Medication – Sterile Compounding – Considerations for Sterile Compounding During COVID-19 Pandemic

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

Any examples are for illustrative purposes only.

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 for the organization.

Beyond-Use Dates (BUD)
The BUDs below may be assigned if compounding does not otherwise deviate from 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 (Please note during this time, an allowance has been made to compound Medium Risk Level items in a Segregated Compounding Area):
  • 12 hours at controlled room temperature
  • 24 hours in a refrigerator 
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 extending the 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 at the regional, state or national level for the organization.  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 (i.e., 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 beyond-use dates (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 the facility when someone is sick.
  • 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 who 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. Click here to access the CMS website for COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers.
Last updated on June 16, 2020
Manual: Home Care
Chapter: Medication Compounding MC

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