RUO vs PUO: What’s the Difference?

Jeff Cohen says clinicians have a responsibility to thoroughly investigate the source of any compounded peptide they use rather than simply trusting the supplier. He believes they should request documentation demonstrating product quality and safety, including certificates of analysis (COAs), third-party laboratory testing and other supporting evidence. He advises clinicians to keep this information on file so they can demonstrate due diligence if questioned by regulators or involved in legal action. According to Cohen, clinicians prescribing compounded GLPs may face scrutiny from regulators or plaintiff lawyers, who could argue they are using compounded products for financial gain rather than patient benefit. He says having documented evidence of product quality and safety helps demonstrate that prescribing decisions were based on patient care rather than profit. RUO vs PUO Cohen explains that Research Use Only (RUO) is a labelling strategy used by manufacturers selling directly to consumers. These products are labelled “Research Use Only” and “Not for Human Consumption” and should not include dosing, reconstitution or cycling instructions. He says Physician Professional Use Only (PUO) or Clinical Use Only labels emerged because clinicians were uncomfortable using products labelled “Not for Human Consumption.” According to Cohen, the same manufacturers began relabelling products to better suit clinician use. However, he emphasises that PUO is a marketing strategy rather than a legal classification. He says it does not provide additional regulatory protection but may reduce concerns clinicians have about being questioned by licensing boards over RUO-labelled products. The Future of PUO Cohen believes PUO-labelled products will continue to expand because involving a healthcare professional makes the overall treatment model more resistant to regulatory scrutiny. Which Clinicians Are Driving Growth? Cohen says relatively few physicians specialise in wellness or peptide therapies because traditional medical training focuses on diagnosing and treating disease rather than preventative wellness. He believes the greatest growth will come from nurse practitioners (NPs), who he says are generally more receptive to wellness approaches, emerging therapies and strong anecdotal evidence. By contrast, he sees physician assistants (PAs) as remaining more closely aligned with traditional physician-led medical practice.