FDA Issues Temporary Policy on PPE for Compounders

FDA 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:

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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