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Dietary supplements manufacturers gain new tool to help ensure quality products
Date:7/7/2009

dance on suitable specifications, including scientifically valid analytical methods and acceptance criteria. Consumers expect and deserve this kind of added protection."

The DSC serves as a tool for manufactures in:

  • Developing, manufacturing and testing new products;
  • Qualifying raw materials;
  • Preparing for international quality control and cGMP audits;
  • Setting and validating standard operating procedures;
  • Collecting in-process and batch-release tests; and
  • Accurately packaging, labeling and storing products.

The DSC draws its quality specifications from the United States PharmacopeiaNational Formulary (USPNF) and the Food Chemicals Codex (FCC), USP's publications of standards for the identity, strength, purity and consistency of medicines and food ingredients, respectively. These specifications include items that may be considered dietary supplements or ingredients, including amino acids, vitamins, minerals, articles of botanical origin and their dosage forms. USPNF is considered an official compendium under the Federal Food, Drug, and Cosmetic Act (FDCA), with the FDCA food misbranding provisions applying to any dietary supplement product represented as conforming to compendial specifications (and such products being deemed misbranded by FDA if they fail to so conform). USP has been setting quality standards for medicines for nearly 200 years.


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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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