FDA Announces That 35% of Drug Samples Were Non-Compliant

The FDA’s Report on The State of Pharmaceutical Quality is published annually to analyze quality measures related to drug manufacturers and products. The report looked at manufacturing site demographics, drug product demographics, product quality defects, import alerts and recalls, and more. One essential outcome published in this report is that non-compliant drug samples increased from 16% to 35% between 2020 and 2021.

To maintain drug quality, the FDA’s Center for Drug Evaluation and Research tests samples of drug products.

“When non-compliant products are discovered, FDA works to protect the public from potential harm by sharing information, recommending that manufacturers initiate recalls, preventing US distribution with import alerts, and monitoring the site until compliance is achieved,” stated the FDA in its report.

In FY2020, only 16% of the samples tested were non-compliant. Throughout FY2021, that number increased by approximately 2.19 times to 35%.

The FDA explains that this increase is related to increased testing for hand sanitizers and COVID-19-related drugs. COVID-19 drugs composed 25% of the non-compliant samples. Additionally, hand sanitizers amounted to 19%, while opioids accounted for 0%.

In addition, the report also found that approximately half of field alert reports (FAR) were not filed. According to the data, about 49.1% of sites did not submit FARs. Of those sites that did not file FARs, 61.1% were foreign sites, and 38.9% were domestic.

The report states that “sites that did not submit FARs tend to be foreign, producing non-sterile products, and have fewer approved applications.”

Almost 65% of the sites that did not submit FARs were manufacturing non-sterile products. The median application count for those sites was three applications compared to the 21 for areas that had submitted FARs

Despite not being required, the FDA believes that “it is a positive sign about industry quality management practices that 97% of sites that submitted an initial FAR submitted at least one follow-up or a final FAR.”

As the FDA continues to monitor the quality of drugs throughout the 2022 fiscal year, these quality measurements may help prevent potentially fatal errors.

The report concluded, “enhanced management of knowledge and an emphasis on risk-based approaches will enable FDA to target its regulatory resources more effectively, better protect the public from non-compliant products, and provide consumers and patients confidence that legally marketed drugs in the US consistently exhibit a high state of quality.”