Draft US FDA Guidance Outlines Heightened Expectations On Sterility Of Non-Sterile Drugs
More testing expected after B. cepacia contamination of OTC liquid drug products, including for Rx drug products.
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Agency will provide guidance in wake of recent outbreaks of Burkholderia cepacia in non-sterile, water-based drug products.
Another outbreak of B. cepacia at hospital intensive care units in multiple states implicates manufacturing and supply chain controls on aqueous non-sterile drug products, particularly for those marketed over the counter under OTC monographs.
Individuals from pharma, biotech, technology and academia create shared database to facilitate development of therapeutic proteins that are unlikely to provoke immune reactions.