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FDA Issues Warning Letter To Drug Distributor McKesson

The Food and Drug Administration Tuesday said it has sent a warning letter to drug distributor McKessson for allegedly shipping "illegitimate" opioid products.

FDA sent its first warning letter under the Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident that involved opioid medications.

Other incidents involved medications for serious medical conditions including HIV, seizures, bipolar disorder and high blood pressure.

Under the DSCSA, manufacturers, repackagers, wholesale distributors and dispensers - which are mainly pharmacies - are all required to have systems and processes in place to quarantine and investigate suspect and illegitimate medications. These systems must be in place in order to respond rapidly to notifications of illegitimate products and to notify trading partners and the FDA when illegitimate products are discovered.

The warning letter to McKesson outlines violations observed during inspections that took place this past summer, including failing to: sufficiently respond to notifications that there was illegitimate product in their supply chain; quarantine and investigate suspect products; and maintain records of investigations of suspect product and disposition of illegitimate product as the law requires.

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