by hormoneaccess | Dec 5, 2021 | Issue: FDA Ban of Compounded Hormones
Under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) – Protein-based drug products like hCG, FSH, and hMG that had been approved as “drugs” over 15 years ago are now considered “Biologics” and now fall under the jurisdiction of the FDA’s Center for...