PharmacoVig_BOS said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
Genuinely useful, thank you. I had the facts and not the framework. Sending this to two other people who asked me the same thing last week.
Adding the clinical framing, because it changes how the question reads.
GMP compliance checklist relevant to compounded supply compounding quality:
- Clean room environment with HEPA filtration
- Environmental monitoring (viable and non-viable)
- Personnel training and competency assessment
- Validated analytical methods for testing
- Stability testing program
- Complete batch records and traceability
- Quality management system with deviation handling
A 503B pharmacy following cGMP should be able to answer questions about ALL of these if you ask. Don't be afraid to ask — it's your health.
pete_nash said:Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…
Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness. A pharmacy that can't answer questions promptly is a red flag.
My current pharmacy: average response time 1 hour. They answered my questions about batch-specific COAs thoroughly and professionally.
Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.
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View ResultsJakeBK_lifts said:They are two different exemptions from the same federal requirements and they buy different things.
Beyond-use dating (BUD) for compounded supply compounded products:
Lyophilized (unreconstituted): typically 6 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 24 hours (no preservative!)
Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.