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On July 12, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show ( print page 79311) Cause (OSC) to Lawrence Rudolph, D.M.D., of Pittsburgh, PA, Washington, PA, and Cranberry TWP, PA (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 3, at 1, 3. The OSC proposed the revocation of Registrant's Certificates of Registration Nos. FR0070538, FR7760728, and FR7760730, alleging that Registrant's registrations should be revoked because Registrant is “currently without authority to prescribe, administer, dispense, or otherwise handle controlled substances in the Commonwealth of Pennsylvania, the state in which [he is] registered with DEA.” Id. at 1-2 (citing 21 U.S.C. 824(a)(3)).[1]
The OSC notified Registrant of his right to file with DEA a written request for hearing, and that if he failed to file such a request, he would be deemed to have waived his right to a hearing and be in default. Id. at 2 (citing 21 CFR 1301.43). Here, Registrant did not request a hearing. RFAA, at 2.[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. § 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), 1301.46. RFAA, at 1; 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, Registrant's Pennsylvania dental license expired on March 31, 2023. RFAAX 3, at 2. According to Pennsylvania online records, of which the Agency takes official notice, Registrant's dental license remains expired.[3] Pennsylvania Licensing System Verification Service, https://www.pals.pa.gov/#!/page/search (last visited date of signature of this Order). Accordingly, the Agency finds that Registrant is not licensed to practice dentistry in Pennsylvania, the state in which he is registered with DEA.
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, D.O.,76 FR 71371, 71372 (2011), pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton, D.O.,43 FR 27,616, 27,617 (1978).[4]
According to Pennsylvania statute, “dispense” means “to deliver a controlled substance, other drug or device to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare such item for that delivery.” 35 Pa. Stat. and Cons. Stat. Ann. § 780-102(b) (West 2024). Further, a “practitioner” means “a physician . . . dentist . . . or other person licensed, registered or otherwise permitted to distribute, dispense, conduct research with respect to or to administer a controlled substance, other drug or device in the course of professional practice or research in the Commonwealth of Pennsylvania.” Id.
Here, the undisputed evidence in the record is that Registrant lacks authority to practice dentistry in Pennsylvania. As discussed above, an individual must be a licensed practitioner to dispense a controlled substance in Pennsylvania. Thus, because Registrant lacks authority to practice dentistry in Pennsylvania and, therefore, is not authorized to handle controlled substances in Pennsylvania, Registrant is not eligible to maintain a DEA registration. Accordingly, the Agency will order that Registrant's DEA registrations 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 Certificates of Registration Nos. FR0070538, FR7760728, and FR7760730 issued to Lawrence Rudolph, D.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 Lawrence Rudolph, D.M.D., to renew or modify this registration, as well as any other pending application of Lawrence Rudolph, D.M.D., for additional registration in Pennsylvania. This Order is effective October 28, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on September 20, 2024, by Administrator Anne Milgram. 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 ( print page 79312) 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.
Footnotes
1. According to Agency records, Registrant's registrations expired on April 30, 2024. The fact that a registrant allows his 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).
Back to Citation2. Based on the Government's submissions in its RFAA dated March 20, 2024, the Agency finds that service of the OSC on Registrant was adequate. Specifically, the submitted Declaration from a DEA Diversion Investigator indicates that Registrant was personally served with the OSC on August 23, 2023. RFAAX 2, at 2.
Back to Citation3. 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). 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.” 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 Office of the Administrator, Drug Enforcement Administration at dea.addo.attorneys@dea.gov.
Back to Citation4. 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,76 FR 71371-72; Sheran Arden Yeates, D.O.,71 FR 39130, 39131 (2006); Dominick A. Ricci, D.O.,58 FR 51104, 51105 (1993); Bobby Watts, D.O.,53 FR 11919, 11920 (1988); Frederick Marsh Blanton,43 FR 27617.
Back to Citation[FR Doc. 2024-22204 Filed 9-26-24; 8:45 am]
BILLING CODE 4410-09-P
Document Information
- Published:
- 09/27/2024
- Department:
- Drug Enforcement Administration
- Entry Type:
- Notice
- Document Number:
- 2024-22204
- Pages:
- 79310-79312 (3 pages)
- PDF File:
- 2024-22204.pdf