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www.fdanews.com/articles/173020-compounders-seek-clarification-on-when-to-report-adverse-events

Compounders Seek Clarification on When to Report Adverse Events

September 9, 2015

Requiring drug compounders to provide information on all products taken by a patient that may be “suspect” in an adverse reaction would be unduly burdensome, necessitating full access to a patient’s medical records, the International Academy of Compounding Pharmacists says.

Instead, compounders that are required to register as outsourcing facilities should have to provide only information on suspect drugs that they are aware of and can access, IACP says. The group was one of seven that commented on the agency’s February draft guidance on adverse event reporting by outsourcing facilities.

In an Aug. 3 Federal Register notice to the Office of Management and Budget detailing the guidance’s anticipated paperwork burden, the FDA said it would clarify that an outsourcing facility is not expected to report information it doesn’t have. The comment period on the draft closed last week.

The final version will also clarify that only serious and unexpected adverse events must be reported, but will urge compounders to report all serious AEs, according to the FDA. Avella Specialty Pharmacy and Specialty Sterile Pharmaceutical say this recommendation will lead to confusion regarding what should and shouldn’t be reported, and urges that it be removed.

Avella also complains that requiring compounders to submit reports to both the FDA and state pharmacy boards also would be burdensome. In response, the agency plans to add language stating that “outsourcing facilities must comply with any applicable state reporting requirements independent of and in addition to reporting adverse events as described in the guidance.”

IACP also wants the FDA to provide a timeline for implementing e-submissions of AE reports, saying the current plan calling for physical forms and hard-copy records is burdensome.

To view all of the FDA’s responses to comments on the guidance, see the Federal Register Notice at www.fdanews.com/09-01-15-OutsourcingAdverseEventNotice.pdf. — Kellen Owings