Clinics in Gilbert, Arizona

In Arizona, cellular products are governed by federal rules under 21 CFR Part 1271. Products that are minimally manipulated and used for homologous use fall under Section 361 and do not require premarket approval. Products that are more than minimally manipulated, used non-homologously, or combined with another article are regulated as biological drugs under Section 351 and require an Investigational New Drug application or Biologics License Application. Most adipose-derived stromal vascular fraction and culture-expanded stem cell procedures marketed for orthopedic, neurologic, or longevity indications are Section 351 products.

• Arizona Revised Statutes Title 32, Chapter 13 (Medical Practice Act)
  Establishes physician licensure and scope of practice under the Arizona Medical Board, including standards that apply to regenerative procedures performed by MDs.
• Arizona Revised Statutes Title 32, Chapter 17 (Osteopathic Practice Act)
  Governs DO licensure and disciplinary authority relevant to cellular therapy administration.
• Arizona Revised Statutes Title 32, Chapter 18 (Pharmacy Act) and Board of Pharmacy Rules
  Regulates compounding activities including 503A and 503B pharmacy involvement in biologic preparations.

The FDA has issued warning letters and untitled letters to stem cell providers operating in Arizona for marketing unapproved biological products. Arizona is home to several high-profile regenerative clinics, and FDA inspections in the state have cited violations of current good manufacturing practice and unapproved drug claims. The Arizona Medical Board has disciplined physicians for unprofessional conduct tied to misleading advertising of stem cell outcomes. No statewide injunction parallel to the US v California Stem Cell Treatment Center case has been issued in Arizona, but enforcement exposure remains elevated.