WFH NETWORK

WFH Statement on Expiry Dates

The World Federation of Hemophilia is an international not-for-profit organization. The WFH is not a regulatory agency and cannot make recommendations relating to specific clotting factor products. Each country’s regulatory authority must make these judgments based on domestic legislation, national health policies and clinical best practices.

The following information may assist regulators in making determinations with regard to clotting factor concentrates and expiry dates. An expiry date on a clotting factor concentrate is a guarantee of potency if stored according to manufacturer’s instructions. After the expiry date, although the manufacturer can no longer guarantee potency, the WFH is not aware of any safety problems with clotting factor concentrates. Clinical experience reported to the WFH suggests that, under appropriate storage conditions, the loss in potency immediately after the expiry date is negligible. Any loss in potency is gradual over months and factor concentrates may still be used safely and effectively in many clinical situations after their labeled expiry date. In critical situations, like life threatening bleeds or major surgery, use of these products should be accompanied by close clinical monitoring and appropriate laboratory assays.

Approved by WFH Executive Committee March 15, 2003