As per MoCRA, owner or operator of a facility that manufactures or processes cosmetic products for US distribution must register with FDA, whether the facility is located in the US or abroad. Registration requires certain information to be provided to FDA, such as all brand names under which the cosmetic products are manufactured or processed in the facility are sold, the product category or categories, and the responsible person for each cosmetic product manufactured or processed at the facility. A responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label.
A manufacturing facility needs to submit only one facility registration regardless of whether that facility manufactures or produces cosmetic products for themselves or on behalf of multiple responsible persons.
This requirement excludes certain beauty shops, salons, and retailers and establishments that only perform labeling, relabeling, packaging, repackaging, holding, and distributing of cosmetic products.
Facilities that manufactured or processed cosmetic products on or before December 29, 2022, must register by July 1st, 2024. Facilities that engaged in manufacturing or processing after December 2022 must register within 60 days of first engaging in such activity or by July 1st, 2024, whichever is later.
Facilities registrations must be renewed biennially. Registration must be updated with new information within 60 days of such a change.
FDA has launched new submission portal to facilitate registration.
Liberty Management Group Ltd. can help you with registration under FDA MoCRA regulations.
Namrata
Regulatory Consultant
support@libertymanagement.us