Fifty-two percent of active pharmaceutical ingredients used in U.S. medications are made outside the country, according to an annual report from the FDA.
The agency released its "Fiscal Year 2022 Report on the State of Pharmaceutical Quality" on June 20, which included details on the FDA's surveillance inspections on drug manufacturers' plants and its COVID-19-era changes to traveling to some facilities.
Here are 10 things to know from the report:
1. The agency discovered 892 of 1,552 samples tested in FDA laboratories were noncompliant. Nearly 600 of these samples were from undeclared drugs and ingredients shipped to customers.
2. For imported samples, 375 were compliant and 592 were not. COVID-19 products — many of which were hand sanitizers — saw 228 noncompliant samples and 117 compliant ones. Better compliant-noncompliant ratios were found within drug quality sampling and testing (57 to 9) and inspections (50 to 1).
3. Of the 72 warning letters the FDA sent, 47 were for facilities in the U.S., eight in Latin America, six in China, four in Europe, three in India and four in other locations. "An increased proportion of warning letters issued to domestic manufacturers, as compared to the prior two years, is attributable to an increased percentage of domestic inspections due to ongoing travel restrictions [and] a significant drop in hand sanitizer related warning letters issued to sites in Latin America," the report said.
4. Compared to the previous four years, fiscal year 2022 saw the smallest number of warning letters.
5. Most warning letters mentioned issues in quality control, production record reviews and investigations, written procedures and deviations, equipment cleaning and maintenance, and testing and release.
6. For recalls among USP therapeutic categories, respiratory tract agents saw 129 recalls, cardiovascular agents 119, non-opioid analgesics 93, antibacterials 89 and gastrointestinal agents 78.
7. The five most recalled drug products were acetaminophen-containing products, losartan with and without hydrochlorothiazide, fexofenadine/pseudoephedrine, oxymetazoline hydrochloride, and magnesium citrate. "Most of these products were recalled due to temperature abuse or improper storage conditions in warehouses," the FDA said.
8. About 4 in 5 import alerts with drug quality issues were in sites manufacturing hand sanitizer.
9. "Sites in China and South Korea accounted for most import alerts, 43 percent and 36 percent, respectively," the report said. "As a point of comparison, China and South Korea represent only 15 percent and 4 percent, respectively, of foreign sites in the catalog."
10. About 9 in 10 essential medicine products have at least one U.S.-based finished dosage form manufacturer. A little over half of these products, or 52 percent, are "completely reliant on foreign sites for active pharmaceutical ingredient manufacturing."