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]
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).
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 also21 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]
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]
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 ( print page 14391) purpose.” Ohio Rev. Code Ann. sections 2925.11(A), (B)(1)(d) (West 2024). Further, a “[l]icensed health professional authorized to prescribe drugs” or “prescriber” means “an individual who is authorized by law to prescribe drugs or dangerous drugs or drug therapy related devices in the course of the individual's professional practice.” Id. section 4729.01(I). The definition further provides a limited list of authorized prescribers, the relevant provision of which is “[a] physician authorized under Chapter 4731[ ] of the Revised Code to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery.” Id. section 4729.01(I)(5). Additionally, Ohio law permits “[a] licensed health professional authorized to prescribe drugs, if acting in the course of professional practice, in accordance with the laws regulating the professional's practice” to prescribe or administer schedule II-V controlled substances to patients. Id. section 3719.06(A)(1)(a)-(b).
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.