In a letter to compounding pharmacy PharMEDium, the U.S. Food and Drug Administration (FDA) stated it was no longer willing to accept an alternate method of satisfying the requirement for a patient-specific prescription. In 2005, working with FDA, PharMEDium developed and implemented a pilot study that linked its compounds to specific patients after they were dispensed through the use of a barcode system.
Early this month, FDA informed PharMEDium that it had changed its mind about this pilot study. FDA stated that the recent fungal meningitis outbreak caused the Agency to reexamine its enforcement discretion with regard to the need for valid patient-specific prescriptions. In light of the outbreak, FDA stated it is now unwilling to accept the alternative approach it developed with PharMEDium as a valid means of satisfying the patient-specific requirement.
In its letter, FDA also referenced its testimony before both houses of Congress in late 2012, where FDA recognized that the industry has evolved to include companies that engage in large-volume compounding of sterile drug products for distribution to healthcare facilities without patient-specific prescriptions. FDA took the opportunity to reiterate its position before Congress—that FDA needs new legislation to effectively regulate large compounding pharmacies.
If you have any questions about this Alert, please contact Rachael G. Pontikes, any member of the Pharmaceutical, Medical Device, Pharmacy & Food industry group or the attorney in the firm with whom you are in regular contact.
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