Thursday, January 16, 2014

What Are The FDA's CGMPs? Ramifications for Compounding Outsourcing Facilities

On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs. In the new law, a compounder can become an “outsourcing facility.” Outsourcing facilities must comply with CGMP requirements. (Source:  FDA.gov - Compounding Quality Act - Title I of the Drug Quality and Security Act of 2013)

The FDA (Food and Drug Administration) puts forth the cGMP regulations (current good manufacturing practice). The CGMPs are also commonly referred to as:
  • GMP - good manufacturing practice, or
  • CGMPR (current good manufacturing practices regulations)
If you're unfamiliar with the FDA cGMPs, then consider taking this online course:

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