Quantification of illicit and prescription drug residues in pasteurized donor human milk: a comprehensive analytical approach.

Abstract

To assess the risk of infant exposure to illicit and prescription drug residues, from infant-ready, pooled, pasteurized donor human milk (PDHM) provided by healthy, screened, voluntary non-remunerated donors to a not-for-profit milk bank. A total of 150 pooled samples, representing 742 donor contributions, were analyzed for 15 illicit and prescription drug analytes using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Detected concentrations were evaluated for clinical significance. All 150 PDHM samples tested negative for residues of marijuana, amphetamines, benzodiazepines, fentanyl, hydrocodone, and morphine. Three samples (2%) contained trace amounts of oxycodone (<0.6 parts per billion), yielding exposures over 455 times lower than established standards for infant safety (Relative Infant Dose: <0.022%; standard safety threshold 10%). Comprehensive analysis detected no clinically relevant illicit or prescription drug residues in infant-ready pasteurized donor human milk, supporting both its safety for neonatal consumption and the effectiveness of current donor screening protocols and milk processing practices.