FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
The FDA has proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. The agency determined there is no clinical need for outsourcing facilities to compound these medications using bulk substances.
This affects 503B outsourcing facilities currently compounding these GLP-1 substances from bulk, as well as the manufacturers of the reference listed drugs. Professional functions involved include regulatory compliance, pharmacy operations, and legal departments.
This proposal signals a significant shift in the regulatory landscape for compounded GLP-1 medications. If finalized, outsourcing facilities would generally be prohibited from using bulk forms of these substances to create compounded drugs under Section 503B, potentially consolidating the market back toward the innovators. The finding of 'no clinical need' suggests the FDA may believe commercially available versions are sufficient for patient requirements.
Outsourcing facilities should evaluate current compounding portfolios and supply chains involving these substances. Regulatory teams should prepare to monitor the federal register for the formal proposal and final rule to ensure compliance with bulk substance limitations.
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.
Open in openFDA / FDA.gov