FDA issues first warning letter under DSCA for opioid distribution

Feb. 13, 2019

McKesson Corp is back in the spotlight for opioid-related violations — this time involving rules under the 2013 Drug Supply Chain Security Act.

For the first time ever, the FDA used DSCA to send a warning letter, and targeted McKesson for non-compliance. 

In a statement, FDA Commissioner, Scott Gottlieb, said that a warning letter was issued to McKesson Corp. for “violations highlighted by a concerning tampering incident that involved opioid medications.”

DSCSA requires that manufacturers, repackagers, wholesale distributors and dispensers have systems in place to address concerns with packages that may have been tampered with or made illegitimate. According to the FDA’s letter, in one instance, McKesson failed to respond to an illegitimate product notification in 2016 concerning a shipment to a Ride Aid. The pharmacy alleged that a bottle that was supposed to contain 100 tablets of 10mg oxycodone arrived with only 15 tablets of naproxen.  

The FDA also said that McKesson failed to quarantine and investigate suspected products, and that it did not keep records of any investigation.

McKesson was at the center of a 60 Minutes investigation in 2017 that included interviews with DEA agents who accused the company of not doing enough to stop suspiciously large amounts of opioids from being distributed to small towns. McKesson later paid $150 million to settle the case for its alleged violations of the Controlled Substances Act. 

McKesson now has 15 working days to notify the FDA about what steps it will take to correct its alleged violations with DSCA. 

Read the full FDA letter.