8 Stem Cell Therapy Clinics in Greenville, South Carolina

South Carolina cellular therapy is governed by 21 CFR Part 1271. Section 361 covers minimally manipulated HCT/Ps used for homologous use without premarket approval. Section 351 covers products that are more than minimally manipulated, used non-homologously, or combined with another article, and these require an IND for clinical use or a BLA for marketing. Most stem cell, stromal vascular fraction, and exosome therapies marketed in South Carolina for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. South Carolina's regulatory environment relies on federal law and the Medical Practice Act.

• South Carolina Medical Practice Act, SC Code Title 40, Chapter 47
  Establishes physician licensure and discipline through the South Carolina Board of Medical Examiners.
• South Carolina Pharmacy Practice Act, SC Code Title 40, Chapter 43
  Regulates compounding pharmacies aligned with federal 503A and 503B standards.
• South Carolina Unfair Trade Practices Act, SC Code Title 39, Chapter 5
  Empowers the Attorney General and private plaintiffs to pursue deceptive marketing claims with treble damages available.

The FDA has corresponded with South Carolina providers offering cellular therapies, and warning letters have been issued to regional clinics. The South Carolina Board of Medical Examiners has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The South Carolina Attorney General has used the Unfair Trade Practices Act to pursue providers making unsupported clinical claims. SCUTPA enables treble damages and attorney fees, raising the financial risk for noncompliant providers.