Guides: Guides for compounding quality teams. Each one cited to the source.
Each guide answers one question a pharmacist-in-charge, a quality lead or a telehealth operations lead has to answer, from the law, the FDA's public tools and the published standards. Where a guide gives our own practice, it says so. Reviewed November 11, 2026.
Five guides. One question each.
Reviewed November 11, 2026. Each guide lists its sources at the end.
The FDA's public tools, in order, and the dated capture to keep in the lot file.
Guide Repackaged API: what the COA has to nameICH Q7 sections 11.4 and 17, the FDA's statements and HHS condition 4, quoted.
Guide COA requirements for 503A pharmacies, by sourceThe statute, USP and state boards, each quoted, and what none of them defines.
Guide API supplier qualification for 503A pharmaciesWhat the file holds, where each item comes from, and what to do with a discrepancy.
Guide How to vet a compounding pharmacy for telehealthLicensure by ship-to state, 503A or 503B, public inspection data and the documents to ask for.
Guide HHS's peptide policy, condition by conditionHHS's 2026 enforcement discretion policy, read one condition at a time.
Policy