SarahChen_PharmD said:Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.
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.BariatricHTX said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.
Dr.ReproEndo 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.
Sigma-Aldrich — Research-Grade Standards
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Shop Reference StandardsFollowing on from CanadaChris — 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?
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.