Two draft FDA guidance documents stir controversy: Hospital and 503B pharmacy repackaging and compounding are at issue

摘要

The Food and Drug Administration (FDA) has a message for hospital pharmacies and bulk compounding facilities that evokes an old Anheuser-Busch commercial: "This BUD's for you." But the BUD the FDA is trying to sell—the "beyond use date" of repackaged Pharmaceuticals or biologies—isn't going down easy with hospital pharmacists, or anyone else involved.