USP 795 & USP 797 - Master Formulation Record/Compounding log?

[PharmDBro2017]

Does anyone have a Master Formulation Record/compounding log template you'd be willing to share that is in compliance with the new USP 795/797 regs on nonsterile and sterile compounding?

Not sure how in-depth these master formulation logs need to be and was hoping any of y'all could share what you use.

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[zelman]

FYI the new regs have been delayed with no set date to go into effect.

 

[owlegrad]

At my job we get recipes from our compound supplier. I hate them (they are like 7 pages long and stupid complicated with even simple recipes having 5+ ingredients) but I assume they are 795 compliant. If they aren't I can't imagine what they would need to add/change to make them compliant.

 

[PharmDBro2017]

FYI the new regs have been delayed with no set date to go into effect.

I'm fully aware they are delayed but trying my best to stay ahead of the game.

 

[BaSsHeAd]

I'm fully aware they are delayed but trying my best to stay ahead of the game.

actually, usp website has the date as december 1

 

[zelman]

actually, usp website has the date as december 1

USP is postponing the official dates of the revised <795> and <797>, and the new general chapter <825> until further notice.

 

[PharmDBro2017]

USP is postponing the official dates of the revised <795> and <797>, and the new general chapter <825> until further notice.

Yup. I'm trying to be proactive and get my policy/procedures in place and was hopeful that someone would have some kind of template to use for the compounding log.

Got to stay ahead of the game.

 

[BidingMyTime]

actually, usp website has the date as december 1

Only USP 800 goes into effect December 1st, USP 795 & 797 are indefinitely on-hold. USP 800 has no effect on practice.

Yup. I'm trying to be proactive and get my policy/procedures in place and was hopeful that someone would have some kind of template to use for the compounding log.
Got to stay ahead of the game.

Or you could just be doing extra, unnecessary work. The idea behind the 7975, 797, and 825 being indefinitely on-hold is that they are being appealed and may be changed.

 

[PharmDBro2017]

Only USP 800 goes into effect December 1st, USP 795 & 797 are indefinitely on-hold. USP 800 has no effect on practice.

Or you could just be doing extra, unnecessary work. The idea behind the 7975, 797, and 825 being indefinitely on-hold is that they are being appealed and may be changed.

It will most definitely effect practice depending on if you do chemo compounding, if you pack or split hazardous drugs in the pharmacy or on the floor, stock them in the omnicell, etc.

Unnecessary work: I don't like the reactive mindset, but sure. Too many folks in our field are getting by doing less than the bare minimum and it shows. I don't want to be associated with that gang. Being proactive > reactive.

edit: From what I've seen, the things being appealed are purely related to BUD too.

 

[BidingMyTime]

It will most definitely effect practice depending on if you do chemo compounding, if you pack or split hazardous drugs in the pharmacy or on the floor, stock them in the omnicell, etc.
Unnecessary work: I don't like the reactive mindset, but sure. Too many folks in our field are getting by doing less than the bare minimum and it shows. I don't want to be associated with that gang. Being proactive > reactive.
edit: From what I've seen, the things being appealed are purely related to BUD too.

According to the official linked website "General Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable."

This sure sounds like no changes will be enforce come December 1st. Now you are correct, if you mean the other 795, 797, and 825 will have huge changes in the field, but these are indefinitely on hold, and may change before they ever go into effect. I agree it's good to be proactive, but I can't see spending a lot of time on this, when nobody yet knows what the final ruling will be.

 

[PharmDBro2017]

According to the official linked website "General Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable."

This sure sounds like no changes will be enforce come December 1st. Now you are correct, if you mean the other 795, 797, and 825 will have huge changes in the field, but these are indefinitely on hold, and may change before they ever go into effect. I agree it's good to be proactive, but I can't see spending a lot of time on this, when nobody yet knows what the final ruling will be.

USP 800 Hazardous drugs is official on 12/1/19, ya.

Strictly discussing USP 800 here: If you don't think you have any changes to implement to be in compliance with USP 800, then I don't think you've looked into it.

The OP in this thread was regarding USP 795/797 and just looking for a compounding log template.... just to get ahead even though they are just informational at this point.

 

[BidingMyTime]

Strictly discussing USP 800 here: If you don't think you have any changes to implement to be in compliance with USP 800, then I don't think you've looked into it.

Well, that is why I don't manager or director. But my manager is now pulling things together, and must say that you are right and I was wrong.

I just can't believe this is all going into effect. The whole list of drugs seems willy-nilly. I'm all about personal safety and protection, but this seems haphazard and overkill. Yea, government and plastic government manufacturers though. I mean seriously, having to wear gloves to open and put away the order? Double chemo gloves and gown to reconstitute fluconazole suspension? And why is isotretinoin not on the list?

 

[PharmDBro2017]

Well, that is why I don't manager or director. But my manager is now pulling things together, and must say that you are right and I was wrong.

I just can't believe this is all going into effect. The whole list of drugs seems willy-nilly. I'm all about personal safety and protection, but this seems haphazard and overkill. Yea, government and plastic government manufacturers though. I mean seriously, having to wear gloves to open and put away the order? Double chemo gloves and gown to reconstitute fluconazole suspension? And why is isotretinoin not on the list?

Couldn't agree with you more. It is getting ridiculous.