Outsourcing Facilities of America (OFA) was created with a simple mission, to help promote the safety of products that health care providers and the public receive from compounding outsourcers
Lake Mary, Florida (PRWEB) June 16, 2015
A group of FDA Registered Outsourcing Facilities has announced the formation of Outsourcing Facilities of America, a new organization dedicated to helping educate the public, the medical industry and appropriate regulatory agencies about the importance of using properly licensed compounding outsourcers. After the 2012 outbreak of life-threatening and fatal infections in patients who had received spinal injections from contaminated samples supplied by an unaccredited compounding facility, Congress passed the Drug Quality and Security Act, intending to protect the public health by including more stringent requirements for facilities that compound drugs. FDA Registered Outsourcing Facilities (often referred to as 503Bs) are registered as Human Drug Compounding Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Frank Ioppolo Jr., Esq., President & CEO of Ioppolo Law Group has been engaged to structure and organize the group. Frank explains why OFA could not have come at a better time: “Outsourcing Facilities of America (OFA) was created with a simple mission, to help promote the safety of products that health care providers and the public receive from compounding outsourcers. These 503B facilities spend hundreds of thousands to ensure that compounds they provide meet the highest state and federal regulations for quality assurance, testing and sterility. These facilities have set themselves apart from those that take dangerous shortcuts and risk patients’ lives. By coming together through the OFA, members are making an investment to help that will assist the FDA in continuing to shape their regulatory framework affecting Outsourcing Facilities, protect the public health and educate healthcare providers and consumers.”
David Axel of Strategic Innovations has been engaged to help group members with its public education and outreach programs. Additionally the group expects to offer its assistance to the FDA in addressing what may be one of the biggest issue facing FDA’s regulatory efforts, the deceptive trade practices of unlicensed outsourcers. “503Bs are plagued with unfair competition from outsourcing facilities that are not properly licensed. Their actions, which we believe to be deceptive, confuse the public and expose them to the same types of risks that resulted in the 2012 outbreak. The FDA does what it can but there are simply not enough resources to monitor and enforce these regulations. The result is a group of bad actors endangering doctors, pharmacies and their patients. As if that is not bad enough, these non-complaint facilities invest the money they save by not being complaint to ‘out market’ everyone else.”
Outsourcing Facilities of America is in the process of completing its organization. OFA is currently accepting new members.