FDA Issues Temporary Policy on PPE for Compounders

by | Apr 10, 2020 | All Posts, FDA

Watch on Youtube - Photo of David HussongFDA has issued a guidance document that addresses the Sterile Compounding Industry’s concerns regarding PPE in light of current shortages during the COVID-19 pandemic. The document entitled “Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities during the COVID-19 Public Health Emergency” was released on Friday, April 10. Eagle has compiled a summary below for your convenience:

Key Takeaways:

  • PPE shortages may be severe in some areas
  • Recommendations for preserving PPE by:
    • Limiting number of personnel who compound sterile preparations
    • Reducing sterile compounding, “considering the risks and need for compounded product intended to be sterile”
  • Use of other PPE that provides equivalent or better protection to sterile product, if available
  • The document does not apply to hazardous drugs


FDA does not intend to take enforcement action during the public emergency. Regarding insanitary conditions when sterile drugs are prepared without standard PPE provided the following:

  • Compounder can’t obtain standard PPE (that you’d usually use to comply with insanitary guidelines)
  • Drugs meet requirements of 503A
  • Compounder:
    • Practices mitigation strategies to reduce the risk of contamination when compounding without standard PPE OR
    • Employs terminal sterilization where standard PPE is not used but basic garbing is (hairnet, clean garment, non-sterile gloves)
  • Compounder:
    • Keeps a record of when compounding without PPE is performed
    • Keeps a record regarding changes in sterilization approach (from aseptic processing to terminal sterilization)
    • Documents mitigation strategies in SOPs

Mitigation Strategies for PPE:

  • Use expired PPE as long as it has been stored appropriately and there are no holes, discoloration, or physical defects
  • If masks are unavailable:
    • Reuse masks within a shift, handling/storing carefully. Don’t remove from compounding area or share among personnel
    • Reuse masks on subsequent days as long as there are no holes, discoloration, physical defects. Store in clean, low-linting fabric mesh bags or stainless steel lattice containers to allow airflow and keep in classified area
    • If reusing, disinfect masks with an appropriate disinfectant
    • If masks are totally unavailable, use clean fabric labeled as low-linting, with new coverings for each compounding session
  • If no sterile gloves are available, use nonsterile gloves that are disinfected
  • Do not reuse foot covers. Wear dedicated shoes instead

Mitigation Strategies for Reducing Contamination:

  • Increase cleaning and disinfecting
  • Use more sporicidal
  • Disinfect gloves more frequently
  • Do more Environmental Monitoring
  • Use shorter BUDs (24h Room Temperature, 3 days Refrigerated, 45 days Frozen)
  • Use sterilizing filter during compounding

Visit the link below to view the complete guidance document on the FDA website.

FDA Temporary PPE Policy for Sterile Compounders During COVID-19

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