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Ranitidine recalls, Dollar Tree warnings prompt new safety steps.
ASHP is taking steps to reduce risks from overseas products in after the FDA issued warnings to Dollar Tree over unsafe OTC products manufactured overseas and the massive recalls of ranitidine (Zantac) due to a carcinogenic impurity.
“Relying predominantly on other countries for necessary ingredients to manufacture crucial drugs, APIs, and devices required to safely prepare and administer drugs presents a potential threat to the stability of the US drug supply,” writes ASHP CEO Paul Abramowitz in a recent blog post.
Approximately 80% of API manufacturers are located outside of the US, which “leaves our supply chain vulnerable to disruption and puts API sourcing at risk,” Abramowitz says.
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ASHP and other healthcare stakeholders are concerned about the massive recalls of ranitidine (Zantac) and popular high blood pressure medications due to carcinogenic impurities. The FDA first warned about ranitidine in mid-September, when a lab found traces of the carcinogenic impurity in N-nitrosodimethylamine (NDMA).
Then, in early November, the FDA warned Dollar Tree about “multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC drugs as well as other drug products sold at Dollar Tree and Family Dollar stores,” the agency says in a press release.
FDA warning letters sent to Dollar Tree’s contract manufacturers in China “show a pattern of serious violations of the law, such as not testing raw materials or finished drugs for pathogens and quality,” the agency says.
In addition, a recent report from the U.S.-China Economic and Security Review Commission underscores the need to “address our nation’s dependence on China for the manufacturing of pharmaceuticals and their active product ingredients (API),” Abramowitz writes.
The report recommends that Congress hold hearings on the topic and pursue new quality oversight mechanisms for foreign-sourced drug products. “The report shines a light on some foreign manufacturing practices that may pose national security and public health risks,” Abramowitz writes.
ASHP previously called for the Department of Health & Human Services and the Department of Homeland Security to conduct a risk assessment of national security threats associated with manufacturing and distribution of critical drugs, their APIs, and associated medical devices used for preparation or administration, Abramowitz says.
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“Please know that ASHP takes the long-term safety and quality of our nation's pharmaceutical supply very seriously and will allocate the necessary resources to lead efforts to help ensure that our patients have consistent access to a safe and effective supply of necessary medicines,” Abramowitz writes.
ASHP says they will convene a summit in partnership with stakeholders and experts including government, medicine, nursing, hospitals, standards-setting bodies, manufacturers, supply chain and others to examine manufacturing quality and foreign sourcing of drug products and formulate recommendations to protect the safety and quality of the US drug supply early next year.