Expert Guidance on MoCRA Facility Registration

Are you prepared for Cosmetic Facility Registration under MoCRA? Let's make sure you are! Under MoCRA, a 'facility' is any establishment (including importers) manufacturing or processing cosmetic products distributed in the U.S. The Act specifies that the 'manufacture of a cosmetic product' involves procedures applied to the bulk formulation. This includes production and manipulation, like filling processes. An establishment is not considered a 'facility' if involved in labelling, re-labelling, packing (without touching the bulk formulation), repackaging (without touching the bulk formulation), holding, or distributing. If an establishment qualifies as a 'facility' under MoCRA, it must complete registration on the FDA Cosmetics Direct platform. MoCRA exempts certain places and establishments, including beauty shops, cosmetic retailers, healthcare facilities, non-profit entities, and those providing complimentary cosmetics. Also excluded are facilities producing cosmetics solely for research or evaluation.Non-U.S. facilities meeting the 'facility' definition must register with the FDA as 'foreign facilities.' Collaboration with a domestic U.S. agent is required, and these facilities are subject to FDA inspections and enforcement actions.