This is a guidance document all outsourcing facilities hope they never have to use. However, if your compounded product makes someone sicker (or worse), what are the regulatory requirements? The guidance released in October describes how to define, report and manage serious unexpected adverse events. But what exactly is a serious unexpected adverse drug event?

According to Section 310.305 a serious unexpected adverse drug event could be a birth defect, significant disability, hospitalization, a life threatening experience and/or finally death. Serious adverse events may also include events that may jeopardize the patient, such as drug abuse, or impact which may require medical intervention to prevent death, hospitalization or disability.

Once an outsourcing facility receives information that their product may have caused harm, they are obligated under the law to report it to the FDA. The report should include four data elements:

  1. Identifiable Patient
  2. Identifiable Reporter (who told the outsourcing facility?)
  3. Suspected Drug Product
  4. Nature of Serious Event.

The guidance gives information on how to report an event, including two options for electronic submission and follow up. The webpages and coordinators email address are included in the guidance.

The guidance also makes it clear, when FDA inspects outsourcing facilities, they will confirm that the outsourcing facility has developed and implemented written processes for the surveillance, receipt, evaluation and reporting of adverse events

For the full guidance see