Notice2026-20226
By Grace Inc. Counseling Services; Decision and Order
Primary source
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Published
October 2, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 91 Issue 190 (Friday, October 2, 2026)</title>
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[Federal Register Volume 91, Number 190 (Friday, October 2, 2026)]
[Notices]
[Pages 62748-62754]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20226]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
By Grace Inc. Counseling Services; Decision and Order
I. Introduction
On October 29, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to By Grace Inc.
Counseling Services of Baltimore, Maryland (Respondent). OSC, at 1. The
OSC proposed the revocation of Respondent's DEA registration, No.
RB0369733, alleging that Respondent, a narcotic treatment program
(NTP), ``demonstrated a lack of effective controls and procedures to
guard against the diversion of controlled substances'' and committed
numerous recordkeeping violations that rendered DEA unable to determine
an accurate and complete inventory of the controlled substances on
hand. Id. at 2-4 (citing 21 U.S.C. 823(g); 21 U.S.C. 824(a); \1\ 21 CFR
1304.11(a)-(c), 1304.11(c), 1304.21(a), (d), 1304.04(a), (f)(2),
1304.24(a), 1305.05). The Government additionally alleged in its
Prehearing Statement that Respondent materially falsified its
application for a DEA registration by falsely responding ``no'' to
Liability Question 4--which asks whether any officer of the corporation
has ever been convicted of a crime in connection with controlled
substances--and by failing to disclose that its owner was convicted of
unlawful possession of controlled substances in Maryland.
Administrative Law Judge Exhibit (ALJX) 6, at 2-3.\2\
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\1\ In addition to alleging that Respondent violated 21 U.S.C.
823(h) by failing to maintain adequate records of its dispensing of
controlled substances, the OSC alleged that Respondent's
recordkeeping violations rendered its registration inconsistent with
the public interest under 21 U.S.C. 824(a). OSC, at 2. Because the
Government's Post-Hearing Brief discussed Respondent's recordkeeping
violations in the context of 21 U.S.C. 823(h) rather than analyzing
the public interest factors, the Agency treats the public interest
allegation as abandoned and does not consider it.
\2\ The Government also alleged that Respondent ordered
controlled substances when it lacked state authority. The Agency
agrees with the ALJ that the Government did not provide notice in
the OSC of the laws violated by this conduct, nor did the Government
demonstrate through substantial evidence that Respondent lacked
state authority when it ordered the controlled substances. RD, at
18-19.
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After conducting a hearing, Administrative Law Judge Paul E.
Soeffing (ALJ) issued his Recommended Rulings, Findings of Fact,
Conclusions of Law, and Decision of the Administrative Law Judge
(Recommended Decision or RD) on May 14, 2025. The RD recommended that
the Agency revoke Respondent's registration. RD, at 28. On June 3,
2025, the Government timely filed exceptions. The Agency adopts and
hereby incorporates by reference the ALJ's credibility findings,\3\
findings of fact, conclusions of law related to the Government's
recordkeeping allegations, sanctions analysis, and recommended
sanction, and summarizes and clarifies portions thereof herein. The
Agency does not adopt the ALJ's conclusions of law related to the
Government's material falsification allegation. Specifically, the
Agency disagrees with the ALJ's conclusion that the Agency does not
have authority to revoke an NTP's registration based on the material
falsification of a DEA application and the Agency finds that the
Government's material falsification allegation is supported by
substantial evidence.
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\3\ The Agency adopts the ALJ's summary of each witness's
testimony, as well as the ALJ's assessment of each witness's
credibility. See RD, at 2-13.
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II. Respondent's Recordkeeping Violations
A. Applicable Law
Congress enacted the Controlled Substances Act (CSA) ``to conquer
drug abuse and control the legitimate and illegitimate traffic in
controlled substances.'' Gonzales v. Raich, 545 U.S. 1, 12 (2005). A
particular concern of Congress was ``the need to prevent the diversion
of drugs from legitimate to illicit channels,'' and it ``devised a
closed regulatory system making it unlawful to manufacture, distribute,
dispense, or possess any controlled substance except in a manner
authorized by the CSA.'' Id. at 12-13.
The CSA's requirements under this closed regulatory system include
that ``every person who dispenses, or who proposes to dispense, any
controlled substance, shall obtain from the [DEA] a registration.'' 21
U.S.C. 822(a)(2); see also Gonzales v. Raich, 545 U.S. at 27-28. To
protect the American people and ensure compliance with the CSA,
Congress empowered the Agency to deny, suspend, or revoke a DEA
registration if the registrant failed to comply with the CSA's
recordkeeping requirements. 21 U.S.C. 824(a); 21 U.S.C. 823(h);
Gonzales v. Oregon, 546 U.S. 243, 251 (2006).
The Respondent in this case is registered as an NTP under 21 U.S.C.
823(h). Under Section 304 of the CSA, ``a registration pursuant to
section 823(h)[ ] of this title to dispense a narcotic drug for
maintenance treatment or detoxification treatment may be suspended or
revoked by the Attorney General upon a finding that the registrant has
failed to comply with any standard referred to in section 823(h)[ ] \4\
of this title.'' 21 U.S.C. 824(a). Section 823(h) outlines three
prerequisites for a practitioner applying for a registration to
dispense narcotic drugs for maintenance treatment or detoxification
treatment:
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\4\ The subsection of 21 U.S.C. 823 applicable to narcotic
treatment programs was modified on December 2, 2022, and again on
December 28, 2022. Prior to the modifications, the relevant
subsection applicable to narcotic treatment programs was designated
as 21 U.S.C. 823(g)(1), and it had three subparts, A-B, which
outlined the prerequisites for registration as a narcotic treatment
program. On December 2, 2022, the subsection was redesignated as 21
U.S.C. 823(h)(1), and it retained the same three subparts as the
previous version, A-B. On December 28, 2022, the subsection was
again redesignated as 21 U.S.C. 823(h), and the three subparts
outlining the registration prerequisites were redesignated as 1-3.
The December 28, 2022, citation is used throughout this decision.
21 U.S.C. 824(a), which authorizes the Attorney General to
suspend or revoke the registration of a narcotic treatment if the
registration prerequisites are not met, references back to the
relevant subsections of 21 U.S.C. 823. Prior to December 2, 2022,
the revocation provisions of Sec. 824(a) referred to the
registration prerequisites in Sec. 823(g)(1)(A-B). On December 2,
2022, 21 U.S.C. 824(a) was modified to reference the registration
prerequisites in Sec. 823(h)(1)(A-B). However, 21 U.S.C. 824(a) was
not modified again to reflect the December 28, 2022 redesignation
from 823(h)(1) to 823(h). As explained below, this was clearly an
unintentional technical error.
As currently written, 21 U.S.C. 824(a) would only authorize the
Attorney General to revoke a registration if the applicant is not
``qualified . . . to engage in the treatment with respect to which
registration is sought,'' because it only references 823(h)(1), and
not (h)(2) or (h)(3). However, there have not been any substantive
changes to Sec. 823 or Sec. 824 that reflect an intent to limit
the Attorney General's authority to revoke or suspend. Section
823(h) continues to clearly state that a registrant is not qualified
to possess a registration unless all three subparts are met.
Therefore, the Agency concludes that the failure to modify Sec.
824(a) on December 22, 2022, was an oversight, and that Congress
intended for the Attorney General to retain authority to suspend or
revoke a registration if a registrant fails to adhere to any of the
three registration prerequisites or standards referred to in section
823(h). See Dept. of Def., Army Air Force Exchange Serv. v. Fed.
Labor Relations Auth., 659 F.2d 1140, 1160 (D.C. Cir. 1981), cert.
denied, 455 U.S. 945 (1982) (A statute should be read in a ``manner
which effectuates rather than frustrates the major purpose of the
legislative draftsmen.'').
(1) ``the applicant . . . is determined by the Secretary to be
qualified . . . to engage in the treatment with respect to which
registration is sought;''
[[Page 62749]]
(2) ``the Attorney General determines that the applicant will
comply with standards established by the Attorney General respecting
(A) security of stocks of narcotic drugs for such treatment, and (B)
the maintenance of records (in accordance with section 827 of this
title) on such drugs''; and
(3) ``the Secretary determines that the applicant will comply
with standards established by the Secretary . . . respecting the
quantities of narcotic drugs which may be provided for unsupervised
use by individuals in such treatment.''
21 U.S.C. 823(h).
As the Agency has previously observed, ``in contrast to every other
category of registration set forth in section 823, Congress did not
characterize these three provisions as `factors' to be considered and
given discretionary weight `[i]n determining the public interest.' . .
. Rather, the three subparagraphs of section 823[h] are conditions for
registration.'' Turning Tide, Inc., 81 FR 47411, 47413 (2016).
In this matter, the Government's evidence in support of its prima
facie case relates to Respondent's failure to comply with the
requirements of 21 U.S.C. 823(h)(2) regarding ``maintenance of
records'' for narcotic drugs. RFAAX 3, at 1-4.
i. Continuing Records
According to the CSA and its implementing regulations, every
registrant dispensing controlled substances, including NTPs, ``shall
maintain, on a current basis, a complete and accurate record of each
controlled substance . . . received, sold, delivered, or otherwise
disposed of . . . .'' 21 U.S.C. 827(a)(3); 21 CFR 1304.21(a).\5\ These
records must include ``the date on which the controlled substances are
actually received, distributed, otherwise transferred, or destroyed.''
21 CFR 1304.21(d). NTPs also must maintain a dispensing log with the
following details about each narcotic controlled substance dispensed:
``(1) Name of substance; (2) Strength of substance; (3) Dosage form;
(4) Date dispensed; (5) Adequate identification of patient (consumer);
(6) Amount consumed; (7) Amount and dosage form taken home by patient;
and (8) Dispenser's initials.'' Id. Sec. 1304.24(a). The Agency has
repeatedly emphasized the importance of maintaining an accurate count
of controlled substances on hand, observing that ``the inability to
account for a significant number of dosage units creates a grave risk
of diversion.'' Houston Maintenance Clinic, 83 FR 42144, 42157 (2018)
(citing Med. Shoppe-Jonesborough, 73 FR 364, 367 (2008); Paul H.
Volkman, M.D., 73 FR 30630, 30644 (2008)).
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\5\ Pursuant to 21 CFR 1304.03, 1304.21, every registrant,
unless exempted, must comply with the recordkeeping and inventory
requirements outlined in DEA's implementing regulations. NTPs are
explicitly named in 21 CFR 1304.04(f) as a registrant that must
maintain records.
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ii. Inventories
NTPs also must maintain an ``initial inventory . . . of all stocks
of controlled substances on hand on the date [the pharmacy] first
engages in the . . . dispensing of controlled substances,'' as well as
a ``biennial inventory . . . of all stocks of controlled substances on
hand.'' 21 CFR 1304.11(a)-(c); see also 21 U.S.C. 827 (``every
registrant . . . shall . . . as soon [] as such registrant first
engages in the . . . dispensing of controlled substances, and every
second year thereafter, make a complete and accurate record of all
stocks thereof on hand''). A biennial inventory ``may be taken either
as of opening of business or as of the close of business on the
inventory date and it shall be indicated on the inventory.'' 21 CFR
1304.11(a). A biennial inventory shall include, for each controlled
substance in finished form: (1) the name of the substance; (2) the
finished form of the substance (e.g., 10 mg tablet); (3) the number of
units or volume of each finished form in each commercial container
(e.g., 100-tablet bottle); and (4) the number of commercial containers
of each such finished form (e.g., four 100-tablet bottles). 21 CFR
1304.11(e)(1)(iii); see 21 CFR 1304.11(e)(6) (``Each person registered
or authorized to dispense or conduct research with controlled
substances shall include in the inventory the same information required
of manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this
section.''). The registrant must make an exact count or measure of
controlled substances listed in Schedule I or II. 21 CFR
1304.11(e)(6)(i). For substances in Schedules III, IV, or V, the
registrant must ``make an estimated count or measure of the contents,
unless the container holds more than 1,000 tablets or capsules in which
case he/she must make an exact count of the contents.'' 21 CFR
1304.11(e)(6)(ii). Inventories and other records must be retained in a
readily retrievable manner ``for at least 2 years from the date of such
inventory or records, for inspection and copying.'' 21 CFR 1304.04(a).
iii. DEA Form 222
The CSA's implementing regulations specify the manner in which a
DEA registrant authorized to order Schedule I and II controlled
substances must fill out and execute a DEA Form 222. When a purchaser
initiates an order of controlled substances, the purchaser fills out
the form according to 21 CFR 1305.12. Then, the purchaser makes a copy
of the original Form 222 and submits the original to the supplier from
which it is ordering. 21 CFR 1305.13(a). Once the order is filled, the
purchaser must record on its copy of the Form 222 the number of
commercial or bulk containers furnished on each item and the dates on
which the containers are received by the purchaser. 21 CFR 1305.13(e).
If a DEA Form 222 cannot be filled for any reason, ``the supplier must
return the original DEA Form 222 to the purchaser with a statement as
to the reason,'' and the purchaser must maintain these records. 21 CFR
1305.15(b), (d). ``The purchaser must retain a copy of each executed
DEA Form 222 and all copies of unaccepted or defective forms with each
statement attached.'' 21 CFR 1305.17(a). ``DEA Forms 222 must be
maintained separately from all other records of the registrant . . .
[and] are required to be kept available for inspection for a period of
two years.'' 21 CFR 1305.17(c).
iv. Powers of Attorney
Generally, only persons who are registered to handle Schedule I or
II controlled substances may obtain and use a DEA Form 222 or issue
electronic orders for Schedule I or II controlled substances. 21 CFR
1305.04(a). However, a registrant may execute a power of attorney to
authorize one or more individuals to issue orders for Schedule I and II
controlled substances on the registrant's behalf. 21 CFR 1505.05. If
the registrant is not an individual, the power of attorney must be
executed by an officer of the registrant in addition to the person to
whom the power of attorney is being granted and two witnesses. 21 CFR
1305.05(d). A power of attorney may be revoked at any time by the
person who signed the most recent application for DEA registration or
reregistration, and the revocation form must be signed by two
witnesses. 21 CFR 1305.05(e), (f). Powers of attorney must be
``retained in the files, with executed Forms 222 where applicable, for
the same period as any order bearing the signature of the attorney,''
and they ``must be available for inspection together with other
records.'' 21 CFR 1305.05(a).
[[Page 62750]]
B. Findings of Fact
Respondent has a history of recordkeeping violations that have
resulted in the issuance of Letters of Admission (LOA) by DEA. Tr. 23;
RD, at 3-4. The first LOA in 2015 cited several recordkeeping
violations, including failing to maintain a biennial inventory, failing
to properly fill out DEA Forms 222, and storing 70 bottles of methadone
(a Schedule II controlled substance) on the floor of the nurses'
station. Tr. 27; GX 2, at 1; RD, at 3. Respondent entered a Memorandum
of Agreement (``MOA'') with DEA in 2018 in which Respondent agreed that
it had committed numerous recordkeeping violations, including failing
to maintain a biennial inventory, failing to accurately record the
number of packages received on DEA Forms 222, and failing to maintain a
functioning alarm system. Tr. 27-29; GX 3, at 1; RD, at 3, 16. The MOA
referenced recordkeeping violations that DEA investigators had
discovered during audits in 2009, 2014, and 2017. GX 3, at 1; RD, at
17.
DEA issued another LOA in 2022 outlining further recordkeeping
violations found during a September 7, 2022 inspection, including
failing to indicate on the biennial inventory whether it was taken at
the beginning of business or the close of business, failing to have two
witnesses execute a power of attorney, and failing to maintain a
written record of individuals authorized to receive controlled
substances. Tr. 30-32; GX 4, at 1; RD, at 3. Respondent denied these
violations in its Answer to the OSC, ALJX 3, at 1, but the Government
submitted a letter written by Respondent on January 23, 2023,
indicating that Respondent was taking corrective action to remedy the
violations outlined in the 2022 LOA. GX 4, at 3; RD, at 17. This letter
indicates that Respondent was aware of the recordkeeping violations in
2022 and did not contest them.
DEA received a complaint from the Maryland Behavioral Health
Administration about Respondent in February of 2024 and DEA conducted
an onsite inspection of Respondent on March 28, 2024. Tr. 20-21, 158;
RD, at 4. DEA investigators \6\ were unable to complete the inspection
on that date because Respondent's owner, Pamela Dukes (Ms. Dukes), was
unable to provide access to the dispensing room or to retrieve
requested records, including dispensing records and DEA Forms 222. Tr.
37-38, 160; RD, at 4.
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\6\ Two Diversion Investigators, DI1 and DI2, testified at the
hearing about the investigation. They are referred to collectively
throughout this Decision as ``DEA investigators,'' or individually
as DI1 and DI2.
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DEA investigators returned to Respondent on April 17, 2024, to
complete the audit. Tr. 39-40, 160. Ms. Dukes, S.R. (a nurse), and
Respondent's attorney were present. Tr. 40, 45; RD, at 4. DEA
investigators retrieved some DEA Forms 222 and dispensing records and
conducted a closing count and an alarm test. Tr. 40-41, 43-44, 46; GX
8, 10, 13. At the conclusion of the April 17, 2024 onsite visit, DEA
investigators requested, but did not receive, powers of attorney, an
alarm testing report, medical licenses, and additional DEA Forms 222.
Tr. 47-48. Subsequently, Respondent provided investigators with the
powers of attorney via email on April 19 and April 20, 2024. Tr. 48-49,
161; GX 9. Respondent also provided two additional dispensing reports
via email. Tr. 51-53; GX 18.
DEA uncovered numerous recordkeeping violations during the 2024
audit.
Continuing Records
DEA's audit of Respondent's controlled substances revealed overages
and shortages. Tr. 94-134; GX 12; RD, at 5, 23-24. These included an
overage of 102,043 milligrams of methadone liquid,\7\ an overage of
four 5-mg tablets of methadone,\8\ a shortage of eleven 10-mg tablets
of methadone, and a shortage of 378 40-mg tablets of methadone. Tr.
106-07, 112-23, 135, 143; GX 12; RD, at 24. The audit also showed that
Respondent had commingled 40-mg methadone tablets from various
manufacturers into one column of dispensing thereby failing to keep a
complete and accurate count of the controlled substances. Tr. 74, 120-
21, 174; RD, at 24.
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\7\ The overage indicates that Respondent dispensed more
methadone than Respondent had on hand. Tr. 106-07, 143; RD, at 6.
\8\ A shortage indicates that tablets that should be on site are
missing. Tr. 112-14; RD, at 6. Respondent's only explanation for the
shortage was that the methadone had been used. Tr. 114-15; RD, at 6.
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Respondent did not provide any reconciliation for the overages and
had no comment on the overages during the closing discussion on July
22, 2024. Tr. 108, 175; RD, at 6. The closing discussion was conducted
with S.R. and Ms. Dukes' child because Ms. Dukes excused herself before
the closing discussion began. Tr. 124; RD, at 6. DEA investigators were
therefore unable to do a reconciliation that reduced the shortage. Tr.
166. At the hearing, Ms. Dukes disputed the Government's calculations
of the overages and shortages, but even under Ms. Dukes' calculations,
there were still minor overages and shortages.\9\ ALJX 18, at 7-8.
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\9\ Ms. Dukes testified that there were ``glitches'' in the
software Respondent used to conduct inventories and testified that
the electronic reports would never be accurate. Tr. 241, 244, 249;
RD, at 10. Ms. Dukes testified that Respondent maintained hand count
inventories that reconciled the shortages. Tr. 244; RD, at 10. For
example, Ms. Dukes testified that Respondent's hand count
inventories for the 12-month period from April 2023 to April 2024
showed that only 1.25 tablets of Methadone and 0.08 milligrams of
liquid Methadone were missing. Tr. 244-45.
DI1 testified that she did not accept Ms. Dukes' reconciliation
because the hand records did not contain adequate information. Tr.
129, 135; GX 11. For example, they did not contain the name of the
controlled substance, they did not adequately identify the patients,
they did not indicate how much of a particular controlled substance
was consumed at the window during the dispensing or how much was
taken home by the patient, and, other than the first page, they did
not include the dosage form. Tr. 132-134; GX 11, at 1-17.
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Accordingly, the Agency finds substantial evidence that
Respondent's controlled substances inventory contained unexplained
overages and shortages, which demonstrates that Respondent failed to
maintain a complete and accurate record of controlled substances.
Further, DEA investigators reviewed the dispensing records supplied
by Respondent on July 22, 2024, and they did not include all the
information required by 21 CFR 1304.24(a). Tr. 127, 131-34; GX 11; RD,
at 24. The records were missing the patient's full name, the name of
the controlled substance and/or the dosage form, the amount
administered on site, and/or the take-home dosage. Tr. 132-34; GX 11,
at 1-17; RD, at 7, 24. Accordingly, the Agency finds substantial record
evidence that Respondent's dispensing records did not contain the
information required by 21 CFR 1304.24(a)(3).
Inventories
DEA investigators received five biennial inventories, dated April
4, 2022, October 24, 2022, April 4, 2023, October 1, 2023, and April 4,
2024. Tr. 55; GX 8; RD, at 4, 20. The testimony and evidence
demonstrated and the Agency finds substantial evidence that all five
inventories failed to include the number of units in each commercial
container, Tr. 57-62; GX 8; that the inventories on April 4, 2022,
October 24, 2022, and April 4, 2023, failed to indicate whether the
inventory was taken at the beginning or the close of business, Tr. 57-
59; GX at 3-5; and that the inventory on April 4, 2024, failed to
properly name the substance. Tr. 61-62; GX 8, at 1; RD, at 20.
[[Page 62751]]
Powers of Attorney
The Government introduced four powers of attorney into evidence.
Tr. 65-71; GX 9. The testimony and evidence demonstrated and the Agency
finds substantial evidence that all four powers of attorney lacked the
requisite witness signatures and therefore were improperly executed
and/or improperly revoked. Tr. 65-71; GX 9; RD, at. Specifically, the
powers of attorney for J.M. and Y.B. and two powers of attorney for
S.R. were missing the second witness signature needed for proper
execution, and the revocation of the power of attorney for Y.B. was
missing the witness signatures needed for proper revocation. Tr. 66-71;
GX 9; RD, at 21.
DEA Forms 222
The testimony and evidence demonstrated and the Agency finds
substantial evidence that fifteen DEA Forms 222 were not properly
executed because they did not include the proper name or strength of
the controlled substance, they did not include the date the controlled
substances were received or included incorrect dates, and/or they
indicated the wrong number of packages or package size. Tr. 74-85, 88-
91; GX 13, RD, at 5, 22. The testimony and evidence also demonstrated,
and the Agency finds substantial evidence that, S.R. executed fourteen
DEA Forms 222 without a properly executed power of attorney authorizing
her to order controlled substances on Respondent's behalf. Tr. 92-93;
GX 13, 15; RD, at 22. Finally, the testimony and evidence demonstrated
and the Agency finds substantial evidence that Respondent failed to
attach a cancellation form to a DEA Form 222 for an order that was
cancelled by the distributor. Tr. 89-90; GX 13; RD, at 23.
C. Conclusions of Law
Evidence is considered under section 823(h)(2) when it reflects a
failure to comply with ``standards established by the Attorney General
respecting . . . the maintenance of records (in accordance with [21
U.S.C.] 827 . . .) on such drugs.'' 21 U.S.C. 823(h)(2). Here, based on
Respondent's admissions and the findings above, the Agency finds
substantial evidence that Respondent: failed to maintain a complete and
accurate record of each controlled substance received and disposed of,
in violation of 21 U.S.C. 827(a)(3) and 21 CFR 1304.21(a); failed to
maintain a dispensing log containing the details required by 21 CFR
1304.24(a); failed to conduct and maintain a biennial inventory with
the details required by 1304.11(e)(1)(iii); failed to properly execute
fifteen DEA Forms 222, in violation of 21 CFR 1305.13, 1305.15,
1307.74; failed to properly execute and/or revoke four powers of
attorney, in violation of 21 CFR 1305.05(d), (e); allowed an individual
without a properly executed power of attorney to order controlled
substances, in violation of 21 CFR 1305.04; and failed to attach a
cancellation form to one DEA Form 222, in violation of 21 CFR
1305.17(a) and 1305.15(d).
The Agency finds that the Government's evidence satisfies its prima
facie burden of demonstrating that Respondent has failed to comply with
the requirements of 823(h)(2) regarding ``maintenance of records'' for
narcotic drugs.\10\ 21 U.S.C. 823(a); 21 CFR 1301.44. The Agency also
finds that there is insufficient mitigating evidence to rebut the
Government's prima facie case.
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\10\ Respondent's recordkeeping violations provide an
independent and sufficient basis to revoke Respondent's
registration. As discussed below, Respondent repeatedly committed
recordkeeping violations over the course of nearly a decade despite
DEA's multiple attempts to bring Respondent into compliance.
Respondent's failure to unequivocally accept responsibility for
these violations demonstrates that DEA cannot trust Respondent with
a registration and that revocation is necessary to achieve goals of
specific and general deterrence.
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III. Allegation That Respondent Materially Falsified DEA Applications
A. Applicable Law
i. Material Falsification of an Application by an NTP
In this case, there is disagreement about whether DEA has authority
under 21 U.S.C. 824(a)(1) to deny, suspend, or revoke an NTP's
registration if the NTP has materially falsified an application for a
DEA registration. The ALJ concluded that DEA does not have such
authority and declined to consider the Government's material
falsification allegation. The Government filed Exceptions disagreeing
with the ALJ. The Agency agrees with the Government and finds that the
CSA authorizes DEA to suspend or revoke an NTP's registration if DEA
makes a finding under any of the subsections of 21 U.S.C. 824(a),
including that the registrant has materially falsified an application
((a)(1)), has been convicted of a felony related to controlled
substances ((a)(2)), has lost state authority to handle controlled
substances ((a)(3)), or has been excluded from participation in a
federal healthcare program ((a)(5)).\11\ This interpretation is
supported by a plain language reading of Section 824(a) and is the most
logical implementation of Congress' intent.
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\11\ The Agency believes that the most logical, plain language
interpretation of 21 U.S.C. 824(a) authorizes DEA to revoke an NTP's
registration if DEA determines that the NTP's registration is
inconsistent with the public interest under 21 U.S.C. 824(a)(4).
However, 21 U.S.C. 824(a)(4) instructs the Agency to consider the
public interest factors applicable to the registrant under 21 U.S.C.
823, and 21 U.S.C. 823(h) does not identify public interest factors
applicable to NTPs. The registration provisions for other
registrants--such as practitioners and manufacturers--do identify
applicable public interest factors. If the Agency were confronted
with a public interest case involving an NTP, the Agency would apply
the set of public interest factors under section 823 that are most
relevant to the entity's operation considering the facts of the
case.
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Background
The CSA's provisions governing registration requirements to
manufacture, distribute, or dispense controlled substances are outlined
in 21 U.S.C. 823. Section 823 contains separate subsections identifying
the registration requirements for different categories of registrants,
including manufacturers (section 823(a), (c), (e)), distributors
(sections 823(b), (f)), practitioners (section 823(g)), and NTPs
(section 823(h)).
The CSA's provisions governing DEA's authority to revoke or suspend
DEA registrations are outlined in 21 U.S.C. 824(a). Section 824(a) has
two unlettered paragraphs that outline the circumstances under which
DEA is authorized to suspend or revoke a registration. The first
unlettered paragraph outlines DEA's authority to suspend or revoke any
registration granted under 21 U.S.C. 823 if DEA makes a finding related
to any of 824(a)'s five subsections (material falsification, felony
conviction, loss of state authority, public interest, or federal
healthcare exclusion). The second paragraph of Section 823(a) outlines
an additional ground for DEA to revoke an NTP's registration if the NTP
``has failed to comply with any standard referred to in section
823(h),'' which outlines the registration requirements for NTPs.
DEA's Authority To Revoke an NTP's Registration
The ALJ, referencing prior Agency decisions, concluded that the
second paragraph of section 824(a)--which was added in 1974 with the
passage of the Narcotic Addict Treatment Act of 1974 (NATA)--identifies
the only grounds available for DEA to revoke the registration of an
NTP, and that DEA is not authorized to revoke an NTP's registration
based on the grounds in section 824(a)(1)-(5). RD, at 14-16
[[Page 62752]]
(citing Turning Tide, Inc., 81 FR 47411, 47413 (2016) \12\; Houston
Maintenance Clinic, 83 FR 42144, 42156 (2018)). The Agency does not
find support for this interpretation in 21 U.S.C. 823 or 824(a). A
plain language reading of the first paragraph of section 824(a)--which
gives DEA authority to revoke ``[a] registration pursuant to section
823 of this title to manufacture, distribute, or dispense a controlled
substance or list I chemical'' for five enumerated reasons--supports
the Agency's interpretation that it may revoke the registration of an
NTP (which is ``a registration pursuant to section 823'') for any of
the five enumerated reasons. There is no language in section 824(a) or
823 that contradicts the straightforward language in the first
paragraph or implies that DEA may not revoke the registration of an NTP
based on the grounds enumerated in the first paragraph.
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\12\ In Turning Tide, a prior administration determined that DEA
did not have authority to revoke an NTP's registration on public
interest grounds in part because the NTP registration provision, 21
U.S.C. 823(h), does not seem to authorize DEA to deny an NTP's
application on public interest grounds, in contrast to the
registration provisions for manufacturers, distributors, and
practitioners. 21 U.S.C. 823. The prior administration also inferred
that because the revocation provision in 21 U.S.C. 824(a) contains a
second paragraph that states that it specifically applies to NTPs,
Congress did not intend for the first paragraph to apply to NTPs. As
discussed herein, the Agency interprets these provisions
differently. Nevertheless, in this case, the Agency is tasked with
determining whether it has authority to revoke an NTP's registration
based on a material falsification allegation, not a public interest
allegation, as in Turning Tide. The potential complexities
associated with applying the public interest factors to an NTP are
not present in a material falsification case.
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The ALJ did not identify any authority suggesting that Congress
intended for NTPs--which dispense the most addictive and dangerous of
the controlled substances--to have fewer guardrails than other
registrants. Of course, an NTP who materially falsifies an application
or whose owner has commited a felony related to controlled substances
is just as likely to pose a threat to the public as any other
registrant who does the same. Thus, the Agency believes that its plain
language interpretation implements Congress' intent.
In its Exceptions, the Government identifies a portion of NATA's
legislative history that supports the Agency's conclusion that Congress
did not intend to limit the Agency's authority to revoke registrations
of NTPs. NATA was passed on May 14, 1974, and amended the CSA to
require, among other things, that ``[p]ractitioners who dispense
narcotic drugs to individuals for maintenance treatment or
detoxification treatment'' must ``obtain annually a separate
registration for that purpose.'' 88 Stat. 124, sec. 3, codified at 21
U.S.C. 823(g) (1974). NATA also added the subparagraph referenced above
to section 21 U.S.C. 824(a) adding additional grounds for revocation of
NTPs' registrations.
The Senate Bill that introduced these amendments (S. 1115, Mar. 6,
1973) proposed to add ``or'' between the already-included revocation
grounds (which, at the time, were limited to material falsification,
felony conviction, and loss of state authority) and the new paragraph
containing the additional revocation ground for NTPs. S. 1115, 93rd
Cong., 1st Sess., at 3 (Mar. 6, 1973). The inclusion of ``or'' would
have removed any ambiguity as to whether an NTP's registration could be
revoked on the original revocation grounds. The bill that was
ultimately passed included alternate language from the text of the
House Bill, introduced as H.R. 12503 by Representative Hastings on
February 4, 1974, which laid out the new revocation grounds for NTPs as
a separate sentence and did not include the word ``or.'' H.R. 12503,
93rd Cong., 2d Sess., at *3 (Feb. 4, 1974). However, as the Government
observes in its Exceptions, ``nothing in the legislative history
suggests that there is any meaningful difference between the bills'
differing approaches to amending 21 U.S.C. 824(a), or that Congress
intended the House bill's approach to limit the Attorney General's
authority for revoking/suspending NTP registrations.'' Government's
Exceptions, at 5.
Accordingly, the Agency concludes that it has authority to revoke
an NTP's registration based on the material falsification of an
application.
ii. Material Falsification of an Application
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 CSA. 21 U.S.C.
824(a)(1).\13\ 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); see also Sasha Melissa Ikramelahai, 90 FR
32017, 32019 (2025); Michael Bouknight, 90 FR 31247, 31249 (2025).
---------------------------------------------------------------------------
\13\ 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.
---------------------------------------------------------------------------
Regarding materiality, 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 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.
B. Findings of Fact
Respondent submitted its initial application for a DEA registration
in 2008 and has submitted at least 16 renewal applications since then.
Tr. 193:24-194:7, GX 14a, 14b. On each application, Respondent answered
``no'' to Liability Question 4, which states, ``If the applicant is a
corporation, association, partnership, or pharmacy, has any officer,
partner, stockholder or proprietor been convicted of a crime in
connection with controlled substances under state or federal law[ . . .
]?'' GX 14b. The testimony and evidence demonstrated, and the Agency
finds clear and convincing record evidence, that these responses were
false. Ms. Dukes, the owner of Respondent and signatory on Respondent's
DEA registration applications, was convicted of Controlled Dangerous
Substance unlawful possession--a crime related to controlled
substances--on June 5, 1991, in Anne Arundel District Court. GX 15.
[[Page 62753]]
C. Conclusions of Law
As the Agency found above, Respondent submitted at least 17
applications for a DEA registration that contained false
statements.\14\ These false statements were material because they
``deprived [DEA] of information potentially relevant to'' the Agency's
analysis. Stirlacci, 85 FR at 45234-35; 21 U.S.C. 823(h). Respondent's
falsities are connected to two of the determinations that must be made
before registering an applicant to dispense narcotic drugs to
individuals for maintenance treatment or detoxification treatment. 21
U.S.C. 823(h). First, the falsity is potentially relevant to DEA's
determination of whether the applicant will ``comply with standards
established by the Attorney General respecting (A) security of stocks
of narcotic drugs for such treatment, and (B) the maintenance of
records . . . on such drugs.'' 21 U.S.C. 823(h)(2). Second, the falsity
is potentially relevant to the Health and Human Services analysis
regarding whether the applicant will ``respect[] the quantities of
narcotic drugs which may be provided for unsupervised use by
individuals in such treatment.'' 21 U.S.C. 823(h)(3). Because
Respondent's false statements deprived the Agency of information
potentially relevant to its analysis, they were ``predictably capable
of affecting . . . [DEA's] official decision'' regarding whether
Applicant met ``the requirements for'' registration. Kungys, 485 U.S.
at 771. DI2 testified that if Respondent had disclosed Ms. Dukes'
conviction, DEA would have conducted ``further research into the
charges and how it could potentially affect [Respondent's] handling
controlled substances in their proposed business activity.'' Tr. 195.
---------------------------------------------------------------------------
\14\ Ms. Dukes testified at the hearing that she did not know
that she had been convicted of a crime because ``it [ ] showed up as
nolle processed.'' Tr. 215-16. Respondent seems to concede in its
Post-Hearing Brief that Ms. Dukes knew about the conviction, but
that her ``failure to disclose was the result of a good-faith belief
that the aged conviction, having long since been resolved, was not
material to the registration process.'' ALJX 18, at 13. Accordingly,
the Agency finds that Ms. Dukes knew about the conviction that she
failed to disclose.
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In sum, the Agency finds clear, unequivocal, and convincing record
evidence that Respondent submitted materially false applications for
registration.\15\ 21 U.S.C. 824(a)(1).\16\
---------------------------------------------------------------------------
\15\ Respondent argues in its Post-Hearing Brief that Ms. Dukes'
failure to disclose her criminal conviction was not a material
misrepresentation because the conviction occurred in 1991, nearly
three decades ago and approximately seventeen years before
Respondent's first DEA application. ALJX 18, at 13. According to
Respondent, the conviction occurred during ``a period of Ms.
Duke[s'] life that has no bearing on her current professional
conduct or eligibility,'' and ``[s]ince that time, Ms. Dukes has
fully been rehabilitated, maintained an unblemished professional
record, and had no further interactions with law enforcement or
disciplinary authorities.'' Id. In support of Respondent's argument
regarding materiality, Respondent asserts that ``[c]ourts have
repeatedly rejected attempts to use `distant, isolated convictions
as dispositive grounds for denial without evidence of current risk
or misconduct''' and provides a citation to a case that the Agency
was unable to locate. Respondent's Post-Hearing Brief, at 14 (citing
Garcia v. Drug Enforcement Admin., 2013 U.S. App. LEXIS 24307 (D.C.
Cir. 2013)). Because it was unable to locate this case, the Agency
cannot verify Respondent's assertion.
Respondent further argues that the Government has not met its
burden of proof regarding materiality because it ``has not shown
that this seventeen-year-old conviction--if it had been disclosed--
would have led to a denial of the application.'' ALJX 18, at 13.
However, the Government need not prove that the application would
have been denied, but rather that the information that was omitted
was ``predictably capable of affecting . . . [DEA's] official
decision'' regarding whether Applicant met ``the requirements for''
registration. Kungys, 485 U.S. at 771. DEA has held that information
is material if it ``connect[s] to at least one of [the section 823]
factors that, according to the CSA, [the Administrator] `shall'
consider'' when analyzing whether or not to register an applicant.
Frank Joseph Stirlacci, M.D., 85 FR 45229, 45238 (2020) (citing 21
U.S.C. 823 and Kungys, 485 U.S. at 771); see also Sasha Melissa
Ikramelahai, 90 FR 32017, 32019 (2025); Michael Bouknight, 90 FR
31247, 31249 (2025). As discussed above, Respondent's conviction
relates to two such factors and DI2 testified that DEA would have
conducted further research if Respondent had disclosed this
conviction. Therefore, the Agency concludes that Respondent's
failure to disclose Ms. Dukes' conviction was material.
\16\ Although Respondent's material falsification of its DEA
applications provides an additional ground to revoke Respondent's
registration, the Agency would have revoked Respondent's
registration solely based on the substantial evidence that
Respondent has repeatedly violated recordkeeping regulations over
the course of nearly a decade. Based on Respondent's recidivism,
revocation is necessary to achieve goals of specific and general
deterrence.
---------------------------------------------------------------------------
As a result of this established violation, the Agency finds that
the Government has established a prima facie case for sanction, that
Registrant did not rebut that prima facie case, and that there is
clear, unequivocal, and convincing record evidence supporting the
revocation of Registrant's registration. 21 U.S.C. 824(a)(1).
IV. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Respondent's continued registration is inconsistent with
the public interest due to its numerous violations pertaining to
controlled substances, the burden shifts to Respondent to show why it
can be entrusted with a registration. Morall, 412 F.3d. at 174; Jones
Total Health Care Pharmacy, 881 F.3d 823, 830 (11th Cir. 2018); Garrett
Howard Smith, M.D., 83 FR 18882 (2018). 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. A registrant's acceptance of responsibility must be
unequivocal. Id. 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, DEA Administrators have found that the egregiousness and
extent of the misconduct are significant factors in determining the
appropriate sanction. Id. at 834 and n.4. DEA Administrators have also
considered the need to deter similar acts by the respondent and by the
community of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
A. Acceptance of Responsibility
Here, the ALJ found, and the Agency agrees, that Respondent did not
unequivocally accept responsibility for its misconduct. RD, at 27.
Although Respondent stated multiple times in its post-hearing brief
that it accepts responsibility for the recordkeeping violations, e.g.,
ALJX 18, at 7, 14, Respondent repeatedly minimized these violations.
For example, Respondent referred to them as ``technical missteps'' and
argued that it was ``grossly misguided'' for the Government to assert
that these errors warranted revocation. Id. Respondent's attempts to
minimize this egregious misconduct undermine any purported acceptance
of responsibility. Michael A. White v. Drug Enf't Admin., 626 F. App'x
493, 496-97 (5th Cir. 2015); see also Phong H. Tran, M.D., 90 FR at
14385.
Respondent also attempted to shift blame for the overages and
shortages to ``glitches'' in the Methasoft software it used and
suggested that it was ``not fair'' that DEA investigators conducted a
physical hand count of controlled
[[Page 62754]]
substances at the nurse's station and did not provide her with
documentation. RD, at 26 (citing tr. 241, 249). Ms. Dukes opted out of
the closing discussion on July 22, 2024, which would have been her
opportunity to reconcile any overages or shortages. Tr. 108, 175; RD,
at 6. Respondent's implication that DEA's investigation was unfair is
not supported by the record and undermines any acceptance of
responsibility. Cf. Ester Mark, M.D., 86 FR 16760, 16762 (2021)
(finding that the respondent did not accept responsibility because she
``pass[ed] blame on DEA for not telling her how to comply with
recordkeeping requirements'').
Respondent also provided incredulous testimony about the material
falsification charge that amounted to a denial of responsibility and
raised significant concerns about the Agency's ability to trust
Respondent moving forward. Ms. Dukes initially testified that she did
not disclose her criminal conviction in response to Liability Question
#4 because she did not know that she was convicted of any crime until
she was served with the OSC. Tr. 215. She further testified that she
answered ``no'' because:
I didn't understand it. I don't know. It was . . . so long ago,
and it looked like--it was [sic] showed up as nolle processed. [ ] I
don't know what I thought. I don't know. I was told that. I don't
know. I just--I'm not going to sit here. I don't know. I just don't
know. I was confused. I don't know.
Tr. 215-16. She continued to explain that she did not know about
the conviction until she received the OSC and discussed it with her
lawyer. Tr. 216. It is not credible for Ms. Dukes to testify that she
did not know that she was convicted of a crime when court records show
that she pled guilty and served one year of probation. GX 15, at 1.
Moreover, if Ms. Dukes was uncertain how to truthfully respond to
Liability Question #4, she should have investigated and inquired rather
than submitting a falsified form to a federal Agency.
B. Remedial Measures
When a registrant fails to make the threshold showing of acceptance
of responsibility, the Agency need not address the registrant's
remedial measures. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019)
(citing Jones Total Health Care Pharmacy, 81 FR at 79202-03); Daniel A.
Glick, D.D.S., 80 FR 74800, 74801, 74810 (2015). Even so, the Agency
finds that Respondent's evidence of remedial measures would not change
the result of this case even if Respondent had unequivocally accepted
responsibility. Respondent's limited remedial evidence consisted of Ms.
Dukes' testimony that she has employed engineers to rectify issues with
Respondent's electronic inventory system and that Respondent now
utilizes two large, graduated cylinders to accurately measure its
Methadone. ALJX 18, at 8. The Agency finds that these remedial efforts
are trivial considering Respondent's decade of recordkeeping errors,
and they are not sufficient to restore the Agency's trust.
C. Deterrence and Egregiousness
In addition to unequivocally accepting responsibility, the Agency
considers both specific and general deterrence when determining an
appropriate sanction. Daniel A. Glick, 80 FR at 74810. In this case,
the Agency agrees with the ALJ that the interests of specific
deterrence militate in favor of revocation given Respondent's repeated
recordkeeping violations over nearly a decade and Respondent's failure
to remediate despite ``repeated actions by DEA to educate the
Respondent and bring it into compliance with DEA requirements.'' RD, at
28. The interests of general deterrence also support revocation, as a
lack of sanction in the current matter would send a message to the
registrant community that the failure to maintain accurate records can
be excused. Id. As the ALJ stated, where Respondent has ``failed to
comply with the requirements concerning controlled substances, despite
numerous attempts by the agency to bring the respondent into long-term
compliance, the unmistakable message to the regulated community of
imposing no sanction or a limited sanction that permits the continued
handling of controlled substances by the respondent would be that such
conduct can be overlooked.'' Id.
Moreover, the Agency agrees with the ALJ that Respondent's actions
were egregious. As the ALJ stated, ``Respondent's violations were not
limited to a single instance or a single type of violation, but
consisted of widespread violations involving numerous biennial
inventories over several years, overages and shortage of controlled
substances, improper combination of controlled substances in its
records, incorrectly filling out DEA 222 forms, and incorrectly
executing powers of attorney.'' \17\ RD, at 27.
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\17\ Respondent's Post-Hearing Brief cites to a 2010 DEA
decision and asserts that, in that case, ``DEA declined to revoke a
pharmacy's registration despite `significant' recordkeeping issues,
noting the absence of diversion and the registrant's good-faith
corrective measures.'' East Main Street Pharmacy, 75 FR 66149
(2010). Respondent misrepresents the case's holding--the Agency
determined that the case was moot. Moreover, the Agency affirmed the
issuance of an Immediate Suspension Order and noted that, ``[w]hile
there is only the suspension order to review . . . , had Respondent
filed a renewal application, I would have denied it.'' Id. at 66165.
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Accordingly, the Agency will order the revocation of Respondent's
registration.
Order
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 revoke DEA Certificate
of Registration No. RB0369733 issued to By Grace Inc. Counseling
Services. 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 any
pending applications of By Grace Inc. Counseling Services to renew or
modify the named registrations, as well as any other pending
application of By Grace Inc. Counseling Services for additional
registration in Maryland. This Order is effective November 2, 2026.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 25, 2026, by DEA Administrator Terrance C. Cole. 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. 2026-20226 Filed 10-1-26; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on October 2, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.