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TWO URGENT CALLS-TO-ACTION FROM IACP:
 

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

  1. Co-sponsor H.R. 1959, which clarifies DQSA’s compounding provisions.
  2. Sign the Welch/Griffith letter to FDA about the MOU.

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

 

1. 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.

 

2. Letter from Members of Congress to FDA regarding the state MOU

Congressmen Peter Welch (D-VT) and Morgan Griffith (R-VA) have drafted a congressional letter to FDA urging FDA to make essential revisions to the state Memorandum of Understanding (MOU), and are seeking additional members of Congress to sign the letter.

 

Contact your congressperson's office and urge them to sign the Welch/Griffith FDA letter as soon as possible. 

 

The key points raised in the letter are as follows:

  • The new revised draft MOU on interstate distributions of compounded medications reflects some stakeholder input to FDA (including from IACP), but still needs work before being finalized.
  • The final MOU should not attempt to redefine the key term "distribution" to include (and thereby give the FDA regulatory authority over) the patient-specific dispensing of medications.
  • Many state BOPs have indicated they do not have the legal authority, state resources, or both to sign and carry out the unfunded mandates the current MOU will have on states.
  • If several states don't sign and the FDA enforces a 5% cap on interstate shipments of ALL compounds, patients will lose access to critical medications.
  • FDA should continue working with stakeholders and finalize an MOU that all states will sign and that will protect patient access and patient safety.

 

The more members of Congress who sign the letter, the stronger our case - and influence - in getting FDA to make those essential amendments to the MOU.

 

HERE’S WHERE TO EMAIL YOUR MEMBER OF CONGRESS ABOUT THE CONGRESSIONAL LETTER TO FDA.

 

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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