USP 1074 Revises Excipient Safety: AAPS PharmSci 360 2026

PharmTech connected with Ron Filler, PhD, president and CEO, Drug Development Consultants, to discuss his presentation on USP’s proposed approach to revising General Chapter 1074 Excipient Biological Safety Evaluation Guidelines.

Filler grounds the revision in a constant priority: "And the challenge is always safety for the consumer and the patient." He adds that advances in the field aim to make safety evaluation more predictable, reliable, and human-relevant without compromising efficacy. "And that is a takeaway lesson that any excipient manufacturer or developer should carry with them because you're bringing forth new modalities to help people face illnesses and disease."

Filler describes 1074 as a guide that gives stakeholders basic direction for conducting excipient safety assessments according to established toxicological principles. The chapter dates to 2005, and the science has moved on since then. "Over the last 25 years, there's been a revolution in scientific thinking regarding safety assessment," Filler says. "And this guide is capturing that evolution to present it to the stakeholders so they have the current concepts if they have to face regulatory approval."

The proposed revision, first introduced through a Stimuli article, incorporates new approach methodologies, weight-of-evidence, and read-across strategies. Together, these are meant to deliver human-relevant safety assessments while reducing reliance on animal testing.

Filler also stresses communication. Concepts familiar to toxicologists can be opaque to formulators and regulatory affairs professionals, and the revised chapter aims to put them in writing. That need also appears in USP's stakeholder survey on novel excipient innovation.