I. Introduction

On January 30, 2025, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Tracy Amerson-Rivers, A.P.R.N., of Houston, Texas (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1. The OSC/ISO informed Registrant of the immediate suspension of her DEA Certificate of Registration, No. MA5242792, pursuant to 21 U.S.C. 824(d), alleging that Registrant'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 proposed the revocation of Registrant's registration, alleging that Registrant's continued registration is inconsistent with the public interest. Id. (citing 21 U.S.C. 823(g)(1), 824(a)(4)).^[1]

More specifically, the OSC/ISO alleged that Registrant, an advanced practice registered nurse (APRN), issued six controlled substance prescriptions, despite lacking a prescriptive authority agreement with a licensed physician, which is required in Texas for an APRN to prescribe controlled substances. RFAAX 1, at 1-2. The OSC/ISO further alleged that Registrant obtained controlled substances by fraud. Id. at 6.^[2]

On May 20, 2025, the Government submitted a RFAA requesting that the Agency issue a default final order revoking Registrant's registration. RFAA, at 1-5. After carefully reviewing the entire record and conducting the analysis as set forth in more detail below, the Agency grants the Government's RFAA and revokes Registrant's registration.

II. Default Determination

Under 21 CFR 1301.43, a registrant entitled to a hearing who fails to file a timely hearing request “within 30 days after the date of receipt of the [OSC/ISO] . . . shall be deemed to have waived their right to a hearing and to be in default” unless “good cause” is established for the failure. 21 CFR 1301.43(a), (c)(1). In the absence of a demonstration of good cause, a registrant who fails to timely file an answer also is “deemed to have waived their right to a hearing and to be in default.” 21 CFR 1301.43(c)(2). Unless excused, a default is deemed to constitute “an admission of the factual allegations of the [OSC/ISO].” 21 CFR 1301.43(e).

The OSC/ISO notified Registrant of her right to file a written request for hearing and answer, and that if she failed to file such a request and answer, she would be deemed to have waived her right to a hearing and be in default. RFAAX 1, at 7-8. The OSC/ISO further notified Registrant that “[s]hould [she] request a hearing and fail to timely file an answer, plead, or otherwise defend, . . . [she] shall be deemed to have waived the right to a hearing and to be in default.” Id. at 8 (citing 21 CFR 1301.43(c)(2), (c)(3), (d)).

Registrant filed a timely hearing request, but did not file an answer. RFAA, at 2; RFAAX 3; RFAAX 4, at 1. The matter was assigned to Administrative Law Judge (ALJ) Paul Soeffing, who issued an Order for Prehearing Statements on March 4, 2025, directing Registrant to file a compliant answer by 5:00 p.m. Eastern Time (ET)/4:00 p.m. Central Time (CT) on March 7, 2025. RFAA, at 2; RFAAX 4, at 1-2, 5. On March 10, 2025, the ALJ granted Registrant's request to extend the deadline for filing an answer to 5:00 p.m. ET/4:00 p.m. CT on April 21, 2025. RFAA, at 2; RFAAX 6, at 1-2.

On April 21, 2025, Registrant filed a purported answer. RFAA, at 2; RFAAX 7. On the same day, the ALJ issued an order notifying Registrant of deficiencies that made her purported answer noncompliant. RFAA, at 2-3; RFAAX 8, at 1-2. The ALJ found that Registrant's purported answer failed to “admit, deny, or state that [she] does not have and is unable to obtain sufficient information to admit or deny” each allegation of the OSC/ISO, as required by 21 CFR 1301.37(d)(3). RFAAX 8, at 2. The ALJ provided Registrant another opportunity to file a compliant answer by 5:00 p.m. ET/4:00 p.m. CT on April 24, 2025. RFAA, at 2-3; RFAAX 8, at 1-2.

On April 24, 2025, Registrant filed a second purported answer after the filing deadline. RFAA, at 3; RFAAX 9; RFAAX 10, at 1. On April 25, 2025, the ALJ issued an order notifying Registrant that her second purported answer was untimely and remained noncompliant with 21 CFR 1301.37(d)(3). RFAA, at 3; RFAAX 10, at 1-2. The ALJ directed Registrant to submit a filing by 2:00 p.m. ET/1:00 p.m. CT on May 2, 2025, correcting the deficiencies in her second purported answer and showing good cause to accept the untimely second purported answer. RFAA, at 3; RFAAX 10, at 2. Registrant did not respond to this order. RFAA, at 3; RFAAX 11, at 1-2.

On May 2, 2025, the ALJ issued an order terminating the proceeding based on his finding that Registrant had failed to file a timely and compliant answer to the OSC/ISO allegations. Id. The ALJ further found that Registrant's failure to submit a timely and compliant answer constituted a waiver of her right to a ( printed page 48885) hearing and that she was in default.^[3] RFAAX 11, at 2 (citing 21 CFR 1301.43(c)(1), (e)). The Agency finds that the ALJ did not err in finding Registrant to be in default due to her untimely second purported answer, failure to show good cause to excuse the untimely second purported answer and correct the deficiencies in her purported answers, and failure to respond to the ALJ's April 25 order.

“A default, unless excused, shall be deemed to constitute a waiver of the [registrant's] right to a hearing and an admission of the factual allegations of the [OSC/ISO].” 21 CFR 1301.43(e). Because Registrant is in default, the Agency finds that Registrant has admitted to the factual allegations in the OSC/ISO. 21 CFR 1301.43(c)(1), (e), (f)(1).

Further, “[i]n the event that [a registrant] . . . is deemed to be in default . . . DEA may then file a request for final agency action with the Administrator, along with a record to support its request. In such circumstances, the Administrator may enter a default final order pursuant to [21 CFR] 1316.67.” 21 CFR 1301.43(f)(1). Here, the Government has requested final agency action based on Registrant's default pursuant to 21 CFR 1301.43(c), (f), and 1301.46. RFAA, at 1, 5; see also21 CFR 1316.67.

III. Findings of Fact

In light of Registrant's default, the Agency finds that the factual allegations in the OSC/ISO are deemed admitted.^[4] 21 CFR 1301.43(e). Accordingly, Registrant is deemed to have admitted to each of the following facts.

A. Dispensing Controlled Substances Without Authority

In Texas, an APRN, such as Registrant, may only “order or prescribe” drugs that are “authorized by a prescriptive authority agreement.” 22 Tex. Admin. Code § 222.4(a)(1)(A); RFAAX 1, at 3. “A physician may delegate to an [APRN] . . . the act of prescribing or ordering a drug or device as authorized through a prescriptive authority agreement between the physician and the [APRN].” 22 Tex. Admin. Code § 193.7(a); ^[5] RFAAX 1, at 3. “The prescriptive authority agreement is a mechanism by which an APRN is delegated the authority to order or prescribe drugs or devices by a physician.” 22 Tex. Admin. Code § 222.5(a); RFAAX 1, at 3. An APRN must also possess valid state authority under state law to qualify as a practitioner for purposes of the Controlled Substances Act (CSA) and to issue controlled substance prescriptions. 21 U.S.C. 802(21), 823(g)(1), 824(a)(3); RFAAX 1, at 4.

On February 1, 2022, pursuant to a prescriptive authority agreement, Registrant was granted prescriptive authority in Texas by Dr. R.K.Y. RFAAX 1, at 4. Dr. R.K.Y. died on March 5, 2023. Id. The prescriptive authority agreement, and therefore Registrant's prescriptive authority, terminated by operation of law upon the death of Dr. R.K.Y. Id. On April 20, 2023, Registrant was granted prescriptive authority by Dr. A.E.G. pursuant to a prescriptive authority agreement, which was terminated on June 9, 2023. Id.

Thus, Registrant lacked prescriptive authority in Texas from March 5, 2023, to April 20, 2023. Id. Nevertheless, between March 5, 2023, and April 20, 2023, Registrant issued six prescriptions for controlled substances. Id. Each controlled substance prescription listed Dr. R.K.Y. as Registrant's supervising physician, even though he was deceased when the prescription was issued. Id. Accordingly, the Agency finds unrebutted record evidence, and Registrant is deemed to have admitted, that she issued six prescriptions for controlled substances without possessing the requisite prescriptive authority in Texas.

B. Obtaining Controlled Substances by Fraud

Under Texas law, it is an offense to knowingly obtain and possess a controlled substance “by misrepresentation, fraud, forgery, [or] deception.” Tex. Health & Safety Code § 481.129(a)(5)(A).

On March 15, 2023, a prescription for alprazolam ^[6] was issued to individual D.R. in the name of Dr. R.K.Y., even though Dr. R.K.Y. died on March 5, 2023. RFAAX 1, at 4, 6. On the day the prescription was issued, Registrant used the prescription to personally obtain alprazolam by claiming that she was filling the prescription for individual D.R. Id. Registrant knew this claim was false because she knew that D.R. was incarcerated at the time. Id.

IV. Public Interest Determination

A. Legal Background

As discussed above, the OSC/ISO alleges that Registrant violated provisions of the CSA and its implementing regulations. As the Supreme Court stated in Gonzales v. Raich, 545 U.S. 1 (2005), “the main objectives of the CSA were to conquer drug abuse and control the legitimate and illegitimate traffic in controlled substances.” Id. at 12. Gonzales explained that:

Congress was particularly concerned with the need to prevent the diversion of drugs from legitimate to illicit channels. To effectuate these goals, Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA . . . . The CSA and its implementing regulations set forth strict requirements regarding registration, labeling and packaging, production quotas, drug security, and recordkeeping.

Id. at 12-14.

Here, the OSC/ISO's allegations concern the CSA's “strict requirements regarding registration” and “the need to prevent the diversion of drugs from legitimate to illicit channels.” Id. Therefore, the allegations 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.” Id. at 12-14.

When the CSA's requirements are not met, the Agency ^[7] “may deny, suspend, or revoke [a] registration if . . . the [registrant's] registration would be `inconsistent with the public interest.'” Gonzales v. Oregon, 546 U.S. 243, 251 (2006) (quoting 21 U.S.C. 824(a)(4)).^[8] In the case of a “practitioner,” the Agency is directed to consider five factors in making the public interest determination. Id.;21 U.S.C. 823(g)(1)(A)-(E).^[9]

The five factors are considered in the disjunctive. Gonzales v. Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting) (“It is well established that these factors are to be considered in the disjunctive” (quoting In re Arora,60 FR 4447, 4448 (1995))); Robert A. Leslie, M.D.,68 FR 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. David H. Gillis, M.D.,58 FR 37507, 37508 (1993). Any one factor, or combination of factors, may be decisive, Gillis, 58 FR at 37508, and the Agency “may give each factor the weight . . . deem[ed] appropriate in determining whether a registration should be revoked or an application for registration denied.” Morall v. Drug Enf't Admin., 412 F.3d 165, 185 n.2 (D.C. Cir. 2005) (Henderson, J., concurring) (quoting Robert A. Smith, M.D.,70 FR 33207, 33208 (2007)); see also Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007).

Moreover, while the Agency is required to consider each of the factors, it “need not make explicit findings as to each one.” MacKay v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (quoting Volkman v. U.S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009)); Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005). “In short, . . . the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's misconduct.” Jayam Krishna-Iyer, M.D.,74 FR 459, 462 (2009). Accordingly, as the Eleventh Circuit has recognized, Agency decisions have explained that findings under a single factor can support the revocation of a registration. Jones Total Health Care Pharmacy, 881 F.3d at 830.

B. Registrant's Registration Is Inconsistent With the Public Interest

While the Agency has considered all the public interest factors of 21 U.S.C. 823(g)(1),^[10] the Government's evidence in support of its prima facie case is confined to Factors B and D. RFAA, at 4; RFAAX 1, at 7. Evidence is considered under Factors B and D when it reflects experience dispensing controlled substances and compliance or non-compliance with laws related to controlled substances. Kareem Hubbard, M.D.,87 FR 21156, 21162 (2022).

Here, the Agency finds unrebutted record evidence, and Registrant is deemed to have admitted, that between March 5, 2023, and April 10, 2023, Registrant issued six prescriptions for controlled substances without a prescriptive authority agreement outside the usual course of professional practice and in violation of federal and Texas law. 21 CFR 1306.04; 22 Tex. Admin. Code §§ 222.4(a)(1)(A), 222.5(a); see also Stephen McCarthy, P.A.,89 FR 71427, 71430 (2024) (“Respondent repeatedly issued controlled substance prescriptions outside the usual course of professional practice by issuing such prescriptions while lacking an active agreement with a supervisory physician as required by state law.”); Richard J. Settles, D.O.,81 FR 64940, 64947 (2016) (finding registrant “violated the CSA and DEA regulations” when he issued controlled substance prescriptions without “the requisite state authority to dispense controlled substances”). Such non-compliance with laws related to controlled substances reflects on Registrant's experience handling controlled substances. 21 U.S.C. 823(g)(1)(B), (D).

Furthermore, the Agency finds unrebutted record evidence, and Registrant is deemed to have admitted, that on March 15, 2023, Registrant used a prescription issued to another individual to obtain a controlled substance for herself by fraudulently claiming that she was filling the prescription for someone else, in violation of Texas law. Tex. Health & Safety Code § 481.129(a)(5)(A). Such non-compliance with laws related to controlled substances reflects on Registrant's experience handling controlled substances. 21 U.S.C. 823(g)(1)(B), (D).

After considering the factors of 21 U.S.C. 823(g)(1), the Agency finds that the Government satisfied its prima facie burden of showing that Registrant's registration would be “inconsistent with the public interest.” ^[11] 21 U.S.C. 824(a)(4). The Agency also finds that there is no mitigating evidence to rebut the Government's prima facie case, and therefore, finds that Registrant's registration is “inconsistent with the public interest.” Id. Thus, the only remaining issue is whether, in light of the Agency's finding that Registrant violated the law, Registrant can be trusted with a DEA registration.

V. Sanction

Where, as here, the Government has presented a prima facie case showing that a registrant's registration is inconsistent with the public interest, the burden shifts to Registrant to show why she can be trusted with a registration. Morall, 412 F.3d at 181; Jones Total Health Care Pharmacy, 881 F.3d at 830; Garrett Howard Smith, M.D.,83 FR 18882, 18904 (2018). The issue of trust is a fact-dependent determination based on the circumstances presented by the individual practitioner. Jeffrey Stein, M.D.,84 FR 46968, 46972 (2019); see also Jones Total Health Care Pharmacy, 881 F.3d at 833. Historically, the Agency has considered acceptance of responsibility, egregiousness, and deterrence when making this assessment.

Specifically, the Agency requires the practitioner to accept responsibility for his or her violation. Jones Total Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). Acceptance of responsibility must be unequivocal. Janet S. Pettyjohn, D.O.,89 FR 82639, 82641 (2024); Mohammed Asgar, M.D.,83 FR 29569, 29573 (2018); see also Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, the Agency considers the egregiousness and extent of the misconduct in determining the appropriate sanction. Jones Total Health Care Pharmacy, 881 F.3d at 834 & n.4. The Agency also considers the need to ( printed page 48887) deter similar acts by Registrant, the registrant community, and by future applicants for registration. Stein, 84 FR at 46972-73.

Here, Registrant did not timely or properly answer the allegations, and was therefore deemed to be in default. 21 CFR 1301.43(c), (e), (f); RFAA, at 1-4. To date, Registrant has not filed a motion with the Office of the Administrator to excuse the default. 21 CFR 1301.43(c)(1). Registrant has thus failed to timely or properly answer the allegations contained in the OSC/ISO and has not otherwise availed herself of the opportunity to refute the Government's case. As such, Registrant has not accepted responsibility for the proven violations, has made no representations regarding her future compliance with the CSA, and has not made any demonstration that she can be trusted with a registration.^[12]

Further, the interests of specific and general deterrence weigh in favor of revocation. Registrant's misconduct in this matter concerns the CSA's “strict requirements regarding registration” and “the need to prevent the diversion of drugs from legitimate to illicit channels,” and, therefore, goes 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.” Gonzales v. Raich, 545 U.S. at 12-14. Registrant's egregious misconduct involved issuing controlled substance prescriptions without state authority to so do and obtaining a controlled substance by fraud. Supra Section IV.B. If the Agency were to allow Registrant to keep her registration under these circumstances, it would send a dangerous message that compliance with the law and preventing diversion are not essential to maintaining a registration.

In sum, Registrant has not offered any evidence on the record that rebuts the Government's case for revocation of her registration, and Registrant has not demonstrated that she can be entrusted with the responsibility of a registration. Accordingly, the Agency will order the revocation of Registrant's registration.

Order

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1) and 21 U.S.C. 824(a)(4), I hereby revoke DEA Certificate of Registration No. MA5242792 issued to Tracy Amerson-Rivers, A.P.R.N. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1) and 21 U.S.C. 824(a)(4), I hereby deny any pending applications of Tracy Amerson-Rivers, A.P.R.N., to renew or modify this registration, as well as any other pending application of Tracy Amerson-Rivers, A.P.R.N., for additional registration in Texas. This Order is effective December 1, 2025.

Signing Authority

This document of the Drug Enforcement Administration was signed on October 9, 2025, by Administrator Terrance Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .