FDA's reclassification of several Section 505 drugs as biologics is set to take effect March 23, 2020. Drugs reclassified as biologics may not be compounded without a biologics license, according to the FDA. Among the drugs to be reclassified is HCG. Because many compounders may not be aware of that reclassification, we are sharing documentation below:  

• Former FDA Commissioner Scott Gottlieb discusses the Biologics Price Competition & Innovation Act that lead to this reclassification
• Preliminary list of drugs being reclassified
• FDA's GFI on mixing, diluting, or repackaging biologics, applying to 503A and 503B entities