What “Research Use Only” means
Research Use Only (RUO) is a regulatory classification for materials sold strictly for laboratory investigation. RUO materials are not manufactured, tested, or labeled to standards required for human therapeutic use. They have not been evaluated by the FDA for safety or efficacy in humans.
What RUO compounds cannot legally be used for
- Treatment, prevention, diagnosis, or mitigation of any disease or condition in humans or animals
- Administration to human subjects outside of an authorized clinical trial
- Use as a dietary supplement, cosmetic, or food additive
- Compounding into therapeutic preparations by unlicensed parties
What RUO compounds are used for
- In vitro receptor binding and cell culture assays
- Analytical method development and reference-standard work
- Biochemical pathway investigation
- Veterinary research conducted under institutional oversight
Why we enforce this
Because the safety profile of research compounds in humans is by definition incompletely characterized. Compounds may degrade unpredictably, may contain impurities tolerable for laboratory work but unsafe systemically, and may have biological effects that have never been studied in clinical context. The RUO framework exists to protect both researchers and the public.