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FDA Has Issued Revised Draft Guidance on Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations
The U.S. Food and Drug Administration (FDA) has issued a revised draft guidance for industry, Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations. Patients who are unable to take nutrition by mouth or a feeding tube can receive nutrients by vein (intravenously), known as parenteral nutrition (PN). Some nutrients, known as small volume parenteral (SVP) products (e.g., multivitamins, minerals), are combined with large volume parenteral (LVP) products (e.g., dextrose, amino acids, lipids) to provide complete nutrition. However, aluminum can be a contaminant in PN products. Aluminum contamination can come from raw materials, manufacturing equipment, and container and closure systems. Although people with normal kidneys can eliminate aluminum efficiently, patients with immature or impaired kidneys receiving prolonged PN treatment may develop aluminum toxicity in multiple organs. Individuals at highest risk include neonates (young babies) and people with chronic kidney failure.
This revised draft guidance, originally published in December 2022, reiterates FDA's position on the importance of minimizing aluminum contamination and provides the rationale for setting an aluminum limit for individual SVPs. The guidance emphasizes that companies that are developing SVPs for PN should assess the aluminum content in their drug because it will be combined with other PN products, with each SVP contributing to the total PN aluminum content. The guidance clarifies the key factors to calculate the acceptable aluminum content in SVPs and further clarifies FDA recommendations regarding the acceptable aluminum concentration in SVPs. It recommends the total allowable aluminum exposure from all the SVP and LVP products in the final PN solution not exceed 5 mcg/kg/day.
Additionally, this draft guidance will help sponsors and applicants in determining the appropriate placement of information on aluminum toxicity in the prescribing information and on the container label and carton labeling of SVPs, pharmacy bulk packages (PBPs) of SVPs, and LVPs.
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