⚠ Compounding pharmacies with FDA 483 observations — what worked for you?

LipidDoc_ATL said:

The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

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.

A narrower follow-up, since the general answer is now clear:

What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?

DoseLogDan said:

GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

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 4 hours. They answered my questions about reconstitution thoroughly and professionally.

Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.

Reporting back.

The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.

james_edin said:

Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness.

That is correct as far as it goes, and here is where it stops going. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.

If somebody has the primary source to hand I would rather cite it than paraphrase it.