USP and 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. To learn about USP activities and their impact on consumers and public health, click on the section links below.

• Medicines
• Dietary Supplements
• Food Ingredients

Medicines

For 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.

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. Read more about USP's recent "at risk" medication activities under Hot Topics "New Standards for Medicines and Supplements."

Drug Classification for Medicare Prescription Drug Benefit
In addition to setting drug standards, 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 about the Medicare Model Guidelines and this activity.

USP Drug Quality and Information Program (USP DQI)
USP DQI is a program supported by the U.S. Agency for International Development that focuses on improving drug quality and appropriate drug use in developing countries through education, access to current drug information, and technical leadership. Since the program began in 2000, USP DQI has established a presence in countries on four continents and has addressed issues such as counterfeit drugs in Asia and Africa and an inadequate anti–malarial drug supply in the Amazon Basin. Learn more about USP DQI.

Consumer Medication Resources

Dietary Supplements

USP 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 very different than those for drugs; manufacturers may voluntarily choose to meet USP standards but are not required to do so. However, 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" or confirms 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

In light of recent FDA actions and news reports about sub–standard dietary supplement products, this added assurance of quality is important, especially to consumers who may rely on supplements to generally enhance their health, or to meet a specific dietary need based on a vitamin deficiency or situation such as pregnancy.

Click here for a list of USP Verified Dietary Supplement products and the places where you can find them.

Consumer Dietary Supplement Resources

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 about FCC standards.