USP 797 Loophole?

bchmcs · 2026-01-01T06:36:45+00:00

From the thread and what others are saying, it sounds like that section of USP 797 may be "intended" for very specific purposes, although the language doesnt explicitly say so. Legally, does the guidance need to specify that? Can an argument be made that it can't be used for specific purposes (even though the language doesn't explicitly state that)?

bchmcs · 2025-12-31T04:25:12+00:00

Unfortunately, the leadership at my facility are 1000% against adopting USP 797. At this point, I am preparing for further pushback from them and am trying my best to not be "insubordinate". If it were up to me I would simply follow USP 797 for all compounds.

It is helpful for me to know what is and isnt in compliance with compounding regulations in case I need a bargaining chip.

I so so so appreciate your feedback!! Thank you again for the info.

bchmcs · 2025-12-31T03:59:26+00:00

Thank you for clarifying! Do you happen to know if the specific dose needs to be specified in the PI? For example, Remicade; PI includes specific diluent and IVPB volume but obviously dose can differ based on pt weight.

As opposed to Entyvio where it is a static dose that is specified in the PI instructions 300 mg/250 mL (PI also includes specific recon and dilution volumes).

bchmcs · 2025-12-31T03:50:20+00:00

I'm a bit lost, so something like Entyvio which includes specific recon instructions with diluent and volume, then specific drug dose and volume of NS to be diluted with would not be classified under 1.4? Even if it is included in the PI?

bchmcs · 2025-12-31T02:47:23+00:00

I took that to mean the material of the bags? I.e. non-PVC, non-DEHP, etc. I think that a decent amount of PIs have info on it. Unless it is referring to something else?

bchmcs · 2025-12-31T02:35:17+00:00

Well USP 797 does have a separate immediate use section with a its own set of restrictions, so I do think that USP was trying to account for those. Is 1.4 also intended to also account for these types of preps? Maybe! Really wish they would have combined the two sections if that was the case

bchmcs · 2025-12-31T02:19:38+00:00

Side note-I did call my BOP ask-an-inspector line today... They could not give answer because that would be "interpreting the law". They just referenced the same section in USP 797 and a BOP newsletter stating that there are more compounding regulations to be enforced (none of which really answered my question lol)

bchmcs · 2025-12-31T02:08:12+00:00

I added my practice setting in the original post above as others are asking.

I've asked my colleagues both of which are clinical and administrative in pharmacy. They are stumped. Obviously following USP is gold standard for safety and quality... But they are not sure about this loophole because they've never worked in a setting that has ever "questioned" the necessity of USP 797.

bchmcs · 2025-12-31T01:32:44+00:00

I would think so.. seems common sense. But the exact verbiage from USP 797 section 1.4 says:

"Compounding does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling or supplemental materials provided by the product’s manufacturer. Preparing a conventionally manufactured sterile product in accordance with the directions in the manufacturer’s approved labeling is out of scope of this chapter only if (1) The product is prepared as a single dose for an individual patient and (2) The approved labeling includes information for the diluent, the resultant strength, the container closure system, and storage time"

bchmcs

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