The FDA Is Coming for Med Spas - Are You Compliant? | James Strafuss

Follow The Beauty Outlaw:   / thebeautyoutlawofficial   Follow James!:   / jamesjstrafuss   Sauna Space – Get 10% off with code "Beauty Outlaw." NuBioAge-Get Get 10% off "The Beauty Outlaw" coupon code https://shop.nubioage.com/products/le... Med spas, injectors, wellness clinics, peptide providers, and medical directors are facing increased scrutiny from the FDA and state regulators—but many practices do not realize they are out of compliance. In this episode of The Beauty Outlaw, James Strafuss breaks down the Drug Supply Chain Security Act, what FDA inspectors look for, common compliance mistakes, peptide regulations, authorized suppliers, medication tracking, staff training, and how to protect your practice from fines, product seizures, or losing your license. Timestamps: 00:00 – Welcome to The Beauty Outlaw 00:29 – Why med spa compliance matters 01:48 – James Strafuss’ background 04:01 – What is the DSCSA? 05:20 – Tracking medication from manufacturer to patient 07:11 – FDA inspections in Texas and New York 10:04 – Fines, penalties, and intent 13:01 – Common compliance mistakes 14:52 – What happens during an FDA inspection? 17:37 – Storage, expired products, and staff training 18:09 – Purchasing and administration logs 20:48 – Compliance rules for peptides and IV therapy 21:10 – What is an FDA Form 483? 22:44 – Why clinics cannot buy medication from each other 24:07 – The med spa compliance assessment 26:10 – The Texas whistleblower investigation 27:29 – How to verify authorized suppliers 30:26 – 503A vs. 503B pharmacies 32:05 – BPC-157 and peptide regulations 35:01 – Building a compliant medication process 36:35 – Compliance assessments and staff training 37:32 – The medical director’s responsibility 39:32 – State and federal data sharing 40:25 – How to protect your practice 41:06 – Final thoughts and upcoming peptide updates