[Federal Register Volume 86, Number 62 (Friday, April 2, 2021)]
[Notices]
[Pages 17403-17406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06801]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-34]


Brenton D. Goodman, M.D.; Decision and Order

    On August 19, 2020, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause (hereinafter, OSC) to 
Brenton D. Goodman, M.D. (hereinafter, Respondent) of Lafayette, 
Indiana. OSC, at 1. The OSC proposed the revocation of Respondent's 
Certificate of Registration No. FG7707409. It alleged that Respondent 
is without ``authority to handle controlled substances in the State of 
Indiana, the state in which [Respondent is] registered with the DEA.'' 
OSC, at 2 (citing 21 U.S.C. 824(a)(3)).
    Specifically, the OSC alleged that Respondent's Indiana medical 
license and Indiana controlled substances registration had both 
expired, leaving Respondent without authority to handle controlled 
substances in the State of Indiana. Id.
    The OSC notified Respondent 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. (citing 21 CFR 
1301.43). The OSC also notified Respondent of the opportunity to submit 
a corrective action plan. OSC, at 3 (citing 21 U.S.C. 824(c)(2)(C)).
    By letter dated September 22, 2020, Respondent timely requested a 
hearing.\1\ Hearing Request, at 1. According to the Hearing Request, 
Respondent denied that his Indiana medical license was expired and 
claimed that his Indiana controlled substance registration was in the 
administrative process of being renewed. Id. He further requested that 
the hearing be delayed ``to afford Registrant a reasonable opportunity 
to be heard before the Indiana Board of Pharmacy'' regarding the 
renewal of his Indiana controlled substance registration. Id.
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    \1\ The Hearing Request was filed on September 22, 2020. Order 
for Supplemental Briefing, at 1. I find that the Government's 
service of the OSC was adequate and that the Hearing Request was 
timely filed on September 22, 2020.
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    The Office of Administrative Law Judges put the matter on the 
docket and assigned it to Chief Administrative Law Judge John J. 
Mulrooney (hereinafter, the Chief ALJ). The Chief ALJ issued a Briefing 
Order, dated September 23,

[[Page 17404]]

2020, directing the parties to brief the Government's allegation that 
the Respondent lacked state authority and denying the Respondent's 
request for a stay. Order Granting Summary Disposition and Recommended 
Rulings, Findings of Fact, Conclusions of Law, and Decision dated 
January 13, 2021 (hereinafter, Recommended Decision or RD), at 2. The 
Government timely complied with the Briefing Order by filing a Motion 
for Summary Disposition (hereinafter, Government MSD) on October 8, 
2020. Id. In its motion, the Government presented evidence that 
demonstrated that Respondent lacks authority to handle controlled 
substances in Indiana, the state in which he is registered with the DEA 
and argued that, therefore, DEA must revoke his registration. 
Government MSD, at 3. Respondent answered the Government MSD in a 
Response in Opposition to Government's Motion for Summary Disposition 
(hereinafter, Respondent's Response) in which Respondent argued that 
``certain procedural and substantive defects'' of the Government's 
argument ``cannot be ignored.'' Respondent's Response, at 2-3. 
Specifically, Respondent argued that in the course of proceedings, the 
Government's theory of the case had changed such that Respondent was 
``deprived of due process guaranteed to him under the United States 
Constitution and the applicable statutes, rules and regulations.'' Id. 
at 3. Additionally, Respondent objected to the Government's 
introduction of what Respondent claimed was ``hearsay evidence that 
lacks appropriate foundation for authenticity.'' Id. at 7. Finally, the 
Respondent argued that the Government had not demonstrated that he had 
had his medical license and controlled substance registration 
``suspended, revoked, or denied by competent State authority,'' and 
argued that the limitation on his ``access'' to controlled substances 
did not limit his prescribing authority. Id. at 9.
    On January 7, 2021, Respondent filed a ``Belated Notice of 
Registrant's Current Status'' (hereinafter, Status Update), which 
stated that the Indiana Board of Pharmacy had issued a Decision 
regarding Respondent's Indiana controlled substances registration and 
argued that the DEA proceeding was now moot. Status Update, at 1. The 
Status Update included a copy of the Board's Decision, which stated 
that it was ``adopt[ing] the June 28, 2019 Medical Board Order.'' 
Status Update Exhibit 1, at 1.
    On January 13, 2021, the ALJ granted the Government MSD finding 
that because ``the Respondent does not have authority as a practitioner 
in Indiana, there is no other fact of consequence for this tribunal to 
decide in order to determine whether or not he is entitled to hold a 
[DEA Certificate of Registration].'' RD, at 7. The ALJ recommended that 
Respondent's DEA Certificate of Registration be revoked based on his 
lack of state authority. Id. By letter dated February 28, 2021, 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 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

Respondent's DEA Registration

    Respondent is the holder of DEA Certificate of Registration No. 
FG7707409 at the registered address of 5165 McCarty Lane, Lafayette, IN 
47905. Government MSD, Exhibit 1 (Certification of Registration 
Status), at 1. Pursuant to this registration, Respondent is authorized 
to dispense controlled substances in schedules II through V as a 
practitioner. Id. Respondent's registration expires on September 30, 
2021. Id.

The Status of Respondent's State License

    At the time DEA issued its OSC, Respondent's Indiana medical 
license and Indiana controlled substances registration were both 
expired. MSD, at 3. Respondent has since renewed his state medical 
license; \2\ however, under the terms of a previous order, Respondent's 
medical license is on indefinite probation. Id. Specifically, the 
Government submitted as evidence an Order issued by the Indiana Medical 
Board on June 28, 2019, which placed Respondent's Indiana medical 
license on indefinite probation and included a provision that 
prohibited Respondent from having ``access to Schedules I through V 
Controlled Substances, except for medications prescribed to him by a 
treating physician for Respondent's recovery or medical needs'' for the 
first two years of probation. MSD, Exhibit 4 (Indiana Medical Board 
Order),\3\ at 3. Respondent further submitted evidence that the Indiana 
Board of Pharmacy had adopted the Indiana Medical Board Order, which 
included all of the provisions of his probation, including the same 
restriction on access to controlled substances. Status Update, Exhibit 
1, at 1.
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    \2\ Respondent notes that the Government added to its foundation 
for revocation the fact that Respondent's medical license is 
currently on probation after the OSC was issued, and argues that the 
addition of this fact at this stage impeded Respondent's 
Constitutional right to due process of law. Respondent's Response, 
at 3-6. Although it is noted that the Indiana Medical Board's Order 
was in effect at the time of the issuance of the OSC, the status of 
Respondent's medical license and controlled substances registration 
at the time was expired, and it was the intervening act of 
Respondent on or about September 14, 2020, to renew his controlled 
substances registration, following the issuance of the OSC, that 
changed his status. See Respondent's Response, Exhibit (Respondent's 
Affidavit), at 1. The agency has frequently determined that an OSC 
does not need to be amended to account for loss of state authority 
grounds. See e.g., Hatem M. Ataya, M.D., 81 FR 8221, 8244 (2016). 
Furthermore, by virtue of Respondent's arguments in his response, I 
find that Respondent has had an opportunity to contest both the 
legal and factual predicates of the Government's case. See e.g., 
Duane v. Dep't of Defense, 275 F.3d 988, 993-96 (10th Cir. 2002); 
Abercrombie v. Clarke, 920 F.2d 1351, 1360 (7th Cir. 1990), cert. 
denied, 502 U.S. 809, 112 S.Ct. 52, 116 L.Ed.2d 29 (1991))(``Absent 
evidence that a party is misled by an administrative complaint, 
resulting in `prejudicial error,' we shall not reverse.'')
    \3\ It is noted that, although Respondent challenges some of the 
Government's supporting documentation, he does not appear to 
challenge the legitimacy or text of this Order, which is the primary 
document in the Government's evidence on which I am relying in this 
decision. See Respondent's Response, at 3 and Respondent's 
Affidavit.
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    According to Indiana's online records, of which I take official 
notice, both Respondent's Indiana medical license and Indiana 
controlled substances registration are listed as on indefinite 
probation.\4\ http://www.mylicense.in.gov/everification (last visited 
date of signature of this Order).
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    \4\ 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 my 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 [email protected].
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    Accordingly, I find that Respondent is currently restricted from 
access to controlled substances in Indiana, the state in which 
Respondent is registered with the DEA.

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 (hereinafter, CSA) ``upon a finding that the 
registrant . . . has had his State license or registration

[[Page 17405]]

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 71,371 (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).
    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.\5\ See, e.g., James L. Hooper, 
76 FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby 
Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43 
FR at 27,617.
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    \5\ I reject the Respondent's arguments related to the 
distinction between expiration and suspension or revocation of the 
registrant's state authority as inconsistent with long-established 
DEA decisions, including the case to which he cited in support of 
his argument. See William D. Levitt, 64 FR 49,822, 49,823 (1999) 
(because ``state authorization was clearly intended to be a 
prerequisite to DEA registration, Congress could not have intended 
for DEA to maintain a registration if a registrant is no longer 
authorized by the state in which he practices to handle controlled 
substances due to the expiration of his state license.'') 
Additionally, Respondent's argument is irrelevant, because the facts 
on the record here demonstrate that both the Pharmacy Board and the 
Medical Board of Indiana placed a restriction on Respondent's access 
to controlled substances.
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    Respondent makes two primary arguments related to the Indiana Board 
of Medicine's Order: (1) That the Indiana Board of Medicine has no 
authority to restrict Respondent's prescribing, Respondent's Response, 
at 9-10; and (2) that the term ``access'' in the Indiana Board of 
Medicine Order was ``in reference to controlled substances that Affiant 
would be in possession of for personal use,'' Respondent's Response, 
Respondent's Affidavit, at 2. In regard to the first argument, 
Respondent submitted evidence that the Indiana Board of Pharmacy had 
adopted the same terms of probation; and therefore, I find this 
argument to be mooted because the entity that Respondent claimed had 
the appropriate jurisdiction has now acted. See Status Update, Exhibit 
1, at 1. Further, I agree with the Chief ALJ's finding that 
Respondent's interpretation of the Indiana Board of Medicine's 
restrictions on his ``access'' to controlled substances as permitting 
him to continue to prescribe controlled substances contradicts the 
plain language of such terms. RD, at 5 (citing Respondent's Response, 
at 3, 6, 9). The Board's Order states that Respondent shall not have 
``access to Schedules I through V Controlled Substances, except for 
medications prescribed to him by a treating physician for Respondent's 
recovery or medical needs.'' MSD, Exhibit 4, at 3.

    The plain language of this provision makes the drafters' intent 
crystal clear: the limitations regarding his access to controlled 
substances do not apply to controlled medications prescribed for his 
benefit, but apply to any controlled substances he may encounter 
outside that scenario (to wit, medications that he might have 
occasion to prescribe or administer). Thus, the Respondent's 
position that the [Indiana Medical Board] used the term ``access'' 
in that clause only to describe controlled medications that might 
come ``in[to his] possession [ ] for personal use'' makes no sense, 
because the plain language of that clause already addresses drugs 
prescribed for his treatment. A contrary interpretation would 
indulge the unlikely supposition that the [Indiana Medical Board] 
was making a provision designed to regulate controlled substances he 
possesses without a prescription (i.e., abuse them).
    RD, at 5.\6\
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    \6\ I find that the Chief ALJ's reading is further bolstered by 
the additional terms of the Indiana Medical Board's Order, which 
state that once the initial two year probation period has ended and 
Respondent has met certain conditions, his medical license will be 
then be subject to a ``subsequent probation,'' which includes that 
``Respondent shall submit Quarterly Reports and Inspect Reports for 
both himself as a patient and as a prescribing physician for this 
Board's review.'' MSD, Exhibit 4, at 6. If the Indiana Medical Board 
intended for Respondent to be able to prescribe under the restricted 
access provision in the first two years of his probation, it would 
make little sense for the terms to have omitted a similar provision 
requiring such reports on his prescribing. The fact that the 
reporting provision appears as the probation becomes more lenient, 
further demonstrates that the Indiana Medical Board did not intend 
for Respondent to be able to prescribe for the beginning two years 
of probation.

    Furthermore, because ``the controlling question'' in a proceeding 
brought under 21 U.S.C. 824(a)(3) is whether the holder of a 
practitioner's registration ``is currently authorized to handle 
controlled substances in the state,'' Hooper, 76 FR at 71,371 (quoting 
Anne Lazar Thorn, 62 FR 12,847, 12,848 (1997)), the Agency has also 
long held that revocation is warranted even where a practitioner is 
still challenging the underlying action or where the state action is 
temporary. Kambiz Haghighi, M.D., 85 FR 5989 (2020); Bourne Pharmacy, 
72 FR 18,273, 18,274 (2007); Wingfield Drugs, 52 FR 27,070, 27,071 
(1987). Thus, it is of no consequence that the action is temporary. 
What is consequential is my finding that Respondent is not currently 
authorized to dispense controlled substances in Indiana, the state in 
which he is registered.
    According to Indiana statute, ``[e]very person who dispenses or 
proposes to dispense any controlled substance within Indiana must have 
a registration issued by the [Indiana Board of Pharmacy] in accordance 
with the board's rules.'' Ind. Code Sec.  35-48-3-3(b) (2021). 
``Dispense'' means ``to deliver a controlled substance to an ultimate 
user or research subject by or pursuant to the lawful order of a 
practitioner and includes the prescribing, administering, packaging, 
labeling, or compounding necessary to prepare the substance for that 
delivery.'' Ind. Code Sec.  35-28-1-12 (2021).
    Additionally, as discussed herein, there is direct evidence on the 
record that the terms of Respondent's probation explicitly prohibit him 
from access to controlled substances in Indiana. See Status Update, 
Exhibit 1, at 1; see also MSD, Exhibit 4.
    Here, the undisputed evidence in the record is that Respondent 
currently lacks authority to dispense controlled substances in Indiana. 
As already discussed, a physician must hold a controlled substances 
registration to dispense a controlled substance in Indiana. Thus, 
because Respondent lacks authority to handle controlled substances in 
Indiana, Respondent is not eligible to maintain a DEA registration. 
Accordingly, I will order

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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. 
FG7707409 issued to Brenton D. Goodman. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby 
deny any pending application of Brenton D. Goodman to renew or modify 
this registration, as well as any other application of Brenton D. 
Goodman, for additional registration in Indiana. This Order is 
effective May 3, 2021.

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-06801 Filed 4-1-21; 8:45 am]
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