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FDA Proposal On 'Inordinate' Interstate Compounding Sparks State Oversight Debate

 
• By Joanne S. Eglovitch

The US FDA’s revised draft MOU on interstate compounding, which stipulates new controls to ensure that pharmacies do not ship an “inordinate” amount of drugs across state lines, needs strong state oversight and robust information collection to work, say some groups commenting on the agreement. Yet two members of Congress are challenging the MOU on the grounds that some states and state boards of pharmacy lack the regulatory authority to implement the agreement.

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A revised US Food and Drug Administration proposal to let more compounded drug products cross state lines has prompted new hand-wringing over how states will make sure compounding pharmacies do not engage in an "inordinate" amount of interstate activity.

US pharmaceutical industry and compounding pharmacy groups weighed in on FDA’s revised memorandum of understanding on interstate compounding. Respondents said...

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