FDA Direct is 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 easily create and submit data directly to the FDA. 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 which allows 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 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 FDA. Section 607(c) of the FD&C Act requires that for each cosmetic product, the responsible person submit to 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 FDA/Office of Cosmetics and Colors (OCAC) about cosmetic product manufacturers/processors and cosmetic products on the market.

Note: Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1993, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.section508.gov/.