The voice for compounding pharmacy  |  November 27, 2019
FDA will reclassify HCG as a biologic
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: