Changes in Compounding Pharmacy Oversight

On April 26^th, the United States Senate produced early compounding legislation, primarily in response to the Meningitis Outbreak in 2012. The legislation was lead by the Senate Committee on Health Education, Labor and Pensions (HELP) and will be important to compounding pharmacists as well as compounding manufactures in the world of pharmacy. This legislation will define the differences between compounding manufacturers and compounding manufacturers. This distinction is critical as the traditional compounding pharmacies function very differently than the pharmacy implicated in the meningitis outbreak. The legislation will also support the increased role of the Food and Drug Administration (FDA) in regulating compounded products and manufacturers. It is important to note that individual states are still primarily responsible for regulation of pharmacies, however the federal government will have an increased role in ensuring compounded products meet minimum standards, as defined by this new legislation.

The most critical aspect of this legislation to me is that the federal government will have increased oversight in communication between states and the FDA. To me, this is something that will greatly increase the safety of drug products and continuity of safety across the U.S. It is unfortunate that the 2012 Meningitis tragedy was the event that exposed fundamental flaws and weaknesses in compounding pharmacy and compounding manufacturers however, I feel confident that federal legislation will promote increased communication between compounding entities and regulatory bodies of pharmacy practice. With increased communication, it will hopefully be easier to catch compounding incidents before they become tragedies. It is my hope that this legislation will give people greater confidence in the safety of compounding pharmacies and push compounding pharmacists to be innovative in their safety practices to promote patient safety as the most critical aspect of their practice.