HDMA RELEASES NEW RECALL AND WITHDRAWAL NOTIFICATION GUIDELINES

New Voluntary Guidelines Will Help Effectively Communicate Recall Information in the Supply Chain

ARLINGTON, VA – May 22, 2007 – HDMA today released the HDMA Product Recall and Withdrawal Guidelines. These voluntary guidelines provide insights into current industry recall and withdrawal practices, as well as strategies for manufacturers and distributors of healthcare products to effectively communicate product recall or withdrawal information to trading partners. These guidelines can be used when the recall or withdrawal is undertaken by the manufacturer, requested by the FDA or initiated to replace existing merchandise with an improved product or new package design.

“Efficient and responsible product recall and withdrawal plans are a necessity in the healthcare industry to protect and preserve patient safety,” said Perry Fri, HDMA Senior Vice President of Industry Relations. “These voluntary HDMA guidelines can help distributors and manufacturers put in place plans and strategies before a recall or withdrawal is initiated, helping to ensure that trading partners clearly understand their roles and responsibilities when swift action is required.” 

To assist in effective recall and withdrawal communications, the HDMA guidelines include sample drug recall notice forms that can be used by manufacturers to provide clear instructions to distributors helping to process recalled products. The forms include areas for the manufacturer to describe the product and the reason for the recall, as well as expected actions for distributors to take.

These guidelines also include information for trading partners to consider when calculating distributor costs associated with multi-layered efforts to efficiently assist manufacturers in removing recalled products from the supply chain. Sample worksheets and approaches included in the guideline use industry-wide, benchmarked data to help trading partners calculate possible distributor reimbursement for recalled merchandise in inventory and other recall processing expenses such as customer returns, shipping and disposals and notifications to customers.

The guidelines are available on the HDMA Web site at www.HealthcareDistribution.org.

About HDMA
The Healthcare Distribution Management Association (HDMA) and its members are committed to patient safety by delivering life-saving health products and services through a secure and efficient healthcare distribution system.  These primary, full-service healthcare distributors are responsible for ensuring that billions of units of medication are safely delivered -- to tens of thousands of retail pharmacies, nursing homes, clinics and providers -- in all 50 states. HDMA and its members are the vital link in the healthcare system that is responsible for medicine safety, quality, integrity and availability in the marketplace.  Through leadership on public policy and industry best practices, HDMA and its members focus on providing value, removing costs and developing innovative solutions to deliver care safely and effectively.  For more information, please visit www.HealthcareDistribution.org.