// August 26, 2014

Who’s Behind U.S. Standards for Medicine and Food Quality

Call for Candidates

When it comes to medicine and food ingredient quality, we’re quite fortunate in the U.S. Most of us take for granted that we have one of the strongest systems in the world for developing, regulating and enforcing requirements that protect the quality of our medicines, foods and dietary supplements.

Yet few Americans are aware of the behind-the-scenes work done by a network of government agencies, non-profits, companies and independent organizations—all working together, to create a safety net that supports good-quality products.

The U.S. Pharmacopeial Convention (USP) is one organization that plays a major role in helping to ensure that medicines, food and dietary supplements are, indeed, of good quality.

The Organization

For nearly 200 years, USP has been providing scientific guidance for what constitutes “good medicines” in this country. It does this through the standards it develops for the identity, strength, quality and purity of particular medicines. In 1938, the enactment of the U.S. Food, Drug and Cosmetic Act recognized a role for USP’s standards in law.

Today, USP’s standards for medicines are enforceable by the U.S. Food and Drug Administration, and by regulatory authorities in many other countries. These standards cover a wide range of medicines and their ingredients. They include standards for chemotherapy drugs, therapies for diabetes, cholesterol medication, agents for controlling blood pressure and much more.

USP also establishes standards for foods, dietary supplements and herbal products, although the regulation of these products in the U.S.—and the role of applicable USP standards—differ from those of medicines.

Scientists and Practitioners from Around the World

USP taps the knowledge and expertise of scientists and practitioners from the U.S. and around the world to create its quality standards.

You might ask why USP needs to pull from global expertise when we’re dealing with medicines and foods in the U.S. The answer is straightforward—with the impact that globalization has played and will continue to play in these arenas, USP would be remiss not to benefit from global expertise in the development of its standards.

Food and drug manufacturing has truly become a global enterprise, and the number of experts from around the world who contribute to that overall process is growing.

Volunteers Drive the Process

A good public standard based on sound science establishes the minimum requirements for ensuring quality.

The scientists who lend their expertise to produce these standards volunteer their service to USP.

Because these volunteers come from industry, academia, the regulatory community, the healthcare arena and scientific and trade associations, USP is able to tap into a diverse range of knowledge and rich experience for defining quality in medicines, foods and dietary supplements.

A Call for Candidates

Right now, USP is in the midst of recruiting expert volunteers for its 2015-2020 cycle. USP’s Call for Candidates involves application and selection processes that are designed to match an elected individual’s expertise with a corresponding USP Expert Committee.

While USP’s experts focus on standards geared to products marketed within the U.S., USP’s interests are also global, with a goal of modernized standards for quality that are harmonized where appropriate with those from other pharmacopeias around the world.

If you are interested in more information about applying to volunteer as a USP Expert Committee member and about the changes to USP’s 2015-2020 committee structure, please visit https://callforcandidates.usp.org/.

Mario Sindaco, M.S., MBA, is director of compendial affairs at USP.