Mixing, Diluting, or Repackaging Biological Products Outside - FDA

https://www.fda.gov/downloads/drugs/guidances/ucm434176.pdf

13 hours ago - Scope of an Approved. Biologics License. Application. Guidance for Industry. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). January 2018.Compounding and Related Documents ...