In its first warning letter issued under the Drug Supply Chain Security Act
the US Food and Drug Administration (FDA) on Tuesday detailed how San Francisco-based McKesson distributed illegitimate drugs to pharmacies.
In September and October 2016, McKesson was notified that three separate Rite Aid pharmacies in Michigan received illegitimate product, which had been distributed by McKesson.
“The seal of the bottle was broken, and the bottle contained no oxycodone hydrochloride. The bottle contained only 15 tablets, which were later determined to be naproxen,” FDA said in one of the instances.
But what FDA found to be “particularly troubling” was that McKesson’s investigation noted that the oxycodone hydrochloride was likely replaced at a McKesson distribution center.
“Also troubling is that during the FDA inspection of your firm’s San Francisco headquarters, a McKesson representative stated that incidents involving stolen or diverted controlled substances are not treated as Drug Supply Chain Security Act
(DSCSA) verification events within the firm. In fact, DSCSA explicitly defines illegitimate product to include ‘a product for which credible evidence shows that the product is counterfeit, diverted, or stolen.’”
Also in 2016, a pharmacy at an Albertsons grocery store notified McKesson of a similar scenario when two drugs were received with no lot number or expiration date.
“Even after both Albertsons and FDA had contacted you regarding this divalproex and losartan, you did not demonstrate that your firm quarantined all such product or conducted an investigation of the suspect product to determine whether the product was illegitimate,” the warning letter says. “Your firm did subsequently provide what appears to be an inventory listing query, with handwritten notes, that seems to document your inventory check of these products at your Oregon facility. However, the handwritten notes were undated, unsigned, and were not made available to FDA investigators at the Wilsonville, Oregon, facility, which previously denied receiving the notification to quarantine these products.”
And in a third example, GlaxoSmithKline said a pharmacy reported receiving two sealed bottles of a product labeled as Triumeq that actually contained gemfibrozil.
In the letter’s section on corrective actions, FDA took issue with McKesson’s response to a Form 483 last November and said it does not demonstrate how the company’s proposed changes will improve its compliance with DSCSA verification requirements. In that Form 483, FDA questioned the firm
on how it detects illegitimate products.
“The security of the supply chain, and continued implementation and enforcement of DSCSA, is an important tool in our efforts to ensure that the American public can have confidence in the products they receive, and that illegitimate opioid products do not find their way into the hands of patients,” FDA Commissioner Scott Gottlieb said.
McKesson told Focus
in a statement: "McKesson takes this situation very seriously. We have been in communication with the FDA over the past several months to respond to their questions and we are in the process of providing additional procedural detail and documentation, including enhancements recently made in response to the FDA’s initial feedback. We are committed to the security of the supply chain and are taking steps to help ensure we comply fully with FDA’s track-and-trace laws for all pharmaceutical products."