USP & Patients/Consumers

Consumers

Few Americans are aware that the United States Pharmacopeia (USP) plays an important role in their general health and well-being. While USP does not manufacture, sell, determine the safety of, or regulate medications, dietary supplements, or food ingredients, it does set standards so that there is uniform, consistent quality that consumers can confidently expect when they buy and use these products. As a nonprofit, scientific organization, USP is in a unique position. It can collaborate with industry, governments, academic institutions, healthcare practitioners, and consumer groups from around the world to set standards that are in the public's best interest. USP standards are relied upon in the United States and in more than 130 countries.

Click on the links below to learn how USP helps to ensure the quality of your medicines, dietary supplements, and food ingredients:

Medicines

Consumer MedicinesFor nearly 200 years, USP has set scientifically developed standards that help to ensure that over-the-counter and prescription medicines are of high quality, are pure, are of the appropriate and expected strength, and are consistent from one pill, bottle, shelf, and pharmacy to the next. Once USP develops a drug standard and it becomes official, it is enforceable by the Food and Drug Administration (FDA), and all manufacturers of that drug must comply with the USP standard if they wish to import it to or market it in the United States. Note: USP does not approve a drug for sale in the U.S. market nor does it make decisions about a drug's safety or efficacy—these are also responsibilities of FDA.

Learn More

USP's standards for medicines in the USP–NF

Updating Standards for "At Risk" Medications

An important and emerging activity for USP is updating standards for drugs that are considered "at risk" for adulteration. In the modern, global manufacturing environment, drugs and their ingredients are produced all over the world. In some instances, counterfeiters have adulterated medicines by substituting lower-cost ingredients for higher-cost ones for their own economic gain—which can have serious and even fatal consequences for patients. Adherence to USP's standards of quality is one of the safety nets that helps secure the drug supply.

Learn More

Drug Classification for Medicare Prescription Drug Benefit

Under a Congressional mandate, USP has developed—and will continue to update—a drug classification system (the Medicare Model Guidelines) for the Medicare prescription drug benefit program. This classification system provides a framework that pharmaceutical benefit managers and prescription drug plan sponsors can use in determining medicines approved for coverage under Medicare.

Learn More

USP Promoting the Quality of Medicines Program (PQM)

The effects of substandard and counterfeit medicines are devastating, and in developing countries where resources to combat them are limited, their impact is hardest felt. PQM is a program supported by the U.S. Agency for International Development (USAID) that focuses on helping developing countries ensure the quality, safety, and efficacy of medicines essential to USAID priority diseases, particularly malaria, HIV/AIDS, and tuberculosis. In addition to providing technical leadership and global advocacy, PQM  helps countries improve their quality assurance and quality control systems, increase the supply of quality assured medicines, and combat substandard and counterfeit medicines.

Learn More


Dietary Supplements

Consumer Dietary SupplementsUSP sets standards for dietary supplements (including vitamins, minerals, botanicals, and herbals) that are recognized in U.S. federal law per the Dietary Supplement Health and Education Act, an amendment to the U.S. Food, Drug, and Cosmetics Act. FDA regulations for dietary supplements are different than those for drugs; manufacturers may voluntarily choose to meet USP standards. Under the law, products that claim to conform to USP standards on their labels must do so or they may be deemed to be misbranded per FDA regulations.

USP Verified Dietary Supplements—Look for the Mark

In addition to setting standards, USP offers a voluntary program for manufacturers that verifies the quality a product's ingredients and its manufacturing processes. Products that meet USP's stringent testing and evaluation criteria are awarded the USP Verified Mark (see image to right) for use on product labels, packaging, and promotional materials.

The USP Verified Mark helps assure consumers of a manufacturer's commitment to quality and helps them easily identify and choose a product that

  • contains the ingredients listed on the label, in the declared potency and amount
  • does not contain harmful levels of specified contaminants
  • will break down and release into the body in a specified amount of time
  • and has been made according to the FDA's Good Manufacturing Processes

The USP Verified has appeared on more than 200 million product labels.

Learn More


Food Ingredients

USP began establishing standards of quality for food ingredients when it acquired The Food Chemicals Codex (FCC) from the Institute of Medicine (IOM) in 2006. Published since 1966 by IOM, the FCC contains standards for the purity and identity of food ingredients that are used by manufacturers around the world. While FCC standards are intended for industry use, they help manufacturers supply food ingredients and finished products to consumers that are of consistent and uniform quality.

As the global marketplace for food ingredients continues to expand, increasing attention is being paid to food ingredient quality and critical issues such as adulteration and contamination. USP is committed to helping the food ingredient industry combat these issues by continuing to revise and update FCC standards to meet contemporary needs. While FCC standards are not enforced in the United States like USP drug standards, they can serve as a legal requirement for manufacturing or importing a food ingredient in other countries, and they can play an important role in helping a manufacturer demonstrate self-regulation and quality assurance.

Learn More