Peptide Regulation Watch · Substance File

Glutathione

Discretion STATUS VERIFIED AUGUST 22, 2026 · HAS A SHELF LIFE

The endogenous tripeptide antioxidant, compounded for injection and infusion — compounded today under enforcement discretion, not approval.

Also encountered as: Glutathione · class: antioxidant

Where it actually stands

Verified directly on FDA's own 503A nominations list (updated 5/14/26): this substance is in interim Category 1 — the agency states it does not intend to take enforcement action against compounding while its review is pending. That is discretion, not approval, and FDA can change position. Lists move; verify before any formulary decision.

The one-sentence version: enforcement discretion while review is pending — not approval, and revocable at any time.

The record

AUG 2026

Sterile-compounding recall signal involving glutathione logged in the RA Signal Ledger — under watch.

APR 22, 2026

FDA's bulk substances / safety-risk category pages last updated — the placement behind this status.

AUG 9, 2026

Status verified against the category pages for the Q3 2026 brief. Re-verify before acting — interim placements move.

Primary sources

FDA bulk substances / safety-risk pages (updated 4/22/26) · industry compounding summaries, cross-checked for the Q3 2026 brief. Full citation list available on request.