US FDA Guidance On B. Cepacia Contamination Coming Soon, CDER Director Cavazzoni Says
Agency will provide guidance in wake of recent outbreaks of Burkholderia cepacia in non-sterile, water-based drug products.
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More testing expected after B. cepacia contamination of OTC liquid drug products, including for Rx drug products.
US FDA oversees plants straining to meet demand for COVID-19 vaccines and treatments, while cracking down on adulterated hand sanitizers.
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.