FDA Finalizes Insanitary Conditions Guidance for Compounding Facilities
The FDA has issued a statement with further emphasis on its intentions to increase enforcement against Insanitary conditions at compounding facilities. The statement comes after the FDA published its Final Guidance Document which adds recent examples from visits to compounding facilities.
According to the update published on Friday, November 6, 2020, at 10:40 EST, “These insanitary conditions include dirt, mold, insects, trash, peeling paint, unclean exhaust vents, and dirty high-efficiency particulate air (HEPA) filters, among many other examples.”
With regards to commentary received from the industry following the initial publication, FDA stated:
“Based on comments to the revised draft guidance, we also added recommendations for compounders to use risk management tools to develop appropriate controls to prevent insanitary conditions at their facilities.”
Follow the links below to access the updates:
Image Credit: FDA.gov- https://www.fda.gov/drugs/news-events-human-drugs/cders-efforts-help-improve-quality-drug-compounding-include-ongoing-focus-insanitary-conditions – Accessed 11/06/2020
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