90 FR 132 pgs. 31247-31251 - Michael Bouknight; Decision and Order
Type: NOTICEVolume: 90Number: 132Pages: 31247 - 31251
Pages: 31247, 31248, 31249, 31250, 31251FR document: [FR Doc. 2025-13117 Filed 7-11-25; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Michael Bouknight; Decision and Order
On December 2, 2024, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Michael Bouknight of Norristown, Pennsylvania (Applicant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 3, at 1, 4. The OSC proposed the denial of Applicant's applications for DEA registration, Control Nos. W24128628C and W24092701C, alleging that he currently lacks state authority to handle controlled substances in Pennsylvania and that he materially falsified his applications for registration. 1 Id. (citing 21 U.S.C. 824(a)(1), 824(a)(3)).
Footnotes:
1 ?The Government's RFAA notes that after the OSC was issued, Applicant submitted a third application, No. W24165770C. RFAA, at 1-2; RFAAX 4, at 2. Because the third application was not alleged in the OSC, the Agency makes no factual findings regarding it. The OSC, however, did allege that the factual allegations supported denial of " any applications for any other DEA registrations." RFAAX 3, at 1 (emphasis added). Thus, this Agency final order is effective as to the two applications identified in the OSC, as well as "any other pending applications," to include the third application submitted after the OSC. See infra Order.
On January 16, 2025, the Government submitted an RFAA to the Administrator requesting that the Agency issue a default final order denying Applicant's applications. RFAA, at 1, 4. After carefully reviewing the entire record and conducting the analysis as set forth in detail below, the Agency finds that Applicant is in default, finds that Applicant is without state authority, and finds that Applicant materially falsified his applications. Accordingly, the Agency grants the Government's RFAA and denies Applicant's applications.
I. Default Determination
[top] Under 21 CFR 1301.43, an applicant entitled to a hearing who fails to file a timely hearing request "within 30 days after the date of receipt of the [OSC] . . . shall be deemed to have waived their right to a hearing and to be in default" unless "good cause" is established for the failure. 21 CFR 1301.43(a), (c)(1). In the absence of a demonstration of good cause, an applicant who fails to timely file an answer also is "deemed to have waived their right to a hearing and to be in default." 21 CFR 1301.43(c)(2). Unless excused, a default constitutes "an admission of the factual allegations of the [OSC]." 21 CFR 1301.43(e).
The OSC notified Applicant of his right to file a written request for hearing and answer, and that if he failed to file such a request and answer, he would be deemed to have waived his right to a hearing and be in default. 2 RFAAX 3, at 3 (citing 21 CFR 1301.43). Here, Applicant did not request a hearing, file an answer, or respond to the OSC in any way. RFAA, at 2-4; RFAAX 4, at 2. Accordingly, Applicant is in default. 21 CFR 1301.43(c)(1); RFAA, at 1-4.
Footnotes:
2 ?Based on the Government's submissions in its RFAA dated January 16, 2025, the Agency finds that service of the OSC on Applicant was adequate. Specifically, the Declaration from a DEA Diversion Investigator (DI) indicates that on December 3, 2024, DI served the OSC on Applicant in-person. RFAAX 4, at 2.
"A default, unless excused, shall be deemed to constitute a waiver of the [applicant's] right to a hearing and an admission of the factual allegations of the [OSC]." 21 CFR 1301.43(e). Because Applicant is in default and has not moved to excuse the default, the Agency finds that Applicant has admitted to the factual allegations in the OSC. 21 CFR 1301.43(c)(1), (e), (f)(1).
Further, "[i]n the event that [an applicant] . . . 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." 21 CFR 1301.43(f)(1). Here, the Government has requested final agency action based on Applicant's default pursuant to 21 CFR 1301.43(c), (f), and 1301.46. RFAA, at 1-2, 4; see also 21 CFR 1316.67.
II. Lack of State Authority
A. Findings of Fact
The Agency finds that, in light of Applicant's default, the factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e). Accordingly, Applicant is deemed to have admitted, in accordance with the OSC, that there is no "record of [Applicant] having ever been authorized to handle controlled substances in Pennsylvania." RFAAX 3, at 2. According to Pennsylvania online records, of which the Agency takes official notice, Applicant does not possess any professional license that authorizes him to handle controlled substances under the laws of Pennsylvania. 3 Pennsylvania Department of State Licensing System Verification, https://www.pals.pa.gov/#!/page/search (last visited date of signature of this Order). Accordingly, the Agency finds that Applicant is not licensed to handle controlled substances in Pennsylvania, the state in which he is registered with DEA. 4
Footnotes:
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).
4 ?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 Applicant, as of the date of this Decision and Order, is not licensed to handle controlled substances in Pennsylvania. Accordingly, Applicant 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 dea.addo.attorneys@dea.gov.
B. Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General may 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. [21 U.S.C.] 802(21)."). The Agency has applied these principles consistently. See, e.g., James L. Hooper, M.D., 76 FR 71,371, 71,372 (2011), pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978). 5
Footnotes:
5 ?This rule derives from the text of two provisions of the Controlled Substances Act (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 at 71371-72; Sheran Arden Yeats, 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 at 27617.
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. §?780-102(b) (West 2025). Further, a "practitioner" means "a physician . . . 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 Applicant lacks authority to handle controlled substances in Pennsylvania. As discussed above, a person must be a licensed practitioner to dispense a controlled substance in Pennsylvania. Thus, because Applicant lacks authority to handle controlled substances in Pennsylvania, he is not eligible to obtain or maintain a DEA registration in Pennsylvania. Accordingly, the Agency will order that Applicant's applications for DEA registration be denied.
III. Material Falsification
A. Findings of Fact
[top] The Agency finds that, in light of Applicant's default, the factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e). Accordingly, Applicant is deemed to have admitted to each of the following facts. On July 8, 2024, and September 6, 2024, Applicant submitted applications for DEA registration as a practitioner in Schedules II through V. RFAAX 3, at 2. The application forms contained the following statement from DEA: "[Applicant] must be currently authorized to prescribe, distribute, dispense, conduct research, or otherwise handle the controlled
When Applicant submitted his applications, he was not authorized in Pennsylvania to handle controlled substances and there is no record that he has ever been authorized to handle controlled substances in Pennsylvania. Id. On each application, Applicant entered the Pennsylvania Medical Physician and Surgeon License number belonging to another person. Id.
B. Discussion
A DEA registration may be denied, suspended, or revoked upon a finding that the applicant or registrant materially falsified any application filed pursuant to or required by the Controlled Substances Act (CSA). 21 U.S.C. 824(a)(1). 6 To present a prima facie case for material falsification, the Government's record evidence must show (1) the submission of an application, (2) containing a false statement and/or omitting information that the application requires, (3) when the submitter knew or should have known that the statement is false and/or that the omitted information existed and the application required its disclosure, and (4) the false statement and/or required but omitted information is material, that is, it "connect[s] to at least one of [the section 823] factors that, according to the CSA, [the Administrator] `shall' consider" when analyzing "whether issuing a registration `would be inconsistent with the public interest.'?" Frank Joseph Stirlacci, M.D., 85 FR 45229, 45238 (2020) (citing 21 U.S.C. 823 and Kungys, 485 U.S. at 771). The Government must establish material falsification with record evidence that is clear, unequivocal, and convincing. Kungys, 485 U.S. at 772; Stirlacci, 85 FR at 45230-39.
Footnotes:
6 ?A statutory basis to deny an application pursuant to section 823 is also a basis to revoke or suspend a registration pursuant to section 824, and vice versa, because doing "otherwise would mean that all applications would have to be granted only to be revoked the next day . . . ." Robert Wayne Locklear, M.D., 86 FR 33738, 33744-45 (2021) (collecting cases).
The Supreme Court's decision in Kungys v. United States, 485 U.S. 759 (1988), and its progeny, guide the Agency's implementation of these CSA provisions.
First, the Government must prove that the applicant or registrant submitted an application for registration pursuant to the CSA. 21 U.S.C. 824(a)(1); see also 21 U.S.C. 822 (persons required to register); 21 U.S.C. 823(g)(1) (registration requirements).
Second, the Government must prove that the application contained a false statement or omitted information that the application required, either of which may constitute a material falsity. See, e.g., Emed Medical Company LLC and Med Assist Pharmacy, 88 FR 21719, 21720 (2023) (applicant falsely answered "no" to Liability Question 3 on seventeen applications when the true answer was "yes"); Richard J. Settles, D.O., 81 FR 64940, 64945-46 (2016) (applicant failed to disclose an interim consent agreement restricting his license based on findings that he issued controlled substance prescriptions without federal or state legal authority to do so). In making this assessment, the Agency will examine the entire application, including registrant's "yes/no" answers to the liability questions and any follow-up response(s). Daniel A. Glick, D.D.S., 80 FR 74800, 74802, 74808-09 (2015). To establish an omission, the Government must show both that omitted information existed and that the application required inclusion of that information. See, e.g., Richard A. Herbert, M.D., 76 FR 53942, 53956 (2011) (omission of a probation which the application required to be identified); Michel P. Toret, M.D., 82 FR 60041, 60042 (2017) (Voluntary Surrender Form alone is insufficient evidence to find material falsification based on registrant's "no" answer to the question regarding "surrender[s] (for cause)").
Third, the Government must prove that the applicant or registrant knew or should have known that the statement is false and/or that the omitted information existed and the application required its disclosure. See John J. Cienki, M.D., 63 FR 52293, 52295 (1998) ("[I]n finding that there has been a material falsification of an application, it must be determined that the applicant knew or should have known that the response given to the liability question was false."); Samuel Arnold, D.D.S., 63 FR 8687, 8688 (1998) ("It is also undisputed that Respondent knew that his Ohio dental license had previously been suspended."); Bobby Watts, M.D., 58 FR 46995, 46995 (1993) ("Respondent knew that the Tennessee Board of Medical Examiners had suspended his medical license on May 7, 1987, and had placed his state medical license on probation on May 2, 1988."); see also Stirlacci, 85 FR at 45236-37 & nn.22-23 (collecting cases).
Fourth, the Government must prove that the false statement and/or required but omitted information is "material." Kungys holds that a statement is material if it is "predictably capable of affecting, i.e., had a natural tendency to affect, the [Agency's] official decision," or stated differently, "had a natural tendency to influence the decision." Kungys, 485 U.S. at 771-72. As already discussed, materiality, for the purposes of the CSA, is tied to the factors that the Administrator "shall" consider when determining whether issuance of a registration "would be inconsistent with the public interest." 21 U.S.C. 823; Kungys, 485 U.S. at 771-72; Stirlacci, 85 FR at 45234, 45238.
The Government has the burden of proof in this proceeding. 21 CFR 1301.44. Here, the Agency finds that the Government's record evidence presents a prima facie case that Applicant submitted a materially false application. 21 U.S.C. 823, 824(a)(1).
Applicant submitted two applications for DEA registration; each form notified Applicant that state authority to handle controlled substances is a prerequisite to obtain a DEA registration. RFAAX 3, at 2. Both applications clearly asked for Applicant's state license number, to which Applicant responded with a license number that did not belong to him, and therefore, did not authorize him to handle controlled substances. Id. Thus, Applicant falsified his applications by representing that he was authorized "under the laws of" Pennsylvania to handle controlled substances and possessed state authority that he, in fact, knew or should have known that he did not possess. Id.
In addition, the falsifications were material. The Agency has consistently held for decades that possessing valid state authority to handle controlled substances is a prerequisite for obtaining a DEA registration. 7 See 21 U.S.C. 823(g)(1) (The Agency "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."). Thus, whether an applicant possesses valid state authority to handle controlled substances in the state for which the applicant seeks registration is a critical factor DEA must consider when reviewing an application. 8
Footnotes:
7 ? See Joely Keen, A.P.R.N., 90 FR 13882, 13883 (2025) ("DEA has . . . 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."); Blanton, 43 FR at 27617 (holding that "[s]tate authorization to dispense or otherwise handle controlled substances is a prerequisite to" obtaining and maintaining a DEA registration).
8 ? See 21 U.S.C. 802(21) (defining a "practitioner" as one who is "licensed, registered, or otherwise permitted, by . . . the jurisdiction in which he practices" to handle controlled substances "in the course of professional practice"); 21 U.S.C. 823(g)(1) ("The 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. 824(a)(3) (providing a basis for revoking a registration where the registrant lacks the requisite state authority to dispense controlled substances); Gonzales v. Oregon, 546 U.S. 243, 270 (2006) ("The structure and operation of the CSA presume and rely upon a functioning medical profession regulated under the States' police powers" and explaining registration requirements and the definition of "practitioner"); Hatem M. Ataya, M.D., 81 FR 8221, 8244 (2016) (explaining "the possession of state authority is a prerequisite for obtaining a registration"); Hoi Y. Kam, M.D., 78 FR 62694, 62696 (2013) ("Because possessing authority to dispense controlled substances under the laws of the State in which a physician practices medicine is a requirement for holding a DEA registration, . . . a false answer to the state license question is material where an applicant no longer holds authority to practice medicine (regardless of the reason for the State's action) or authority to dispense controlled substances . . . .") (emphasis added).
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In Steven Bernhard, D.O., the Agency found that an application was materially false where the applicant falsely represented that he possessed valid state authority to handle controlled substances, when in fact, he did not. 82 FR 23298, 23300 (2017). The Agency explained that "[b]ecause the possession of state authority is a prerequisite to obtaining and maintaining a practitioner's registration, Respondent's false representation[?] that he currently possessed a state license . . . [was] capable of influencing the Agency's decision to grant his . . . application." Id.; see also Thomas G. Easter II, M.D., 69 FR 5579, 5580 (2004) (finding that applicant materially falsified an application for registration by falsely representing that "he was `currently authorized to prescribe' controlled substances `under the laws of the State or jurisdiction in which [he was] operating or propose[d] to operate'?").
Here, Applicant's representations that he possessed authority in Pennsylvania to handle controlled substances had the capacity to lead DEA to believe that he met the qualifications for registration, when, in fact, he did not, because those qualifications did not belong to Applicant; they belonged to another practitioner. RFAAX 3, at 2. Thus, the falsities directly affected the statutory analysis that DEA was required to make when it reviewed his applications. 21 U.S.C. 802(21), 823(g)(1), 824(a)(3); Gonzales, 546 U.S. at 270; Stirlacci, 85 FR at 45238; Bernhard, 82 FR at 23300; Easter, 69 FR at 5580. Stated differently, his false representations of possessing state authority that he did not possess implicated DEA's statutory mandate to only issue registrations to practitioners possessing valid state authority. 21 U.S.C. 802(21), 823(g)(1), 824(a)(3). Thus, the false representations in Applicant's applications were material because they were "predictably capable of affecting . . . [DEA's] official decision" regarding whether Applicant met "the requirements for" registration. Kungys, 485 U.S. at 771.
In sum, the Agency finds clear, unequivocal, and convincing record evidence, and Applicant is deemed to have admitted, that he submitted two materially false applications for registration. 21 U.S.C. 824(a)(1); 21 CFR 1301.43(e).
As a result of this established violation, the Agency finds that the Government has established a prima facie case for sanction, that Applicant did not rebut that prima facie case, and that there is substantial record evidence supporting the denial of Applicant's applications. 21 U.S.C. 824(a)(1).
C. Sanction
Where, as here, the Government has presented a prima facie case showing that an applicant submitted a materially false application for registration, the burden shifts to Applicant to show why he can be trusted with a registration. Morall v. Drug Enf't Admin., 412 F.3d 165, 181 (D.C. Cir. 2005); Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D., 83 FR 18882, 18904 (2018). The issue of trust is a fact-dependent determination based on the circumstances presented by the individual practitioner. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total Health Care Pharmacy, 881 F.3d at 833. Historically, the Agency has considered acceptance of responsibility, egregiousness, and deterrence when making this assessment.
Specifically, the Agency requires the practitioner to accept responsibility for his or her violation. Jones Total Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). Acceptance of responsibility must be unequivocal. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024); Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see also Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, the Agency considers the egregiousness and extent of the misconduct in determining the appropriate sanction. Jones Total Health Care Pharmacy, 881 F.3d at 834 & n.4. The Agency also considers the need to deter similar acts by Applicant and by future applicants for registration. Stein, 84 FR at 46972-73.
Here, Applicant did not timely request a hearing, or timely or properly answer the allegations, and was therefore deemed to be in default. 21 CFR 1301.43(c)(1), (e), (f)(1); RFAA, at 1-4. To date, Applicant has not filed a motion with the Office of the Administrator to excuse the default. 21 CFR 1301.43(c)(1). Applicant has thus failed to answer the allegations contained in the OSC and has not otherwise availed himself of the opportunity to refute the Government's case. As such, Applicant has not accepted responsibility for the proven violations, has made no representations regarding his future compliance with the CSA, and has not made any demonstration that he can be trusted with registration.
Moreover, the evidence presented by the Government shows that Applicant used another person's license number on two applications to falsely represent that he possessed state authority to handle controlled substances, further demonstrating that Applicant cannot be trusted with the responsibilities of holding a controlled substances registration. To permit Applicant to receive a registration under these circumstances would send a dangerous message that fraud is an acceptable means of acquiring a DEA registration and that DEA does not require truthfulness from applicants and registrants.
Accordingly, the Agency will order the denial of Applicant's applications. 9
Footnotes:
9 ?In this matter there are two separate and distinct grounds by which the Government proposed denial, Applicant's lack of state authority and his material falsification; each ground, standing alone, supports the Agency's decision to deny.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823 and 824, I hereby deny the pending applications for a DEA Certificate of Registration, Control Nos. W24128628C and W24092701C, submitted by Michael Bouknight, as well as any other pending applications of Michael Bouknight for additional registration in Pennsylvania. This Order is effective August 13, 2025.
Signing Authority
[top] This document of the Drug Enforcement Administration was signed on July 8, 2025, by Acting Administrator Robert J. Murphy. 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
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-13117 Filed 7-11-25; 8:45 am]
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