Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The final guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug compounders that choose to register as outsourcing facilities. Such compounders must report information on the drugs they compounded in Structured Product Labeling (SPL) format using FDA's electronic submissions system unless FDA grants a request for a waiver of such requirement because use of electronic means is not reasonable for the person requesting the waiver. This guidance supersedes the revised draft guidance entitled ``Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.''