Dear IACP Member,

I'm pleased to report that  The Preserving Patient Access to Compounded Medications Act was  reintroduced this week in Congress by Reps. Morgan Griffith (R-VA) and Henry Cuellar (D-TX) .  The bill, H.R. 1959, would   clarify provisions of the Drug Quality Security Act of 2013 related to pharmacy compounding. We're deeply grateful to Congressmen Griffith and Cuellar for their leadership on this important issue.
 
The reason for this email is two-fold: I want to brief you about the legislation and I want to ask for your help.
 
ABOUT THE BILL:
As I suspect you'll agree, clarifying DQSA is essential. The U.S. Food & Drug Administration has misinterpreted congressional intent, overstepped its regulatory authority, and is jeopardizing patient access to compounded medications as a result. This legislation, which has broad support both in Congress and from an impressive  coalition of groups representing pharmacists, physicians, and patients , seeks to assure that FDA's role and actions in regulating compounding pharmacies are in line with Congress' stated aims when it passed DQSA in 2013.
 
The bipartisan legislation would require FDA to develop policies regulating compounding through the formal rulemaking process, rather than via agency guidance documents. Those policies must better balance patient safety with patient access, we believe. The bill also would formally recognize state boards of pharmacy as the primary regulators of pharmacy compounding. 
 
Specifically, the Griffith/Cuellar legislation would:
  • Authorize "office-use" compounding by 503A pharmacies where permitted by state law.
  • Clarify that dietary supplements with USP or NF monographs are appropriate ingredients for compounding.
  • Define the terms "distribute" and "dispense" consistent with the NABP model pharmacy act and other state and federal law definitions.
  • Clarify that compounding pharmacies are retail pharmacies for purposes of FDA inspection authority.
  • Require FDA to go through the formal rulemaking process for establishing DQSA policies rather than issuing "guidance documents" that circumvent requirements for public notice and input.
 
WHAT WE NEED YOU TO DO:
Here are three important ways you can help assure that this bill gains support in Congress:
  1. You can encourage your member of Congress to sign-on as a bill sponsor. Call them, invite them to your pharmacy, even tag them in a tweet via social media. Get their attention and tell them why this legislation matters to you and your patients.
  2. Come to Washington, DC for IACP's May 21 Compounders on Capitol Hill, the day when we visit with members of Congress on their turf to tell them about this legislation and to ask for their support. When you come to them to make your case, it makes a difference. Details here.
  3. Help fuel IACP's advocacy success by making an investment in OneFund, which funds our lobbying team. Your investment in any amount - $100 or $1000 - helps assure we have the resources to get this legislation across the finish line. Invest here. 
 
Thanks for taking the time to read about this important legislation, and for your support for IACP. I'll hope to see you at Compounders on Capitol Hill in May!
 
Cheers!
Jennifer Burch, PharmD, RPh, CDE
IACP President
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