RUO (Research Use Only)

The acronym RUO stands for Research Use Only. It designates the regulatory status of a product (peptide, reagent, molecule, analysis kit) that has not received market authorization for diagnostic, therapeutic or veterinary use. The RUO mention strictly mandates use of the product in a laboratory setting, by qualified personnel, respecting experimental protocols and local ethics approvals.

The RUO status is internationally recognized and harmonized with American (FDA, 21 CFR 809.10), European (IVDR 2017/746 for in vitro diagnostic devices, regulation (EC) 1394/2007 for advanced therapy medicinal products) and French (ANSM, Directorate General for Health) regulations. It stands opposed to IVD (In Vitro Diagnostic, authorized for clinical diagnosis) and pharmaceutical MA (Marketing Authorization for human use) statuses.

Concretely, an RUO-sold peptide must clearly display "Research Use Only - Not for human or veterinary use" on the label, technical sheet, Certificate of Analysis and invoice. The supplier must ensure the buyer is a legitimate research actor (academic lab, biotech company, CRO, university hospital in research) and cannot endorse nor promote off-frame use.

Legally authorized uses include: in vitro studies on cell cultures or primary lines, in vivo experiments on animal models with ethics authorization (CEEA committee in France), analytical method development, upstream diagnostic test validation, PhD and lab technician training, exploratory pharmacological screening.

Any use on a human being — including personal self-experimentation — exits the RUO frame and crosses into illegality (illegal pharmacy practice, drug counterfeiting, use diversion). The boundary is strict and its violation exposes to criminal, health and civil sanctions. Respecting the RUO frame preserves the open, accessible peptide research ecosystem.