For most of 2013, the U.S. Senate and House of Representatives have been drafting legislation that will effectively give the FDA more direct control of compounding pharmacies, like your local Peoples Rx compounding pharmacies, and potentially restrict patient access to these personalized medications. This is an issue that we take very seriously and continue to monitor as it can directly affect you, the customer.
The first version of this piece of legislation was SB959, drafted in January 2013 by the Senate. The intent was to give the FDA more authority over sterile compounding pharmacies in response to the New England Compounding Center tragedy in September 2012 where a batch of an injectable steroids contaminated with fungal meningitis was distributed to 75 different facilities in 23 states; 48 people died and over 700 were injured. Despite the intent to prevent any future tragedies like the one involving New England Compounding Center, the legislation would have also had numerous unintended consequences for all compounding pharmacies with much of the wording left so vague that it essentially would have given the FDA the power to make all compounding illegal overnight. Many of our loyal customers and concerned citizens across the country sent letters and emails to Congress in response to help inform them of the very real, negative effects of such legislation.
The House eventually presented its own version in early September (HR3089), which was much friendlier to compounding pharmacies. However, the bill was quickly rejected by the Senate which prompted a resolution committee with members from both sides of Congress. The result is HR3204, which the House passed on September 28, and which is expected to pass in the Senate in late October. This bipartisan bill, though not perfect, is much less restrictive than earlier proposed versions. For now, it’s a bill that compounding pharmacies can “live with.”
We want to thank all of the patients and doctors in our community who have made their voices heard on Capitol Hill. For more complete info about HR3204 and the history of the previous bills, visit www.protectmycompounds.com.
by Steve Helm, RPh.