This year’s upcoming Compounders on Capitol Hill is fast approaching! IACP Leadership has taken a considerable amount of time preparing a robust schedule which will give compounders the tools necessary to protect our pharmacy practice.
As 2016 is an election year, the activity level with FDA and Capitol Hill has been fast and fluid. Despite clear Congressional intent to allow pharmacies to compound for office-use pursuant to State law, FDA released new draft guidance documents prohibiting all office-use compounding for 503A pharmacies, restricting office-use compounding for hospitals and health care entities, and narrowly defining 503B outsourcing facilities. Congress is taking action through multiple letters to FDA, hearings, and language within federal legislation. FDA has continued its overreach in utilizing the Pharmacy Compounding Advisory Committee and the production of the do not compound lists as well as the bulk Active Pharmaceutical Ingredient (API) positive lists contrary to Congressional intent. In addition, FDA continues inspecting 503A pharmacies under current Good Manufacturing Practices (cGMPs) instead of under State law.
Through all this organized chaos, our collective goal is to remain steadfast in our message to Congress and FDA: pharmacists and our supporting members have the right to practice pharmacy and provide the best care possible for our patients. The challenge, as we all know, is to continue to stress to Congress that FDA is overreaching and violating the Congressional intent of the Drug Quality & Security Act (DQSA) by restricting access, their primary goal, rather than supporting USP and the States Pharmacy Practice Acts.
This very issue is where we must lean on Congress to help share our concerns with FDA. As of the posting of this email, we are starting to see favorable responses from key Congressmen who recognize the validity of our concerns and our issues. We are thankful for them! In its relatively short existence, the IACP-led DQSA coalition of 30+ organization members has done a fantastic job in remaining consistent with our messaging and motivating Congress to respond to our concerns.
Representative Doug Collins (R-GA) is one example of how a Congressman is listening to our concerns, assisting in our efforts and motivating other Congressmen for their support. In turn, we’ve asked Rep. Collins to take time out of his busy schedule and meet with us at this year’s upcoming COMP PAC dinner. Given that the date of our COMP PAC is the same day as a political party conference in Philadelphia, it is truly an honor to have Rep. Collins serve as our guest speaker during an important juncture for his party! That said, what COMP PAC needs now is YOUR support! In the world of IACP’s COMP PAC, like any other Political Action Committee, we must work to support those on the Hill that understand our issues and contribute to helping those Congressmen be in a better position that will help meet our members’ needs.
Please click here to read more about Representative Doug Collins and the COMP PAC Dinner.
As this is such a crucial time for our profession, and we need every channel possible to protect us from FDA, I’m asking for your help in one of two ways.
Option #1: Please join us for Congressman Doug Collin’s COMP PAC Dinner. This is an excellent way of personally voicing your concern to someone who will listen! With Congressmen Collins in office, our chances of success in protecting our profession substantially increases.
Option #2: If you are unable to attend the dinner, COMP PAC needs your donations to remain effective in our efforts! Please consider contributing to the COMP PAC. We have a fantastic team working with us to ensure PAC money raised is used efficiently and effectively. As a personal donor myself, I expect a return on my investments and you should expect the same!
Please click here to access the COMP PAC Dinner/Contribution Form.
Thank you in advance for your generosity, contributions and support of IACP’s COMP PAC. We will win, and continue to protect patient access to compounded medications!
Yours In Health,
Shawn Hodges, PharmD
IACP COMP PAC Chair