Reed Smith Client Alerts

Last week, the U.S. Food and Drug Administration (FDA) updated its guidance for pharmacy compounders that experience shortages of personal protective equipment (PPE) as a result of the COVID-19 public health emergency. Due to the emergency, FDA has received numerous queries from compounders related to the impact of supply interruptions of PPE, specifically, face masks, gowns, gloves, and other protective garb. FDA therefore issued the 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 Guidance for Industry (Temporary PPE Guidance) to ensure continuous access to compounded medications and to reduce the risk of compounding when standard PPE is not available. It has since been updated.
Closeup green-blue antibiotic capsule pills in blister pack

The COVID-19 pandemic has had a significant impact on health care systems and has resulted in an increased demand for PPE by health care professionals. By way of background, pharmacists and technicians who compound sterile human drugs use PPE to reduce the risk of microbes and other particles present on human skin, hair, and clothing contaminating a drug preparation, which could deem the drug “adulterated.” Under the Federal Food, Drug, and Cosmetic Act (FDCA), a compounded drug product is deemed adulterated if it has been prepared, packed, or held under insanitary conditions. See 21 U.S.C. § 351(a)(2)(A). Some insanitary conditions are related to the improper use of PPE during the compounding of sterile drugs, which include, for example:

  • Engaging in aseptic processing wearing non-sterile gloves;
  • Putting on gowning apparel in a way that may cause the gowning apparel to become contaminated; or
  • Failing to disinfect or change gloves frequently enough given the nature of the operations to prevent contamination.

Due to the PPE supply chain impact brought on by COVID-19, FDA initially issued the Temporary PPE Guidance to communicate how it related to pharmacists’ and technicians’ use of PPE during human drug compounding at traditional compounding pharmacies. (Note: the Temporary PPE Guidance does not apply to federal facilities registered with FDA as outsourcing facilities.) FDA understood that compounders are currently experiencing difficulties obtaining PPE for sterile compounding, and in areas where PPE shortages are most severe, these shortages have the potential to impact the availability of compounded preparations for patients, especially those in critical need.