Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 84

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 84
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 comply with the applicable requirements to prevent the diversion of controlled substances to illicit channels
of commerce.

21

The DEA categorizes controlled substances into
one of five schedules - Schedule I, II, III, IV, or V - with varying qualifications for listing in each schedule. Schedule I substances
have a high potential for abuse, have no currently “accepted medical use” in treatment in the United States and lack accepted
safety for use under medical supervision. They may be used only in federally approved research programs and may not be marketed or sold
for dispensing to patients in the United States. THC, along with other substances derived from the cannabis plant, and psilocybin are
Schedule I controlled substances under the CSA. Pharmaceutical products having a currently accepted medical use that are otherwise approved
for marketing may be listed as Schedule II, III, IV or V substances, with Schedule II substances presenting the highest potential for
abuse and physical or psychological dependence and Schedule V substances the lowest relative risk for abuse and dependence. The regulatory
requirements are more restrictive for Schedule II substances than Schedule III-V substances. For example, all Schedule II drug prescriptions
must be signed by a physician, physically presented to a pharmacist in most situations, and cannot be refilled.

Following FDA approval of a drug containing a Schedule
I controlled substance, that substance must be rescheduled as a Schedule II, III, IV or V substance before it can be marketed. For example,
products approved for medical use in the United States that contain THC, other cannabis plant extracts, or synthetic versions of such
substances must be placed in one of Schedules II-V as approval by the FDA satisfies the “acceptable medical use” requirement.
In November 2015, the Improving Regulatory Transparency for New Medical Therapies Act, which law removed uncertainty associated with timing
of the DEA rescheduling process after FDA approval, was signed into law. Specifically, the law requires the DEA to issue an “interim
final rule,” pursuant to which a manufacturer may market its product within 90 days of FDA approval. The law also preserves the
period of orphan marketing exclusivity for the full seven years such that this period only begins after DEA scheduling.

Facilities that research, manufacture, distribute,
import or export any controlled substance must register annually with the DEA. The DEA registration is specific to the particular location,
activity(ies) and controlled substances utilized. For example, separate registrations are required for importation and manufacturing activities,
and each registration authorizes the registrant to handle