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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
Mr. Parrado conceded that dual prescriptions for hydromorphone and methadone represented a red flag, but one which could be resolved by contacting the physician. Id. at 54243.
As to Patient B.F., Mr. Parrado did not consider multiple different opioid prescriptions concerning, explaining that physicians often try different medications to find an effective treatment. Id. at 54344; RX 24, pp. 2
3. Further, Mr. Parrado did not view the simultaneous prescription of methadone and hydromorphone concerning, as methadone could be used as an extended release reliever, while the hydromorphone was an immediate release. Id. at 544. Mr. Parrado conceded he had testified previously that that combination was a red flag, but a resolvable red flag. Id.
As to Patient A.V., the prescription bore a code for sciatica. Id. at 545. Mr.
Parrado Z testified that the diagnostic code for sciatica was inherently reliable because it was handwritten as opposed to created by a computer. Id. at 54546, 551; GX 10, p. 15.
Mr. Parrado testified that due diligence files in a pharmacy would include all information used by the pharmacists to resolve red flags. Tr. 546.
Mr. Parrados Sur-Rebuttal Testimony During the second part of the hearing, the Respondent recalled Mr. Parrado to give sur-rebuttal testimony to the Governments rebuttal case. The Government objected to the testimony by Mr. Parrado and argued that surrebuttal testimony was not permitted by the rules. Id. at 1027. This Tribunal sustained the governments objection, but permitted the Respondent to continue questioning Mr. Parrado to make his record for the Administrators consideration should the Administrator find this Tribunals evidentiary ruling in error. Id. at 102829.
This Tribunal instructed the parties to brief the issue as to the propriety of surrebuttal testimony. In their Posthearing Brief, the Government concedes that there is no express prohibition of surrebuttal testimony, however, the regulations provide that unduly repetitious testimony will not be admitted. Govt Posthearing Brief at 46
47; 21 CFR 1316.59a. The Government argues that the Respondent did not identify what was being proffered and Z The ALJ found that Mr. Parrado was not concerned by the sciatica code, as errors happen.
I understand, and have edited this finding accordingly, Mr. Parrados testimony to be that here the sciatica code was inherently reliable because it was handwritten rather than generated by a computer error, which he previously testified occurs frequently. Tr. 545.

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the additional testimony was doing nothing more than seeking to bolster the Respondents case. Govt Posthearing Brief at 46.
Upon a review of the Governments brief and the transcript of the proceedings, I find that sustaining the Governments objection to sur-rebuttal testimony was ill-advised. Although there is no relevant regulation or rule authorizing sur-rebuttal, neither is there a regulation or rule authorizing rebuttal testimony.43 However, the Attorney Generals Manual on the APA finds in Presentation of Evidence, Section 7 c that every party shall have the right to present his case or defense by oral or documentary evidence, to submit rebuttal evidence, and to conduct such cross-examination as may be required for a full and true disclosure of the facts. Accordingly, this Tribunal recommends that the Administrator find the subject ruling in error and fully consider Mr. Parrados sur-rebuttal testimony as direct evidence, to the extent it does not exceed the scope of rebuttal evidence.44
On sur-rebuttal, in explaining the differences between the Governments and the Respondents versions of the medical record exhibits, Mr. Parrado affirmed the propriety of updating pharmacy records as relevant information is learned. Id. at 102930.
Mr. Parrado further affirmed the propriety of including Schedules 35
prescriptions within the pharmacy records to reflect the totality of the dispensing, and not just the Schedule 2
prescriptions.AA Id. at 103334.
Mr. Parrado further opined that many of the medical conditions and diagnoses noted in Pharmacy 4 Less files, chronic pain, cancer, neoplasms, broken backs are conditions which cannot be treated by surgery, but rather by opioid therapy.
Id. at 102931. The dosage and frequency of such opioid therapy is designed to permit the patient to operate at a normal level. Id. at 1032. As to Dr.
Hamiltons expectation of the tapering down of opioid doses, Mr. Parrado noted tapering in chronic pain patients was often difficult and ineffective. Id. at 43 The Agency has permitted and considered surrebuttal evidence in the past. Flavio D. Gentile, M.D.; 55 FR 3113 1990.
44 Sur-rebuttal evidence is permitted to confront the opposing partys rebuttal evidence.
AA Mr. Parrado testified that when considering the total profile of all prescriptions for these patients, the patients were getting all their medications there . . . . that is what you want. . . . You do not want him just buying controls from you because now you do not know what else is going on with that patient. . . . It essentially resolved that red flag meaning the person is not just trying to obtain narcotics from the pharmacy. Tr. 103334.

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1036. Finally, Mr. Parrado offered that the Respondent issued a below average number of oxycodone tablets as compared to other Florida pharmacies during the relevant period. Id. at 1037
40. Mr. Parrado conceded there were no pharmacy records explaining that the long distances traveled by customers of the Respondent was due to pharmacies going out of business. Id. at 1041. Nor did Mr. Parrado observe records in this case suggesting patients could not afford extended release medications. Id. at 1041.
The Facts Stipulations of Fact The Government and the Respondent, through counsel, have agreed to thirteen stipulations, which I recommend be accepted as fact in these proceedings:
1. Pharmacy 4 Less, LLC, is registered with the DEA to handle controlled substances under Schedules II to V
under DEA COR No. FP5459082. Its registered address is: 805 Douglas Avenue, Suite 159, Altamonte Springs, Florida 32714.
2. Pharmacy 4 Lesss COR was issued on February 2, 2018.
3. Richard Sprys, R.Ph., C.Ph., is the owner and manager of Pharmacy 4 Less.
4. Amy Mincy, R.Ph., is a pharmacist at Pharmacy 4 Less.
5. On June 6, 2017, DEA conducted an audit of Pharmacy 4 Less.
6. Proposed Governments Exhibit 2 is a true and correct copy of the June 22, 2017 Administrative Subpoena served upon Pharmacy 4 Less.
7. Pharmacy 4 Less completed its compliance with the administrative subpoena on July 11, 2017.
8. DEA served Pharmacy 4 Less with an Order to Show Cause on July 5, 2018.
9. Pharmacy 4 Less submitted a Corrective Action Plan to John J. Martin, Assistant Administrator for the Diversion Control Division of DEA, on July 31, 2018.
10. Pharmacy 4 Less submitted a Request for Hearing to the Office of the Administrative Law Judges at DEA
Headquarters on August 1, 2018.
11. On August 8, 2018, Mr. Martin denied Respondents request to discontinue or defer administrative proceedings.
12. Ms. Amy Mincy signed the DEA
Form 82, Notice of Inspection of Controlled Premises on behalf of Pharmacy 4 Less during the June 6, 2017
on-site inspection. Tr. 38.
13. RX 19, 21, 23, 25, 27, 29, 31, 33, 35, 37 were supplied to the DEA in response to the July 9, 2018
administrative subpoena. Tr. 81213.

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