My pharmacy just stopped compounding sema - now what?? — need advice

JenPlateau said:

Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

Thank you — that is the clearest version of this I have read, and I have read a lot of them. Sending this to two other people who asked me the same thing last week.

Adding the clinical framing, because it changes how the question reads.

FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA website.

Check for: Form 483 observations (violations), warning letters, and recall history. A clean inspection record is a strong indicator of quality. My pharmacy has had 1 Form 483 observations in their last 2 inspections.

This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations

DeniseRN_TPA said:

503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously: Feature 503A 503B Regulation State Board of Pharmacy…

GMP compliance checklist relevant to compounded supply compounding quality:

• Clean room environment with HEPA filtration
• Environmental monitoring (viable and non-viable)
• Personnel training and competency assessment
• Validated analytical methods for testing
• Stability testing program
• Complete batch records and traceability
• Quality management system with deviation handling

A 503B pharmacy following cGMP should be able to answer questions about ALL of these if you ask. Don't be afraid to ask — it's your health.

Dr.RaviCardio said:

The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

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.

Moderator note: a couple of off-topic posts removed.