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HR 2871: Preserving Patient Access to Compounded Medications Act of 2017
 
 

HR 2871 - The Preserving Patient Access to Compounded Medications Act of 2017, introduced by U.S. Congressmen Morgan Griffith (VA) and Henry Cuellar (TX) on June 12, 2017.

 

Dear Colleague Letter from Congressmen Griffith and Cuellar to Fellow House Representatives

 

IACP Legislative Action Center - Please visit IACP's Action Center, and ask your House Representatives to Support HR 2871.

 

The International Academy of Compounding Pharmacists (IACP) strongly supports new legislation, introduced by U.S. Congressmen Morgan Griffith (VA) and Henry Cuellar (TX), H.R. 2871 – The Preserving Patient Access to Compounded Medications Act of 2017, formally introduced on June 12, 2017.


In an IACP Press Release, IACP President Baylor Rice, RPh, FIACP, says, “On behalf of the International Academy of Compounding Pharmacists and the patients we serve, thank you, Congressman Griffith and Congressman Cuellar, for your leadership in introducing the bipartisan legislation, HR 2871 - The Preserving Patient Access to Compounded Medications Act.  


This important bill will help protect access to medications physicians rely upon for their patients. It will help clarify the Drug Quality & Security Act (DQSA) in a way that will better align the statute with congressional intent and better balance public safety and patient access. We applaud your dedication on behalf of patients, physicians, pharmacists, and other healthcare providers who are united in a mission to preserve patient safety and access to needed compounded medications pursuant to state and federal laws and regulations.”  

 

Urge your Representatives to Co-sponsor this Legislation because it will:

  • Provide the records and registration exemptions provided to pharmacies under the Food Drug and Cosmetic Act (FDCA) when inspected by the Food & Drug Administration (FDA) to compounding pharmacies that are compliant with state and local pharmacy laws and 503A of the (FDCA).
  • Allow for "office-use" compounding of medications where authorized by state law.
  • Allow for compounding with dietary supplements that comply with the monograph standards of the U.S. Pharmacopoeial Convention (USP) or National Formulary.
  • Prevent FDA regulatory authority over interstate "dispensing" of compounded medications pursuant to prescriptions for identified patients, which is left to state law and state boards of pharmacy.
  • Require FDA to follow formal rulemaking procedures that allow stakeholder input and decrease confusion by providing formal FDA procedure and statements on the record. Currently, FDA is issuing "guidance documents" that FDA is enforcing through Warning Letters without following formal rulemaking procedures. 

As such, it’s vital that Congress support HR 2871 in order to preserve patient access to compounded medications by directing FDA to act within Congressional intent. 

 

HOUSE Correspondence









SENATE Correspondence





 

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

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