United States Pharmacopeial Convention (USP)

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USP is a scientific nonprofit public health organization that sets standards for the quality, strength, purity, and identity of drugs, dietary supplements, and food ingredients.  USP’s drug standards are enforceable by the Food and Drug Administration in the United States, and all three types of standards are used and relied upon in more than 130 countries.  USP has been setting standards for the quality of medicines since 1820.

USP’s Role In Assuring Global Access To Quality Medicines

Today, global access to quality medicines increasingly is threatened by many factors, including the presence of both substandard and counterfeit medicines. Substandard medicines1 can occur even when they are manufactured according to quality standards and Good Manufacturing Practices (GMPs). Counterfeit medicines2, on the other hand, which account for a larger percentage of poor quality medicines in resource-limited countries, occur because there is a deliberate intention to mislead. In both instances, however, the result is poor quality medicines that deny practitioners and patients of achieving expected health outcomes. Poor quality medicines can be especially burdensome in developing countries where they not only fail to produce needed results, but also absorb limited resources, undermine faith in already tenuous health systems, and may promote antimicrobial resistance to devastating infectious diseases such as HIV, malaria, and tuberculosis. Poor quality medicines represent a failure of standards and conformity assessments to standards, and such failures can and do arise at multiple points in the medicines continuum; from discovery, to development, to registration, through manufacturing and distribution, to utilization. The globalization of pharmaceutical markets has exacerbated this growing problem of poor quality drugs, particularly in countries that lack strong drug regulatory systems and oversight. Whatever standards and conformity assessments there are for medicine supply chains—from suppliers to manufacturers, and thereafter from practitioners to patients—these supply chains are becoming increasingly fragmented and fragile.

Access To Good Quality Dietary Supplements

The 1994 Dietary Supplement Health and Education Act (DSHEA) amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) provided a regulatory framework to allow marketing of vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Now, more than 15 years later, a vast array of dietary supplements in different combinations and amounts are available to United States patients/consumers. Sales of dietary supplements are approaching $25 billion/year, with about $4 billion of this amount representing sales of botanicals. While DSHEA was instrumental in providing consumers with easy access to dietary supplements, a recent U.S. Government Accountability Office (GAO) report stated that consumers of dietary supplements are not adequately protected under current U.S. law and regulations.1 Pre-market oversight and registration of products are recommended in the GAO report.2 Outside the United States, dietary supplements are frequently considered as traditional medicines with few standards and conformity assessments to these standards. In this white paper, USP’s Council of the Convention Section on the Quality of Food Ingredients and Dietary Supplements provides background information on the topic and advances proposals for consideration by the Convention membership to further improve the quality of dietary supplements.

USP’s Role In Patient Safety

For the last four decades, the United States Pharmacopeial Convention (USP) has relied on spontaneous reporting information to support creation of safe medication use and quality of care standards in the United States Pharmacopeia (USP) and allied reports. For the most part, these are standards and supporting information that speak to how practitioners within healthcare systems should adjust their processes and practices to promote safe medication use. At times, USP product standards call for the adjustment of labels and labeling to reduce the likelihood of error.

Importance Of Standards In Assuring Good Quality Food Ingredients And Foods

Most recent public concern and policy discussions about issues for food safety focus on surface (microbial) contamination, where substantial morbidity and mortality occurs in the United States (U.S.) each year. However, recent incidents of intentional adulteration of food with melamine have shown that harm arises not only from microbes, but from deliberately-added inappropriate substances as well. Within the U.S., the ability of regulatory bodies and food manufacturers to provide safe, high quality food to consumers is challenged by: 1) the increase in global trade, which places enormous competitive pressure on companies that, in turn, may put good quality and safe foods at risk; 2) supply chains that are longer, more complex, and international; and 3) fragmentation of the U.S. food regulatory framework, which is split among multiple agencies and levels with each frequently lacking sufficient resources. Further, if one looks at the value of all processed food sold globally—$3.2 trillion—the significance to global economies becomes obvious. This huge market is supported by a complex web of domestic and foreign food and food ingredient suppliers. Could the United States Pharmacopeial Convention (USP) help in some way? Does USP have an obligation to do what it can within its standards-setting role to protect U.S. citizens and people around the world from tainted foods and food ingredients?

USP’s Role In Setting Enforceable Quality Standards For Medicines

For nearly two hundred years, the United States Pharmacopeial Convention (Convention or USP) has worked to set quality standards for drugs (medicines and their ingredients). Much has changed during that period, including the globalization of the pharmaceutical industry, ongoing availability of better drugs to promote health and treat disease, demands for access to good quality medicines, systems that deliver interchangeable multi-source products after periods of patent and market protection, advances in measurement and manufacturing science, and calls for regulatory and compendial harmonization. In these contexts, USP’s public standards continue to play an important role in assuring both practitioners and patients that the medicines they use are of good quality relative to their safety and efficacy. If anything, recent events such as the rise in counterfeit and substandard medicines and adulteration crises (diethylene glycol, melamine, heparin) have heightened concerns about the quality of drugs, and reinforced the importance of USP’s public standards as part of the safety net that protects practitioners and patients in the U.S. and elsewhere.

A Model System To Promote Access To Good Quality Compounded Medicines

Extemporaneous compounding of preparations is a worldwide practice dating back centuries. Today, compounding is commonly defined as the preparation of a medicine in accordance with a licensed practitioner’s prescription or medication order. This definition evolves from a triad—the prescribing practitioner, the compounding professional, and the patient/consumer. Historically, what was once viewed as an art is now deeply rooted in the scientific study of how to prepare and assess compounded preparations, together with provision of stability data to allow assignment of a beyond-use date (BUD).

Opportunities For Drug Information And Use Standards

As a standards-setting organization for medicines and other healthcare articles, the United States Pharmacopeial Convention (USP) has contributed broadly and deeply to the provision of information supporting rational therapeutic decision-making and safe medicine use. In this white paper, USP’s Council of the Convention Section on the Quality of Patient Care provides a situation analysis of these and allied contributions, focusing on the general topic of drug information and use standards. A separate white paper will consider safe medication use.