Research use only (revision 4)

Research use only is a label applied by a seller to material offered for laboratory work rather than for administration to humans or animals. The phrase, and its abbreviation RUO, appears on the great majority of research-peptide listings, invoices and certificates.^[1]

The label is a commercial and regulatory category, not an approval. Material carrying it has not been assessed by any medicines regulator, is not manufactured under the obligations that apply to medicines, and is not approved for human use in any major jurisdiction. Its identity, purity, sterility and endotoxin content are not assured by anybody outside the supply chain that produced it.^[2][3]

The obligations that attach to a medicine and do not attach to research-use-only material are extensive. The following are the ones that bear directly on what a purchaser can and cannot infer.

• No marketing authorisation. No regulator has assessed the material for quality, safety or efficacy for any use.
• No manufacturing authorisation. Production need not take place under good manufacturing practice, and no inspectorate has visited the site.^[2]
• No pharmacopoeial compliance requirement. Compendial monographs and general chapters describe what a determination should look like; nothing requires unregulated material to meet them.^[3]
• No sterility or endotoxin requirement. A lyophilised powder is not sterile unless it is stated to be, and an absence of statement is not a statement of absence.
• No pharmacovigilance. There is no adverse-event reporting route, so no signal accumulates anywhere.
• No labelling standard. Strength, fill convention and storage statements follow no prescribed form; see the discussion of nominal fill at Peptide content.