21 CFR 211.132 - Tamper-Evident Packaging Requirements for OTC Human Drug Products

What it says

Most over-the-counter drug products for retail sale must have a tamper-evident package designed to provide visible evidence to consumers that tampering has occurred, with a prominently labeled statement alerting consumers to the specific tamper-evident feature so its absence can be recognised.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The labeling statement identifying the specific tamper-evident feature is as important as the feature itself, since the requirement's consumer-protection purpose depends on consumers actually knowing what to look for.
• This provision arose directly from historical incidents of product tampering after retail sale, making it one of the clearer examples of a regulation whose specific requirements can be traced to a documented real-world harm event.
• Packaging validation must confirm the tamper-evident feature actually functions as intended and survives normal distribution and handling without false triggering or failure.

What FDA inspectors look for

• Whether the tamper-evident feature used is appropriate for the specific package type and whether its presence is clearly and accurately described in the product labeling.
• Whether packaging validation data demonstrates the tamper-evident feature reliably functions through normal distribution and handling conditions.
• Whether packaging line operations include verification that the tamper-evident feature was correctly applied to each unit, not just assumed based on the packaging equipment's general performance.

Related regulations