Notice To All 503B Outsourcing Facilities
Product Reporting Technical Problem
The Agency has not yet finalized the revised draft guidance, Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM424303.pdf. As a result, for the December 2016 reporting period the Agency is requesting that outsourcing facilities submit reporting data in an Excel spreadsheet via an email attachment. Reports must include drug products compounded during the six month period from June 1, 2015 through November 30, 2016. Product reports should be submitted to firstname.lastname@example.org Section 503B requires outsourcing facilities to submit product reports for this reporting period between December 1, 2016 and December 30, 2016 to satisfy their product reporting obligation.
- The 10 digit National Drug Code (NDC) number of the final product, if assigned
- The active ingredient and strength of active ingredient per unit;
- The 10 digit National Drug Code number of the source drug or bulk active ingredient, if available;
- The source of the active ingredient;
- The dosage form and route of administration;
- The package description; and
- The number of individual units produced;
Attached is an Excel template that you can use for your report.
- The Drug Quality and Security Act: Human Drug Compounding Outsourcing Facility
- Guidance for Industry: Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB) (Draft Guidance)
- Guidance for Industry: Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB) (Draft Guidance)
- For questions related to Registration and Listing: eDRLS@fda.hhs.gov
- For questions related to compounding practices: email@example.com