Revisiting: US compounding rules and how they changed

On the subject in the title: Revisiting: US compounding rules and how they changed Working notes rather than a conclusion.

Regional question, dated February 2026, because everything in this category expires.

The position differs between the jurisdictions people usually treat as one, and the differences are not marginal. I have set out what I can verify for my own region from primary sources rather than summaries.

If you can confirm or contradict this for yours, please date the answer.

Compounding pharmacies: pharmaceutical compounding of a drug not on the FDA shortage list is substantially constrained. The landscape changed when supply normalised. Current compounding availability is limited.

Worth separating two things that the opening post runs together.

Both are useful and different. The account tells you what happens in practice; the criterion tells you what to write.

Cost comparisons should state whether they include the device and the dispensing fee, because those differ between routes and between states.

Adding the caveat now so it does not have to be extracted later.

Emotional language in an appeal does not help, however justified it is. The reviewer is checking criteria and the job is to make them checkable.

Noting that I have skin in this question and have tried to discount for it.