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Amid growing concerns over the pharmaceutical supply chain, regulators sternly warned the Dollar Tree (DLTR), which runs a vast network of stores serving mostly low-income communities, for selling over-the-counter medicines made by companies that failed to ensure the drugs were safely manufactured and tested. In a Nov. 6 warning letter, the Food and Drug Administration noted the retailer purchased medicines from foreign companies that failed to follow manufacturing standards and displayed a pattern of serious violations. (Silverman, 11/14)

The letter outlines "multiple violations" of manufacturing practices at those contract manufacturers used to produce Dollar Tree's Assured Brand over-the-counter drugs as well as other drug products sold at Dollar Tree and Family Dollar stores. Now, in its warning letter to Dollar Tree, the FDA is requesting that the company implement a system to ensure that it does not import adulterated drugs. (Howard, 11/14)

The FDA analyzed import data and found Dollar Tree bought and received products from foreign companies that had received warning letters and had been placed on import alert for manufacturing issues. The agency also alleges that Greenbrier, operating as Dollar Tree, has used contract manufacturers and suppliers with “significant” violations for its private-label Assured Brand drugs. (LaVito, 11/14)

“Americans expect and deserve drugs that are safe, effective and that meet our standards for quality,” Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the release. “In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans.” In the Nov. 6 letter to Dollar Tree CEO Gary Philbin, the FDA identifies Chinese manufacturers that failed to test products and cited an example where “rodent feces (were) found throughout the manufacturing facility.” (Tyko, 11/15)