Updated <797> and <795> released today 11/1/2022

[PharmDBro2017]

The new sterile compounding 797 and nonsterile compounding 795 were released today, but I'm having trouble finding the actual chapters. I keep seeing some crap about subscribing.

Attaching the updated BUD fact sheet and commentary, but the actual chapter I'm having difficulty finding. Anyone have access or the document they could share?

Discuss new chapter stuff.

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[owlegrad]

So glad this doesn’t affect me.

Sorry not much of a contribution but there you have it.

 

[PharmDBro2017]

So glad this doesn’t affect me.

Sorry not much of a contribution but there you have it.

I understand this sentiment. USP 800 is now enforceable which will be the greatest headache of all I think.

 

[PharmDBro2017]

Found out it costs $250 just to access the new chapters. Kind of disgusting... these are federal regulations we are supposed to abide by and we have a year to get our policy & SOP together, yet they put a charge on it.

Surely it will become free by the time they are enforceable?

 

[Dred Pirate]

Found out it costs $250 just to access the new chapters. Kind of disgusting... these are federal regulations we are supposed to abide by and we have a year to get our policy & SOP together, yet they put a charge on it.

Surely it will become free by the time they are enforceable?

Probably the day before they are enforceable

 

[Sparda29]

I understand this sentiment. USP 800 is now enforceable which will be the greatest headache of all I think.

****ing so annoying that I have to treat so many regular meds as "hazardous". Meaning, if I'm found crushing tablets of topiramate or warfarin outside the chemo hood, it could be my ass. Also affected, drugs like carbamazepine, phenytoin.

Why would I be crushing these? Because now with USP 800, nurses aren't allowed to crush the tablets for patients on feeding tubes on the nursing floor anymore, so now we have to crush them in our chemo hood, put the powder in this little packet, seal them, label them and then send them up.

In the past, we only really took special care with chemo.

 

[JustFillIt]

I understand this sentiment. USP 800 is now enforceable which will be the greatest headache of all I think.

Oh damn…. Usp 800 is that hazardous drug handling thing right?

 

[JustFillIt]

Found out it costs $250 just to access the new chapters. Kind of disgusting... these are federal regulations we are supposed to abide by and we have a year to get our policy & SOP together, yet they put a charge on it.

Surely it will become free by the time they are enforceable?

Capitalism….

 

[PharmDBro2017]

****ing so annoying that I have to treat so many regular meds as "hazardous". Meaning, if I'm found crushing tablets of topiramate or warfarin outside the chemo hood, it could be my ass. Also affected, drugs like carbamazepine, phenytoin.

Why would I be crushing these? Because now with USP 800, nurses aren't allowed to crush the tablets for patients on feeding tubes on the nursing floor anymore, so now we have to crush them in our chemo hood, put the powder in this little packet, seal them, label them and then send them up.

In the past, we only really took special care with chemo.

I agree. That's excessive. Your USP 800 designated person should do a risk analysis and change that, but that's just my two cents. Only Table 1 HD meds (antineoplastics) should be done in the hood like that. Table 2 and table 3 HD meds can be crushed/split on the floor if the nurse wears proper PPE (gloves and a mask to prevent inhalation of powder). Insane to do that with topiramate and table 3 drugs.

 

[Sparda29]

I agree. That's excessive. Your USP 800 designated person should do a risk analysis and change that, but that's just my two cents. Only Table 1 HD meds (antineoplastics) should be done in the hood like that. Table 2 and table 3 HD meds can be crushed/split on the floor if the nurse wears proper PPE (gloves and a mask to prevent inhalation of powder). Insane to do that with topiramate and table 3 drugs.

How about this? Pharmacy has to mix the Valproate drips now. In the past we just sent the vials upstairs and the nurses would draw it up and shoot it into a 100 mL D5W or NS bag. Now, we gotta prime the line, and draw up and inject it in the chemo hood.

 

[PharmDBro2017]

How about this? Pharmacy has to mix the Valproate drips now. In the past we just sent the vials upstairs and the nurses would draw it up and shoot it into a 100 mL D5W or NS bag. Now, we gotta prime the line, and draw up and inject it in the chemo hood.

Doesn't make sense. Are you priming the line for fluconazole drips too?

 

[Dred Pirate]

How about this? Pharmacy has to mix the Valproate drips now. In the past we just sent the vials upstairs and the nurses would draw it up and shoot it into a 100 mL D5W or NS bag. Now, we gotta prime the line, and draw up and inject it in the chemo hood.

I am shocked you had nurses mixing up anyting - doesn't that go against just about every 707 rule? I know you can make immediate use exemptions- but in our hospital I am not sure if nurses mix anything - there might be some odd ball thing in the OR that we don't have a premix for, but I don't cover them much to know for sure.

But valproate priming lines sounds silly

 

[KidPharmD]

I am shocked you had nurses mixing up anyting - doesn't that go against just about every 707 rule? I know you can make immediate use exemptions- but in our hospital I am not sure if nurses mix anything - there might be some odd ball thing in the OR that we don't have a premix for, but I don't cover them much to know for sure.

But valproate priming lines sounds silly

Immediate use is a pretty big exemption. Our nurses reconstitute and mix quite a bit.

 

[PharmDBro2017]

I am shocked you had nurses mixing up anyting - doesn't that go against just about every 707 rule? I know you can make immediate use exemptions- but in our hospital I am not sure if nurses mix anything - there might be some odd ball thing in the OR that we don't have a premix for, but I don't cover them much to know for sure.

But valproate priming lines sounds silly

No, that is not against USP 797. There is a place for immediate use only (1 hour BUD from time of mixing). Nurse admixture on the floor is common and expected, and nursing should receive yearly competency training.

 

[Dred Pirate]

No, that is not against USP 797. There is a place for immediate use only (1 hour BUD from time of mixing). Nurse admixture on the floor is common and expected, and nursing should receive yearly competency training.

Immediate use is a pretty big exemption. Our nurses reconstitute and mix quite a bit.

Y'alls work place is very different than mine. We have pretty much eliminated RN admixture everywhere that I cover (floors, ED, ICU) - I mentioned the OR might be different, but even then our satelite pharmacy does just about everything I am fairly sure.
Not sure if RN managers cater to nurses and want to make their job easier, or our mgmt has convinced them that anybody but a phamacist/tech making a product will lead to instance death, but it simply just doesn't happen here. I suggested it once when making ketamine for pain since the doses are pt specific, but the RN director said that was a bad idea for reasons X,Y, and Z - and our rphs make them on demand.

 

[PharmDBro2017]

Y'alls work place is very different than mine. We have pretty much eliminated RN admixture everywhere that I cover (floors, ED, ICU) - I mentioned the OR might be different, but even then our satelite pharmacy does just about everything I am fairly sure.
Not sure if RN managers cater to nurses and want to make their job easier, or our mgmt has convinced them that anybody but a phamacist/tech making a product will lead to instance death, but it simply just doesn't happen here. I suggested it once when making ketamine for pain since the doses are pt specific, but the RN director said that was a bad idea for reasons X,Y, and Z - and our rphs make them on demand.

I'm sure you are correct about RN managers catering to nursing. I've witnessed too many passive pharmacy leaders that allow nursing leaders to trample on them and pharmacy workflow. Edit: Then again, our ultimate job is zero harm/patient safety... so taking one thing off nursing's plate is probably a good thing, and allows better patient care ultimately. It's a thin line that can cause major headaches for pharmacy, however.

 

[KidPharmD]

Y'alls work place is very different than mine. We have pretty much eliminated RN admixture everywhere that I cover (floors, ED, ICU) - I mentioned the OR might be different, but even then our satelite pharmacy does just about everything I am fairly sure.
Not sure if RN managers cater to nurses and want to make their job easier, or our mgmt has convinced them that anybody but a phamacist/tech making a product will lead to instance death, but it simply just doesn't happen here. I suggested it once when making ketamine for pain since the doses are pt specific, but the RN director said that was a bad idea for reasons X,Y, and Z - and our rphs make them on demand.

We don't have the staff to deliver golden hour antibiotics to the ED in a timely manner if we made them all in the pharmacy (no ED satellite). The fact that we don't have a choice but to let them do some makes them better at doing it so we allow a decent range of things to be made down here. I would rather have a 24hr ED satellite that could do it all, but that isn't my decision. Of course, this also helps with things like levetiracetam for status epilepticus since we cant just give increments of premixed 1500mg bags like the adult ED does.

 

[Dred Pirate]

We don't have the staff to deliver golden hour antibiotics to the ED in a timely manner if we made them all in the pharmacy (no ED satellite). The fact that we don't have a choice but to let them do some makes them better at doing it so we allow a decent range of things to be made down here. I would rather have a 24hr ED satellite that could do it all, but that isn't my decision. Of course, this also helps with things like levetiracetam for status epilepticus since we cant just give increments of premixed 1500mg bags like the adult ED does.

again - the difference between kids and adults - all of our abx are pre-mixed, or we do IVP in set doses stocked in pyxis

 

[Sparda29]

Doesn't make sense. Are you priming the line for fluconazole drips too?

Yep. If the dose is 100 mg, we gotta fkin remove half of the liquid from the 200 mg bag and stick it into an empty bag and prime the line but this process has to be done in the chemo room.

 

[Sparda29]

Y'alls work place is very different than mine. We have pretty much eliminated RN admixture everywhere that I cover (floors, ED, ICU) - I mentioned the OR might be different, but even then our satelite pharmacy does just about everything I am fairly sure.
Not sure if RN managers cater to nurses and want to make their job easier, or our mgmt has convinced them that anybody but a phamacist/tech making a product will lead to instance death, but it simply just doesn't happen here. I suggested it once when making ketamine for pain since the doses are pt specific, but the RN director said that was a bad idea for reasons X,Y, and Z - and our rphs make them on demand.

Yeah, we still have a lot of stuff that mix. Whenever something is ordered IVPB and is a simple process like draw liquid from vial and shoot into D5W/NS bag, it is on nursing to mix. Sometimes we get new nurses who come from other institutions who are shocked that they have to mix anything and make a stink about it. In that case, management tells us that we have to mix if a nurse requests it/is uncomfortable mixing something themselves.

 

[PharmDBro2017]

Yep. If the dose is 100 mg, we gotta fkin remove half of the liquid from the 200 mg bag and stick it into an empty bag and prime the line but this process has to be done in the chemo room.

My previous job would do this for certain chemo medications, but we're talking table 1 HD/legit chemo drugs. Not fluconazole.

 

[Dred Pirate]

My previous job would do this for certain chemo medications, but we're talking table 1 HD/legit chemo drugs. Not fluconazole.

ya - as far as I know we only do this for chemo, and a very few select hazardous drugs (cellcept I think