Can I file formulations in the VCRP for products that are considered drugs but also have a cosmetic function?
Yes, products that are considered drugs in the United States, such as sunscreens, but also make cosmetic type claims, such as moisturizing, can be filed in the VCRP. However, it is important to remember that if your product is either solely a drug or a drug/cosmetic combination, it is subject by law to different requirements than those for products that are solely cosmetics. These include special requirements for product listing and establishment registration (Federal Food, Drug, and Cosmetic Act, section 510), among others. Filing your formulations or registering your establishment with the VCRP does not fulfill any of your legal responsibilities for marketing drugs.
Related Questions
- The cosmetic formulations that I previously filed in the VCRP using paper forms are not in my online account. How can I get them moved so I can manage them?
- 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?
