FDA · Guidance

FDA finalizes interim policy for 503B outsourcing-facility use of bulk substances

FDA published final guidance describing its interim regulatory policy for bulk drug substances used by registered outsourcing facilities under section 503B.

Final guidance legal stageJan 6, 2025 record dateUnited States jurisdiction

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Final guidance

Agency: U.S. Food and Drug Administration
Action: Final guidance
Stage: Final guidance
Last verified: Jul 10, 2026

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Jan 6, 2025Final guidance publishedSource

Editorial boundary: Peptide Report summarizes the public source and preserves its procedural stage. This page does not convert an allegation, proposal, advisory discussion, or warning into a final legal conclusion.

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