Patient Safety Is Our Priority
KRS Global is dedicated to maintaining strict regulatory compliance, whether that be with the FDA, DEA, or State Boards of Pharmacy. Our pharmacists are licensed and where necessary, are Pharmacists in Charge for the various State Board, which require such licensure. The Pharmacy Technicians at KRS are continually trained on SOPs and the latest advances in safety and compounding.
KRS maintains all necessary product liability insurance and bonds that are required by the marketplace. Our quarterly quality assurance reports are also available upon request. According to the Compounding Quality Act, as a Registered Outsourcing Facility, KRS Global Biotechnology Inc. must meet certain conditions in order to be exempt from the FDA’s approval requirements and the requirement to label products with proper directions for use. All drugs must be compounded in compliance with cGMP (CFR-21 Manufacturing) or under the direct supervision of a licensed pharmacist in a registered facility. In addition, we must report specific information about the products that we prepare, including a list of all the products prepared during the previous six months, and information about the prepared products, such as the source of ingredients used to compound. Finally, we are required to meet other conditions such as reporting adverse events and labeling our compounded products with certain information.
KRS is an industry-leading customized FDA registered and inspected 503b Human Outsourcing Facility, that provides sterile and non-sterile compounding services to patients, surgery centers, ophthalmology clinics, hospitals and universities nationwide. For more information about pharmacy outsourcing...