USP Opens Extended Public Comment Period for Revised Compounding Standards

Rockville, Md., September 1, 2021 — USP published revisions to Compounding General Chapters <795> Pharmaceutical CompoundingNonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations for an extended 150-day public comment period—until January 31, 2022.

In addition, the USP Compounding Expert Committee (CMP EC) is hosting four Open Forum sessions in September 2021 and January 2022 to discuss questions from interested stakeholders. The CMP EC has also published several informational documents intended to supplement the proposed Chapters and explain the CMP EC’s rationale behind the revisions.

Revisions to chapters <795> and <797> reflect public health considerations, scientifically robust approaches, and numerous stakeholder engagement activities. The CMP EC engaged healthcare practitioners, regulators, academicians, and other key stakeholders in various sessions including semi-structured interviews with stakeholders, a small roundtable discussion with invited participants, and a broader open forum discussion. These engagements helped the CMP EC consider a wider range of perspectives to inform the revisions while maintaining scientific rigor and accounting for today’s public health and practice needs.

For more information on the USP Compounding General Chapters, visit www.usp.org/compounding.

About USP
U.S. Pharmacopeia (USP) is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements and food ingredients worldwide. USP’s quality standards are legally recognized in the U.S. and elsewhere, and are used in more than 150 countries. These standards are continuously developed and revised by more than 800 volunteer experts in science, industry, healthcare and academia. Learn more at www.usp.org.