Consumer Product Safety Commission July 22, 2011 – Federal Register Recent Federal Regulation Documents

The Consumer Product Safety Commission (``CPSC,'' ``Commission,'' or ``we'') is amending its child-resistant packaging requirements to exempt powder formulations of two oral prescription drugs, colesevelam hydrochloride and sevelamer carbonate. Colesevelam hydrochloride, currently marketed as Welchol [supreg], is available in a 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 [supreg], is also available as a powder formulation and is indicated for the control of elevated serum phosphorus in chronic kidney disease patients on dialysis. The rule exempts 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.