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.

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 also21 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); see21 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 ( printed page 61447) 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.

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).

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]

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 .