Stability Testing for Medicated Premixes Draft Guidance

FDA published draft guidance revising VICH GL8(R), the harmonized international guideline on stability testing for medicated premixes. The revision updates testing protocols, storage conditions, and documentation requirements for veterinary pharmaceutical premixes.\n\nPharmaceutical manufacturers producing medicated premixes for animal health should monitor this guidance and submit comments by June 15. Once finalized, the revised stability testing standards will affect product registration and quality assurance processes for veterinary drug products.