Home/News/Regulatory

Regulatory

FDA decisions, advisory committee meetings, warning letters, compounding rules under Sections 503A and 503B, and the legal status of specific peptides. Articles are built from primary agency documents where available and explain what a given action does and does not change.

32 articles by Brian Gossett. Read our editorial standards.

October 3, 2026

FDA Updates the Path for Generic Peptide Drugs

FDA issued 17 revised draft guidances for generic peptide products in July 2026. Learn what changed, why quality matters, and what this does not approve.

October 3, 2026

What FDA's Latest Peptide Warning Letter Actually Says

What FDA's August 2026 NuScience Peptides warning letter says about intended use, research labeling, named products, and the limits of its conclusions.

August 28, 2026

FDA Expands Mounjaro to Reduce Cardiovascular Risk: What SURPASS-CVOT Actually Showed

What the FDA's August 2026 Mounjaro cardiovascular approval means, what SURPASS-CVOT proved versus dulaglutide, who it covers, and key safety caveats.

August 28, 2026

FDA Approves Mimrylo (Rusfertide): A Hepcidin-Mimetic Peptide for Polycythemia Vera

FDA approved Mimrylo (rusfertide) for erythrocytosis in adults with polycythemia vera. Review VERIFY efficacy, hepcidin biology, dosing, and safety facts.

FDA Peptide Approvals and Rejections: What the July 23–24, 2026 Government Meeting Decided

Final results of the FDA's July 23–24, 2026 PCAC meeting: six of seven peptides (BPC-157, KPV, TB-500, MOTS-C, Semax, Epitalon) won favorable 503A votes; emideltide (DSIP) was rejected. What it means for pharmacies and clinics.

FDA Peptide Update 2026: Everything Researchers Need to Know About the July PCAC Meeting

On July 23, 2026 the FDA's PCAC meets to reconsider peptide compounding rules for BPC-157, TB-500, KPV, MOTS-c and more. What's on the agenda and why.

KPV Peptide: FDA Review, Research Applications & Regulatory Status

KPV peptide FDA review 2026: what the Lys-Pro-Val tripeptide is, its research uses, why it has no lawful compounding path, and the July PCAC context explained.

MOTS-c Under FDA Review: What Researchers Need to Know

MOTS-c is not FDA approved, not a supplement, and has no lawful compounding path. What the July 2026 PCAC peptide review means for this research peptide.

Semax FDA Update 2026: Regulatory Status, Research & the July PCAC Review

Semax FDA update for 2026: why this ACTH(4-10) nootropic peptide is not FDA-approved, has no lawful US compounding path, and what the July PCAC review means.

Epitalon (Epithalon) FDA Update 2026

Epitalon (Epithalon) FDA update for 2026: why the pineal tetrapeptide is not approved, has no lawful compounding path, and what the July PCAC review means.

DSIP (Emideltide) FDA Review Explained

DSIP (Emideltide), the delta sleep-inducing peptide, explained: structure, sleep research, US regulatory status, the July 2026 PCAC review, and RUO reality.

Is BPC-157 FDA Approved?

No — BPC-157 is not FDA approved: no approved drug, not a supplement, sold research-use-only. Learn what approval means and why unapproved isn't illegal.

Can Doctors Prescribe BPC-157?

Can a doctor prescribe BPC-157 in 2026? No FDA-approved BPC-157 drug exists and pharmacies can't compound it (Category 2). The off-label myth, explained.

Can Pharmacies Compound TB-500?

Can compounding pharmacies legally make TB-500 (thymosin beta-4) in 2026? Why it fails all three FDA 503A sourcing paths and 503B cannot supply it either.

Is KPV Legal?

Is KPV legal in 2026? The Lys-Pro-Val tripeptide is not scheduled and not FDA-approved, but has no lawful compounding path — so it is sold research-use-only.

Is MOTS-c FDA Approved?

MOTS-c is not FDA approved for any use — not a drug, not a supplement, sold research-use-only. Learn what approval means and why it is not the same as illegal.

What Does 'Bulk Drug Substance' Mean?

A bulk drug substance is the raw active pharmaceutical ingredient a compounder starts from. Here's what it means, why it matters, and how it affects peptides.

What Is Section 503A?

Section 503A of the FD&C Act governs traditional, patient-specific pharmacy compounding. Learn the three 503A(b) sourcing paths and Category 1 vs 2 rules.

What Is a 503B Outsourcing Facility?

Section 503B outsourcing facilities compound drugs under federal cGMP in batches without patient-specific prescriptions. How 503B works and differs from 503A.

What Is PCAC? The FDA's Pharmacy Compounding Advisory Committee

PCAC is the FDA's Pharmacy Compounding Advisory Committee. Learn what it does, how it advises on the 503A bulks list, and its non-binding July 2026 vote.

FDA Peptide Update: July 2026

The FDA's July 23, 2026 advisory committee will review peptide compounding rules for BPC-157, TB-500, and more. What's on the agenda and what won't change.

What Happens After an FDA Advisory Committee Vote?

What happens after an FDA advisory committee votes? A clear guide to non-binding recommendations, rulemaking, timelines, and the July 2026 peptide review.

What Is the FDA 503A Bulks List?

The FDA 503A bulks list decides which bulk drug substances pharmacies can compound. Here is how Category 1 and Category 2 work — and why peptides landed there.

Can Compounding Pharmacies Compound BPC-157?

Can compounding pharmacies legally make BPC-157 in 2026? Why it fails all three FDA 503A sourcing paths, what 503B changes, and what the July review could mean.

Is BPC-157 Legal in 2026?

Is BPC-157 legal in 2026? A clear breakdown of its US federal status, FDA 503A compounding restrictions, research-use-only sales, and anti-doping bans.

Is TB-500 Legal in 2026?

Is TB-500 legal in 2026? A clear breakdown of its US federal status, FDA 503A compounding restrictions, research-use-only sales, and anti-doping bans.

Research Peptides vs Prescription Peptides

Research peptides vs prescription peptides compared: legal status, oversight, sterility, purity testing, labeling, cost, and risk for RUO reagents vs medicines.

FDA-Approved Peptides 2026: Major Drugs & What Approval Means

A guide to the major FDA-approved peptide drugs in 2026 — semaglutide, tirzepatide, tesamorelin, sermorelin and more — what FDA approval actually means, and how approved peptides differ from research-grade compounds.

FDA Peptide Ban Reversal 2026: What It Means for BPC-157, Ipamorelin & More

On April 15, 2026, the FDA announced an advisory panel to reconsider peptide compounding restrictions. Here's what it means for BPC-157, GHK-Cu, Ipamorelin, CJC-1295, and over a dozen other compounds under review.

Why Peptides Are "Research Only" Explained

What "research only" actually means for peptides: FDA approval economics, the patent problem, 2023-2024 compounding pharmacy actions, and what to look for in a compliant supplier.

February 6, 2026

FDA's February 2026 Compounded GLP-1 Enforcement Announcement, Explained

What FDA's February 6, 2026 compounded GLP-1 announcement means for 503A and 503B pharmacies, telehealth marketers, patients, and legal access.

January 13, 2026

FDA Asks to Remove Suicidal Ideation Warnings From Three GLP-1 Drug Labels

FDA asked Saxenda, Wegovy, and Zepbound makers to remove suicidality warnings after a large evidence review found no increased risk. What that means now.