Final Guidance for Compounders Clarifies “Unexpected Event” in AE Reporting

Serious adverse events associated with compounded drugs whose labeling doesn’t include any adverse experiences should be considered unexpected and reported to the FDA within 15 days, the agency clarifies in final guidance released last week.

Reports should include four key elements: an identifiable patient, an identifiable reporter, a suspect drug and a serious adverse event. If a facility isn’t able to include all four data points, it should keep records of the due diligence it took to try to obtain them — for example, dates of discussions with a reporter to determine how many patients experienced a particular event, the FDA says.

Defining an “unexpected” event was a major sticking point in comments from compounding facilities on the FDA’s Feb. 13 draft guidance on adverse event reporting.

The final guidance also stipulates that for compounded drug products with multiple components — such as excipients and drug substances — each component and its manufacturer should be listed, if known. Further, as part of each adverse event report, outsourcing facilities should submit a copy of the current labeling for the affected product.

Also new in the final guidance, the FDA puts compounders on notice that adverse event reports may trigger an inspection of the outsourcing facility or manufacturer of a component of the compounded drug.

The agency notes that adverse event reports can help to distinguish between issues with outsourcing facilities and issues with active pharmaceutical ingredients manufacturers. While multiple adverse event reports from the same compounder may signal a quality issue with that facility, multiple adverse event reports from various outsourcing facilities may suggest a quality problem with the APIs used in those compounded drugs.

To view the final guidance, go to www.fdanews.com/10-08-15-AdverseEventGuidance.pdf. — Kellen Owings