FDA allows pharmacists to use nonstandard PPE during pandemic

The FDA said it will allow pharmacists to use nonstandard personal protective equipment to compound drugs during the COVID-19 pandemic in an effort to combat supply shortages. 

The agency said it has received questions from pharmacists about shortages of face masks, gowns, gloves and other protective gear. In response, it listed strategies to conserve crucial supplies that wouldn't be allowed under normal circumstances. 

The agency said it will allow nonstandard protective equipment to be used if standard protective gear can't be obtained by pharmacies, but it warned that pharmacists must keep records when compounding is performed without standard protective gear and when anything is changed in the sterilization process. 

"Although FDA is establishing this temporary policy due to the current public health emergency, FDA expects that compounders will carefully consider the risk and benefit of conducting compounding activities without standard PPE by considering the potential for contamination of the product, risk to patients and the need for the drug to support patient care," the agency stated. 

It also endorsed such strategies as using unused face masks past their expiration date if they were stored properly and sterilizing face masks and reusing them. 

If a compounding pharmacy has limited supplies, it should limit the number of personnel conducting sterile compounding activities and consider reducing sterile compounding activities overall, considering the risks and need for compounded products intended to be sterile, the agency recommended. 

The guidance only applies during the time the COVID-19 pandemic is considered a public health threat in the U.S., the agency said. 

Read the full guidance here.


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