during the

August 29, 2014 inspection, the DOH Inspector found that Respondent was non-compliant with Florida law requiring that it maintain controlled substances records “for 4 years.”
Id.
at 1. Also at the latter inspection, the Inspector noted that “controlled substance invoices are mixed in with non-controlled” and that “CII should be separate and CIII-V should be marked if filed with noncontrols [sic] [and] must be readily retrievable from all other records.”
Id.
Of note, under 21 CFR 1304.04(h)(1), “[i]nventories and records of all controlled substances listed in schedule I and II shall be maintained separately from all other records of the pharmacy.”

Respondent also argues that because “the State has taken no action adverse to [it], the ALJ should have found that this factor weighed in favor of continued registration.”
Id.
(citing
Physicians Pharmacy, L.L.C.
, 77 FR 47096 (2012)). However, while Respondent retains its state authority, the Agency has long held that possession of state authority is a prerequisite for obtaining and maintaining a registration.
26

Whether a registrant retains its state license is not a factor in determining whether it has committed acts which render its registration inconsistent with the public interest.
27

Thus, in the absence of a recommendation regarding Respondent's registration, Respondent's continued possession of its State authority is not dispositive and neither supports nor refutes the Government's contention that its registration is “inconsistent with the public interest.” 21 U.S.C. § 823(f). Accordingly, I agree with ALJ's ruling that factor one “does not weigh for or against a determination as to whether the Respondents' continued registration is consistent with the public interest,” R.D. 58, and reject the exception.

26
Thus, consistent with the structure of section 823(f), determining whether an applicant possesses state authority is an inquiry which is required before the Agency considers the public interest factors.
See
21 U.S.C. § 823(f). And in revocation proceedings, a registrant's loss of state authority is a basis for revoking a registration which is independent from the determination of whether a registrant has committed such acts as to render its registration inconsistent with the public interest.
Compare id.
§ 824(a)(3)
with id.
§ 824(a)(4).

To be sure, there are cases in which the Agency has adopted a recommended decision which endorsed the view that the possession of a valid state license “weighs against a finding that Respondent's registration would be inconsistent with the public interest.” However, whether an applicant possesses the requisite state authority is properly viewed as a threshold matter which is to be considered before the public interest determination is made.

27
Certainly conduct which causes a State Board to suspend or revoke a practitioner's controlled substances authority may involve controlled substances and provide a basis to revoke under the public interest standard. But a State Board may also suspend or revoke a practitioner's state authority for reasons having nothing to do with a registrant's controlled substance activities; while such cases do not implicate the public interest standard, they are nonetheless grounds to revoke based solely on the registrant's loss of state authority. 21 U.S.C. § 824(a)(3).

Exceptions to the ALJ's Legal Conclusions as to Factors Two and Four

In her decision, the ALJ found that Respondent “violated recordkeeping requirements by failing to record whether [its] biennial inventory was taken at the opening or close of business, and by failing to indicate the number of tablets per opened commercial container, the number of tablets shipped in each commercial container, and the number of commercial containers that Ms. Jones had on hand.” R.D. at 59 (citing 21 CFR 1304.11(e)(3)). Reasoning that without “a complete inventory, the DEA is unable to conduct an accurate accountability audit,” the ALJ, while acknowledging that “the inventory was complete in other aspects,” then explained that “Ms. Jones' partial compliance does not obviate her failure to record the required the information on the biennial inventory.”
Id.
at 60. The ALJ further explained that “Respondent's lack of attention to detail with its accountability of the controlled substances received and dispensed is adequate grounds for recommending [the] revocation of [its] registration.”
Id.
(citing
Alexander Drug Co.
, 66 FR 18299, 18303 (2001) (citing
Singers-Andreini Pharmacy, Inc.
, 63 FR 4668 (1998))).

Respondent argues that the ALJ's conclusion “was one of form over substance” and that “the unrebutted testimony of Ms. Jones, the biennial inventories presented, [its] expert['s] testimony . . . , and the DOH inspections, all establish that Jones Pharmacy was in substantial compliance with the applicable regulation,” and that this standard “is recognized in DEA regulations.” Exceptions, at 17, 19 (citing 21 CFR 1301.71(b)). Respondent further argues that revocation is not warranted based on “these minor deficiencies.”
Id.
at 19.

Contrary to Respondent's understanding, the “substantial compliance” standard applies only with respect to the Agency's assessment of an applicant's/registrant's “overall security system.” 21 CFR 1301.71(b). Moreover, in the Controlled Substances Act, Congress set the standard for assessing the adequacy of a registrant's inventories by requiring that “every registrant . . . make
a complete and accurate record
of all stocks thereof on hand.” 21 U.S.C. § 827(a)(1) (emphasis added).
See also id.
§ 827(a)(3) (requiring that “every registrant . . . shall maintain . . . a complete and accurate record of each such substance . . . received, sold, delivered, or otherwise disposed of”).

Under DEA's regulations, Respondent's inventories were neither complete nor accurate. They were not complete because they did not list the number of commercial containers on hand and the number of units in each such container.
See
21 CFR 1304.11(e)(3);
id.
§ 1304.11(e)(1)(iii)-(iv). Nor were they accurate because they did not indicate whether the inventory was taken “as of [the] opening of business or as of the close of business.”
Id.
§ 1304.11(a). In the absence of the inventories indicating whether they were taken at the opening or close of business, DEA personnel conducting an audit would not know whether to count the prescriptions dispensed and any shipments received (as well as any returns or other dispositions) on the dates that the inventories were taken.

Respondent nonetheless argues that because the inventories listed the NDC number of the controlled substances, and “the last two digits of the NDC number represent the bottle size,” the inventories contained the required information. Exceptions, at 18. While it may be that the last two digits of an NDC number indicate the bottle size, there are a multitude of different manufacturer's controlled drug products on the market and DEA personnel had no obligation to investigate what bottle size corresponded with the various NDC numbers listed on Respondent's inventories.
28

28
Respondent also asserts that its Expert “found it compelling that the DOH remarked in the October 12, 2011 DOH report that [it] had a zero (0%) percent error rate on its physical inventory.” Exceptions, at 18. Putting aside that the Inspector's comment pertained to an audit he conducted and not an inventory,
see
RX 8, at 7; the Inspector's Report noted that Ms. Jones had not provided a controlled drug report and that the software company had to be contacted “in order to figure out how to print the report.”
Id.
Thus, the DOH Inspector's audit likely did not include controlled substances.

Moreover, despite her factual finding that 480 line items on Respondent's schedule II order forms were not completed correctly, the ALJ did not draw a legal conclusion as to whether Respondent was in compliance with DEA's regulations.
Compare
R.D. at 18-19 (FOF Nos. 89-91),
with id.
at 58-60 (discussing legal conclusions with respect to recordkeeping). I find that Respondent violated DEA regulations by failing to properly record “the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser.” 21 CFR 1305.13(e).

While Respondent argues that the violations found by the ALJ do not support revocation, I need not decide whether these violations, including those based on its failure to properly complete the order forms, would support the revocation of Respondent's registration as opposed to some lesser sanction. This is so because the evidence shows that Respondent has committed egregious dispensing violations which fully support the denial of both its and SND's applications.

Exceptions to the ALJ's Findings That Respondent Violated Its Corresponding Responsibility

Respondent raises five arguments as to why I should reject the ALJ's legal conclusion that it violated 21 CFR 1306.04(a). The first three of these are based primarily on the ALJ's reliance on the testimony of the Government's Expert that many of the prescriptions presented red flags which were unresolvable. They include that: (1) Government's Expert was not qualified to testify as an Expert; (2) the Expert was biased; and (3) its right to due process was violated when the ALJ denied its request for a copy of the Expert's report. Exceptions, at 20-24. As for its other contentions, Respondent argues that: (4) Substantial evidence does not support a finding that Respondent knew or should have known of the various red flags,
id.
at 24-29; and (5) this proceeding “may have been brought for punitive reasons” because Respondent's owner complained to her congressional representatives when DEA failed to approve her request to change her registered location.
Id.
at 30. I find that none of these contentions have merit.

Respondent's Challenges to the Government's Expert

Respondent first challenges the ALJ's ruling accepting the Government's Expert as an Expert in retail pharmacy. Tr. 224. According to Respondent, the Government's Expert was not qualified to testify as such because she has “no expertise of ever serving on pharmacy boards,” has “never taught pharmacy,” has “never worked at an independent pharmacy . . . or testified about any expertise with independent pharmacies,” and “is not currently working in a capacity where she [is] dispensing.” Exceptions, at 21. Respondent also argues that the Government's Expert's “retail pharmacy experience was limited to that of an assistant manager at Publix [a supermarket chain]—and before that [as] a pharmacist at Walgreens,” these being “large retail institutions that had significant resources.”
Id.
And Respondent argues that the Expert “had never before been qualified as an expert,” that she “has not published any articles relating to red flags of diversion,” nor written “any policies or procedures relating to diversion” or “controlled substances.”
Id.
at 21-22.

The evidence shows, however, that Government's Expert holds both a Bachelor of Science in Pharmacy and a Doctor of Pharmacy degree. GX 25, at 1. She testified that she had 17 years of experience working in retail pharmacies, Tr. 214, and her CV shows and she has 10 years of experience working a pharmacist, an assistant manager and a pharmacy manager at retail pharmacies. GX 25, at 2, 4. She testified to having dispensed an estimated five million prescriptions. Tr. 216.

She also testified that based on her education and professional experience she was familiar with a pharmacist's responsibilities in dispensing controlled substances and issues involving the diversion and abuse of controlled substances.
Id.
at 218-19. Thus, the Government's Expert's experience and education provided an ample basis for the ALJ to deem her qualified to testify as an expert witness.
See, e.g.
,
United States
v.
Roach
, 644 F.3d 763, 764 (8th Cir. 2011) (physician qualified to testify as expert on issues based on knowledge acquired “solely from on-the-job observations and attendance at conferences and seminars”);
American General Life Ins. Co.
v.
Schoenthal Family, LLC
, 555 F.3d 1331, 1338-39 (11th Cir. 2009) (rejected argument that “[e]xperience alone . . . can never form the basis for expert testimony,” and noting that expert's education and experience rendered him qualified to testify as expert on insurance industry standards). I therefore reject Respondent's argument to the contrary.
29

29
While Respondent invokes Rule 702 of the Federal Rules of Evidence (which provide only guidance in this proceeding,
see Rosalind A. Cropper
, 66 FR 41040, 41041 (2000)), even under Rule 702, the Government's Expert would have been deemed qualified to testify as such based on her experience and knowledge. There is no requirement that an expert has served on a Board of Pharmacy, has written articles on or taught the subject matter, or has previously testified as an expert.
See
Fed. R. Evid.702 (Advisory Committee Notes 2000 Amendments) (“Nothing in this amendment is intended to suggest that experience alone-or experience in conjunction with other knowledge, skill, training or education-may not provide a sufficient foundation for expert testimony.”);
Beins
v.
United States
, 695 F.2d 951, 609 (D.C. Cir. 1982) (expert's lack of publications in field not disqualifying). As for Respondent's argument that the Expert's experience was limited to working “in large retail institutions” and not independent pharmacies, the Agency's corresponding responsibility rule applies in the same manner to all pharmacies.

Respondent further maintains that the Expert was biased because she “testified that she helped write the Order to Show Cause.” Exceptions, at 22. Respondent also notes that the Expert testified that she had provided a report to DEA, which was in existence when it sought discovery from the Government, but that the ALJ denied its request for discovery. Respondent further argues that the ALJ's ruling denying its request for the Expert's report was a denial of its right to due process.
Id.
at 23 (citing
McClelland
v.
Andrus
, 606 F.2d 1278, 1286 (D.C. Cir. 1979)). Respondent then asserts that the Expert's report “likely contained the identity of other witnesses and may have lead [sic] to the discovery of additional evidence.”
Id.
at 24.

As for Respondent's claims that the Government's Expert was biased because she “testified that she helped write the Order to Show Cause,” the Expert's testimony was: “Yes, I provided a report of my findings and my opinion only.” Tr. 303. And when then asked by Respondent if she had “seen that report in any documents that have been shown to you in this proceeding,” the Expert “I think they showed it to me after the fact. This is what we submitted to you. They showed me the Order after, yes. After they gave it to you, they forwarded it to me too, but I'm going to be honest, I don't read all that stuff.”
Id.

Of note, the record contains no indication that the Show Cause Order (which was in the record as ALJ Ex. 1) was presented by Respondent to the Expert when this colloquy occurred.
See id.
And when the Government objected to this line of questioning on the ground that “we're using terms here . . . in a confusing manner” and asked that Respondent's counsel “show her the document,” the ALJ instructed Respondent's Counsel that “if you would be precise in what you're referring to, that would be very helpful,” before adding that “[i]t is confusing.” Tr. 304. Respondent's Counsel then proceeded to ask the Government's Expert about the report she submitted.
Id.
at 305. As I also find the record confusing, I do not find it established that the Government's Expert helped to write the Order to Show Cause other than in the sense that she reviewed the prescriptions and provided a report to the Government.

I also reject Respondent's contention that it was entitled to discovery of the Expert's report. As several courts of appeals have recognized, “[t]he

Administrative Procedure Act contains no provision for pretrial discovery in the administrative process . . . and the Federal Rules of Civil Procedure for discovery do not apply to administrative proceedings.”
Silverman
v.
CFTC
, 549 F.2d 28, 33 (7th Cir. 1977);
see also Mister Discount Stockbrokers, Inc.
, v.
SEC
, 768 F.2d 875 (7th Cir. 1985). Rather, “ `[t]he extent of discovery that a party is entitled to is primarily determined by the particular agency.' ”
Mister Discount Stockbrokers
, 768 F.2d at 878 (quoting
McClelland
, 606 F.2d at 1285).

DEA's regulations do not, however, provide for broad-based discovery. Rather, consistent with the Due Process Clause, they provide only the right to receive in advance of the hearing a summary of the anticipated testimony of the Government's witnesses and copies of the Government's proposed exhibits.

To be sure, the Agency has recognized that “discovery must be granted if in the particular situation a refusal to do so would so prejudice a party as to deny [it] due process.”
Margy Temponeras
, 77 FR 45675, 45676 n.4 (2012) (quoting
McClelland
, 606 F.2d at 1285)).
See also Goldberg
v.
Kelly
, 397 U.S. 254, 270 (1970) (“where governmental action seriously injures an individual, and the reasonableness of the action depends on fact findings, the evidence used to prove the Government's case must be disclosed to the individual so that he has an opportunity to show that it is untrue”) (int. quotations and other citation omitted). However, “the party seeking discovery must rely on more than speculation and must show that the evidence is relevant [and] material, and that the denial of access to the documents is prejudicial.”
Beau Boshers
, 76 FR 19401, 19403 (2011) (citing
Echostar Comm. Corp.
v.
FCC
, 292 F.3d 749, 756 (D.C. Cir. 2002);
Silverman
, 549 F.2d at 34). The prejudice must be of such “a significant degree so as to result in a denial of due process.”
Mister Discount Stockbrokers
, 768 F.2d at 878.

While Respondent contends that the denial of its right to the report of the Government's Expert violated its right to due process, I conclude that Respondent has failed to identify any prejudice, let alone prejudice resulting in the denial of due process. Notably, in advance of the hearing, the Government provided Respondent with a thorough disclosure of the testimony it expected to elicit from its Expert regarding the various red flags of diversion present in the prescriptions she reviewed and it also identified those sets of prescriptions which its Expert would testify were “filled in the face of numerous unresolvable red flags for diversion.” ALJ Ex. 11, at 16-19 (Govt. Prehearing Statement). Moreover, Respondent makes no claim that the Government failed to provide copies of its proposed exhibits in advance of the hearing as required by the ALJ's Prehearing Ruling. ALJ Ex.16, at 3. Thus, Respondent was fully apprised of the Government's theory of the case and the evidence it intended to rely on and Respondent had ample opportunity to prepare a defense.

While Respondent asserts that by denying it “access to [the Expert's] report, [it] was denied access to part of the evidence on which the DEA relies [on] to revoke its license,” Exceptions, at 24; the Government did not introduce the report into evidence and thus did not rely on it to prove its case. Moreover, Respondent was able to thoroughly cross-examine the Government's Expert as to the basis of her opinions that the prescriptions presented unresolvable red flags.
See
Tr. 289-359; 375-79.

Respondent further asserts that it has been prejudiced because the Expert's report “likely contains the identity of other witnesses and may have lead [sic] to the discovery of additional evidence.” Exceptions, at 24. However, earlier in its Exceptions, Respondent argued that I should reject the ALJ's findings as to the prescriptions in GX 22 because the Government's Expert acknowledged that “she had not . . . spoken with the doctors, or the patients or any physicians that had issued the prescriptions at issue in this action.” Exceptions, at 13 (citing Tr. 317). As Respondent has not even suggested what other type of witnesses it believes the Expert's report refers to, its claim of prejudice rests on pure speculation. I therefore reject its exception.
30

30
In light of my conclusion that Respondent has not shown that the denial of the Expert's report is so prejudicial as to deny it due process, I do not address the Government's argument that the report was a draft report which even under the Federal Rules of Civil Procedure need not be disclosed to the opposing party. Govt. Resp. to Respondents' Exceptions, at 20-21 (citing Fed. R. Civ. P. 26(b)(4)(B)). Nor do I address the Government's contention that the parties agreed that the only documents subject to disclosure were the prehearing summaries of the expected testimony, the experts' CVs, and any documents that their experts would be expected to refer to on direct examination and that Respondents “are complaining about a document they abandoned months before the hearing.”
Id.
at 19.

Respondent's Contention That Substantial Evidence Does Not Support a Finding That It Knew or Should Have Known of the Red Flags

Respondent argues that “[t]he ALJ improperly concluded that [Respondent] knew or should have recognized a red flag prior to the time the controlled substances were dispensed.” Exceptions, at 24. Noting the ALJ's reliance on
Holiday CVS,
Respondent argues that “unlike the
Holiday CVS
case, there was no evidence in the record of this case that any controlled substance was diverted, or any prescription [was] issued by a prescribing physician who lacked authority to prescribe controlled substances.”
Id.
at 24-25. Respondent further argues that in
Holiday CVS,
the pharmacies “were specifically advised by DEA staff on more than one occasion of prescribing patterns to look out for as potential indicators of diversion.”
Id.
at 25 (citing 77 FR at 62326, 62331). Respondent thus contends that “[n]one of these facts are [sic] present in this action.”
Id.

While it is true that in
Holiday CVS,
the Agency found that pharmacies knowingly filled prescriptions issued by two physicians who were no longer registered and did so well after the pharmacies should have known that the physicians were no longer registered, that was only a small part of the case.
See
77 FR at 62316-317. Rather, the heart of the Government's case was that the pharmacies' pharmacists had repeatedly violated their corresponding responsibility by dispensing prescriptions when they either knew or were willfully blind to the fact that the prescriptions lacked a legitimate medical purpose.
See id.
at 62317-322;
see also id.
at 62332-334.

Contrary to Respondent's contention, the Government's proof was similar to that put forward in this case in that it was based entirely on circumstantial evidence. More specifically, the evidence showed that: (1) The patients were travelling long distances (and frequently from out-of-state) to obtain their prescriptions; (2) the prescriptions were for large quantities of such highly abused drugs as oxycodone 30 and alprazolam; (3) the doctors issued prescriptions for combinations of oxycodone (including two dosage strengths both oxycodone 30 and 15) and alprazolam; and (4) the patients were paying cash for the prescriptions.
See id.
at 62332-34.

As in this matter, in
Holiday CVS,
the Government did not put forward any witness who testified that he/she had “personal knowledge” that the drugs were being diverted. While Respondent further argues that the Government did not put on any evidence “that any diagnosis was not legitimate . . . or that any controlled substance was diverted after a prescription was filled,” Exceptions, at 29; the Government did introduce evidence showing that several

of the physicians either surrendered their registrations or had their registrations revoked after a hearing in which they were found to have issued prescriptions in violation of 21 CFR 1306.04(a).
See Rene Casanova,
77 FR at 58151-52; GX 42, at 1 (registration printout for
Randall L. Wolff
);
Wolff,
77 FR at 5121-22; GX 41, at 1 (registration printout showing Dr. Neuringer surrendered his registration for cause).
31

31
The evidence also shows that Respondent filled controlled substance prescriptions issued by Drs. Jacobo Dreszer (4 Rxs), Michael Aruta (7 Rxs), Beau Boshers (12 Rxs), and Cynthia Cadet (2 Rxs).
See
GX 2 (line entries nos. 25, 41, 53-60, 70-83, 87). I take official notice that on February 25, 2010, the former Administrator ordered the immediate suspension of each of these doctor's registrations, and following a consolidated hearing before an ALJ, the former Administrator found that each of these doctors had issued controlled substance prescriptions outside of the usual course of professional practice and which lacked a legitimate medical purpose and revoked their respective registrations.
See Cynthia M. Cadet,
76 FR 19450, 19451, 19465 (2011);
Michael J. Aruta,
76 FR 19420, 19420, 19434 (2011);
Beau Boshers,
76 FR 19401, 19404, 19419 (2011);
Jacobo Dreszer,
76 FR 19386, 19389-90, 19401 (2011).

Nor do I find persuasive Respondent's attempt to distinguish
Holiday CVS
because in that matter, agency Investigators met with CVS employees and discussed both a pharmacist's corresponding responsibility and various red flags attendant with illegitimate prescriptions. To the extent Respondent suggests that its owner and pharmacists were entitled to a similar briefing, and should be excused from liability because they did not receive such a briefing, it is mistaken. DEA does not have the resources to personally brief every registrant following its discovery of new patterns of diversion.
32

Rather, as a participant in a highly regulated profession, Respondent's owner had an obligation to keep herself informed regarding regulatory developments which affected her profession.
Cf. Holiday CVS,
77 FR at 62317 (citing
United States
v.
Southern Union Co.,
630 F.3d 17, 31 (1st Cir. 2010) (“[T]hose who manage companies in highly regulated industries are not unsophisticated. . . . It is part of [a company's] business to keep abreast of government regulations.”)).

32
In
Holiday CVS,
one of the Government's Investigators (who also testified in this proceeding) testified that the DEA Weston Office had decided in 2005 “to interview all new pharmacy applicants and also treat all new pharmacy applications the same and alert the chains. So when there was a new pharmacy opening up, I would contact them and they would come in for a discussion of the situation.” 77 FR at 62331. Respondent cites to this testimony and argues that “[t]here was no testimony from DEA staff that the DEA ever provided similar information to [it] during the . . . time period covering the prescriptions at issue in this action.” Exceptions, at 29 n.32. Respondent thus suggests that “there was a disparity of treatment between types of pharmacies despite the DEA seeking to impose the same knowledge on [it] that was given to Holiday CVS.”
Id.

To the extent Respondent raises the lack of such a briefing as an affirmative defense, the burden of production was on Respondent to show that it did not occur and Respondent produced no evidence as to whether DEA Investigators visited it prior to granting its initial application, let alone that they failed to conduct a briefing on red flags associated with unlawful prescriptions. Second, even if Respondent had established that it was treated differently than chain pharmacies because it was an independent pharmacy, the Government's basis for treating it differently would only be subject to rational basis review.
Cf. FCC
v.
Beach Comm., Inc.,
508 U.S. 307, 316-17 (1993). Finally, because the regulation provides constitutionally adequate notice of a pharmacist's legal obligation to not knowingly dispense prescriptions which lack a legitimate medical purpose,
see United States
v.
Hayes,
595 F.2d 258, 260-61 (5th Cir. 1979), and the red flags themselves are simply factual circumstances which provide evidence to suspect that a prescription was not issued for a legitimate medical purpose, Respondent cannot claim that it has been denied fair notice that its filling of the prescriptions at issue was unlawful.

Moreover, even prior to Respondent's first engaging in the dispensing of controlled substances, this Agency had identified several of the same red flags that are present here, such as the prescribing of drug cocktails of narcotics (oxycodone), benzodiazepines (alprazolam), and carisoprodol and patients obtaining large doses and multiple prescriptions for narcotics.
See Paul H. Volkman,
73 FR 30630, 30637 (2008) (discussing testimony of expert in pain management that physician's practice of prescribing drug cocktails of opioids, which often included multiple opioids, a benzodiazepine and carisoprodol, “greatly increased the chance for drug abuse, diversion, [and]/or addiction”);
33

see also Your Druggist Pharmacy,
73 FR 75774, 75775 n.1 (2008) (discussing carisoprodol's use by drug abusers as a part of a drug cocktail which also includes an opiate and benzodiazepine).

33
Indeed, the Government's Expert in
Volkman
discussed at length six patients who received multiple controlled substance prescriptions from the doctor and died of overdoses only a few days later.
See
73 FR at 30637 n.23.

Also, as discussed above, on October 27, 2010, the Agency identified additional red flags in the
East Main Street Pharmacy
case such as patients paying cash, patients travelling long distances to obtain prescriptions, and patients obtaining prescriptions for alprazolam in the two milligram dosage. To the extent Respondent believes that it should be excused for its dispensing violations which occurred prior to this date because no Agency decision had explicitly found that these circumstances were red flags, the circumstances of patients, who had traveled long distances and frequently from out-of- state, presenting prescriptions for multiple controlled substances including large quantities of oxycodone (and frequently prescriptions for both 30 and 15 milligrams dosages), alprazolam 2mg, and at times also carisoprodol, for which they paid large sums of cash (or cash equivalents), created an obvious and compelling level of suspicion that the prescriptions lacked a legitimate medical purpose.
See Holiday CVS,
77 FR at 62322 (“[T]he red flags presented by the circumstances of patients travelling from Kentucky or Tennessee to South Florida to obtain prescriptions, including for a schedule II narcotic, which by definition has the highest potential for abuse of any drug that may be lawfully prescribed, and then travelling to Respondents to fill them, are so obvious that only those who are deliberately ignorant would fill these prescriptions.”) (citation omitted).
34

Because I conclude that these red flags rendered it obvious that the prescriptions likely lacked a legitimate medical purpose, I reject Respondent's further contention that “the ALJ . . . improperly concluded that there was a general knowledge of `red flags' among . . . independent pharmacies.” Exceptions, at 29.

34
In this exception, Respondent also repeats its argument that the Government's Expert “provided no credible evidence that the term [red flags] was known by pharmacists [sic] the State of Florida other than her unsubstantiated testimony.”
Id.
at 27. Respondent also relies on the discredited testimony of its Expert to the effect that the first reference she found on the Agency's website to the term red flag was in the
Holiday CVS
decision and that she did not believe that in 2010, such circumstances as patients paying cash or traveling to obtain prescriptions was widely known by pharmacists to be an indicator of abuse or diversion.
Id.
at 28. I reject these arguments for the reasons explained in my discussion of Respondent's exceptions to the ALJ's factual findings and credibility determinations regarding the parties' experts.

Respondent further argues that the ALJ erred in “credit[ing] the DEA's argument that cash and high prices charged are evidence of knowledge [on Ms. Jones's part] that her `acts were illegal.' ”
Id.
According to Respondent, this “argument turns the principles of due process and burden of proof on their head,” apparently because both parties' Experts testified that there are no “prohibitions of pharmacies charging any particular price on controlled substances.”
Id.
(citing Tr. 758).

Respondent, however, cites no authority for its contention. Moreover, even granting that there are no prohibitions on the prices a pharmacy can charge for controlled substances, when those prices far exceed what other pharmacies would charge, the Agency may properly draw the inference that

the pharmacy is charging those prices because it knows it is supplying persons who are seeking the drugs to either abuse them or divert them to others.
See United States
v.
Leal,
75 F.3d 219, 223 (6th Cir. 1996) (holding that evidence that pharmacist “marked up controlled substance prices 788% as compared to a national average of 86%” supported finding that pharmacist knew prescriptions were unlawful”);
United States
v.
Cooper,
868 F.2d 1505, 1512 (6th Cir. 1989) (evidence that pharmacy charged prices well in excess of average prices supports an inference that the pharmacist knew drugs were prescribed illegally);
Hayes,
595 F.2d at 261 (holding that evidence that “the prices charged by [pharmacist] for drugs were unusually high” supported conclusion that pharmacist “knew that the prescriptions were not issued for a legitimate medical purpose”).

Here, the evidence shows that Respondent was charging prices as high as $1620 for 180 dosage units of oxycodone 30 mg when it paid $58.66 for the drugs.
See, e.g.,
GX 2 (line entries Nos. 3172, 3192, 3249). Moreover, the DOH Inspector, who had inspected approximately 1,500 pharmacies in Broward and Dade counties and who had 33 years of experience as a practicing pharmacist, testified that the typical price for 180 oxycodone 30 was “less than $200” and “at most $250.” Tr. 168. The Inspector further testified that the $1620 price Respondent was charging at the time of the 2012 DOH Inspection was “extraordinary” and that “in charging that amount of money,” Respondent's owner knew the prescriptions were not issued for a legitimate medical purpose.
Id.
at 167. I agree and I reject Respondent's contention to the contrary.

Respondent's Contention That This Proceeding May Have Been Brought For Punitive Reasons

Respondent further argues that “the objective evidence indicates that the instant action may have been brought for punitive reasons.” Exceptions, at 30. As support for its contention, Respondent cites to the evidence showing that in March 2012, Ms. Jones leased a new location; that on June 2, 2012, she applied to change her registered address to her new location; and that in both July and October 2012 she had sent DEA Investigators the dispensing report (GX 2), but that DEA did not approve the modification until April 2, 2013, several weeks after Respondent's owner had written her congressional representatives to complain about the delay.
Id.
at 30-33.

In its Exceptions, Respondent further quotes from Ms. Jones' letter to her congressional representatives in which she asserted that “I can only think of negative reason of why someone would sit on our file so long,” that “[i]t feels like an abuse of power for someone in this position,” and “I feel this is an adult version of being bullied. I am emailing and calling and I can't get any response on the status of our application and why it is taking so long.” RX 7 (quoted in Exceptions, at 32-33). Noting that one of the Government's Investigators testified that when he conducted the April 2, 2013 inspection, he was aware that Ms. Jones had sent this letter to her congressional representatives, Respondent thus suggests that the proceeding was brought to retaliate against Ms. Jones for complaining to her representatives. Exceptions, at 32-33 & n.33.

I reject the contention that the proceedings were brought to retaliate against Respondent's owner. Here, notwithstanding that Ms. Jones engaged in constitutionally protected speech when she complained to her congressional representatives, the Government's case for seeking the revocation of Respondent's registration is amply supported by the evidence showing that Respondent's pharmacists filled numerous controlled substance prescriptions in violation of 21 CFR 1306.04(a) thus rendering its registration inconsistent with the public interest. In the related context of a
Bivens
action for a retaliatory criminal prosecution, the Supreme Court has held that a plaintiff must show that the prosecutor lacked probable cause.
See Hartman
v.
Moore,
547 U.S. 250, 265-66 (2006);
see United States
v.
Armstrong,
517 U.S. 456, 464 (1996) (holding that “a presumption of regularity” supports prosecutorial decisionmaking, and where probable cause exists the decision to bring a charge “generally rests entirely” in the prosecutor's “discretion”) (int. quotations and citations omitted). Because there is no evidence in the record, other than Ms. Jones' assertion, that the proceeding was brought to punish her for having complained to her congressional representative, and because the case against Ms. Jones is amply supported by the evidence in the record, I reject her contention.

Respondent's Exception That the ALJ Failed To Consider Respondent's Evidence as to Ms. Jones' Acceptance of Responsibility and Remedial Actions

The ALJ further found “that Ms. Jones has not unequivocally accepted responsibility for” the “unlawful dispensing that occurred at [Respondent] from 2010 [through] 2012.” R.D. at 73. Based on this finding, the ALJ applied Agency precedent which holds that a registrant's acceptance of responsibility and showing that it has undertaken adequate remedial measures are independent and “essential requirements for rebutting the Government's
prima facie
showing that continuing an existing registration would be `consistent with the public interest,'” and declined to consider Respondent's evidence of remedial measures.
Id.
(citing
Holiday CVS,
77 FR at 62346 (quoting 21 U.S.C. § 823(f))).

Respondent takes exception to the ALJ's finding that Ms. Jones failed to unequivocally accept responsibility for its misconduct. It argues that the ALJ erred in concluding that Ms. Jones' testimony that she believed “that she was dispensing in accordance with appropriate methods, demonstrates a lack of acceptance of responsibility.”
Id.
at 33-34. Respondent argues that “there is no specific language that is required to `unequivocally accept responsibility” because “not all individuals are the same and different individuals express themselves in different ways.”
Id.
at 34. Respondent then argues that “Ms. Jones repeatedly indicated that she accepted responsibility for her actions that she felt bad in that she would not want to have done something to hurt anyone.”
Id.
Respondent further points to Ms. Jones' testimony “that knowing what she knows now, she could have done more to determine if prescriptions were written for legitimate purposes” but that “she did not believe any of the prescriptions in 2010 that were issued were not for legitimate medical purpose at that time . . . [a]lthough knowing what she knows now, she concedes it is possible they may not have been.”
Id.
After discussing two older agency cases which Respondent asserts stand for the proposition “that there is no specific way in which a party may accept responsibility,” Respondent all but acknowledges the insufficiency of its showing on this issue when it argues that “[i]n the instant action, there was substantial evidence on the record that Ms. Jones
equivocally
took responsibility for her actions.” Exceptions, at 34-36 (emphasis added and citing
Barry H. Brooks,
66 FR 18305 (2001) and
Mary Thomson,
65 FR 75969 (2000)).

While it is true that in these two cases the Agency granted registrations to persons whose acceptance of responsibility was less than unequivocal, in subsequent cases the Agency has made clear that where the Government has proved that a registrant

has engaged in intentional or knowing misconduct, revocation is warranted in the absence of the registrant's unequivocal acceptance of responsibility for its misconduct.
See Jayam Krishna-Iyer,
74 FR 459, 464 (2009). As the former Administrator explained:

While some isolated decisions of this Agency may suggest that a practitioner who committed only a few acts of diversion was entitled to regain his registration even without having to accept responsibility for his misconduct, the great weight of the Agency's decisions are to the contrary. . . . Because of the grave and increasing harm to public health and safety caused by the diversion of prescription controlled substances, even where the Agency's proof establishes that a practitioner has committed only a few acts of diversion, this Agency will not grant or continue the practitioner's registration unless he accepts responsibility for his misconduct.
35

35
In
Krishna-Iyer,
the Agency further overruled any case to the contrary. 74 FR at 464 n.9.

Id. See also Michael A. White,
79 FR 62957, 62958, 62967-68 (2014) (adopting ALJ's finding that physician did not accept responsibility when his “acceptance of responsibility was tenuous at best,” “not once during the hearing did [he] unequivocally admit fault for his improper . . . prescriptions,” and he “minimized the severity of his misconduct”);
The Medicine Shoppe,
79 FR 59504, 59508-10 (2014) (adopting ALJ's finding that pharmacy had not accepted responsibility for its misconduct when its owner/pharmacist initially testified that he accepted responsibility but on cross-examination denied ever having filled an unlawful prescription notwithstanding proof to the contrary);
Holiday CVS,
77 FR at 62323 (rejecting challenge to ALJ finding that pharmacy registrants had failed to acknowledge their misconduct when corporate official testified only that company “takes its responsibility seriously, and given . . . the elevated level of drug abuse that's being observed broadly in Florida, we don't want to contribute to that”).
36

36
The Agency's rule has been upheld on review.
See MacKay
v.
DEA,
664 F.3d 808, 820 (10th Cir. 2011) (“The DEA may properly consider whether a physician admits fault in determining if the physician's registration should be revoked. When faced with evidence that a doctor has a history of distributing controlled substances unlawfully, it is reasonable for the . . . Administrator to consider whether that doctor will change his . . . behavior in the future. And that consideration is vital to whether continued registration is in the public interest.”);
Chein
v.
DEA,
533 F.3d 828, 837 (D.C. Cir. 2008) (upholding revocation of physician's registration based on physician's failure to accept responsibility where physician “continued [to] insist[] that his dispensing of anabolic steroids to the undercover agents was proper”);
Hoxie
v.
DEA,
419 F.3d 477, 483 (6th Cir. 2005).

Here, Respondent's evidence falls well short of the mark and even putting aside the egregious nature and scope of Respondent's misconduct, Ms. Jones' testimony establishes that she still does not understand what her obligations are under the CSA. Notably, when asked on cross-examination about specific sets of prescriptions, Ms. Jones maintained that at the time she dispensed the prescriptions she thought she was properly exercising her corresponding responsibility. Tr. 578-79. She further denied that she had reason to believe the prescriptions were not issued for a legitimate medical purpose, explaining that “I did what I had done at other pharmacies and I thought that was enough.”
Id.
Ms. Jones further testified that her process for checking the legitimacy of the prescriptions was limited to “calling the doctor and verifying that the prescription was written by the office.”
37

Id.
at 581.

37
Contrary to Ms. Jones' understanding, it has been settled law for years that a pharmacist's obligations under the corresponding responsibility rule requires more than just calling the prescriber. As the Fifth Circuit has explained:

Verification by the issuing practitioner on request of the pharmacist is evidence that the pharmacist lacks knowledge that the prescription was issued outside the scope of professional practice. But it is not an insurance policy against a factfinder's concluding that the pharmacist has the requisite knowledge despite a purported but false verification. . . . What is required by [a pharmacist] is the responsibility not to fill an order that purports to be a prescription but is not a prescription within the meaning of the statute because he knows that the issuing practitioner issued it outside the scope of medical practice.

United States
v.
Hayes,
595 F.2d 258, 261 (5th Cir. 1979).
See also United States
v.
Seelig,
622 F.2d 207, 213 (6th Cir. 1980) (violation of 21 CFR 1306.04(a) “may be inferred from proof that [pharmacists] deliberately closed their eyes to what would otherwise be obvious to them”);
Medicine Shoppe-Jonesborough
v.
DEA,
300 Fed. Appx. 409 (2008). And not only is ignorance of the law no excuse, those who choose to participate in a highly regulated profession cannot reasonably claim ignorance of the legal obligations imposed on them as a practitioner in that profession.
See David A. Ruben;
78 FR 38363, 38387 n.54 (2013);
cf. Hageseth
v.
Superior Court,
59 Cal. Rptr.3d 385, 403 (Ct. App. 2007).

While Ms. Jones further testified that “[k]nowing what I know today, I think I could have done more digging to test the legitimacy of the prescriptions,”
id.
at 583, she then explained that “there are doctors who will still write prescriptions like this and who are still practicing. So, I feel like we have to be the police of the legitimacy of the prescriptions,
even though that should be their responsibility to make sure legitimate prescriptions are written based on the diagnosis of the patient.” Id.
at 585 (emphasis added).

Throughout the cross-examination, Ms. Jones continued to maintain her belief that she had complied with her obligations under 21 CFR 1306.04(a) when she filled the prescriptions while denying that she had any obligation to do anything other than call the doctor's office. For example, when asked if her “due diligence include[d] assessing whether” the prescriptions in Government Exhibit 17 and 45
38

(which were presented by two persons who provided the same address in Tennessee and were for three controlled substances) were issued “for legitimate medical purposes,” Ms. Jones answered: “Well we call the office to verify the prescription and to make sure it was valid. I disagree with what you're saying that we didn't make sure that the prescription was legitimate. I don't agree to that. I'm sorry, I don't.” Tr. 593-94. When then asked whether there was “reason to believe that” the prescriptions were not issued for a legitimate medical purpose, Ms. Jones answered:

38
These prescriptions were obtained by two patients (D.H. and K.S.) who provided the same residence address in Harriman, Tennessee and obtained prescriptions on same day (on two occasions) from a clinic in Opa Locka which Respondent filled for oxycodone 30 (three of the prescriptions being for 180 du, one being for 150 du), oxycodone 15 (all four prescriptions being for 90 du), and alprazolam 2 (all four prescriptions being for 60 du). GXs 17, 45. D.H. and K.S. paid for each prescription with cash. GX 45, at 2.

At face value of the prescription, no, because they're actual medications. They're written by a doctor. I've done a lot of training. Pain is what the patient says it is. Someone can, I have a patient who has sickle cell and has told me he's went to the hospital and sat there and waited and they asked him what his pain level was and he told them ten and it wasn't until they took his vitals that they actually believed him. So, I don't think you could look at someone to say you're not in pain and that's not a legitimate prescription.

Id.
at 595.

However, even if a pharmacist cannot look someone in the eye and determine whether she is actually in pain, a pharmacist can certainly evaluate the likelihood that prescriptions are legitimate when two patients, who provided the same address in Tennessee, presented essentially identical prescriptions for large quantities of oxycodone 30 and 15, as well as alprazolam 2, which they obtained from the same doctors, paid cash for the prescriptions and just happened to drop by her pharmacy to fill the prescriptions.

Next, the Government pursued the same line of questioning regarding the 49 prescriptions which were presented by 22 patients and filled by Respondent on April 19 and 20, 2010. Tr. 596; GXs 46 and 18. Of note, none of the 22

patients who filled these controlled substance prescriptions was from Florida. Rather, the patients were from Ohio, West Virginia, Georgia, Tennessee, Kentucky, and Mississippi. Moreover, 40 of the prescriptions were written by Dr. Wolff of Deerfield Beach, who registration was revoked by this Agency following a hearing at which he was found to have violated 21 CFR 1306.04(a).
39

Each of the patients filled a prescription for oxycodone 30, with sixteen of the patients obtaining 180 dosage units or more, fourteen of the patients also obtained prescriptions for alprazolam 2mg, and thirteen of the patients also obtained a third prescription for oxycodone 15.
See
GX 46. Moreover, each of the patients paid cash for their prescriptions.
Id.
at 3-4
.
Here, as well, these out-of-state patients just happened to know to go to Respondent, out of all the pharmacies in South Florida, and which had been opened for just over two months, to fill their prescriptions.
40

39
The other nine prescriptions were written by a doctor in Miami. GX 46, at 12.

40
A review of the spreadsheet of Respondent's controlled substance dispensings shows that even in the initial months of its dispensing activity, filling prescriptions for persons who provided non-Florida addresses predominated over filling prescriptions for Florida residents. For example, from February 15, 2010 through the end of May 2010, Respondent filled 706 controlled substance prescriptions for persons who provided a non-Florida address and only 152 prescriptions for Florida residents.
See
GX 2 (line entries 2-706). Indeed, between February 15 and March 12, 2010 (its first month of dispensing as no dispensings occurred on March 13-14), it filled controlled substance prescriptions for 42 persons who provided addresses in Kentucky, Ohio, West Virginia, Tennessee, and North Carolina but only eight Florida residents.
Id.
(line entries 2-102). With the exception of three carisoprodol prescriptions, the prescriptions were comprised entirely of oxycodone in both 30 and 15 milligram dosage forms and alprazolam in either the 2 or 1 milligram dosage form. Of the patients who filled controlled substance prescriptions at Respondent during its first month of dispensing, 43 of them obtained prescriptions for oxycodone 30 and each paid cash.

Asked whether she thought she was exercising her corresponding responsibility to ensure that these prescriptions were issued for a legitimate medical purpose, Ms. Jones testified: “I think I was at the time, yes.” Tr. 599. When subsequently asked if she “understand[s]s those responsibilities differently today,” Ms. Jones answered:

Differently today—differently in the sense of I can do more; differently, no, in the sense if the prescription is written by the prescriber, I don't think it makes it an illegitimate, not a legitimate prescription for medical purposes. I think I can do more digging to make sure that the patient is going to use it appropriately and not make it so that somebody else has access to it. I do that by looking at their history that the inspector made me aware of in August of 2014, but I still do rely on the prescriber to write prescriptions for legitimate medical purposes.

Id.
at 599-600. Here again, notwithstanding the obvious and compelling evidence that the prescriptions lacked a legitimate medical purpose, Respondent continued to deny that the prescriptions were unlawfully dispensed.
41

41
Asked about additional sets of prescriptions, Ms. Jones adhered to the same theme that she believed that when she filled the prescriptions she properly exercised her corresponding responsibility, but today, she “would do more digging.” Tr. 606. She did so no matter how strong the indicia of suspicion were with respect to the prescriptions, such as when she was asked about an oxycodone prescription that cost her $58.56 and for which she charged the patient $1620.
Id.
at 611-12.

Moreover, at other points in her testimony, Ms. Jones left no doubt that she still does not understand her obligations under 21 CFR 1306.04(a). To be sure, Ms. Jones testified that she “would shy away” from filling a prescription for a patient who is paying cash.
Id.
at 623.

However, when then asked if she “believe[s] there are circumstances where a pharmacist should refuse to fill a prescription after making the judgment that it is not issued for [a] legitimate medical purpose,” she testified:

That still leaves us diagnosing whether the patient has pain or not. I wouldn't say for legitimate medical purpose. I would say by looking at the totality of what the situation is and as much information as you can collect and then deciding if you're okay, if you feel comfortable filling it or not.

Id.
at 624.

While on further questioning Ms. Jones testified that “[t]here are circumstances that would cause me to reject a prescription,” she then added that “I don't think I can make the determination whether it's for legitimate medical purposes because I would have to say that I'm in that person's body and I know how they feel if we're just speaking about pain medications.”
Id.
at 625. And subsequently, Ms. Jones testified that with respect to pain medications, “I might question the quantity, maybe the duration, but for legitimate medical purpose, that would lead me into me having to diagnose because I'm someone who will give recommendations and tell you what I think, but I can't, I don't think it's a fair statement that you could say someone is not in pain.”
Id.
at 628.
42

42
The federal courts have also rejected this view. As the Fifth Circuit has further explained: “ `a pharmacist can fulfill [her] responsibility under [21 CFR] 1306.04 without practicing medicine. . . . [A] pharmacist can know that prescriptions are issued for no legitimate medical purpose without [her] needing to know anything about medical science.' ”
United States
v.
Henry,
727 F.2d 1373, 1378 (5th Cir. 1984) (quoting
Hayes,
595 F.2d at 261 n.6).

Subsequently, Ms. Jones was asked after if she understood her corresponding responsibility under the Controlled Substances Act.
Id.
at 639. Ms. Jones answered:

Well, I understand that I have a responsibility to make sure that patients are safe with the medication they receive. But, you, you're saying medical legitimacy. The law is saying that we had a—to make sure it says medical, it's—the law says medical legitimacy? That's what I'm not understanding.

Id.

When then asked whether she knew “one way or another” if she had a corresponding responsibility, Ms. Jones answered: “I did not know that the law said that I had to make sure that prescriptions said it was legitimate, medically legitimate.”
Id.
at 639-40. Ms. Jones then admitted that she did not know this even while “sitting here today.”
Id.
at 640
.
When then asked for her “understanding of what the law requires of . . . a pharmacist [who] dispens[es] controlled substances,” Ms. Jones testified “that I need to make sure that the patients are safe and that I need to make sure that the prescription is a, a true and correct prescription. That's my understanding of my responsibilities.”
Id.
at 640-41. And when asked if she has “any responsibility to ensure that the prescription is issued for a legitimate medical purpose,” Ms. Jones testified: “I thought that was the prescriber's responsibility. The person actually writing the prescription.”
Id.
at 641.

Thereafter, Ms. Jones was asked whether she “acknowledge[s]” that she did not exercise her responsibility to ensure that that prescriptions at issue “were issued for a legitimate medical purpose?”
Id.
at 642. Ms. Jones answered: “[i]n my scope of what I did I, that was not a part of what I was doing anyway if that makes sense.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2016-27120. Public record. Not legal advice.