Rep. Chris Stewart (R-Utah) and Rep. Earl L. “Buddy” Carter (R-Georgia) led a bi-partisan group of 65 Members of Congress urging the Federal Drug Administration (FDA) to rescind their decision that restricts state-licensed pharmacies from compounding prescription drugs for healthcare providers to use in their offices.
Drug compounding is used to prepare personalized prescriptions for patients or for physicians to use for procedures in their offices. Compounding pharmacists can combine certain ingredients or medications in the exact strength and dosage to customize a prescription to meet specific needs.
Ignoring a specific Congressional directive, the FDA issued final Guidance on December 29, 2016, that prohibits office-use compounding by smaller traditional compounding pharmacies, known as 503A compounding pharmacies.
“The policies finalized in this GFI are contrary to the plain language of Section 503A as amended by the Drug Quality and Security Act (DQSA) and ignore clear, bipartisan, bicameral congressional intent expressed during passage of the bill,” the letter states. “The FDA has unfortunately chosen to ignore broad and diverse stakeholder input, multiple congressional letters from both chambers, and clear directives in the House Report accompanying the FY2016 FDA appropriations legislation (House Report 114-205). More importantly, the FDA’s misinterpretation of the law and related enforcement actions against pharmacies are jeopardizing patients’ access to critical compounded medications. “
The letter is signed by 65 Member of the House of Representatives Including:
Representatives Chris Stewart, Buddy Carter, Mac Thornberry, Rob Bishop, Paul Gosar, Phil Roe, Pete Olson, Pete Sessions, Mia Love, Marsha Blackburn, Morgan Griffith, Doug Collins, Frank LoBiondo, Cathy McMorris Rodgers, Mark Pocan, Lou Barletta, John Carter, Kevin Cramer, Collin Peterson, Walter Jones, Ted Poe, Dutch Ruppersberger, Barbara Comstock, Rick Crawford, Jason Chaffetz, Don Young, Gus Bilirakis, Drew Ferguson, Rod Blum, Jaime Herrera Beutler, Billy Long, David Young, French Hill, Bill Flores, Henry Cuellar, Bob Goodlatte, Leonard Lance, Mike Gallagher, Darren Soto, Mimi Walters, Mario Diaz-Balart, Rodney Frelinghuysen, Andy Biggs, Louie Gohmert, Ted Yoho, Mark Walker, Dan Donovan, Rick Allen, Carlos Curbelo, Ileana Ros-Lehtinen, David Joyce, Robert Pittenger, John Culberson, Peter DeFazio, Andy Barr, Vicente Gonzalez, David Rouzer, Mo Brooks, Roger Marshall, John Rutherford, Martha McSally, Austin Scott, Randy Weber, Martha Roby and Barry Loudermilk
The Full text of the letter is below. For a PDF copy, click here.