On April 29, 2020, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Emmanuel Ayodele, M.D. (hereinafter, Applicant) of Compton, California. OSC, at 1. The OSC proposed the denial of Applicant's application for a DEA Certificate of Registration. Id. It alleged that Applicant is without “authority to handle controlled substances in California, the state in which [Applicant] seek[s] registration with DEA.” Id. (citing 21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that the Medical Board of California (hereinafter, MBC) issued an order on February 3, 2020, revoking Applicant's California Physician's and Surgeon's Certificate. Id. at 2. The OSC further alleged that, because the Board revoked Applicant's medical license, Applicant lacks the authority to handle controlled substances in the State of California. Id.
The OSC notified Applicant of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. at 2-3 (citing 21 CFR 1301.43). The OSC also notified Applicant of the opportunity to submit a corrective action plan. Id. at 3 (citing 21 U.S.C. 824(c)(2)(C)).
On June 24, 2020, Applicant, through counsel, requested a hearing, stating that Applicant “has filed a writ of administrative mandate in the Superior Court of California, San Francisco Division . . . for judicial review of the decision of the Medical Board of California” and that “DEA should await the final judgment.” Request for a Hearing, at 1.
The Office of Administrative Law Judges put the matter on the docket and assigned it to Chief Administrative Law Judge John J. Mulrooney II (hereinafter, Chief ALJ), who issued an Order Directing the Filing of Government Evidence Regarding its Lack of State Authority Allegation and Briefing Schedule on June 25, 2020, with which the Government complied by filing a Motion for Summary Disposition (hereinafter, Govt Motion) on July 7, 2020.
In its Motion, the Government submitted evidence that the MBC “found [Applicant] non-compliant with the probationary terms of its June 2017 order, ultimately resulting in the revocation of his California Physician's and Surgeon's Certificate.” Govt Motion, at 3-4. Further, the Government noted that the MBC had denied Applicant's Petition for Review of his revocation on April 14, 2020. Id. In light of these facts, the Government argued that DEA must deny Applicant's application. Id. at 5.
On July 15, 2020, Applicant filed “Applicant's Reply” (hereinafter, App Start Printed Page 24021Reply), in which he argued that there are no proceedings to stay, because Applicant is not requesting an action on his application at this time; therefore, he argued that the “sole issue presented is whether the DEA should withhold action on [Applicant's] application—which was submitted before his [California] medical license was revoked—until a final judgment is entered on his state petition for judicial review of the MBC's decision.” App Reply, at 1.
On July 21, 2020, the Chief ALJ issued an Order Granting the Government's Motion for Summary Disposition, and Recommended Rulings, Findings of Fact, Conclusions of Law, and Recommended Decision of the Administrative Law Judge (hereinafter, Summary Disposition or SD). The Chief ALJ noted that, “[c]ontrary to the [Applicant's] assertions . . . the instant proceedings are, in fact, proceedings.” SD, at 4 (citations omitted). Further, the ALJ noted that it appeared that Applicant was not contesting the underlying facts surrounding the grounds for the proceedings. Id. at 5. Therefore, the Chief ALJ determined that “in view of the Applicant's current lack of state authority, denial of the Applicant's application stands as the only legally available resolution.” Id. The Chief ALJ further concluded that “[s]ummary disposition is proper in an administrative enforcement proceeding where no genuine factual dispute exists.” Id. at 6 (citing Veg-Mix, Inc. v. U.S. Dept. of Agriculture, 832 F.3d 601, 607 (D.C. Cir. 1987) (comparing the standard for summary disposition in an administrative proceeding to summary judgment in a civil proceeding); Citizens for Allegan County, Inc. v. Federal Power Commission, 414 F.2d 1125, 1128 (D.C. Cir. 1969) (affirming that “the right of opportunity for hearing does not require a procedure that will be empty sound and show, signifying nothing”)).
By letter dated August 18, 2020, the ALJ certified and transmitted the record to me for final Agency action. In that letter, the ALJ advised that neither party filed exceptions. I find that the time period to file exceptions has expired. See 21 CFR 1316.66.
I issue this Decision and Order based on the entire record before me. 21 CFR 1301.43(e). I make the following findings of fact.
Findings of Fact
Applicant's DEA Registration
On or about June 6, 2018, Applicant filed an application (Application Control No. H18074119C) for a DEA Certificate of Registration as a practitioner in schedules II-V, with the proposed registered location of 1406 W 134th Street, Compton, California 90222. Govt Motion Exhibit (hereinafter, GX) 2 (Certification of Registration History), at 1.
The Status of Applicant's California License
On February 3, 2020, the MBC revoked Applicant's medical license. GX 3 (MBC Order), at 19. According to the Order, Applicant was suspended by the MBC following Applicant's October 10, 2013 felony conviction for health care fraud. Id. On June 16, 2017, the MBC adopted a Stipulated Settlement and Disciplinary Order, which imposed a period of probation, during which Applicant would be required to complete continuing medical education coursework, perform community service, obtain a psychological evaluation at his own expense, pay all probation costs, and complete a clinical competence assessment program. Id. at 3. Applicant failed to meet the terms of his probation and therefore, the MBC revoked Applicant's medical license. GX 3, at 19. The Applicant petitioned the MBC for reconsideration and his petition was denied on April 14, 2020. GX 4 (MBC Order Denying Petition for Reconsideration).
According to the online records of the California Department of Consumer Affairs, of which I take official notice, Applicant's license remains revoked.
https://search.dca.ca.gov/results (last visited date of signature of this Order). California's online records show that Applicant's medical license remains revoked and that Applicant is not authorized in California to practice medicine. Id.
As the Chief ALJ noted, Applicant does not appear to contest the status of his medical license or his state authorization to handle controlled substances. See SD, at 5 (citing App Reply, at 2). Based on the entire record before me, I find that Applicant currently is not licensed to engage in the practice of medicine in California.
Applicant's application requests registration as a “practitioner” in California. GX 1 (Applicant's Application). With respect to a practitioner, the 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 (2011), pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (1978).
This rule derives from the text of two provisions of the Controlled Substances Act (hereinafter, CSA). Controlled Substances Act (hereinafter, CSA). Pursuant to section 303(f) of the CSA, a prerequisite to registration as a practitioner is authorization to dispense controlled substances under the laws of the state in which the Applicant seeks to be registered.
21 U.S.C. 823(f) (“The Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the Applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.”). Further, the CSA defines “practitioner” as “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).
The Agency has long interpreted these statutory requirements strictly. The “controlling question” is “whether the Applicant is currently authorized to handle controlled substances in the state.” Anne Lazar Thorn, M.D., 62 FR 12847, 12848 (1997); see also Frederick Marsh Blanton, M.D., 43 FR 27616 (1978). Accordingly, the Agency has rejected arguments that it should relax these statutory requirements. For example, the Agency rejected as “of no consequence” the fact that the MBC summarily suspended a doctor's California medical license. Robert T. Perez, M.D., 84 FR 3247, 3248 (2019). “What is consequential,” the Agency Start Printed Page 24022determined, “is my finding that Registrant is no longer currently authorized to dispense controlled substances in California, the State in which he is registered.” Id. Similarly, the Agency rejected as “of no consequence” the argument that the MBC had not yet afforded the doctor a hearing to challenge the suspension of his California medical license. Frank D. Li, M.D., 82 FR 11238, 11240 (2017). See also Miles J. Nelson, M.D., 84 FR 3248, 3250 (2019) (summary suspension of state authority or state authority pending a final decision on the merits are of no consequence); Bourne Pharmacy, Inc., 72 FR 18273, 18274 (2007) (“Under the . . . [CSA], it is irrelevant that Applicant's state registration is being held in escrow pending state proceedings. Under the . . . [CSA], a practitioner must be currently authorized to handle controlled substances in `the jurisdiction in which [it] practices' in order to maintain its DEA registration.”).
According to California statute, “[n]o person other than a physician . . . shall write or issue a prescription.” Cal. Health & Safety Code § 11150 (West 2021). Further, “physician,” as defined by California statute, is a person who is “licensed to practice” in California. Id. at § 11024.
Here, the undisputed evidence in the record is that Applicant currently lacks authority to practice medicine in California. As already discussed, a physician must be a licensed practitioner to dispense a controlled substance in California. Thus, because Applicant lacks authority to practice medicine in California and, therefore, is not authorized to handle controlled substances in California, Applicant is not eligible to be granted a DEA registration. Accordingly, I will order that Applicant's application for a DEA registration be denied.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny the application submitted by Emmanuel Ayodele, M.D for a Certificate of Registration, Control Number H18074119C, as well as any other pending application of Emmanuel Ayodele, M.D. for additional registration in California. This Order is effective June 4, 2021.
D. Christopher Evans,
[FR Doc. 2021-09461 Filed 5-4-21; 8:45 am]
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