For US over-the-counter human drug products, an FDA tamper-evident package has one or more entry indicators or barriers. Under the rule, breach or absence of an indicator or barrier can reasonably be expected to provide visible evidence to consumers. The feature is designed to make a changed or missing condition observable.
Tamper-evident does not mean tamper-proof. The observed condition is evidence about the indicator or barrier, not conclusive proof of the original contents or a complete account of everything that happened before the package was examined. Package designs may differ while serving the same visible-warning purpose.
What the visible warning communicates
Breach and absence are the two conditions named in the FDA rule. An intact feature presents neither of those warnings; a visibly breached or missing feature supplies information that the consumer can observe. One package can use an indicator, another a barrier and another more than one feature. The definition turns on the visible warning produced by breach or absence rather than one required construction.
Protecting and investigating forensic items
The England-and-Wales forensic framework addresses a different setting. The Forensic Science Regulator requires items to be appropriately packaged, protected, preserved, transported and stored to protect their integrity. Protecting, preserving, transporting and storing are continuing duties applied to the same item, not alternative descriptions of the initial package.
Where there is evidence of tampering, or a suggestion that it occurred or was attempted, the Regulator requires investigation and escalation according to the outcome. That provision addresses the response to a concern, while the handling duties govern continuing care of the item. Both protect integrity through different actions.
The distinction matters when a changed feature is found. In the OTC example, the indicator or barrier gives consumers observable information about the package. In the forensic setting, packaging is one part of continued protection, and a tampering concern enters investigation. The visible feature and the forensic framework therefore answer different questions: what package condition can be seen, and how an item and a concern about interference must be managed.
