Clinics in Sandy Springs, Georgia

Georgia 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 for orthopedic, neurologic, autoimmune, and longevity indications in Georgia are Section 351 biologics that lack FDA approval. The FDA's enforcement discretion period ended in May 2021, so clinics in Georgia operating outside Section 361 face direct federal exposure.

• Georgia Medical Practice Act, OCGA Title 43, Chapter 34
  Establishes physician licensure and discipline through the Georgia Composite Medical Board.
• Georgia Pharmacy Practice Act, OCGA Title 26, Chapter 4
  Regulates compounding pharmacies and aligns with federal 503A and 503B rules for biologic preparation.
• Georgia Fair Business Practices Act, OCGA Title 10, Chapter 1
  Empowers the Attorney General to pursue deceptive trade practice claims against providers making unsupported clinical claims.

The FDA has issued warning letters and untitled letters to Georgia clinics offering stem cell and exosome therapies. The Georgia Composite Medical Board has authority to discipline physicians for unprofessional conduct including misleading regenerative medicine advertising. The Georgia Attorney General's Consumer Protection Division has used the Fair Business Practices Act to pursue deceptive health marketing. Georgia has not produced a federal injunction comparable to the Florida US Stem Cell case, but the state's busy Atlanta market draws federal attention. Clinics that label products as homologous-use Section 361 HCT/Ps face inspection and labeling scrutiny.