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Poison Prevention Packaging – Colesevelam Hydrochloride and Sevelamer Carbonate


PROPOSED RULE: February 16, 2011

The Consumer Product Safety Commission (‘‘CPSC,’’ ‘‘Commission,’’ or ‘‘we’’) is proposing to amend its childresistant packaging requirements to exempt powder formulations of two oral prescription drugs, colesevelam hydrochloride and sevelamer carbonate. Colesevelam hydrochloride, currently marketed as Welchol®, is available in a new powder formulation and is indicated to reduce elevated LDL cholesterol levels and improve glycemic control in adults with type 2 diabetes mellitus. Sevelamer carbonate, currently marketed as Renvela®, is available as a new powder formulation and is indicated for the control of elevated serum phosphorus in chronic kidney disease patients on dialysis. The proposed rule would exempt these prescription drug products on the basis that child-resistant packaging is not needed to protect young children from serious injury or illness from powder formulations of colesevelam hydrochloride and sevelamer carbonate because the products are not acutely toxic, lack adverse human experience associated with acute ingestion, and in powder form, are not likely to be ingested in large quantities by children under 5 years of age.

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