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Tamper evident

And capsule sealing technologies

On this page13
The statement has to identify them. We sell no capsule and no sealing.

The phrase appears in the statement requirement

Paragraph (c) requires a statement that identifies all tamper-evident features and any capsule sealing technologies used to comply with paragraph (b).

So a sealed capsule can be the tamper feature

Which is a different place to put the function: in the dosage form itself rather than in the container around it.

And the statement has to name it

All features and any capsule sealing technologies. So a package relying on a sealed capsule still carries a statement about it.

This property does not describe those technologies

They are a manufacturing subject rather than a packaging one, and nothing here sets out what qualifies.

And we sell neither capsules nor sealing

Our catalog is containers and closures. A capsule is a dosage form and its sealing is part of making it.

Which is worth noting because it changes where the feature lives

A maker with sealed capsules has a tamper feature that is not a liner, and the container question becomes simpler.

For everything else the container carries it

Which on this shelf means a liner, because there is no tamper-evident closure and no sealing disc among the 128.

The two can be combined

The regulation speaks of one or more indicators or barriers, and the statement identifies all of them. Nothing limits a package to one.

And more than one is the stronger position

Because the test includes missing as well as breached, and two features are harder to remove without trace than one.

And the statement reaches both kinds together

Paragraph (c) names tamper-evident features and capsule sealing technologies in the same breath, so a package using both describes both in one statement.

Which is why the statement is specific to the package

It identifies what is actually there. Two products with different closures carry different statements even if everything else matches.

None of which is on our product pages

We publish a liner type. Whether it is printed, and whether anything else in the package is a feature, is yours to specify.

References

21 CFR 211.132(c) requires a statement that "(i) Identifies all tamper-evident feature(s) and any capsule sealing technologies used to comply with paragraph (b) of this section; (ii) Is prominently placed on the package; and (iii) Is so placed that it will be unaffected if the tamper-evident feature of the package is breached or missing." law.cornell.edu
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
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.