FDA Direct is a U.S. Food and Drug Administration's web-based and free structured product labeling (SPL) authoring tool. Previously CDER Direct, FDA Direct now includes CDER Direct and Cosmetics Direct. Users can create separate accounts, depending on drugs or cosmetics submissions, or a single account that includes both CDER Direct submissions as well as Cosmetics Direct submissions.

CDER Direct

CDER Direct allows users to create and submit data directly to the FDA easily. This system will provide information to FDA/CDER about drug manufacturers and private label distributors, outsourcing facilities, wholesale drug distributors and third-party logistics, and generic drug facilities, along with their drugs in U.S. commercial distribution.

CDER Direct has several sections that allow the submission of the following data to the FDA: Establishment Registration and Drug Listing, including NDC Labeler Code Requests and NDC Reservations, Outsourcing Facility and Product Reporting, DSCSA Annual Reporting, and Generic Drug Self-Identification.

Cosmetics Direct

On December 29, 2022, the President signed the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) into law, which included the Modernization of Cosmetics Registration Act of 2022 (MoCRA). Among other provisions, MoCRA added section 607 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), establishing requirements for cosmetic product facility registration and cosmetic product listing.

Section 607(a) of the FD&C Act requires every person who 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. Section 607(c) of the FD&C Act requires that for each cosmetic product, the responsible person submit to the FDA “a cosmetic product listing.” Certain small businesses, as defined in section 612 of the FD&C Act, are exempt from the registration and listing requirements. Click here to learn more about MoCRA.

This free tool allows you to create and submit the following types of data directly to the FDA: Registration of Cosmetic Product Facility and Cosmetic Product Listing. This system will provide information to the FDA/Office of Cosmetics and Colors (OCAC) about cosmetic product manufacturers/processors and cosmetic products on the market.

If you need any assistance or have any questions, please get in touch with us via test@cirs-group.com.

Further Information

Cosmetic Direct