What should my pharmacy do if we have limited supplies of compounding garb?

In light of the current escalation of the spread of COVID-19 and the origin of production (namely, Wuhan, China), there may be limitations in the supply chain of protective garbing supplies. This guidance from the Board is intended to offer recommendations and strategies to conserve protective garb while maintaining the highest level of containment and limiting exposure of compounded sterile products to contaminants.

Please note that engaging in some of these recommendations may result in being out of compliance with USP Chapter 795, 797, and 800. The Board will exercise enforcement discretion during this time of limited supplies IF your pharmacy can demonstrate it complied with best practices during a period of documented supply limitations. If your pharmacy decides to implement any of the following recommendations during a shortage period, and implementation results in noncompliance with USP Chapter 797, you must develop and maintain a policy demonstrating compliance with best practices (e.g., if reusing face masks, you must develop a policy and procedure for identification, storage, and handling of face masks subject to reuse).

Recommendations:

  • Inventory your pharmacy’s current supplies of garb to determine how long the garb is likely to last under current policies. If your current supply is running low, attempt to order more (regular size order, not hoarding) if you can. If your supply (existing plus future order capability) will not be sufficient to last TWO months, consider immediate implementation of one or more of these strategies for conservation.
  • Utilize existing Standard Operating Procedures to limit exposure and limit use of garb
    • Limit personnel entering the clean room (exclude anyone exhibiting signs of any illness, reduce the number of personnel engaged in compounding activities, stage supplies outside the compounding area, minimize trips into the clean room, etc.)
    • Limit contamination (ensure personnel hygiene, wear freshly laundered scrubs every day, meticulous disinfection, walk slowly and deliberately in the clean room, re-sanitize frequently, don’t talk while compounding, don’t touch your face mask after donning, etc.)
  • Responses to a shoe cover shortage
    • Consider use of cleanable, facility-dedicated shoes that are not worn outside the compounding area. 
    • Source alternative shoe covers, such as those used on construction sites. 
    • Use dedicated shoes in Hazardous Drug (HD) compounding areas and reduce use to one set of covers.  
    • Do not reuse shoe covers, including turning them inside out for reuse. 
    • Develop systems to deliver materials to compounding employees to reduce HD garb change required when entering the HD space.  The use of pass-throughs and dedicated carts should be formalized and maximized. 
  • Responses to a mask shortage
    • If available, substitute N-95 masks for clean room masks.  When using an N-95 mask for non-HD sterile compounding procedures, fit testing is not required. 
    • Consider limited reuse of face masks used in non-HD compounding.
      • Store the mask in a new, paper bag (or something clean and breathable) after each use.  Masks should never be shared between employees. 
      • Retained masks should be stored where they are donned, individually identified, donned prior to hand washing, and not touched after proper placement. 
      • Retained masks should be replaced when the mask condition is questionable, the mask is visibly soiled, or after a period of time as determined in facility policy.   
  • Responses to a gown shortage
    • Decrease the number of employees in the sterile compounding area to reduce use. 
      • Consider using already garbed compounding staff for facility cleaning/disinfecting activities, rather than utilizing more garb for environmental services employees. 
    • Retain and reuse gowns for an entire shift/day. 
    • If gowns are reused for longer periods of reuse (no more than 1 week), store them on individual hooks.  Do not store them inside out.  Deliberate and careful removal is recommended. 
      • Gowns should be stored on the clean side of the ante room away from the sink. 
      • Gowns should be discarded when they are visibly soiled or after a period of time as determined in facility policy. 
      • Gowns used for cleaning or HD compounding should not be retained or reused. 
    • When gowns are reused, add disposable sleeve covers (sterile or non-sterile are permitted).  
  • Use of sleeve covers
    • Sleeve covers should be opened in the buffer room/SCA area after handwashing procedures and the gown is donned.
    • Sleeve covers should be placed over the donned gown sleeve and should close tightly at the wrist. 
    • Sterile gloves should be donned last and cover the wrist of the sleeve cover.   
  • Response to hand sanitizer shortage
    • Consider limiting hand sanitizer use to glove change procedures only. 
    • Alcohol-based hand sanitizer not intended for clean room or surgical use may be utilized as a replacement. 
  • IF you have implemented any of the above recommended conservation strategies, implement additional environmental monitoring in the PEC used for sterile compounding.
    • Weekly, dynamic microbial surface sampling inside the PEC on the Direct Compounding Area (DCA). 
      • If growth occurs, consider changes to supply cleaning/disinfecting procedures, changes to the procedure for material transfer into the PEC, or increasing the frequency of DCA sanitation procedures. Further testing growth to genus level would only be expected when growth exceeds action levels.
      • If a growth occurs that exceeds action levels, retrain staff, resample the site, and potentially decrease the BUD until a compliant sample is obtained. 
    • While weekly, dynamic microbial surface sampling inside the PEC is preferred, if this is not possible, BUDs must be limited to Category 1 compounding (12 hours at room temperature or 24 hours under refrigeration).
  • When a garb shortage affects Personal Protective Equipment (PPE) used for HD compounding
    • The current recommendation is that garb used in HD compounding should not be reused. 
    • Implement process changes that reduce the use of PPE, such as: 
      • Grouping HD compounding together,
      • Designating a time when HD compounding is performed,
      • Adjusting personnel schedules to limit to the extent possible the number of HD compounding personnel,
      • Encouraging HD handling in PECs (per Assessments of Risk (AoRs), PPE including respiratory protection may be required when handling occurs outside a PEC, but some may not be required when using a PEC), and/or
      • Considering the use of other respiratory protection such as a PAPR (Powered Air Purifying Respirator), if available, when an N95 mask is otherwise required.

For additional information and resources on COVID-19:​
CDC website for COVID-19
Strategies for Optimizing the Supply of N95 Respirators
Critical Point Peer Network - information, including a recorded webinar entitled “COVID-19: Downstream Implications for Sterile Compounding”, is available via the FREE “Silver Subscription”​
Iowa Dept of Public Health website for COVID-19