Clinics in Tulsa, Oklahoma

Oklahoma 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 Oklahoma for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. Oklahoma's regulatory environment relies on federal law and the Oklahoma Allopathic Medical and Surgical Licensure and Supervision Act.

• Oklahoma Allopathic Medical and Surgical Licensure and Supervision Act, 59 OS Section 480 et seq
  Establishes MD licensure and discipline through the Oklahoma State Board of Medical Licensure and Supervision.
• Oklahoma Osteopathic Medicine Act, 59 OS Section 620 et seq
  Establishes DO licensure and discipline through the Oklahoma State Board of Osteopathic Examiners.
• Oklahoma Pharmacy Act, 59 OS Section 353 et seq
  Regulates compounding pharmacies aligned with federal 503A and 503B standards.

The FDA has corresponded with Oklahoma providers offering cellular therapies. The Oklahoma State Board of Medical Licensure and Supervision and the Board of Osteopathic Examiners have disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Oklahoma Attorney General can pursue deceptive marketing under the Oklahoma Consumer Protection Act. Oklahoma's smaller market means enforcement is less frequent than in larger states, but federal warning letters apply nationally.