On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more
6/29/2023
/ Comment Period ,
Draft Guidance ,
Drug Compounding ,
Food and Drug Administration (FDA) ,
Hospitals ,
Outsourcing ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Wholesale
Key Takeaways:
..FDA created a new category for voluntary firm registration after NECC compounding fungal meningitis outbreak in 2012.
..Individuals face criminal liability for misrepresentations made to FDA....more