FDA_TrackerJim 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.
One thing that is still open after newstart_MO’s answer:
What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?
raj_cambridge said:Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…
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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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.
TinaHashiRN said:Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…
That is correct as far as it goes, and here is where it stops going. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.