What goes wrong

The seal was assumed to be enough

On this page12

A plain induction seal was treated as compliant And distinctive by design was assumed So the printing was left off A resealing liner was treated as a tamper feature Child resistance was treated as tamper evidence The missing half of the test was skipped The statement was printed on the seal Or on a band over the cap And the statement was written generically And the feature was chosen after the container Specify the liner, and specify the printing References

A blank foil seal satisfies one limb and not the other.

A plain induction seal was treated as compliant

It is a barrier to entry that shows interference, which satisfies the first limb. The packaging also has to be distinctive by design or carry an identifying characteristic.

And distinctive by design was assumed

It means packaging that cannot be duplicated with commonly available materials or through commonly available processes. An unprinted foil seal is the commonest article there is.

So the printing was left off

Which is the fix the regulation itself offers: a pattern, a name, a registered trademark, a logo or a picture on the feature.

A resealing liner was treated as a tamper feature

11 F217, 11 foam, 6 PE foam and 10 Plastis standard on this shelf reseal on closing. Resealing is the opposite of showing interference.

Child resistance was treated as tamper evidence

18 CT CRC closures here. Two different functions, two different articles, and both available separately.

The missing half of the test was skipped

If breached OR MISSING. A feature that can be removed and replaced with a blank equivalent fails on the second word.

The statement was printed on the seal

Which is exactly what paragraph (c) forbids: it must be so placed that it will be unaffected if the feature is breached or missing.

Or on a band over the cap

Same failure. The text about the feature cannot live on something that goes away with the feature.

And the statement was written generically

It has to identify all tamper-evident features and any capsule sealing technologies used. Saying a package is sealed for your protection does not identify anything.

And the feature was chosen after the container

Which is the wrong order, because on this shelf the feature IS the liner and the liner is part of the closure. One decision, made as two.

Specify the liner, and specify the printing

We publish the liner type on most closures here. The printing is a separate request and it is the one the distinctiveness limb turns on.

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

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

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.