US Food and Drug Administration (FDA)’s warning letter to McKesson, a pharmaceutical distributor, outlines the violations observed during inspections that took place at its facility from June 25 to July 3, 2018.
The violations include failing to sufficiently respond to notifications that there was an illegitimate product in its supply chain, failing to quarantine and investigate suspect products, as well as failing to maintain records of investigations of suspect product and disposition of illegitimate product as the law requires.
The warning letter to McKesson outlines an incident in which the company was notified that a pharmacy received bottles that were supposed to contain opioid pills but had been replaced with non-opioid medications.
The pharmacy notified McKesson about the discovery of illegitimate products, and the company initially stated that it was likely the opioid medication was replaced while in its possession; however, but it did not sufficiently respond to the notification that it may have distributed illegitimate products.
According to the FDA, McKesson could not demonstrate that it took efforts to identify or quarantine additional illegitimate products that may have still been in its distribution facilities, nor did it notify other pharmacy customers who may have received the products with the same lot number. The FDA said in a statement, “This is simply unacceptable.”
Beyond issues with opioids, a statement from FDA commissioner Scott Gottlieb in regards to the warning letter details that McKesson has also had incidents involving medications for HIV, seizures, bipolar disorder, and high blood pressure.
Highlighting security issues
A spokesperson for the FDA told us, “The warning letter highlights security issues in the supply chain.”
“This is a teachable moment for others in the supply chain to check to make sure that their verification systems and processes are in place and are followed,” they continued.
These issues in the supply chain are addressed within the FDA’s drug supply chain security act (DSCSA), which requires manufacturers, repackagers, wholesale distributors, and dispensers to have systems and processes in place to quarantine and investigate suspect and illegitimate products.
“DSCSA requirements will improve the security of the drug supply chain by increasing the oversight of those involved in the manufacture and distribution of prescription drugs, which includes opioids,” the spokesperson explained.
Parts of the DSCSA have been in effect since 2014, including product identifier requirements that involve serializing packaging that went into effect in 2017 and 2018.
Further implementation of the act will see members of the industry build an electronic, interoperable system to support identification and tracing of certain prescription drugs as they are distributed within the US by 2023.
