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REGULATORY INTELLIGENCE · ALL 50 STATES + DC

Compound-Class Regulatory Tracker

What every state says you can and can't do with exosomes, peptides, GLP-1s, stem cells, and biologics. Filter by compound, filter by route, click any state for the full breakdown.

As of Aug 17, 2026  ·  5 compound classes × 7 routes × 50 states + DC  ·  Federal framework ↓
IMPORTANT: No exosome product holds FDA approval for any therapeutic use. State laws govern provider conduct, consent, and disclosure — they do not override federal FDA authority or make products FDA-approved. Most research peptides have no FDA-approved products. This tracker documents the regulatory landscape for market intelligence only.
Compound Class
Route of Administration

State Heat Map

click a state → full regulatory profile
Click a state on the map — or select a compound class to recolor the nation.
Two-mode drill-down

Federal Classification Framework — Compound-Class Specific

0
FDA Enforcement Actions (2024-26)
0
FDA-Approved Exosome Products
6
States With Board GLP-1 Positions
5
PCAC Bulks Additions (Jul 2026)
Route of Administration — Federal Default
Injectable / IV
Full drug/biologic pathway. BLA, IND, or valid prescription (compounded) required. No exosome product approved. Peptides: no approved products; 503A bulks list governs compounding.
Topical (Cosmetic Only)
Permissible IF no structure/function claims. Claims = drug trigger. State laws generally do not restrict topical cosmetic use.
Microneedling + Compound
FDA considers microneedling a procedure that breaches the skin barrier — application after = administration, not topical. #1 enforcement target.
Compound Classes — Federal Status

Exosomes

PHS Act Section 351 biologic. No FDA-approved product for any indication. Fails the 361 minimal-manipulation exception. States with permissive stem cell laws generally extend by analogy; TN is the first state to reference exosomes by name; UT has supplier-side duty. CA/MN restrictive.
Enforcement: 7+ warning letters & DOJ actions 2024-26.

Peptides (BPC-157, TB-500…)

No FDA-approved products. Compounding governed by 503A Bulks List — in July 2026 the PCAC voted to add BPC-157, TB-500, KPV, DSIP, Semax, and Epitalon to the bulks list. States without specific statutes default to federal rules.
Widespread gray-market availability; state boards increasingly active.

GLP-1s (Semaglutide, Tirzepatide)

FDA-approved products exist (Wegovy, Ozempic, Mounjaro). 503A/503B compounding allowed during shortages; FDA cracked down 2024-25 with 30+ warning letters to telehealth companies. State boards (AL, NJ, OH, KS, KY, CA) issued position statements.
More regulated than peptides, but legal compounding pathways exist.

Stem Cells

Most state laws target stem cells specifically — 7 permissive (FL, GA, TN, TX, WY, NV, MS), 4 regulated (UT, WA, VT, NC), 2 restrictive (CA, MN). Federal authority governs regardless; state laws govern provider conduct.
This tracker's tier data maps directly to this class.

Biologics (351 Products)

Federal 351 products — BLA or IND required for therapeutic use. State laws referencing "regenerative medicine" or "cellular therapy" cover these. Cosmetic-only positioning keeps products outside drug jurisdiction while claims hold.
Same federal floor as exosomes; state posture varies by regen law.

FDA Enforcement Timeline — Exosome & Stem Cell Products

Data API — Cross-Venture Access

# Full regulatory dataset (JSON) — free, no auth needed. Includes per-state compound-class + route data.
GET /api/regulation → all 50 states + DC + federal enforcement + compounds data

# Single state lookup
GET /api/regulation?state=FL → Florida profile incl. compounds

# Filter by compound class
GET /api/regulation?compound=exosomes → exosome posture for all states

# Federal enforcement actions only
GET /api/regulation?federal=true → FDA warning letters + DOJ actions

# Filter by tier
GET /api/regulation?tier=permissive → all permissive states
KnownChem Compound-Class Regulatory Tracker — part of the KnownChem market intelligence platform.
Data compiled from state statutes, FDA enforcement records, medical board publications, and legal analysis.
This is market intelligence, not legal advice. ← Back to KnownChem Terminal