GFI: Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

This information collection supports agency guidance. The guidance implements provisions added to the Federal Food, Drug, and Cosmetic Act by the Drug Quality and Security Act in which Congress created a new category of "outsourcing facilities" that compound human drugs. Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b) allows persons or entities to register with FDA as outsourcing facilities, and the guidance discusses the process for doing so. Respondents to the collection are those engaged in these activities.

The latest form for GFI: Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act expires 2020-12-31 and can be found here.

Electronic Submission of Registration Information Using SPL Format

Federal Enterprise Architecture: Health - Consumer Health and Safety