⚠ Compounding pharmacies with FDA 483 observations — updated list

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:

1. No verifiable physical address
2. No pharmacist available for consultation
3. COA not available or clearly template/fake
4. Prices dramatically below market ($30-40/month = suspicious)
5. No prescription required
6. Ships without cold pack or temperature control
7. No batch/lot numbers on product labeling
8. 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:

1. State Board of Pharmacy license — check on your state BOP website
2. FDA registration (for 503B) — check on fda.gov
3. DEA registration if handling controlled substances
4. PCAB accreditation — voluntary but demonstrates commitment to quality
5. USP <797>/<800> compliance for sterile compounding

This takes 10 minutes of research and could save you from receiving substandard or unsafe medication.

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.

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.