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Regulatory Focus™ > News Articles > 2019 > 9 > FDA Calls on Compounders to be More Diligent About Their Bulk Suppliers

FDA Calls on Compounders to be More Diligent About Their Bulk Suppliers

Posted 19 September 2019 | By Michael Mezher 

FDA Calls on Compounders to be More Diligent About Their Bulk Suppliers

The US Food and Drug Administration (FDA) is calling on drug compounders to be more diligent with their suppliers to ensure that bulk active pharmaceutical ingredients (API) they receive have been tested and properly handled throughout the supply chain.
"The agency urges compounders to know your bulk supplier and know if they are testing the drugs before you purchase bulks for patient use," FDA writes.
The advisory comes after drug repacker Darmerica LLC last week issued a nationwide voluntary recall of two lots of bulk API due to a labeling mix-up. According to FDA, the company distributed bulk API labeled as quinacrine dihydrochloride API to 14 compounding pharmacies that was later tested and confirmed to be artemisinin API.
"Improper repackaging or lack of supply chain oversight of API can cause serious vulnerabilities in the supply chain and may lead to patient safety issues," FDA writes.
FDA points to several recent examples of safety issues such as inconsistent potency and contamination tied back to improper repackaging, including alerts over porcine thyroid API, baclofen API and dietary ingredient glutathione used to compound sterile injectables.
Additionally, FDA notes that it has sent at least 10 warning letters to API repackers for good manufacturing practice (GMP) violations since June 2018 and placed several others on import alert.

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