Clinics in Charlotte, North Carolina

North 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 North Carolina for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. The Research Triangle hosts substantial academic IND-based regenerative medicine research.

• North Carolina Medical Practice Act, NC General Statutes Chapter 90, Article 1
  Establishes physician licensure and discipline through the North Carolina Medical Board.
• North Carolina Pharmacy Practice Act, NC General Statutes Chapter 90, Article 4A
  Regulates compounding pharmacies aligned with federal 503A and 503B standards.
• North Carolina Unfair and Deceptive Trade Practices Act, NC General Statutes Chapter 75
  Empowers the Attorney General and private plaintiffs to pursue deceptive marketing claims with treble damages available.

The FDA has issued warning letters to North Carolina clinics offering stem cell and exosome therapies. The North Carolina Medical Board has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The North Carolina Attorney General has used the Unfair and Deceptive Trade Practices Act to pursue providers making unsupported clinical claims, and Chapter 75 enables private class actions with treble damages, which raises the financial risk for noncompliant providers. Federal warning letters apply nationally.