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A package that has to be distinctive

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Most packaging rules ask for capability This one asks for uniqueness Which is a requirement about the rest of the world And it lands on our shelf exactly A plain foil induction seal is a barrier to entry And it is about as commonly available as packaging gets The regulation gives the answer in its own alternative limb So the fix is printing on the seal And we publish the liner and not the printing The scope is narrower than it sounds References

Cannot be duplicated with commonly available materials. That is the standard.

Most packaging rules ask for capability

A capacity ceiling, a type size, a closure that resists a child, a wall that does not react. Things a package either does or does not do.

This one asks for uniqueness

A tamper-evident package has to be distinctive by design, or it has to carry an identifying characteristic. Distinctive by design means it cannot be duplicated with commonly available materials or through commonly available processes.

Which is a requirement about the rest of the world

Whether something can be duplicated with commonly available materials is not a property of the package alone. It depends on what is commonly available.

And it lands on our shelf exactly

The only tamper-evident capability here is a liner: 53 heat induction seals and 18 pressure sensitive out of 128 closures.

A plain foil induction seal is a barrier to entry

It visibly shows if it has been breached or removed, which is what the first limb of the definition asks for.

And it is about as commonly available as packaging gets

Which is the thing the distinctiveness clause is aimed at. An unprinted foil seal is the standard article.

The regulation gives the answer in its own alternative limb

An identifying characteristic, printed. The examples given are a pattern, a name, a registered trademark, a logo or a picture.

So the fix is printing on the seal

Which is ordinary practice and is exactly what makes a seal hard to replace with a blank one from a drawer.

And we publish the liner and not the printing

Which is the data gap, and it is precise: we record that a closure carries a heat induction seal and nothing about whether it is printed.

The scope is narrower than it sounds

The section reaches an OTC human drug product packaged for retail sale and accessible to the public while held for sale. A kit assembled at home from bulk is not that.

References

21 CFR 211.132(b)(1): "A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred." The same paragraph requires the packaging to be "distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture)", with distinctive by design meaning packaging that "cannot be duplicated with commonly available materials or through commonly available processes." The section reaches an over-the-counter human drug product packaged for retail sale and accessible to the public while held for sale, and nothing here asserts it binds any particular activity. law.cornell.edu

The Davis Pack Supply catalog, measured 19 October 2026. The only tamper-evident capability among the 128 closures indexed to this group is a liner: 53 carry a heat induction seal and 18 a pressure sensitive liner, with 11 F217, 11 foam, 10 Plastis standard, 6 PE foam, 1 F217 and PS, 8 recorded as No Liner and 10 unrecorded. There is no tamper-evident closure and no sealing disc on the shelf at all. We publish the liner type and not whether it carries a printed pattern, name, trademark, logo or picture.

Written from 21 CFR 211.132 and from the catalog as it stood on 19 October 2026. That section reaches an over-the-counter human drug product packaged for retail sale and accessible to the public while held for sale; a kit assembled at home from bulk is not that, and nothing here asserts the section binds any particular activity. The only tamper-evident capability on this shelf is a liner, and we publish the liner type and not whether it carries a printed identifying characteristic, which is the attribute the distinctiveness requirement turns on.