Which statement best describes SNI in the context of DSCSA?

Which statement best describes SNI in the context of DSCSA?

• A. A batch of multiple packages
• B. A hospital's inventory
• C. Each package or homogeneous case
• D. A single bottle only

Answer: (C)

SNI in DSCSA identifies the unit that gets serialized for tracing. In practice, that unit is either an individual package or a homogeneous case—meaning a case that contains identical units of the same product. This is why the best description is that SNI refers to each package or homogeneous case. A batch of multiple packages isn’t the unit because DSCSA tracks at the level of each package or a single, uniform case, not a mixed batch. A hospital’s inventory isn’t the unit of serialization, and while a single bottle is a valid package, the rule also covers cases of identical items, so the broader option—each package or homogeneous case—captures the intended unit for serialization and tracing.

SNI in DSCSA identifies the unit that gets serialized for tracing. In practice, that unit is either an individual package or a homogeneous case—meaning a case that contains identical units of the same product. This is why the best description is that SNI refers to each package or homogeneous case.

A batch of multiple packages isn’t the unit because DSCSA tracks at the level of each package or a single, uniform case, not a mixed batch. A hospital’s inventory isn’t the unit of serialization, and while a single bottle is a valid package, the rule also covers cases of identical items, so the broader option—each package or homogeneous case—captures the intended unit for serialization and tracing.