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US FDA Makes Final Decision On 'Inordinate' Out-Of-State Compounding

 
• By Joanne S. Eglovitch

Under the US FDA’s final MOU on interstate compounding, states are given more time to decide whether to sign the agreement and investigate complaints of adverse events associated with drugs compounded by 503A pharmacies. Agreement draws mixed reactions from pharmacy groups. 

Contract parties sent memorandum of understanding (mou) document folder.
FDA's final offer of standard mou language on Interstate Compounding • Source: Shutterstock

By keeping tabs on the number of compounded drugs going across state lines, states that sign a final memorandum of understanding (MOU) that the US Food and Drug Administration’s Center for Drug Evaluation and Research has published will help the agency ensure against uncontrolled distribution of compounded drugs.

The document, which was years in the making, establishes expectations for states to monitor out-of-state distribution of pharmacy-compounded drugs and report any adverse events to the FDA.

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