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Wednesday, April 23, 2014

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:

Percentage

Range

Absolute amount

No amount

Per product or total or both

How can it be made implementable by states and FDA?

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?

 
Source found here

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