90 FR 61 pgs. 14390-14391 - Mary Massullo, D.O.; Decision and Order
Type: NOTICEVolume: 90Number: 61Pages: 14390 - 14391
Pages: 14390, 14391FR document: [FR Doc. 2025-05528 Filed 3-31-25; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Mary Massullo, D.O.; Decision and Order
On April 8, 2024, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Mary Massullo, D.O. of Brookfield, Ohio (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 2, at 1, 4. The OSC proposed the revocation of Registrant's Certification of Registration No. BM0548238, 1 alleging that Registrant's registration should be revoked because Registrant is "currently without authority to handle controlled substances in the State of Ohio, the state in which [she is] registered with DEA." RFAAX 2, at 2 (citing 21 U.S.C. 824(a)(3)). 2
Footnotes:
1 ?According to Agency records, Registrant's registration expired on January 31, 2025. The fact that a registrant allows her registration to expire during the pendency of an OSC does not impact the Agency's jurisdiction or prerogative under the Controlled Substances Act (CSA) to adjudicate the OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 68474, 68476-79 (2019).
2 ?The OSC also proposed the revocation of Registrant's registration because Registrant was mandatorily excluded from participation in Medicare, Medicaid, and all federal health care programs pursuant to 42 U.S.C. 1320a-7(a). Id. In its RFAA, the Government referenced this mandatory exclusion allegation in the introductory paragraph, the procedural background, and the proposed findings of fact. RFAA, at 1-3. However, in the "Proposed Conclusions of Law and Argument" section of the RFAA through the remainder of the document, the Government only discussed the aforementioned loss of state authority allegation. Id. at 3-5. As such, the Government appears to have dropped the mandatory exclusion allegation and the Agency does not consider it in this decision.
The OSC notified Registrant of her right to file a written request for hearing, and that if she had failed to file such a request, she would be deemed to have waived her right to a hearing and be in default. RFAAX 2, at 2 (citing 21 CFR 1301.43). Here, Registrant did not request a hearing. RFAA, at 2. 3 "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).
Footnotes:
3 ?Based on the Government's submissions in its RFAA dated June 25, 2024, the Agency finds that service of the OSC on Registrant was sufficient. Specifically, the included Declaration from a DEA Diversion Investigator (DI) indicates that on May 2, 2024, a copy of the OSC was left in the mailbox of Registrant's registered address following an attempt of personal service on the Registrant. RFAAX 3, at 3. The DI had made a previous unsuccessful attempt to serve Registrant with the OSC via certified mail to Registrant's registered address on May 1, 2024. Id. at 2-3; see also id., Appendix D.
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. §?1301.43(f)(1). Here, the Government has requested final agency action based on Registrant's default pursuant to 21 CFR 1301.43(e), (f), 1301.46. RFAA, at 3; see also 21 CFR 1316.67.
Findings of Fact
The Agency finds that, in light of Registrant's default, the factual allegations in the OSC are admitted. According to the OSC, effective January 31, 2024, Registrant's Ohio medical license was permanently revoked. RFAAX 2, at 2. According to Ohio online records, of which the Agency takes official notice, Registrant's Ohio medical license remains under a "Permanent Revocation" status. 4 eLicense Ohio Professional Licensure License Look-Up, https://elicense.ohio.gov/oh_verifylicense (last visited date of signature of this Order). Accordingly, the Agency finds that Registrant is not licensed to practice medicine in Ohio, the state in which she is registered with DEA. 5
Footnotes:
4 ?Under the Administrative Procedure Act, an agency "may take official notice of facts at any stage in a proceeding-even in the final decision." United States Department of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979).
5 ?Pursuant to 5 U.S.C. 556(e), "[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary." The material fact here is that Registrant, as of the date of this decision, is not licensed to practice medicine in Ohio. Accordingly, Registrant may dispute the Agency's finding by filing a properly supported motion for reconsideration of findings of fact within fifteen calendar days of the date of this Order. Any such motion and response shall be filed and served by email to the other party and to the DEA Office of the Administrator, Drug Enforcement Administration at dea.addo.attorneys@dea.gov.
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. Gonzales v. Oregon, 546 U.S. 243, 270 (2006) ("The Attorney General can register a physician to dispense controlled substances `if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.' . . . The very definition of a `practitioner' eligible to prescribe includes physicians `licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices' to dispense controlled substances. §?802(21)."). The Agency has applied these principles consistently. 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
Footnotes:
6 ?This rule derives from the text of two provisions of the CSA. First, Congress defined the term "practitioner" to mean "a physician . . . or other person licensed, registered, or otherwise permitted, by . . . the jurisdiction in which he practices . . ., to distribute, dispense, . . . [or] administer . . . a controlled substance in the course of professional practice." 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner's registration, Congress directed that "[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices." 21 U.S.C. 823(g)(1). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the CSA, DEA has held repeatedly that revocation of a practitioner's registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the state in which he practices. See, e.g., James L. Hooper, M.D., 76 FR 71371-72; Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby Watts, M.D., 53 FR 11919, 11920 (1988); Frederick Marsh Blanton, M.D., 43 FR 27617.
[top] According to Ohio statute, "[n]o person shall knowingly obtain, possess, or use a controlled substance or a controlled substance analog," except pursuant to a "prescription issued by a licensed health professional authorized to prescribe drugs if the prescription was issued for a legitimate medical
Here, the undisputed evidence in the record is that Registrant currently lacks authority to practice medicine in Ohio. As discussed above, an individual must be a licensed health professional authorized to prescribe drugs in order to handle controlled substances in Ohio. Thus, because Registrant lacks authority to practice medicine in Ohio and, therefore, is not authorized to handle controlled substances in Ohio, Registrant is not eligible to maintain a DEA registration. Accordingly, the Agency will order that Registrant's DEA registrant be revoked.
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. BM0548238, issued to Mary Massullo, D.O. 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 Mary Massullo, D.O., to renew or modify this registration, as well as any other pending application of Mary Massullo, D.O., for additional registration in Ohio. This Order is effective May 1, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on March 25, 2025, by Acting Administrator Derek Maltz. 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 .
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-05528 Filed 3-31-25; 8:45 am]
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