According to a news report posted on healthleadersmedia.com, the U.S. Food and Drug Administration has issued its final guidance that defines the FDA’s expectations regarding voluntary drug and product recalls. The thirteen-page final guidance document furnishes additional clarity about initiating voluntary product recalls. The guidance explains how the FDA was forced to move around its priorities due to the COVID-19 pandemic.
The report states that prescription drug recalls “do not fall under FDA’s legal purview,” such as medical devices and other products. This now places more accountability on drug makers. The U.S. Food and Drug Administration also urges companies to be “recall ready” in order to protect public health, and the FDA outlined the steps.
The FDA’s 13-page final guidance document resembles most of the 2019 draft version, with the exception of new additions that furnish more clarity on the FDA’s expectations when initiating voluntary product recalls.
According to Judith McMeekin, FDA associate commissioner for regulatory affairs, voluntary recalls are the most effective and quickest way for a manufacturer to remove potentially harmful products from the market. The FDA also stated that it is critical that all manufacturers become “recall ready” to make sure the correct actions are handled quickly across all distribution channels to protect the integrity of the supply chain and public health. The FDA continues to work with manufacturers to improve its recall procedures and reduce the public’s exposure to potentially harmful products.
The FDA’s final guidance defines two new terms, market withdrawal, and correction. “Correction” is defined as the relabeling, repair, destruction, modification adjustment, or inspection of a product without physically removing the product. A “market withdrawal” is defined as a company’s removal of a product from distribution and involves a minor infringement of FDA regulations.
The FDA recommends general preparations to identify applicable personnel, establish a recall communications plan, train personnel on their responsibilities, determine reporting requirements for distributed products, maintain distribution records, and use good product coding.
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