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.