With the enactment of the Drug Quality and Security Act, pharmacy compounders find themselves in a myriad of regulations that are not well understood within the practice of compounding pharmacy. Its difficult to establish processes and revise procedures to comply with GMPs. Outsourcing pharmacies will require many changes organizationally, training and a comprehensive mind set of attitudes to achieve GMPs. Althougth the path ahead appears difficult in theory outsourcing pharmacies will reap benefits of having better exposure to distribute to hospitals and health care providers as FDA is encouraging medical professionals who use compounded products to purchase from FDA registered outsourcing facilities
In addition, traditional compounders must recognize how FDA will investigate and inforce the FD&C Act
EAS’ Drug Compounding Pharmacy seminar will discuss these subjects and more and provide an understanding of how FDA will enforce the act. Compounders can learn more about the DQSA, GMP requirements, FDA enforcement of the law and more at a two day intensive training December 2-3 in Charlotte, NC. See our seminars page for more information.