Clinics in Virginia Beach, Virginia

Virginia 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 Virginia for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. Northern Virginia clinics often draw patients from the District of Columbia.

• Virginia Medical Practice Act, Code of Virginia Title 54.1, Chapter 29
  Establishes physician licensure and discipline through the Virginia Board of Medicine.
• Virginia Pharmacy Practice Act, Code of Virginia Title 54.1, Chapter 33
  Regulates compounding pharmacies aligned with federal 503A and 503B standards.
• Virginia Consumer Protection Act, Code of Virginia Title 59.1, Chapter 17
  Empowers the Attorney General and private plaintiffs to pursue deceptive marketing claims against providers making unsupported clinical claims.

The FDA has corresponded with Virginia providers offering cellular therapies, and warning letters have been issued to regional clinics. The Virginia Board of Medicine has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Virginia Attorney General has used the Virginia Consumer Protection Act to pursue providers making unsupported clinical claims. Virginia's proximity to FDA headquarters in Maryland keeps Northern Virginia clinics under close federal observation.