Released earlier this week, the compendium provides lists of quality specifications for dietary supplements and their ingredients.
“With the current cGMPs from FDA stipulating that dietary supplements manufacturers determine the quality of ingredients they buy from suppliers by setting their own specifications, the DSC can significantly assist manufacturers by providing guidance on suitable specifications, including scientifically valid analytical methods and acceptance criteria. Consumers expect and deserve this kind of added protection,” said James Griffiths, PhD, vice president of food, dietary supplement and excipient standards for USP.
Setting standards
The final rule of the GMP legislation was passed last year in an effort to provide standards specific to supplements for purity, safety and legality in manufacturing. Big companies (over 500 employees) had to implement the new standards in June last year. Mid-sized firms (20-499 employees) were required to become compliant last month, while small firms (less than 20 employees) have until June 2010 to comply.
USP said its compendium provides information on standards for identity, strength, purity and performance characteristics (such as dissolution, disintegration) of more than 500 dietary supplements and ingredients.
It also includes general and regulatory information, guidance documents, appendices, and macro/microscopy, thin layer chromatography (TLC) and high performance liquid chromatography (HPLC) full-color images that “greatly simplify” the analysis of ingredients of botanical origin, it said.
The new DSC draws its quality specifications from the Food Chemicals Codex (FCC) as well as USP’s National Formulary (USP-NF), which is considered an official compendium under the Federal Food, Drug, and Cosmetic Act (FDCA).
Raising quality
According to USP, the DSC can help manufacturers to develop and test new products, as well as qualify their raw materials. In addition, it provides guidance on preparing for international quality control and cGMP audits. It can also serve as a tool in: Setting and validating standard operating procedures; collecting in-process and batch-release tests; and accurately packaging, labeling and storing products.
“With the release of this new Dietary Supplements Compendium, USP is seeking to partner with ingredient suppliers, dietary supplements manufacturers, contract laboratories, regulatory bodies and independent consultants to raise the quality of supplements and to fulfill the need for public standards in the dietary supplement community,” said Griffiths.