Knowing that food ingredients are authentic is key in preventing food fraud, a pervasive problem in the food industry. Food Chemicals Codex (FCC)Ĭontaining 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. 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. 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. 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. government, USP’s public drug standards help regulators and manufacturers ensure that safe, high-quality medicines make their way to consumers. Pharmacopeia-National Formulary (USP-NF)Įnforced by the U.S. USP publishes several compendia, which contain descriptions, tests and methods to help ensure the quality of drugs, foods and dietary supplements: U.S. 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. 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. Our collective knowledge about medicines has grown exponentially over time. 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. Today in the U.S., we can have confidence in the medicines we take, thanks to the work of the U.S. This collection of knowledge plays a critical role in protecting public health, especially for medicines and other aspects of healthcare.īefore 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. What is a Compendium?Ī compendium is a compilation of knowledge about a particular subject (“compendia” is plural and “compendial” is an adjective). But their meaning can be a bit of a mystery to people who work outside of the pharmaceutical industry and regulatory bodies. For purposes of New York and New Jersey State ethics rules, please take notice that this website and its case reviews may constitute attorney advertising.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. Before making any decision or accepting any legal advice, you should have a proper legal consultation with a licensed attorney with whom you have an attorney-client privilege. It is not a substitute for professional legal assistance. All information available on our site is available on an "AS-IS" basis. It is possible that the law may not apply to you and may have changed from the time a post was made. The law is also subject to change from time to time and legal statutes and regulations vary between states. The people providing legal help and who respond are volunteers who may not be lawyers, legal professionals or have any legal training or experience. When you submit a question or make a comment on our site or in our law forum, you clearly imply that you are interested in receiving answers, opinions and responses from other people. Legal Disclaimer: The content appearing on our website is for general information purposes only.
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