Tuesday, August 11, 2009

FDA Instructs Pharma Companies to Watch for Melamine

Pharmaceutical-Technology.com reported in its August 7, 2009 on-line edition on FDA guidance and instructions on protection to the pharmaceutical supply chain, specifically as it relates to Melamine. Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides.

Here are some highlights from the article:

  • The US Food and Drug Administration (FDA) warned drug companies to scrutinize certain pharmaceutical ingredients for the presence of melamine and has issued industry guidance on how to protect against contamination.

  • The FDA has stressed that there is no evidence that melamine, which if ingested in significant amounts can lead to kidney failure or death, has entered the pharmaceutical chain but that recent contaminations in pet food and in infant milk in China have proven the need to be vigilant.

  • The FDA has released guidance as an initial measure with pharmaceutical manufacturers, re-packers, other suppliers and pharmacists to conduct melamine testing.

  • The FDA identified specific pharmaceutical ingredients recommended for screening, and has also recommended specific FDA-published methods for this testing.

  • "The FDA urges the implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain," Hamburg said.

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To read the article in full, follow the link below:

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