On February 19, 2025, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Esther Villanueva Valdes, M.D., of Arecibo, Puerto Rico (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1, 4. The OSC proposed the revocation of Registrant's Certification of Registration No. BV4657485, alleging that Registrant is “currently without authority to . . . handle controlled substances in the Commonwealth of Puerto Rico, the U.S. territory in which [she is] registered with DEA” and has been mandatorily excluded from participation in Medicare, Medicaid, and all Federal health care programs pursuant to 42 U.S.C. 1320a-7(a). Id. at 2 (citing 21 U.S.C. 824(a)(3), (5)).^[1]

The OSC notified Registrant of her right to file a written request for hearing, and that if she failed to file such a request, she would be deemed to have waived her right to a hearing and be in default. Id. at 3 (citing 21 CFR 1301.43). Here, Registrant did not request a hearing, and the Agency finds her to be in default. RFAA, at 3.^[2] “A default, unless excused, shall be deemed to constitute a waiver of the registrant's/applicant's right to a hearing and an admission of the factual allegations of the [OSC].” 21 CFR 1301.43(e).

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.” Id. at 1301.43(f)(1). Here, the Government has requested final agency action based on Registrant's ( printed page 59799) default pursuant to 21 CFR 1301.43(c), (f), and 1301.46. RFAA, at 4; see21 CFR 1316.67.^[3]

I. Loss of State Authority

A. Findings of Fact

The Agency finds that, in light of Registrant's default, the factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e). According to the OSC, Registrant's Puerto Rico medical license, issued by the Puerto Rico Board of Medical Licensure and Discipline (Board), expired on July 4, 2022. RFAAX 1, at 2. Registrant also held a Board controlled substance license that expired on August 31, 2023. Id.

According to Puerto Rico online records, of which the Agency takes official notice,^[4] Registrant's medical license is expired and remains in such status. Commonwealth of Puerto Rico Department of Health, Division of Board of Licensing and Medical Discipline Verification Search, orcps.salud.pr.gov/​mbps/​verificacion (last visited date of signature of this Order). Accordingly, the Agency finds that Registrant is not licensed to practice medicine in Puerto Rico, the jurisdiction in which she is registered with DEA.^[5]

B. Discussion

Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under 21 U.S.C. 823 “upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration. See, e.g., James L. Hooper, M.D.,76 FR 71371, 71372 (2011), pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D.,43 FR 27616, 27617 (1978).^[6]

According to the Puerto Rico Controlled Substances Act, “[a]ny person who manufactures, distributes and dispenses controlled substances in the Commonwealth of Puerto Rico . . . shall obtain a registration certification annually, issued by the Secretary of Health, pursuant to the rules and regulations approved and promulgated by said government official.” P.R. Laws Ann. tit. 24, § 2302(a) (current through all acts translated by the Translation Office of the Puerto Rico Government through the 2025 Legislative Session). Further, “dispense” means “the prescribing, administering or delivering of a controlled substance to an ultimate user, by prescription or order for administering it. It includes the process of the compounding, labeling and packaging of a controlled substance for such delivery. The term `dispenser' means the practitioner who so delivers a controlled substance.” Id. § 2102(11).

Here, the undisputed evidence in the record is that Registrant lacks authority to dispense controlled substances in Puerto Rico. As discussed above, an individual must hold a controlled substance license and be licensed to practice medicine to dispense a controlled substance in Puerto Rico. Thus, because Registrant lacks authority to handle controlled substances in Puerto Rico, Registrant is not eligible to maintain a DEA registration in that jurisdiction. Accordingly, the Agency will order that Registrant's DEA registration be revoked.

Registrant's lack of state authority to handle controlled substances in Puerto Rico is sufficient by itself to support revoking Registrant's DEA registration. Infra n.9. The following mandatory exclusion ground provides an additional, independent basis for revoking Registrant's DEA registration.

II. Mandatory Exclusion From Federal Health Care Programs

A. Findings of Fact

Registrant is deemed to admit that on April 7, 2021, in the United States District Court for the District of Puerto Rico, Registrant pled guilty to one count of healthcare fraud in violation of 18 U.S.C. 1347 and judgment was entered against her on August 30, 2021.^[7] RFAAX 1, at 2. As a result of Registrant's guilty plea and criminal conviction, the U.S. Department of Health and Human Services, Office of Inspector General (HHS/OIG), mandatorily excluded Registrant from participation in Medicare, Medicaid, and all Federal health care programs, effective March 20, 2022, for a minimum period of 8 years, pursuant to 42 U.S.C. 1320a-7(a). Id.

B. Discussion

Pursuant to 21 U.S.C. 824(a)(5), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the CSA upon finding that the registrant “has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a-7(a) of Title 42.” The Agency has consistently held that it may also deny an application upon finding that an applicant has been excluded from a federal health care program. Mark Agresti, M.D.,90 FR 30098, 30099 (2025); Samirkumar Shah, M.D.,89 FR 71931, 71933 (2024); Arvinder Singh, M.D.,81 FR 8247, 8248 n.3 (2016).

The Agency finds substantial record evidence that Registrant has been, and ( printed page 59800) remains, mandatorily excluded from federal health care programs pursuant to 42 U.S.C. 1320a-7(a).^[8] Accordingly, the Agency finds that substantial record evidence establishes the Government's prima facie case for revocation of Registrant's registration under 21 U.S.C. 824(a)(5).

III. Sanction

Where, as here, the Government has met its prima facie burden of showing that Registrant's registration should be revoked, the burden shifts to Registrant to show why she can be entrusted with a registration. Morall v. Drug Enf't Admin., 412 F.3d. 165, 174 (D.C. Cir. 2005); Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D.,83 FR 18882 (2018). The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual practitioner. Jeffrey Stein, M.D.,84 FR 46968, 46972 (2019); see Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is the best predictor of future performance, DEA Administrators have required that a registrant who has committed acts inconsistent with the public interest must accept responsibility for those acts and demonstrate that the registrant will not engage in future misconduct. 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). Historically, the Agency has considered acceptance of responsibility, egregiousness, and deterrence when making this assessment. See Michael Bouknight,90 FR 31247, 31250 (2025); Sasha Melissa Ikramelahai,90 FR 32017, 32020-21 (2025); Frank Joseph Stirlacci, M.D.,85 FR 45229, 45239-40 (2020).

The Agency requires a registrant's unequivocal acceptance of responsibility. Janet S. Pettyjohn, D.O.,89 FR 82639, 82641 (2024); Mohammed Asgar, M.D.,83 FR 29569, 29573 (2018); see Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, a registrant's candor during the investigation and hearing, if one is requested, is an important factor in determining acceptance of responsibility and the appropriate sanction. See Jones Total Health Care Pharmacy, 881 F.3d at 830-31; Hoxie v. Drug Enf't Admin., 419 F.3d 477, 483-84 (6th Cir. 2005). Further, the Agency has found that the egregiousness and extent of the misconduct are significant factors in determining the appropriate sanction. Jones Total Health Care Pharmacy, 881 F.3d at 833 n.4, 834. The Agency also considers the need to deter similar acts by a registrant and by the community of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.

Here, Registrant did not timely request a hearing or answer the allegations in the OSC and was deemed to be in default. 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 properly answer the allegations contained in the OSC 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 demonstrated that she can be trusted with registration.

Accordingly, the Agency will order the revocation of Registrant's registration.^[9]

Order

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. BV4657485, issued to Esther Villanueva Valdes, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of Esther Villanueva Valdes, M.D., to renew or modify this registration, as well as any other pending application of Esther Villanueva Valdes, M.D., for additional registration in Puerto Rico. This Order is effective October 21, 2026.

Signing Authority

This document of the Drug Enforcement Administration was signed on September 11, 2026, by DEA Administrator Terrance C. 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 .