modernization of cosmetics regulation act of 2022
In 2023, Congress passed the Modernization of Cosmetics Regulation Act (MoCRA) which updated Chapter VI of the Food, Drug, and Cosmetic Act.
As part of this revision, any manufacturer of a cosmetic product, regardless of size, must notify the FDA when they become aware of a serious adverse event related to any of their products.
To assist in following the activities required in MoCRA, a downloadable Word procedure and required forms and instructions are available below.
Serious Adverse Event Reporting Package
$10.00
Reporting of serious adverse events to the FDA is a requirement for all cosmetics manufacturers. Included in this download is an SOP template and the mandatory reporting form with instructions to complete it.
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