Clinics in Dallas, Texas

Texas 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 Texas for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. Texas enacted a state-level investigational adult stem cell framework in 2017 that does not override federal law.

• Texas HB 810 (2017), Texas Health and Safety Code Chapter 1003
  Authorizes administration of investigational adult stem cell treatments to eligible patients with severe chronic or terminal illness when conducted by Texas-licensed physicians at facilities meeting defined institutional review board oversight criteria.
• Texas Medical Practice Act, Texas Occupations Code Title 3, Subtitle B
  Establishes physician licensure and discipline through the Texas Medical Board.
• Texas Pharmacy Act, Texas Occupations Code Chapter 551 et seq
  Regulates compounding pharmacies aligned with federal 503A and 503B standards.

The FDA has issued warning letters to Texas clinics offering stem cell and exosome therapies. The Texas Medical Board has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Texas Attorney General has used the Texas Deceptive Trade Practices Act to pursue providers making unsupported clinical claims. HB 810 expressly does not preempt federal law, so even Texas providers operating under HB 810 must comply with 21 CFR Part 1271 and remain subject to FDA enforcement if products fall outside Section 361.