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Advisor
Posts: 42
Registered: ‎05-17-2016
0

Receipt of HDs According to USP <800>

Can non-HD and HDs (including antineoplatics) be unpacked from the external shipping container within the same environment? USP <800> states that antineoplastic HDs and HD APIs must be unpacked in an area that is neutral/normal or negative pressure realtive to the surrounding areas. My current distributer does not seperate HDs from non-HDs within the external shipping container. I do not have an additional negative pressure room availble to do these activities. So i am assuming that my receiving areas must be seperated from all other areas by doors and walls and that based on the pressure differential requirements of neutral or neagtive to surrounding areas, I will need to have a pressure monitor in my receiving area? That my receiving area cannot be open/within the same area of other operations if receiving HDs in this area and must be physically closed off to all other areas?

Advisor
Posts: 42
Registered: ‎05-17-2016
0

Re: Receipt of HDs According to USP <800>

Still looking for help with my question if anyone can provid eguidance. Thanks!

Advisor
Posts: 25
Registered: ‎10-16-2014
0

Re: Receipt of HDs According to USP <800>

They can be unpacked in a neutral/normal environment-  so a normal room with no pressure monitoring.

Expert
Posts: 1,152
Registered: ‎02-23-2010
0

Re: Receipt of HDs According to USP <800>

Erika,

 

Thanks for your patience.  I have been advising folks to do that when you get your tote from your wholesaler, who hopefully has segregated the HDs from non-HDs, that you take the bag(s) of HDs and move them directly into the HD buffer or negative-pressure room.  The act of receiving to me is when you open the bag that the HDs come in.  How puts them into inventory can let the purchaser know what was shipped so everyone is happy.  Hope this helps. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 24
Registered: ‎09-22-2017
0

Re: Receipt of HDs According to USP <800>

In larger pharmacy remodels, separate small negative pressure rooms are being installed to open/receive these totes.  In smaller remodels, this isnt an option, so the ability of grabbing the HD bag from the tote, wiping it down, and moving into a negative pressure buffer room is good.  However, the architects/engineers are questioning this interpretation.  The tote, as they read it, must be opened up in a negative pressure room and therefore, the main pharmacy in these smaller remodels needs to be under negative pressure to the other parts of the hospital.  Now, lets add the AIA regs.. stating the pharmacy is to be under positive pressure.  So, the architects are little concerned on which way to go on the main pharmacy pressure.  Thoughts?