the FDA language around the resolved shortage and the 503A enforcement posture has shifted enough times now that the practical question for anyone still buying compounded sema or tirz is: what does the current framework actually require the pharmacy to document on YOUR vial, not on their facility. the short version of what i’m seeing on the compounding side: - 503A facilities are still permitted to compound patient-specific prescriptions, but the “essentially a copy” language is the part doing the heavy enforcement work now. the carveouts for clinically significant difference are narrower than the marketing copy suggests.
- 503B language got tightened around finished-vial release testing, but the gap between “adopted the framework on paper” and “validated to it on your batch” is where most of the 483s i’ve seen are landing.
- BUD methodology hasn’t really moved. what changed is what you can ask for: the sterility study underpinning the BUD on your specific batch is a fair request now in a way it wasn’t 18 mos ago. ask for batch-level docs, not facility-level policy. those are different documents answering different questions.