If you are not registered as an outsourcing compounder but are a pharmacy/hospital-based compounder of sterile products, FDA has provided advice for you if the garb that you need (including masks and gloves) are in short supply.  The document does not detail outlining the steps that such compounders can take help assure the sterility and quality of the compounded products they prepare.

The guidance, 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, is only in effect until the coronavirus public health emergency is over.  Of note, the document provides strategies to preserve the personal protective equipment (PPE) that may mitigate the reuse of masks, outlines the use of disinfecting agents, along with proper storage of the masks to be preserved and reused if the shortage is severe.  One of the most important points mentioned in the guidance is that, if these shortage conditions do exist and standard PPE is not available, that the method of sterilization should be change from aseptic filling to terminal sterilization.

The document also provides the following mitigation strategies to

  • reduce the risk of product contamination related to compounding without standard PPE
  • use related to reuse of PPE or the use of inferior PPE
  • reduce risk of contamination in the compounding environment when compounding without standard PPE
  • reduce risk of microbial proliferation in a potentially contaminated product
  • preserve PPE supply and obtaining alternative equivalent or better PPE

In addition, there is a discussion of appropriate documentation practices to use in the various scenarios. FDA notes it “does not intend to take enforcement action regarding compliance with the insanitary conditions provision when drugs intended or expected to be sterile are compounded without standard PPE provided the circumstances” outlined in the guidance are adhered to.

The full guidance can be found here.  It is important to remember that these steps should be used only when a severe shortage of PPE occurs and only during the current public health emergency.  It should be of utmost importance to recognize the fragile nature of the patients being treated with the compounded products and the need to assure the sterility of products they may need.  While these options are less than optimal, what’s a mother to do?  Let’s hope that another New England Compounding Center tragedy does not occur under the public health crisis due to shortage of standard PPE.