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or Appears on the 503A bulks list or 503A Category 1 – Bulk Drug Substances Under Evaluation list (i.e., the “interim 503A bulks list”) provided by the FDA if requirements one or two are not met *note that the FDA’s position is that specifically refers to USP/NF drug monographs, not dietary supplement monographs 503B outsourcing facilities are even further restricted in their allowed bulk materials and may not compound a drug product unless the relevant bulk drug product, in addition to being accompanied by a valid CoA and manufactured in an FDA registered facility, meets one of the below requirements: Appears on the list identifying bulk drug substances for which there is a clinical need (503B bulks list or 503B Category1: Bulk Drug Substances Under Evaluation (i.e., the “interim 503B bulks list”)
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