Questions Presented by FDA As to the MOUs between States and the FDA for Compounding Pharmacies

How should FDA define “inordinate amounts” in the MOU? Options include:
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Percentage
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Range
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Absolute amount
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No amount
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Per product or total or both
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How can it be made implementable by states and FDA?
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Should it take into account contiguous states? If so, how?

What should the MOU say about the handling of complaints? What complaints should the MOU address? Options: Related to compounded products shipped interstate or all complaints?

Limit to complaints related to adverse events (AEs)? Or include quality problems (e.g, contamination, potency) that haven’t yet led to AEs? Other types of complaints?

 

Related to compounded products shipped interstate or all complaints?

•Limit to complaints related to adverse events (AEs)? Or include quality problems (e.g, contamination, potency) that haven’t yet led to AEs? Other types of complaints?

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