What is USP?
The United States Pharmacopeia (USP) is a private, non-profit scientific organization that develops standards and science-based solutions that help increase the supply of quality medicines, dietary supplements and food ingredients. Used in 150+ countries, USP standards play a critical role in supporting the availability of quality medicines for billions of people worldwide.
What role does USP play in meeting people’s health needs worldwide?
Through rigorous science and collaboration with governments, industry, and health experts around the world, USP helps strengthen the systems that support access to quality medicines by:
- Setting quality expectations for medicines, grounded in scientific rigor, robust stakeholder engagement, and good governance
- Supporting stronger, more aligned regulatory systems through science‑based decision‑making, clear quality expectations, and regulatory convergence
- Building local and regional capability through technical assistance and training
- Enabling efficient and predictable adoption of innovation, including advances in science, manufacturing, and technology
- Integrating environmental sustainability considerations and technologies into USP standards
Together, this work helps increase the supply of, and trust in, quality medicines for people around the world, supporting efficient market access and helping reduce drug shortages.
How does USP translate quality expectations into practice across the medicines lifecycle?
USP establishes clear quality benchmarks through standards and other science-based solutions supporting the quality of medicines from development to delivery, including active pharmaceutical ingredients, key starting materials, excipients, and finished dosage forms. These tools help manufacturers and regulators validate methods and critical quality attributes, control impurities, and ensure product performance across the product lifecycle.
Why are USP standards important?
Public quality standards are essential because they:
- Aid regulatory predictability and efficiency
- Enable consistent medicine quality across manufacturers and production locations
- Facilitate a multi-manufacturer environment
- Reduce risks of substandard or falsified medicines
Who uses USP standards?
USP standards are trusted by:
- Pharmaceutical and biopharmaceutical manufacturers to help streamline quality processes and reduce costs and complexity
- Regulators to enable consistent quality expectations and faster reviews
- Healthcare providers to maintain public confidence in quality medicines
How does USP enable innovation and sustainability?
USP supports industry, facilitating innovation and environmental sustainability by:
- Updating standards for emerging therapies, technologies, test methods, and digital lab environments
- Advancing eco-friendly practices that keep quality at the center of all we do
- Addressing related gaps in education and technical training
Does USP only focus on medicines?
No. USP also develops standards for:
- Dietary supplements and herbal medicines
- Food ingredients
These standards help manufacturers produce safe, quality products that protect consumer health.
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