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Pharmaceutical Components at Risk for Melamine Contamination

Posted: February 5, 2010

What's New

FDA Guidance for Industry, Pharmaceutical Components at Risk for Melamine Contamination, August 6, 2009

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 has launched a new “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 Hot Topics website:

FDA Guidance entitled 'Pharmaceutical Components at Risk for Melamine Contamination', August 6, 2009 (72KB)
USP Letter to FDA, October 5, 2009 (102KB)
FDA Letter to USP, December 4, 2009 (110KB)
USP Letter to FDA, January 18, 2010 (62KB)

Web Content

USP's 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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USP Contacts

Catherine Sheehan, MS, Director, Excipients ( or 301-816-8262)

Related Links

New Tests for Identifying Potentially Deadly Adulterants Part of Revised Standards (October 30, 2009)
FDA's Request to USP to Revise the USP monographs for Propylene Glycol and Sorbitol Solution (305KB) (January 12, 2009)
USP's Response to FDA (65KB) (March 9, 2009)
Propylene Glycol, Sorbitol Solution, and Sugar Alcohols (updated January 18, 2010)