3 Stem Cell Therapy Clinics in Columbia, Maryland

Maryland 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 Maryland for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. Maryland is FDA's home state, and the agency operates extensive review and inspection capacity within state lines.

• Maryland Medical Practice Act, Health Occupations Article Title 14
  Establishes physician licensure and discipline through the Maryland Board of Physicians.
• Maryland Pharmacy Act, Health Occupations Article Title 12
  Regulates compounding pharmacies aligned with federal 503A and 503B standards.
• Maryland Consumer Protection Act, Commercial Law Article Title 13
  Empowers the Attorney General to pursue deceptive marketing claims against providers making unsupported clinical claims.

Maryland's proximity to FDA headquarters in Silver Spring places state clinics under close federal observation. The FDA has corresponded with Maryland providers offering cellular therapies. The Maryland Board of Physicians has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Maryland Attorney General's Consumer Protection Division can pursue deceptive marketing under the Maryland Consumer Protection Act. NIH and academic medical centers in the Baltimore-DC corridor conduct compliant IND-based cellular research, which contrasts with smaller direct-to-patient clinics that may be operating without appropriate authorization.