Key Issue: Pharmaceutical Components at Risk for Melamine Contamination

Posted: 05–Feb–2010

Contacts

• Excipient Monograph Technical Services Support: Bob Lafaver, (rhl@usp.org or 301-816-8335)
• Reference Standards Technical Support: RS Technical Service (rstech@usp.org or 301-816-8129)
• Reference Standards Ordering: USP Customer Service (custsvc@usp.org or 800-227-8772)
• Media: Laura Provan (lnp@usp.org or 301-816-8268)

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:

• FDA Guidance entitled 'Pharmaceutical Components at Risk for Melamine Contamination' (06–Aug–2009)
• USP Letter to FDA (05–Oct–2009)
• FDA Letter to USP (04–Dec–2009)
• USP Letter to FDA (18–Jan–2010)

Compendial Updates

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

Related Information

• New Tests for Identifying Potentially Deadly Adulterants Part of Revised Standards (30–Oct–2009)
• FDA's Request to USP to Revise the USP monographs for Propylene Glycol and Sorbitol Solution (12–Jan–2009)
• USP's Response to FDA (09–Mar–2009)