2024-31320. Shiva Akula, M.D.; Decision and Order

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Department of Justice

Drug Enforcement Administration

1. [Docket No. 24-58]

On June 24, 2024, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Shiva Akula, M.D., of New Orleans, Louisiana (Respondent). OSC, at 1, 4. The OSC proposed the revocation of Respondent's DEA Certificate of Registration No. BA7786013, alleging that Respondent's DEA registration should be revoked because Respondent is “without authority to prescribe, administer, dispense, or otherwise handle controlled substances in the State of Louisiana, the state in which [he is] registered with DEA.” Id. at 2 (citing 21 U.S.C. 824(a)(3)).

By letter dated July 29, 2024, (filed August 7, 2024) Respondent requested a hearing. On August 29, 2024, the Government filed a Motion for Summary Disposition, to which Respondent did not respond. On September 26, 2024, Administrative Law Judge Teresa A. Wallbaum (the ALJ) granted the Government's Motion for Summary Disposition and recommended the revocation of Respondent's registration, finding that because Respondent lacks state authority to handle controlled substances in Louisiana, the state in which he is registered with DEA, “[t]here is no genuine issue of material fact in this case.” Order Granting the Government's Motion for Summary Disposition, and Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (RD), at 5. Respondent did not file exceptions to the RD.^[1]

Having reviewed the entire record, the Agency adopts and hereby incorporates by reference the entirety of the ALJ's rulings, findings of fact, conclusions of law, and recommended sanction as found in the RD and summarizes and expands upon portions thereof herein.

Findings of Fact

On January 12, 2024, the Louisiana State Board of Medical Examiners suspended Respondent's Louisiana medical license. RD, at 4.^[2] On March 31, 2024, Respondent's Louisiana medical license expired. RD, at 3. On June 1, 2024, Respondent's Louisiana controlled substance license expired. Id. at 4.

According to Louisiana online records, of which the Agency takes official notice, Respondent's Louisiana medical license remains suspended.^[3] Louisiana State Board of Medical Examiners, License Verification, https://online.lasbme.org/​#/​verifylicense (last visited date of signature of this Order). Further, Respondent's Louisiana controlled substance license status is “[l]apsed; not valid for practice.” Louisiana Board of Pharmacy, License Lookup, https://secure.pharmacy.la. gov/Lookup/LicenseLookup.aspx (last visited date of signature of this Order).

Accordingly, the Agency finds that Respondent is not currently licensed to practice medicine nor to handle controlled substances in Louisiana, the state in which he is registered with DEA. ( print page 106589)

Discussion

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 Controlled Substances Act (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, 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).^[4]

Under Louisiana statute, “dispense” means “to deliver a controlled dangerous substance to the ultimate user or human research subject by or pursuant to the lawful order of a practitioner, including the packaging, labeling, or compounding necessary to prepare the substance for such delivery.” La. Stat. Ann. section 40:961(14) (2024). A “practitioner” means “a physician . . . or other person licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or administer a controlled dangerous substance in the course of professional practice or research in th[e] state.” Id. section 40:961(35).

Further, Louisiana statute states that “[e]very person who . . . distributes, procures, possesses, prescribes, or dispenses any controlled dangerous substance within th[e] state . . . shall obtain a controlled dangerous substance license issued by the Louisiana Board of Pharmacy in accordance with the rules and regulations promulgated by the board prior to engaging in such activity.” Id. section 40:973(A)(1).

Here, the undisputed evidence in the record is that Respondent currently lacks authority to handle controlled substances in Louisiana because Respondent's Louisiana medical license is suspended, and Respondent's Louisiana controlled substance license is lapsed. As discussed above, an individual must be a licensed practitioner and must hold a Louisiana controlled substance license to dispense controlled substances in Louisiana. Thus, because Respondent lacks authority to practice medicine in Louisiana, as well as lacks authority to handle controlled substances in Louisiana, Respondent is not eligible to maintain a DEA registration. RD, at 5-6. Accordingly, the Agency will order that Respondent's DEA registration 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. BA7786013 issued to Shiva Akula, 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 Shiva Akula, M.D., to renew or modify this registration, as well as any other pending application of Shiva Akula, M.D., for additional registration in Louisiana. This Order is effective January 29, 2025.

Signing Authority

This document of the Drug Enforcement Administration was signed on December 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 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.  By letter dated September 18, 2024, (filed October 7, 2024) Respondent requested a 60-day extension to respond to the RD due to the pending appeal of an underlying conviction. Respondent's Request for Extension to File Response to Pending Action on DEA License (Respondent's Extension Request), at 1. The request was denied.

2.   See also Government's Notice of Filing of Evidence and Motion for Summary Disposition, Exhibit 1.

3.  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, Respondent 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 [e-mail].

4.  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.