State-by-state compounding pharmacy regulations — looking for input

Dr.PulmRoch said:

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

That reframing is the part I needed. 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.

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 9 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 7 days (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.

pete_nash said:

For compounded supply users considering compounded for the first time: here's a step-by-step guide: Get a prescription from your doctor (telehealth…

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.

nancy_portland said:

They are two different exemptions from the same federal requirements and they buy different things.

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.

Moderator note: two posts asking for a source have been merged into one. Please search the thread before asking again. Thread quality here is what the rules are for. Keep it up.