Drug Compounding Facilities and FDA Compliance Strategies

Drug compounding facilities are an essential part of the healthcare industry. However, they are subject to strict regulations and guidelines set by the FDA to ensure the safety and efficacy of compounded drugs. In this blog post, we will discuss the FDA compliance strategies that DC facilities can implement to avoid penalties and maintain compliance.

FDA Regulations for Drug Compounding Facilities

Drug compounding (DC) facilities are subject to several regulations and guidelines set by the FDA. These regulations include Current Good Manufacturing Practice (CGMP), Current Good Compounding Practice (CGCP), and the Drug Quality and Security Act (DQSA). Understanding these regulations is essential for DC facilities to maintain compliance.

  • CGMP regulations: These regulations ensure that drugs are manufactured under safe and sanitary conditions and meet quality standards. 
  • CGCP regulations: These regulations ensure that compounded drugs are prepared under strict quality standards and meet their intended use. 
  • DQSA regulations: These regulations establish a new regulatory framework for compounded drugs and outsourcing facilities.

Implementing Quality Control Measures

Drug compounders must implement quality control measures to comply with FDA. These measures involve drug testing, process documentation, and staff training on CGMP and CGCP regulations.

  • Regular testing of compounded drugs: DC facilities should test compounded drugs regularly to ensure their safety and efficacy. 
  • Documentation of manufacturing and testing processes: DC facilities should maintain detailed documentation of their manufacturing and testing processes to ensure compliance with CGMP and CGCP regulations
  • Training of staff: Drug compounding facilities should provide regular training to their staff on CGMP and CGCP regulations and ensure that they are aware of the importance of compliance.

Ensuring Proper Sterilization and Cleaning Procedures

Drug compounding facilities require proper sterilization and cleaning to comply with FDA regulations. This involves using sterile equipment, disinfecting compounding areas, and monitoring the environment.

  • Use of sterile equipment: DC facilities should use sterile equipment to ensure the safety and efficacy of compounded drugs. 
  • Cleaning and disinfection of compounding areas: DC facilities should regularly clean and disinfect their compounding areas to prevent contamination. 
  • Environmental monitoring: DC facilities should regularly monitor their environment to ensure that it meets the required standards for sterile compounding.

Maintaining Proper Documentation and Record-Keeping

Proper documentation is vital for DC facilities to comply with FDA regulations. This includes batch records, expiration dates, and drug tracking.

  • Batch records: DC facilities should maintain batch records for each compounded drug to ensure traceability and accountability. 
  • Expiration dates: Drug compounding facilities should ensure that compounded drugs have appropriate expiration dates and that they are properly labeled. 
  • Tracking of compounded drugs: Drug compounding facilities should implement a system for tracking compounded drugs from the point of manufacturing to the point of dispensing.

Regular Auditing of Drug Compounding

Regular auditing and inspections are essential for drug compounding facilities to maintain compliance with FDA regulations. Auditing and inspections include self-inspections, third-party audits, and FDA inspections.

  • Self-inspections: DC facilities should conduct regular self-inspections to identify areas of non-compliance and implement corrective actions. 
  • Third-party audits: DC facilities can hire third-party auditors to conduct audits and identify areas of non-compliance. 
  • FDA inspections: Drug compounding facilities should prepare for FDA inspections by ensuring that their documentation, record-keeping, and manufacturing processes meet FDA regulations.

Implementing Risk Management Strategies

Implementing risk management strategies is essential for drug compounding facilities to maintain compliance with FDA regulations. Risk management strategies include identifying potential risks, implementing risk mitigation measures, and monitoring risks.

  • Identifying potential risks: DC facilities should identify potential risks in their manufacturing and compounding processes. 
  • Implementing risk mitigation measures: DC facilities should implement measures to mitigate potential risks, such as using sterile equipment and regular testing of compounded drugs. 
  • Monitoring risks: Drug compounding facilities should regularly monitor potential risks and implement corrective actions to ensure compliance with FDA regulations.

Drug Compounding with FDA Regulations

Drug compounding facilities must stay current with FDA regulations to comply. Monitor guidance, attend FDA training, and join industry associations.

  • Monitoring FDA guidance documents: DC facilities should regularly monitor FDA guidance documents to ensure that they are aware of any changes or updates to FDA regulations. 
  • Attending FDA training sessions: Drug compounding facilities can attend FDA training sessions to stay up-to-date with FDA regulations and guidelines. 
  • Participating in industry associations: DC facilities can participate in industry associations to stay informed about best practices and industry trends.


Drug compounders must comply with FDA regulations for drug safety. Implementing quality control measures, proper sterilization, maintaining records, auditing and inspections, risk management, and keeping up-to-date with FDA regulations are essential for compliance and patient safety.