Guide on Aluminum Content in Parenteral Drugs

FDA has issued a revised draft guidance entitled Small Volume Parenteral (SVP) Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations. The document reiterates the agency’s position on the importance of minimizing aluminum contamination and provides the rationale for setting an aluminum limit for individual SVPs. It says that companies developing SVPs for parenteral nutrition (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 and provides recommendations on the acceptable aluminum concentration in SVPs. The total allowable aluminum exposure from all the SVP and large volume parenteral products in the final PN solution should not exceed 5 mcg/kg/day, according to FDA.

Additionally, the guidance is intended to help sponsors in determining the appropriate placement of information on aluminum toxicity in the prescribing information and on the container label and carton labeling of such products.