A factual changelog of the peptide regulatory landscape, primary FDA sources only, reviewed, and translated into what it changes for you. Not opinion.
On July 24, the PCAC recommended Semax and Epitalon for the 503A Bulks List (tallies reported as 8–5–1 for Semax, and as 7–4–1 or 7–5–1 for Epitalon depending on the outlet; FDA has posted no minutes or transcript) but narrowly rejected Emideltide/DSIP (6–7, 1 abstention). Across both days, six of seven peptides advanced. A recommendation is not approval, not authorization, and not availability — verdict dots stay amber.
Read the updateOn July 23, 2026, the FDA's Pharmacy Compounding Advisory Committee voted to recommend adding BPC-157, KPV, TB-500 and MOTS-c to the 503A Bulks List, against its own scientists' advice. A recommendation is not approval, not authorization, and not availability. Nothing you can buy changed. Verdict dots stay amber.
Read the updateThe FDA's Pharmacy Compounding Advisory Committee will review seven peptides on July 23–24, 2026. The vote is advisory: a favorable recommendation leads to rulemaking, not instant availability. We'll publish the outcome the same day.
Read the updateThe FDA has proposed excluding semaglutide, tirzepatide and liraglutide from 503B bulk compounding. Public comments close June 29, 2026. The approved branded products remain available; the proposal targets compounded supply.
Read the updateSome are reading the April 2026 removal of peptides from compounding Category 2 as a green light. The more authoritative legal reading does not: removal is not the same as Category 1, the Bulks List, or availability. We keep the verdict dot amber until a molecule can legitimately be dispensed.
Read the update“RFK-14” is shorthand for the group of peptides swept into the 2026 compounding-policy review. Reclassification changes how, and whether, a licensed pharmacy may compound them. It is a regulatory mechanism, not a clinical endorsement.
Read the updateCompounded medications are not FDA-approved. PCAC is advisory, a favorable vote leads to rulemaking, not instant availability. Sources are primary (FDA dockets, Federal Register, press releases).