21 CFR 610.15 — Constituent materials (general requirements for biological products)

Government Record · U.S. Food and Drug Administration (eCFR, current)

The federal ceiling the book alludes to: no single US vaccine dose may contain more than 0.85-1.25 mg of aluminum. Infant-schedule vaccines that contain aluminum adjuvants (e.g., DTaP, HepB, Hib, PCV, HepA) each fall under this per-dose cap; cumulative aluminum across the infant series is a multiple of per-dose amounts, which is why critics compare the sum to single-dose limits.

The amount of aluminum in the recommended individual dose of a biological product shall not exceed: (1) 0.85 milligrams if determined by assay; (2) 1.14 milligrams if determined by calculation on the basis of the amount of aluminum compound added; or (3) 1.25 milligrams determined by assay provided that data demonstrating that the amount of aluminum used is safe and necessary…

The federal ceiling the book alludes to: no single US vaccine dose may contain more than 0.85-1.25 mg of aluminum. Infant-schedule vaccines that contain aluminum adjuvants (e.g., DTaP, HepB, Hib, PCV, HepA) each fall under this per-dose cap; cumulative aluminum across the infant series is a multiple of per-dose amounts, which is why critics compare the sum to single-dose limits.

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