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CR exemptions proposed for two oral drugs


The Consumer Product Safety Commission (CPSC) is proposing to amend its child-resistant packaging requirements to exempt powder formulations of two oral prescription drugs, colesevelam hydrochloride and sevelamer carbonate. The Commission has the authority to do so under the Poison Prevention Packaging Act of 1970.

 

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.

 

Comments on the proposal should be submitted no later than May 2, 2011.

 

Read details on the proposed rule here.

 

Source: Consumer Product Safety Commission

 

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