Company: ARAI
Filing Date: 2025-05-14
Form Type: DRS
Source: 0001641172-25-010170
Chunk: 89

Company: Arrive AI Inc.
Filing Date: 2025-05-14
Form: DRS
Chunk 89
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 or perceived failure to comply with them, could harm our business and commercial operations” for detailed discussion. Despite the need to comply with HIPAA, we are only a provider of intelligent mailboxes and do not and will not manufacture, sell or transport medical or biological products or prescriptions, we are not and will not be subject to any regulations in those areas, for example, the Federal Food, Drug, and Cosmetic Act of 1938 and the Medical Device Amendments of 1976.

Regulations Related to the Transportation of Pharmaceutical and Biomedical Products

Even though we do not and will not manufacture,
sell or transport medical or biological products or prescriptions, there are several regulations related to the transportation of pharmaceutical
and biomedical products and our potential third party service providers may be subject to such regulations, described further below.

Title 21 of the Code of Federal Regulations (CFR)
regulates the shipping, warehousing, distribution, and record keeping of pharmaceuticals. Because of the sensitive nature of some pharmaceutical
products, there are many federal, state, and local laws that dictate how to package and transport the items. There are also several different
federal agencies with oversight, including the Food and Drug Administration (FDA), the FDA’s role is to protect the public’s health
by ensuring that the items to be consumed are safe. Prescription drugs and medical devices undergo rigorous screening and testing to
ensure they work as the manufacturer claims. Within the context of pharmaceuticals, this means information on the approved temperature
range for shipping, warehousing, and distribution. In addition to the FDA’s temperature control requirements, there are other requirements
which include hygiene, security, and recordkeeping. The packaging procedures of manufacturers and the transportation third parties must
ensure compliance with FDA’s temperature control requirements. When transporting products that require temperatures outside the
normal bounds, it usually requires a particular type of vehicle or trailer. These vans and trucks are modified to allow temperature control
while traveling. This helps ensure the products stay within the safe temperature range. The modifications to the trailers and vehicles
often include improved gaskets, seals, and partitions that allow the transport of products in different temperature zones. The FDA also
sets state licensing laws for pharmaceutical companies.

The most relevant of the FDA requirements is the
cold supply chain, which is crucial to many different industries. If products go outside of their safe temperature range, it can lead
to ineffective medications, vaccines, or devices. This is what makes compliance so crucial in the medical community. For most products,
storage and transportation