Key Issue: Pharmaceutical Components at Risk for Melamine Contamination

Posted: 05–Feb–2010


  • Excipient Monograph Technical Services Support: Bob Lafaver, ( or 301-816-8335)
  • Reference Standards Technical Support: RS Technical Service ( or 301-816-8129)
  • Reference Standards Ordering: USP Customer Service ( or 800-227-8772)
  • Media: Theresa Laranang-Mutlu ( or 301-816-8167)

FDA Guidance

FDA issued a guidance document entitled "Pharmaceutical Components at Risk for Melamine Contamination" on August 6, 2009. In an effort to keep both FDA and stakeholders informed of USP's activities in this matter, USP launched a "Hot Topics" web page on Pharmaceutical Components at Risk for Melamine Contamination. USP has offered to collaborate with FDA and industry stakeholders toward the development of appropriate analytical methods related to melamine testing.

The following FDA guidance and related USP activities are posted on the Key Issues website:

Compendial Updates

To keep informed about any activities relating to melamine, sign up for USP's free Compendial Updates email service.

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