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Sterile Compounding Considerations During COVID-19


Robert Campbell, PharmD, director, Clinical Standards Interpretation for Hospital/Ambulatory Programs

Editor’s Note: This blog post is part of The Joint Commission’s daily communication on issues relevant to organizations managing the COVID-19 pandemic. The full list of FAQs is available here.

With the current high demand for compounded medication, are there interim guidelines an organization can follow for sterile compounding while remaining compliant with Joint Commission medication management requirements?

The USP Compounding Expert Committee (CMP EC) has developed operational strategies in anticipation of challenges that may arise during the COVID-19 pandemic. Organizations may utilize these guidelines and remain in compliance with Joint Commission standards until the state of emergency has been lifted at the regional, state or national level.

Beyond-Use Dates (BUD)
BUDs may be assigned if compounding does not otherwise deviate from USP General Chapter <797> standards:

For low and medium-risk level compounded sterile preparations (CSPs) prepared in a segregated compounding area, apply BUDs conservatively, not to exceed:

  • 12 hours at controlled room temperature
  • 24 hours in a refrigerator 

Please note, during this time, an allowance has been made to compound medium-risk level items in a segregated compounding area. 
For low and medium-risk level CSPs prepared in a clean-room suite, apply BUDs conservatively, not to exceed: 

  • 4 days at controlled room temperature
  • 10 days in a refrigerator for medium-risk level CSPs 
  • 14 days in refrigerator for low-risk level CSPs 
  • 45 days in a solid frozen state at −25° to −10° or colder

If a single-dose container is entered or punctured only in ISO Class 5 or cleaner air, it may be used up to: 

  • 12 hours after initial entry or puncture, as long as the storage requirements during that 12-hour period are maintained. 
  • Opened single-dose ampules must not be stored for any time period. 

When assigning these BUDs, considerations should be given to:

  • Ensuring personnel monitoring (e.g., gloved fingertip and thumb sampling) is successfully completed every 6 months.
  • Increasing frequency of surface sampling in the primary engineering control to determine effectiveness of cleaning procedures and work practices.

Certification and Re-Certification
USP released guidance which allows for the following extension of testing and certification frequency during the COVID-19 pandemic. Organizations may utilize these guidelines and remain in compliance with Joint Commission standards until the state of emergency has been lifted.  

Testing and certification must be completed within 60 days of the end of the declared state of emergency at the regional, state or national level (whichever gives organizations the longest time to complete).

Primary and secondary engineering controls should not be used without initial (startup) certification.  

Understanding resource constraints during the COVID-19 pandemic, facilities may consider delaying recertification of primary and secondary engineering controls if they are served by a continuous monitor. The continuous monitor may help assure that a state of control is established and maintained from the previous certification.   

The interval between certification should not exceed 12 months.   

Consider increased environmental monitoring and applying shorter BUDs if certification is delayed.

Cleaning and Disinfecting
In addition to the cleaning and disinfecting standards in <797> to help ensure quality CSPs, the Centers for Disease Control (CDC) has published considerations for cleaning and disinfecting a facility when someone is sick. These include:

  • Follow facility policies and procedures for environmental cleaning and disinfection consistently and correctly.
  • Routinely clean and disinfect frequently touched surfaces and objects. 
  • Use soap and water or detergent prior to applying an Environmental Protection Agency (EPA)-registered disinfectant (or equivalent). 
  • Follow manufacturer-recommended contact times.  
  • Refer to List N on the EPA website for EPA-registered disinfectants that have qualified under EPA’s emerging viral pathogens program for use against SARS-CoV-2.3.
  • Consider surface materials when selecting agents. 
  • Dispose of cleaning supplies according to facility procedures.

Organizations that choose to adopt these guidelines will not be considered out of compliance with Joint Commission expectations. In addition, please continue to monitor the USP website for updated information.

Additional Resources:
UPS Compounding Resources during COVID-19 Pandemic
CDC: Cleaning and Disinfecting Your Facility
EPA: List N: Disinfectants for Use Against SARS-CoV-2
Coronavirus (COVID-19) Guidance and Resources

Organizations that use Joint Commission accreditation for deemed status purposes should monitor the CMS website as waivers are being approved frequently and may include state-specific waivers.Please review the CMS website for COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers.

Robert Campbell, PharmD, is director, Clinical Standards Interpretation Hospital/Ambulatory Programs and director, Medication Management. Prior to these roles, he served as the pharmacist for Clinical Standards Interpretation in the Division of Healthcare Improvement at The Joint Commission. Campbell also surveys as a field representative for The Joint Commission in the Hospital Accreditation and Critical Access Hospital Accreditation Programs and is a reviewer in the Medication Compounding Certification Program. Prior to joining The Joint Commission, Campbell worked in health care organizations and held leadership positions with oversight responsibilities for performance improvement, accreditation readiness, risk management, infection control and medical staff services, as well as inpatient and outpatient pharmacy services.