Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Tuesday, June 25, 2019
Statement by Acting FDA Commissioner Ned Sharpless, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products
Today, U.S. District Judge Ursula Ungaro of the Southern District of Florida issued an order that stops US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D., from manufacturing or distributing any and all stromal vascular fraction (SVF) products, which are adipose (fat) tissue derived stem cell products, until they come into compliance with the law.
The U.S. Department of Justice, on FDA’s behalf, initiated this action against US Stem Cell Clinic LLC and US Stem Cell Inc., and Comella in May 2018, seeking a permanent injunction after they failed to come into compliance with the law, including FDA regulations intended to ...