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# Guide on Outsourcing Facility Adverse Event Reporting
- URL: https://www.fdaweb.com/guide-on-outsourcing-facility-adverse-event-reporting/
- Published: 2018-09-28T12:00:00.000Z
- Updated: 2026-09-15T00:34:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142476

FDA has released a [final guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf?ref=fdaweb.com) entitled “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” FDA regulations require an outsourcing facility to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation.” The document explains FDA’s current thinking on adverse event reporting for outsourcing facilities. It says that for purposes of reporting adverse drug experiences pursuant to 503B(b)(5), the term prescription drug products includes any compounded drug product subject to the prescription requirements in section 503(b)(1) of the FD&C Act. The adverse event reporting requirements apply to prescription drug products regardless of whether the outsourcing facility distributes them pursuant to prescriptions, it says.