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The complete documents released can be viewed here: Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding | FDA Interim 503B Bulks List: download (fda.gov) Interim 503A Bulks List: 503A Categories Update for September 2023 (fda.gov) What Are the 503A and 503B Bulks Lists

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In FDAs RUO/IUO IVD guidance, RUO labeling is discussed as a way to prevent research products in that category from being represented for clinical diagnostic use [5]

[PubMed: 38753454] [Free PMC Article] Ludwig MQ, Coester B, Gordian D, et al

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