The Medicine Shoppe; Decision and Order
Federal Information & News Dispatch, Inc. |
Citation: "79 FR 59504"
Document Number: "Docket No. 14-01"
Page Number: "59504"
"Notices"
On
Having reviewed the entire record including Respondent's Exceptions, I have decided to adopt the ALJ's findings of fact, conclusions of law, and recommended order. A discussion of Respondent's Exceptions follows.
Respondent's Exceptions
Respondent raises twelve different exceptions to the ALJ's decision in no logical order. His contentions can be summarized as follows:
(1) That the ALJ failed to consider less punitive sanctions than revocation;
(2) that the ALJ improperly rejected his evidence of remedial measures by requiring him to produce corroborating evidence because she failed to rule on the Government's motion in limine and never granted him permission to introduce such evidence;
(3) that the ALJ "imposed an undefined and vague standard of proof" on the issue of his remedial measures because she rejected his testimony in the absence of corroborating evidence;
(4) that the ALJ improperly relied on the testimony of the Government's Expert for various reasons and thus made multiple findings which are unsupported by substantial evidence (exceptions 4-6, 8);
(5) that the ALJ's application of the public interest factors is unsupported by substantial evidence and is arbitrary and capricious;
(5) that the ALJ's findings of fact and conclusions of law regarding Respondent's employment of a convicted drug felon are unsupported by substantial evidence;
(6) that the ALJ's findings of fact and conclusions of law regarding Respondent's recordkeeping deficiencies are unsupported by substantial evidence;
(7) that the ALJ's findings of fact and conclusions of law regarding Respondent's audit and inventory deficiencies are unsupported by substantial evidence; and
(8) that his acceptance of responsibility and evidence of remedial measures renders his continued registration consistent with the public interest.
Resp. Exceptions, at 5-26. Notwithstanding the order in which Respondent presents his exceptions, I first address his challenges that the ALJ's findings of various violations are unsupported by substantial evidence.
Challenges to the Substantiality of the Evidence
At the hearing, the Government alleged that Respondent (through its pharmacists) violated its corresponding responsibility under the Controlled Substances Act (CSA) by dispensing prescriptions that lacked a legitimate medical purpose, See 21 CFR 1306.04(a), as well as prescriptions that did not comply with 21 CFR 1306.05(a) because they were missing required information such as addresses and/or were not signed by the prescribing practitioner. As support for the allegations, the Government introduced several hundred controlled substance prescriptions, and elicited the testimony of an Expert witness in pharmacy practice.
Respondent asserts that the Government's Expert was not competent to testify as an Expert because, while she teaches a class in pharmacy law, "on cross-examination . . . she could [not] name the federal and state statutes that govern the standards she applied when rendering her expert opinion." Exceptions, at 13. Respondent contends that "[t]hese are of course the Federal Controlled Substances Act and the Texas Controlled Substances Act found in the
It is true that the Expert stated that "I can't answer that" when asked what the federal and state statutes were called. However, she then testified that "It's just federal law and
Moreover, Respondent does not identify any testimony on the part of the Expert which is inconsistent with the decisional law of either the courts or this Agency. I thus reject Respondent's Exception (Number Five) that the Government's Expert was not qualified to testify as an Expert in pharmacy law and practice. /1/
FOOTNOTE 1 Respondent also contends that the ALJ overlooked the Expert's testimony that: she "is only a fill-in part-time pharmacy at
Exceptions, at 13. Respondent does not, however, cite to where in the transcript the quoted testimony occurred, and while the Expert acknowledged that she works as a relief pharmacist, at no point did she testify that "she has no real applicable experience to assist the ALJ in understanding whether . . . Respondent errors were to such a degree as to support" the ALJ's ultimate conclusion of law. I thus reject this contention. END FOOTNOTE
Respondent also takes exception to the ALJ's reliance on the Expert's testimony when she found that Respondent violated its corresponding responsibility when it failed to verify the validity of 154 prescriptions it dispensed which presented red flags. Exceptions, at 11-12. According to Respondent, the ALJ should have rejected the Expert's testimony because during cross-examination, it was established that she was provided with "photocopies of one side of the prescriptions, instead of both sides which included the data she claimed was missing." Exceptions, at 12. Moreover, Respondent contends that included in the exhibits was a spreadsheet which listed "the prescriptions and a description of what finding its expert was to make regarding each prescription." Id. Respondent then argues that the Expert "testified she never asked for any other information about the prescriptions and simply endorsed the findings provided to her by the Government" while its owner "testified to the resolution of those `red flags' but his testimony was INEXPLICABLY rejected in favor of [that of] the Government's expert." Id.
No citations to the record are provided to support Respondent's assertions that the Expert was provided with only one side of the prescriptions. Indeed, the prescriptions submitted for the record include a photocopy of the front of the prescription and the back on which the dispensing labels were placed. See Tr. 72-73 (Expert's testimony that the second page of the prescription "was provided with all of the prescriptions."). Thus, Respondent's assertion is a blatant mischaracterization of the record.
Nor is there any evidence to support the contention that the Expert "simply endorsed the findings provided to her by the Government" on a spreadsheet. Here again, there is no reference to this in the transcript, and even assuming that there was such a spreadsheet, the Expert fully explained the basis for her conclusions as to why the prescriptions she was asked about raised various red flags. These included that: (1) The patient's address was missing on some 169 prescriptions; (2) 98 prescriptions contained a stamped signature rather than the prescriber's actual signature; (3) the prescribers' DEA numbers were missing or incorrect on 33 prescriptions; (4) the name of the physician on the label was different from the name of the actual prescriber on 157 of the prescriptions; (5) several doctors were prescribing drug cocktails of narcotic and benzodiazepines; (6) a patient was prescribed a narcotic cough syrup in an amount that far exceeded the quantity ordinarily prescribed in the course of legitimate medical treatment; (7) some patients filled prescriptions for duplicative narcotics such as hydrocodone tablets and hydrocodone cough syrup; (8) some patients only filled narcotic prescriptions and not their prescriptions for non-controlled drugs; (9) at least 22 times, Respondent returned the original prescription to a patient notwithstanding that it had filled the controlled substances and typically made no marking as to what it had filled on the returned prescription; (10) Respondent disregard physician's instructions to either fill all the prescriptions or none of them; (11) Respondent filled prescriptions in which the number of refills was left blank; and (12) and in five instances, the prescriptions had not been signed by the prescriber. R.D. at 10-12.
The Government's Expert further testified that it is the usual custom in pharmacy practice for a pharmacist to document his/her attempts to resolve red flags on the face of the prescription. Tr. 33. However, the Expert found no evidence that this occurred with respect to any of these prescriptions. Id.
In his sixth exception, Respondent contends that the ALJ's recommended sanction of revocation is arbitrary and capricious because it is "unsupported by substantial evidence of egregious and intentional diversion." Resp. Exceptions, at 13-14. Putting aside for the moment whether this is so, Respondent correctly notes that this Agency considers the egregiousness and degree of culpability of a Registrant's misconduct in making the public interest determination. However, this Agency has long held that "[j]ust because misconduct is unintentional, innocent, or devoid of improper motivation, [this] does not preclude revocation or denial. Careless or negligent handling of controlled substances creates the opportunity for diversion and [can] justify revocation or denial."
In any event, there is ample evidence of egregious misconduct including evidence that supports the inference that Respondent engaged in the intentional or knowing diversion of controlled substances. Here, the evidence shows that the Government conducted an audit of Respondent's handling of controlled substances which revealed massive shortages of multiple controlled substances. More specifically, the Government's audit, which covered slightly more than a one-year period, showed that Respondent had a shortage of 27,334 milliliters (929 ounces) of promethazine with codeine cough syrup (a schedule V drug); a shortage of 3,445 hydrocodone 10mg tablets (a schedule III drug), and shortages of 43,359 alprazolam 1mg and 7,769 alprazolam 2mg tablets (schedule IV). /2/ Tr. 138-40; GX 13.
FOOTNOTE 2 The Government's evidence also showed that Respondent had overages of 445 tablets of methadone 10mg; 1,508 tablets of hydrocodone 5mg; and 18,721 of hydrocodone 7.5mg. Tr. 138-40; GX 13. END FOOTNOTE
These shortages are extraordinary and support a finding of massive and egregious recordkeeping failures on Respondent's part. This alone supports a finding that Respondent violated the Controlled Substances Act, which requires the maintenance of "complete and accurate" inventories, as well as a "complete and accurate record of each substance . . . received, sold, delivered or otherwise disposed of." 21 U.S.C. 827(a). And while later in his Exceptions, Respondent takes issue with the ALJ's findings regarding the audit, arguing that "[t]he ALJ presumes these audit results are the correct and final tallies," Exceptions, at 24; notably, Respondent put forward no evidence that calls into question the validity of the audit's findings.
Moreover, the quantities involved support the inference that Respondent was engaged in the intentional diversion of controlled substances, given that it has put forward no evidence to provide a plausible explanation for the shortages. /3/ And even if the Government proved no other violations, "the audit results alone are sufficient to satisfy the Government's prima facie burden of establishing that Respondent's registration would be `inconsistent with the public interest.'"
FOOTNOTE 3 Indeed, Respondent notes that the pharmacy has no "history of break-ins or burglaries." Exceptions, at 15 (citing Tr. 157-58). Thus, theft is not a plausible explanation for the massive shortages. END FOOTNOTE
Nor is this the only evidence that supports a finding that Respondent engaged in intentional diversion. Rather, the Government showed that Respondent filled drug cocktails of narcotics such as hydrocodone, benzodiazepines such as alprazolam (Xanax), and Soma (carisoprodol). /4/ Indeed, the Government's evidence showed that with respect to patient B.B., Respondent filled prescriptions she presented on a single day for 90 Norco (hydrocodone/apap) 10/325, 90 Xanax 1mg, 90 Soma 350mg, and four ounces of promethazine with codeine cough syrup. /5/ GX 3, at 19-20. Moreover, the prescription B.B. presented did not include her address, a violation of 21 CFR 1306.05(a). /6/ Id. at 19. B.B. was allowed to take the original prescription, notwithstanding that DEA's regulations require that the prescription be filed and maintained by the pharmacy. 21 CFR 1306.24(d). Finally, the evidence suggests that notwithstanding that B.B. had filled four of the five prescriptions on the form, no marking was made on the returned prescription to indicate that Respondent had dispensed the Norco, Xanax, Soma and promethazine with codeine prescriptions. See Tr. 53-54 (Expert's testimony that where Respondent returned the original prescription after dispensing controlled substances and did not mark through the drug or note the dispensing on the prescription, this "allows the patient to refill the same two medications again at another pharmacy").
FOOTNOTE 4 In decisions published before Respondent dispensed the prescriptions at issue here, DEA had discussed the abuse of drug cocktails which included hydrocodone, alprazolam, and carisoprodol.
FOOTNOTE 5 The prescriptions were written on a single form, and also included a prescription for Lyrica which B.B. did not fill. GX 3, at 19-20. END FOOTNOTE
FOOTNOTE 6 The labels for the dispensed prescriptions list B.B.'s address as being in
There were also multiple other instances in which patients presented prescriptions for a similar drug cocktail of hydrocodone, alprazolam, and carisoprodol, and Respondent filled at least some of the prescriptions. See GX 3, at 43 (Rx for J.F., with no patient address, for 240 Norco 10mg, 60 Xanax 1mg, 120 Soma 350mg); id. at 47 (Rx to J.G., with no patient address, for 60 Vicodin Extra Strength, 60 Xanax 1mg, and 60 Soma); id. at 66-67 (Rx to K.J., with no patient address, for 90 Norco 10mg, 90 Xanax 1mg; 30 Soma; and 4 ounces of Tussionex (hydrocodone) cough syrup).; id. at 76 (Rx to S.J., with no patient address, for 240 Norco 10mg, 90 Xanax 1mg; 120 Soma 350mg, and 120 ml of phenergan with codeine); id. at 78 (Rx to B.M., with no patient address, for 60 hydrocodone 10/325mg, 60 alprazolam 1mg, 60 Soma 350mg, and 4 ounces of promethazine with codeine); id. at 90 (Rx to D.R., with no patient address, for 90 Vicodin 10/500, 60 Xanax 2mg, 60 Soma 350mg, and 4 ounces of Tussionex).
There were also other prescriptions which Respondent filled, notwithstanding that they provided for duplicative therapy of both hydrocodone tablets and narcotic cough syrups, such as Tussionex, which contains hydrocodone; Promethazine with codeine; and Cheratussin AC, a cough medicine which also contains codeine. Here again, the Expert noted that these prescriptions presented red flags which should have been resolved before dispensing the drugs because they contain "the same ingredient or drug." Tr. 44-45. However, there was no evidence that Respondent's pharmacist even attempted to resolve the red flag. Id. at 45. /7/ See also GX 3, at 13 (Tussionex and hydrocodone/apap 10/500); id. at 55 (Tussionex and Vicodin 10/500 along with Xanax); id. at 57 (Tussionex, Norco 10/325, and Xanax); id. at 60-65 (promethazine with codeine, Norco 10/325, and Xanax 2mg); id. at 70 (Tussionex, Norco 10/325, and Xanax); id. at 97 (Vicodin 10/500, Tussionex, and Xanax); id. at 104 (Norco 10/325, Promethazine with codeine, and Xanax 2mg); id. at 107 (Norco 10/325, Promethazine w/codeine, and Xanax).
FOOTNOTE 7 The Expert also explained that "hydrocodone is a codeine derivative." Tr. 44. END FOOTNOTE
As it did with B.B., in several instances Respondent returned the original prescriptions to the patient and did so without making any markings or notes indicating that it had dispensed some of the controlled substances. See Tr. at 53-54. For example, M.F. presented prescriptions (all on the same form) which authorized the dispensing of both 90 alprazolam 1mg and 60 Xanax 1mg (these being the same drug) but with different dosing instructions, as well as 240 Norco 10mg. GX 3, at 41. While Respondent returned the original prescription to M.F., there is no indication on the copy it retained that it had noted on the original that it had dispensed the 90 tablets of alprazolam. Id. at 41-42. See also id. at 13 (no marking on Rx indicating dispensing of hydrocodone and alprazolam); id. at 43 (no marking on Rx indicating dispensing of alprazolam); id. at 70 (no marking on RX indicating dispensing of Tussionex); id. at 90 (no marking on Rx indicating dispensing of Xanax); id. at 104 (no marking on Rx indicating dispensing of alprazolam and promethazine w/codeine). /8/
FOOTNOTE 8 In another instance in which Respondent return the hard copy of a prescription to B.M., there are check marks next to hydrocodone, alprazolam, and promethazine, each of which was dispensed on the date the prescription was issued. GX 3, at 78. As the original prescription is not in the record, it is unknown whether these checkmarks were placed on it. However, none of the three drugs were lined out and there is no other notation advising any subsequent pharmacist to whom B.M. might present the prescription that the drugs had been dispensed by Respondent. Id. END FOOTNOTE
In still another other instance, Respondent dispensed a prescription for a 30-day supply of promethazine with codeine cough syrup. GX 4, at 218-19. According to the Expert, cough syrups are typically dispensed in 10-14 day quantities "for the length of the cough." Tr. 47. Moreover, here again, the prescription did not contain the patient's address and was facially invalid. Id. at 47; GX 4, at 218. Yet there was no evidence that Respondent resolved the red flags raised by the prescription. Tr. 47; GX 4, at 218-19. /9/
FOOTNOTE 9 The prescription also authorized one refill. While there is no evidence that Respondent refilled the prescription (as there is no label corresponding to a refill on the back of the copy of the prescription), as noted above, Respondent had a shortage of more than 27,000 milliliters of promethazine with codeine. END FOOTNOTE
Accordingly, I reject Respondent's assertion that it's "misconduct cannot be characterized as anything more than negligence." Exceptions, at 15. Between the shortages of tens of thousands of dosage units of controlled substances and the numerous dispensing violations, many of which establish that Respondent's pharmacists were engaged in knowing or intentional diversion, the Government has more than met is burden in showing why Respondent's misconduct is egregiousness enough to warrant revocation. /10/
FOOTNOTE 10 So too, I reject Respondent's eighth exception, in which it argues that most of the suspicious prescriptions raised resolvable red flags and "unresolvable red flags were not the type that predominated with the Respondent." Exceptions, at 18. Notably, as the Government's Expert testified, while some of the red flags were resolvable, there was no evidence that Respondent's pharmacists ever attempted to do so. See generally Tr. 30-69, 75, 82-83, 85. As for its contention that prescriptions which raised "unresolvable red flags" did not "predominate[]" at Respondent, suffice it to say that there were more than enough of them to conclude that Respondent knowingly diverted controlled substances.
In this exception, Respondent also contends that even the Government's Expert acknowledged that sometimes patients may have been given drug samples and thus may not need to fill all of their prescriptions at that time, as well as that some lower income "patients do not have the funds to get both non-controlled and controlled substances filled at the same time." Exceptions, at 18. Putting aside that most of the controlled substances at issue here are available as generic drugs, the fact that a patient may not have sufficient funds to fill all of his/her prescriptions does not excuse Respondent's practice of returning the original prescription form to the patient and then failing to mark on the form what drugs have been dispensed, thus allowing the patient to present the prescription to another pharmacy for filling. END FOOTNOTE
Respondent further argues that because it was not subject to an immediate suspension of its registration and has been permitted to continue to operate since the execution of the Administrative Inspection Warrant in
FOOTNOTE 11 In his seventh exception, Respondent contends that the ALJ's analysis was arbitrary and capricious because she failed to consider factor one--the recommendation of the state licensing board--and factor three--the registrant's conviction record of controlled substances offense. Exceptions, at 16. It is true that the ALJ made no findings with respect to either factor. See R.D. at 21-31.
For purposes of this review, I have assumed that Respondent holds an unrestricted state license. There is, however, no recommendation from the
As for factor three, I find that there is no evidence that either Respondent, or its principal, has been convicted of an offense related to the manufacture, distribution or dispensing of controlled substances. There are, however, a number of reasons why a person (whether a corporate entity or natural person) may never be convicted of an offense falling under this factor, let alone be prosecuted for one. Thus, "the absence of such a conviction is of considerably less consequence in the public interest inquiry" and is not dispositive.
I therefore reject Respondent's exception. END FOOTNOTE
Exceptions Two and Three--The ALJ's Failure To Rule on the Government's Motion in Limine and Rejection of Respondent's Testimony Regarding Remedial Measures
According to Respondent, in its Prehearing Statement and Supplemental Prehearing Statement, it provided notice of its intent to introduce evidence of its remedial measures. Exceptions, at 5-6. In response, the Government filed a Motion in Limine to bar the evidence on the ground that because Respondent had provided no notice of its intent to accept responsibility for its misconduct, this evidence was irrelevant. Id. at 6. Thereafter, Respondent filed a "Motion for Leave to File Second Supplemental Prehearing Statement," which included a section in which Respondent provided notice to the Government "admit[ting] that the Government . . . has met its burden and shown by a preponderance of evidence that Respondent has committed acts inconsistent with the public interest." Response to Gov. Motion in Limine and Motion for Leave to File Resp.'s Second Supp. Pre-hearing Statement, at 2. /12/
FOOTNOTE 12 In this pleading, Respondent provided notice that it intended to withdraw two witnesses it had previously identified as J.A.C. and L.D.A. Resp. to Gov. Mot. in Limine and Motion for Leave to File Resp.'s Second Supp. Prehearing Statement, at 5. However, Respondent reiterated its earlier notice that it intended to call Respondent's owner and pharmacist-in-charge, a second pharmacist-employee, and a pharmacy technicians, maintaining that "their testimony is relevant and material to show the Respondent will not engage in future misconduct." Id. END FOOTNOTE
According to Respondent, "the ALJ never ruled on the Government's Motion in Limine and never gave [it, i.e., Respondent] permission to include in its Prehearing Exhibits any evidence related to the remedial measures it had taken since being served with the" Administrative Inspection Warrant. Exceptions, at 6. Respondent maintains that had such permission been granted, it would have put forward such evidence as its policies and procedures, continuing education certificates, evidence of criminal background checks conducted on its employees, and its operations manual which includes training of its pharmacists and pharmacy technicians in identifying and resolving red flags. Id. at 6-7. However, it then asserts that because the ALJ "had not granted [it] permission to supplement its [p]rehearing [e]xhibits . . . it was consigned to discussing these remedial measure through the sworn testimony of" its owner. Id. Continuing, Respondent asserts that because the ALJ ultimately gave little weight to its owner's testimony, the ALJ "put Respondent in an unwinnable situation." Id. at 9.
While it is true that the ALJ did not rule on either the Government's motion in limine or Respondent's motion to file a second supplemental pre-hearing statement prior to the hearing, I find Respondent's argument entirely unpersuasive for several reasons. First, Respondent ignores that prior to the ALJ's ruling, it filed a Response to the Government's Motion in Limine in which it expressly stated that it "does not intend to introduce any other documentary evidence other than that made a part of his" Supplemental Pre-Hearing Statement. Response to Gov't Mot. in Limine, at 5. However, in its Supplemental Pre-Hearing Statement, Respondent had proposed to introduce only three exhibits: (1) A criminal background check of its employee A.G. from 2008; (2) a copy of the
Second, while the ALJ did not rule on either motion prior to the hearing, her Order made clear that she would "decide on the admissibility of each piece of evidence as it is offered." Order Deferring Judgment on Govt. Mot. in Limine and Resp.'s Mot. to File Second Supp. Prehearing Statement, at 2. However, at the hearing, Respondent did not seek to introduce any documentary evidence other than the two exhibits identified above.
Third, notwithstanding that in its Pre-Hearing Statement, Respondent identified two witnesses (A.C., a pharmacist, and R.G., a pharmacy tech) in addition to its owner/pharmacist-in-charge, and proffered that these witnesses would testify as to various procedures being employed by the pharmacy to ensure compliance with federal law, See Resp. Pre-Hrng. Statement at 19-21, Respondent did not call either person to testify. Notably, in its Response to the Government's Motion in Limine, Respondent continued to identify these two witnesses (in addition to its owner) as offering "testimony [that] is relevant and material to show the Respondent will not engage in future misconduct." Resp. to Govt's Motion in Limine, at 5. Thus, even if the ALJ's deferral of her ruling created some uncertainty as to whether the testimony of these witnesses would be admissible, Respondent's failure to call these witnesses constitutes a waiver of the issue.
Nor do I find merit in Respondent's contention that the ALJ imposed on it an undefined and vague standard of proof when she rejected its owner's testimony as to several assertions regarding remedial measures it had undertaken in the absence of corroborating evidence. Indeed, even were I to find some merit to this contention, it would not change my ultimate decision, because Respondent ignores that the ALJ also questioned the credibility of its owner's testimony regarding his acceptance of responsibility. Moreover, my own review of the record finds that Respondent's testimony as to his acceptance of responsibility is properly described as double talk, because while he initially testified that he accepted responsibility for his misconduct, on further questioning he denied having ever diverted drugs. So too, while the Government put forward Expert testimony that there were numerous prescriptions which raised red flags and which should not have been filled, either because Respondent never attempted to resolve the red flag (if it was resolvable) or the red flags were not resolvable,
While the ALJ noted that on direct examination,
FOOTNOTE 13 In his ninth exception, Respondent challenges the ALJ's finding that it violated DEA regulations because it employed a person with a felony drug conviction as its delivery driver. Exceptions, at 19-23. While Respondent does not dispute that this was a violation of a DEA regulation, it argues that the ALJ acted arbitrarily and capriciously because she "placed great emphasis" on the violation, which it maintains was unintentional. Id. at 19-20. It further maintains that the former employee "lied during his testimony and stated that he informed [Respondent's owner] at the time he was hired as a delivery driver in 2008 that he had a felony conviction for a drug offense." Id. at 20.
To the extent the ALJ found credible the former employee's testimony that he had told Respondent's owner about his felony drug conviction at the time of his employment interview, See R.D. at 29, I adopt her finding. Indeed, the evidence showed that following the interview, Respondent directed the employee to obtain his criminal history. Thus, there was obviously some discussion between the employee and Respondent's owner as to the former's criminal history.
Most significantly, the report which was provided by the
Moreover, a DEA Investigator credibly testified that she had told
As another example of his inconsistent testimony regarding his acceptance of responsibility, the ALJ relied on
As for
When asked if he had disobeyed the prescribing physician's instructions,
FOOTNOTE 14 The Government's Expert testified that a red flag is raised when a customer presents a prescription for both controlled and non-controlled drugs but requests that the pharmacy fill only the controlled substances. Tr. 32-33. She further testified that the resolution of the red flag would be documented "directly on the hard copy prescription and possibly in the patient's profile." Id. at 33. END FOOTNOTE
When the Government again asked
Well, he said one of the problems he having [sic] is he put them in to see if they'll get them, but if they don't have insurance, than they should get what they want. I told him personally, I said, [q]uit having your employee stamp the prescriptions; it's affecting the customers. He said, [t]hat's the procedure we do here, and they're supposed to fill the prescriptions at that doctor's pharmacy, and I don't know why they brought them out. That's what he told me. And he make me have some of them come back with the prescriptions.
Tr. 210.
Noting that Respondent failed to produce any evidence to support
Moreover, while
Well, that the cocktail medication that you fill in the pharmacy has to be for good legitimate reasons, and diversion is costing the country and everybody a lot of problems. There's a lot of drug addicts out there, but I never do diversion at
But diversion is when multiple patients . . . bring cocktail medication, like controlled substances, Xanax, Soma, hydrocodone, all in one prescription, scripts, with the intent to--like in this case, if Dr. [L] give me a prescription with all the same patients have the same prescriptions, and they brought it to the pharmacy, and we were filling it, we made a lot of calls to him, especially those that work for him, all they say, That's what the doctor wants, and that's how the doctor write his prescriptions.
Tr. 197 (emphasis added). Unexplained by
This view, however, has been squarely rejected by both the federal courts and this Agency. See
Moreover, when asked whether there were "any specific prescriptions" which the Government's Expert opined should not have been filled, which he "agree[d] should not have been filled," Tr. 219, Respondent again offered testimony inconsistent with his earlier statement that he accepted responsibility. He testified that:
There's no prescription that she said that I shouldn't have filled that I looked at it from her point of view. But most of the things she said was factual. But not filling the prescriptions--I know the prescription; I know the doctors; I know the patients more than she does, so she was looking at it from somebody who do relief. I don't relieve. I'm a regular pharmacist on this station, so I know most of my customers.
Tr. 219-20 (emphasis added).
However, as explained above, the Expert identified twelve different issues with the prescriptions Respondent filled. These include, inter alia, that various prescriptions were missing the patient's address; some prescriptions bore a stamped signature rather than the prescriber's actual signature; some prescriptions were entirely missing the prescriber's signature; some prescriptions were missing the prescriber's DEA number; some labels bore a different prescriber name than that of the actual prescriber; some doctors were prescribing drug cocktails of narcotics, benzodiazepines, and carisoprodol; some patients were filling prescriptions for duplicative narcotics such as hydrocodone tablets and hydrocodone cough syrups; and a prescription for a narcotic cough syrup authorized the dispensing of a quantity of the drug that far exceeded the quantity ordinarily prescribed in the course of legitimate medical treatment. Finally, Respondent filled controlled substance prescriptions for multiple patients and then returned the original prescriptions to the patients without making any marking on the original prescriptions that a controlled substance had been dispensed, thus allowing the patients to obtain the same drug at a second pharmacy. /15/
FOOTNOTE 15 In his tenth exception, Respondent maintains that his recordkeeping deficiencies "were situational and the result of the turbulent and catastrophic demise and ultimate death of
Respondent also argues that his recordkeeping errors are not sufficiently egregious to warrant revocation. Id. (citing
As for the first contention, in Terese, the Government put forward no evidence that it had done an audit and found that the pharmacy could not account for the controlled substances it handled, and the three recordkeeping violations that were proved were comparatively minor and corrected as soon as they were brought to the attention of the pharmacist. See 76 FR at 46848. So too, while in
Yet Respondent asserted that none of these dispensings was improper. Moreover, as the ALJ found, Respondent entirely failed to address the shortages found during the DEA audit.
I thus conclude that Respondent has not accepted responsibility for its misconduct. As such there is no need to address whether the remedial measures he claims to have instituted are adequate to protect the public interest. Medicine Shoppe--Jonesborough, 73 FR 363, 387 (2008). Indeed, in light of
Finally, in its twelfth exception, Respondent contends that the ALJ's recommended order of revocation is arbitrary and capricious because:
[c]urrent DEA precedent sets up a no win scenario for any registrant that has in its history one or two violations of DEA Regulations. That is, DEA precedent holds that unless the Respondent accepted responsibility for its "misconduct." Even if there is no intentional diversion by the Respondent. Consequently, the Respondent's due process rights have been denied since there is no meaningful and fair due process proceeding available.
Exceptions, at 25-26.
As found above, Respondent is in no position to argue that it has been placed in a "no win" scenario either because it has committed only one or two violations of DEA regulations or has not intentionally diverted controlled substances. Rather, the record is replete with various violations of the CSA, including violations which support a finding that it intentionally diverted drugs. So too, the record establishes that it cannot account for tens of thousands of dosage units. Thus, to the extent Respondent is in a "no win scenario," this is entirely of its own making.
As for its opaque suggestion that it has been denied a fair hearing because the Agency's precedent required it to acknowledge its misconduct, this is an argument which, while not framed in constitutional terms, has previously been tried and rejected. As the Tenth Circuit held in rejecting a challenge to the Agency's rule:
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 Deputy Administrator to consider whether that doctor will change his or her behavior in the future. And that consideration is vital to whether continued registration is in the public interest.
MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011) (citing Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005)); see also Hoxie, 419 F.3d at 483 ("The DEA properly considers the candor of the physician . . . and admitting fault [to be] important factors in determining whether the physician's registration should be revoked."). I therefore also reject this exception.
Conclusion
Finding no merit in any of Respondent's Exceptions, I reject its contention that I should either reopen the hearing or impose a lesser sanction such as probation with monitoring. Because I find that substantial evidence supports the conclusion that Respondent's registration is "inconsistent with the public interest," 21 U.S.C. 824(a)(4), I adopt the ALJ's recommendation that I revoke its registration.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a)(4), as well as 28 CFR 0.100(b) and 0.104, I order that DEA Certificate of Registration BT8599891, issued to The
Dated:
Deputy Administrator.
RECOMMENDED FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE
I. INTRODUCTION
Gail A. Randall, Administrative Law Judge. This proceeding is an adjudication governed by the Administrative Procedure Act, 5 U.S.C. SUBSEC
I. PROCEDURAL BACKGROUND
On
A hearing was held in
II. ISSUE
The issue in this proceeding is whether or not the record as a whole establishes by a preponderance of the evidence that the
III. FINDINGS OF FACT
I find, by a preponderance of the evidence, the following facts:
A. Stipulated Facts
The parties have stipulated to the following fact: Respondent is registered with DEA as a retail pharmacy authorized to handle controlled substances in Schedules II-V under DEA COR (Certificate of Registration) number BT8599891 at
At the hearing, the parties also stipulated to the following fact: Respondent, The
B. The Investigation
Diversion Investigator ("DI") Ramirez has been a Diversion Investigator for DEA for approximately four-and-one-half years. [Tr. 102]. She began her investigation of the Respondent after she learned that patients of a specific doctor accused of issuing illegitimate prescriptions were filling those prescriptions at the Respondent pharmacy. [Tr. 103]. The investigation was not started in response to any complaints about the Respondent's dispensing practices. [Tr. 157].
On
FOOTNOTE 16 DEA had difficulties downloading data from the Respondent's computer. DI Ramirez testified that this was why information from the computer was not utilized or made part of the record in this proceeding. [Tr. 166]. END FOOTNOTE
The record contains no evidence that the Respondent pharmacy, any pharmacist or pharmacy technician who has worked for the Respondent has ever been charged with any crime by a state or federal law enforcement agency. /17/ [Tr. 183]. Further, the Respondent has not had any suspicious reports regarding break-ins or burglaries. [Tr. 157-58].
FOOTNOTE 17 However, the Respondent hired and fired a delivery driver with a felony conviction related to the handling of controlled substances. This will be discussed infra. END FOOTNOTE
C. Red Flags
Dr.
As a professor,
Dr. Witte explained the method a pharmacist would use to dispense a controlled substance. First, the pharmacist would look at the prescription to determine if it is facially valid. Specifically, the pharmacist would ensure the prescription contains the patient's name and address. Next, she would look at the bottom of the prescription to verify that a physician has manually signed the prescription, and has entered the date of the prescription and a DEA number. Lastly, she would look at the body of the prescription for the drug name, the strength or dose of the drug, the quantity to dispense, and the directions for use. [Tr. 30].
Dr. Witte confirmed that a pharmacist has a corresponding responsibility to ensure that a prescription for a controlled substance is issued for a legitimate medical purpose. [Tr. 31]. To determine this purpose, the pharmacist talks to the patient and reviews the patient's prescription profile. [Tr. 31]. The pharmacist looks to determine if the patient has used the controlled substance in the past, whether the patient is obtaining the drug from multiple physicians, and whether the prescription is tailored to the patient's needs. [Tr. 31-32].
The pharmacist may encounter "red flags" when presented with the prescription.
Dr. Witte reviewed several hundred prescriptions dispensed at the Respondent. [Tr. 36; Govt Exhs. 3, 4, 8, 9]. These prescriptions were for both controlled and noncontrolled substances. [Tr. 36]. In general,
Dr. Witte also explained that a "drug cocktail" is usually two or more controlled substances on a prescription that are usually highly abused drugs sought by drug-seeking individuals. [Tr. 39]. A prescription containing a "drug cocktail" would be a potential "red flag" for diversion. [Tr. 39]. In one instance, customer C.H. received a "drug cocktail" of Tussionex, hydrocodone, and alprazolam. The prescription also contained non-controlled substances, which the customer declined to get filled. The non-controlled substances were "maintenance meds" which are "used to treat chronic health conditions" and would be needed "right away." [Tr. 60; Gov't Exh. 3 at 57-58].
"Pattern prescribing" occurs when a physician prescribes the same drug and the same dosage to every patient the physician sees. This is another "red flag," for the prescription should be tailored to each patient's individual needs based on their chronic conditions. [Tr. 39-40]. In reviewing prescriptions from the Respondent,
FOOTNOTE 18 Such prescriptions would be for a "drug cocktail." [Tr. 40-41; Gov't Exh. 9 at 66]. END FOOTNOTE
Another of
Dr. Edwards also prescribed two medications to patient D.K., hydrocodone, a Schedule III controlled substance, and Skelaxin, a non-controlled drug. Both of these drugs are designed to treat the same condition in the same manner. [Tr. 45-46; Gov't Exh. 8 at 16].
Reviewing another prescription,
Reviewing another prescription,
In her review of prescriptions,
FOOTNOTE 19 However, on cross-examination, DI Ramirez credibly testified that she had not investigated whether or not these prescriptions resulted in duplicate filling of controlled substances. [Tr. 165]. END FOOTNOTE
FOOTNOTE 20 Dr. Witte also credibly testified that on one prescription an annotation stating "Pt took hard copy back" meant that the patient took back the hard copy of the prescription. [Gov't Exh. 3 at 70]. However, since the comment was not initialed,
On a prescription dated
Dr. Witte reviewed another prescription dated
Dr. Witte also reviewed two prescriptions written for the same patient. One was dated
Lastly,
Overall,
D. Prescription Issues
After reviewing the prescriptions found in Government Exhibit 3, DI Ramirez credibly testified that she found six instances when the controlled substances were filled and the non-controlled substances were not filled. [Tr. 111].
Further, DI Ramirez found five examples in Government Exhibit 3 of prescriptions that did not contain a signature from the prescribing practitioner. [Tr. 114]. DI Ramirez also found approximately 44 prescriptions in Government Exhibit 3 that failed to contain a patient address. [Tr. 115-16]. She also found approximately 11 prescriptions in Government Exhibit 3 that had a missing or incorrect DEA number. [Tr. 116]. DI Ramirez also found 4 prescriptions where the name on the front of the prescription for controlled substances did not match the name on the dispensing label. [Tr. 117-19; see also Tr. 121-22, Gov't Exh. 4 at 192-93].
After reviewing Government Exhibit 4, DI Ramirez found approximately 125 prescriptions for controlled substances without a patient address. [Tr. 124]. This exhibit also contained approximately 157 prescription labels for controlled substances that identified the wrong prescribing practitioner. [Tr. 116-17, 124-25; Gov't Exhs. 3, 4]. There were also 22 prescriptions for controlled substances that either had a missing or incorrect prescriber DEA number. [Tr. 125].
DI Ramirez also credibly testified that 98 prescriptions purportedly from a Dr.
On at least 22 occasions, the Respondent's personnel filled controlled substance prescriptions and then returned the original paper prescriptions to the customer. [Tr. 109-10; Gov't Exh. 3 at 5, 11, 13, 19, 28, 35, 37, 39, 41, 43, 45, 47, 53, 70, 75, 76, 78, 82, 84, 90, 92, and 104].
DI Ramirez found several instances in which controlled substances were provided to customers without any valid prescription whatsoever for that individual. For example, Respondent's personnel distributed alprazolam to customer T.J., but the only record attached to the prescription label was a prescription for hydrocodone issued to customer R.S. [Tr. 117; Gov't Exh. 3 at 99-100; see also Tr. 118-19, 121-22; Gov't Exh. 3 at 103, 111; Tr. 121-22; Gov't Exh. 4 at 192-93].
DI Ramirez did not discover any evidence of any outright forged or fraudulent prescriptions. [Tr. 168]. She also did not identify any clientele that were coming from out of state. [Tr. 168].
E. The Audit
On the date that the Administrative Inspection Warrant was served,
FOOTNOTE 21 DI Ramirez confirmed that an annual inventory was conducted at the Respondent pharmacy. When DI Ramirez executed the Administrative Inspection Warrant,
F. Recordkeeping Deficiencies
When DI Ramirez reviewed the Respondent's receiving invoices, she noted that the dates of the receipt of the controlled substances and verification of the quantities received were missing. [Tr. 146; Gov't Exh. 5]. Of these eight invoices, there were 19 entries for controlled substances, and the required annotations were lacking. [Tr. 146; Gov't Exh. 5]. This pattern was repeated for other invoices. [Tr. 148-51; Gov't Exh. 6, 7]. Also, in looking at the DEA 222 forms, which are used to record the receipt of Schedules I and II controlled substances, DI Ramirez also noted that the forms lack what was received, the quantity received, and the date that the controlled substances were received by the pharmacy. [Tr. 152; Gov't Exh. 12].
G. Hiring of a Prior Felon
A.G. worked for the Respondent from 2008 to September of 2013. [Tr. 14; Gov't Exh. 11, 14]. He worked as a delivery driver, and he delivered controlled substances as part of his work responsibilities. [Tr. 15, 127-28].
In 1989, A.G. was convicted of distribution of crack cocaine. [Tr. 15-16]. This was a felony conviction. [Tr. 16, 1321-33; Gov't Exh. 10].
Mr. Lekwa asked A.G. to retrieve a document showing his criminal conviction, and A.G. went to the
At the hearing,
In July of 2013, DI Ramirez told
H. Mr. Lekwa
Mr. Lekwa, the pharmacist in charge and the owner of the Respondent, graduated from
Mr. Lekwa hired a permanent pharmacist, rather than using relief pharmacists like in the past. [Tr. 189]. He also trains the pharmacy technicians to ensure they follow the DEA requirements. [Tr. 189]. Specifically, he requires the technicians to put the address and phone number on the front of a prescription prior to filling it. [Tr. 190]. As for prescriptions for "drug cocktails,"
Mr. Lekwa also trained his personnel who sign for the receipt of controlled substances to fill out the paperwork completely at the time the controlled substances are actually received, rather than to wait until the end of the month to reconcile the receipts. [Tr. 190].
Mr. Lekwa has served many of his customers for the past ten-plus years. [Tr. 193]. Most of
Also,
Mr. Lekwa has never been the subject of an investigation or disciplinary action by any state board. [Tr. 182].
Mr. Lekwa acknowledged that mistakes were made at the Respondent pharmacy. [Tr. 184, 220, 223]. Specifically, after he understood the true nature of A.G.'s criminal record, he fired him. [Tr. 185-86]. He also instructed his personnel to make sure the patient's address and phone number are on the front of the prescription. [Tr. 220].
FOOTNOTE 22 The Government made the point that
IV. CONCLUSIONS OF LAW AND DISCUSSION
A. Position of the Parties
1. The Government's Position
The Government seeks revocation of the Respondent's Certificate of Registration because to continue its registration would be against the public interest. [Gov't Br. at 30]. Specifically, the Government argues that DEA is bound by agency precedent to revoke Respondent's DEA registration. Citing to DEA final orders, the Government asserts that the Respondent violated state and Federal law by failing to exercise its corresponding responsibility to ensure that prescriptions for controlled substances are issued for a legitimate medical purpose, as required by the Controlled Substances Act and the implemented regulations. [Gov't Br. at 13]. The Government further argued that the Respondent repeatedly filled facially invalid prescriptions, failed to maintain adequate records, and failed to keep an accurate inventory of the controlled substances it purchased. [Gov't Br. at 13-14]. Lastly, the Respondent violated Federal law by employing a convicted drug felon in a position where the felon had access to controlled substances. [Gov't Br. at 14].
Next, the Government asserts that the Respondent dispensed controlled substances despite the unresolved red flags. [Gov't Br. at 14]. Specifically, the Government argues that the Respondent's personnel distributed controlled substances pursuant to prescriptions that contained one or more unresolved "red flags."
Additionally, the Government argues that the Respondent's failure to keep accurate records violated Federal statutory and regulatory provisions that require an accurate inventory of controlled substances. [Gov't Br. at 16]. The inadequacy of the Respondent's system is evidenced by the audit conducted by the DEA resulting in large shortages and overages. [Gov't Br. at 17]. The Respondent's records were also deficient because
The Government also argues that the Respondent violated DEA regulations by hiring A.G., a felon convicted of a drug-related crime, and by failing to do a proper and thorough background check. [Gov't Br. at 19]. Also, the Respondent failed to prove that it accepted responsibility for its actions or to demonstrate that it will not engage in future misconduct. Further, a Respondent's lack of candor and inconsistent explanations may serve as a basis for denial of a registration. [Gov't Br. at 20-24].
The Government asserts that the Respondent's practices significantly increased the risk of diversion. [Gov't Br. at 24]. Further, the Respondent has provided insufficient evidence of facts that demonstrate mitigating circumstances. [Gov't Br. at 25].
Lastly, the Government argues that
In light of all of the above, the Government requests that I recommend that the Respondent's Certificate of Registration should be revoked. [Gov't Br. at 30].
2. The Respondent's Position
The Respondent asserts that its Certificate of Registration should not be revoked and any pending applications for renewal should be granted. [Resp't Br. at 23]. First, Respondent asserts that it holds a valid license in the
As for factor three, the Respondent states that the record does not contain evidence that the Respondent, its owner, or any pharmacist or key employee of the pharmacy has been convicted of a crime related to the manufacture, distribution, or dispensing of controlled substances. [Resp't Br. at 7].
As for factor two, the Respondent asserts that neither the Respondent,
As for factor four, the Respondent admitted that the Government has met its burden of proof and has shown by a preponderance of the evidence that the Respondent has committed acts inconsistent with the public interest. [Resp't Br. at 8].
The Respondent then analyzes the difference between resolvable and unresolvable red flags. As for resolvable red flags, the Respondent asserts that such indicators may be resolved through discussions with patients and prescribers, as well as through the pharmacist's own knowledge of the patient's past history as a customer. [Resp't Br. at 10]. Unresolvable red flags are situations in which "no amount of information gathered or verification made by the pharmacist could foresee any explanation that would satisfy a Pharmacist's corresponding responsibility under federal law not to fill the scripts." [Resp't Br. at 10]. He concludes that "[r]esolvable red flags, if resolved, are lawful prescriptions. Unresolvable red flags are illegal and substantial evidence of drug diversion." [Resp't Br. at 11]. The "type of red flags that support a finding that Respondent's pharmacists repeatedly and intentionally dispensed prescriptions are those where they had reason to know that the prescriptions lacked a legitimate medical purpose and were issued outside of the usual course of professional practice." [Resp't Br. at 12].
The Respondent asserts that now there are policies and procedures in place at Respondent to correct missing or incomplete data on prescriptions. [Resp't Br. at 12]. For example, the Respondent has hired another pharmacist to supervise employees in
Yet,
The Respondent cites DEA precedent for the proposition that the DEA "has declined to revoke a registration where non-egregious recordkeeping errors were acknowledged by the pharmacy PIC and remedied promptly."
FOOTNOTE 23 The Respondent asserts that
Next, the Respondent argues that its "acceptance of responsibility was . . . significant and deserving of great weight and consideration since it occurred before the hearing and presentation of the evidence." [Resp't Br. at 17]. It has presented sufficient mitigating evidence to assure the Administrator that it can be entrusted with the responsibility of a continued registration, the Respondent asserts. [Resp't Br. at 17-18]. According to Respondent, "[t]he evidence shows that the Respondent's continued registration would not threaten the public safety." [Resp't Br. at 20]. /24/ In conclusion, the Respondent asserts that although the Government has met its burden of proof, "the evidence further shows that Respondent will not commit future acts of misconduct making its continued registration consistent with the public interest." [Resp't Br. at 23].
FOOTNOTE 24 The Respondent rebuts the Government's expert witness by asserting that her professional opinion was based upon incomplete information. [Resp't Br. at 20]. END FOOTNOTE
B. Statement of Law and Discussion
Pursuant to 21 U.S.C.
FOOTNOTE 25 The Deputy Administrator has the authority to make such determinations pursuant to 28 C.F.R. SUBSEC 0.100(b) and 0.104 (2009). END FOOTNOTE
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
21 U.S.C.
Factors two and four are relevant.
Further, in an action to revoke a registrant's certificate, the DEA has the burden of proving that the requirements for revocation are satisfied. 21 C.F.R.
1. Prescriptions
Pursuant to the Controlled Substances Act and its implementing regulations, a pharmacy, a prescription-dispensing registrant, has a corresponding responsibility, along with the physician, a prescription-issuing registrant, to ensure the prescription is valid. 21 C.F.R.
The applicable regulations state that the test for the proper prescribing and dispensing of controlled substances is as follows:
A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.
21 C.F.R.
DEA has consistently interpreted the prescription provision as prohibiting a pharmacist from filling a prescription for a controlled substance when he either "knows or has reason to know that the prescription was not written for a legitimate medical purpose."
Yet, when an attempted transaction would give rise to suspicion in a "reasonable professional," there is a duty to "question the prescription[]." Bertolino, 55 Fed. Reg. at 4730. The "reasonable professional" has been further developed into the "reasonable pharmacist" standard.
In support of its allegation that the Respondent has violated its corresponding responsibilities, the Government has introduced evidence that the Respondent pharmacy: (1) dispensed controlled substances without a prescription; (2) dispensed controlled substances when the prescription was "signed" using a signature stamp; (3) allowed customers to retain the original controlled substances prescriptions; (4) dispensed controlled substances when the prescription contained irregular dosing instructions; (5) dispensed controlled substances when the prescriptions revealed "pattern prescribing" by the physician; (6) dispensed controlled substances when the prescription lacked a patient's address and the physician's DEA registration number; (7) placed a prescription label on the back of the prescription with a physician's name that is not consistent with the name on the front of the prescription; (8) accepted prescriptions where the refill line was blank; and (9) allowed patients with prescriptions containing both controlled and non-controlled substances to fill only the controlled substances' portion of the prescription.
Further, the Respondent also violated state law, which prohibits dispensing controlled substances pursuant to prescriptions that lack a correct DEA registration number, patient address, or prescriber's signature. See Tex. Health & Safety Code Ann.
FOOTNOTE 26 These statutory and regulatory requirements provide in relevant part that a prescription for a controlled substance must show the quantity of the substance prescribed, the date of the issue, the name, address, and date of birth or age of the patient, the name and strength of the controlled substance prescribed, the directions for use, the name, address, DEA number, and telephone number of the practitioner at the practitioner's usual place of business, and, if the prescription is handwritten, the signature of the prescribing practitioner. Tex. Health & Safety Code Ann.
The record contains no evidence that these "red flags" were resolved prior to the dispensing of the controlled substances. A preponderance of the evidence proves that the Respondent violated its corresponding responsibility in the way it dispensed controlled substances pursuant to these defective prescriptions.
2. Recordkeeping Deficiencies
Further, "[r]ecordkeeping is one of the CSA's central features," and "a registrant's accurate and diligent adherence to this obligation is absolutely essential to protect against the diversion of controlled substances."
Here, the Respondent's recordkeeping was deficient. The Government presented evidence that the Respondent's invoices were incomplete, and the DEA 222 forms lacked a notation of what was received, the quantity of the controlled substance received, and the date the controlled substance was received by the pharmacy. 21 C.F.R.
FOOTNOTE 27 This regulation provides in relevant part that the pharmacy, as the purchaser, must record on the DEA Form 222 the number of commercial containers furnished on each item, and the dates on which the containers were received. END FOOTNOTE
DEA, however, attempted to conduct an audit of the Respondent. The results were telling, for the Respondent was unable to accurately account for 27,344 ml. of Promethazone with codeine (or 929 ounces), 1,508 Hydrocodone 5 mg. tablets, 18,721 Hydrocodone 7.5 mg. tablets, 3,445 Hydrocodone 10 mg. tablets, 43,359 Alprazalam 1 mg. tablets, and 7,769 Alprazalam 2 mg. tablets. This inability to account for this significant number of dosage units creates a grave risk of diversion.
3. Hiring of a Convicted Felon
DEA regulations provide that a registrant "shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances." 21 C.F.R.
Here, the Respondent hired an individual who had a felony conviction for distributing crack cocaine to deliver prescribed drugs, to include controlled substances. Prior to employing this individual,
FOOTNOTE 28 There was testimony challenging whether the applicant told
Thus, the burden of production now shifts to the Respondent to demonstrate that it takes full responsibility for its unlawful conduct and that it has put in place remedial measures so that such violations will not happen in the future.
On direct examination,
Next,
As for remedial measures, the record contains unrefuted evidence that
Next,
V. CONCLUSION AND RECOMMENDATION
Given the extent of the misconduct and the unreliability of the testimony concerning the acceptance of responsibility, I conclude that the Respondent's registration should be revoked. Accordingly, that is my recommendation based on this record.
Dated:
Gail A. Randall
Administrative Law Judge
[FR Doc. 2014-23473 Filed 10-1-14;
BILLING CODE 4410-09-P
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