FDA has issued its first warning letter under DSCSA to San Francisco-based distributor McKesson Corp. for failing to exercise adequate control over products that were tampered with while stored in its facility. The firm was also chastised for its lax response to reports from pharmacies that opioids and other prescription drugs were removed from bottles and replaced with other drugs while the bottles were in its possession.
The US FDA has responded to an opioid diversion case by issuing a first-ever warning letter stemming from requirements in the November 2013 Drug Supply Chain Security Act to quarantine and investigate suspect and illegitimate medications.
The warning letter announced Feb. 12 said San Francisco-based McKesson Corp. distributed illegitimate drugs and did not respond quickly to...