FDA Proposes New Drug Manufacturing Rule: What Distributed Manufacturing and Foreign API Registration Changes Could Mean for Pharma Compliance

Key Takeaways FDA’s proposed rule would allow qualifying distributed manufacturing establishments (DMEs) to register as a single drug establishment under a new hub-and-spoke model, provided they operate under a single management structure, unified pharmaceutical quality system, and meet applicable preapproval inspection requirements. The proposed rule would require foreign active pharmaceutical ingredient (API) manufacturers whose products ultimately enter the U.S. supply chain to register … Continued