USP Dietary Supplements Compendium
In 2009, USP introduced the USP Dietary Supplements Compendium (DSC)—an industry-directed resource featuring relevant documentary standards previously only accessible through the USP–NF and FCC compendia, along with industry and regulatory guidance documents, supplemental information, and reference tools. USP updates and publishes the DSC every two years.
The DSC offers the dietary supplement community a comprehensive resource for finding suitable, unbiased, and scientifically sound specifications for their products, associated analytical methodology for ingredients they buy and for products common to many manufacturers. DSC standards and information can help with developing, manufacturing, and testing new products; qualifying raw materials; preparing for international quality control and cGMPs audits; setting and validating standard operating procedures; conducting in-process and batch-release tests; and accurately packaging, labeling, and storing products.
USP's dietary supplement standards are created and continuously revised through USP's open comment and review processes. Learn more and how you can get involved.
DSC Contents: Monographs, Methods, and More
The DSC includes nearly 800 monographs—documentary specifications of identity, strength, quality, and purity—for dietary supplements, dietary ingredients, and other components of dietary supplements from the USP–NF and FCC. (View sample monograph)
The DSC also includes USP–NF General Chapters and FCC General Tests and Assays relevant to the monographs, reference tables (such as international reference amounts for vitamins and minerals), industry guidance documents, macro- and microscopic photographs and diagrams, and HPLC/TLC/GC chromatograms (several hundred in full color). In addition, the DSC features Admissions Criteria Safety Reviews, completed by USP Expert Committees, on commonly used dietary ingredients: view sample.
International Impact & Regulatory Considerations
The DSC is published in the United States, but regulatory agencies, manufacturers, vendors, and other users of dietary supplements use USP standards around the world. They are a proven tool in establishing and managing quality, and their use helps promote buyer-supplier relationship and helps protect the global supply chain.
Standards derived from the official edition of USP–NF are recognized by the Federal Food, Drug & Cosmetic Act per the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA provides that a dietary supplement may be deemed to be misbranded if it is represented as conforming to a USP–NF monograph but fails to so conform.
In some countries, standards from the FCC may serve as a legal requirement for manufacturing or importing a food ingredient.