FDA Electronic Submissions
All OTC drugs are required to be listed with FDA and manufactured by a registered drug establishment. In addition, it is up to both the manufacturer and the brand placing the product on the market) to list all drugs that they manufacture and/or distribute. Both the manufacturer and the brand need to have an NDC Labeler code assigned by the FDA. An NDC number is assigned when a drug product is listed. FDA requests, but does not require, the NDC number to appear on the label.
Repertoire Consulting can help with all your FDA electronic filings for establishment registration, NDC labeler code requests, GDUFA registration, OTC drug listings and annual updates. We can register your products and facilities with speed and accuracy.
Reporting for the California Safe Cosmetics Act
The primary purpose of the California Safe Cosmetics Program is to collect information on hazardous and potentially hazardous ingredients in cosmetic products sold in California and to make this information available to the public. The California Safe Cosmetics Act (CSCA) was signed into law in 2005. For all cosmetic products sold in California, the Act requires the manufacturer, packer, and/or distributor named on the product label to provide to the California Safe Cosmetics Program in the California Department of Public Health (CDPH) a list of all cosmetic products that contain any ingredients known or suspected to cause cancer, birth defects, or other reproductive harm.
Repertoire Consulting can set up your company account and submit required information for formulas containing reportable materials. Examples of reportable materials found in cosmetic and personal care products are BHA, retinol/retinyl esters, titanium dioxide, Black 2, and formaldehyde (found in DMDM Hydantoin).