Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 85

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 85
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 controlled substances within specific schedules. However, certain coincident
activities are permitted without obtaining a separate DEA registration, such as distribution of controlled substances by the registered
manufacturer that produces them.

The DEA inspects all manufacturing facilities to
review security, recordkeeping, reporting, handling and compliance with other DEA regulatory requirements prior to issuing a controlled
substance registration and periodically thereafter to ensure continued compliance. The specific security requirements vary by the type
of business activity and the schedule and quantity of controlled substances handled. The most stringent requirements apply to manufacturers
of Schedule I and Schedule II substances. Required security measures commonly include background checks on employees and physical control
of controlled substances through storage in approved vaults, safes and cages, and through use of alarm systems and surveillance cameras.
An application for a manufacturing registration as a bulk manufacturer (not a dosage form manufacturer or a repacker/relabeler) for a
Schedule I or II substance must be published in the Federal Register and remain open for 30 days to permit interested persons to submit
comments, objections, or requests for a hearing. A copy of the notice of the Federal Register publication is forwarded by the DEA to all
those registered, or applicants for registration, as bulk manufacturers of that substance.

Once registered, manufacturing facilities must
maintain records documenting the manufacture, receipt and distribution of all controlled substances. Manufacturers must submit periodic
reports to the DEA of the distribution of Schedule I and II controlled substances, Schedule III narcotic substances, and other designated
substances. Registrants must also report any controlled substance thefts or significant losses and must obtain authorization to dispose
of controlled substances. As with applications for registration as a bulk manufacturer, an application for an importer registration for
a Schedule I or II substance must also be published in the Federal Register, which remains open for 30 days for comments. Imports of Schedule
I and II controlled substances for commercial purposes are generally restricted to substances not already available from a domestic supplier
or where there is not adequate competition among domestic suppliers. In addition to an importer or exporter registration, importers and
exporters must obtain a permit for every import or export of a Schedule I or II substance a Schedule III, IV or V narcotic, a specially
designated Schedule III non-narcotic, or a Schedule IV or V narcotic controlled in Schedule I or II by the Convention on Psychotropic
Substances and submit import or export declarations for a Schedule III, IV or V non-narcotic.

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For drugs manufactured in the United