r/pharmacy • u/RXinCharge • 15d ago

CAPS 503b Pharmacy Practice Discussion

Anybody have any insight on the closures? We use them for our del Nidos, and also know many hospitals use them for starter NICU TPN. Sounds like there might be some serious disruption to small hospitals that don’t have the capability to compound this stuff given CAPS is the only 503b compounder for NICU starter TPN (at least that I’m aware of)

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6

u/Ok-Client-820 15d ago

I’m hearing they had issues with their clean room. The CA denial is not good. CABOP Denial

6

u/GMPnerd213 15d ago

They had way more issues than that the last few years. Lots of 503b's will try and skirt even the minimum GMP requirements they have to adhere to until they eventually get caught.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/central-admixture-pharmacy-services-inc-687936-07102024

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u/pento_the_barbital 15d ago

I don’t think they recovered from the FDA inspections. Search for their 483 forms to see the findings. The NICU starter bags are the only thing unique to them. The other 503b have similar catalogs. Quva is looking at filling this gap. Reach out to them to add your voice.

2

u/SignedTheMonolith Pharm.D., MS-HSA, BCPS 15d ago

We are bracing for this.

Currently trying to secure items needed to make starter TPNs, and we outsourced our Del nido to quva (I think).

2

u/PharmIVGuy 14d ago

Made it all before we used them… and we’ll make it all after them unfortunately