Some pharmacies, federal facilities, physicians, and outsourcing facilities engage in various drug production activities that may not be addressed in sections 503A and 503B of the […]

I am pleased to share the FDA’s 2018 Compounding Policy Priorities Plan. This plan provides an overview of the key priorities our agency will pursue to […]

Updated: March 14, 2018 FDA laboratory analysis found the glutamine in United Pharmacy’s compounded glutamine, arginine, and carnitine (GAC) 10/100/200 mg/mL product for injection is degrading […]

Introduction Hemorrhagic occlusive retinal vasculitis (HORV) is a rare, potentially blinding postoperative complication that has been observed in dozens of patients who have received intraocular injections […]

FDA will explore developing training for state regulators on insanitary conditions and key elements of current good manufacturing practice requirements. In November of 2017, FDA will […]

Most prescription drugs are required to: undergo premarket approval to demonstrate safety and efficacy; be labeled with adequate directions for use so patients can safely use […]

What types of facilities should register with FDA as an outsourcing facility? The guidance states that only facilities that intend, upon registration, to comply with all […]

On January 8, 2014, FDA sent letters from Commissioner Hamburg regarding the pharmacy compounding provisions of the Compounding Quality Act to hospital and other health care […]

FDA has established a public docket to receive information, recommendations, and comments on matters related to the Agency’s regulation of compounding of human drug products under […]