Dr.NateNeph said:They are two different exemptions from the same federal requirements and they buy different things.
Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to. It is a different legal universe with no pharmacy oversight, no patient relationship and no content guarantee, and conflating the two in these threads helps nobody.
PharmHunterJen 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…
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.
PharmacoVig_BOS said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
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 1 Form 483 observations in their last 2 inspections.
This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations
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View ResultsA narrower follow-up, since the general answer is now clear:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
OP back with an update, since a thread like this is useless without one.
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.