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FDA’s Final MOU On Interstate Compounding Now Awaits Signatures From States

Pharmacy Group Says FDA Has Underestimated Amount Of Work For MOU

 
• By Joanne S. Eglovitch

US pharmacy group says that 10 to 12 states have indicated through an informal survey that they do not have the manpower or funding to implement the US FDA’s final MOU on inordinate compounding. They say what is at stake in these states is patient access to compounded medicines.

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Some States Not Expected To Sign Compounding MOU • Source: Shutterstock

A pharmacy compounding group said it believes the US Food and Drug Administration has overestimated the number of states that will sign its recently issued final memorandum of understanding (MOU) on interstate compounding, and that some states cannot implement the agreement because there do not have the funding nor the manpower to support the MOU’s reporting requirements.

Pharmacy groups say that what is at stake is lack of out-of-state patient access to medicines compounded in states that do not sign the agreement. 

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