Notice2026-19842
JT Medical, LLC; Decision and Order
Primary source
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Published
September 29, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 91 Issue 187 (Tuesday, September 29, 2026)</title>
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[Federal Register Volume 91, Number 187 (Tuesday, September 29, 2026)]
[Notices]
[Pages 61446-61447]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19842]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
JT Medical, LLC; Decision and Order
On September 29, 2025, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to JT Medical, LLC, of
Lewistown, Pennsylvania (Applicant). Request for Final Agency Action
(RFAA), Exhibit (RFAAX) 2, at 1, 6. The OSC proposed the denial of
Applicant's application for DEA registration, Control No. W17047690E,
alleging that Applicant's registration would be inconsistent with the
public interest. Id. at 1 (citing 21 U.S.C. 823(a)).
More specifically, the OSC alleged that Applicant could not provide
a bona fide supply agreement and did not have ``a substantially secured
cabinet to store marihuana.'' RFAAX 2, at 4 (citing 21 U.S.C. 822(f);
21 U.S.C. 823(a); 21 CFR 1301.71; 21 CFR 1301.72(a)(1)(ii); 21 CFR
1318.05(a)(1); 21 CFR 1318.05(b)(3)(i)). On November 24, 2025, the
Government submitted an RFAA requesting that the Agency issue a default
final order denying Applicant's application for registration. RFAA, at
1-3.
After carefully reviewing the entire record and conducting the
analysis as set forth in detail below, the Agency \1\ grants the
Government's RFAA and denies Applicant's application for registration.
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\1\ The CSA delegates authority to the Attorney General, who has
delegated it to the Administrator of DEA (the Agency). 28 CFR 0.100.
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I. Default Determination
As a preliminary matter, the Agency finds that service of the OSC
was adequate. On October 1, 2025, a DEA Diversion Investigator
``personally served'' the OSC on Applicant at its proposed place of
business in Lewistown, Pennsylvania. RFAAX 3, at 1. At the time of
service, Applicant's president, Mr. S.N., signed a Form DEA-12, Receipt
for Cash or Other Items, acknowledging receipt of the OSC. RFAAX 3, at
1-2 & Appendix A.
Under 21 CFR 1301.43, an applicant entitled to a hearing who fails
to file a timely hearing request ``within 30 days after the date of
receipt of the [OSC] . . . shall be deemed to have waived their right
to a hearing and to be in default'' unless ``good cause'' is
established for the failure. 21 CFR 1301.43(a), (c)(1). In the absence
of a demonstration of good cause, an applicant who fails to timely file
an answer also is ``deemed to have waived their right to a hearing and
to be in default.'' 21 CFR 1301.43(c)(2).
Here, the OSC notified Applicant of its right to file a written
request for hearing and answer, and that if it failed to file such a
request and answer, it would be deemed to have waived its right to a
hearing and be in default. RFAAX 2, at 4-5 (citing 21 CFR 1301.43).
Here, Applicant did not request a hearing or file an answer. RFAA, at
2. Accordingly, Applicant is in default. 21 CFR 1301.43(c)(1).
``A default, unless excused, shall be deemed to constitute a waiver
of [Applicant's] right to a hearing and an admission of the factual
allegations of the [OSC].'' 21 CFR 1301.43(e). Because Applicant is in
default and has not moved to excuse the default, the Agency finds that
Applicant has admitted to the factual allegations in the OSC. 21 CFR
1301.43(c)(1), (e), (f)(1).
Further, ``[i]n the event that [an applicant] . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] 1316.67.'' 21 CFR 1301.43(f)(1). Here, the
Government has requested final agency action based on Applicant's
default pursuant to 21 CFR 1301.43(c), (f)(1), and 1301.46. RFAA, at 2;
see also 21 CFR 1316.67.
II. Applicable Law
The Controlled Substances Act (CSA) states that the Agency shall
register an applicant to manufacture controlled substances in schedule
I or II if such registration is determined to be ``consistent with the
public interest and with United States obligations under international
treaties, conventions, or protocols in effect on May 1, 1971.'' 21
U.S.C. 823(a); see 21 CFR 1318.03(a); RFAAX 2, at 2. The CSA provides
six factors the Agency must consider in determining the public interest
in the context of registering a manufacturer of controlled substances
in schedule I or II. 21 U.S.C. 823(a)(1)-(6); 21 CFR 1318.05(a)(1)-(6);
RFAAX 2, at 2.
One of the CSA's required considerations is the ``maintenance of
effective controls against diversion of particular controlled
substances and any controlled substance in schedule I or II compounded
therefrom into other than legitimate medical, scientific, research, or
industrial channels, by limiting the importation and bulk manufacture
of such controlled substances to a number of establishments which can
produce an adequate and uninterrupted supply of these substances under
adequately competitive conditions for legitimate medical, scientific,
research, and industrial purposes.'' 21 U.S.C. 823(a)(1); 21 CFR
1318.05(a)(1); RFAAX 2, at 2.
DEA regulations further provide that in determining which
applicants to grant a manufacturer registration, the Agency shall place
``particular emphasis'' on certain ``criteria'' when assessing the six
public interest factors of 21 U.S.C. 823(a). 21 CFR 1318.05(b); RFAAX
2, at 3. Relevant here, DEA regulations direct the Agency to determine
``the number of qualified applicants necessary to produce an adequate
and uninterrupted supply of cannabis under adequately competitive
conditions.'' 21 CFR 1318.05(b)(3)(i); RFAAX 2, at 3. In making this
determination, the Agency ``shall place particular emphasis on the
extent to which any applicant is able to supply cannabis or its
derivatives in quantities and varieties that will satisfy the
anticipated demand of researchers and other registrants in the United
States who wish to obtain cannabis to conduct activities permissible
under the [CSA], as demonstrated through a bona fide supply agreement
with a registered researcher or manufacturer as defined in this
subpart.'' 21 CFR 1318.05(b)(3)(i); RFAAX 2, at 3.
In other words, the regulation directs the Agency to determine the
number of qualified applicants necessary to produce an adequate supply
of cannabis and, in doing so, to ``place particular emphasis'' on the
extent to which a bona fide supply agreement demonstrates whether any
individual applicant is capable of meeting demand. 21 CFR
1318.05(b)(3)(i); RFAAX 2, at 3; MCRGC, LLC, 90 FR 48431, 48432 (2025).
DEA regulations also establish various security requirements for
the storage of controlled substances. 21 CFR 1301.71, .72; RFAAX 2, at
4. In general, DEA regulations require that ``[a]ll applicants and
registrants shall provide effective controls and procedures to guard
against theft and diversion of controlled substances,'' and that in
order for DEA ``to determine whether a registrant has provided
effective controls against diversion, the Administrator shall use the
security requirements set forth in [21 CFR 1301.72-1301.76] as
standards for the physical security controls and
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operating procedures necessary to prevent diversion.'' 21 CFR
1301.71(a); RFAAX 2, at 4.
DEA regulations also establish specific security requirements for
controlled substances in schedules I and II. 21 CFR 1301.72(a); RFAAX
2, at 4. Relevant here, these regulations require that the ``[r]aw
material, bulk materials awaiting further processing, [and] finished
products which are controlled substances listed in Schedule I or II . .
. shall be stored in . . . a safe or steel cabinet . . . [w]hich safe
or steel cabinet, if it weighs less than 750 pounds, is bolted or
cemented to the floor or wall in such a way that it cannot be readily
removed.'' 21 CFR 1301.72(a)(1)(ii); RFAAX 2, at 4.
III. Findings of Fact
In light of Applicant's default, the factual allegations in the OSC
are deemed admitted.\2\ 21 CFR 1301.43(e). Accordingly, Applicant
admits that on or about May 22, 2017, Applicant's president submitted
an application on behalf of Applicant to obtain a DEA registration as a
manufacturer (bulk) in schedule I controlled substances (marihuana,
marihuana extract, and tetrahydrocannabinol).\3\ RFAAX 2, at 4; 21 CFR
1308.11(d)(23), (31), (58). Applicant further admits that it cannot
provide a bona fide supply agreement and that it does not have ``a
substantially secured cabinet to store marihuana.'' RFAAX 2, at 4.
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\2\ According to the CSA, ``[f]indings of fact by the [DEA
Administrator], if supported by substantial evidence, shall be
conclusive.'' 21 U.S.C. 877. Here, where Applicant is found to be in
default, all the factual allegations in the OSC are deemed to be
admitted. These uncontested and deemed admitted facts constitute
evidence that exceeds the ``substantial evidence'' standard of 21
U.S.C. 877; it is unrebutted evidence.
\3\ A Notice of Applicant's application was published in the
Federal Register on August 27, 2019. Bulk Manufacturer of Controlled
Substances Applications: Bulk Manufacturers of Marihuana, 84 FR
44920, 44922 (2019); RFAAX 2, at 4.
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IV. Discussion
Here, Applicant cannot provide a bona fide supply agreement, nor
any other evidence, for the Agency to consider under 21 CFR
1318.05(b)(3)(i). RFAAX 2, at 4; 21 U.S.C. 823(a)(1); MCRGC, LLC, 90 FR
at 48432. In addition, Applicant does not have a secured cabinet to
store marihuana for the Agency to consider under 21 CFR 1301.71 and
.72. RFAAX 2, at 4; 21 U.S.C. 823(a)(1). Therefore, these criteria \4\
under Agency consideration weigh against Applicant. 21 U.S.C.
823(a)(1); 21 CFR 1301.71, .72; 21 CFR 1318.05(a), (b)(3)(i).
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\4\ The burden is on the applicant to establish that its
registration is consistent with the public interest. 21 CFR
1301.44(a); 21 CFR 1318.03(b); RFAAX 2, at 2. Here, by virtue of its
default, Applicant has failed to present any evidence whatsoever to
establish its registration is consistent with the public interest,
and the deemed admitted facts (i.e., the lack of a bona fide supply
agreement and effective controls against diversion), weigh against a
finding in favor of registration. Although the lack of a bona fide
supply agreement and secured cabinet are only factors, they are
dispositive here because Applicant's default means it not only
waived the right to present evidence regarding these two factors,
but it also waived the right to present any other evidence that its
registration would be consistent with the public interest.
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Considering the public interest factors of 21 U.S.C. 823(a), and
specifically Applicant's failure to provide a bona fide supply
agreement and have a secured cabinet to store schedule I controlled
substances, the Agency determines that issuing Applicant a manufacturer
registration (bulk) for marihuana would not be consistent with the
public interest. Accordingly, the Agency will order the denial of
Applicant's application for registration.\5\
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\5\ Denial of Applicant's application in this Order does not
prohibit Applicant from submitting an application through the new
framework established for issuing registrations based on state
licenses to handle marihuana for medical purposes, if applicable.
See Schedules of Controlled Substances: Rescheduling of Food and
Drug Administration Approved Products Containing Marijuana From
Schedule I to Schedule III; Corresponding Change to Permit
Requirements, 91 FR 22714, 22721 (2026) (adding paragraph (k) to 21
CFR 1301.13 ``establish[ing] an expedited review process for
entities holding state medical marijuana licenses who seek
registration as a marijuana manufacturer''); see also id. at 22722
(adding paragraphs (g)(2)-(4) to 21 CFR 1308.13 placing into
schedule III marihuana, marihuana extract, and delta-9-
tetrahydrocannabinols ``subject to a state medical marijuana
license'').
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(a), I hereby deny the pending application for a DEA
Certificate of Registration, Control No. W17047690E, submitted by JT
Medical, LLC, as well as any other pending application of JT Medical,
LLC, to amend or modify this application, or for additional
registration in Pennsylvania. This Order is effective October 29, 2026.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 8, 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. 2026-19842 Filed 9-28-26; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on September 29, 2026.
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