The FDA recently updated the FDA to Compounders: Know Your Bulks and Excipients Suppliers page, which now includes links to guidance documents, examples of past quality issues, and a log of FDA actions against trading partners for violations of Good Manufacturing Practice Requirements (GMP).
The Drug Supply Chain Security Act (DSCSA) is Title II of the Drug Quality and Security Act (DQSA) and is designed to protect consumers from potentially harmful drugs. New requirements roll out on November 27th of each year. Each new requirement progresses toward building an electronic, interoperable system to[...]
The Drug Supply Chain Security Act (DSCSA) is Title II of the Drug Quality and Security Act (DQSA), which was enacted to enhance FDA’s ability to protect consumers from exposure to potentially harmful drugs. The act outlines steps to build an electronic, interoperable system to identify and trace certain prescription[...]