Federal Register Extracts

I. Procedural Background

On August 20, 2018, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Maura Tuso, D.M.D. (hereinafter, Applicant) of San Diego, California. OSC, at 1. The OSC proposed the denial of Applicant's application for DEA Certificate of Registration, Application Control No. W18011889C, because Applicant has "been convicted of a felony relating to controlled substances and because [she has] committed acts which render [her] registration inconsistent with the public interest." Id. (citing 21 U.S.C. 824(a)(2) & (a)(4)).

Specifically, the OSC alleged that on August 25, 2015, Applicant entered a guilty plea to "four felony counts related to unlawfully issuing controlled substance prescriptions in violation of California Health and Safety Code Section 11153(a), and related counts of conspiracy, prescription fraud, and insurance fraud. This guilty plea was accepted in the Superior Court of California, County of San Diego, as part of the Court's Finding and Order." Id. at 2.

The OSC also alleged that, "[p]ursuant to a July 6, 2016 Stipulated Settlement and Disciplinary Order between [Applicant] and the Dental Board of California (the "Board"), which was effective on September 16, 2016, [Applicant was] ordered to surrender a DEA Registration which [she] previously held and ordered not to reapply for a new DEA Registration without approval from the Board." Id.

Further, the OSC stated that, "[o]n April 12, 2018 and April 13, 2018, the [DEA San Diego Field Division (hereinafter, SDFD)] attempted to provide" Applicant with a proposed Memorandum of Agreement with conditions in order to grant her application. Id. During Applicant's visits to the SDFD, the OSC alleged that she used "vulgar language and obscenities in an uncivilized display." Id.

The OSC continued to allege that since this encounter, Applicant has "engaged in a pattern of sending many dozens of emails to various DEA personnel, including emails of a harassing nature." Id. It alleged that Applicant's actions constitute "conduct which may threaten the public health and safety within the meaning of 21 U.S.C. 823(f)(5) and [ ] acts that render [her] registration inconsistent with the public interest within the meaning of 21 U.S.C. 824(a)(4)." Id.

The OSC notified Applicant of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. at 4 (citing 21 CFR 1301.43). The OSC also notified Applicant of the opportunity to submit a corrective action plan. OSC, at 4-5 (citing 21 U.S.C. 824(c)(2)(C)).

On October 2, 2018, Applicant, represented by counsel, filed a timely request for hearing, in which she disputed the allegations. Request for Final Agency Action (hereinafter, RFAA) Exhibit (hereinafter, RFAAX) 3. However, on October 25, 2018, Applicant withdrew her request for hearing. RFAAX 5. The Administrative Law Judge thereby entered an Order Terminating Proceedings on October 25, 2018. RFAAX 6.

The Government forwarded its RFAA, along with the evidentiary record, to this office on April 1, 2020. The Government requests denial of Applicant's application for a DEA Certificate of Registration, "because of her previous state felony conviction related to controlled substances." 1 /2/ Id. at 5.

FOOTNOTE 1 It is noted that the Government no longer requests denial of Applicant's DEA application based on the allegation in the OSC that her registration would be inconsistent with the public interest; therefore, I will not assess the allegations in the OSC related to the public interest grounds. END FOOTNOTE

FOOTNOTE 2 In the RFAA, the Government also argued for revocation based on a ground that does not appear in the OSC--that the Applicant currently lacks a dental license in California, the state in which she is applying for a DEA registration, and that her application is thus also subject to denial pursuant to 21 U.S.C. 824(a)(3). Although state authority is a prerequisite to holding (or having) a DEA registration, see 21 U.S.C. 823, I see no evidence in the record that Applicant was notified of this additional charge and I am declining to consider it at this time. See Shelton Barnes, M.D., 85 FR 5983 n.3 (2020). END FOOTNOTE

I find that Applicant has waived the right to a hearing and the right to submit a written statement and corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this Decision and Order based on the record submitted by the Government, which constitutes the entire record before me. 21 CFR 1301.43(e).

II. Findings of Fact

A. Applicant's DEA Application

On February 8, 2018, Applicant submitted an application (Application Control No. W18011889C) for a DEA Certificate of Registration, at the proposed registered location of 4177 West Point Loma Blvd., San Diego, CA 92110, for the business activity of practitioner in drug schedule V. RFAAX 1 (Certification of Nonregistration), at 1. The application is in "a new pending status." Id.

B. Applicant's Conviction

On August 25, 2015, Applicant /3/ entered a guilty plea to one felony count related to unlawfully issuing controlled substance prescriptions in violation of California Health and Safety Code Section 11153(a), and one related count for obtaining a prescription by fraud under California Health and Safety Code Section 11173(a), and two other felony counts for conspiracy and insurance fraud related to the prescriptions. RFAAX 8, at 12-14.

FOOTNOTE 3 There is substantial record evidence to support a finding that Maura Cathleen O'Neill is the same person as Maura Tuso. The Government's Certification of Non Registration for Maura Tuso lists previous registrations "assigned to Maura Tuso under the name of Maura C O'Neill DMD." RFAAX 1, at 2; see also, RFAAX 7a & b (Dental Board of California records naming Maura Tuso as an alias for Maura O'Neill). Therefore, I find that the substantial record evidence demonstrates that the conviction in RFAAX 8 for Maura O'Neill applies to Applicant. END FOOTNOTE

On August 25, 2015, the Superior Court of California, County of San Diego (the "state court") accepted Applicant's guilty plea. Id. at 12-14. In her guilty plea, Applicant admitted that she "knowingly and unlawfully obtained prescriptions for controlled substances . . . for reasons other than a medical purpose." Id. at 14.

In its Finding and Order, the state court held, it "accepts the defendant's plea and admissions, and the defendant is convicted thereby." Id. On September 23, 2015, the state court ordered Applicant to receive five years of probation. Id. at 17-19. On October 2, 2017, the state court reduced the four felony counts to misdemeanors and ordered summary probation. Id. at 20-21.

III. Discussion

A. Analysis of Applicant's Application for Registration

In this matter, the Government calls for my adjudication of the application for registration based on the charge that Applicant was convicted of a felony related to controlled substances, which is a basis for revocation or suspension under 21 U.S.C. 824(a)(2). OSC, at 1-2. The Government dropped the allegation that Applicant's application should be denied because her registration would be inconsistent with the public interest pursuant to section 823 in the OSC and did not advance any arguments or present any evidence under the public interest factors in its RFAA. See supra n.1. Accordingly, the remaining actionable substantive basis for proposing the denial of applicant's registration application is her felony conviction under 21 U.S.C. 824(a)(2).

Prior Agency decisions have addressed whether it is appropriate to consider a provision of 21 U.S.C. 824(a) when determining whether or not to grant a practitioner registration application. For over forty-five years, Agency decisions have concluded that it is. Robert Wayne Locklear, M.D., 86 FR 33744-45 (collecting cases). In the recent decision Robert Wayne Locklear, M.D., the former Acting Administrator stated his agreement with the results of these past decisions and reaffirmed that a provision of section 824 may be the basis for the denial of a practitioner registration application. 86 FR 33745. He also clarified that allegations related to section 823 remain relevant to the adjudication of a practitioner registration application when a provision of section 824 is involved. Id.

Accordingly, when considering an application for a registration, I will consider any actionable allegations related to the grounds for denial of an application under 823 and will also consider any allegations that the applicant meets one of the five grounds for revocation or suspension of a registration under section 824. Id.; see also Dinorah Drug Store, Inc., 61 FR 15972, 15973-74 (1996).

1. 21 U.S.C. 823(f): The Five Public Interest Factors

Under Section 304 of the Controlled Substances Act, "[a] registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined by such section." 21 U.S.C. 824(a)(4). Because the Government has not alleged that Applicant's registration is inconsistent with the public interest under section 823, I will not deny Applicant's application based on section 823, and although I have considered 823, I will not analyze Applicant's application under the public interest factors. Therefore, in accordance with prior agency decisions, I will move to assess whether the Government has proven by substantial evidence that a ground for revocation exists under 21 U.S.C. 824(a). Supra II.C.

2. Applicant's Felony Conviction

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

Citation: "86 FR 59196"

Federal Register Page Number: "59196"

"Notices"