CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products.

U.S. Food and Drug Administration. CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products.

Type

Web resource

Intellectual base

Web

Link

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-450500-tamper-resistant-packaging-requirements-certain-over-counter-human-drug-products

Cited from

computer_science

Cited by

1 citation across 1 artifact.

Each citation links to the sentence it supports in the citing article.

Primes

• Trusted Intermediary Compromise
  • Pharmaceuticals and food. Tampering written into the distribution channel of a trusted brand, and upstream supplier substitution of a cheaper adulterant that passes identity tests designed for accidental contamination, propagating through trusted retail channels.

    This sourceDocuments the regulatory response to the 1982 Chicago Tylenol cyanide tampering — a hostile payload written into a trusted brand's distribution channel — and the resulting tamper-resistant packaging rule (21 CFR 211.132).

    Supported in partVerified against the work's full text

    The FDA guide covers tamper-resistant packaging against tampering with over-the-counter products at retail; it does not address upstream supplier substitution of cheaper adulterants.

    “can reasonably be expected to provide visible evidence to consumers that tampering has occurred.”

    Read by an automated reader; not a human review. How support was checked

Verification

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