|FDA Inspections Accelerate|
In the past week, more than a dozen IACP members reported that FDA representatives are inspecting their pharmacy practice. While these practices are engaged in sterile compounding, the FDA also is inspecting all non-sterile compounding activities as well. Even though a pharmacy may be in full compliance with its state pharmacy practice act, the agency continues to interpret the compounding of any medication for office-use as a violation of section 503A of the federal Food Drug and Cosmetic Act.
FDA has stated in numerous settings that they intend to use a risk-based approach for inspections and their initial inspection efforts are focused on sterile compounders. Some reports indicate that the FDA plans to inspect all sterile compounding facilities within the next 12 to 18 months.
IACP Webinar on October 6, 2015
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