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FDA Guidance: Adverse Event Reporting by 503B Outsourcing Facilities


If you are registered as a 503B Outsourcing Facility, you must electronically report adverse event experiences. Recently, the U.S. Food & Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), issued guidance in October 2015 that address the FDA’s expectation as to what, when, and how to report as well as record retention requirements related to such reports.

Under the Drug Quality and Security Act (DQSA) enacted in 2013, an Outsourcing Facility is a compounding pharmacy at one geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility, and thus complies with all other 503B requirements, which include submitting adverse event reports to the FDA.

What Events to Report

Outsourcing Facilities are required to report all serious, unexpected adverse events associated with the use of their compounded prescription drug products. The FDA's recent guidance recommends that Outsourcing Facilities report all serious adverse events whether expected or unexpected, although not legally required.

Threshold for Reporting

The FDA guidance clarifies that an Outsourcing Facility must submit its initial report within 15 calendar days (15-day Alert Report) as long as the facility has information on the suspect drug and the adverse event, even if it does not yet have information on an identifiable patient or identifiable reporter.

Follow-up Reports

If the Outsourcing Facility is unable to include an identifiable patient or identifiable reporter in its 15-day Alert Report, the FDA indicates that the facility should exercise due diligence in obtaining these missing data elements and keep a record of the steps it took to obtain the necessary information. The Outsourcing Facility must also submit a report (Follow-up Report) within 15 calendar days of acquiring any new information about the adverse event that could assist the FDA in its investigation. The FDA guidance also states that the Outsourcing Facility should submit a Follow-up Report when it receives any new relevant information about the initial 15-day Alert Report.

Description of the Data Elements to Include in a Report

The FDA guidance also includes a description of the type of information that would satisfy each of the four data elements for the 15-day Alert Report. Information for the identifiable patient element should be enough to indicate the existence of a specific patient (e.g., age, gender, initials, birthdate, name, or patient identification number). Information for the identifiable reporter element should be enough to indicate the reporter is a person who claims to have information about the other data elements (e.g., name, occupation, or contact information). Information for the suspect drug product element should describe the product's attributes (e.g., active ingredients, dosage, strength, color, and lot number). Information for the serious adverse event element as defined in the FDA regulations (i.e., death, life-threatening adverse event, hospitalization, disability, incapacity, congenital anomaly, or birth defect) should be described in terms of signs, symptoms, or disease diagnosis if available.

Reporting Procedures & Record Keeping Requirements

In addition to the mandate that an Outsourcing Facility submit a copy of the current labeling for the compounded drug product that is the subject of an adverse event report, the FDA guidance also recommends providing the FDA, when appropriate, with other potentially helpful information, such as hospital discharge summaries, lab and clinical data, autopsy reports, and death certificates. The FDA guidance also clarifies that the FDA Adverse Event Reporting System (FAERS) electronic submission coordinator should be notified before the first time an Outsourcing Facility submits an adverse event report, so that submission is successfully executed using one of the two electronic submission formats available. Finally, the FDA guidance mentions that the FDA may review adverse event information when inspecting an Outsourcing Facility, and that the facility should not only maintain records of the adverse events for 10 years as required by law, but also maintain records of its efforts to obtain information regarding each of the four data elements.

For questions, please contact Samuel A. Magnuson at (414) 277-5637/sam.magnuson@quarles.com, or your Quarles & Brady attorney.

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