Upcoming Issue Highlights

U.S. Pharmacopeial Convention


12601 Twinbrook Pkwy.
Rockville, MD
Phone: (301) 230-7452
Website: www.usp.org

Setting Public Standards for Dietary Supplements, Food Ingredients & Pharmaceuticals

Company Description
The U.S. Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances global health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. USP is headquartered in Rockville, MD, in the United States and has facilities in Basel, Switzerland; Hyderabad, India; Shanghai, China; and São Paulo, Brazil. Volunteer experts from around the world set USP standards in an open and public process based on scientific exchange. USP standards are used in more than 140 countries.

What Does USP Do?
Product Quality—Documentary Standards & Reference Materials
USP establishes documentary standards and chemical reference materials for demonstrating and authenticating the identity, strength, quality, and purity of dietary supplements and food ingredients, as well as pharmaceuticals.

• USP Dietary Supplements Compendium (DSC)
The DSC combines dietary supplement standards from the United States Pharmacopeia and the National Formulary (USP–NF) with food ingredient standards from the Food Chemicals Codex (FCC). The two-volume compendium features monograph standards, test procedures and acceptance criteria, DSC Admissions Criteria Safety Reviews, regulatory guidance and full-color illustrations—including macro/microscopic photographs and TLC chromatograms of selected botanical articles. The DSC offers a comprehensive resource for suitable, scientifically sound specifications for components used in dietary supplement manufacturing.

• Food Chemicals Codex
The FCC is a compendium of internationally recognized documentary standards for authenticating the purity and quality of food ingredients, including processing aids, preservatives, flavorings, colorants, nutrients and other ingredients. It includes monographs, tests and assays, general good manufacturing practice (GMP) guidelines for food ingredients, and excerpted data from the USP Food Fraud Database.

• Reference Materials
USP offers highly characterized chemical specimens for use in conducting quality control tests and analytical test procedures associated with documentary standards found in the USP–NF, DSC and FCC. Its catalog features more than 200 reference materials for dietary ingredients (e.g., vitamins, minerals, amino acids, botanicals, fish oils), more than 200 for excipients and more than 150 for food ingredients (e.g., flavorings, preservatives, nutrients, colorants).

USP Dietary Supplement Verification Program
USP’s voluntary, third-party testing and auditing program helps dietary supplement manufacturers confirm the quality of their products. Supplements that meet USP’s stringent criteria are awarded the USP Verified Mark for Dietary Supplements to display on product labels and promotional materials. Finding the USP Verified Mark on a label makes it easy for consumers to identify supplements whose quality, purity and potency have been verified by a reputable independent organization.

USP Dietary Ingredient Verification Program & USP Pharmaceutical Ingredient (Excipient) Verification Program
USP also offers voluntary, third-party verification services to help manufacturers and suppliers demonstrate the quality of components used in the manufacture of dietary supplements. Dietary ingredients and excipients that meet USP’s comprehensive, stringent testing and auditing criteria are awarded the USP Verified Mark for Dietary Ingredients or USP Verified Mark for Pharmaceutical Ingredients, respectively, to display on ingredient containers, plus a Certificate of Analysis. To learn more about USP and the services offered, visit www.usp.org and follow USP on Facebook at www.facebook.com/uspharmacopeia