U.S. Regulatory Compliance Cheat Sheet

Using real examples and imagery, this simple cheat sheet provides practical and simplified ways to identify and report both sellers shipping diverted non-compliant product to US consumers and product listings advertising and showing images of non-compliant products.

Regulatory areas included:

[1] FPLA §4 · identity, quantity and business identification

[2] 21 CFR 201.60–201.61 · PDP and OTC identity

[3] 21 CFR 201.62 · OTC quantity, placement and type size

[4] 21 CFR 201.66 · Drug Facts content, warnings and format

[5] 21 CFR 201.15 · OTC prominence and language

[6] 21 CFR 201.1 · Drug manufacturer, packer or distributor

[7] FDA Cosmetics Labeling Guide · category-specific checks

[8] FDA · Nonprescription drug adverse-event contact guidance

[9] Cosmetics rule · 21 CFR 701.13 · quantity, placement and pressure-dispensed contents

[10] 21 CFR 201.66(c)–(e) · content, format and exemptions

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