Clinics in Portland, Oregon

Oregon 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 Oregon for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. Oregon licenses naturopathic doctors with one of the broadest scopes in the country, which can affect who legally administers some therapies.

• Oregon Medical Practice Act, ORS Chapter 677
  Establishes physician licensure and discipline through the Oregon Medical Board.
• Oregon Naturopathic Physicians Act, ORS Chapter 685
  Provides licensed naturopathic physicians with prescriptive and injection authority broader than most states; specific cellular biologic injections may still fall outside scope and remain subject to FDA constraints.
• Oregon Pharmacy Practice Act, ORS Chapter 689
  Regulates compounding pharmacies aligned with federal 503A and 503B standards.

The FDA has corresponded with Oregon providers offering cellular therapies. The Oregon Medical Board has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Oregon Board of Naturopathic Medicine has disciplinary authority over NDs operating outside scope. The Oregon Attorney General has used the Oregon Unlawful Trade Practices Act to pursue providers making unsupported clinical claims. Federal warning letters apply nationally.