A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle circumstances in which the product is spoiled, breaks, or otherwise becomes unusable after purchase by physicians, clinics, and hospitals. Many manufacturers have designed product replacement programs intended to strike a balance between assuring patient safety and the risk that replacing product in those circumstances can be seen as removing a business risk or subsidizing a provider’s business expense in a way that implicates the federal healthcare program anti-kickback statute.