|FDA Says "No Office Use" to Congress|
Letters to FDA Regarding the Implementation of the DQSA
With FDA not providing any guidance as to “office use” or repackaging, Representatives Morgan Griffith (R-VA), Gene Green (D-TX), Diana DeGette (D-CO), and Gus Bilirakis (R-FL) sent letters to FDA reiterating Congressional intent to leave these issues to be governed by State law and asking for FDA’s plan of future action against pharmacies that compound for office use or repackage. IACP was successful in helping the Representatives collect almost 50 bipartisan signatures.
Just this week, FDA answered Congress in the form of a response to the Congressional letter and responses to Questions for the Record that were submitted by Congressman Griffith and Bilirakis during a House Energy and Commerce Committee hearing. Responding to the Congressional letter, FDA stated that contrary to Congressional intent, FDA will be using its “discretion” to prohibit all 503A pharmacies from compounding for office use. Regarding repackaging, FDA stated that it is reviewing its policies to determine whether FDA will allow repackaging and will communicate the results of its review to all interested stakeholders as soon as it is able to do so.”
When pressed in the Questions for the Record on what authority FDA has toward pharmacies providing office use where the State law allows such action, FDA failed to answer the question of State vs. Federal authority and stated that “FDA is examining its compounding enforcement policies….” and “anticipate communicating further with the public as the examination progresses.”
IACP will be working with compounding pharmacy champions in the House and Senate and all stakeholder on next steps to address FDA’s failure to comply with Congressional intent with a legislative initiative. We will keep our Members apprised of developments.
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