FDA sends first DSCSA compliance warning letter

The FDA has sent what is thought to be its warning letter related to non-compliance with the Drug Supply Chain Security Act (DSCSA) to medicines distributor McKesson.

The letter stems from an inspection of McKesson’s headquarters in San Francisco and a distribution facility in Wilsonville, Oregon conducted last year, and focus on failure to adhere to DSCSA verification requirements.

Specifically, McKesson failed to quarantine and investigate suspect products flagged by illegitimate product notifications, and didn’t meet record-keeping requirements, says the letter addressed to McKesson’s chief executive John Hammergren.

 “These verification requirements are intended to help preserve the security of the supply chain for prescription drug products, thereby protecting patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful,” says the FDA.

“The verification requirements at issue include those that apply to wholesale distributors when they determine or are notified that a product is suspect or illegitimate.”

The regulator initially sent the company a Form 483 notice indicating areas where it needed to tighten up processes, but  after deciding the response to that was inadequate followed up with the warning letter.

The letter cites a number of incidents in which trading partners – including pharmacies Rite Aid and Albertsons and drugmaker GlaxoSmithKline – reported finding illegitimate products in shipments sent by the distributor.

That included packs of the opioid painkiller oxycodone that had their contents removed and replaced with other drugs, including naproxen and ciprofloxacin, that according to the FDA seem likely to have been swapped while they were in McKesson’s possession.

“You did not demonstrate that you identified all illegitimate product subject to the notification, such as by searching for product with the same lot number or NDC, or that you quarantined any such product,” says the letter amongst the listed violations.