Enhanced Drug Distribution Security under the DSCSA/ GMPs for Medical Gases

1. Public Meeting: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA)

The FDA is holding a series of public meetings entitled, “Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA).” These public meetings are intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss and provide input on strategies and issues related to the enhanced drug distribution security provisions of the DSCSA. See the Federal Register notice for more information.

2. Current Good Manufacturing Practice for Medical Gases; Draft Guidance for Industry 

FDA has published a revised draft guidance for industry entitled ‘‘Current Good Manufacturing Practice for Medical Gases.’’  This guidance is intended to assist manufacturers of medical gases in complying with applicable current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211). Medical gases are generally regulated as finished pharmaceuticals and are subject to CGMP requirements  regardless of the processing stage. Compliance with applicable CGMP requirements helps to ensure the safety, identity, strength, quality, and purity of medical gases. Medical gases that are not manufactured, processed, packed, or held according to applicable CGMP requirements can cause serious injury or death.