The FDA recently released new temporary guidelines on non-standard personal protective equipment (PPE) practices for sterile compounding by pharmacy compounders during the coronavirus disease 2019 (COVID-19) pandemic. The temporary policy is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the US Department of Health and Human Services (HHS).

The FDA plays an important role in protecting the United States from infectious diseases such as COVID-19. For this reason, the agency has received multiple questions from compounders about the effects of supply interruptions for PPE, such as face masks, gowns, gloves, and other garb.

The new temporary guidance was intended to clarify current policies in regard to PPE use during human drug compounding at state-licensed pharmacies or federal facilities that are not registered with the FDA as outsourcing facilities, which are referred to collectively in the guidance as compounders.

Due to the shortage of PPE during the pandemic, the FDA recognized that the potential for a lack of access to PPE for compounders is an issue. Since the Federal Food Drug and Cosmetic Act (FD&C) states that a drug is adulterated if it has been prepared, packed, or held in conditions where it may have been contaminated, such as by a compounder who is not wearing PPE, the FDA made sure to clarify that this provision of the FD&C Act has not been lifted during the pandemic.

The FDA listed some examples of insanitary conditions related to the improper use of PPE by compounders:
 
  • Performing aseptic manipulations with exposed skin or hair.
  • Engaging in aseptic processing wearing critical gown components (eg, gloves) that are non-sterile.
  • Putting on gowning apparel in a way that may cause the apparel to become contaminated.
  • Engaging in aseptic processing after leaving the cleanroom and reentering from a non-classified area without first replacing gowning apparel (eg, mask, goggles, foot covers, gloves).
  • Failing to disinfect or change gloves frequently enough to prevent contamination.

For cases in which PPE is in short supply for compounders, the FDA recommended preserving PPE by limiting the number of personnel conducting sterile compounding activities and reducing the number of sterile compounding activities overall, with considerations paid to the risks and need for specific compounded products. The FDA also recommended that compounders, if possible, use alternative PPE that confers equivalent or better protection than the standard PPE.

However, the FDA explained further that they did not intend to enforce compliance with these temporary regulations if certain conditions are met by the compounder. These conditions included:
 
  • The compounder is unable to obtain sufficient supply of PPE that it typically relies on (or PPE that is equivalent or better) to assure compliance for its compounding activities.
  • The drugs compounded meet the conditions in section 503A of the FD&C Act and applicable FD&C Act requirements.
  • The compounder either employs mitigation strategies to reduce the risk of product contamination related to compounding when compounding is performed without standard PPE; or employs terminal sterilization where standard PPE is not used, as long as basic apparel expectations (eg, hairnet, clean garment, non-sterile gloves, other appropriate coverings) are followed.
  • The compounder: keeps a record when compounding is performed without standard PPE; keeps a record of changes in the sterilization approach (eg, from aseptic processing to terminal sterilization); and documents mitigation strategies in a new or updated standard operating procedure.

The FDA added that, despite this lenience in compliance enforcement, it expects compounders to carefully consider the risk and benefit of conducting compounding activities without standard PPE.

Additionally, the guidance included some strategies for reducing the risk of contamination, which included increasing the frequency of cleaning and disinfecting surfaces, using sporicidal agents on surfaces, disinfecting gloves more frequently, and considering more frequent environmental monitoring to assess the efficacy of cleaning and disinfecting.

The FDA recognized that during this pandemic, compounders may be forced to consider other risk mitigation strategies besides those stipulated in the guidance when standard PPE is no longer available. It advised that such alternatives should be approached cautiously and on a case-by-case basis.

REFERENCE
US Food and Drug Administration. 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. fda.gov/media/136841/download. Published April 2020. Accessed May 7, 2020.