If a product is available before FDA approval, it is not the same as the drug being studied in clinical trials
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What compounding pharmacies typically provide: Sterile preparation under USP clean-room conditions Benzyl alcohol at the 0.9% USP specification Lot-numbered vials with expiration dating Glass vial packaging (typically) Where compounding pharmacy documentation varies: COA availability ranges from full five-test panels to sterility-plus-benzyl-alcohol-only confirmation Third-party testing may or may not be standard some pharmacies rely on internal QC Endotoxin testing and particulate matter testing are sometimes performed per-lot, sometimes on a sampling schedule Documentation format is less standardized than FDA-registered manufacturer COAs Community sources describe compounding pharmacy bacteriostatic water as a middle tier in the documentation spectrum
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