Notice2025-05528
Mary Massullo, D.O.; Decision and Order
Primary source
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Published
April 1, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 90 Issue 61 (Tuesday, April 1, 2025)</title>
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[Federal Register Volume 90, Number 61 (Tuesday, April 1, 2025)]
[Notices]
[Pages 14390-14391]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-05528]
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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\
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\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.
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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).
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\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.
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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] Sec. 1316.67.'' Id. Sec. 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, <a href="https://elicense.ohio.gov/oh_verifylicense">https://elicense.ohio.gov/oh_verifylicense</a> (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\
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\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
<a href="/cdn-cgi/l/email-protection#badedfdb94dbdeded594dbceced5c8d4dfc3c9fadedfdb94ddd5cc"><span class="__cf_email__" data-cfemail="88ecede9a6e9ecece7a6e9fcfce7fae6edf1fbc8ecede9a6efe7fe">[email protected]</span></a>.
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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. Sec. 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\
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\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.
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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
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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.
[FR Doc. 2025-05528 Filed 3-31-25; 8:45 am]
BILLING CODE 4410-09-P
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