Sterile Compounding Regulations and Resources For Running Compounding Pharmacy

[clarkbar]

I am familiar with compounding technique and math, but not with the regulations and stipulations surrounding maintaining such a facility up to code. What resources, official and third party are available for such a PIC role? Though there may be consultant help, I would definitely like to read more with self-study. Much obliged!

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[PharmDBro2017]

Read up on USP 797 & 800

 

[CetiAlphaFive]

I am familiar with compounding technique and math, but not with the regulations and stipulations surrounding maintaining such a facility up to code. What resources, official and third party are available for such a PIC role? Though there may be consultant help, I would definitely like to read more with self-study. Much obliged!

The new USP guidelines are excruciatingly detailed.

You should hire a consultant

 

[clarkbar]

The new USP guidelines are excruciatingly detailed.

You should hire a consultant

Where should one find them?

 

[CetiAlphaFive]

Where should one find them?

Oh, TPhSASP has a list

 

[Xarelto-10]

Where should one find them?

You can directly go to the USP website and find the most up to date USP-795/800.

If your company can afford it a consultant will make the process easier but you can also do it on your own.

 

[clarkbar]

You can directly go to the USP website and find the most up to date USP-795/800.

If your company can afford it a consultant will make the process easier but you can also do it on your own.

It says one needs to purchase

 

[APN-59 rph]

Call Druggist Mutual or whichever company covers you before doing anything....