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URGENT CALL-TO-ACTION FROM IACP:
 

Please contact your member of Congress today and urge them to:

 

Co-sponsor H.R. 1959, which clarifies DQSA’s compounding provisions.

 

Help us protect your patients’ access to compounded medications. Read on for details, then take action. You can make a difference!

 

H.R. 1959

Reps. Morgan Griffith (R-VA) and Henry Cuellar (D-TX) have reintroduced The Preserving Patient Access to Compounded Medications Act, H.R. 1959, which would clarify provisions of the Drug Quality Security Act of 2013 related to pharmacy compounding.

 

That clarification 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 should better balance patient safety with patient access. 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” to be 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.

In the previous Congress, more than sixty members co-sponsored the legislation. We NEED your help in making sure those lawmakers renew their support for the measure in this Congress – and that many more members of Congress join them!

 

HERE’S WHERE TO EMAIL YOUR MEMBER OF CONGRESS ABOUT H.R. 1959.

 

 

PLEASE ACT NOW.

Contact your member of Congress TODAY!

 

IACP Legislative Action Center

Please visit IACP's Legislative Action Center, and ask your House Representatives to Support HR 1959 and the Congressional letter to FDA regarding the state MOU.

 

Please email IACP at iacpinfo@iacprx.org with questions.

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