[Federal Register Volume 90, Number 30 (Friday, February 14, 2025)]
[Notices]
[Pages 9631-9635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02622]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23-1]
Robert L. Carter, D.D.S.; Decision and Order
On September 29, 2022, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Robert L. Carter,
D.D.S., of Camden Wyoming, Delaware (Respondent). Request for Final
Agency Action (RFAA), Appendix (RFAAX) A, at 1, 9. The OSC proposes the
revocation of Respondent's DEA registration in Delaware, Number
BC5574048 (Registration), and the denial of Respondent's application
for a DEA registration in New Jersey, Application Number W20128194C
(Application), pursuant to 21 U.S.C. 824(a)(1), (a)(3), and (a)(4), and
823(g)(1), because Respondent materially falsified multiple renewal
applications and his registration is inconsistent with the public
interest.\1\ OSC, at 1.
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\1\ The OSC also proposes an additional ground for denial of
Respondent's application for a DEA registration in New Jersey on the
basis that he lacks authority to handle controlled substances in New
Jersey. The record contains no evidence showing that Respondent has
regained authority to handle controlled substances in New Jersey in
the time since his New Jersey controlled dangerous substance license
expired, but that evidence dates back to 2022. RFAA, GX 6. Even
without considering Respondent's state authority to handle
controlled substances in New Jersey, the Agency has ample grounds to
deny Respondent's 2020 application due to the substantial record
evidence that Respondent materially falsified multiple applications
and that granting the application would be inconsistent with the
public interest.
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I. Procedural Background
The OSC notified Respondent of the right to request a hearing. OSC,
at 7-8 (citing 21 CFR 1301.43). On October 25, 2022, Respondent timely
requested a hearing in this matter. RFAAX B. The matter was placed on
the docket of DEA Chief Administrative Law Judge John J. Mulrooney, II
(the Chief ALJ), who, on October 26, 2022, issued an Order for
Prehearing Statements. RFAAX C. The Order for Prehearing Statements
directed the parties to submit prehearing statements and explained the
criteria these statements must meet to be considered adequate. Id. at
2. Consistent with Agency practice, the Order for Prehearing Statements
explained that an adequate prehearing statement must include the names
of witnesses expected to testify at the hearing, a summary of their
expected testimony, and a list of evidentiary exhibits expected to be
offered at the hearing. Id.; see also 21 CFR 1316.52(c), 1316.58. The
Order for Prehearing Statements further notified the parties that
failure to submit a compliant prehearing statement may incur a
sanction, to include ``a waiver of hearing and an implied withdrawal of
a request for hearing.'' RFAAX C, at 4. The Order for Prehearing
Statements also set the date for the prehearing conference. Id. at 3;
see also 21 CFR 1316.54.
Both parties submitted timely prehearing statements. RFAAX D & E.
The Chief ALJ, however, found Respondent's prehearing statement to be
deficient. RFAAX F, at 1. Specifically, the Chief ALJ noted that
instead of providing names of witnesses, summaries of testimony, and
proposed exhibits as directed, Respondent's prehearing statement stated
that Respondent could not comply with the Order for Prehearing
Statements because the Government had not turned over documents
supporting the OSC. Id. at 2. The Chief ALJ found that Respondent's
noncompliant prehearing statement amounted to ``a refusal to follow the
issued directions.'' Id. The Chief ALJ issued an Order Directing
Compliance (Compliance Order) in which he provided Respondent another
opportunity to submit a compliant prehearing statement and again
informed Respondent that failure to do so could result in ``dismissal
of his request for hearing.'' Id. The Compliance Order further
explained the tribunal's ``[l]ongstanding practice'' of requiring
parties to identify proposed evidentiary exhibits in their prehearing
statements before being directed to exchange evidence. Id. at 2 n.3.
The Compliance Order additionally informed Respondent that he would be
provided the opportunity to file a supplemental prehearing statement at
a later time. Id.
Instead of submitting a compliant prehearing statement in response
to the Compliance Order as directed, Respondent submitted a letter in
which he reiterated his position that he cannot comply with the Order
for Prehearing Statements or the Compliance Order until he receives the
Government's ``supporting documents.'' RFAAX G, at 1. Specifically,
Respondent stated that he ``simply cannot respond without reviewing the
documents the Government has referenced'' and it is ``impossible'' to
identify witnesses and proposed testimony ``without the documents the
Government references.'' \2\ Id. at 2. Respondent concludes by stating
that ``once [he] receives the requested documents, [he] will provide an
appropriate response,'' but until then, he ``cannot provide an
appropriate response . . . without the documents supporting the
Government's case.'' \3\ Id. Attached to this letter were emails
between Respondent's counsel and DEA counsel in which it was explained
that the Government would supply its evidentiary exhibits to Respondent
according to the deadline established by the Chief ALJ at the
prehearing conference. Id. at 3-11.
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\2\ Respondent's argument that he does ``not know what is
contained in'' the Government's documents underlying the OSC is
disingenuous. RFAAX G, at 2. The Government's Prehearing Statement
noticed proposed exhibits of Respondent's Delaware registration
history, his New Jersey application history, his Delaware dental
license and controlled substances registration, his New Jersey
dental license, a letter showing the current status of his New
Jersey controlled dangerous substances registration, documents from
Respondent's New Jersey state administrative case, emails to
Respondent, and prescriptions he wrote. RFAAX D, at 14-17.
Respondent received a clear description of the exhibits, most of
which were publicly available records concerning Respondent, and
seven pages of detailed testimony in the Government's Prehearing
Statement. It is difficult to believe that Respondent truly felt
that he could not prepare a prehearing statement, which he was
informed could be supplemented after receiving the Government's
evidence.
\3\ In his letter to the Chief ALJ, Respondent stated that the
Government's documents supporting the OSC ``must be produced.''
RFAAX G, at 2. The question is not, however, whether the
Government's evidence ``must be produced''; the issues are whether
Respondent is entitled to receive the evidence prior to filing a
prehearing statement and whether the prehearing filing schedule
should be handled differently in this case than all other matters
that come before the tribunal. Respondent provided no authority to
support his claim that the evidence ``must be produced'' on demand
at the specific time that he requested it. Id. Likewise, he provided
no authority to support his expectation that this case be handled
differently than how the tribunal typically handles prehearing
procedures. Id.
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Following receipt of Respondent's letter and prior to the deadline
set by the Compliance Order, the Chief ALJ issued an Order Terminating
Proceedings (Termination Order) in which he found that Respondent had
``effectively waived his right to a hearing'' by failing to comply with
the Order for Prehearing Statements and Compliance Order, and by
informing the tribunal that he did not intend to
[[Page 9632]]
comply. RFAAX H, at 3. The Termination Order dismissed the request for
hearing, cancelled the scheduled prehearing conference, and terminated
the proceedings. Id. The Chief ALJ found that Respondent had failed to
show good cause for not submitting a compliant prehearing statement,
and that the sole basis for his continued noncompliance was his claim
that he could not comply until he received the Government's evidence.
Id. The Chief ALJ further found that Respondent's basis for not
complying did not constitute good cause to handle this case's
prehearing procedures ``in any manner that varie[d] from the multitudes
of cases that have been litigated in this forum in the past.'' Id.
After issuance of the Termination Order but shortly before the
deadline set by the Compliance Order,\4\ Respondent submitted an
amended prehearing statement. RFAAX I. In response, the Chief ALJ
issued a letter informing Respondent that because the matter had been
terminated, no action would be taken on the amended prehearing
statement \5\ and the matter would be returned to the Office of Chief
Counsel for any action it deemed appropriate. RFAAX J. In the month
following the Termination Order, Respondent submitted a letter
addressed to the DEA Administrator. RFAAX K.
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\4\ Respondent has not raised any argument concerning the timing
of the Termination Order, specifically, the fact that the
proceedings were terminated before the original 2:00 p.m. deadline
for filing an amended prehearing statement.
\5\ Respondent's amended prehearing statement was filed after
the matter had been terminated by the Chief ALJ. Nevertheless, the
Agency has reviewed the submission and finds that the amended
prehearing statement remains deficient. The only substantive
revisions include identifying Respondent as a witness, providing a
two-sentence summary of his proposed testimony, and indicating that
Respondent does not anticipate offering any evidence not offered by
the Government. RFAAX I, at 3. As for the summary of Respondent's
proposed testimony, the amended prehearing statement indicates that
he ``will testify to his knowledge of his application, license, and
application renewals. [Respondent] will testify in opposition to the
allegations in the [OSC].'' Id. This two-sentence summary fails to
comply with the Chief ALJ's order that summaries must disclose
``each and every matter as to which he intends to introduce evidence
in opposition'' and ``summaries are to state what the testimony will
be, rather than merely list the areas to be covered.'' RFAAX C, at
2.
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In this letter, Respondent reiterated the same arguments that he
advanced before the tribunal; specifically, that he was ``deprived of
the ability to defend himself,'' and that he was (and still is)
entitled to receive evidence from the Government prior to the normally
scheduled deadline for the exchange of evidence. Id. In support,
Respondent cited Transportation Leasing Co. v. Department of Employment
Services, 690 A.2d 487 (DC App. 1997). But that case stood for the
proposition that ``an individual is entitled to fair and adequate
notice of administrative proceedings that will affect his or her
rights, in order that he or she may have an opportunity to defend his
or her position.'' Id. at 489 (internal quotations and brackets
omitted). The Agency finds that Respondent received adequate notice of
the issues to be litigated and was given an opportunity to defend
himself. Respondent was notified of the allegations against him in the
OSC, afforded the right to request a hearing, received the Government's
Prehearing Statement which contained a detailed description of the
testimony that would be elicited to support the Government's
allegations, was put on notice of the evidence to be offered, and was
afforded the opportunity to submit his own prehearing statement and
propose his own evidence after reviewing the Government's submission.
Respondent was simply unwilling to proceed pursuant to the normal
prehearing process.
The Agency finds that the Chief ALJ acted within his authority in
determining that Respondent failed to cooperate with the tribunal's
prehearing procedures after being afforded two opportunities to come
into compliance and being cautioned on both occasions that failure to
comply would be treated as an implied waiver of his right to a hearing.
RFAAX C, at 2, 4; RFAAX F, at 2. The Chief ALJ did not err in using his
discretion to find that Respondent's failure to file a compliant
prehearing statement amounted to an implied waiver of his hearing
request.\6\
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\6\ The Agency distinguishes this case from Daniel B. Brubaker,
D.O., 77 FR 19322 (2012). In Brubaker, the ALJ found that despite
filing several deficient prehearing statements, the respondent's
repeated noncompliance did not amount to an implied waiver of his
hearing request. Id. at 19,322-23. The Agency notes that the present
matter is different from that case, in that the respondent in
Brubaker did not argue that his inability to file a compliant
prehearing statement was due to the Government's waiting to provide
its evidence until directed by the tribunal, an argument that the
Agency finds lacks merit. Moreover, in Brubaker, the respondent's
supplemental prehearing statement did disclose some details about
his defense, such as the identity of several witnesses and a
``vague[ ] outline[ ] [of] the testimony of his witnesses.'' Id. at
19,322. Furthermore, in both the present matter and Brubaker, the
Agency deferred to the ALJ's use of discretion in how to handle
repeated noncompliant filings.
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II. Findings of Fact
A. Material Falsification Allegation
The Agency finds clear, unequivocal, and convincing record evidence
for each of the following facts, which are uncontroverted. On October
31, 1995, the New Jersey State Board of Dentistry (State Board) issued
an Administrative Action (Complaint) against Respondent. RFAA, GX 7(B).
That Complaint alleged that Respondent improperly prescribed chloral
hydrate,\7\ to multiple individuals in violation of state law and
``accepted dental practices.'' Id. at 1-2, 5-8, 11-12, 17. The
Complaint further alleged that Respondent engaged in ``the
indiscriminate prescribing of [chloral hydrate],'' prescribed dosages
of chloral hydrate in excessive amounts, recorded inaccurate dosages of
chloral hydrate in his medical records compared to the amount actually
prescribed, and failed to create accurate patient medical records
supporting the issuance of chloral hydrate prescriptions. Id. at 6-17.
The Complaint alleged that a child who Respondent was treating died as
a result of Respondent's improper prescribing of chloral hydrate, and
that another child underwent emergency hospitalization due to being
``over-sedated'' with chloral hydrate prescribed by Respondent. Id. at
5-6, 10. The Complaint recommended that Respondent's state license to
practice dentistry in New Jersey be suspended or revoked. Id. at 18.
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\7\ Chloral hydrate is a schedule IV controlled substance sold
under the brand name Noctec. RFAAX A, at 4. The generic name
(chloral hydrate) is used in this Decision.
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The Agency finds clear, unequivocal, and convincing record evidence
that, on September 25, 1996, the State Board and Respondent entered a
Consent Order in which they agreed that, based upon the allegations in
the Complaint, Respondent's New Jersey dentistry license would be
suspended for one year, with 60 days of active suspension followed by
probation for the remaining period. RFAA, GX 7(C), at 2.
The Agency finds clear, unequivocal, and convincing record evidence
that, on January 19, 2004, and August 28, 2006, Respondent applied to
renew DEA registration BC5574048. RFAA, GX 1, at 4-5, 17-22. These
renewal applications asked whether ``the applicant [has] ever
surrendered (for cause) or had a state professional license or
controlled substance registration revoked, suspended, denied,
restricted, or placed on probation, or is any such action pending?''
(Liability Question 3). RFAA, GX 1, at 17.\8\ The Agency finds clear,
[[Page 9633]]
unequivocal, and convincing record evidence that Respondent accurately
answered ``yes'' to Liability Question 3 on both renewal applications.
Id. When an applicant answers ``yes'' to Liability Question 3, the
application prompts the applicant to provide additional information
explaining the answer. Id. On the January 2004 application, Respondent
entered the following narrative response explaining his ``yes'' answer
to Liability Question 3: ``1996 sixty day suspension for improper
record keeping. NJ license.'' Id. at 21. Respondent did not provide any
narrative information on the August 2006 application explaining his
``yes'' answer to Liability Question 3. Id. at 17-20.
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\8\ The quoted language appears in the 2006, 2009, 2012, 2015,
2018, and 2021 applications. RFAA, GX 1, at 7, 9, 11, 13, 15.
Liability Question 3 was phrased slightly differently on the 2004
renewal application, which asked whether ``the applicant ever
surrendered or had a state professional license or controlled
substance registration revoked, suspended, denied, restricted, or
placed on probation? Is any such action pending?'' RFAA, GX 1, at
21.
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The Agency finds clear, unequivocal, and convincing record evidence
that, on August 23, 2009, July 24, 2012, August 28, 2015, August 8,
2018, and August 15, 2021, Respondent submitted applications to renew
DEA registration BC5574048. RFAA, GX 1, at 2-15. On each of these
applications, Respondent falsely answered ``no'' to Liability Question
3, representing that he had never had a state professional license or
controlled substance registration suspended or placed on probation. Id.
at 7, 9, 11, 13, 15.
The Agency finds clear, unequivocal, and convincing evidence that,
on December 11, 2020, Respondent applied for a new DEA registration
addressed in New Jersey (Application Number W20128194C). RFAA, GX 2, at
1-3. On this application, Respondent answered ``yes'' to Liability
Question 3. Id. at 3. Respondent entered the following narrative
response explaining his ``yes'' answer to Liability Question 3: ``My
license was suspended in 1992, 22 years ago for failure to keep
adequate records. I agreed to a consent order, rather than pay for an
investigation at my expense. My license was suspended for 30 days. The
license was suspended for 30 days and restored.'' Id. at 6-7.
B. Prescriptions Issued in Violation of the CSA's Requirement That
Registrant Maintain Separate Registrations at Each Principal Place of
Business or Professional Practice Where the Registrant Dispenses
Controlled Substances
The Agency finds substantial record evidence for each of the
following facts, which are uncontroverted. Respondent is a licensed
dentist in both Delaware and New Jersey. RFAA, GX 3-6. Respondent's DEA
registration, BC5574048, was originally registered in the State of New
Jersey, but Respondent applied to change the registered address to
Delaware. RFAA, GX 1, at 1. On May 23, 2019, Respondent's change of
address application was approved, and the registered address for DEA
registration BC5574048 became the State of Delaware. RFAA, GX 1, at 1.
DEA registration BC5574048 has been registered to an address in
Delaware ever since May 23, 2019. Id. Prior to that date, it was
registered in New Jersey. Id.
The Agency finds substantial record evidence that, from June 19,
2019, to November 28, 2020, Respondent issued eight prescriptions \9\
for controlled substances using a State of New Jersey prescription pad
bearing registration number BC5574048 and a place of business address
in New Jersey. RFAA, GX 11-18. Respondent issued these New Jersey
prescriptions even though he did not have a DEA registration in New
Jersey at that time. RFAA, GX 1-2.
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\9\ The eight prescriptions are: (1) acetaminophen-codeine 300/
30 mg, Schedule III, issued to M.J. on June 19, 2019, RFAA, GX 11;
(2) hydrocodone-acetaminophen 7.5/325 mg, Schedule II, issued to
L.L. on July 13, 2019, RFAA, GX 12; (3) acetaminophen-codeine 300/30
mg, issued to R.J. on December 14, 2019, RFAA, GX 13; (4) tramadol
50 mg, Schedule IV, issued to G.B. on March 7, 2020, RFAA, GX 14;
(5) diazepam 10 mg, Schedule IV, issued to T.R. on July 24, 2020,
RFAA, GX 15; (6) tramadol 50 mg, issued to G.B. on October 14, 2020,
RFAA, GX 16; (7) acetaminophen-codeine 300/30 mg, issued to C.M. on
November 28, 2020, RFAA, GX 17; acetaminophen-codeine 300/30 mg,
issued to N.F. on November 28, 2020, RFAA, GX 18. See also 21 CFR
1308.12-14.
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III. Discussion
A. The CSA and the OSC Allegations
Pursuant to the CSA, the Attorney General is authorized to suspend
or revoke a registration ``upon a finding that the registrant . . . has
materially falsified any application filed pursuant to or required by
this subchapter.'' 21 U.S.C. 824(a)(1).
Also according to the CSA, ``[a] registration . . . to . . .
distribute[ ] or dispense a controlled substance . . . may be suspended
or revoked by the Attorney General upon a finding that the registrant .
. . has committed such acts as would render his registration under . .
. [21 U.S.C. 823] inconsistent with the public interest as determined
by such section.'' 21 U.S.C. 824(a)(4). In the case of a
``practitioner,'' Congress directed the Attorney General to consider
five factors in making the public interest determination. 21 U.S.C.
823(g)(1)(A-E).\10\ The five factors are considered in the disjunctive.
Gonzales v. Oregon, 546 U.S. 243, 292-93 (2006) (Scalia, J.,
dissenting) (``It is well established that these factors are to be
considered in the disjunctive,'' citing In re Arora, 60 FR 4447, 4448
(1995)); Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor
is weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 412
F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination of
factors, may be decisive. Penick Corp. v. Drug Enf't Admin., 491 F.3d
483, 490 (D.C. Cir. 2007); Morall, 412 F.3d. at 185 n.2; David H.
Gillis, M.D., 58 FR 37507, 37508 (1993).
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\10\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
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In this matter, while all of the 21 U.S.C. 823(g)(1) factors have
been considered, the Agency finds that the Government's evidence in
support of its prima facie public interest revocation case is confined
to factors B and D.
According to DEA regulations, ``[a]t any hearing for the revocation
. . . of a registration, the . . . [Government] shall have the burden
of proving that the requirements for such revocation . . . pursuant to
. . . 21 U.S.C. [Sec. ] 824(a) . . . are satisfied.'' 21 CFR
1301.44(e); see also Morall, 412 F.3d. at 174; 21 CFR U1301.44(d) (same
as to the ``denial of a registration'').
B. Material Falsification
As already discussed, Respondent submitted registration renewal
applications in 2009, 2012, 2015, 2018, and 2021 and falsely answered
``yes'' to the third liability question regarding whether he ever
surrendered (for cause) or had a state professional license revoked,
suspended, denied, restricted, or placed on probation, or whether any
such action is pending. Supra section II.A. Respondent answered ``no''
to the same liability question in 2004, 2006, and 2020. Id. The Agency
finds based on clear, unequivocal, convincing, and uncontroverted
evidence that these conflicting responses show that Respondent knew
that his false answers on certain renewal applications were, in fact,
falsities. Frank Joseph Stirlacci, M.D., 85 FR 45237-40 (collecting
cases).
Regarding materiality, the Supreme Court explained decades ago that
``the ultimate finding of materiality turns on an interpretation of
substantive law.'' Kungys v. United States, 485 U.S. 759, 772 (1988)
(citing a Sixth Circuit case involving 18 U.S.C. 1001 and explaining
that, even though the instant case
[[Page 9634]]
concerned 8 U.S.C. 1451(a), ``we see no reason not to follow what has
been done with the materiality requirement under other statutes dealing
with misrepresentations to public officers''). The Supreme Court also
clarified that a falsity is material if it is ``predictably capable of
affecting, i.e., had a natural tendency to affect, the official
decision.'' 485 U.S. at 771.
Respondent's false submissions are material under the Supreme
Court's materiality analysis because they are ``capable of affecting .
. . the [Agency's] official decision.'' Id. Indeed, Respondent's
falsifications relate to three of the five factors that the Agency must
consider in determining whether an application is consistent with the
public interest, and should be granted or denied: Factors A, B, and D.
21 U.S.C. 823(g); Frank Joseph Stirlacci, M.D., 85 FR 45229, 45234-35
(2020). Therefore, Respondent's falsifications directly implicate the
Agency's CSA mandated analysis and final decision by depriving it of
legally relevant facts needed to decide whether to grant Respondent's
application. Universal Health Servs., Inc. v. United States ex rel.
Escobar, 579 U.S. 176, 193 (2016) (``Under any understanding of the
concept, materiality `look[s] to the effect on the likely or actual
behavior of the recipient of the alleged misrepresentation.' '');
Maslenjak v. United States, 582 U.S. 335, 348 (2017) (concluding that
when ``there is an obvious causal link between the . . . lie and . . .
[the] procurement of citizenship,'' the facts ``misrepresented are
themselves disqualifying'' and the fact finder ``can make quick work of
that inquiry''). In other words, there is no doubt that Respondent's
falsifications were ``predictably capable of affecting, i.e., had a
natural tendency to affect, the official decision'' the CSA instructs
the Agency to make. Kungys, 485 U.S. at 771.
Consequently, the Agency must find, based on the CSA and the
analysis underlying multiple Supreme Court decisions involving
materiality, that Respondent's false responses on multiple registration
renewal applications dated 2009, 2012, 2015, 2018, and 2021 are
material.
C. Unlawful Prescribing and Public Interest Analysis
Under the CSA, ``[e]very person who dispenses[\11\] . . . any
controlled substance, shall obtain from the Attorney General a
registration issued in accordance with the rules and regulations
promulgated by him.'' 21 U.S.C. 822(a)(2). Moreover, ``[a] separate
registration [is] required at each principal place of business or
professional practice where the [registrant] . . . dispenses controlled
substances.'' Id. Sec. 822(e).
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\11\ ``The term `dispense' means to deliver a controlled
substance to an ultimate user . . . by, or pursuant to the lawful
order of, a practitioner, including the prescribing and
administering of a controlled substance . . . .'' 21 U.S.C. 802(10).
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As already discussed, the Agency found substantial record evidence
that while Respondent's registered place of business was in Delaware,
he issued multiple controlled substance prescriptions on a New Jersey
prescription pad containing a New Jersey place of business. Supra
section II.B. Because Respondent did not have a DEA registration in New
Jersey when the prescriptions for controlled substances were issued,
issuance of these prescriptions violated DEA's separate registration
requirement. The Agency finds that Respondent unlawfully issued
controlled substance prescriptions, implicating Factors B and D. 21
U.S.C. 823(g); 21 U.S.C. 822(e); Wedgewood Vill. Pharm., Inc. v.
Ashcroft, 293 F.Supp.2d 462, 467 (D.N.J. 2003). The Agency further
finds that Respondent's continued registration is inconsistent with the
public interest. 21 U.S.C. 823(g)(1).
While Respondent initially requested a hearing, his non-compliance
with prehearing proceedings resulted in his implied waiver of that
right. As such, Respondent also waived the opportunity to present
evidence and, therefore, to rebut the Government's prima facie case.
The Government's prima facie case was established by substantial record
evidence and clear, unequivocal, and convincing record evidence. Supra
section II. Accordingly, the Agency finds that there is substantial,
clear, unequivocal, convincing, and uncontroverted record evidence
supporting the revocation of Respondent's registration and denying his
application for registration in New Jersey. 21 U.S.C. 824(a)(1) and
(a)(4); 21 U.S.C. 823(g); supra section II.
IV. Sanction
Here, the Government has met its prima facie burden of showing that
Respondent's existing registration should be revoked and his
application for a new registration denied due to his multiple material
falsifications, and has shown that Respondent's continued registration
is inconsistent with the public interest due to his numerous violations
pertaining to his controlled substance prescribing. Accordingly, the
burden shifts to Respondent to show why he can be entrusted with a
registration. Morall, 412 F.3d. at 174; 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); supra sections
II and III. The issue of trust is necessarily a fact-dependent
determination based on the circumstances presented by the individual
respondent. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also
Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover, as past
performance is the best predictor of future performance, DEA
Administrators have required that a registrant who has committed acts
inconsistent with the public interest must accept responsibility for
those acts and demonstrate that it will not engage in future
misconduct. 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). A
registrant's acceptance of responsibility must be unequivocal. Jones
Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, a
registrant's candor during the investigation and hearing has been an
important factor in determining acceptance of responsibility and the
appropriate sanction. Id. Further, the Agency has found that the
egregiousness and extent of the misconduct are significant factors in
determining the appropriate sanction. Id. at 834 & n.4. The Agency has
also considered the need to deter similar acts by the respondent and by
the community of registrants. Jeffrey Stein, M.D., 84 FR 46972-73.
Regarding these matters, there is no record evidence that
Respondent takes responsibility, let alone unequivocal responsibility,
for the founded violations meaning, among other things, that it is not
reasonable to believe that Respondent's future controlled substance-
related actions will comply with legal requirements. Accordingly,
Respondent did not convince the Agency that he can be entrusted with a
registration.
Further, the interests of specific and general deterrence weigh in
favor of revocation. Given the foundational nature and vast number of
Respondent's violations, a sanction less than revocation would send a
message to the existing and prospective registrant community that
compliance with the law is not a condition precedent to maintaining a
registration.
Accordingly, I shall order the sanction the Government requested,
as contained in the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C.
[[Page 9635]]
824(a) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate of
Registration No. BC5574048 issued to Robert Carter, D.D.S. Further,
pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C.
824(a) and 21 U.S.C. 823(g)(1), I hereby deny pending application
Number W20128194C and any other pending application of Robert Carter,
D.D.S., for registration in Delaware or New Jersey. This Order is
effective March 17, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
February 3, 2025, by Acting Administrator Derek Maltz. 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.
[FR Doc. 2025-02622 Filed 2-13-25; 8:45 am]
BILLING CODE 4410-09-P