Resources
Current enforcement updates, compliance guides, and industry insights for medical practices, med spas, and aesthetic clinics navigating federal and state regulatory requirements.
Enforcement updates
March 2026 — FDA Issues Draft Guidance on Form 483 Responses
The FDA released draft guidance outlining exactly what it expects when a regulated entity receives a Form 483. Practices have 15 business days to respond. Responses must be signed by senior leadership and include documented root cause investigation and a formal CAPA plan.
April 2026 — FDA One-Day Surprise Inspection Pilot Launched
The FDA launched a pilot program for one-day inspectional assessments using ELSA 4.0 — an AI targeting system. 46 assessments already conducted. Zero advance notice. If significant concerns are found the assessment escalates immediately to a full multi-day inspection.
January 2026 — New York Conducts 223 Med Spa Inspections
New York state regulators inspected 223 med spa and aesthetic practices. 87 were cited for drug traceability and unauthorized dispensing violations.
2025–2026 — State Legislative Wave
Texas, Rhode Island, Florida, Oregon, Indiana, Arizona, Iowa, California, and New York have all introduced or passed new med spa regulation bills. State boards are rewriting the rules for how med spas are classified, licensed, and held accountable.
Understanding your exposure
What is DSCSA?
The Drug Supply Chain Security Act was enacted in 2013. Dispenser requirements formally brought physician practices into scope in November 2023. Enhanced traceability requirements became enforceable November 2024. The FDA stabilization period ended August 2025. Full enforcement is now active.
What are 503A and 503B compounding rules?
503A governs traditional compounding pharmacies. 503B governs outsourcing facilities. Practices sourcing peptides, GLP-1s, or compounded drugs outside these frameworks face significant regulatory exposure beyond DSCSA.
What is an Authorized Trading Partner?
An Authorized Trading Partner is an FDA-registered manufacturer, wholesale distributor, repackager, or dispenser. Every Rx product your practice purchases must come from a verified ATP. Most practices have never confirmed ATP status for any of their vendors.
What is a Form 483?
A Form 483 is issued by an FDA investigator at the conclusion of an inspection when objectionable conditions are found. It is the first step toward a warning letter, injunction, or enforcement action. You have 15 business days to respond.
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Their attention to detail and commitment to quality truly stood out. We’ve already recommended them to others.
Their attention to detail and commitment to quality truly stood out. We’ve already recommended them to others.
Their attention to detail and commitment to quality truly stood out. We’ve already recommended them to others.
Their attention to detail and commitment to quality truly stood out. We’ve already recommended them to others.