The FDA has issued its first warning letterunder the Drug Supply Chain Security Act (DSCSA) to
McKesson Corp. for tampering with opioid medications.
The FDA said the distributor didn’t address several instances of reported drug tampering for medications including opioids and treatments for HIV, seizures, bipolar disorder and high blood pressure.
The warning letter to McKesson outlines violations observed during inspections of McKesson’s San Francisco corporate headquarters and an Oregon distribution center. The violations include 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.
The warning letterexplains that in one instance, McKesson was notified by a pharmacy customer that multiple of their pharmacy locations received bottles that were supposed to contain potent opioid pills. However, once opened, the pharmacies discovered that bottles at three pharmacy locations did not contain the correct medications, and the opioid pills were missing, having been replaced with other non-opioid medications.
The pharmacy customer notified McKesson about the discovery of illegitimate products. While McKesson’s internal investigation noted that it was likely the opioid medication was replaced while in their possession or control, McKesson did not sufficiently respond to the notification that they may have distributed illegitimate products. McKesson could not demonstrate that they took efforts to identify or quarantine additional illegitimate products that may have still been in their distribution facilities. Additionally, McKesson did not notify other pharmacy customers who may have received products with the same lot number or National Drug Code to make them aware of potential illegitimate product in the supply chain. Additional examples are given in the warning letter of similar failures by McKesson to: respond to illegitimate product notifications; quarantine and investigate suspect and illegitimate products; and maintain records as required by DSCSA.