Regulatory Compliance

​​Drug Quality and Security Act, established in 2013, created a new category of pharmacy: the 503(B) outsourcing facility. These facilities that are also registered with the Food and Drug Administration (FDA) are required to follow current Good Manufacturing Practices (cGMPs). cGMP requirements help ensure safe product and help educate personnel of their work surroundings.

All team members contribute to cGMP

compliance, and correct documentation

and procedures are required to ensure

our product always maintains


Some of the processes used by our outsourcing facility for cGMP compliance include: 

  • ​Environmental Monitoring
  • Standard operating procedures
  • Personnel training
  • Beyond use Dating (BUD) validations
  • Aseptic process validations
  • Label accountability and verification 
  • ​Product complaint/incident system
  • Corrective and Preventative Action (CAPA)