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
Wednesday, June 12, 2013
FDA inspection finds a mess at pharmacy in second fungal outbreak By Maggie Fox, Senior Writer, NBC News
A Tennessee pharmacy believed to be the source of a second outbreak of fungal infections linked to pain shots was a mess when Food and Drug Administration inspectors went in last month, with stray spiders in a clean room and few written procedures for making sure products were sterile, the FDA says.
The FDA has found fungus and bacteria in at least two vials of steroid distributed by Main Street Pharmacy of Newbern, Tenn. So far, 25 patients in four states have developed abscesses after getting injections of the pharmacy’s product.
On Wednesday, the FDA released the report from an inspection it made at the pharmacy on May 30. It found conditions similar to what the agency has found at several pharmacies that make products to order and distribute them on large scale. Although these so-called compounding pharmacies manufacture large quanties of products, they don’t follow what FDA calls continue reading here