FDA Press Releases · 4/30/2026

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List

FDA is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.

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