Registrant Actions - 2020
[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28678]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Annamalai Ashokan, M.D.; Decision and Order
On June 1, 2020, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, Government), issued an Order to Show Cause (hereinafter, OSC) to Annamalai Ashokan, M.D. (hereinafter, Registrant). OSC, at 1. The OSC proposed the revocation of Registrant's Certificate of Registration No. BA0859174. Id. It alleged that Registrant is without "authority to handle controlled substances in the State of California, the state in which [Registrant is] registered with the DEA." Id. at 1-2 (citing 21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that Registrant surrendered his medical license pursuant to an agreement he entered into with the Medical Board of California on November 12, 2019, and that his license remains surrendered. Id. at 1-2. The OSC further alleged that because Registrant surrendered his medical license, Registrant lacks the authority to handle controlled substances in the State of California. Id. at 2.
The OSC notified Registrant of the right to either request a hearing on the allegations or submit a written statement in lieu of exercising the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. (citing 21 CFR 1301.43). The OSC also notified Registrant of the opportunity to submit a corrective action plan. Id. at 3 (citing 21 U.S.C. 824(c)(2)(C)).
On June 4, 2020, a DEA Diversion Investigator placed a copy of the OSC addressed to the Registrant in his "office's outgoing mail pickup box for pickup by DEA mailroom staff that day. The letter would have been placed in the United States mail by DEA's mailroom staff no later than the following day, June 5, 2020." Request for Final Agency Action (hereinafter, RFAA) Exhibit (hereinafter, RFAAX) 4, at 1 (Declaration of Diversion Investigator). Registrant's attorney sent a letter, dated July 22, 2020, to the Assistant Administrator, Diversion Control Division, stating that Registrant had surrendered his medical license and that "he hereby waives his right to a hearing on this matter." RFAAX 5 (Letter from Registrant's Attorney), at 1. I find that more than thirty days have now passed since the Government accomplished service of the OSC.
Further, based on the Government's written representations, I find that neither Registrant, nor anyone purporting to represent Registrant, requested a hearing, submitted a written statement while waiving Registrant's right to a hearing, or submitted a corrective action plan. Further, I find that Registrant, through counsel, explicitly waived his right to a hearing. RFAA, at 2; RFAAX 5. Accordingly, I find that Registrant has waived the right to a hearing and the right to submit a written statement and corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this Decision and Order based on the record submitted by the Government, which constitutes the entire record before me. 21 CFR 1301.46.
I. Findings of Fact
a. Registrant's DEA Registration
Registrant is the holder of DEA Certificate of Registration No. BA0859174 at the registered address of 581 McCray Street, Suite E, Hollister, CA 95023. RFAAX 1 (Certification of Registration Status). Pursuant to this registration, Registrant is authorized to dispense controlled substances in schedules II through V as a practitioner-DW/30. Id. Registrant's registration will expire on June 30, 2021. Id.
b. The Status of Registrant's State License
On November 12, 2019, Registrant and the Medical Board of California entered into a Stipulated Surrender of License and Order, whereby Registrant surrendered his California medical license. RFAAX 3. The accusations surrounding the surrender included unprofessional conduct involving the prescription of controlled substances. Id. at 12-14. On November 20, 2019, the Medical Board of California entered an Order adopting the Stipulated Surrender with an effective date of November 27, 2019. Id. at 1. The Medical Board of California's online records, of which I take official notice, document that Registrant's license is still surrendered.\1\ Medical Board of California License Verification, https://www.mbc.ca.gov/Breeze/License_Verification.aspx (last visited date of signature of this Order).
\1\ 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 my finding by filing a properly supported motion for reconsideration within fifteen calendar days of the date of this Order. Any such motion shall be filed with the Office of the Administrator and a copy shall be served on the Government. In the event Registrant files a motion, the Government shall have fifteen calendar days to file a response. Any such motion and response may be filed and served by email (email@example.com).
Accordingly, I find that Registrant currently is not licensed to engage in the practice of medicine in California, the state in which Registrant is registered with the DEA.
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the CSA "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, 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 Fed. Appx. 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 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(f). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the CSA, the 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 at 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, 43 FR at 27617.
According to California statute, "[n]o person other than a physician . . . shall write or issue a prescription." Cal. Health & Safety Code Sec. 11150 (West 2020). Further, "physician," as defined by California statute, is a person who is "licensed to practice" in California. Id. at Sec. 11024.
Here, the undisputed evidence in the record is that Registrant 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 Registrant lacks authority to practice medicine in California and, therefore, is not authorized to handle controlled substances in California, Registrant is not eligible to maintain a DEA registration. Accordingly, I will order that Registrant's DEA registration be revoked.
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. BA0859174 issued to Annamalai Ashokan, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. Sec. 823(f), I hereby deny any pending application of Annamalai Ashokan, M.D. to renew or modify this registration or for any other registrations in the State of California. This Order is effective January 28, 2021.
Timothy J. Shea,
[FR Doc. 2020-28678 Filed 12-28-20; 8:45 am]
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