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 4, 2019
Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law
U.S. District Judge Ursula Ungaro of the Southern District of Florida granted the government’s motion for summary judgment against 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. The court held that the defendants in that case adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.
“Cell-based regenerative medicine holds significant medical opportunity, but those in this field who do not operate in compliance with the law can potentially cause serious harm to patients,” said Acting FDA Commissioner Ned Sharpless, M.D. “We support sound, scientific research and regulation of cell-based regenerative medicine. The FDA has advanced a comprehensive policy framework to ...