Draft · pending review by KOVARIS Research and legal counsel before publication
All products sold by KOVARIS Research are research compounds intended exclusively for in-vitro laboratory research by qualified personnel. For Research Use Only. Not for Human or Animal Use. These products have not been evaluated by the U.S. Food and Drug Administration (FDA) for any purpose. KOVARIS Research is a supplier of research materials only and does not operate under Section 503A or Section 503B of the Federal Food, Drug, and Cosmetic Act.
What this means in practice
- Every product is labeled and sold For Research Use Only · Not for Human or Animal Use.
- Products are research compounds and reference materials for in-vitro laboratory work.
- We provide technical documentation only: specifications, storage according to technical documentation, and the report filed for each lot.
- Buyers confirm the research-only purpose when they enter the site, when they register and again at checkout.
Sections 503A and 503B of the FD&C Act
Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act set the conditions for compounding by state-licensed professionals (503A) and by FDA-registered outsourcing facilities (503B). FDA keeps lists of the bulk substances that may be used under each section and updates them over time.
KOVARIS Research does not operate under Section 503A or Section 503B. We supply research materials for in-vitro laboratory work only. For the current FDA lists, see FDA’s pages on compounding laws and policies and bulk substances under 503A.
Full terms are in our Research Use Policy and Terms of Sale.