In May 2026, the pharmaceutical drug product and biopharmaceutical drug substance and drug industries will face a significant regulatory milestone: the enforcement of USP <665>, a new chapter of the United States Pharmacopeia designed to control the risks associated with polymeric (plastic) materials used in manufacturing processes. With the USP 665 effective date approaching, the regulations address a long-standing gap in global quality standards by requiring manufacturers to evaluate the potential release of process related impurities substances from plastic components that come into direct contact with drug substances and drug products during manufacturing.
Their implementation comes at a time when the widespread adoption of single‑use technologies, the industry’s growing reliance on polymer‑based equipment, and increasing environmental concerns have heightened scrutiny of plastics across the entire manufacturing ecosystem.
While USP <665> introduces detailed requirements and complex decision pathways, one principle stands above others: initial component or system risk assessment is the first step to compliance.