Bill Would Protect Compounded Drugs

The International Academy of Compounding Pharmacists (IACP) said it strongly supports a bipartisan bill that would protect patients’ access to compounded medications.

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

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The bill 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,” said Baylor Rice, RPh, President of IACP.

When Congress originally passed the DQSA, legislators “came together in a bipartisan and bicameral fashion to make clear that pharmacists’ ability to provide compounded medications for a physician’s administration to or treatment of a patient within their practice should be left to the states,” IACP said.

IACP, partnering with the DQSA Coalition, has worked with the FDA and Congress on improving the agency’s compounding policies in a way that better balances public safety with patient access to critical medications, according to the group. “Unfortunately, despite these efforts, FDA continues to misinterpret the DQSA and assert regulatory authority over the practice of pharmacy and medicine in a way Congress never intended,” IACP said.

In the last two appropriations bills (fiscal years 2016 and 2017), Congress included language directing the FDA to alter their policies on compounding to align with congressional intent and the language of the statute, the group said. “FDA has, to date, ignored those congressional directives and continues to substitute their desired regulatory authority over compounding,” IACP said.

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Once enacted, the FDA, compounding pharmacies, medical providers, and patients will have much greater certainty as to where the line between pharmacy compounding and drug manufacturing lies, according to the group. IACP said that this will better balance public safety and patient access to the medications they need.

“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,” the group said.

More than 300 compounding pharmacists traveled to Washington, D.C. this week to urge them to cosponsor HR 2871.