Developing documentary standards and Reference Standards is the core of what we do at USP. These standards help to assess the quality, strength, identity, and purity of chemical medicines, biologics, food chemicals and ingredients, dietary supplements, among other items.
FACT: There are two types of standards.
Documentary standards (also known as monographs)—covering everything from developing a drug to storing it—appear in our reference text, the United States Pharmacopeia-National Formulary (USP–NF).
A USP Reference Standard (also known as a physical standard) is a known quantity of a drug substance or ingredient, developed in alignment with the specifications outlined in the USP–NF. These standards come in small vials, and enable pharmaceutical manufacturers to test their product against USP’s standards to ensure it meets published specifications.
FACT: Many of USP’s standards are enforceable by federal law
The Federal Food, Drug and Cosmetic Act of 1938 made the USP–NF an official pharmacopeia. A variety of provisions of the Act require adherence to our standards.
FACT: Our standards are used in more than 140 countries
Some international regulatory authorities and lawmaking bodies incorporate our documentary standards into their laws to ensure the quality of medicines produced in, or exported to, their countries. Some international pharmaceutical companies use our Reference Standards as part of their manufacturing process.
FACT: The United States Food and Drug Administration (FDA) relies on USP’s standards as part of its work to ensure the safety and quality of foods and drugs.
USP–NF standards play a role in the adulteration and misbranding provisions of the Federal Food, Drug and Cosmetic Act (which apply as well to biologics, a subset of drugs, under the Public
Health Service Act). USP has no role in enforcement of these or other provisions that recognize USP–NF standards, which is the responsibility of FDA and other government authorities in the United States and elsewhere.
FACT: Good-quality standards are essential to manufacturing good-quality medicines and foods.
Maintaining and growing USP's collection takes the concerted effort of industry donors and experts, regulatory agencies, USP staff, and the volunteers of the USP Council of Experts. Through this collaborative process, USP strives to produce Reference Standards of the highest quality and make them readily available to the public.
