2022-26564: Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations." This draft guidance is intended to clarify the key factors in determining the appropriate aluminum content in a small volume parenteral (SVP) drug product and/or a pharmacy bulk package (PBP) intended as a component of parenteral nutrition (PN) and provide FDA's recommendations regarding the concentration of aluminum in SVP drug products and PBPs for PN. Additionally, this guidance is intended to assist applicants in determining the appropriate content and placement of information on aluminum in SVP and PBP human prescription drug product labeling.
The agency’s own summary, as published.
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