FDA shared a post on LinkedIn:
“The FDA is proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, which identifies bulk drug substances that outsourcing facilities may use in compounding when there is a clinical need.
After carefully reviewing nominations for these three substances, FDA did not identify sufficient support to include these drugs on the list.
Under Section 503B of the FD&C Act, outsourcing facilities generally cannot compound drugs using bulk substances unless they appear on the 503B bulks list or the drug is on FDA’s shortage list
A determination of clinical need is based on patient safety and medical necessity under the law.
We want to hear from you. Interested parties can submit comments electronically through the docket by June 29, 2026. FDA will carefully consider all submitted comments before making a final determination.”
Proceed to the video attached to the post.
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