FDA Issues Guidance on Adverse Event Reporting for Outsourcing Facilities

Food and Drug Administration (FDA) has published a guidance document, Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act, intended for firms registered with FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as human drug compounding outsourcing facilities. The guidance document describes the agency’s recommendations for adverse event reporting by outsourcing facilities, including what to report, threshold for reporting, follow-up reports, description of the four data elements, report attachments and additional information, how to report adverse events, inspection of adverse event reporting, and record keeping. FDA recommends that reports should be submitted as long as the outsourcing facility has information on at least the suspect drug and the adverse event. The guidance states that “adverse event reporting for drug products compounded by outsourcing facilities is a critical mechanism by which FDA identifies signals of potential quality problems that may be associated with a particular drug or drug component and which may have been caused by substandard conditions or processes at a facility where the drug or its components were made or handled.”

Under section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).” Certain state boards of pharmacy may also require outsourcing facilities licensed in their states to report adverse events. Outsourcing facilities must comply with any state reporting requirements independent of and in addition to reporting adverse events as described in the guidance. Section 310.305 requires, among other things, that manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug application or an abbreviated new drug application establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiences associated with the use of their prescription drug products. The adverse event reporting requirements apply to prescription drug products regardless of whether the outsourcing facility distributes them pursuant to prescriptions.

Failure to report adverse events by an entity that is registered in accordance with section 503B(b) is a prohibited act under section 301(ccc)(3) of the FD&C Act. Violations relating to this provision are subject to regulatory and enforcement action. Text of the Compounding Quality Act is available online.