Compounding

The Preserving Patient Access to Compounded Medications Act – H.R. 1959
Introduced by Representatives Morgan Griffith (R-Va.) and Henry Cuellar (D-Texas)

Compounding is a backbone of pharmacy practice and for many decades independent community pharmacists have provided millions of adults, children, and animals with access to safe, effective and affordable medications through compounding services. When manufactured drugs aren't an option, independent community pharmacists provide traditional pharmacy compounding to prepare customized medications for patients.

  • HR 1959 is bipartisan legislation that will 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.

  • HR 1959 will allow for pharmacists to compound medications for prescribers to administer to their patients where authorized by state law.

  • HR 1959 will 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.

  • HR 1959 will preserve the State Boards of Pharmacy role over pharmacy inspections.

  • HR 1959 will require FDA to follow formal rule making 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 rule making procedures.

It is vital that Congress support HR 1959 to preserve patient access to compounded medications by directing FDA to act within Congressional intent.

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