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HR 1959 compounding pharmacy

Urge Your Representative to Co-sponsor HR 1959

Clarify provisions of the Drug Quality Security Act of 2013 related to pharmacy compounding

Protect patients’ access to compounded medications! Take action below.

 

H.R. 1959

The Preserving Patient Access to Compounded Medications Act, H.R. 1959, which would clarify provisions of the Drug Quality Security Act (DQSA) of 2013 related to pharmacy compounding was reintroduced by Reps. Morgan Griffith (R-VA) and Henry Cuellar (D-TX) to significant support both in Congress and from pharmacists, physicians, and patients. 

This legislation 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.

Because the U.S. Food and Drug Administration has misinterpreted congressional intent, overstepped its regulatory authority, and is jeopardizing patient access to compounded medications, clarification is VITAL. 

This bipartisan legislation requires:

  1. FDA develop policies regulating compounding through the formal rulemaking process, rather than via agency guidance documents; and
  2. Formal recognition of 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.

Please act now to ask your Congressional representative to support this measure in this Congress – and ask that many more members of Congress join them!



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