FDA warning letters to compounding pharmacies — November 2025

carl_compliance said:

Compounding pharmacy customer here with experience relevant to compounded supply.

FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA website.

Check for: Form 483 observations (violations), warning letters, and recall history. A clean inspection record is a strong indicator of quality. My pharmacy has had 0 Form 483 observations in their last 3 inspections.

This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations

mel_PDX said:

Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…

Saving this. It is the first explanation that did not require me to already understand it.

carl_compliance said:

Compounding pharmacy customer here with experience relevant to compounded supply.

Vendor communication red flags for compounded supply:

• Won't provide COA before purchase — walk away
• Claims "100% pure" without analytical data — unrealistic
• No physical address or phone number — accountability matters
• Pushes you to buy more than you need — pressure tactics
• Won't answer questions about their compounding process — transparency is key
• Payment only via crypto or wire transfer — legitimate pharmacies accept cards

A legitimate compounding pharmacy operates like a healthcare business, not a gray market dealer.

gary_naperville said:

Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…

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 2 hours. They answered my questions about storage conditions thoroughly and professionally.

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

Moderator note: good thread. Keeping it here rather than moving it, because the question is general enough to be useful. Report rather than reply if it drifts again.