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We also proposed, and are now finalizing, a policy that if more recent data were to subsequently become available (for example, a more recent estimate of the PPI for Pharmaceuticals for Human Use, Prescription), we would use such data, if appropriate, to determine the CY 2026 diagnostic radiopharmaceutical packaging threshold in the final rule

reactions persisting beyond 48 hours or involving induration suggest sensitivity to the bacteriostatic water preservative (benzyl alcohol) rather than the peptide itself

Exposure to excessive moisture, heat, direct sunlight, or frequent freeze-thaw cycles may negatively impact product stability during laboratory applications

of this final rule with comment period) of the revisions to 180.50 to April 1, 2026, to provide hospitals with more time to comply