title: Is cosmetic platelet-rich plasma a drug to be regulated by the Food and Drug Administration?
abstract: In the area of cosmetic dermatology, some physicians have been injecting activated platelet-rich plasma into the face to promote cosmesis or using it to enhance fat grafts. However, subtle changes to the federal drug code (21 CFR 1271.1) made in 2004, when applied to activated PRP, purport to make this autologous substance a federally regulated drug requiring an extensive and costly Biologics License Application. Are autologous cells drugs? Many physicians believe there are significant problems with this regulatory paradigm.
authors: The Centeno-Schultz Clinic, 403 Summit Blvd., Sutie 201, Broomfield, CO 80021, USA. centenooffice@centenoschultzclinic.com
authors: Christopher J
authors: CJ
authors: Centeno
authors: Mitchell
authors: M
authors: Fuerst
authors: Stephen J
authors: SJ
authors: Faulkner
authors: Michael
authors: M
authors: Freeman
mesh_terms: D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D006801:Humans; D053657:Platelet-Rich Plasma; D014182:Transplantation, Autologous / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*