MoCRA Updates: How to Conduct Cosmetic Product Facility Registration in the U.S.?
Aug 11, 2023
Winnie Xu
FDA issued a draft guidance for facility registration and product listing on August 7, offering comprehensive directions for the entities responsible for facility registration, necessary dossiers, submission methods, submission deadlines, etc.
Prior to initiating facility registration, facility owners or operators shall obtain an FDA Establishment Identifier number in advance.
For facilities already in operation before December 29, 2022, the registration must be completed before December 29, 2023.
In a significant move on August 7, 2023, the U.S. Food and Drug Administration (FDA) unveiled a draft guidance on cosmetic facility registrations and product listings (draft guidance). As a crucial supporting document of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), this draft guidance is open for public consultation until September 7, 2023.
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