FDA compounding enforcement update — June 2026 guidance document

HPLC_Greg said:

Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. The objection nobody has made: this only works if the measurement is doing what we assume it is doing, and that assumption has not been tested here.

HPLC_Greg said:

Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

That holds where the measurement is reliable. Where it is noisy — and a lot of what gets tracked here is noisy — the same reasoning produces confident nonsense.

HPLC_Greg said:

Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

Thank you for spelling out the reasoning rather than just the conclusion.

Adding the clinical framing, because it changes how the question reads. The version of this that has an answer is narrower than the version being asked. Narrow it and it becomes tractable; leave it broad and the thread will produce nine confident and incompatible replies.

julia.endo said:

The version of this that has an answer is narrower than the version being asked.

Adding a me-too, because a thread of one person's experience is not much use. The detail I would add is minor and it is already implied above.