Aluminum in large and small volume parenterals used in total parenteral nutrition--FDA. Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend its regulations to add certain labeling requirements concerning aluminum in large volume parenterals (LVP's) and small volume parenterals (SVP's) used in total parenteral nutrition (TPN). FDA is also proposing to specify an upper limit of aluminum permitted in LVP's and to require applicants to develop and to submit to FDA for approval validated assay methods for determining aluminum content in parenteral drug products. The agency is proposing these requirements because of evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients on TPN therapy, especially premature infants and patients with impaired kidney function.
D000535:Aluminum / Q000633:toxicity*; D004340:Drug Contamination; D004349:Drug Packaging; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007262:Infusions, Intravenous / Q000009:adverse effects; D008452:Maximum Allowable Concentration; D010289:Parenteral Nutrition, Total / Q000009:adverse effects / Q000401:mortality / Q000592:standards*; D051437:Renal Insufficiency; D014481:United States; D014486:United States Food and Drug Administration