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RRx
Occasional Contributor
Posts: 6
Registered: ‎10-03-2016
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Infusion suite USP 797 compliance

We are working with some local providers to create an off site infusion center to accomidate 6 infusion chairs. The nursing manager is asking to have her nursing staff with proper aseptic technique and policy/procedures etc to compound the medicaitons in the med room prior to administration if "hung" within one hour from the preparation time. Treat it as "Immediate use". 

Please clarify/confirm my intentions why I would like to have a glove box in this facility. 

How I interpret USP 797: Immediate use of CSPs are exempt from the requirements described for "Low Risk" compounding only if

1. The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile non-hazard products

2. Not more than two entries into any one container (bag or vial) 

3 Administration begins no later than one hour following the start of the preparation of the CSP. 

Most of our medications to be infused will comply with the above requirements- Is it as of right now standard of practice for the nurses to mix these compounds?

My intention is overall still to have a glove box for the Medium Risk CSP's where it is highly unlikely there is more than three packages and possibly more than two entries to a container (i.e Remicade). If a glovebox is there- It makes the most sense to have everything compounded in it. However there is unfortunatley some resistance. 

We will not be compounding and hazardous medications on the NIOSH list. 

Any feedback is appreciated

 

 

Expert
Posts: 1,174
Registered: ‎02-23-2010
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Re: Infusion suite USP 797 compliance

RRx,

 

I would first consult with your board of pharmacy to find out if they have any licensing requirements for this type of facility.  The intent of immediate-use was not routine compounding activities as you are describing below. The language in the chapter is based on emergency situations. I have attached a copy of the APIC guidance on safe injection and infusion practices that speaks to the activities you are describing.  If the board of pharmacy was to come in and see this activity, I don't believe they would agree with your interpretation of the chapter.   Hope this helps. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
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RRx
Occasional Contributor
Posts: 6
Registered: ‎10-03-2016
0

Re: Infusion suite USP 797 compliance

Thank you for your quick response. Yes we are checking with the State Board of Pharmacy into regards of licensing requirements etc.

It is very clear in this article the USP 797  standards "apply to all persons who compound sterile preparations and all health care settings in which compunding takes place (i.e treatment clinics)" 

We will be purchasing the Glove box/Isolator indeed for all compounding of products.