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FDA Inspections Accelerate
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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.  

That means that FDA considers any office-use medication compounded and distributed ineligible to the exemption provisions within 503A. Those exemptions enable a compounder to prepare a medication for an individually identified patient without having to compound in compliance with cGMP (current Good Manufacturing Practice) standards, or to file labeling with the agency for approval, or to submit an NDA (New Drug Application) with the agency.  

As such, all inspections that identify an office-use medication – either sterile or non-sterile – immediately triggers an inspection based on manufacturing standards rather than the universally recognized USP <795> and <797> standards.


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

Are you ready if – or when – an FDA inspection team arrives at your pharmacy? Do you and your team know your rights and your responsibilities for complying with an FDA inspection? On Tuesday, October 6, IACP will hold a special live continuing education webinar FDA Inspections for Compounders: The Impact of DQSA to assist Academy members in understanding how to prepare their practice for an FDA inspection. Watch for registration information and how to attend this "must attend" program in your e-mail!

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