KRS Global Biotechnology, Inc. Announces FDA Approval of Becoming a Registered Outsourcing Facility (via section 503B); Compounding Quality Act
KRS Global Biotechnology, Inc. a specialty pharmacy preparing drugs no longer commercially available or in short supply announces today that they have become a registered Outsourcing Facility under the new Compounding Quality Act.
Boca Raton, FL (PRWEB) April 16, 2014
KRS Global Biotechnology, Inc. is pleased to announce that it has been recognized as a registered 503B Large-scale sterile compounding “Outsourcing Facility” by the Food & Drug Administration (FDA) under the Drug Quality & Security Act (DQSA).
‘This is the next evolution for compounding and more importantly it safeguards the public,’ states the president and CEO of the facility. He also says, ‘KRS Global Biotechnology, Inc. always had the highest standards in the compounding industry and now everyone is forced to operate at these standards; the playing field is now even.’
About FDA’s Implementation of the Compounding Quality Act
“The new law allows an entity that compounds sterile drugs to register as an outsourcing facility. Once registered, an outsourcing facility must meet certain conditions in order to be exempt from the FDCA’s approval requirements and the requirement to label products with adequate directions for use. Under the new law, the drugs must be compounded in compliance with CGMP by or under the direct supervision of a licensed pharmacist in a registered facility (section 503B(a)). The outsourcing facility must also report specific information about the products that it compounds, including a list of all of the products it compounded during the previous six months, and information about the compounded products, such as the source of the ingredients used to compound (section 503B(3)). In addition, the outsourcing facility must meet other conditions described in the new law, including reporting adverse events and labeling its compounded products with certain information (section 503B(b)(5) and section 503B(a)(10)).”
About KRS Global Biotechnology, Inc.
KRS Global Biotechnology, Inc. has been serving the Healthcare Community since 2001. KRS Global is a premiere specialty pharmacy that specializes in providing medications that are not commercially available or in short supply from distributors & manufacturers.
For more information, contact:
John Swartz, Vice President, Business Development
For the original version on PRWeb visit: http://www.prweb.com/releases/Compounding-Quality-Act/KRS-Global-Biotechnology/prweb11761373.htm