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MoCRA Product Listing
Section 607(c) of the FD&C Act requires that each cosmetic product on the US market (with a few exceptions) must be listed with the FDA, detailing ingredients (including fragrance or flavor), responsible party, the facility of manufacture, its location and more.
The statutory deadline for listing submissions was December 29, 2023, which was later amended that FDA enforcement would not take effect until July 1, 2024.
New cosmetics must be listed with the FDA 120 days after introduction to commerce in the United States.
MoCRA Facility Registration
Section 607(a) of the FD&C Act requires every person that owns or operates a facility that “engages in the manufacturing or processing of a cosmetic product for distribution in the United States” to register each facility with the FDA.
Similar to cosmetic product listings, the statutory deadline for facility registration was December 29, 2023, which was later amended to July 1, 2024, as the enforcement date by the FDA.
New facilities must register with FDA within 60 days after first engaging in manufacturing or processing of a cosmetic product.
Drug Listing & Certification
All OTC products on the US market must comply with specific FDA formulation rules (monographs).
All OTC drug establishments that formulate, process or pack, manufacture, and distribute OTC drugs in the US must register and/or list all their OTC products with FDA. This includes both domestic and foreign manufacturers, processors, packers, and labelers. Companies based outside the US must have a US agent assigned as primary point of contact. All OTC drug establishment registrations must be renewed annually between October 1- December 31.
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