Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 83

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 83
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Product seizure or detention, or refusal to permit the import or export of products;

●Injunctions or the imposition of civil or criminal penalties;

●Consent decrees, corporate integrity agreements, debarment, or exclusion from federal healthcare programs; and/or

●Mandated modification of promotional materials and labeling and the issuance of corrective information.

In addition, the distribution of prescription pharmaceutical
products is subject to the Prescription Drug Marketing Act (“PDMA”), which regulates the distribution of drugs and drug samples
at the federal level and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA
and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability
in distribution. Most recently, the Drug Supply Chain Security Act (“DSCSA”) was enacted with the aim of building an electronic
system to identify and trace certain prescription drugs distributed in the United States. The DSCSA mandates phased-in and resource-intensive
obligations for pharmaceutical manufacturers, wholesale distributors, and dispensers over a ten-year period, which culminated in November
2023. However, the FDA announced a one-year “stabilization period” until November 2024, followed by trading partner-specific
exemptions through specified dates in 2025, to accommodate additional time that trading partners in the pharmaceutical supply chain needed
in order to fully implement DSCSA requirements for electronic drug tracing at the package level.

From time to time, new legislation and regulations
may be implemented that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products
regulated by the FDA. It is often impossible to predict whether further legislative or regulatory changes will be enacted, whether FDA
regulations, guidance or interpretations will be changed or what the impact of such changes, if any, may be.

Regulation of Controlled Substances

Our drug candidates contain active substances derived
from the cannabis plant and psilocybe mushrooms (or that are synthesized versions of such substances), which are classified as controlled
substances, as defined in the CSA. The CSA and its implementing regulations establish a “closed system” of distribution for
controlled substances. The CSA imposes registration, security, recordkeeping and reporting, storage, manufacturing, distribution, labeling,
importation, exportation, disposal and other requirements under the oversight of the DEA, the federal agency responsible for regulating
controlled substances. The DEA requires those individuals or entities that manufacture, import, export, distribute, research, or dispense
controlled substances to