HR 3204 in Senate
Last Thursday, Chairman Fred Upton of the House Energy and Commerce Committee introduced a compromise bill (HR 3204) that combined compounding and “track and trace” bills in the House of Representatives. This new bill, markedly different from both the pending Senate 959 and the HR 3089 from Congressman Morgan Griffith’s office, moved quickly and was passed by voice vote on Saturday, 28 September.
The new legislation, now awaiting action in the Senate, does two things for compounders. First, it creates a “voluntary” registration for a new FDA-regulated entity called, an “outsourcing facility.” Those facilities would be businesses that wish to compound sterile medications and distribute or sell them without a patient-specific prescription. Second, it reaffirms the 1997 section 503(a) of the Food Drug & Cosmetic Act with the removal of a clause that had previously been determined to be unconstitutional by the US Supreme Court.
IACP opposes HR 3204 for several important reasons:
- The current language in 503(a) does not recognize “office-use” dispensing. That only continues the ambiguity and inherent conflicts between federal and state laws. Resolving that has been a top priority for IACP throughout all of our negotiations and work with both chambers of Congress.
- The new outsourcing facility does not have to be a pharmacy. That means that a non-pharmacy compounding facility is not subject to the laws and regulations of Boards of Pharmacy which IACP members are required to follow.
- Though an outsourcing facility is a “voluntary” registration, IACP has seen ample evidence that the FDA may continue its inspections and actions against pharmacies that provide sterile “office-use” medications. That so-called “choice” to register may not be a choice at all.
IACP Seeks Solution to HR 3204 Problems
In addition to pursuing amendments from Senators to resolve the problems still contained in HR 3204, IACP is working with leadership and compounding supporters to:
- Demonstrate Congressional intent not to interfere with current office-use and repackaging practices by traditional compounders by securing a formal letter from Senators Harkin and Alexander to FDA Commissioner Hamburg.
- Insert a formal statement for the record on office-use and repackaging.
- Schedule a Congressional member meeting with the FDA to have their position and intended "enforcement discretion" activities explained.
- Request an expansion of the GAO report in the bill to assess the impact that traditional compounders have had on helping fill the drug shortage gap.
- Schedule hearings in 2014 and 2015 to review the FDA's actions on HR 3204 implementation.
- Introduce a bill clarifying 503(a) after enactment of HR 3204.