Remove 2025 Remove Documentation Remove Sterile Compounds
article thumbnail

Out of Shortage, Into Controversy: The Fight Over GLP-1 Compounding

Pharmacy Times

Rumore, PharmD, Esq, MS, LLM, FAPhA Key Takeaways The removal of tirzepatide and semaglutide from the FDA's shortage list impacts 503A compounders, requiring adherence to complex legal and regulatory frameworks. The definition of "essentially a copy" is pivotal, influencing compounding practices and legal interpretations.