Dr.ObesityMed 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.
Dr.PulmRoch said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source:
- No verifiable physical address
- No pharmacist available for consultation
- COA not available or clearly template/fake
- Prices dramatically below market ($30-40/month = suspicious)
- No prescription required
- Ships without cold pack or temperature control
- No batch/lot numbers on product labeling
- Pushes "research use only" products for human injection
Your health depends on product quality. Don't cut corners on source verification.
JennaRN said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously:
| Feature | 503A | 503B |
|---|---|---|
| Regulation | State Board of Pharmacy | FDA-registered |
| Prescription | Required (patient-specific) | Can compound without patient Rx |
| Testing | Varies by state | cGMP required |
| Scale | Small batches | Larger production |
| Quality consistency | Variable | Generally higher |
I strongly recommend 503B facilities. The FDA oversight and cGMP requirements mean more consistent product quality.
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View ResultsOne thing that is still open after AttorneyGrant’s answer:
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.