FDA Compounding Agreement with States May Cause Hardship for Some Patients

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MOU could disrupt the current operational model of home infusion pharmacies.

A proposed Food and Drug Administration (FDA) agreement with states outlining requirements and regulations for sterile compounding could negatively impact some home infusion pharmacy services, ASHP warned in comments to the FDA this week. The Drug Quality and Safety Act (DQSA) limits to five percent of the total drugs dispensed or distributed the amount of compounded medications that can be distributed across state lines unless the state has a memorandum of understanding (MOU) in place with the FDA. Pharmacies in states that sign the MOU may distribute up to 30 percent compounded products relative to the total number of drugs dispensed or distributed. 
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