Quality Standards

Our Concerns Regarding Congressional Proposal to Discard Public Quality and Safety Standards for Biologics

Biologics Standards Proposal

For a hundred years, federal law has required that all drugs adhere to public quality standards—part of ensuring safety and protecting the public’s health. Language that would exempt biologics, including biosimilars, from adhering to the same public quality standards as other prescription medicines was recently added to the FDA and NIH Workforce Authorities Modernization Act. Learn about the potential impact this biologics quality exemption may have on competition, product development, and the public's confidence in biologics and biosimilars.

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Quality Standards for Gummy Dietary Supplements Topic of Recent USP Roundtable Discussion

USP Roundtable on Gummy Dietary Supplements

Stakeholders representing major gummy manufacturers, ingredient manufacturers, contract laboratories, and trade associations recently participated in a USP roundtable discussion on gummy dietary supplements. They shared their views on technical and quality challenges in manufacturing as well as scientific and public health considerations related to the future development of USP quality standards for gummy dietary supplements.

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USP Reference Standards: 5 Tools You Should Know About

Resources for USP Reference Standards Users

Discover convenient tools and helpful tips related to using USP Reference Standards in your work. USP Reference Standards are intended for quality control use in conducting assays and tests in USP’s documentary standards for drugs, dietary supplements, and foods. 

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