Thymosin Alpha-1
RestrictedImmune Peptide
Based on public FDA bulk-substance and shortage listings, it appears to be off the permitted bulk substances list, or a shortage-based exception has ended. That's our read that no established pathway currently applies — not a formal legal bar, and not a determination we're qualified to make. Confirm current status with FDA sources or counsel.
Not legal advice. Every status on this page is our own reading of public FDA guidance, shortage listings, and committee materials — it has not been reviewed by an attorney and is not a legal determination. "Contested" means pharmacies and regulators publicly disagree, not that we're resolving the disagreement. Verify independently, and check with counsel, before relying on any entry here.
Current status
Not currently on the permitted 503A bulk substances list, and has no FDA approval or shortage-list history. FDA's April 15, 2026 interim bulks-list update removed it from the stricter 'Category 2' safety-restricted tier, and HHS Secretary Kennedy named it among roughly a dozen peptides he said were headed back to the more permissive 'Category 1' in a February 2026 interview — but multiple outlets report FDA had not taken that formal action as of their publication, and removal from Category 2 does not by itself make a substance eligible for 503A compounding. Treat as outside the permitted list until FDA publishes something formal.
Last changed: 2026-04-15