USP postpones <797>, <795>, & <825>-Again.

September 24, 2019

Here we go again folks.  USP to suspend the December 1, 2019 deadline.  <800> is in still slated for December 1, 2019 and is to be seen as informational only.  Bottom line-most are not compliant and USP keeps getting successfully pressured to move final dates.  At some point, USP<797>, <795> & <825> should be taken seriously and adhered to.  It is not like this is a first round with this mandate.  These were proposed in the early 2,000's with an enforcement date of 10 years ago.  

 

I think the confusion in the industry is due to financial and location needs and tracking requirements.  Most hospitals don't have the funds allocated to the pharmacy for renovations/new additions.  Those that have are very fortunate.  The smaller community hospitals are left to fend for themselves and hope that a large chain will purchase them.  It is a very frustrating time and has been leading to stressful situations for those in the field.  

 

What most need to remember is that their individual state boards can still enforce the USP<797>/<795> in the existing publication.  It is only the FDA that is not going to be coming in with fines/closures/etc...

 

 I know that it seems overwhelming but what job isn't?  The overall reasoning behind <797>/<795>/<825> is to protect the integrity of compounding and safety of the general public receiving CSP's.    What is your facility doing to be proactive with USP recommendations?

 

How do you all feel about this extension?

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