SarahChen_PharmD said:They are two different exemptions from the same federal requirements and they buy different things.
Pushing back on SarahChen_PharmD here. 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.
AussieAnna 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 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.
NeuroNate said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials:
- State Board of Pharmacy license — check on your state BOP website
- FDA registration (for 503B) — check on fda.gov
- DEA registration if handling controlled substances
- PCAB accreditation — voluntary but demonstrates commitment to quality
- USP <797>/<800> compliance for sterile compounding
This takes 10 minutes of research and could save you from receiving substandard or unsafe medication.
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View ResultsFollowing on from hannah_MT — and this may be the naive question:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
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.