Distinctive

Commonly available

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The phrase Which is relative, not absolute So the bar rises as packaging improves The induction seal is the clearest example Which does not make it useless It is the distinctiveness limb it struggles with So the two limbs divide the work sensibly And printing has the same relative quality Which is a reason to use the strongest available And the examples in the regulation are ordered Which gives a practical ranking None of this is a judgment we can make for you References

What is common today was distinctive once.

The phrase

Cannot be duplicated with commonly available materials or through commonly available processes.

Which is relative, not absolute

A material or a process is commonly available or not depending on the state of the world, and the state of the world changes.

So the bar rises as packaging improves

A feature that was hard to reproduce when it was new becomes a stock item, and at that point it stops being distinctive by design.

The induction seal is the clearest example

It is now about the most widely available tamper feature there is, and 53 of our 128 closures carry one.

Which does not make it useless

It is still a barrier to entry that shows interference, and it still satisfies the first limb of the definition.

It is the distinctiveness limb it struggles with

And the regulation anticipated that by offering the identifying characteristic as the alternative.

So the two limbs divide the work sensibly

Construction for the rare case, and printing for the ordinary one. A stock package plus your own mark is the designed route.

And printing has the same relative quality

A pattern is easier to approximate than a logo, and a logo easier than a registered trademark. The examples are not equivalent.

Which is a reason to use the strongest available

A registered trademark on a seal is both the hardest to duplicate and the one with a separate remedy if somebody tries.

And the examples in the regulation are ordered

A pattern, a name, a registered trademark, a logo, a picture. Five illustrations of an identifying characteristic, and they are not equally hard to reproduce.

Which gives a practical ranking

Use the one that is hardest to duplicate and easiest to notice. A mark nobody recognizes is a weak indicator even if nobody can copy it.

None of this is a judgment we can make for you

Whether a particular feature is duplicable with commonly available materials is a question about the market, and we publish a liner type.

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.