Infectious substances are those substances containing viable microorganisms or their toxins which are known, or are suspected to cause disease in animals or humans. Diagnostic specimens are any human or animal material including but not limited to, excreta, secreta, blood and its components, tissue, tissue fluids, etc., which the shipper reasonably believes may contain an etiologic agent and that is being shipped for purposes of diagnosis. Biological product means a product prepared in accordance with regulations that govern the manufacture of vaccines, reagents, etc. Materials containing certain etiologic agents means materials known to contain or reasonably believed by the shipper to contain an etiologic agent from a list included in the regulation. Patient specimens that are expected to contain an etiologic agent should be shipped according to these requirements.
Interstate shipping is interpreted to include intrastate shipping.
Packaging of diagnostic specimens and biological products should be such that the package will withstand leakage of contents, shocks, pressure changes and other conditions incident to ordinary handling in transportation. Contents should not leak to the outside of the shipping container, even if leakage of the primary container occurs. Packages should be able to withstand rough handling and passage through cancellation machines, sorters, conveyers, etc. Packaging of materials containing etiologic agents varies depending on the volume shipped. The primary container must be placed in a durable, watertight secondary container.