USP and Pharmaceutical Manufacturers

To combat inconsistent drug quality and protect the public health, USP was founded in 1820 to create a system of standards to help ensure medication quality and uniformity in the United States. Today, with the help of pharmaceutical manufacturers from around the world, USP has established standards of identity, quality, purity, and strength for more than 4,000 active pharmaceutical ingredients (APIs), dosage forms, and excipients. Updated continuously to help manufacturers comply with the latest regulatory requirements, official USP standards are legally enforceable by the U.S. Food Drug and Administration (FDA) for drugs imported to or marketed in the United States. USP establishes both written standards and physical USP Reference Standards and offers a wide range of beneficial resources for manufacturers.

Written/Documentary Standards

USP written standards for prescription and over–the–counter medications are published each year in the United States Pharmacopeia and the National Formulary (USP–NF) compendia. USP–NF standards provide essential specifications for product development, quality control, production, labeling, and storage. The USP–NF also features step–by–step tests, assays, and methods along with additional reference information for APIs, dosage forms, biologics, medical devices, excipients, and dietary supplements. Learn more about USP–NF standards and the most up–to–date edition.

USP Reference Standards

USP's physical Reference Standards are highly characterized specimens of drug substances, excipients, impurities, degradation products, dietary supplements, compendial reagents, and performance calibrators. They are specified for use in conducting official USP–NF tests and assays and can help with complying with regulatory requirements. A potential time– and cost–savings resource, USP Reference Standards are created from material donated by pharmaceutical manufacturers and are quality tested in at least three independent labs. Learn more about USP Reference Standards or view available products in the current electronic USP Catalog.

Participate in the Standards–setting Process

USP standards are developed and vetted through a collaborative standards–setting process that allows manufacturers to participate in establishing both the written and physical reference standards they are required to use in their work. Click on the links below to learn how you can help.

• Submit new USP–NF monographs and revisions
• Donate bulk material and provide testing services for USP Reference Standards

Related Resources

USP offers a wide range of resources and tools for pharmaceutical manufacturers. Links to additional resources can be found on the right sidebar.

Publications: USP offers several complimentary publications to its standards, including Pharmacopeial Forum, the USP Dictionary, and Chromatographic Columns. Visit our products section to learn more about these and other quality titles.

Education Courses: To help you interpret and apply USP standards accurately, USP offers a variety of classroom and on–demand online education courses. USP Pharmacopeial Education curriculum is developed by the USP experts who set the standards. Click here for the latest course offerings.

USP Verification: USP offers comprehensive, third–party auditing and testing services to verify the identity, quality, purity, and potency of active pharmaceutical ingredients and excipients. Ingredients and manufacturing processes are evaluated against USPs stringent standards, current FDA GMPs, and applicable ISO standards. Learn more about USP Verified Pharmaceutical Ingredients and how your products can benefit from this unique program in the marketplace.

Frequently Asked Questions