Clinics in Washington, District of Columbia

Cellular therapy in the District of Columbia is governed by 21 CFR Part 1271. Minimally manipulated HCT/Ps for homologous use fall under Section 361 and are exempt from premarket approval. Products that are more than minimally manipulated, used non-homologously, or combined with another article fall under Section 351 and require an IND for clinical use or a BLA for marketing. Most stem cell, stromal vascular fraction, and exosome therapies marketed in the District for orthopedic, neurologic, or longevity indications are Section 351 biologics that lack FDA approval. The District is also subject to FDA inspections and direct federal enforcement.

• District of Columbia Health Occupations Revision Act, DC Code Title 3, Chapter 12
  Establishes physician licensure under the DC Board of Medicine and disciplinary authority over regenerative medicine practitioners.
• DC Pharmacy Act, DC Code Title 47, Chapter 28
  Regulates compounding pharmacies operating within the District in alignment with federal 503A and 503B standards.
• DC Consumer Protection Procedures Act, DC Code Title 28, Chapter 39
  Empowers the DC Attorney General to pursue deceptive trade practice claims against providers making unsupported clinical claims.

The FDA has corresponded with DC area providers offering stem cell and exosome therapies, and federal enforcement applies directly without the intermediation of a state authority. The DC Board of Medicine has authority to discipline physicians for unprofessional conduct, including misleading advertising of regenerative procedures. The DC Office of the Attorney General has used the Consumer Protection Procedures Act to pursue deceptive health claims. Because the District is small in geographic terms, many DC patients receive cellular therapy in nearby Maryland or Virginia, where state-specific rules also apply.