Who should file cosmetic formulations in the VCRP (Form FDA 2512), and what if my products are made by a contract manufacturer?
Any firm, whether domestic or foreign, that manufactures, packs, or distributes cosmetics in the United States may submit a separate Form FDA 2512 in the online VCRP system for each cosmetic formulation (21 CFR 720.1). When a product is made by a contract manufacturer and distributed by a different firm, either the contract manufacturer or the distributor can enter the formulation into the VCRP, but not both. The two companies need to decide who will enter the formulation.
Related Questions
- If I wish to participate in the VCRP, do I need to file both a Form FDA 2511 (Establishment Registration) and a Form FDA 2512 (Cosmetic Product Ingredient Statement)?
- Who should file cosmetic formulations in the VCRP (Form FDA 2512), and what if my products are made by a contract manufacturer?
- Can I file formulations in the VCRP for products that are considered drugs but also have a cosmetic function?
