Rep. Chris Stewart (R-Utah) lead a bi-partisan group of 61 Members of Congress urging the Federal Drug Administration (FDA) to allow smaller traditional compounding pharmacies to continue 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Ignoring a specific Congressional directive, the FDA issued Draft Guidance on April 15, 2016, that prohibits office-use compounding by smaller traditional compounding pharmacies, known as 503A compounding pharmacies.
“The Congress has been very clear with the FDA in its intent behind the Drug Quality and Security Act (DQSA),” the letter states. “Unfortunately, the FDA has to date ignored that congressional intent and substituted the agency’s own, incorrect interpretation of the law in implementing and enforcing the DQSA. We write to reiterate the directive contained in this year’s appropriations report for the FDA and now in the House committee-passed FY17 report to issue a final guidance document on how office-use compounding can be done in a manner consistent with 503A and which protects both patient safety and patient access to critical medications.”
The letter is signed by 61 Members of the House of Representatives including:
Representatives Chris Stewart, Judge Carter, Buddy Carter, Morgan Griffith, Henry Cuellar, David Young, Rob Bishop, Dave Brat, Joe Heck, Mia Love, John Culberson, Marsha Blackburn, Pete Olson, Reid Ribble, Pete Sessions, Collin Peterson,Michael Burgess, Billy Long, Cathy McMorris Rogers, David Roe, Gus Bilirakis, Barbara Comstock, Jason Chaffetz, Cresent Hardy, Lou Barletta, Randy Forbes, Kevin Cramer, French Hill, Tom Price, Lynn Jenkins, Don Young, Bruce Westerman, Doug Collins, Ryan Zinke, Jaime Herrera Beutler, Kurt Schrader, Robert Pittenger, Scott Garrett, James Sensenbrenner, Kenny Marchant, Frank LoBiondo, Leonard Lance, Matt Salmon, Martha McSally, Tom McClintock, Mac Thornberry, Richard Nugent, Mark Pocan, Charles Boustany, Steve Womack, Dave Trott, Paul Gosar, Bob Goodlatte, Rodney Frelinghuysen, Tom Reed, Rod Blum, Tom Marino, Rick Crawford, Barry Loudermilk, Austin Scott and Bill Flores
The Full text of the letter is below. For a PDF copy, click here.
Dear Commissioner Califf,
As the Congress considers appropriations for the Food and Drug Administration (FDA) for Fiscal Year 2017, we write to express our concern that the FDA has ignored a clear directive in the House Report accompanying the FY2016 FDA appropriations legislation (House Report 114-205). That report language directed the FDA, within 90 days of enactment, to issue a guidance document on how state-licensed compounding pharmacies can provide healthcare providers with compounded medications for administration to their patients in an office setting (commonly referred to as “office-use”) consistent with Section 503A of the Food, Drug and Cosmetic Act (FDCA). Instead of complying with this congressional directive, on April 15, 2016, the agency issued a Draft Guidance entitled “Prescription Requirement under Section 503A of the Food, Drug and Cosmetic Act” that expressly prohibits office-use compounding by 503A compounding pharmacies.
It is unacceptable that the FDA would ignore the Congress and continue to take the position that Section 503A specifically prohibits office-use compounding, despite clear congressional intent to the contrary and despite previous FDA actions that directly contradict that position, including the recent statement by Health and Human Services Secretary Burwell that also directly conflicts with FDA’s current position on “office-use”. For these reasons, the House Appropriations Committee on April 19, 2016, included report language in the FY17 FDA Appropriations legislation that passed out of the full committee acknowledging the Draft Guidance referenced above and directing that the Final Guidance document issued by the FDA allow for office-use compounding by 503A pharmacies.
Prior to the passage of the Drug Quality and Security Act (DQSA) of 2013, FDA circulated a draft Compliance Policy Guide (CPG) in 2012 to Congress that recognized office-use as legitimate and permissible and explained how compounding pharmacists can engage in office-use compounding before the receipt of a patient-specific prescription consistent with the provisions of 503A of the FDCA. The DQSA did not change the statutory language in 503A that was the basis of that CPG. During the consideration of the DQSA, six Members of Congress, on a bipartisan, bicameral basis, made statements in the Congressional record to clarify that the intent of the legislation was to preserve patient access to medications compounded for office-use.
The Congress has been very clear with the FDA in its intent behind the DQSA as it relates to office-use compounding by 503A pharmacies. Unfortunately, the FDA has to date ignored that congressional intent and substituted the agency’s own, incorrect interpretation of the law in implementing and enforcing the DQSA. We write to reiterate the directive contained in this year’s appropriations report for the FDA and now in the House committee-passed FY17 report to issue a final guidance document on how office-use compounding can be done in a manner consistent with 503A and which protects both patient safety and patient access to critical medications. We look forward to your prompt response.
