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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices findings of fact, as modified, conclusions of law and recommended sanction with minor modifications, where noted herein.C

DEPARTMENT OF JUSTICE
Drug Enforcement Administration Docket No. 1841

Pharmacy 4 Less; Decision and Order On July 5, 2018, a former Assistant Administrator of the Drug Enforcement Administration hereinafter, DEA or Government, issued an Order to Show Cause hereinafter, OSC to Pharmacy 4
Less, hereinafter, Respondent of Altamonte Springs, Florida.
Administrative Law Judge Exhibit hereinafter, ALJ Ex. 1, OSC at 1. The OSC proposed to revoke its DEA
Certificate of Registration hereinafter, COR No. FP5459082, and deny any pending applications for renewal or modification of such registration pursuant to 21 U.S.C. 823f and 824a4 for the reason that Respondents continued registration is inconsistent with the public interest.
Id.
In response to the OSC, Respondent timely requested a hearing before an Administrative Law Judge. ALJ Ex. 2.
The hearing in this matter was held in Orlando, Florida, on November 57, 2018, and continued in Arlington, Virginia, on February 25, 2019. On May 22, 2019, Administrative Law Judge Mark M. Dowd hereinafter, the ALJ
issued the Recommended Rulings, Findings of Fact, Conclusions of Law and Decision hereinafter, Recommended Decision or RD, and on June 11, 2019, the Government timely filed exceptions hereinafter, Govt Exceptions to the Recommended Decision. On June 23, 2019, the Respondent filed what it styled as a response to the Governments Exceptions hereinafter, Resp Exceptions.A According to the ALJ, the Respondent Pharmacy did not request an extension of time to file exceptions, nor did it request an extension of time to file a response to the Governments Exceptions pursuant to 21 CFR
1316.66c. See ALJ Transmittal Letter dated June 25, 2019. Even though Respondent did none of those things, I
have decided to address the Exceptions filed by Respondent as part of my review of the record.B Having reviewed the entire record, I find the Respondents Exceptions are without merit and I adopt the ALJs rulings, A Despite the title, Respondents filing appears to assert its own Exceptions to the RD rather than respond to the Governments Exceptions.
B My decision to consider the Respondents Exceptions is based on the particular circumstances of this case, including but not limited to, the withdrawal of Respondents counsel after the conclusion of the hearing.

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Order Pursuant to 28 CFR 0.100b and the authority vested in me by 21 U.S.C.
824a, I hereby revoke DEA Certificate of Registration No. FP5459082 issued to Pharmacy 4 Less. Further, pursuant to 28 CFR 0.100b and the authority vested in me by 21 U.S.C. 823f, I
hereby deny the pending application for renewal or modification of this registration by Pharmacy 4 Less in Florida. This Order is effective November 1, 2021.
Anne Milgram, Administrator.

The Governments Exceptions The Government, though in agreement with much of the ALJs opinion, filed exceptions to the RD on June 11, 2019. The Government described its primary concern as being delay caused by the ALJs conditional admission of documents and proffer testimony, and asked that I specify the manner in which the ALJ is to balance the risk of delay with the risk of being reversed, and to, where appropriate, allow only limited proffers. Govt Exceptions, at 3. The presiding ALJ has the duty to conduct a fair hearing, to take all necessary action to avoid delay, and to maintain order and has the power to receive, rule on, exclude, or limit evidence. 21 CFR 1316.52 and f.
In other words, he possesses discretion to regulate the course of the hearing.
5 U.S.C. 556c5 West 2021. As such, I decline to broadly instruct ALJs in the manner requested by the Government.
Next, the Government alleged that the ALJ erroneously admitted Respondent Exhibits 1837, which consisted of due diligence files for the patients at issue in this case which had been updated by Respondent after the dates relevant to this case and after a Government subpoena for these same records. Govt Exceptions, at 36. The Government conceded that the records could have been relevant to establish remedial measures taken by Respondent Pharmacy, but argues that they would C I have made minor modifications to the RD. I
have substituted initials or titles for the names of witnesses and patients to protect their privacy, I
have corrected an occasional citation, and I have made minor, non-substantive, grammatical changes.
Where I have made substantive changes, omitted language for brevity or relevance, or where I have added to or modified the ALJs opinion, I have noted the edits with an asterisk, and I have included specific descriptions of the modifications in brackets following the asterisk or in footnotes marked with an asterisk and a letter.

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have been relevant only if Respondent Pharmacy first accepted responsibility for its actions. Id. The Government alleges that the ALJs admission of RX
1837, even conditionally, was improper without Respondent first establishing responsibility or proffering that acceptance of responsibility was forthcoming. As I have already discussed, I decline to instruct the ALJs on how to balance the risk of delay against the need to receive evidence as it lies within their discretion, because every case will be different. Here, the ALJ ultimately found that the Respondent Pharmacy did not accept responsibility for its actions, but it would have been difficult for the ALJ to have reached that conclusion at the beginning of the evidentiary hearing.
The remainder of the Governments exceptions are addressed in the relevant sections of the RD as footnoted below.
The Respondents Exceptions On June 23, 2019, the Respondent filed its exceptions to the Recommended Decision. Exceptions 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 and citations of the authorities relied upon.
21 CFR 1316.66. For the most part, the Respondents Exceptions not only fail to comply with this regulatory requirement, but also lack evidentiary support in the Administrative Record.
Some of Respondents Exceptions D
repeat facts which were already raised at the hearing in this matter and addressed by the ALJ in the adopted Recommended Decision herein.
Most of Respondents Exceptions introduce evidentiary facts that Respondent Pharmacy appears to be offering to establish remedial measures.E Many of these facts are not D Respondents Exceptions 1 asserting that starting doses for opioid patients were not high and that the Pharmacy had detailed medical records; 7
regarding the initial inventory; 8 asserting the accuracy of the perpetual inventory; 12 claiming the opioid naivety red flag was resolved by checking e-FORCSE. Respondents Exceptions, at 2
3.
E Respondents Exceptions 4 asserting that the pharmacy can now bill insurance companies and that 80% of the Schedule II controlled substances prescriptions it fills are through insurance now; 5
asserting the pharmacy now fills only 10% of the Schedule II controlled substances prescriptions it was filling in 2015 and 2016, admitting they filled too many Schedule II prescriptions in the past and claiming they are not extremely due diligent in filling; 6 asserting that the pharmacy does not fill prescriptions from a neighboring pain doctor who will not share medical records; 7 asserting that Respondent Pharmacy passed every Department of Health inspection from 2015 to 2019; 9 asserting that Patient A.R. has been discharged; 11 asserting
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