Find your gaps before they do.
Med spa owners, aesthetics practices, and Medical Directors FDA and state regulators are now jointly inspecting your practices for drug supply chain failures. Most don't know they are in scope until an inspector walks in.
This applies to you if:
You own or operate a med spa or aesthetics practice.
You are a Medical Director covering one or more locations.
You administer Botox, Dysport, GLP-1s, peptides, or IV therapy in-office.
If any of these describe you — you are in scope today.
Four ways your practice is exposed - right now.
DSCSA (FDA)
Can you prove where every Rx product came from? The FDA requires documented, verifiable sourcing and traceability for every product purchased, stored, or administered in your practice. Now armed with ELSA 4.0 — an AI targeting system the FDA is selecting inspection targets based on documentation risk signals. One-day surprise inspections began April 2026. No advance notice. No warning.
Compounding & Peptides (503A / 503B)
Peptides are one of the fastest-growing service categories in aesthetics and one of the least understood from a compliance standpoint. Ipamorelin, BPC-157, Sermorelin, and similar compounds sourced outside compliant 503A/503B frameworks create regulatory exposure that goes entirely beyond DSCSA. Ohio suspended four physician licenses specifically over peptide and compounded drug violations.
State Agencies
The FDA sets the standard. State boards are the army on the street enforcing it. Boards of pharmacy and cosmetology are actively co-enforcing using shared FDA inspection data with faster consequences and no advance notice. New York, Ohio, and California are already documented. More states are following.
IV Therapy & Adulteration Risk
Adding substances to IV bags can shift your practice into unlicensed compounding territory. Combined with non-compliant peptide sourcing, this is your highest-risk exposure category and the one with the most serious documented consequences. A Texas med spa owner faces felony charges following a patient death linked to IV therapy administration failures.
This is already happening. In your state.
Texas — First FDA Form 483 ever issued to a physician-owned medical spa. A med spa owner faces felony charges following a patient death linked to IV therapy failures.
New York — 223 med spa and aesthetic practice inspections conducted. 87 practices cited for drug traceability and unauthorized dispensing violations.
Ohio — 4 physician practice licenses suspended following peptide and compounded drug dispensing violations.
California — Board of Pharmacy conducting active inspections of physician-owned aesthetic practices. Multiple citations pending.
Florida — Distributor warning letter issued. Downstream practices dispensing injectables under active scrutiny.
FDA — April 2026 — One-day surprise inspection pilot launched. 46 already conducted. Zero advance notice. ELSA 4.0 AI system selecting targets based on documentation risk signals.
If you are a Medical Director, your license is at every location you cover.
Most Medical Directors cover multiple med spa locations simultaneously. You are not an employee of any single practice but your license is on the line at every one of them. If a state inspector or FDA investigator walks into any location you cover today, can you account for every Rx product, every peptide, every IV therapy compound administered at that practice? Most Medical Directors cannot. And most have no idea what documentation exists or doesn't at the locations they cover.
How enforcement reached your practice
2013 — DSCSA enacted. Congress mandates full drug supply chain traceability.
Nov 2023 — Dispenser requirements take effect. Physician practices formally brought into scope for the first time.
Nov 2024 — Enhanced traceability enforceable. Full verification and documentation requirements active for all practice-level dispensers.
Aug 2025 — FDA stabilization period ends. State agencies begin co-enforcement using shared FDA inspection data.
2026 — Now — First physician-practice Form 483 issued. State boards actively inspecting across multiple states.
Know your risk in minutes. Fix it at your pace.
TIER 1 — FREE
10-question compliance snapshot. Weighted scoring engine. Instant result — Low Risk, Moderate Exposure, or High/Critical Exposure. No sales call. Results in under five minutes.
TIER 2 — $99
Full 81-question assessment covering all 10 FDA-evaluated areas. Includes ATP Registry and Personnel & Roles sections. Practice-specific gap report delivered instantly. Fully automated — no human required.
Find the gaps before the regulators do.
The Claritas Axis compliance snapshot takes five minutes. The full assessment is $99. Both are available right now, no sales call, no commitment required.