In conversations about the role of quality standards in public health, you might come across the words “compendia” and “compendial.” At USP, terms like “compendial approaches,” “compendial standards,” and “compendial tools” are part of our everyday vocabulary. But their meaning can be a bit of a mystery to people who work outside of the pharmaceutical industry and regulatory bodies.
What is a Compendium?
A compendium is a compilation of knowledge about a particular subject (“compendia” is plural and “compendial” is an adjective). This collection of knowledge plays a critical role in protecting public health, especially for medicines and other aspects of healthcare.
Before USP was created – and in the early years of USP’s existence – medicines were mostly made without consistency by individuals in apothecaries; the dosing levels and the quality of the ingredients often varied greatly, which could harm patients. Today in the U.S., we can have confidence in the medicines we take, thanks to the work of the U.S. Food & Drug Administration and the Good Manufacturing Procedures followed by the drug manufacturing industry, with support from the quality standards USP develops with our partners.
Our collective knowledge about medicines has grown exponentially over time. This knowledge, accumulated over the years, and continuously reviewed and discussed, has been compiled in a variety of formats, including compendia, which are used by pharmaceutical manufacturers, health policy makers, regulatory bodies, and healthcare practitioners. Compendia of pharmaceutical knowledge also may be referred to as “pharmacopeia,” and nearly every country has designated at least one as the basis for consistent drug manufacturing.
USP publishes several compendia, which contain descriptions, tests and methods to help ensure the quality of drugs, foods and dietary supplements:
U.S. Pharmacopeia-National Formulary (USP-NF)
Enforced by the U.S. government, USP’s public drug standards help regulators and manufacturers ensure that safe, high-quality medicines make their way to consumers. When “compendial standards” refer to pharmaceutical standards in the USP-NF, this means the official quality standards to be used for all drugs sold in the U.S. marketplace. Compendial drug standards are also known as pharmacopeial standards, and the term is used to describe the quality standards contained in USP–NF and other pharmacopeias around the world.
Paired with USP’s reference standards – pure samples of materials used for comparison to manufacturer’s own materials – USP quality standards help ensure that drugs can be made consistently.
Food Chemicals Codex (FCC)
Containing standards for the purity and quality of food ingredients, the FCC is used throughout the world to help manufacturers ensure the ingredients they produce, procure and use are of high purity and quality.
Knowing that food ingredients are authentic is key in preventing food fraud, a pervasive problem in the food industry. Food fraud causes economic and reputational losses to manufacturers that have been victim to it, and can cause serious public health consequences to consumers, especially when it relates to unknown allergens and contaminants introduced into otherwise safe foods. FCC monographs provide blueprints for ingredient quality and authenticity and are a valuable tool in the fight against food fraud.
Dietary Supplements Compendium (DSC)
Used worldwide, and much like the FCC, the DSC provides quality standards to help manufacturers ensure the identity, potency and purity of their dietary supplement products.
Dietary supplements are widely used around the world, and because their regulation differs greatly from country to country, having public standards to establish their quality is extremely important. Dietary supplements and their ingredients also are vulnerable to adulteration, and the DSC is a tool that helps assure ingredient authenticity, increasing confidence that dietary supplements are free of contaminants and adulteration with other drugs.
Herbal Medicines Compendium (HMC)
The HMC contains standards for herbal ingredients that have been approved by a national authority for use in herbal medicines or are included in a national pharmacopeia. HMC monographs provide the definition of an herbal ingredient along with the analytical test procedures and acceptance criteria for specified tests.
Used by practitioners when compounding medicines, the Compounding Compendium contains all the compounding-related standards from the USP–NF, including more than 170 compounding monographs, as well as over 40 supporting general chapters such as those on Sterile and Non-Sterile Pharmaceutical Compounding.
What Makes USP Compendia Unique?
USP’s status as the only non-governmental pharmacopeia, and the fact that our standards are set by independent volunteer experts from around the world, make the USP compendia unique in their ability to safeguard the quality of medicines, dietary supplements and food ingredients.
Public input is crucial to our open and collaborative development process, and we engage with stakeholders throughout. Our quality standards are developed with input from government representatives and independent experts – including scientists, academicians, practitioners, and other professionals who volunteer their expertise. Proposed standards are made available for public review and comment in Pharmacopeial Forum (PF), the Food Chemicals Codex Forum (FCCF), or on the HMC website before they are finalized by a USP Expert Committee.
The public standards we create are critical to constructing and reinforcing the foundation for quality in health and healthcare, and are used in more than 140 countries around the world. Collaborating with the world’s top health and science experts — including 800 volunteers from universities, nonprofits, industry and government — USP sets the bar for manufacturing and distributing quality medicines, dietary supplements and foods around the globe. We continuously revise our portfolio to keep it current and ensure quality products are available worldwide, so we can help protect and improve the health of people everywhere.