Svetlana Burtman, N.P.; Decision and Order

Federal Register Extracts

Drug Enforcement Administration

I. Introduction

On December 28, 2023, the then-Administrator issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Svetlana Burtman, N.P., of Tucson, Arizona (Respondent). OSC/ISO, at 1. The OSC/ISO informs Respondent of the immediate suspension of her Drug Enforcement Administration (DEA or Government) Certificate of Registration, No. MB2645767, pursuant to 21 U.S.C. 824(d), alleging that Respondent's continued registration constitutes "an imminent danger to the public health or safety." Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also proposes the revocation of Respondent's registration, No. MB2645767, as well as the denial of Respondent's application for a new registration for her Green Valley clinic (GVC), No. W23106194M, alleging that Respondent's registration is inconsistent with the public interest. Id. at 1-2.

More specifically, the OSC/ISO alleges that Respondent (1) dispensed controlled substances from an unregistered location, in violation of 21 CFR 1301.12(a) (a separate registration is required for each principal place of business or professional practice where controlled substances are dispensed), (2) failed to maintain, readily retrievable from her ordinary business records, a complete and accurate record of each controlled substance received, in violation of 21 U.S.C. 827(a)(3) and 827(b) and 21 CFR 1304.04(a) and 1304.21(a), and (3) failed to maintain the requisite dispensing logs, in violation of 21 CFR 1304.22(c). /1/ OSC/ISO, at 2-4.

FOOTNOTE 1 The OSC/ISO also alleges violations of Arizona law, none of which the Agency is adjudicating due to the seriousness of the alleged federal violations. Each of the alleged federal violations alone, if proven, is a sufficient basis to revoke Respondent's registration and deny her registration application. END FOOTNOTE

Respondent requested a hearing. /2/ The hearing was held before Chief Administrative Law Judge, John J. Mulrooney, II, (Chief ALJ) who, on June 20, 2024, issued his Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (RD). The RD recommends that Respondent's Tucson registration be revoked and that her application for a GVC registration be denied. RD, at 35-36. On July 10, 2024, Respondent timely filed "Exceptions to ALJ Recommendations" (Exceptions). Eleven exceptions challenge the RD's Conclusions of Fact, and four challenge the RD's Conclusions of Law. /3/

FOOTNOTE 2 The Agency agrees with the final rulings contained in the Order Regarding the Government's Motions In Limine and for Partial Summary Disposition (May 9, 2024). END FOOTNOTE

FOOTNOTE 3 The Agency carefully considered each of Respondent's Exceptions. Infra.

Respondent's first factual Exception concerns "Conclusions Regarding the 2021 Investigation" and states, in essence, that the Chief ALJ wrongly denied Respondent the opportunity to present one of the several attorneys who represented her during the "2021 Investigation" as a rebuttal witness. Exceptions, at 4. That rebuttal witness, according to the first factual Exception, would testify that the United States Attorney's Office "never informed [him] of any purported regulatory violations arising from the 2021 visit." Id. at 5. Accordingly, the first factual Exception continues, Respondent "had a reasonable belief that her storage and record-keeping practices were compliant following the 2021 visit." Id.

The Agency rejects Respondent's first factual Exception. The violations alleged in the OSC/ISO do not date back to 2021, and matters dating back to 2021 are not factually relevant to the Agency's adjudication of the allegations. Further, the Agency rejects Respondent's theory that, if a registrant's "storage and record-keeping practices" are compliant in one year, the registrant may maintain a "reasonable belief" that she will remain compliant going forward regardless of changes in the registrant's practices or without the registrant continuously monitoring for required changes.

The content of Respondent's first factual Exception, however, indicates a pattern of Respondent's failure to follow up with DEA staff about their encounters. Infra. section V.

Respondent's fourth factual Exception states that the Government's case wrongly claims that Respondent had "6 mg Testosterone pellets at the GVC," because "no such formulation exists in the record." Id. at 8-9. As the Agency's Decision and Order does not mention, let alone rely on, the Exception's alleged factual inaccuracy, the Agency rejects Respondent's fourth factual Exception.

Respondent's second, fifth, sixth, seventh, and eleventh factual Exceptions concern the credibility of record evidence. The second factual Exception challenges the credibility of a DEA Investigator's testimony about whether Respondent said that she "did not plan on conducting regulated activities" at GVC. Id. at 6. The fifth factual Exception attacks the credibility of "aspects" of the DEA Investigator's testimony that the Exception admits have "limited significance to the Chief ALJ's recommendations." Id. at 9-10. The sixth factual Exception concerns the Chief ALJ's "characterization" of Respondent's testimony about the "storage of controlled substances at GVC" as "inconsistent and fatal to her credibility." Id. at 10-12. The seventh factual Exception concerns the Chief ALJ's "[r]eference to [a] [n]on-[e]xistent August 9, 2023 [v]isit [f]rom the D[EA] Audit Team." Id. at 12-13. And the eleventh factual Exception, like the sixth factual Exception, concerns the Chief ALJ's recommendation that, when there is a conflict, the DEA Investigator's testimony should be credited, not Respondent's testimony. Id. at 16-17.

The Agency carefully evaluated each of these five factual Exceptions. As discussed in this Decision and Order, the Agency's found facts are based on Respondent's own testimony, on Respondent's own evidence, and/or on evidence that Respondent does not contest. Accordingly, Respondent's second, fifth, sixth, seventh, and eleventh factual Exceptions play no role in the Agency's adjudication of the OSC/ISO's allegations and, therefore, the Agency rejects them. END FOOTNOTE

Having carefully reviewed the entire record, the Agency agrees with the RD's recommended sanction of (1) revocation of Respondent's registration and (2) denial of Respondent's GVC registration application.

II. The Alleged Violations

As already discussed, the OSC/ISO alleges that Respondent violated multiple provisions of the Controlled Substances Act (CSA) and its implementing regulations. /4/ As the Supreme Court stated in Gonzales v. Raich, the "main objectives of the CSA were to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances. Congress was particularly concerned with the need to prevent the diversion of drugs from legitimate to illicit channels." 545 U.S. 1, at 12-13 (2005). The Supreme Court further explained that, to accomplish its objectives, "Congress devised a closed regulatory system making it unlawful to . . . dispense[ ] or possess any controlled substance except in a manner authorized by the CSA." Id. at 13. Accordingly, the Supreme Court stated, the "CSA and its implementing regulations set forth strict requirements regarding registration, . . . drug security, and recordkeeping." Id. at 14; see also Gonzales v. Oregon, 546 U.S. 243, 266 (2006) ("Law enforcement decisions respecting the security of stocks of narcotic drugs and the maintenance of records on such drugs are to be made by the Attorney General.").

FOOTNOTE 4 The OSC/ISO also mentions 21 U.S.C. 1301.71 and 1301.75. OSC/ISO, at 3. The Government's Proposed Findings of Fact, Conclusions of Law, and Argument (Closing Brief), however, does not mention either of these provisions, apparently abandoning them. Accordingly, the Agency is not adjudicating them and they are not sustained.

The OSC/ISO also mentions 21 U.S.C. 1301.72(b)(8)(ii) ("Non-controlled drugs, substances and other materials may be stored with Schedule III through V controlled substances in any of the secure storage areas required by 21 CFR 1301.72(b), provided that permission for such storage of non-controlled items is obtained in advance, in writing, from the Special Agent in Charge of DEA for the area in which such storage area is situated."). OSC/ISO at 3. The Government's Closing Brief addresses this provision. It does so, however, in only one sentence, followed by a cite to four lines of the transcript about Respondent's registered Tucson location. The Agency finds that the Government did not submit substantial evidence that Respondent violated 21 U.S.C. 1301.72(b)(8)(ii) and, therefore, the Agency does not sustain the 21 U.S.C. 1301.72(b)(8)(ii) allegation. END FOOTNOTE

The OSC/ISO's allegations concern the CSA's "strict requirements regarding registration . . . and recordkeeping" and, therefore, go to the heart of the CSA's "closed regulatory system" specifically designed "to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances," and "to prevent the diversion of drugs from legitimate to illicit channels." 545 U.S. at 12-14.

A. Dispensing Controlled Substances From an Unregistered Location (21 CFR 1301.12(a))

First, the OSC/ISO alleges that Respondent dispensed controlled substances from GVC, an unregistered location. OSC/ISO, at 2-4. According to the applicable CSA regulation, "[a] separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are . . . dispensed by a person." 21 CFR 1301.12(a). /5/ Further, "dispense" means "to deliver a controlled substance to an ultimate user . . . including the prescribing and administering of a controlled substance." 21 U.S.C. 802(10).

FOOTNOTE 5 See also 21 U.S.C. 822(e)(1). The OSC/ISO does not allege a violation of the statutory provision, so the statutory provision plays no role in the Agency's adjudication. END FOOTNOTE

--This is a summary of a Federal Register article originally published on the page number listed below--

Citation: "90 FR 16881"

Document Number: "Docket No. 24-32"

Federal Register Page Number: "16881"

"Notices"