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FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products

Posted 09 October 2018 | By Zachary Brennan 

FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products

The US Food and Drug Administration (FDA) recently posted a Form 483 sent in July to the nation’s largest drug distributor, McKesson, and questioned the firm on how it detects illegitimate products.

The release of the Form 483 follows an investigation last year from the Washington Post and 60 Minutes highlighting McKesson’s failure to report suspicious orders involving millions of painkillers and opioids sent between facilities, some of which were reported to be fraudulent pharmacies. But government attorneys settled the case with McKesson, which paid a $150 million fine.

The findings from that Washington Post/60 Minutes report mirrors this latest Form 483 from FDA, which includes three observations following inspections conducted in June and July at the wholesale distributor’s San Francisco site.

“Transaction data for prescription drug purchases from the firm show that lot/batch numbers are not captured/retained; as such the firm does not have sufficient processes in place to determine and notify, within 24 hours, all the immediate trading partners that the firm had reason to believe may have received illegitimate product,” the 483 says.

FDA also found the firm failed to make a determination on product subject to an illegitimate product notification from a trading partner.

“Your firm did not demonstrate compliance with the requirements of the FD&C Act Section 582(c)(4)(B) to: a. quarantine such product b. take reasonable and appropriate steps to assist a trading partner to disposition such illegitimate product not in the possession or control of the firm c. retain a sample,” FDA says.

McKesson did not respond to a request for comment.

Form 483

Categories: Regulatory News

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