Pay-Per-Click (PPC) advertising sites, primarily search engines, are largely unaware of the new regulations governing 503B Outsourcing Facilities. In most cases, the only requirement for advertisement approval is a pharmacy license.
Lake Mary, FLorida (PRWEB) September 04, 2015
Outsourcing Facilities of America (OFA) has taken important steps to protect the public and the interests of 503B Outsourcing Facilities by eliminating advertising by non-compliant compounding pharmacies. Over the last several weeks, OFA has been working with various Pay-Per-Click advertising sites, including major search engines, to establish a process that insures compounding pharmacies are not advertising their products and services in areas they are not legally able to.
David Axel, Director of Compliance Services at Ioppolo Law Group explains this important issue as follows: “Pay-Per-Click (PPC) advertising sites, primarily search engines, are largely unaware of the new regulations governing 503B Outsourcing Facilities. In most cases, the only requirement for advertisement approval is a pharmacy license. Advertisers are not requiring pharmacies to show that they are either FDA Registered Outsourcing Facilities (503Bs) or that they have a Memorandum of Understanding with the states in which they are offering their products and services.”
Frank Ioppolo Jr., Esq., President and CEO of Ioppolo Law Group further elaborates, “OFA’s mission is focused on protecting consumers from pharmacies that are not properly licensed to sell their products. By helping to educate advertising sites and search engines about the licensing requirements for outsourcing facilities and what they are designed to prevent, OFA hopes to make it easier for consumers, physicians and hospitals to find properly licensed suppliers and safe medications. The continued and purposeful action of many non-compliant outsourcing facilities continues to confuse the public and expose people to the same types of risks that caused the FDA to establish the 503B regulatory rules in the first place. Once accepted, these new guidelines would help direct consumers to 503B compounding pharmacies that have much stricter guidelines to follow when producing their products, thus achieving the FDA’s goal of making them safe for consumers. We plan to submit our proposed process to certify that an outsourcing facility is compliant before they can purchase PPC ads to the FDA for approval.”
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). This process was created 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.
Outsourcing Facilities of America, is dedicated to helping educate the public, the medical industry and appropriate regulatory agencies about the importance of using properly licensed compounding facilities.
Outsourcing Facilities of America is in the process of completing its organization and is currently accepting new members.