Homeopathic Product Statistics in FDA’s Office of Pharmaceutical Quality Annual Report

For the seventh time, the Office of Pharmaceutical Quality (OPQ) in FDA’s Center for Drug Evaluation and Research (CDER) published its “Fiscal Year 2024 Report on the State of Pharmaceutical Quality.” The August 8 report contains two statistics for homeopathic products and manufacturing sites. 

Manufacturing Site Demographics (page 4) 

At the end of FY2024, CDER’s Site Catalog included 4,619 manufacturing sites globally, with 41% of sites located in the U.S. Of these, FDA conducted 989 drug quality assurance inspections in FY2024 — a 27% increase over the previous year. 

“The number of sites in the CDER Site Catalog increased 11% over the past five years. Approximately 30% of this increase was due to sites in the “No Application” sector, which is a similar proportion to the current Site Catalog. Of all FY2024 drug manufacturing sites, 36% are in the “No Application” sector, indicating that all products manufactured at those sites are marketed in the U.S. without approved FDA applications. The majority of this sector includes OTC monograph products, but also includes marketed unapproved prescription drug products and homeopathic products.” 

Drug Product Demographics (page 8) 

“The CDER Product Catalog is regularly updated for all application and non-application products. Its comprehensive product information comprises proprietary names, active ingredients, manufacturing sites, National Drug Codes (NDC), and other data. At the end of FY2024, the Product Catalog included 14,168 ANDAs (4.4% increase from FY2023), 3,625 NDAs (0.9% increase from FY2023), 383 BLAs (8.2% increase from FY2023), and 140,119 non-application product NDCs (6.7% increase from FY2023). During FY2024, the total count of products increased 6.3% after a similar increase of 6.1% during FY2023.” 

Recalls (page 16) 

In FY2024, 165 sites generated 260 recall events, resulting in 421 recalled products. The report highlights four manufacturing sites that were collectively responsible for 54 product recalls, all of which involved a prominent issue in 2024 — contamination. It is in this context that homeopathy is found for the second time in the report: “10 product recalls attributed to a single manufacturing site for lack of assurance of sterility for homeopathic sterile eye drops.” Ophthalmic agents (59 allopathic and homeopathic products collectively) had the highest recalls (14%) in 2024 by drug classification (as defined by the United States Pharmacopeia). 

Contamination recalls include those for microbial contamination (31%), sterility assurance issues (28%), foreign material/particulates contamination (20%), product mix-up/cross contamination (17%), and chemical contamination (4%). Notably the number of products recalled due to failed specifications increased from FY2023. Most of these failed specification recalls were discovered during stability testing and are related to impurities above specification limits (46%) and dissolution failures (36%). Recalls related to CGMP deficiencies were approximately 50% for FY2020–FY2023 but fell to 24% in 2024. 

Although the number of recall events increased by 15%, the number of recalled products per event in FY2024 was the lowest in five years, resulting in only 421 recalled products.