Guidance on Sanitation at Compounding Facilities Gets Mixed Reviews

October 12, 2016

The FDA draft guidance on unsanitary conditions at drug compounding facilities got mixed reviews in comments on the draft.

One commenter questioned the need for the guidance, calling it an overreaction to the event that led to the guidance, a 2012 meningitis outbreak. The comment pointed to evidence that between 2000 and 2012 only 20 adverse events were linked to compounders that were not related to the New England Compounding Center, the source facility of the 2012 outbreak.

A second commenter said the guidance ignores other significant issues.

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